Task force 5: Expert testimony and opinions

ACCF/AHA Consensus Conference Report onProfessionalism and Ethics

Richard J. Popp, MD, MACC, FAHA, Conference Co-ChairSidney C. Smith, Jr, MD, FACC, FAHA, Conference Co-Chair

The recommendations set forth in this report are those of the conference participants and do not necessarily reflect the official position of the AmericanCollege of Cardiology Foundation and the American Heart Association, Inc.

When citing this document, the American College of Cardiology Foundation and the American Heart Association would appreciate the followingcitation format: ACCF/AHA consensus conference report on professionalism and ethics. Presented in Bethesda, Maryland, June 2–3, 2004. Circulation.2004;110:2506–2549.

This document is available on the World Wide Web sites of the American College of Cardiology (www.acc.org) and the American Heart Association(www.americanheart.org). Single copies of this document as published in the October 19, 2004, issue of the Journal of the American College ofCardiology and the October 19, 2004, issue of Circulation are available for $10.00 each by calling 1-800-253-4636 or writing to the American Collegeof Cardiology Foundation, Resource Center, 9111 Old Georgetown Road, Bethesda, MD 20814-1699.

Multiple copies, modification, alteration, enhancement, and/or distribution of this document are not permitted without the express permission of theAmerican College of Cardiology Foundation. Please direct requests to [email protected].

(Circulation. 2004;110:2506-2549.)© 2004 American College of Cardiology and American Heart Association, Inc.

Circulation is available at http://www.circulationaha.org DOI: 10.1161/01.CIR.0000147952.60985.b0

This Conference, sponsored by the American College of Cardiology Foundation and theAmerican Heart Association, was held at Heart House, Bethesda, Maryland, June 2–3, 2004.

Participants/AuthorsROBERT J. ADAMS, MD, FAHA

Professor of Neurology, Department ofNeurology

Medical College of Georgia1467 Harper Street, HB2060Augusta, GA 30912-3200

JOSEPH S. ALPERT, MD, FACC, FAHARobert S. and Irene P. Flinn Professor of

Medicine and Head, Department ofMedicine

University of ArizonaHealth Sciences Center1501 N. Campbell AvenuePO Box 245035Tucson, AZ 85724-5035

JEFFREY L. ANDERSON, MD, FACC,FAHA

Associate Chief of CardiologyLDS Hospital Cardiology8th Avenue & C StreetSalt Lake City, UT 84143

BRIAN H. ANNEX, MDAssociate Professor of MedicineDuke University Medical CenterVA Medical Center508 Fulton Street (111A)Durham, NC 27705-3875

ELLIOTT M. ANTMAN, MD, FACC,FAHA

Director, Samuel A. Levine Cardiac UnitBrigham & Women’s Hospital75 Francis StreetBoston, MA 02115-6110

BRUCE BELLANDE, PHDExecutive DirectorAlliance for Continuing Medical

Education1025 Montgomery Highway, Suite 105Birmingham, AL 35216

GEORGE A. BELLER, MD, MACC,FAHA

Chief, Cardiovascular DivisionUniversity of Virginia Health SystemPrivate Clinics Building, Room 5593P.O. Box 800158Charlottesville, VA 22908-0158

DAVID W. BILHEIMER, MDVice President, Medical AffairsMerck & Co., Inc.One Merck Drive, WS3C-25Whitehouse Station, NJ 08889-0100

ROBERT O. BONOW, MD, FACC,FAHA

Chief, Division of CardiologyNorthwestern UniversityFeinberg School of Medicine201 East Huron Street, Suite 10-240Chicago, IL 60611-2957

NANCY A. BROWNChief Operating OfficerAmerican Heart Association7272 Greenville AvenueDallas, TX 75231-4596

ROBERT M. CALIFF, MD, FACCAssociate Vice Chancellor for Clinical

ResearchDuke University Medical CenterDuke Clinical Research InstituteRoom 0311, Terrace Level2400 Pratt StreetDurham, NC 27705-3976

MELVIN D. CHEITLIN, MD, MACC,FAHA

Emeritus Professor of MedicineUniversity of California–San Francisco3333 California Street, Suite 445San Francisco, CA 94118

JAY N. COHN, MD, FACC, FAHAProfessor of MedicineUniversity of Minnesota Medical SchoolCardiovascular Division420 Delaware Street SE MMC508Minneapolis, MN 55455

KAREN J. COLLISHAWDivision Vice PresidentAmerican College of CardiologyHeart House9111 Old Georgetown RoadBethesda, MD 20814

ANTHONY N. DEMARIA, MD, MACC,FAHA

Professor of MedicineDivision of CardiologyUniversity of California, San Diego200 W. Arbor DriveSan Diego, CA 92103-8411

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PAMELA S. DOUGLAS, MD, FACC,FAHA

Head, Cardiovascular Medicine Section;Professor of Medicine

University of Wisconsin-MadisonH6/352 Clinical Science Center600 Highland AvenueMadison, WI 53792-0001

DAVID P. FAXON, MD, FACC, FAHAChief of CardiologyUniversity of ChicagoSection of CardiologyMail Code 6080Room B-6085841 S. Maryland AvenueChicago, IL 60637-1463

DAVID W. FEIGAL, JR, MD, MPHFormer Director, Centers for Devices and

Radiological Health, FDA2 Boathouse CourtNorth Potomac, MD 20878-4230

GREGG C. FONAROW, MD, FACCThe Eliot Corday Chair in Cardiovascular

Medicine and ScienceProfessor of MedicineUCLA Division of CardiologyDirector, Ahmanson–UCLA

Cardiomyopathy Center10833 LeConte Avenue, 47-123 CHSLos Angeles, CA 90095-1679

LAWRENCE FRIEDMAN, MDActing Deputy DirectorNational Heart, Lung and Blood Institute31 Center Drive, MSC 2490Building 31 Room 5A47Bethesda, MD 20892

ROBERT L. FRYE, MD, MACCConsultant, Cardiovascular DiseaseRose M. and Morris Eisenberg Professor

of MedicineMayo Clinic College of Medicine200 First Street, SWRochester, MN 55905-0001

VALENTIN FUSTER, MD, PHD, FACC,FAHA

Director, Zena and Michael A. WienerCardiovascular Institute

Mount Sinai Medical CenterOne Gustave Levy Place, Box 1030New York, NY 10029

TIMOTHY J. GARDNER, MD, FACC,FAHA

Professor of SurgeryHospital of the University of Pennsylvania3400 Spruce StreetPhiladelphia, PA 19104-4206

ARTHUR GARSON, JR, MD, MPH,MACC, FAHA

Vice President and DeanUniversity of Virginia School of MedicinePO Box 800793Hospital Drive, McKim Hall, 3rd Floor,

Room 3027Charlottesville, VA 22908

RAYMOND J. GIBBONS, MD, FACC,FAHA

Arthur M. and Gladys D. Gray Professorof Medicine

Mayo Clinic College of Medicine200 First Street, SWGonda Room 5-412Rochester, MN 55905-0001

LARRY B. GOLDSTEIN, MD, FAHAProfessor of Medicine and DirectorDuke Center for Cerebrovascular DiseaseDuke University Medical CenterBryan Research Boulevard, Room 201ADurham, NC 27710-3651

AUGUSTUS O. GRANT, MD, PHD,FACC, FAHA

Professor of MedicineDuke University Medical CenterBox 3504Durham, NC 27702-3504

LINDSAY A. HAMPSONBioethics FellowNational Institutes of Health10 Center Drive, MSC 1156Bethesda, MD 20892

ROBERT A. HARRINGTON, MD,FACC

DirectorCardiovascular Clinical Trials/Professor of

MedicineDuke Clinical Research InstituteDuke University Medical Center2400 Pratt StreetDurham, NC 27705

EDWARD F. HINES, JR, JDAttorneyHines and Corley55 Hayden AvenueSuite 3200Lexington, MA 02421

JOHN W. HIRSHFELD, JR, MD, FACC,FAHA

Professor of MedicineDirector, Cardiac Catheterization LabHospital of the University of Pennsylvania9119 Founders Pavilion3400 Spruce StreetPhiladelphia, PA 19104-4206

MARCIA J. JACKSON, PHDSenior Advisor EducationAmerican College of CardiologyHeart House9111 Old Georgetown RoadBethesda, MD 20814

ALICE K. JACOBS, MD, FACC, FAHAProfessor of MedicineDirector, Cardiac Catheterization LabBoston University Medical Center88 East Newton StreetBoston, MA 02118-2308

RAE ELLEN WEBB KAVEY, MD,FACC, FAHA

Division Chief of CardiologyChildren’s Memorial HospitalDivision of Pediatric CardiologyNorthwestern University School of

Medicine2300 Childrens PlazaChicago, IL 60614-3394

HARRY R. KIMBALL, MDPresident EmeritusAmerican Board of Internal Medicine510 Walnut Street, Suite 1700Philadelphia, PA 19106

DAVID KORN, MDSenior Vice PresidentBiomedical and Health Science ResearchAssociation of American Medical Colleges2450 N Street, NWWashington, DC 20037

JOAO A. C. LIMA, MD, FACC, FAHAAssociate Professor of MedicineJohn Hopkins HospitalDivision of CardiologyBlalock 524, 600 N. Wolfe StreetBaltimore, MD 21287

BRUCE D. LINDSAY, MD, FACC,FAHA

Associate Professor of MedicineDirector, Clinical ElectrophysiologyWashington University School of

Medicine660 S. Euclid, Box 8086St. Louis, MO 63110-1010

DAVID WM. LIVINGSTON, JDExecutive Vice President, Corporate

Secretary and CounselAmerican Heart Association7272 Greenville AvenueDallas, TX 75231

BEVERLY H. LORELL, MD, FACC,FAHA

Vice President, Chief Medical andTechnology Officer

Guidant Corporation111 Monument Circle #2900Indianapolis, IN 46204

Popp et al ACCF/AHA Consensus Conference Report 2507



CHRISTINE W. MCENTEEChief Executive OfficerAmerican College of CardiologyHeart House9111 Old Georgetown RoadBethesda, MD 20874-1699

JON F. MERZ, JD, PHD, MBAAssistant ProfessorUniversity of Pennylvania School of

Medicine3401 Market Street, Suite 320Philadelphia, PA 19104

JOSEPH V. MESSER, MD, MACC,FAHA

Professor of Medicine, Rush MedicalCollege

Senior Attending PhysicianRush Presbyterian St. Luke’s Medical

Center1725 W. Harrison Street, Suite 1138Chicago, IL 60612-3835

RICK A. NISHIMURA, MD, FACC,FAHA

Professor of MedicineMayo Clinic College of MedicineDivision of Cardiovascular Disease200 First Street, SWRochester, MN 55905-0001

STEVEN E. NISSEN, MD, FACC,FAHA

Professor of MedicineMedical Director, Cardiovascular

Coordinating CenterCleveland Clinic FoundationDepartment of Cardiovascular Medicine9500 Euclid Avenue, Desk F-15Cleveland, OH 44195-0001

ELIZABETH OFILI, MD, MPH, FACCAssociate Dean of Clinical ResearchMorehouse School of Medicine720 Westview Drive, SWAtlanta, GA 30310-1458

ERIK MAGNUS OHMAN, MD, FACCChief of CardiologyCraige Professor of MedicineUniversity of North Carolina/Chapel Hill338 Burnett-Womack Building, CB#7075Chapel Hill, NC 27599

WILLIAM W. PARMLEY, MD, MACC,FAHA

Conference Keynote SpeakerMember of the Quorum of SeventyThe Church of Jesus Christ of Latter-Day

Saints47 East, South Temple StreetSalt Lake City, UT 84150

CARL J. PEPINE, MD, MACC, FAHAProfessor and ChiefDivision of Cardiovascular MedicineUniversity of Florida College of Medicine1600 SW Archer RoadGainesville, FL 32610-0277

ERIC D. PETERSON, MD, FACCAssociate Professor of MedicineDuke University Medical CenterDuke Clinical Research Institute2400 Pratt Street, Room 7009Durham, NC 27705

BERTRAM PITT, MD, FACC, FAHAProfessor of Internal MedicineDivision of CardiologyUniversity of Michigan School of

Medicine1500 E. Medical Center Drive,

3910 Taubman CenterAnn Arbor, MI 48109-0366

RICHARD L. POPP, MD, MACC,FAHA

Professor of Medicine and DirectorSection on Ethics and PolicyProgram in BiodesignStanford University School of MedicineJames H. Clark Center for Biomedical

Engineering318 Campus Drive, Room E-100-DStanford, CA 94305-5428

ERIC N. PRYSTOWSKY, MD, FACC,FAHA

Director, Clinical Electrophysiology LabThe Care Group, LLC8333 Naab Road, Suite 200Indianapolis, IN 46260-1983

SHAHBUDIN H. RAHIMTOOLA, MD,MACC, FAHA

Distinguished ProfessorG.C. Griffith Professor of CardiologyChairman, Griffith CenterUniversity of Southern California2025 Zonal AvenueLos Angeles, CA 90033-1034

JAMES L. RITCHIE, MD, FACC, FAHADirector Emeritus, Division of CardiologyUniversity of Washington School of

Medicine SeattleClinical Professor of MedicineUniversity of WashingtonThe Cardiology Group2516 NW O’Brien CourtBend, OR 97701

ROSE MARIE ROBERTSON, MD,FACC, FAHA

Chief Science OfficerAmerican Heart Association7272 Greenville AvenueDallas, TX 75231

THOMAS J. RYAN, MD, MACC, FAHAProfessor of MedicineSenior Consultant, CardiologyBoston University Medical CenterSchool of Medicine88 E. Newton StreetBoston, MA 02118-2308

PRAVIN M. SHAH, MD, MACC, FAHAMedical DirectorHoag Heart InstituteOne Hoag Drive, PO Box 6100Newport Beach, CA 92658-6100

KENNETH I. SHINE, MD, FACCExecutive Vice Chancellor for Health

AffairsThe University of Texas System601 Colorado StreetAustin, TX 78701

LYNN A. SMAHA, MD, PHD, FACC,FAHA

Senior Vice President Academic AffairsGuthrie Glinic1 Guthrie SquareSayre, PA 18840-1625

SIDNEY C. SMITH, JR, MD, FACC,FAHA

Professor of Medicine; DirectorCenter for Cardiovascular Science and

MedicineUniversity of North Carolina School of

Medicine130 Mason Farm Road, Suite 4140

CB# 7075, Bioinformatics BuildingChapel Hill, NC 27599-7075

L. SAMUEL WANN, MD, MACC,FAHA

Clinical Professor of MedicineMedical College of WisconsinWisconsin Heart & Vascular Clinic, SC,

Suite 5122901 W. Kinnickinnic River ParkwayMilwaukee, WI 53215-3677

GAYLE R. WHITMAN, PHD, RN, FAAN,FAHA

Associate ProfessorUniversity of Pittsburgh, School of

Nursing325 Victoria Building3500 Victoria StreetPittsburgh, PA 15261

JAMES T. WILLERSON, MD, FACC,FAHA

Professor and ChairmanPresident’s OfficeUniversity of Texas Health Science Center7000 Fannin, Suite 1700Houston, TX 77225-0036

2508 Circulation October 19, 2004



MICHAEL J. WOLK, MD, FACCClinical Professor of MedicineWeill Medical College of Cornell

University520 East 72nd StreetNew York, NY 10021-4849

DOUGLAS P. ZIPES, MD, MACC,FAHA

Distinguished Professor of Medicine,Pharmacology and Toxicology

Director, Krannert Institute of CardiologyIndiana University School of Medicine1800 North Capitol Street, E475Indianapolis, IN 46202

Conference Steering CommitteeRICHARD L. POPP, MD, MACC, FAHA, CONFERENCE CO-CHAIR

SIDNEY C. SMITH, JR, MD, FACC, FAHA, CONFERENCE CO-CHAIR

KENNETH I. SHINE, MD, FACCJOSEPH S. ALPERT, MD, FACC, FAHAROBERT O. BONOW, MD, FACC, FAHAROBERT M. CALIFF, MD, FACCPAMELA S. DOUGLAS, MD, FACC, FAHAALICE K. JACOBS, MD, FACC, FAHABRUCE D. LINDSAY, MD, FACC, FAHACHRISTINE W. MCENTEESTEVEN E. NISSEN, MD, FACC, FAHAJAMES L. RITCHIE, MD, FACC, FAHAROSE MARIE ROBERTSON, MD, FACC, FAHATHOMAS J. RYAN, MD, MACC, FAHAMICHAEL J. WOLK, MD, FACCDOUGLAS P. ZIPES, MD, MACC, FAHA

StaffAmerican College of Cardiology Foundation

CHRISTINE W. MCENTEE, CHIEF EXECUTIVE OFFICER

KAREN J. COLLISHAW, DIVISION VICE PRESIDENT

CHARLENE L. MAY, DIRECTOR, CLINICAL POLICY AND DOCUMENTS

FRANCES RAAB, CONFERENCE SPECIALIST, CLINICAL POLICY AND DOCUMENTS

EVA MARIE GRACE, ASSOCIATE SPECIALIST, SCIENTIFIC COMMITTEES

PATRICIA JONES, SENIOR COORDINATOR, CLINICAL POLICY AND DOCUMENTS

American Heart Association

NANCY A. BROWN, CHIEF OPERATING OFFICER

ROSE MARIE ROBERTSON, MD, FACC, FAHA, CHIEF SCIENCE OFFICER




INTRODUCTION

Cardiovascular Professionalismand Ethics in the Modern EraRichard L. Popp, MD, MACC, FAHA, Co-ChairSidney C. Smith, JR, MD, FACC, FAHA, Co-Chair

The health care professions have always enjoyed special trustand position in our society. Patients trust health careprofessionals (HCPs) to guard their health, inform them,and put a patient’s interests above any other consideration.This is one definition of “professionalism.” When HCPsdeal with human subjects in research there are basic ethicalprinciples, articulated in the classic Belmont Report of1979, that have been accepted by all (1).

We believe from our experience that the members andstaff of the American College of Cardiology Foundation(ACCF) and the American Heart Association (AHA) striveto do “good” for society in general and for patients specif-ically. They put patients’ interests first, above their own, inan overwhelming majority of situations. There are virtuallyhundreds of thousands of patient-HCP encounters daily inthe U.S. It is assumed that HCPs are trying their utmost tobenefit their patients even when the outcome is not optimalor when disease progression cannot be effectively treated.Complications of therapy occur despite the best of inten-tions. Clinician-scientists and the medical industry developnew therapies to improve the lives of patients living withcardiovascular disease, and society has seen the benefits ofthis effort over the past several years. Everything in thissystem works well until or unless a conflict between theHCP’s interests and those of the patient results in actionsthat harm the patient. Then it is assumed that there hasbeen a breach of that respected patient-HCP trust.

Many modern situations exist in which the personalinterest of the HCP may not be aligned with that of thepatient. Ethical choices must be made by the HCP in thesesituations. Examples include:

● A physician is awakened and gets out of bed in the middleof the night to assess a patient with chest pain.

● A procedure is done or an antibiotic is given withmarginal indication by the HCP to satisfy the patient’swishes rather than the HCP providing a long or detailedexplanation of why the action need not be taken.

● Procedures produce income for HCPs and provide expe-rience and prestige that are valuable for the HCP in waysbeyond those only for the individual patient’s directbenefit.

● Medical scientists have a deep interest in developing newmethods or therapies requiring testing in humans despitethe initial imperfection of the agents being tested.

● HCPs continue to devote precious time to help patientsmake important behavioral changes (smoking and sub-stance abuse cessation, dietary counseling, and so on),despite a lack of reimbursement or support from healthcare delivery systems and payers.

● An HCP advocates for a product or procedure because ofhis or her role as an adviser or consultant to a companyprofiting from the product or procedure while trying todifferentiate this role from that of an impartial physicianor other HCP educator.

● The HCPs are chosen for their opinions to serve as paidexperts in legal actions, de facto taking “sides” in casesrelated to patient care or product liability issues.

● A physician prescribes a new statin drug for secondaryprevention because he or she heard about it at a recentmeeting hosted by a drug representative, although thisdrug is less proven to prevent subsequent events thanolder medications.

Specific high-profile cases in recent years have broughtgreat attention to the issues of conflict of interest amongthose dealing with patients and with subjects of clinicaltrials (2,3). There has been sensationalism in the pressaddressing some of those cases. In many instances, theimportant issue centers around the lack of disclosure to allconcerned of a potential conflict of interest in the HCP’srelationship with the patient. Although these cases are rare,they are very important in our profession.

We must ask ourselves, as members of responsible pro-fessional organizations, “what are the issues in moderncardiovascular care that create real or potential problems ofconflict of interest for our members and for the organiza-tions themselves?” We believe the first steps toward provid-ing advice and direction for HCPs are to identify suchsituations and to bring them to an open discussion. Werecognize that publication of some of the specific issuesaddressed in this conference may have the effect of increas-ing the anxiety of the general public and of the mediaregarding the extent to which some of the negative situa-tions occur. However, we believe the initial step on the pathto setting standards for uniform and optimal behavior forHCPs and the protection of patients is to discuss fully thoseareas in which we see cause for concern.

The ACCF and the AHA decided to convene thisconference in order to highlight the potential conflict ofinterest in major defined areas and to offer comments about




their management and resolution. We believe it is ourresponsibility to examine ourselves carefully because thenature of our work and developments in our own specialty ofcardiovascular disease allow us to understand the complex-ities of many of these issues in 2004 perhaps as well as, orbetter than, others.

This conference, which was held in Bethesda, Maryland,was different from the prior ACCF conferences with “Ethics”in their titles (4,5). With this conference, we have taken a freshapproach since many of the issues to be addressed are “new” inlight of the social, economic, and political environment inwhich we now find ourselves. The participants in the confer-ence were widely experienced and brought both “real-world”and varied perspectives to these issues. They were activelyinvolved in many areas of cardiovascular subspecialty practice,teaching, and research. Some of the cardiovascular specialistparticipants were employees of industry whose perspectiveswere seen as important to the discussions. Nevertheless, theywere invited as colleagues and not as representatives of industry(nor was their participation sponsored by their companies).Participants did not uniformly agree on every point, but theywere able to reach consensus on the issues as expressed in thefollowing Task Force reports.

The Co-Chairs initially did not request a disclosure fromattendees regarding their individual relationships with in-dustry as none of the groups addressed or discussed specificcompanies or products. During the conference and after-ward, it was appreciated that having a relationship with

industry might be seen as a factor informing or affectingone’s opinion about the general issues discussed and therecommendations made. For this reason, we subsequentlyasked all participants to disclose such relationships; thisdisclosure is published as Appendix 1 to these conferencereports so those reading the reports may be aware of theserelationships with industries.

We believe these reports will be useful for many constit-uencies. However, the ongoing discussions of the topicscovered here are truly the responsibility of the cardiovascularHCPs we represent. A responsible profession must policeitself. We hope that this particular function is assisted bythis conference. The decision regarding whether to adoptthe recommendations from this conference as official policyof the organizations will be the responsibility of the lead-ership of the ACCF and the AHA.

INTRODUCTION REFERENCES

1. Protection of human subjects: Belmont Report—ethical principles andguidelines for the protection of human subjects of research. Fed Regist1979;44:23192–7.

2. Stolberg SG. The biotech death of Jesse Gelsinger. NY Times Maga-zine, November 28, 1999;136–50.

3. Marshall E. Biomedical ethics. Penn report, agency heads home in onclinical research. Science 2000;288:1558–9.

4. Thier SO. 21st Bethesda conference: ethics in cardiovascular medicine.Keynote address. J Am Coll Cardiol 1990;16:5–6.

5. Parmley WW, Passamani ER, Lo B. 29th Bethesda conference. Ethicsin cardiovascular medicine (1997). Introduction. J Am Coll Cardiol1998;31:922–5.




TASK FORCES

Task Force 1: The ACCF and AHACodes of Conduct in Human Subjects ResearchCo-Chairs: Joseph S. Alpert, MD, FACC, FAHA, Kenneth I. Shine, MD, FACCAuthors: Robert J. Adams, MD, FAHA, Elliott M. Antman, MD, FACC, FAHA,Rae Ellen W. Kavey, MD, FACC, FAHAParticipants: Lawrence Friedman, MD, Robert L. Frye, MD, MACC, Robert A. Harrington, MD, FACC,David Korn, MD, Jon F. Merz, JD, PHD, MBA, Elizabeth Ofili, MD, MPH, FACC

SCOPE OF ETHICAL ISSUESINVOLVED IN HUMAN SUBJECTS RESEARCH

Human participant research is a crucial element in the devel-opment and approval of new drugs, biologics, devices, andprocedures that seek to improve patient care. Participation inclinical research is an important professional obligation forcardiovascular practitioners. This involvement ranges fromstudy design and implementation as investigators to the criticalrole of subject enrollment for all cardiovascular practitioners.The conduct of such research is one of the highest callings ofthe clinical researcher/practitioner and must be conductedaccording to the highest standards of science and ethics. Allhuman subjects research should be conducted according tosuch standards. Difficult issues continue to require awarenessand careful management. Some of these issues are examined inthis report; conflict of interest is the first of these. A conflict ofinterest may exist when a secondary interest has the potential todistort, or appear to distort, the integrity of judgment relativeto the primary interest. The Hippocratic tradition and theprinciple of beneficence require that the physician always act inthe patient’s best interest. However, when the physician profitsboth professionally and financially from the patient’s partici-pation in a clinical trial, the situation may become ethicallytenuous for the involved physician. Conversely, informationderived from clinical trials improves patient care. Thus, pa-tients may also benefit from participation in clinical trials. Thismight mitigate, in part, the ethical dilemma just described.Non-financial conflicts of interest. Physician-investigatorsobtain a number of non-financial benefits from participationin clinical research trials (1). Career advancement, fulfill-ment of a desire to do good, an opportunity to publish in apeer-reviewed journal, fame, invitations to present at na-tional and international meetings, future success in obtain-ing grant funding for research, prestigious research prizes,professional accolades for obtaining a positive outcome froma particular clinical trial, and a personal sense of worth—allpotentially accrue to the physician-investigator. Althoughthese non-financial incentives are not well known outside ofacademia, they are well recognized within the academiccommunity.

Levinsky (2) has recently pointed out that the deaths ofthree research participants in clinical trials were not related

to financial factors at all. These deaths all occurred atprominent research universities and were apparently theresult of excessive zeal, inadequate research, and/or ethicalknowledge or training deficits on the part of the investigatorand/or his staff (2–5). Financial conflicts of interest areeasier for the public to understand. Non-financial conflictsof interest, such as academic promotion and accolades, areoften more subtle and may require some thought and studybefore they become evident. Levinsky (2) suggests thatcommittees charged with the review of experiments involv-ing human subjects (Institutional Review Boards [IRBs])should consider these non-financial conflicts of interestduring their deliberations. Additionally, investigators andthose responsible for oversight should be aware of this formof conflict of interest and should bear it constantly in mindduring the conduct of a clinical trial.

Clinical trials involving human subjects are essential tothe advancement of medical science, but the ethical situa-tion for a physician-investigator who is simultaneously incharge of caring for the patient-subject is particularlychallenging. As noted, the physician may benefit in anon-financial manner—for example, from enhanced repu-tation, publications, and so forth. At the same time, thephysician who serves as a clinical investigator enhances hisor her own career and may occasionally benefit financiallyfrom payments made to the physician or the physician’sinstitution by the sponsor of the clinical trial. Thus, physi-cians who act as both investigator and attending physicianfor a patient are caught in a clear ethical dilemma. Thephysician might subtly coerce or induce the patient toparticipate in the trial for the physician’s personal benefit.This same conflict of interest might also arise in dailyclinical practice where the physician profits from the care ofthe patient (see Task Force 4).

Patients who participate in clinical trials, whether theyreceive experimental treatment or if they are in a controlgroup, can benefit from meticulous attention to their care,by learning more about their disease process, and poten-tially, from the trial environment itself (6). Because resultsof research usually apply more directly to those patientgroups included in the studies, it is especially important toinclude subjects from all socio-economic strata and allethnic groups. Cardiovascular practitioners should consider




participation of their patients for these reasons, and becausethis type of research is essential to advance care in the field.The process of enrollment must be undertaken carefully. Inaddition, a physician must not allow patients to assume,incorrectly, that they will receive the experimental therapyand not the control regimen or device being tested.Physician-investigators may not disabuse their patients’expectations in an overzealous attempt to increase enroll-ment in the clinical trial. All physician-investigators shouldbear these points in mind when explaining participation ina clinical trial. This same care should apply to all thoserecruiting for a clinical trial. These issues become particu-larly complex in the setting of tertiary care centers, wheremultiple individuals may be involved in recruiting patientsfor clinical trials. Indeed, everyone involved in the recruit-ment process must avoid overzealous recruiting with poten-tial failure to inform the patient adequately concerning therisks involved in the experimental intervention (7–9).

Throughout the clinical trial process, it is important thatthe physician-investigator maintain a state of mind referredto by ethicists as “equipoise.” During the initial discussionswith the patient, equipoise exists when the physician-investigator accepts the concept of uncertainty about thebenefits of one treatment relative to the other. At theanalytic stage, equipoise exists when the investigator isequally willing to accept a negative or a positive outcomefrom a clinical trial. Because a positive outcome in a trial ismore likely to lead to reward, there is subtle but persistentpressure on the physician-investigator to favor a positiveoutcome. Such pressure should not lead to multiple re-analyses of trial data in an attempt to state something“positive” about the investigation.Financial conflicts of interest. Financial relationships area highly controversial aspect of human research. This topicmust be addressed because of the potential for real orperceived conflict of interest. Some physicians devote asubstantial portion of their professional life to clinical trialwork. For these individuals, a potential problem arisesbecause they derive substantial income from participation inclinical trials. A cardiovascular practitioner may functionmerely as a “recruiting agent” for large pharmaceutical ordevice manufacturing companies. This practice is inappro-priate and is not condoned as it deviates from the principleof putting a patient’s best interest first. Nevertheless, enroll-ing patients in clinical trials is critical to advancing cardio-vascular care. Participation in trials requires extra time forthe cardiovascular practitioner, and this can impact usualpatient care flow. Despite these issues, cardiovascular prac-titioners need to support clinical trial enrollment.

Some physicians are truly the most knowledgeable indi-viduals available with respect to a specific drug or device. Itis thus not surprising that industry values the opinion andintellectual assistance of such individuals. It is reasonable forsuch clinician-investigators to be compensated appropriatelyfor their time and effort. At times, payment includes stockoptions or even shares in a new company founded to exploit

a new drug or device. In the latter circumstance, thepotential financial rewards for the physician-investigator canbe substantial. A conflict of interest is clear when suchindividuals participate in clinical trials of that new drug ordevice. The physician has a financial stake in the successfulinitiation, implementation, and outcome stemming fromthis particular research protocol. At times, such induce-ments have led physicians to abrogate their social contractwith patients, and the results of these ethical failures haveoccasionally been catastrophic for patients.

Following the passage of the Bayh-Dole Act, academi-cians were encouraged to transfer their discoveries to indus-try so the advances could be made available to patients;many academic investigators became integrally involved inthe development and testing of innovative biomedical prod-ucts. The resulting conflicts of interest have attracted theattention of clinical investigators, academic physicians, pro-fessional organizations, the media, the federal government,and the public, thereby leading to a number of editorials,surveys, and task force reports dealing with these problems(10–16). The recommendations from all of these commen-taries and task force publications are in many ways similar.For example, the threshold employed in most of thesedocuments, including the rules of the National Institute ofHealth (NIH), defined a “significant” financial arrangementas one that exceeds $10,000 (see Task Force 3).

THE ROLE OF THE IRB OR HUMANEXPERIMENTATION REVIEW BOARD INOVERSEEING RESEARCH INVOLVING HUMAN SUBJECTS

Four comprehensive publications dealing with the regula-tion of human experimentation have emanated from theAssociation of American Medical Colleges (AAMC) andthe Institute of Medicine within the last three years (13–16). These reports explore the various potential and actualconflicts of interest, financial and non-financial, that exist inhuman experimentation in the U.S. today. Responsible Re-search describes a systematic approach for improving humansubject protection during clinical research trials. A variety oftopics are thoroughly examined, including research ethics,the role of the IRB, investigator conflicts of interest, andnational and local regulation of human experimentation.Numerous recommendations are presented for improvingthe current situation. Preserving Public Trust is a compre-hensive review of the U.S. system of human subject researchprotection (14). This latter text also suggests numerousreforms for national accreditation and oversight of humansubjects review boards (IRBs). Highly prominent in thisdocument is the recommendation that research oversight beexpanded to include conflict of interest review by a processindependent of the IRB. Two AAMC reports, “ProtectingSubjects, Preserving Trust, Promoting Progress I—Policyand Guidelines for the Oversight of Individual FinancialInterests in Human Subjects Research” (15) and “ProtectingSubjects, Preserving Trust, Promoting Progress II—




Principles and Recommendations for Oversight of an Insti-tution’s Financial Interests in Human Subjects Research”(16), explore in great detail potential financial conflicts ofinterest and ways to defend against inappropriate behavioralresponses to such conflicts.

THE ACCF/AHA CONSENSUS CONFERENCERECOMMENDATIONS CONCERNING THEMANAGEMENT OF HUMAN SUBJECT RESEARCH

Physician-Investigator Responsibilities

1. Participation in clinical research is an important obliga-tion for cardiovascular practitioners and is stronglyencouraged.

2. Physicians who participate in clinical research must befamiliar with both the experimental therapy to be testedand the principles of human subject research.

3. The ACCF/AHA Consensus Conference strongly en-courages cardiovascular practitioners to enroll patientswho are members of underrepresented groups in clinicaltrials.

Conflicts of Interest

1. Transparency in all dealings with clinical trial subjects isthe cornerstone of management of investigator relatedconflict of interest. Cardiovascular investigators in-volved in the clinical trial must disclose their financialconflicts of interest to potential subjects.

2. Investigators must disclose very specific and detailedfinancial information as per the guidelines in Task Force3 to the IRB overseeing the trial (13,15).

3. The ACCF/AHA Consensus Conference supports theconcept of limitations on the amount of financialinvolvement that physician-investigators and collabora-tors may have in a particular research project. Physician-investigators/collaborators with a significant financialrelationship (excluding funding for the trial itself) withthe sponsor of a particular drug or device under inves-tigation should not personally participate in clinicaltrials involving these drugs or devices. Unique circum-stances can be adjudicated through the IRB mechanismfor single-center studies (e.g., primary trial for new drugor device). For multicenter studies, the steering/execu-tive committee for the study should address issues offinancial involvement at the individual investigator level.These financial limitations do not apply to employees ofthe medical product industry.

Informed Consent

1. A trial investigator who is the physician of a potentialsubject has a special obligation to provide full disclosureof his or her role in the investigation. Because of thevulnerable status of the patient in such circumstances, itmust be made clear that refusal to participate in the trialwill not affect current or future care.

2. The ACCF/AHA Consensus Conference supports ef-forts to improve the process of trial enrollment, such asuse of a neutral third party (i.e., a research subjectadvocate or an ombudsman) to observe the informed-consent process and make recommendations forimprovement.

IRBs

1. The IRBs should focus on the ethical implications ofeach and every human research protocol (14). Bothfinancial and non-financial potential conflicts of interestshould be addressed.

2. The ACCF/AHA Consensus Conference recommendstwo separate but coordinated processes, one for theprotection of the experimental subjects and one for theexamination and management of potential conflicts ofinterest (financial and non-financial) on the part of thephysician-investigator.

3. Investigators should be given ample opportunity torebut the presumption that they cannot participate inthe research due to the conflict of interest that has beenraised by the oversight process.

4. Advertising copy aimed at recruiting research subjectsshould be examined carefully by the IRB to ensure thatpotentially misleading statements are not included inthese ads.

5. Special care must be taken when obtaining informedconsent from children and their parents, particularlychildren too young to comprehend the implications ofthe suggested intervention. Parental and/or guardianinvolvement is critical to this process. These same issuesapply to other vulnerable individuals including but notlimited to the homeless, prisoners, and the uninsured.

Data Analysis, Integrity, and Publication

1. All human subjects’ research, not limited to randomizedtrials, and regardless of sample size, should have a planfor monitoring data collection and subject safety.

2. Physician-investigators should not have a primary rolein data analysis of a clinical trial involving a drug ordevice in which they have a major personal financialinterest. This does not apply to employees of themedical products industry (see Task Force 2).

3. At the outset of a sponsored clinical trial involving anexperimental therapy, a contractual arrangement shouldbe in place to ensure that publication of the results willnot be unduly delayed or obstructed by the sponsor ofthe trial (see Task Force 2).

WHEN DOES MODIFICATION OF A MEDICALOR SURGICAL PROCEDURE, DEVICE, ORDRUG BECOME AN EXPERIMENTAL PROCEDURE?

The issue of subtle variations in drugs and devices that havealready been approved rising to the level of investigationalstatus is not clearly described in the regulatory literature.




What level of modification is required before an originalsubmission of a new drug or device application is required?Decisions regarding the point of transition from an ap-proved entity to an investigational entity are usually indi-vidualized for each product. For the physician who modifiesa procedure or a device for use in daily practice, thefollowing distinction is important: “When a clinician de-parts in a significant way from standard or accepted practice,the innovation does not, in and of itself, constitute research.The fact that a procedure is experimental in the sense ofnew, untested, or different, does not automatically place it inthe category of research. Radically new procedures of thisdescription should, however, be made the object of formalresearch at an early stage in order to determine whether theyare safe and effective” (17).

With respect to the development of such new proceduresor devices from the point of view of the developer, someguiding principles from the Food and Drug Administration(FDA) document, Guidance for Industry, Providing ClinicalEvidence of Effectiveness for Human Drugs and BiologicalProducts (May 1998) provide an informative perspective.The purpose of that guidance document was to articulatethe FDA’s thinking concerning the quantitative and quali-tative standards for demonstrating effectiveness of drugs andbiologics. The guidance document also describes the evi-dence necessary to support approval of a new use of anexisting drug.

In certain cases, effectiveness of an approved drug orproduct for a new indication, or effectiveness of a newproduct, may be adequately demonstrated without addi-tional clinical efficacy trials. Ordinarily, this will be becauseother types of data provide a way to apply the knowneffectiveness to a new population or a different dose,regimen, or dosage form. The following are examples ofsituations in which effectiveness might be extrapolated fromefficacy data for another claim or product: bioequivalence,modified-release dosage forms, or different dose regimens.

Single studies for new uses of an existing drug, device, orprocedure may be submitted as per the following examples:different doses, regimens, or dosage forms where the rela-tionship between blood concentration and response is lesswell established; studies in other phases of the disease;studies in other populations; studies in combination or asmonotherapy; studies in a closely related disease; studies ina less closely related disease, but where the general purposeof the therapy is similar; studies of different clinical endpoints; and studies of different pharmacologic/patho-physiologic end points. The Center for Devices and Radio-logical Health offered an algorithm for submission ofevidence for approval of a device (18).

Post-marketing surveillance studies offer the opportunityto submit evidence for a new indication for an existingproduct. However, in a guidance document on discretionarypost-marketing study of pacemaker leads, the FDA haspointed out that the definition of what constitutes a distinctentity versus a minor modification of an existing entity is

highly specific to a particular setting and should be individ-ualized (19).

ISSUES PERTAINING TOHUMAN SUBJECTS RESEARCH INVOLVINGSUBJECTS WITH COMPROMISEDCAPACITY FOR GIVING INFORMED CONSENT

Within cardiovascular medicine, clinical research may in-volve individuals with limited capacity to grant informedconsent. Although no one contests or argues the criticalconcept of informed consent, it must be recognized that inthe heart/brain injury domains there are several time-sensitive situations in cardiovascular medicine where in-formed consent may not be practical. These include cardiacresuscitation, brain impairment from stroke, acute myocar-dial infarction, and severe congestive heart failure. Othervulnerable populations include children and those who arementally incapacitated. Although research in these popula-tions may be difficult, investigation is particularly importantbecause of limited data to support therapeutic decision-making (20).Emergency research. Federally sanctioned guidelines allowcertain emergency and resuscitation human subjects re-search to proceed without prospective informed consent(20). The FDA regulations (21 CFR 50.24) provide anarrow exception to the requirement for informed consentfrom each human subject, or his or her legally authorizedrepresentative, before initiation of an experimental interven-tion. The exception applies to a limited class of researchactivities involving human subjects who are in need ofemergency medical intervention but cannot give informedconsent because of their life-threatening medical condition,and/or who do not have a legally authorized person torepresent them in a timely fashion. The intent of theregulations is to allow research on life-threatening condi-tions for which available treatments are unproven or unsat-isfactory and where it is not possible to obtain informedconsent, while establishing additional protections to providefor safe and ethical studies (21 CFR 50.24).

The FDA recognizes that persons with life-threateningconditions who can neither give informed consent norrefuse enrollment are a vulnerable population. Also, theFDA recognizes that the lack of autonomy and inability ofsubjects to give informed consent requires additional pro-tective procedures in the review, approval, and operation ofthis research. The exception from the informed-consentrequirement permitted by the rule is conditional upondocumented findings by an IRB. For this group of patientsubjects, a case-by-case independent determination is re-placed by the general concurrence of a licensed physician.Readers are referred to the full text of the regulation and thepreamble for additional guidance (20).Research in pediatric patients. Research in pediatric pa-tients (younger than 21 years of age) represents a specialchallenge because of issues in the informed-consent process,




and because of limitations on the kind of research permitted(21–24). Federal regulations limit clinical research in chil-dren to that in which the risks are no greater than minimal;no greater than a minor increase over minimal where theresearch offers the potential to acquire new knowledge aboutthe child’s condition; or where the research offers a prospectfor direct benefit to the child. Research that involves greaterrisk with no prospect of direct benefit to the child may onlybe performed with permission of the U.S. Secretary ofHealth and Human Services. Application of the risk andbenefit categories is subjective, and, therefore, researchersand IRBs must be careful to ensure that appropriate researchis allowed while risk is avoided.

Depending on the level of development, a child may notbe competent to provide autonomous consent. Ethically, thebest interest of the child must always be considered mostimportant; therefore, one must be more careful to consultwith all relevant parties and not use only the standard ofautonomy applied in adult consent. For pediatric subjects,what we call “informed consent” is usually a combination ofinformed parental permission and assent of the child. In thissetting, the potential for influence by factors unrelated tothe best interest of the child, such as payment for partici-pation, can significantly impact parental decision-making.Therefore, pediatric researchers are particularly obligated tostrive for informed consent to the greatest extent possible.For adolescents and young adults, the informed-consentprotocol applied to adults should be used (13,15,20,22,24).Research in cognitively impaired subjects. Although nospecific regulations guiding research in cognitively impairedsubjects exist, a comprehensive report was prepared by theNational Bioethics Advisory Commission (25). Principlesinvolved in research in this group reflect the vulnerablenature of these populations.

TASK FORCE 1 REFERENCES

1. Morin K, Rakatansky H, Riddick FA, Jr., et al. Managing conflicts ofinterest in the conduct of clinical trials. JAMA 2002;287:78–84.

2. Levinsky NG. Non-financial conflicts of interest in research. N EnglJ Med 2002;347:759–61.

3. Solov D, McEnery R. Healthy woman died in UH Alzheimer’s study.Cleveland Plain Dealer, December 21, 2001:A1.

4. Steinbrook R. Protecting research subjects—the crisis at Johns Hopkins.N Engl J Med 2002;346:716–20.

5. Wentzel M. Toxic dose given UR student. Rochester, NY: RochesterDemocrat and Chronicle, 1996.

6. Kizer JR, Cannon CP, McCabe CH, et al. Trends in the use ofpharmacotherapies for acute myocardial infarction among physicianswho design and/or implement randomized trials versus physicians in

routine clinical practice: the MILIS-TIMI experience. MulticenterInvestigation on Limitation of Infarct Size-Thrombolysis InMyocardial Infarction. Am Heart J 1999;137:79–92.

7. Katz J. Human experimentation and human rights. St. Louis UnivLaw J 1993;38:7–54.

8. Fisher B, Redmond CK. Fraud in breast-cancer trials. N Engl J Med1994;330:1458–60.

9. Schulz KF. Subverting randomization in controlled trials. JAMA1995;274:1456–8.

10. Korn D. Conflicts of interest in biomedical research. JAMA 2000;284:2234–7.

11. Cech TR, Leonard JS. Science and business. Conflicts of interest—moving beyond disclosure. Science 2001;291:989.

12. La Puma J. Physicians’ conflict of interest in post-marketing research:what the public should know, and why industry should tell them. In:Vanderpool HY, editor. Ethics of Research Involving Human Sub-jects: Facing the 21st Century. Frederick, MD: University PublishingGroup, Inc., 1996;203–19.

13. Committee on Assessing the System for Protecting Human ResearchSubjects. Preserving Public Trust: Accreditation and Human ResearchParticipant Protection Programs. Washington, DC: The NationalAcademy Press, 2001.

14. Federman DD, Hanna KE, Rodriguez LL. Responsible Research: ASystems Approach to Protecting Research Participants. Washington,DC: The National Academy Press, 2003.

15. AAMC Task Force. Protecting subjects, preserving trust, promotingprogress I—policy and guidelines for the oversight of individualfinancial interests in human subjects’ research. Acad Med 2003;78:225–36.

16. AAMC Task Force. Protecting subjects, preserving trust, promotingprogress II—principles and recommendations for oversight of aninstitution’s financial interests in human subjects’ research. Acad Med2003;78:237–45.

17. Protection of human subjects: Belmont report—ethical principles andguidelines for the protection of human subjects of research. Fed Regist1979;44:23192–7.

18. Center for Devices and Radiological Health. Guidance for Industryand FDA Reviewers on Evidence Models for the Least BurdensomeMeans to Market. Food and Drug Administration. Available at:www.fda.gov. Last update 1999.

19. Kennedy D. The Lasker Forum on Ethical Challenges in BiomedicalResearch and Practice. Lasker Foundation. Available at: www.laskerfoundation.org. Last update May 14, 2003.

20. U.S. Food and Drug Administration. Department of Health andHuman Services. Guidance for Institutional Review Boards andClinical Investigators. 1998 Update. Rockville, MD.

21. Kodish E. Informed consent for pediatric research: is it really possible?J Pediatr 2003;142:89–90.

22. Rossi WC, Reynolds W, Nelson RM. Child assent and parentalpermission in pediatric research. Theor Med Bioeth 2003;24:131–48.

23. NIH Policy and Guidelines on Inclusion of Children as Participants inResearch Involving Human Subjects. March 6, 1998. Available at:http://www.nih.gob/grants/guide/notice-files/not98-024.html. Lastupdate March 6, 2004. Accessed April 14, 2004.

24. Shah S, Whittle A, Wilfond B, Gensler G, Wendler D. How doinstitutional review boards apply the federal risk and benefit standardsfor pediatric research? JAMA 2004;291:476–82.

25. National Bioethics Advisory Commission. Research Involving Personswith Mental Disorders that May Affect Decision-Making Capacity.Available at: www.georgetown.edu. Last update 1998. Accessed Au-gust 26, 2004.




Task Force 2:Investigator Participation in Clinical ResearchCo-Chairs: Robert M. Califf, MD, FACC, Steven E. Nissen, MD, FACC, FAHAAuthors: Anthony N. DeMaria, MD, MACC, FAHA, Erik Magnus Ohman, MD, FACC,Bertram Pitt, MD, FACC, FAHA, James T. Willerson, MD, FACC, FAHAParticipants: David W. Bilheimer, MD, Jay N. Cohn, MD, FACC, FAHA,David W. Feigal, JR, MD, MPH, Lindsay Hampson, Beverly H. Lorell, MD, FACC, FAHA,Carl J. Pepine, MD, MACC, FAHA, Richard L. Popp, MD, MACC, FAHA

INTRODUCTION

Cardiovascular health care professionals (HCPs) bear aheavy professional responsibility. Indeed, the professionitself is defined by the commitment to place the well-beingof the patient ahead of the self-interest of the professional.An obligation of professional behavior of cardiovascularHCPs is to encourage the development of new knowledgethat can ultimately improve patient care. One way toaccomplish this is by participation in clinical research, whichinvolves a complex interaction of multiple parties (includingindividuals, institutions, commercial organizations, and reg-ulatory agencies). Because cardiovascular disease is theleading cause of death and disability in the technologicallydeveloped world (1) and is projected to increase in preva-lence over the next 30 years, appropriate ethical behavior bycardiovascular HCPs could have a major impact on thewell-being of both individuals and society. Lack of appro-priate participation in efforts to improve care could under-mine the delicate balance in the clinical research system (2),which ensures the protection of human subjects and formsthe basis for the evidence upon which rational clinicalpractice is based.

Clinical research studies encompass a broad array ofactivities, ranging from reviews of medical records to smallPhase I safety studies to large multicenter clinical trials. Theroles and responsibilities of parties to this complex endeavorhave not reached a level of complete clarity. For example,the first textbook on the function of data-monitoringcommittees was just published in the past two years (3).Accordingly, any effort currently to define appropriatebehavior of individual investigators must be viewed as a“moving target.”

The most easily identifiable situation in which profes-sional behavior is called into question occurs when thecardiovascular HCP interacts with the industry that invents,manufactures, and sells medical products. The enormousmagnitude of the clinical research enterprise and the highfinancial stakes of transactions between cardiovascularHCPs and the industry provide fertile ground for sensa-tional claims and concerns. Indeed, as technology continuesto advance at a rapid pace, the interdependence of cardio-vascular HCPs and the medical products industry is increas-ingly evident. The advances of drugs and devices for

diagnostic and therapeutic purposes have been an over-whelmingly positive development for society, but the largeimpact of technology on health outcomes and cost rein-forces the importance of professional conduct in the devel-opment and assessment of these new products.

Although the majority of cardiovascular clinical researchis funded by the industry, a significant minority is fundedfrom public sources, most notably the National Heart,Lung, and Blood Institute (NHLBI), a division of theNational Institutes of Health (NIH). However, the NHLBIand the NIH as a whole are encouraging public-privatepartnerships for clinical research (www.nihroadmap.nih.gov), in which resources from both sectors are combined tocover the enormous cost of technology development andevaluation. The principles of appropriate investigator par-ticipation are applicable across the range of funding sources,including industry, public sources, and public-private part-nerships.

For the most part, the medical products industry andcardiovascular HCPs are aligned in a professional manner.Both aim to develop and use technology that will diagnosecardiovascular disease more accurately, treat it when it ispresent, and prevent its development in people at risk.However, significant tension and/or conflict of interest mayoccur in the development and evaluation of medical tech-nology by cardiovascular HCPs. Society rightfully expectsthat, in evaluating medical products and technology, thecardiovascular HCP will act in a professional manner andplace the well-being of patients ahead of his or her personalinterests. The industry has given attention to the issue of itsinteraction with HCPs, and the Advanced Medical Tech-nology Association (AdvaMed) has published a code ofethics on interaction with HCPs that became effective inJanuary 2004 (4).

TYPES OF CONFLICT

Conflict of interest in relation to industry is not a mono-lithic issue. Rather, there are varying levels of conflict,requiring different remedies to ensure that the public trust isbeing kept. One consideration is whether the conflict relatesto an individual cardiovascular specialist or to an institutionas a whole. A second consideration is the intensity of theconflict.




Individual conflict. Conflict of interest may begin with anidea for research, regardless of the source of funding. Thosewho design clinical trials and observational studies almostalways have bias in terms of which theories they favor orupon which they may have staked their professional repu-tations. Accordingly, when considering the relationshipbetween industry and the profession, one should not dismissnon-financial sources of bias and conflict, but should con-sider the whole spectrum of conflict. In fact, in general thedegree of conflict for an individual may have several aspectsas described in the Task Force 1 report and in the followingtext.

When a physician enrolls patients into clinical studies, anumber of individual issues may arise, including questionsof financial and personal professional gain. Because researchis paid for by a public or private sponsor, the potentialfinancial conflict is obvious to almost everyone involved.Fundamentally, the question is: how can the investigatormaintain independence of thought and action from thesponsor in the conduct and evaluation of the research? Theendorsement of the concepts involved in a study can lead tobias in how research is conducted and interpreted. However,the major issue in industry-sponsored research, as discussedin the following text, is the relationship between paymentand the results of the study. Of equal concern, given theintense pressure on individual HCPs to create a revenuestream through efficient procedure-oriented practice, pa-tients may not be offered the opportunity to participate inclinical research studies because it would reduce the incomeof the HCP or the practice. This could occur because arevenue-generating procedure might not be performed orbecause the time spent obtaining consent is compensated ata lower rate than direct clinical activity.Institutional conflict. Until recently, little attention hadbeen paid to institutional conflict of interest. However,recent difficulties with a particular research project—theGelsinger case (5)—led to a major report by the Associationof American Medical Colleges (AAMC) (6) stressing thedifficulties when an institution has equity or other majorfinancial interest in the outcome of a study. When aninstitution stands to benefit in reputation or finance from aresearch study, a potential conflict exists. Conversely, aninstitution can discourage investigation when it interfereswith normal operation at the hospital. Additionally, clinicalinvestigators are frequently under intense pressure to gen-erate revenue to support the salaries of research nursesbecause of lack of reserve funds in institutions and practicesto cover those salaries during periods of slow enrollment.

Universities, medical centers, and professional organiza-tions have significant financial entanglements with theindustry that go well beyond the conduct of research. Themajority of continuing medical education (CME) is fundedby industry, and significant donations and funding oftraining and faculty positions are awarded to academicinstitutions by industry. Both the American College ofCardiology Foundation (ACCF) and the American Heart

Association (AHA) rely on industry funding in the form ofdirect support, training money, and exhibits at nationalmeetings (7) (see the Task Force 6 report).

LEVELS OF RESPONSIBILITYAND POTENTIAL CONFLICT

Individual clinicians play a variety of roles in the develop-ment and assessment of cardiovascular technology, andthese roles may be considered according to the degree towhich the clinician is financially involved with the sponsorof the research. At the most basic level, when the industryneeds to conduct human research, it must contract with aphysician-investigator to perform the research. The inves-tigator, in turn, has a dual responsibility: the primaryresponsibility is to the research subjects to ensure that theresearch conforms to the ethical standards defined in doc-uments such as the Declaration of Helsinki (8), the GenevaDeclaration (9), and the Belmont Report (10). Theseobligations are spelled out in the informed-consent docu-ment, which is a contract between the investigator and thesubject or patient. The second responsibility of the investi-gator is to complete the research in a professional manner.These issues are detailed in the regulatory document fromthe Food and Drug Administration entitled “Good ClinicalPractices” (11,12). The contract between the investigatorand the sponsor provides evidence of the seriousness of thisobligation. Therefore, cardiovascular HCPs who enrollpatients in clinical research studies have a potential conflictbecause they are paid to conduct the research, but societyhas also assigned investigators an independent role to act onbehalf of the human subject in the conduct of the research.

A researcher may also be involved in disseminating theresearch findings. Because most CME is paid for by themedical products industry, interactions with industry arecommon, both in the writing of manuscripts for the peer-reviewed literature and in the preparation and delivery oflecture materials, slide sets, and other CME materials.Although the dissemination of research findings is increas-ingly recognized as a responsibility of the clinicians partic-ipating in research (13), as discussed in the Task Force 1report, the degree to which the payment for these activitiesbiases the control of the content of the material represents apotential conflict in this situation, and adherence to stan-dards of conduct in CME is essential (see the Task Force 3report).

The industry depends heavily on consultants from theacademic and practice communities. These consultants offerinsight into clinical and scientific issues and often providefeedback on dissemination of ideas and technology into thecommunity. Consultancy contracts can vary considerably, ascan the financial transactions around consulting.

A significant number of cardiovascular HCPs becomeinventors of technology. This privileged position is a majorsource of societal interest and concern. Much of the ad-vancement of cardiovascular medicine in the U.S. has been




driven by ingenious inventor-investigators who were able tocombine scientific and engineering insights with knowledgeof cardiovascular medicine (14). A cardiovascular specialistwith a patented invention that could result in substantialfinancial and status benefits and who uses that invention toperform procedures or studies on patients perhaps repre-sents the highest level of direct conflict. It is recognized thatthe participation of the clinician-inventor in the clinical trialcan be valuable. However, the clinician-inventor should notbe the principal investigator of the clinical trial. Further-more, special oversight is necessary when the clinician-inventor is involved in the informed-consent process (15).

Finally, a growing number of cardiovascular HCPs workdirectly in the medical products industry. This may lead tomultiple issues of conflict of interest, particularly in conductof clinical research developing or evaluating medical prod-ucts. Such individuals may be involved but should not be theprincipal investigator of a study.

COMMON ISSUES

Declaration of conflict. When an individual or institutionworks with the medical products industry, society agreesthat disclosure is a minimal standard. Although the issues inCME are discussed in the Task Force 3 report, less energyhas been placed on appropriate declarations by investigatorsenrolling patients in clinical research studies. Recently, theAAMC (6,16,17) guidelines have emphasized disclosure tothe patient when the investigator or the institution hasequity interest or the potential for royalties in the productbeing evaluated (6,18). The degree to which these guide-lines are being followed has not been quantified. More dataneeds to be collected in order to evaluate this type ofdisclosure. At minimum, financial interests must be dis-closed to the Institutional Review Board (IRB).Publication. The conduct of clinical research obligatorilyinvolves an agreement between a subject (often a patient)and an investigator that the study is being done “to creategeneralizable knowledge.” This term has become standardin the definition of clinical research under which institu-tional ethics committees review and approve protocolsunder federal guidelines (18). However, the literature isreplete with flaws in the approach to creating this body ofknowledge. A critical report by Dickersin (19) highlightsthe degree to which failure to publish results can lead toinaccurate assessments of the balance of risk and benefit ofdiagnostic and therapeutic technologies. A particularly in-teresting report from the Johns Hopkins and Oxford uni-versities (20) documented, in a review of all protocolssubmitted to institutional IRBs in the 1980s, that industryfunding of research is an independent and major predictorof failure to publish. Recent publications have emphasizedthat this problem has not gone away (21–23), and multiplejournals and investigators have called for a registry of allclinical trials (24).

Beyond the failure to publish is the issue of determination

of the editorial content of publications. The content may beheavily influenced by the commercial sponsor in severalways in addition to simply not releasing the data. Thesponsor may control the analysis for, or the writing of, theresearch publication, or may pressure investigators to por-tray a particular point of view.

A recent trend in the medical products industry is theassignment of publications managers to product develop-ment teams. These managers often are company employees,but increasingly major “medical education” firms are com-bining CME, project promotion, and the production ofscientific articles for peer review into package contracts.This effort may lead to “ghost writing,” in which thepublications group manager writes the manuscript while theinvestigators are listed as the authors. This practice seemscommonplace in the production of journal supplements,which are highly valuable to industry because the law allowssales representatives to distribute publications from peer-reviewed journals. In this manner, an investigator can writeabout an off-label use of a product, and although thecompany cannot advertise that indication, it can distributethe supplement to practitioners. Perhaps of more concern isthe use of names of prominent key opinion leaders on majorreports from clinical research without independent input oreditorial control from these investigators. There should beformal disclosure in the manuscript, if the manuscript iswritten, in whole or in part, by an individual or group otherthan the listed authors. All publication supplements shouldname the sponsor, anyone other than the listed authorsinvolved in preparing the supplement, and whether or not itwas peer-reviewed.

An additional issue is access to data. In most industry-funded research, the investigators are restricted from per-forming their own analyses. The industry sponsor eitherdirectly provides statistical support or contracts with acontract research organization for the purpose of analysis forregulatory and publication purposes. The industry contendsthat access to printouts of the analyses is sufficient to ensurethat investigators have independent access to the data(Bayh-Dole Act of 1980; P.L. 96-517). Others have arguedthat the conduct of the analyses themselves should be in thepurview of statisticians and clinicians free of high-levelfinancial ties with the sponsor (25). Finally, the industry canapply significant pressure to investigators who wish tocontinue to do research with that company to shade reportsfavorably for the sponsor. The degree to which this happenshas not been assessed, although some highly publicizedcases have brought the issue to public attention (15,26,27).

These potential problems must be balanced with thelegitimate concerns of industry. Many investigators haveneither the capacity to manage complex datasets nor theknowledge of biostatistics to do their own analyses. Withoutthe stimulus of industry support, and at times ghost writing,important research results can languish for months to yearsbecause of time constraints on academic investigators or lackof motivation and interest. Additionally, unmonitored ac-




cess to data from a study can allow the data to end up in thehands of individuals without either the in-depth knowledgeof the topic or the skills to perform appropriate analyses.Optimally, the database should be shared by both thesponsor and the committee responsible for publication (seethe following text).

PROPOSED APPROACHES

Accordingly, we advocate the following set of principles toallay the concerns of both cardiovascular specialty investi-gators and the medical products industry:

● The primary results of human subjects’ research must bemade public. Surveys or analyses conducted for qualityassurance purposes are not intended to be included.When the findings have insufficient priority for publica-tion in the peer-reviewed literature, other means ofdisseminating knowledge should be used, such asthrough professional meetings, publicly available ar-chives, web sites, or online tutorials. It is acknowledgedthat the mechanisms for public disclosure are not yetstandardized, but the principle is that the default posi-tion in human investigation is that the results of thestudy should be made public so that they can contributeto generalizable knowledge.

● The publication must adhere to the principles regardingauthorship, conflict of interest, and publication ethics asexpressed in the International Committee of MedicalJournal Editors’ “Uniform Requirements” (28).

● A committee responsible for publication should beconstituted as part of the contract encompassing multi-site human research studies. All decisions regardingdevelopment, authorship, and submission of any manu-script, abstract, or other presentation arising from thestudy should be made by the committee responsible forpublication. Such a committee should be comprised ofinvestigators participating in the study who are scientificand medical experts in their respective fields. It isappropriate to include representatives from the sponsoras full voting members of the committee. The committeeresponsible for publication should act as an independentbody to fulfill the professional obligation to subjectsparticipating in the research by representing their inter-ests and by serving the professional mission of develop-ing, improving, and disseminating scientific and medicalknowledge. In small studies, this committee may consistof only a few people involved in the study. In largerstudies that could inform clinical practice or better defineimportant mechanisms of disease, such a committeeshould be carefully constructed as a critical component ofthe trial’s organization.

● The committee responsible for publication should reviewand approve all analyses and publication topics proposedby participating investigators and institutions, whetherbased upon the data collected by all participating insti-

tutions, by a subset of the participating institutions, or byonly a single participating institution.

● The committee responsible for publication should reviewand constructively critique all proposed submissions thatresult from an approved analysis or publication topic,and should consider their scientific merit with the aim ofpromoting the dissemination of scientific and medicalknowledge. This should be done in a timely mannerbefore submission for presentation or publication.

● The industry sponsor should ensure that the study dataare available for any analysis or publication topic ap-proved by the committee responsible for publication, andthe resulting manuscript or presentation should be sentto the sponsor for its timely review and comment. Thereshould be no restrictions on the topics or analyticalapproaches used in developing manuscripts and presen-tations. Both the industry sponsor and the investigatorsshould be free to suggest topics and analyses for consid-eration by the publications committee.

● When the research sponsor chooses to submit publica-tions independent of the committee responsible forpublications, the Trial Steering Committee should de-velop procedures for acknowledgment and disclosure ofthe publication’s relationship to the study.

● In the case of multicenter studies, the first publication ofthe results of the study should be a multicenter publica-tion reflecting the results of the study as a whole asspecified in the protocol and/or statistical analysis plan.

● The author(s) of the initial and subsequent multicenterpublication(s), as approved by the committee responsiblefor publication, should have access to all of the data fromthe study and should have the ability to analyze thosedata, independent of the sponsor, although this principleis subject to review of the capability of the authors toperform appropriate analyses. In the case that the inves-tigators are not capable of independent analysis, it ispreferable for a statistician independent of the sponsor tobe contracted to either perform the analyses or to checkthe analyses of the sponsor. This statistician should havea copy of the database.

● The initial multicenter publication should be publishedas soon as practicable after completion of the study, andthe committee responsible for publication should at-tempt to have the first manuscript submitted to areputable, peer-reviewed biomedical journal within areasonable period of time (not more than one year) fromthe end of the study.

● The committee responsible for publication shouldpromptly provide a copy of a planned submission to theSteering Committee for timely review by that committeeand the sponsor within a reasonable period of time.

● The committee responsible for publication should reviewthe documents, including any comments from the Steer-ing Committee and sponsor. If confidential informationwould be released inappropriately in the manuscript orother presentation, it should be removed if possible, or




the sponsor should be given appropriate time to protectintellectual property. However, information that thecommittee responsible for publication finds to be neces-sary for the accurate presentation and interpretation ofthe study results, or which is required by the publishingjournal to enable other researchers to reproduce thoseresults, should not be withheld beyond this reasonableperiod of time (typically 90 days).

● In the conduct of industry-funded clinical research, thereis a possibility of the discovery of new findings that couldbe classified as intellectual property. Typically, the spon-sor will desire to claim all intellectual property derivedfrom the research. This stance is understandable giventhat the industry is paying for the research and requirespatent protection to enable the investment in research torecoup profits for its employees and investors. However,after a reasonable period of time has elapsed to protectintellectual property, the intellectual property issueshould not be used to limit the publication of results.Although formal review of a manuscript by the sponsoris typically provided in the contract for clinical trials,such review should not unduly delay the disseminationof key trial findings.

● The support of the sponsor must be recognized in anypublication or presentation arising from the research orthe study. If representatives of the sponsor make sub-stantive contributions to the intellectual content of themanuscript or other presentation, as described in the“Uniform Requirements,” they should be invited to serveas co-authors of the manuscript or other presentation.Acceptance of this invitation should be at the discretionof the representative.

CONFIDENTIALITY

In general, investigators are required to maintain confiden-tiality with regard to knowledge about the product beingevaluated when clinical research is conducted with industry.Given the competitive research environment, this stipula-tion is quite understandable. Disagreements arise, however,about the scope of confidentiality and the duration of theagreement.

Increasingly, industry has considered confidentiality notonly to include intellectual property about the drug ordevice, but also know-how related to the drug or device andeven the protocol itself. This approach has led to extensivedelays in the conduct of clinical research because of therequirement to review and sign confidentiality agreementsbefore protocols can be reviewed. Such an approach alsoinhibits one’s ability to discuss a protocol’s merits andfeasibility among professional colleagues. In general, confi-dentiality about the drug or device seems reasonable, butclinical know-how may belong to the investigator. Protocolsshould be considered non-confidential at the point at whichthey are dispersed to principal investigators at the sites,because broad discussion in the clinical community is

required to determine whether the research study is appro-priate for the local environment.

Few people in our society are capable of maintainingconfidentiality for a lifetime. Accordingly, a time limit istypically placed on the duration of confidentiality. Althoughthere is no objective standard or empirical base on which tomake a judgment, confidentiality (except regarding studyresults—see the following text) should be limited to fiveyears or until the end of the study, whichever is longer.

INDEMNIFICATION

Clinical research is no more immune from our societalpreoccupation with lawsuits than is any other area ofmedicine. Indeed, injury occurring to human subjects hasbecome an increasing source of concern and a topic ofincreasing interest by the legal profession. In general, thesponsor of the research should hold the investigator harm-less for injury complications resulting from conduct of thestudy in accordance with the protocol. Obviously, thesponsor should not be responsible for negligence in theconduct of the protocol by the investigator.

COMPENSATION

Clinical research is a complex and demanding endeavor.Accordingly, payment for involvement in many aspects ofclinical research activities is reasonable and should beexpected. The question arises, however, concerning whatshould constitute reasonable professional standards for pay-ment. Consulting may occur at several points during med-ical product development and interpretation of data:

● During the early phases of product development, con-siderable effort is required to guide decision making onthe design of the molecule or device and in the design ofanimal and human studies. As the human studies areconducted, expert advice often is needed for interpreta-tion of the data.

● In the later phases, product acceptance and messageacceptance research is commonly done by marketinggroups. Individual investigators should be careful tosegregate consulting, marketing efforts, and CME intodifferent categories with different purposes (see the TaskForce 3 report).

● Conflict can arise at several levels as a result of consult-ing. When a cardiovascular HCP cares for an individualpatient, decisions on product selection are made everyday. It is critical to the public trust that neither patientnor product selection be based on payments occurringfor the conduct of clinical research.

At a broader level, key opinion leaders can be identified atlocal, regional, national, and international levels. Theseindividuals are highly valuable to industry because theiropinions have a wide impact on prescribing and product-usedecisions by other physicians. A complex issue arises whenconsidering payments for lectures and other CME efforts




(see the Task Force 3 report). This becomes particularlyimportant for key opinion leaders who also serve on profes-sional society committees that devise clinical practice guide-lines and performance measures (see the Task Force 6report). The level of compensation should be commensuratewith the work performed.

THE INVENTOR-INVESTIGATOR DILEMMA

The investment of the NIH in biomedical research hasspawned a large number of investigators who make discov-eries that may have beneficial applications to human health.The Bayh-Dole Act (29) instructs academic medical centersto support the transformation of these ideas into commer-cial reality. Similarly, particularly in the device world,physician entrepreneurs have invented new approaches totechnology, leading to “start-up” companies.

Recent events in the arena of gene therapy have high-lighted the special nature of this situation. In the highlypublicized case of Jesse Gelsinger, a research subject with agenetic deficiency (30), the University of Pennsylvaniaallegedly had supported the commercialization of an ap-proach to gene therapy delivery. The faculty member wasthe principal inventor, allegedly with major equity in thecommercial entity, and the university also allegedly heldmajor equity. In addition, the experimental material appar-ently was manufactured at the university. When Jesse, an18-year-old reasonably healthy boy, died as a direct result ofthe experimental therapy, the lawyers for the family arguedthat the process of consent and adverse-event reporting wasflawed, and that neither the investigator nor the institutioncould be unbiased about the human experiment beingperformed.Avoiding inventor-investigator conflict of interest. Ide-ally, invention and investigation of new discoveries shouldmaintain rigorous barriers to avoid both the appearance ofand the opportunity for bias (see the Task Force 1 report).Typically, this requires physician-scientists to allow otherinvestigators to perform the human testing of their inven-tions. Although difficult for some inventors, this approach isthe only reliable means to protect both the patient and thescientific integrity of the research. It is often simply toodifficult to maintain rigorous standards for evidence-basedresearch for drugs or devices in situations in which aninvolved inventor stands to profit substantially from thesuccess of the project. Even when the scientific integrity ofthe investigation is impeccable, other physician-scientists,the public, regulators, and the press are likely to question theindependence and reliability of the research. In this situa-tion, fairly strict separation of the inventor is most often thebest policy. One exception may occur when the inventor isthe best or only person with the skill to operate the devicein experimental circumstances involving humans (15,25). Inthis circumstance, special precautions must be taken toindependently verify that subjects are fully informed aboutthe issues involved in their participation. As soon as others

become facile with the device, the inventor-investigatorshould be removed from experimental subject contact (26).

AVOIDING BIAS IN REPORTING CLINICAL TRIALS

In recent years, disturbing cases have surfaced in whichphysician-scientists played a passive or active role in pub-lishing scientific results of clinical trials in which it wasclaimed major distortion of the findings had occurred (26).These issues may involve selective reporting of results inwhich findings with unfavorable impact on a commercialdrug or device were withheld. Such episodes have a devas-tating effect on the acceptance of clinical trial results,bringing them all under close scrutiny. Several criticalprinciples should govern the analysis and reporting of allclinical trials:

● The physician-investigator should be critically involvedin the design of the trial and selection of the efficacymeasures.

● A completely passive role, in which the sponsor designsthe trial and the physician is “offered” a role as StudyChair or member of the Steering Committee, is unac-ceptable; such roles may be acceptable if significant inputinto final study design and conduct occurs.

● The Study Chair and Steering Committee should besignatories to the protocol and to a formal statisticalanalysis plan (SAP). Studies should be monitored forsafety independent of both the sponsor and the investi-gators (31).

● In reporting results, the investigators should be guidedby the SAP and should disclose any analyses that deviatefrom this plan.

● The editors of the publishing journal should be suppliedwith the SAP at the time of submission for publication.

● Full disclosure of negative results is imperative. In thecase of an entirely negative study, posting on a publicweb site may be necessary owing to the well-publicizednegative reporting bias of medical journals (see thepreceding text). When the primary end point of a studyis negative but secondary end points seem to be positive,it is critical to emphasize the negative result beforediscussing the implications of secondary analyses.

● Delay in reporting results that are unfavorable to a drugor device is equally problematic. Such delays may resultin reduced quality of care for individual patients, or maylead to another sponsor conducting a similar trial therebyexposing other patients to unneeded risks.

ETHICAL ISSUES IN TRIAL DESIGN:ADEQUATE STATISTICAL POWER

The purpose of the study design should be clear, and itshould be able to answer the question being addressed. Inthis regard, there are appropriate times for pure superioritytrials, for non-inferiority trials, and for combinedsuperiority/non-inferiority trials. The key issue is that the




trial design and sample size should be adequate for thestated purpose.

There are conflicting views in the clinical trial communityregarding the ethical considerations in deciding the samplesize for a trial. Some authorities believe that a deliberatelyunderpowered trial, particularly when the goal of the trial isto demonstrate “non-inferiority,” is inherently unethical.These arguments center on the principle that all trialsinvolve known and unknown risks to the subject. Accord-ingly, it is appropriate to expose patients to such risks onlywhen the results are likely to provide significant incrementalmedical knowledge. According to some, an underpowered“non-inferiority” trial cannot benefit medical science, there-fore intrinsically constituting an unacceptable risk to thepatient. Opponents of this point of view argue that all trialshave the potential to result in unanticipated scientificdiscoveries, and that an underpowered trial may eventuallybe included in a useful meta-analysis. Accordingly, thisproblem represents a “gray zone” in clinical trial ethics inwhich there is no universal agreement. Non-inferiority trialshave a place in medicine, but underpowered non-inferioritytrials have questionable value.

CONCLUSIONS AND RECOMMENDATIONS

The interaction between cardiovascular HCPs and themedical products industry in the setting of clinical researchis complex and evolving. The principles of disclosure arecritical. However, continued evaluation, empirical study,and publication of studies examining the “rules of engage-ment” in clinical research are needed to enable the profes-sion to maintain appropriate independence while participat-ing in a partnership with industry to develop new diagnosticand therapeutic technologies and to assess older ones.Critical principles to be considered by individual investiga-tors are as follows:

● Encouragement for the development of new knowledgeis a professional responsibility of cardiovascular HCPs.

● The investigator enrolling patients has an obligation toconduct the study according to the protocol, but also hasa legal and ethical responsibility to the human subjectfrom whom consent has been obtained. Thus, althoughthe investigator is obligated to the sponsor he or she hasa superseding obligation to act independently from thesponsor if necessary on behalf of the subject.

● Results of human studies must be made public regardlessof their outcome. This responsibility can be accom-plished preferentially by publication in a peer-reviewedjournal, but it may require posting on a public web siteor other means of public access.

● In multicenter studies, a formal mechanism for a com-mittee to oversee publication and publish the resultsshould be established by contract before the start of thestudy. This committee should prevent control of theprocess either by the sponsor or by individual investiga-tors and should prevent “renegade” publication without

due consideration of the interest of the many people whomust work together to conduct a clinical research study.

● The complex endeavor of multicenter studies continuesto evolve so that standards of conduct and appropriatebehavior by all parties will become optimized withcontinued discussion. Research on methods of perform-ing clinical research and public discussion of the findingsof that research should be a high priority for all partic-ipants, especially HCPs such as ACCF and AHAmembers.


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Task Force 3: Disclosure ofRelationships With Commercial Interests:Policy for Educational Activities and PublicationsCo-Chairs: Alice K. Jacobs, MD, FACC, FAHA, Bruce D. Lindsay, MD, FACC, FAHAAuthors: Bruce J. Bellande, PHD, Gregg C. Fonarow, MD, FACC,Rick A. Nishimura, MD, FACC, FAHA, Pravin M. Shah, MD, MACC, FAHAParticipants: Brian H. Annex, MD, Valentin Fuster, MD, PHD, FACC, FAHA,Raymond J. Gibbons, MD, FACC, FAHA, Marcia J. Jackson, PHD,Shahbudin H. Rahimtoola, MD, MACC, FAHA

BACKGROUND

Physicians, scientists, patients, and the public rely onprofessional organizations to provide an independent, un-biased forum for presentation of research, publications, andeducational activities at their scientific sessions and inscientific publications. Attendees at educational activitiessponsored by not-for-profit organizations usually incur fi-nancial and other costs. The attendees expect to gaininformation from leading experts that may modify theirbehavior and result in a change in patient care. Concernsabout real or perceived conflicts of interest among organi-zations, physicians, scientists, patients, and educators re-garding their relationships with the medical products indus-try have been debated in the press and in medical journals(1,2). Concerns about these relationships have been dis-cussed extensively by the Association of American MedicalColleges (AAMC), which issued guidelines for conflict ofinterest in human subjects’ research based on a consensus ofa committee including clinicians, scientists, legislators, eth-icists, consumers, and representatives from commercial in-terests (3).

The Accreditation Council for Continuing Medical Ed-ucation (ACCME), which accredits continuing medicaleducation (CME) provider organizations, currently requiresfull disclosure of pertinent commercial relationships. TheACCME has revised the Standards for Commercial Sup-port which were adopted on April 1, 2004. Both theAmerican College of Cardiology Foundation (ACCF) andthe American Heart Association (AHA) policies must be incompliance to maintain their accreditation (Table 1).

“Disclosure” must never include the use of a trade nameor a product-group message. A provider must disclose thisinformation to learners before beginning the educationalactivity. The ACCME standards allow for relationships tobe disclosed verbally, and for a representative of the CMEprovider who was in attendance to attest in writing thatverbal disclosure did occur.

Medical societies have struggled to define a significantfinancial relationship that poses a real or perceived conflictof interest. The American Society of Clinical Oncologyrecently amended its regulations to encompass any moneyexceeding $100 an investigator received from a firm fundinga trial (5). One criticism of this regulation is that thethreshold for disclosure is so low that the large number ofdisclosures might obscure more serious financial relation-ships. The New England Journal of Medicine has maintainedthat authors of reviews and editorials must not have anyfinancial interest in a company or its competitor that makesa product discussed in the article. Journal editors relaxed thepolicy for reviewers in June 2002 because their ability torecruit individuals for review articles and editorials wasconstrained (6). The new policy prohibits a “significant”financial interest, which the journal defined as a lower limitof $10,000 in accordance with guidelines developed by theNational Institutes of Health (7) and the AAMC (3).

The concerns of consumers and professional organiza-tions over conflicts of interest in medical research challengethe ACCF and the AHA to review their policies on conflictof interest, acknowledgment of commercial support, anddisclosure of financial relationships with the medical prod-




ucts industry. The integrity of the ACCF, the AHA, andcardiovascular subspecialty societies as well as their commit-ment to truth and evidence-based, unbiased scientific in-quiry, provides the foundation upon which their missionsdepend. This fundamental tenet is critical to the validity andsuccess of the various organizations’ annual scientific ses-sions, regional educational meetings, publications, and clin-ical guidelines.

THE DISCLOSURE POLICY

Introduction. Participants in this Consensus Conferencecannot make policy for the ACCF and the AHA. However,we can offer the following for consideration by thoseorganizations with hope they will adopt a uniform policyaddressing these issues. The following is meant to demon-strate the ACCF’s and AHA’s high ethical standards andscientific integrity, and to convey a commitment to ethicalbehavior.Policy statement. Audiences for any of the ACCF and theAHA programs, products, policies, services, and scientificpublications are to be informed, prior to their participation,of relevant relationships with commercial interests with anyproprietary entity producing health care goods or services(with the exception of non-profit or government organiza-tions and non-health care-related companies) on the part ofthe ACCF and the AHA as organizations and by individualACCF and AHA contributors (including directors, plan-ners, reviewers, moderators, speakers, faculty, and authors ofprograms, products, services, and publications). The policyshould apply to authors of book chapters and editors ofjournals. Members of the ACCF and the AHA are expected

to adhere to these policies when they participate in “satellitesessions” around the time of local or national scientificsessions and that are not sponsored or endorsed by theACCF and the AHA.

These policies also should apply to members who partic-ipate in other educational activities such as live case dem-onstrations, which may serve to disseminate knowledge,management strategies, or advances in technology, but theyshould not be used primarily to promote a product. The useof the demonstrated technology always should be put inproper clinical perspective. The provision of money by acommercial interest to support a demonstration course mustnot influence the content of the program.

Finally, it is the current policy of the ACCF and theAHA to comply with the following:

1. The American Medical Association’s (AMA) Opinion8.061, “Gifts to Physicians From Industry” (adoptedDecember 1990) (8) and Opinion 9.011, “Ethical Issueson CME” (adopted by the AMA in December 1993and updated June 1996) (9).

2. The ACCME’s “Standards for Commercial Support”(10).

3. The Accreditation Council for Graduate Medical Educa-tion’s (ACGME) “Principles to Guide the RelationshipBetween Graduate Medical Education and Industry” (11).

Individual financial relationships to disclose. The fol-lowing relevant relationships with commercial interests withany proprietary entity producing health care goods orservices (with the exception of non-profit or governmentorganizations and non-health care-related companies) sup-porting a program, product, service, or document, includingfinancial interest for individual contributors (and his or herspouse and dependent children) or for any foundation orentity controlled or directed by the individual or his or herspouse, must be disclosed before an individual contributor’sparticipation in an ACCF or an AHA activity. The levelsrecommended in this document were influenced by policiespreviously established by the National Institutes of Health(7) and by the Food and Drug Administration (12).

The Consensus Conference recommends that relevantrelationships be defined in terms of levels and nature ofsupport. The levels are as follows:

● None● Modest: less than or equal to $10,000● Significant: greater than $10,000

The categories of support are defined as follows:

Personal Income/Investments*1. Consulting fees, honoraria (including honoraria from a

third party, if the original source is a financiallyinterested company), gifts or other emoluments, or “inkind” compensation from a financially interested com-pany (or entitlement to the same), whether for con-sulting, lecturing, travel, service on an advisory board,

Table 1. Minimum Requirements for Compliance WithACCME’s Standards for Commercial Support: Standards toEnsure the Independence of CME Activities

● CME providers must be able to show that every person in a positionto control the content of an educational activity has disclosed allrelevant financial relationships with any commercial interest to theprovider. The ACCME defines “relevant relationships” as financialrelationships in any amount occurring within the past 12 months thatcreate a conflict of interest.

● An individual who refuses to disclose relevant financial relationshipswill be disqualified from being a planning committee member, ateacher, or an author of CME, and cannot have control of, orresponsibility for the development, management, presentation, orevaluation of the CME activity.

● The CME provider must have implemented a mechanism to identifyand resolve all conflicts of interest prior to the education activitybeing delivered to learners. When an individual discloses to learnersany relevant financial relationship(s), the information must include:a) The name of the individualb) The name of the commercial interest(s)c) The nature of the relationship the person has with each

commercial interest● The source of all support from commercial interest must be disclosed

to learners.● When commercial support is “in-kind,” the nature of the support

must also be disclosed to learners.

Source: Excerpt from Accreditation Council for Continuing Medical Education,Standards to Ensure the Independence of CME Activities (4).




legal testimony or consultation, or for any other similarpurpose in the prior calendar year.

2. Equity interests (or entitlement to the same), includingstock options, of any amount in a non-publicly tradedand financially related company.

3. Equity interests (or entitlement to the same) in apublicly traded and financially related company (seethe exceptions in the following text).

4. Royalty income or the right to receive future royaltiesunder a patent license or copyright, where the topic isdirectly related to the licensed technology or workunder discussion.

5. Any non-royalty payments or entitlements to pay-ments in connection with the activity that are notdirectly related to the reasonable costs of that activity.

6. Service as an officer, director, or in any other fiduciaryrole for a financially interested company, whether ornot remuneration is received for such service.

7. Sole ownership, partnership, or principal of anenterprise.

*Exceptions: interests of any amount in financially inter-ested company(ies) by virtue of ownership of publiclytraded, diversified mutual funds.

Programmatic Support8. Research grants from a financially interested company.9. Fellowship support.

10. Funding of a salary or position (partial or full) or“in-kind” support of the program.

A potential conflict of interest level should reflect acumulative value of personal income/investments and pro-grammatic support. All royalties or stock options should beacknowledged because their value could become significant,and having such arrangements implies a vested interest inthe future of the related commercial interest. Full disclosureof relationships with commercial interests should be avail-able to the learner prior to the activity. The speaker mustacknowledge whether specific categories and the cumulativevalue of relationships is none, modest (less than or equal to$10,000), or significant (greater than $10,000). The name(s)of the commercial interest(s) must be printed in the syllabusand should be presented verbally or visually on a slide at thetime of presentation. The introductory slides should includethe information in Table 2.

Both the ACCF and the AHA should develop a uniformsecure database, updated yearly, containing full disclosure ofrelationships with commercial interests for individuals (in-

cluding planners and reviewers of programs and publica-tions) participating in ACCF and AHA educational activ-ities, products, policies, services, and scientific publications.

Disclosure of Financial Relationships to AudiencesThe need to disclose specific financial involvement onlyapplies if it is germane to the content of the CME activityor related to commercial supporters of the educationalactivity. All audiences and readers will be informed, prior toor as an integral part of the activity, whether the contribu-tor: 1) has no individual relationships to disclose as previ-ously described, or 2) has individual relationships to discloseas previously described. It is incumbent on the speaker toprovide full disclosure of germane relationships to commer-cial interests. It is the responsibility of the moderator torequest this information at the time of presentation if it hasnot been provided. Non-compliance, which includes willfulrefusal or incomplete disclosure, should prohibit futureparticipation by that individual in ACCF and AHA activities.

The ACCF and AHA organizational financial relation-ships to disclose should be acknowledged before or as anintegral part of the activity by indicating the corporate nameof the supporter and the level of financial support aspreviously defined.

MECHANISMS FOR DISCLOSURE

Participants in educational activities. The content orformat of a CME activity or its related materials mustpromote improvements or quality in health care and notspecific proprietary business or commercial interests. Pre-sentations must offer a balanced view of therapeutic options.Use of generic names will contribute to impartiality. If theCME educational material or content includes trade names,where available, trade names of products from severalcompanies should be used, not just trade names from asingle company. The program syllabus and/or a slide shoulddisclose relationships with commercial interests to identify apotential conflict of interest of both planners and reviewers.Authors of editorials and original articles. The ACCFand AHA journal editors should obtain information regard-ing relationships with industry at the time of submission ofan original manuscript and before inviting an editorialsubmission from an expert. When feasible, an additionalexpert opinion may be sought from another peer without apotential conflict of interest. Transparency concerning po-tential conflict of interest for authors of original publicationsand editorialists is sufficiently important to warrant a morein-depth statement specifying the nature and magnitude ofthe relevant relationship with a commercial entity. Theinformation disclosed should include: 1) the name of theindividual, 2) the name of the company/enterprise, 3) thenature of the contract with industry (e.g., data handling,statistics, censorship of results, ability to report adversefindings), and 4) the level of financial support.

Table 2. Disclosure of Financial Relationships

Nature of SupportLevel ofSupport

CommercialEntity

Personal Income/Investments Specify Level SpecifyRoyalties/Stock Options Yes or No SpecifyProgrammatic Support Specify Level SpecifyCumulative/Total Support Specify Level Specify




Members of the writing groups of the ACCF and theAHA scientific statements and practice guidelines. Thepotential conflict of interest of the writing group should beprovided in detail. The ACC/AHA Task Force on PracticeGuidelines developed a policy for the guideline process thatincorporates several unique elements (8). The ConsensusConference endorses this approach. Each writing commit-tee member is required to make full oral disclosure at theinitial writing committee meeting of any potential conflictof interest. At each subsequent meeting, a written summaryof disclosure is provided to the entire committee, and eachmember is asked to update his or her information regardingany new potential conflict of interest. Full disclosure isthought to be critical to the credibility of the process, and itis carefully monitored by the Task Force. Those members ofthe writing committee who have disclosed a relationshipwith industry are invited to supply information on the topicfor which they provided a disclosed relationship, but theyare excused from the room for the vote on guidelinerecommendations pertaining to the disclosed conflict. In-formation on relationships with commercial interests foreach writing group member and peer reviewer of a practiceguideline is published with the document. Finally, membersof the writing committee are prohibited from sharinginformation pertinent to the writing effort with commercialinterests until the document has been posted on the ACCand/or AHA web sites.

CONSEQUENCES FOR NONCOMPLIANCE

Personal and professional. Consequences for refusal orfailure to disclose a relationship with industry or to bewillfully out of compliance with the ACCF and the AHApolicies need to be substantial enough to ensure the integrityof the policies. The policies and potential sanctions shouldbe fully disclosed to all participants in educational activities,products and services, and publications. The ACC/ACCFEthics and Discipline Committee and the AHA Conflict ofInterest Review Committee should be responsible for ad-ministering and enforcing appropriate sanctions. TheACCF and the AHA should create a mechanism torandomly audit disclosures and to create a process whereACCF and AHA members and attendees of educationalactivities can report potential violations, including partialdisclosure or non-disclosure, for further investigation.

Refusal by an individual to provide adequate disclosureconsistent with the conflict of interest policy should prohibitparticipation by that individual in ACCF and AHA activ-ities. As a further safeguard, violations may also be reportedto the individual’s academic institution or entity with whomhe or she is professionally affiliated.

A mechanism should be established for disqualification ofindividuals with a conflict of interest that cannot be ade-quately dispelled with disclosure. Such matters might beplaced under the jurisdiction of the ACC/ACCF Ethics

and Discipline Committee and the AHA Conflict ofInterest Review Committee.Potential legal risks. The Office of the Inspector General ofthe U.S. Department of Health and Human Services (HHS)has published a Compliance Program Guidance (13) relevantto this subject. Because HHS is responsible for proper use ofMedicare and other government programs, it is vigilant toprevent improper use of the program funds. The Guidancespeaks to support provided by pharmaceutical manufacturers inSection B: “Key Areas of Potential Risk.” With regard toeducational grants, the Guidance addresses the issue that, tothe extent the medical product manufacturer has any influenceover the substance of an educational program or the speaker,there is a risk that the educational program may be used forinappropriate marketing purposes.

To reduce the risks that a program supported by a grantis used improperly to induce or reward product purchases orto market products inappropriately, manufacturers are ad-vised to separate their grant-making function from the salesand marketing function. Effective separation of these func-tions should help ensure that grant funding is not inappro-priately influenced by sales or marketing motivations andthat the educational purposes of the grant are legitimate.With regard to research funding, the Guidance advises clearseparation of research contracts from marketing.

The HHS Guidance also states that manufacturers,providers, and suppliers of health care products and servicesfrequently cultivate relationships with physicians in a posi-tion to generate business for them through a variety ofpractices, including gifts, entertainment, and personal ser-vices compensation arrangements. The activities have apotential for fraud and abuse and, historically, have gener-ated a substantial number of anti-kickback convictions (seethe Task Force 4 report). The Guidance speaks to consult-ing and advisory payments and conveys concern aboutcompensation relationships with physicians for servicesconnected directly or indirectly to a manufacturer’s market-ing sales activities, such as speaking, certain research, orpreceptor or “shadowing” services. These may pose a risk offraud and abuse. It is important to note that the Guidanceis advisory in intent; nonetheless, it does have the legalauthority of federal anti-kickback statute, which poses riskof prosecution by the U.S. Attorney General’s office.

RECOMMENDATIONS

The Consensus Conference believes the policies proposedherein would represent the ACCF, the AHA, and cardio-vascular subspecialty societies’ commitment and dedicationto the highest levels of professionalism and ethical behaviorin educational activities and publications. Therefore, the Con-sensus Conference proposes the following recommendations:

1. Disclosure of financial relationships with commercial in-terests should be mandatory for educational activities andpublications (original articles, policy statements, editorials,texts, and guidelines). The policy and disclosure guidance




discussed in this document should be adopted by theACCF, the AHA, and cardiovascular subspecialty societiesusing as uniform a mechanism as possible.

2. The ACCF, the AHA, and cardiovascular subspecialtysocieties should develop a secure uniform databasecontaining full disclosure of relationships with commer-cial interests for individuals (including planners andreviewers of programs and publications) participating inACCF and AHA educational activities, products, pol-icies, services, and scientific publications. The databaseshould be updated yearly.

3. The ACCF, the AHA, and cardiovascular subspecialtysocieties should educate their members and promotecompliance with: the AMA’s policy on “Gifts to Physi-cians from Industry” (8); the ACCME’s “Standards forCommercial Support” (10); and the ACGME’s “Princi-ples to Guide the Relationship Between Graduate MedicalEducation and Industry” (11).


1. Landro L. Good medicine, bad journalism. Wall Street Journal.March 19, 2002.

2. Morin K, Rakatansky H, Riddick FA, Jr., et al. Managing conflicts ofinterest in the conduct of clinical trials. JAMA 2002;287:78–84.

3. The Association of American Medical Colleges. Task Force onFinancial Conflicts of Interest in Clinical Research. Available at:

http://www.aamc.org/members/coitf/start.htm. Last update 2004.Accessed April 15, 2004.

4. Lindsay B. Standards to Ensure the Independence of CME Activities.Available at: http://www.accme.org/. Last update July 1, 2004. Ac-cessed September 22, 2004.

5. The American Society of Clinical Oncology. Revised conflict ofinterest policy. J Clin Oncol 2003;21:2394–6.

6. Drazen JM, Curfman GD. Financial associations of authors. N EnglJ Med 2002;346:1901–2.

7. The National Institute of Health. Conflict of Interest Requirementsfor Grantees. Available at: http://grants2.nih.gov/grants/policy/coi/index.htm. Last update 2004. Accessed September 22, 2004.

8. Gibbons RJ, Smith S, Antman E. American College of Cardiology/American Heart Association clinical practice guidelines: part I: wheredo they come from? Circulation 2003;107:2979–86.

9. The Council on Ethical and Judicial Affairs. American MedicalAssociation. Code of Medical Ethics. Chicago, IL: 2002-2003, 91.

10. The Association of American Medical Colleges. ACCME’s Standardsfor Commercial Support. Available at http://www.accme.org. Lastupdate August 5, 2004. Accessed September 22, 2004.

11. The Accreditation Council for Graduate Medical Education.ACGME’s Principles to Guide the Relationship Between GraduateMedical Education and Industry. Available at http://www.acgme.org.Last update August 5, 2004. Accessed September 22, 2004.

12. The Food and Drug Administration. Guidance for FDA AdvisoryCommittee Members and Other Special Government Employees onConflict of Interest 2000. Available at: www.fda.gov. Last update2004. Accessed September 22, 2004.

13. The Office of the Inspector General of the U.S. Department of Healthand Human Services. OIG compliance program guidance for phar-maceutical manufacturers. Available at: oig.hhs.gov/authorities/docs/050503FRCPGPharmac.pdf. Last update June 17, 2003. AccessedSeptember 22, 2004.

Task Force 4: AppropriateClinical Care and Issues of “Self-Referral”Co-Chairs: James L. Ritchie, MD, FACC, FAHA, Michael J. Wolk, MD, FACCAuthors: John W. Hirshfeld, JR, MD, FACC, FAHA, Joseph V. Messer, MD, MACC, FAHA,Eric D. Peterson, MD, FACC, Eric N. Prystowsky, MD, FACC, FAHAParticipants: Timothy J. Gardner, MD, FACC, FAHA, Harry R. Kimball, MD,Richard L. Popp, MD, MACC, FAHA, Lynn Smaha, MD, PHD, FACC, FAHA,Sidney C. Smith, JR, MD, FACC, FAHA, L. Samuel Wann, MD, MACC, FAHA

INTRODUCTION“Professionalism is the basis of medicine’s contract withsociety. It demands placing the interests of patients abovethose of the physician, setting and maintaining standards ofcompetence and integrity, and providing expert advice tosociety on matters of health . . . . Essential to this contract ispublic trust in physicians, which depends on the integrity ofboth individual physicians and the whole profession” (1).Cardiovascular specialists support the fundamental princi-ples of primacy of patient welfare, patient autonomy, andthe promotion of social justice.

For the purposes of this document, “self-referral” occurswhen a physician recommends a patient intervention fromwhich the physician may benefit personally. Such recom-mendations usually facilitate the provision of efficient,effective, and high-quality care, but may also afford thepotential for abuse. As former JACC Editor-in-Chief

William Parmley stated so clearly: “At issue is the questionof intent; if the intent is to provide excellent medical care,the practice is laudable. If the intent is to subjugate medicaldecision-making, then the practice is unethical” (2). Thosefew physicians who are publicized for violating our trust donot reflect the rank and file of cardiovascular specialists.

The cardiovascular specialist’s primary duty is to thepatient. His or her role is to promote patient welfare in anincreasingly complex health care environment, one that hasbeen made even more complex by the anti-kickback statutesand Stark laws (see the following sections). Having enteredinto a physician-patient relationship, physicians must coun-sel their patients regardless of individual financial or medicalcare delivery system considerations or other factors, such associo-economic status, race, gender, or sexual orientation(3). The physician’s clinical judgment must not be influ-enced by financial incentives from a fee-for-service system




or disincentives from a capitated care system. Recommen-dations should be made based only on medical merit (4,5).Physicians must also contribute to the responsible steward-ship of health care resources.Growth and geographic variation in cardiac procedures.The use of cardiac procedures in the U.S. is increasing overtime. Figure 1 displays changes in the number of diagnosticcardiac procedures performed for Medicare patients be-tween 1994 and 2002. Office-based procedures account formuch of the rise in nuclear and echocardiographic testing.Many factors, such as the aging of the population, theepidemic of diabetes and obesity, advances in technology,and new therapies, may partially drive these increases.Studies have demonstrated marked geographic variations inthe use of both invasive and non-invasive cardiac procedures(6–10). The exact cause for geographic variation in proce-dure use remains elusive. Similar studies have found a linearrelationship between the availability of cardiovascular diag-nostic equipment in a given region and the use of suchequipment. The strongest predictor of catheterization in astudy of acute myocardial infarction was the availability ofonsite angiographic facilities (8). Other studies have con-firmed this relationship across a variety of health carepractice settings. More recent studies have demonstratedsimilar correlations between the availability and use ofnuclear equipment in a given area and the additionalcorrelation between rates of cardiac catheterization andcoronary revascularization (9). These data suggest that theuse of non-invasive diagnostic technologies appears to havea multiplying effect on subsequent cardiac resourceutilization.

The important question raised by these studies of thevariation in cardiac procedure utilization is which rate is

“right.” Specifically, is higher use in a given region or amongthose cared for by sub-specialists indicative of “over-use” ofprocedures or is there “under-use” elsewhere? The availableliterature on this topic is conflicting. Various studies haveexamined the appropriateness of cardiac procedures invarious settings. In the majority of these studies, even inhigh-use areas, more patients with accepted indications fora procedure (ACC/AHA Guidelines, Class I Recommen-dations) do not receive the procedure compared with thosepatients who receive procedures without an accepted indi-cation or with a contraindication (ACC/AHA Guidelines,Class III Recommendations) (11). Studies examining theimpact of this variation in care on patient outcomes havehad conflicting results. Some studies show that patientstreated in regions with lower utilization of invasive proce-dures have outcomes similar to those treated in regionsusing more resource-intensive care strategies (6,12,13).Other studies, however, have found that patients treated inregions using more invasive procedures had fewer symptomsand improved long-term survival (14). Outcomes in acutemyocardial infarction are better when the admitting physi-cian is a cardiovascular specialist, reflecting higher usage ofappropriate medications and procedures (15).

ENSURING APPROPRIATE USE OF PROCEDURES

Various options exist for managing potential conflicts ofinterest regarding self-referral in clinical practice. In-office/in-lab procedures performed in accordance with ACC/AHA guidelines by a physician who is competent in theperformance of the procedure simply reflects efficiency andthe appropriate standard of care. Physician ownership ofmedical equipment, especially high-cost, high-revenue

Figure 1. Number of cardiovascular imaging procedures among Medicare patients, 1994 to 2002.




equipment, is a complex professional issue. In all cases, theownership should be fully disclosed to the patient asdescribed in the American Medical Association (AMA)Code of Medical Ethics (16). The core question is whetherclinical decisions are in the patient’s interest or influenced bypotential personal gain by the physician owner. Althoughthis potential conflict exists, these arrangements may im-prove access and quality of care for patients. In general, thefollowing approaches should optimize care and reduceconcerns about inappropriate self-referral:

● use of evidence-based guidelines● physician and laboratory credentialing● periodic case conferences● oversight/review processes● consultation with other providers● full discussion with the patient regarding risks, benefit,

alternatives, and the option for a second opinion● disclosure/transparency of ownership

Utilization of ACC/AHA practice guidelines and clinicalcompetence statements. The cardiovascular communityhas access to extensive and disease-specific treatment guide-lines to inform diagnosis and treatment decisions. Thesejoint ACC/AHA documents include comprehensive guide-lines for the management of most major cardiovasculardiseases, including acute coronary syndromes, stable coro-nary artery disease, congestive heart failure, valvular heartdisease, atrial fibrillation, supraventricular arrhythmias, andpreoperative evaluation for noncardiac surgery. Additionalguidelines for specific therapeutic interventions are availableincluding percutaneous coronary intervention and coronaryartery bypass surgery. Utilization guidelines for most tech-nical procedures have been developed by the ACCF, theAHA, and other subspecialty societies. These includeguidelines for echocardiography, electrocardiography, am-bulatory electrocardiographic monitoring, cardiac catheter-ization, nuclear studies, pacer-defibrillator implantation,and exercise testing.

Where appropriate, guideline-writing groups includerepresentatives from many specialties, including cardiovas-cular surgery, internal medicine, family practice, emergencymedicine, and anesthesiology. These guidelines are easilyaccessed, either in full text or in an executive summary formon both the ACCF and the AHA web sites (www.acc.organd www.americanheart.org) and can be downloaded tohandheld computers. The guidelines are reviewed at leastyearly and updated as needed. Thus, current evidence-basedinformation about best practices is now available to physi-cian, payer, and patient alike, providing a powerful resourcefor appropriate evidence-based care (17,18). These guide-lines also provide recommendations for the frequency ofperformance of office procedures and allow responsibleparties to play a key role in understanding the need fortesting. Specific recommendations for the performance ofdiagnostic and therapeutic interventions are thus clearlydefined and are available to the entire health care commu-

nity; these broaden participation in determining when andin whom to carry out patient interventions.

The ACC/AHA guidelines form the basis for threeadditional instruments of great value in providing continu-ous quality improvement. Systems-based approaches such asthe ACCF’s “Guidelines Applied in Practice” and theAHA’s “Get With the Guidelines” programs have beenshown to enhance effective application and improve out-comes (19). In addition, performance measurements arebeing developed jointly by the ACCF and the AHA forperformance improvement and appropriateness of care.Closely related are issues of physician training and compe-tence in performing specific procedures. Practitioners per-forming procedures on their own patients or by referralshould achieve certification of adequate training and main-tenance of competence over time. The ACCF, the AHA,the American Board of Internal Medicine, and subspecialtygroups have developed a series of documents that detail theappropriate training and experience for competence in awide variety of cardiovascular procedures (20).Laboratory oversight. Appropriate oversight by physicianlaboratory directors is another approach to monitoringself-referral while broadening responsibility and encourag-ing proficiency in the performance of procedures. Regularreview by physician directors of catheterization, echocardi-ography, nuclear, and other laboratories is important inascertaining that indications for patient referral, proceduralquality, and outcomes all are satisfactory. Additionally, theyensure that caseload or other factors do not drive clinicallyinappropriate laboratory utilization.

Participation in laboratory databases is essential, withregular review and comparison to databases such as theACC National Cardiovascular Data Registry™ (21), whichcan be used for benchmarking of individuals, groups, orhospitals. While it is often difficult to determine theappropriateness of any single procedure in any single pa-tient, patterns of “diagnostic yield” from these tests can behelpful. For example, a laboratory whose rate of findingnon-occlusive coronary disease that is significantly higherthan one’s peers may need to review its selection criteria andthreshold for testing. Professional review groups consistingof experts from outside of the geographic region also can beemployed when local review is impractical. Diagnosticlaboratories should participate in accreditation and creden-tialing.Broadening health care responsibility. Given that thepotential for real or unconscious bias can be driven byfinancial conflicts, another approach to avoiding such bias isto involve other physicians without any financial stakes ineither clinical case-management conferences or conjointpatient management.

Although the vast majority of care decisions are made onan individual physician-patient basis, the potential forinappropriate self-referral may be moderated by employingclinical case conferences. Such meetings may include inva-sive and non-invasive cardiologists, primary care providers,




independent cardiovascular surgeons, cardiac care associates,and others, thus broadening the input into patient manage-ment decisions.

Another approach for responsibility sharing involves“partnerships in care,” wherein patients are cared for con-jointly by their primary care provider and a cardiovascularspecialist. In this care model, it is implicit that the cardiol-ogist will perform specialized diagnostic and therapeuticprocedures, with input from the referring and consultingphysician, as well as from the informed patient.

Physicians are often viewed by their patients as havingultimate authority in health care decisions. Therefore, phy-sicians must present the patient with a comprehensivediscussion of treatment alternatives, including the option todo nothing, along with the relative risks and benefits of eachalternative course. Whenever doubt exists on the part of thepatient or the physician, there should be the opportunity toseek additional opinions. For example, patients proposed formultivessel angioplasty should generally be told of surgery asan alternative and have the opportunity to consult a cardio-vascular surgeon. For those patients who cannot or will notparticipate in a discussion of care alternatives, it may beappropriate to involve other family members, friends, spir-itual advisors, and patient advocates in decision making. Insummary:

● The ACC/AHA guidelines are available for most car-diovascular conditions and for diagnostic and therapeuticprocedures, and are readily accessible to physicians andpatients on the ACC and the AHA web sites.

● Physician compliance with ACC/AHA guidelines formanagement of patients with cardiovascular diseaserepresents appropriate care in the majority of cases, andsuch compliance should reduce concerns about self-referral by cardiovascular practitioners.

● Procedural oversight by a professional laboratory directorand laboratory accreditation are both essential.

● Both procedural training and the credentialing of phy-sicians, technicians, and other health care providers arecritical to good care.

● Involving other health care providers in medical caredecisions, such as cardiovascular surgeons and primarycare providers, limits bias.

DIRECT-TO-CONSUMERADVERTISING AND SCREENING

Advertising of health-related services and products hasgrown significantly in recent years. Direct-to-consumer(DTC) advertising appears to be well entrenched and hasbeen legal for pharmaceuticals since the early 1970s. Morerecently, advertising in the public media has grown rapidlyfor medical devices, diagnostic testing (such as computedtomography-based coronary artery calcium screening orcholesterol screening), and for many non-cardiac or relatedprocedures. Sometimes performed in shopping malls orchurch parking lots, these activities have raised a variety of

ethical concerns for the medical profession. At question isthe propriety of such DTC advertising, physician ownershipor investment in such enterprises, concern about patientreferral by a physician to a facility in which he or she is anowner or investor, and the value of such screening inpromoting the public health.

Physician advertising is now recognized as legal under theprovisions of Section 5 of the Federal Trade CommissionAct. Regulations were clarified extensively by the Food andDrug Administration (FDA) in 1997, including such lan-guage as the requirement for “adequate provision: sideeffects, contraindications, and effectiveness—this shouldinclude either reference to a toll-free phone number, areferral to a physician or pharmacist, a referral to a printadvertisement containing a summary of risk, and a web site.”No such guidelines exist for device manufacturers fordiagnostic testing; in fact, the FDA has opposed some ofthe diagnostic screening and testing advertisements (22,23).

Both the AMA and the American College of Physicianshave reviewed these issues and published similar guidelines(4,5). These guidelines state that such advertisements “shallnot be misleading because of the omission of necessarymaterial information, shall not contain any false or mislead-ing statement, or shall not otherwise operate to deceive.”The AMA states that advertisements should “communicatethe information contained therein to the public in a readilycomprehensible manner” (22,23). Further, “the key issue,however, is whether advertising or publicity regardless offormat or content is true and not materially misleading.” Itthus seems clear that advertising per se is professionallyaccepted and legal, and the issues are those of appropriatecontent and disclosure.

Guidelines similar to those for DTC pharmaceuticaladvertisements seem appropriate and in part have beenproposed by the AMA for DTC advertising of diagnostictesting. Where cardiovascular testing is involved, profes-sional societies such as the ACCF and the AHA shouldassume a leadership role in defining these guidelines at thepolicy level rather than at an individual patient level. Insummary:

● The DTC advertising for diagnostic tests is unregulatedand needs oversight by appropriate regulatory agencies.

● Professional societies should develop guidelines for suchadvertising and for the appropriateness of such tests.

CARDIOVASCULAR SPECIALTYHOSPITALS AND SELF-REFERRAL

The role and quality of specialty hospitals. Cardiovascu-lar specialty hospitals are a recent phenomenon. Althoughcardiovascular care has traditionally been a component offull-service general hospitals, in recent years a small numberof free-standing cardiovascular specialty hospitals have beencreated. Virtually all of these hospitals are for-profit and arelocated in jurisdictions with minimal or absent governmen-tal control over the creation of health care facilities.




The cardiovascular specialty hospital vision is a facilityspecifically tailored to provide optimal cardiovascular care.Ideally, a dedicated heart hospital can operate without anyof the compromises that result from the design and resourcecompetition issues of a full-service hospital. Such facilitiestypically offer complete inpatient and outpatient cardiovas-cular diagnostic and therapeutic services, but often do notprovide many of the non-cardiovascular services that aretraditionally included in a full-service hospital. Several incen-tives foster the creation and operation of heart hospitals:

1. The heart hospital architecture, equipment, and opera-tional protocols can be optimized for cardiovascularcare. Thus, it has the potential to provide the bestworking environment for cardiovascular health careproviders and an optimal clinical care environment forpatients.

2. Reimbursement rates for cardiovascular care under pro-spective payment systems are generally favorable. Thisgives the heart hospital reasonable reimbursement and agreater potential to be profitable, when compared to thefull-service hospital, which provides many services forwhich prospective payment is less favorable.

3. Full-service hospitals, unlike heart hospitals, may divertrevenue from cardiovascular care to support other ser-vice lines that are less well reimbursed. This does nothappen in a heart hospital.

Conversely, there are potential concerns about the appro-priateness and positioning of such institutions in the overallhealth care system. For example:

1. Can such institutions provide optimal care to all cardio-vascular patients?

2. Do such hospitals undermine the strength and integrityof full-service hospitals?

3. Do physicians who invest in these for-profit hospitalshave a conflict of interest when deciding where to admita particular patient?

The U.S. General Accounting Office recently released astudy of specialty hospitals in the U.S. that was commis-sioned by the U.S. Congress (24). It identified 15 currentlyoperating heart hospitals with approximately a dozen morein various stages of planning and construction. Virtually allwere for-profit institutions and virtually all had significantinvestment on the part of physicians who held privileges atthat hospital.

With respect to economics and regional competition, thestudy found that, whereas the majority of heart hospitalswere relatively small institutions, generally with 60 or fewerbeds, they frequently had a major regional impact in thatthey tended to deliver a large fraction of the cardiovascularservices in their service area. Thus, they had a potentiallylarge impact on the cardiovascular service lines of thecompetitive full-service institutions in their region. Thespecialty hospitals tended to have a somewhat more favor-able payer mix (smaller fraction of Medicaid-reimbursed

patients) than the full-service hospitals. In addition, spe-cialty hospitals tended to have a slightly lower case-severityindex than full-service hospitals. All of these trends work toenhance such institutions’ financial performance relative tofull-service hospitals.

With respect to clinical quality, other published studiesindicate that heart hospitals achieve outcomes comparableto those of full-service hospitals with a potentially reducedlength of stay (25).Ethical issues related to specialty hospitals. PHYSICIAN

FINANCIAL CONFLICT OF INTEREST. Most heart hospitalsare for-profit. Many are capitalized in part through physi-cian investment. Thus, some physicians who have privilegesat a heart hospital have a financial stake in the institution. Ithas been pointed out that, in most cases, physicians provideless than 50% of the start-up capital and, in general,individual physicians have small ownership shares (26).Thus, it can be argued that an individual physician’sfinancial stake in an institution is modest, and a physician’sincome is not significantly influenced by the heart hospital’sfinancial performance. However, the physician’s capital is atrisk, and should the hospital fail financially, he or she wouldstand to lose the capital investment. Thus, such a conflictmight cause a physician to admit less complicated, betterinsured patients to the heart hospital while diverting themore complex, less well insured patients to the full-servicehospital.

IMPACT ON COMPETING FULL-SERVICE HOSPITALS. Thefull-service hospital is often a vital community resource, andthe quality of health care within the community may bedependent upon its financial and clinical success. Hearthospitals can have a competitive advantage over full-servicehospitals for several reasons, including more favorable payermix and the ability to avoid caring for the more complicatedcases under the rationale that such patients require servicesthat might be offered only at full-service hospitals. Thus,there is the potential for heart hospitals to “skim the cream”of the cardiovascular service line. At this time, sufficientpublished studies are not available to evaluate this concernproperly. In summary:

● Heart hospitals present an alternative to traditionalfull-service hospitals for the delivery of straightforwardcardiovascular care.

● Heart hospitals have several characteristics that may beappealing to individual cardiologists and their patients.

● Heart hospitals may present a possible conflict of interestfor involved physicians.

● Heart hospitals have the potential to affect a communi-ty’s overall health care delivery system.

The ACC Board of Trustees has not taken a position foror against such hospitals, but has endorsed the followingstatement: “Given the wide range of opinions expressed byACC members and the ACC Board of Trustees, the ACCrecommends monitoring the data being collected during the




18-month congressionally mandated moratorium on spe-cialty hospitals. There remains significant, unansweredquestions about the financial impact on general, acute-carehospitals, patient severity of illness at referral, and quality ofcare in specialty hospitals. The primary concern of the ACCis delivery of high-quality cardiovascular care to all Ameri-cans; sufficient data do not now exist to judge whetherspecialty heart hospitals are a useful innovation or aredetrimental to this mission. The ACC urges use of stan-dardized databases such as NCDR and the Society forThoracic Surgery in an objective analysis of the performanceof specialty hospitals” (ACC Board of Trustees Minutes,December 18, 2003). Likewise, the AHA’s primary missionis the reduction of disability and death from cardiovasculardisease and stroke, and in the absence of adequate data, theAHA has not taken a position on heart hospitals. The AHAagrees that the data from the 18-month mandated morato-rium must be studied carefully before conclusions can bereached.

LEGAL ISSUES IN SELF-REFERRAL

The anti-kickback statute. Fraud and abuse laws providecriminal penalties to those who knowingly and willfullyoffer, pay, solicit, or receive remuneration in exchange forreferrals of patients or business reimbursed by a federalhealth care program (27,28). The law was aimed to preventoutright payments for referrals by clinical laboratories, homehealth agencies, durable medical equipment vendors, andother suppliers. These policies were enacted to:

1. prevent referrals based on financial benefit to the healthcare provider making the referral, rather than thegreatest benefit for the beneficiary;

2. prohibit solicitation of such payments;3. prevent overutilization of services; and4. control governmental cost of providing health care

coverage.

Violation of the statute is a felony punishable by fines ofup to $25,000 and imprisonment for up to five years.Individuals found guilty might be excluded from participa-tion in federal and state health care programs.

Congress also directed the Secretary of Health andHuman Services to develop regulations that would specifi-cally exclude certain arrangements from being consideredanti-kickback violations. The safe-harbor exceptions recog-nize that there are legitimate reasons for a health care entityto pay a physician—as, for example, a hospital medicaldirector—or for clinical laboratory oversight. Potentiallyillegal hospital-physician incentives have also been definedand can include the use of discounted office space orequipment in facilities usually located near the hospital.Such arrangements are considered inurements designed toinfluence physicians’ utilization decisions. Fair-market leaseagreements are advised to avoid such liabilities. The Officeof the Inspector General accepts requests for formal advi-

sory opinions although these may not be relied upon bythird parties as legal precedent (28).The Stark laws. The Stark Law seeks to prohibit referralsby physicians of Medicare or Medicaid patients to facilitiesin which the physician has an ownership interest or fromwhich the physician receives compensation (28,29). Com-pensation can be any form of remuneration, direct orindirect, between the physician or family member and thedesignated health service provider. These include clinicallaboratory services, radiology diagnostic services, inpatientand outpatient hospital services, and durable medical equip-ment covered in the Medicare fee schedule. The Starklegislation is based on the presumption that physicians willoverutilize such services if they profit from the referrals orthe orders. “Stark” is distinct from the anti-kickback statute.First, Stark evaluates exclusively the financial incentives ofthe provider making the referral and not the intent of theparties. Second, Stark is a civil, rather than criminal, statute.Violators are not subject to criminal prosecution but may beexcluded from federal health care programs and face civilmonetary fines.

Much confusion has resulted from the passage of twoStark bills, from the complexity of the laws, and from theslow issuance of rational implementing regulations. Al-though the basic prohibition for a referral was clearlydefined, Stark II provides exceptions to the general prohi-bition on referrals (29). The most common exception is thein-office ancillary services exception, when the service isperformed within a group practice. In summary:

● The Stark law and the anti-kickback legislation areextremely complex and confusing. It has taken 10 yearsfor the government to publish only a portion of the finalregulations.

● Safe-harbors are difficult to interpret without legalcounsel.

● Although these laws have prevented some of the mostethically egregious examples of kickbacks and fee split-ting, they have not limited the significant growth incardiovascular activities that are in part due to self-referral within the solo or group practice setting.

OVERVIEW AND SUMMARY

Both the ACCF and the AHA take seriously the respon-sibility of their members to optimize care for their patients.This can best be done by effective application of evidence-based medicine and practicing the highest standards ofmedical care. The issue of “self-referral” and its possibleincentive for inappropriate utilization is an important con-sideration in medical practice. In this document, we havediscussed the pertinent background of this issue and madepositive recommendations to address this concern. Mostself-referral is entirely appropriate. This “self-referral” isopen and obvious to all parties. The management ofself-referral also includes procedural laboratory oversightand accreditation and physician competence in a given




procedure. Physician ownership of equipment outside of thephysician’s practice setting is a complex professional issueand should conform to AMA guidelines, which promi-nently include full disclosure and transparency.

The commercialization of screening tests and advertise-ments for these tests are largely unregulated. This fieldneeds both regulatory oversight and guidance from profes-sional organizations such as the ACCF, the AHA, andcardiovascular specialty societies.

Cardiovascular specialty hospitals have raised issues aboutpotential conflicts of interest among physician investors andtheir possible impact on community hospitals. The ACCFand the AHA have not taken a specific position on thisissue, but members of this Consensus Conference currentlysupport the collection of more data about the quality of careand outcomes provided by such hospitals.

AcknowledgmentsThe authors appreciate the review and commentary pro-vided by J. Ward Kennedy, MD, MACC, FAHA, andNathan R. Every, MD, MPH, FACC.


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2. Parmley WW. Changing guidelines on conflict of interest. J Am CollCardiol 2001;37:1749–50.

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Task Force 5: Expert Testimony and OpinionsCo-Chairs: Robert O. Bonow, MD, FACC, FAHA, Douglas P. Zipes, MD, MACC, FAHAAuthors: Jeffrey L. Anderson, MD, FACC, FAHA, Melvin D. Cheitlin, MD, MACC, FAHA,Larry B. Goldstein, MD, FAHA, Augustus O. Grant, MD, PHD, FACC, FAHAParticipants: David Faxon, MD, FACC, FAHA, Joao A. C. Lima, MD, FACC, FAHA,Rose Marie Robertson, MD, FACC, FAHA

INTRODUCTION

The American College of Cardiology Foundation (ACCF)and the American Heart Association (AHA), premierorganizations in cardiovascular medicine, are consideredtrusted sources of consensus about matters related to car-diovascular health. It is important to make clear when oneis or is not representing one of these organizations.

HOW DOES ONE DIFFERENTIATE ANDDESIGNATE PERSONAL PROFESSIONALOPINION FROM EXPRESSION OF THEPOSITION OF THE ACCF OR THE AHA?

Members of the ACCF or the AHA have a variety of rolesaside from their professional relationships with these orga-nizations. Delineation of these varying roles may not alwaysbe entirely clear. A member’s particular expertise in researchor as a care provider naturally provides the impetus for his orher official contributions to the organization’s programs,written position statements, and guidelines. Individuals mayalso serve each organization in a variety of official capacities,including as officers, board members, committee chairs, andmembers.

It is the responsibility of the individual member not tomisrepresent or imply an opinion as being that of theACCF or the AHA unless the person is functioning as anofficially designated representative of either organization.This may require a formal statement by the individual toexclude any possibility that his or her personal opinion couldbe reasonably interpreted as being that of the organization(as may be the case if one’s organizational service orcontributions are highlighted as part of one’s qualificationsas an expert), unless organizational affiliation is absent fromthe stated qualifications. This is particularly important if theexpert is an officer, board member, or committee chair of theACCF or the AHA.

HOW SHOULD THE ACCFAND THE AHA DESIGNATE ASPOKESPERSON FOR A SPECIFIC ISSUE?

An individual’s qualifications as an expert are often based onrecognized clinical expertise, which is at times difficult toquantify, or on one’s contributions to medical knowledgebased on research productivity as reflected in peer-reviewpublications. Both ACCF and AHA volunteers (and staff)

file annual conflict of interest declarations. Spokespersonsfor specific topic areas should have expertise in that areabased on qualifications noted in the preceding text, and,wherever possible, should not have any actual or perceivedconflicts of interest that could influence their opinions orcall into question the independence or integrity of theorganization’s positions. If it is not possible to find aspokesperson without such conflicts, these conflicts must beclearly stated.

WHAT ARE THE RESPONSIBILITIESOF INDIVIDUAL MEMBERS ACTING AS EXPERTWITNESSES IN LITIGATION REGARDING INDUSTRY?

The ACCF supports the concept that the cardiovascularspecialist has the obligation and duty as a citizen, a physi-cian, and a member of a profession to act as an expertwitness in litigation where issues appropriate to his or hertraining and expertise are involved to see that justice is doneto both the plaintiff and the defendant. Undeniably, it is truethat physicians may be wrongly accused of malpractice whena bad outcome not due to negligence has occurred. It is alsotrue that physicians have injured patients as a result ofnegligence or malpractice. The interests of society and themedical profession are best served when scientific andunbiased expert witness testimony is available to bothplaintiffs and defendants in medical malpractice litigation.Acting as an expert witness, the physician serves as aknowledgeable, experienced, impartial individual, present-ing his or her own considered opinions of the case and notacting in any official ACCF capacity.

Suggestions to encourage physicians to act as expertwitnesses and discourage the use of “professional expertwitnesses” have been offered, each of which has merit. Onesuggestion is that medical schools include training of phy-sicians in the skills required to act as an expert witness (1,2).Another suggestion is that the medical societies maintain alist of qualified physicians willing to act as expert witnessesso that the lawyers can use this as a pool of medical expertsfrom which to draw (3,4).

The American Medical Association has written thatmedical expert witness testimony is effectively part of thepractice of medicine (5). The expert witness either for theplaintiff or the defendant is not an advocate for the side thathas engaged him or her; that is the duty of the lawyers.Before agreeing to act as an expert witness, the physicianshould assess the merits of the case and give an honest




opinion to the requesting attorney (6). The role of theexpert witness is to assist the judge and jury to understandthe medical facts of the case. As such, the expert witness actsboth as a consultant to the court and as a teacher (7,8). Thetestimony must be honest, objective, and fully impartialregarding the medical information in the case. Becausejudge, lawyers, and jury are lay people, the medical testi-mony must be clearly stated, concise, and understandable.The expert witness should review all of the relevant recordsused to establish the facts of the case as well as the standardof practice as it existed at the time of the alleged occurrence.The expert witness has the ethical obligation to give truthfulanswers within the bounds of his or her expertise and mustbe able to sincerely and validly justify the position he or shebelieves. Consequently, physicians acting as expert witnessesshould be willing to testify for plaintiffs or defendants indifferent cases depending on the merits of the case. Properexpert testimony is balanced, and where doubt exists, suchdoubt should be readily admitted (9).

In 1990, the Guidelines for the Physician Expert Witnesswere published by the American College of Physicians(ACP) (10). On October 15, 1995, the ACC Board ofTrustees approved this policy statement, which is derivedfrom the ACP guidelines (11).

Medicine, as a profession, has the obligation to policeitself (3). Poor practitioners who are a danger to theirpatients should be held accountable, and good physiciansmistakenly accused must be defended (9). The expertwitness testifying to the standard of care should be of thespecialty or field that is the same as the defendant physicianor medical professional. An internist or family-practicephysician should not be held to the same standard of care asa cardiologist. Within the field of cardiovascular disease, ageneral cardiologist can act as an expert witness in all aspectsof the diagnosis and general management of patients withcardiovascular disease. Questions involving technical detailsof an interventional or electrophysiologic procedure shouldbe the province of a practicing specialist who is boardcertified in these areas.

RECOMMENDED CRITERIA FOR EXPERTWITNESSES IN MALPRACTICE LITIGATION

1. The cardiovascular expert witness must have a current,valid, and unrestricted license within his or her area ofprofessional practice.

2. For medical testimony in the field of cardiovasculardisease, the expert witness should be board certified bythe American Board of Internal Medicine or the Amer-ican Board of Osteopathic Internal Medicine in thespecialty of cardiovascular disease or equivalency inpediatric cardiology or cardiovascular surgery. The car-diovascular expert should be actively and primarilyengaged in the practice of the specialty or subspecialtyunder consideration. Similar criteria apply to the car-

diovascular subspecialties, such as electrophysiology andinterventional cardiology.

3. For testimony by other health care professional expertwitnesses, the experts should have equivalent qualifica-tions appropriate to their area of practice.

4. The expert must be knowledgeable, familiar with, andqualified in the specific area in which he or she istestifying, and with commonly accepted clinical practicestandards as they relate to the case and locale.

5. Compensation for expert testimony should be reason-able and commensurate with the time and effort ex-pended. It is unethical for an expert witness to acceptcompensation that is contingent on the outcome oflitigation.

6. The expert witness should be willing to submit tran-scripts of prior and current depositions and courtroomtestimony for peer review.

7. Expert witness testimony should be fair, thorough, andobjective. It should not exclude any relevant informationthat has a bearing on the case.

WHAT ARE THE RESPONSIBILITIESAND/OR OBLIGATIONS OF INDIVIDUALMEMBERS ACTING AS EXPERT WITNESSESIN OTHER LITIGATION, CLASS ACTIONLITIGATION, OR PATENT ISSUES, REGARDING THEPHARMACEUTICAL AND MEDICAL DEVICE INDUSTRIES?

The expert witness should testify in the area of his or herexpertise. Unfortunately, not all expert witnessing is done byexperts (12). There are physicians who have become “pro-fessional expert witnesses” or “hired guns” and make theirentire living testifying as “medical experts” (3). Theirtestimony may not always be objective and unbiased, andthey may function as partisans rather than scholars (1,8).They exist because physicians have been reluctant to testifyas expert witnesses for several reasons: distrust of lawyers,uneasiness with the legal system and the process of testify-ing, not wanting to encourage malpractice or other types oflawsuits, and fear of being censured by other physicians(13). The AMA, the ACP, and the ACCF have all madestrong recommendations that it is the duty of physicians toact as expert witnesses in their areas of expertise (9,11,14).With the availability of adequate numbers of physicianswilling to act as expert witnesses, it is hoped that the use ofthe “professional expert witness” will decrease (10).

Expert witnesses must be truthful, and violators should besanctioned. The question remains as to what mechanismshould exist to perform the necessary function of developingdisciplinary steps to deal with the physician who gives falseexpert witness testimony. Numerous suggestions have beenmade (12). Among these is that the ACCF should have apanel to review cases where physicians have been accused ofgiving false or misleading expert testimony, as has beendone by other organizations (i.e., American Academy ofNeurology) (12). It is possible that this could lead to




controversy among the Fellows of the ACCF and litigationagainst the organization and could entail significant invest-ment of time and money. The issue is an important one andrequires additional discussion to determine the best ap-proach. If such a panel is created, it is suggested that thereview of cases be narrowly focused on the contestedtestimony of the expert witness. Another suggestion is toinclude independent court-appointed, expert filing of opin-ion letters by experts with supporting documentation, and asanction process by courts and/or authoritative boards fortestimony that is deemed inaccurate, false, or contradictoryto the standard of care (15). This, too, requires furtherdiscussion.

In product liability litigation, class action litigation, andpatent issues regarding the pharmaceutical and medicaldevice industries, court-appointed neutral expert witnessesidentified by the appropriate medical societies could play aconstructive role in providing unbiased testimony in medicallegal disputes. All of the professional and ethical behaviorcharacterizing the conduct of an expert witness shouldapply.Experts in the media. When an expert is contacted by themedia for an opinion, he or she must make it clear whetherthe opinions expressed are the individual’s personal opinionsor whether the expert is acting as a spokesperson for theACCF and/or the AHA. If the latter, the individual mustbe certain that he or she accurately expresses the position ofthe organization.Experts providing public testimony. When an expert isasked to testify before Congress or another governmentbody, a different level of responsibility exists. If the expert isacting only as a witness in the area of his or her expertise andnot representing an official position of the ACCF and/orthe AHA, then the expert should clarify that he or she isexpressing a personal/professional opinion. However, if theexpert is testifying about the position of the ACCF and/orthe AHA, then this testimony carries the weight of thecommunity that is represented by the ACCF and/or theAHA. Such a witness either should be appointed by theorganization to represent its official position, or he or she

should make clear that the views expressed do not representthe organization.

When an expert witness is testifying about what is said inan ACC/AHA guideline, if what he or she quotes is directlyfrom the guideline, then that has the imprimatur of theACCF and the AHA. It makes no difference whether thephysician was or was not on the writing committee for thatguideline. It is what is in the guideline that has the officialendorsement of the ACCF and the AHA.


1. Brent RL. The irresponsible expert witness: a failure of biomedicalgraduate education and professional accountability. Pediatrics 1982;70:754–62.

2. Awerbuch M. The doctor as expert witness. Med J Aust 1993;159:206–8.

3. Masella RS, Meister M. The ethics of health care professionals’opinions for hire. J Am Dent Assoc 2001;132:361–7.

4. Kaufman HH. The expert witness. Neither Frye nor Daubert solvedthe problem: what can be done? Sci Justice 2001;41:7–20.

5. Weintraub MI. Expert witness testimony: an update. Neurol Clin1999;17:363–9.

6. Boyarsky S. Practical measures to reduce medical expert witness bias.J Forensic Sci 1989;34:1259–65.

7. Weinstein JB. Expert witness testimony: a trial judge’s perspective.Neurol Clin 1999;17:355–62.

8. Anderson B, Jr. The expert witness. Ophthalmology 1990;97:1390–2.9. The American Academy of Pediatrics. Guidelines for expert witness

testimony in medical malpractice litigation. Committee on MedicalLiability. Pediatrics 2002;109:974–9.

10. The American College of Physicians. Guidelines for the physicianexpert witness. Ann Intern Med 1990;113:789.

11. The American College of Cardiology. Recommended criteria forexpert witnesses. Board of Governors’ Ad Hoc Task Force to developrecommendations for malpractice reform. J Am Coll Cardiol 1996;27:250.

12. Milunsky AJ. Lies, damned lies and medical experts: the abrogrationof responsibility by specialty organizations and a call for action. ChildNeurol 2003;18:413–9.

13. Fish R, Rosen P. Physicians should be expert witnesses. J Emerg Med1990;8:659–63.

14. The American Medical Association, Council on Ethical and JudicialAffairs. Recent opinions of the Council on Ethical and Judicial Affairs.JAMA 1986;256:2241.

15. Fisher CW, Dombrowski MP, Jaszczak SE, Cook CD, Sokol RJ. Theexpert witness: real issues and suggestions. Am J Obstet Gynecol1995;172:1792–7.




Task Force 6: Code of Conductfor Staff and Volunteer LeadershipCo-Chairs: Pamela S. Douglas, MD, FACC, FAHA, Thomas J. Ryan, MD, MACC, FAHAAuthors: George A. Beller, MD, MACC, FAHA, Edward F. Hines, JR, JD, David Wm. Livingston, JD,Christine W. McEnteeParticipants: Nancy A. Brown, Karen J. Collishaw, Arthur Garson, JR, MD, MPH, MACC, FAHA,Rose Marie Robertson, MD, FACC, FAHA, Sidney C. Smith, JR, MD, FACC, FAHA,Gayle R. Whitman, PHD, RN, FAAN, FAHA

INTRODUCTION

Over the past several years leadership in general, andcorporate leadership in particular, has come under war-ranted scrutiny by the American public not only for uneth-ical but, in many instances, fraudulent practices. The pro-fessions, and particularly the medical and scientificprofessions, have also been placed under increased scrutinyby government officials and the public. To be sure, thesestains on the moral fabric of American leadership are spottyand hardly reflect the norm that characterizes the leadershipof the totality of American enterprise. Notwithstanding, itseems both timely and important to examine and codify, ifpossible, the behavioral patterns that should be operativewithin the leadership of organized cardiology as reflected inits two principal institutions, the American College ofCardiology Foundation (ACCF) and the American HeartAssociation (AHA). The goal of this Task Force is tohighlight those high moral and ethical standards that willserve to convey the integrity and professionalism of ourorganizations. It is the obligation of leadership and staff toreflect values by acting in a morally responsible and profes-sional manner.

The ACCF and the AHA are both uniquely intertwinedwith the dual obligation that the health care professional(HCP) has to both the patient and to society. The primaryobligation of the HCP is to the patient and to do that whichis best for his or her well-being. This is the principle ofbeneficence (the obligation to protect persons from harm bymaximizing anticipated benefits and minimizing possiblerisks of harm). In addition to supporting members in caringfor individual patients, the ACCF and the AHA must alsoaddress societal concerns and adhere to the principle ofdistributive justice (which requires that the benefits andburdens of research and other health care resources bedistributed fairly). Another tension is the dual obligation ofthe ACCF and the AHA to advocate for their professionalmembers, and to advocate for patients and society as awhole. These multiple responsibilities, with their inherenttensions, mandate that the basic tenets of organized cardi-ology must be founded on a moral model in addition to theeconomic and contractual models currently practicedthroughout corporate America today. This premise was setforth almost 15 years ago in 21st Bethesda Conference:

Ethics in Cardiovascular Medicine (1), and what holds truefor the contemporary HCP most certainly applies to itscorporate leadership. The face of American cardiology isreflected in the image of both the staff and the volunteerleadership of the ACCF and the AHA as seen not just bypatients but also by the scientific and clinical communities,the public-at-large, the media, government, industry, andcorporate America. Additionally, the ACCF’s and theAHA’s tax-exempt status carries further obligations tosociety. Accordingly, in this Task Force report we haveattempted to underscore those qualities essential to thestructural and operational prerequisites that constitute themoral model. This is as difficult as it is similar to theAristotelian concept of defining the virtuous man.A statement of the problem. Upon reflection, it wouldappear that over the closing decades of the last century therehas been an erosion of trust pervasive throughout thiscountry in virtually all sectors of society. The hyperboleassociated with current marketing techniques, the expandedmedia coverage with its emphasis on sensationalism, and agenerally fading “truth-in-lending” ethos are likely contrib-uting to the erosion of what used to be a solid andgeneralized trust. More subtle forces probably explain otheracknowledged ills we witness today, which range from gradeinflation to an absence of accurate disclosure in letters ofrecommendation, from failure of full disclosure to falseclaims, and from overpricing to outright stealing, to identifybut a few. Mistrust has tainted such icons as the New YorkStock Exchange and many of its leading members, theOlympic Organizing Committee, the Federal Bureau ofInvestigation laboratories, prominent philanthropies, andeven to the churches of organized religions. The professionsof law and medicine have also been caught in the glare ofthis penetrating spotlight. Only recently, cardiology itselfhad to endure the revelation of alleged greed within amedical institution in California (2). Stories of conflict ofinterest linked to biased clinical research continue toemerge.

Amidst this threatening climate it seems prudent toexamine integrity and trust as they presently exist within allreaches of cardiovascular medicine. Where they are foundlacking or weakened, remedies need to be devised for theirrestoration. Although this is the overarching objective of the




Consensus Conference, this Task Force addresses the de-lineation of a code of conduct for staff and volunteers andhas identified three separate areas that relate to the issue oftrust in cardiovascular medicine: 1) the moral obligations ofits leadership, 2) the stewardship of the organization, and 3)the identification of potential or perceived conflicts ofinterest.

These are meant to apply to anyone in a position ofauthority, influence, or privileged knowledge. It is alsomeant to apply to conduct governing professional andinterpersonal relationships, including staff-to-staff interac-tions, staff-leadership interactions, staff-volunteer interac-tions, and volunteer-to-volunteer interactions.

MORAL OBLIGATIONS OF VOLUNTEER LEADERSHIPAND SENIOR STAFF OF NON-PROFIT ORGANIZATIONS

The law generally imposes three primary obligations on themembers of the board of a charitable organization (3). Thefirst is a “duty of care,” which means that board memberswill act with the same degree of care or diligence as theywould in their own personal or professional activities. Thesecond is a “duty of loyalty,” which means that a boardmember must always act in good faith and avoid placing hisor her own interests ahead of those of the organization. Thethird is a “duty of obedience,” which means that a boardmember must faithfully discharge the obligations imposedon him or her by law and by the corporation’s bylaws andpolicies. Senior staff and volunteer leadership of a non-profitorganization share on a moral level these duties to protectand care for the organization they serve and the resourcesthey steward (4).

These duties obligate senior staff and volunteers to takethe time to inform themselves of the organization’s bylaws,policies, and procedures. Only by so doing can senior staffand volunteers ensure that, in carrying out their duties asvolunteer leaders or senior staff, they avoid misrepresentingor misstating the organization’s position or taking action inconflict with its established policy or consenting to orparticipating in inappropriate actions or decisions of othersin the organization.

Volunteers and staff should act only within the scope oftheir authority. For example, in their contact with potentialdonors, they must avoid making promises they lack theauthority to make or that the organization is not capable offilling without violating its established policies and proce-dures. In contacts with the press, both volunteers and staffmust avoid making statements regarding the organization’sposition unless the organization in fact has an establishedposition and unless these individuals are authorized andprepared to comment on it. In contact with public officials,both volunteers and staff members must exercise care inlobbying and political activities to avoid jeopardizing theorganization’s tax-exempt status or subjecting it to criticismin the press. In general, volunteers and staff must avoidcommitting the organization to any action unless they are

duly authorized to do so. Creating unfulfilled expectationson the part of donors or other members of the public tendsto erode the trust or goodwill on which the organization’ssuccess is based.

Volunteers and staff must always act in accordance withthe organization’s policy and should understand and respectthe dynamic of governance/policy-setting and distinguish itfrom operational/management decision-making. Also, vol-unteers and staff must diligently carry out agreed-upon tasksand assignments, knowing that their failure to dischargeundertaken tasks may expose the organization to embarrass-ment and legal claims, and may jeopardize the organiza-tion’s ability to accomplish its mission. This is particularly arisk in the case of volunteers who at the time they agree todo something may fail to recognize the consequences to therest of the organization of their own failure to perform.Prudent staff and governing bodies recognize this risk andmanage their volunteers accordingly.

Volunteers and staff must protect the confidentiality oftheir organization’s information, such as its intellectualproperty, its business and operational plans, its personnelinformation and actions, member lists, and the identity ofindividual donors.

Moreover, volunteers and staff should understand that theorganization’s reputation, which is so important to its abilityto accomplish its mission, is based on the public’s trust,which, as recent events make clear, is fragile and can easilybe eroded. To protect this public trust, volunteers and staffmembers should report misconduct by others in the orga-nization to the appropriate officials who have the authorityto deal with it.

The ACCF and the AHA, as organizations sensitive toethical issues, should have a carefully articulated set of corevalues. All volunteers and staff have a responsibility toadhere to these values, especially senior volunteers and staff,who are obligated to set an example for other staff andvolunteers and also to the public.

It is the expectation that, during deliberations, differencesof opinion may arise; these differences are encouraged andshould be aired. However, once a final decision has beenduly made by the organization, members of the board andsenior staff should support it.

STEWARDSHIP OF THE ORGANIZATION

It is the duty of the membership, both volunteer and staff, tosupport and achieve the principal aims of the organizationsthey serve. The leadership, both volunteer and staff, have theadded obligation of assuming the stewardship of theirrespective organizations. Because this entails not only over-sight, management, and, in some instances, fiduciary re-sponsibility, their efforts must also be directed at achievingand ensuring optimal value of their undertakings anddecision-making on behalf of the organization.

The organization must have policies and supportingprocedures for the following:




Reputation/Integrity

1. Expenditure/use of resources to assure that they are forthe organization’s benefit, and within the organization’soperational plan, not for personal benefit.

2. Purchasing and vendor selection to assure decisions aremade on appropriate criteria and with appropriate au-thorizations.

3. Relationships with industry to assure that both volun-teer and staff are sensitive to the issue of conflict ofinterest and guide them to act in the interest of theorganization, not for self or other organizations, andthat decisions are not tainted by perceived or realconflicts or personal gain.

4. Nominations/elections that assure qualified candidates areidentified and nominated for leadership positions and whohave leadership abilities, competencies appropriate to thatorganization, and high ethics and integrity.

5. Board-operating policies that can address issues relatedto board members or others requesting resources/actionsthat are unsupported by board policy, and issues relatedto unprofessional conduct in board meetings and otherleadership meetings.

6. Internal and external controls and audits to protect thefinancial and accounting integrity of the organization.

7. Internal audit or other process for identifying andaddressing non-compliance with policies and proce-dures.

8. Employment practices/policies including: a) hiring/dis-cipline/firing policies to protect both the rights ofcandidates/employees and those of the organization; b)grievance process for employees who believe they havebeen treated unfairly, which requires a response bymanagement and which also protects the employeeagainst retaliation or discipline for making a good-faithgrievance; and c) policies to assure proper oversight ofcompensation practices.

9. Protecting the integrity of the organization’s name,logo, assets, and reputation so they are not used forunauthorized purposes or for personal gain, includingmisrepresentation of the organization’s position or mis-use of one’s employment by or leadership position withthe organization in consultation, expert testimony, orpersonal endorsements.

Legal/Regulatory

1. Compliance with laws including those governing finan-cial reporting, employment and compensation, privacy,fiduciary duties, and not-for-profit obligations and re-strictions (e.g., taxes, solicitations, lobbying, politicalactivities, compensation).

2. Process for volunteers and staff to identify suspectedviolations of policies, laws, or ethics to a designatedorganization official, which assures anonymity and noretaliation. Also, procedures to address suspected viola-tions that assure fairness to all parties should be in place.

3. Examination of the Sarbanes-Oxley Act (Sarbanes-Oxley Act of 2002; P.L. 107-204) and implementationof those provisions that are relevant and appropriate tothe organization, including, at a minimum, provisions toassure independent and financially literate audit com-mittee members, independence and authority of theaudit committee to oversee financial reporting and theaudit process, and written statements from the chiefexecutive officer and chief financial officer certifying thefair representation of financial information. Althoughthe Sarbanes-Oxley Act applies to public corporations,the law sets standards with which the public will expectprivate and not-for-profit corporations also to comply.

4. Both a policy and a cultural expectation that volunteersand staff act consistent with and carry out the organi-zation’s bylaws/policies.

Authority/Decision-Making

1. Decisions are made according to authority granted andspecified in bylaws and policies (e.g., who can authorizewhat level of expenditures).

2. Decisions carry out the board’s policy priorities andintent, and are not based on individual power/influence;and decisions are made in the best interest of theorganization as a whole, not of a specific constituency.

3. Board members are provided an orientation, includingthe board’s responsibilities and authorities, the organi-zation’s bylaws, policies and strategic plan, applicablenot-for-profit laws, and fiduciary duties.

RELATIONSHIPS CREATINGPOTENTIAL CONFLICTS OF INTEREST

Relationships that can pose potential conflicts of interestexist both internally within the organization and externally.There is potential for conflict on the part of both staff andvolunteer leadership. The existence of multiple, overlappingresponsibilities and interests can create opportunity for bias,which cannot be addressed unless recognized.

Many kinds of relationships can create a potential forconflict, including, but not limited to, those with industry(e.g., grants, donations, sponsorships, promotions, researchfunding, consultantships), leadership in other professionalsocieties or consultancies, which may represent either aconflict of interest or a conflict of commitment, obligationsto a volunteer’s university or employer, relationships withcolleagues, family, and household members, and relation-ships with other businesses or individuals with competing oroverlapping interests. Additional potential conflicts may becreated by ownership of intellectual property related to theorganization’s area of expertise or activity, or by investmentauthority or decision-making responsibility for competingorganizations or entities (e.g., other societies, for-profitventures).

Within these relationships, certain activities/actions areprone to creation of conflict, and they should be viewed




seriously and avoided whenever possible. These center onapparent prospect of gain that could improperly influencejudgment and actions, including the actual or apparentpossibility of financial, political, or material benefit to self,family, colleagues, or to the organization as a whole.Situations likely to create opportunities for such benefitinclude possessing the authority for decisions or actions thatcould possibly interfere with or affect the organization’s bestinterests—including fiscal responsibilities, purchasing deci-sions, co-ventures with outside entities, and other transac-tions. Also to be avoided is any situation that has thepotential to create an unfair advantage for self, family,and/or colleagues, such as non–merit-based judgment ofperformance and skills; accepting gifts from vendors; anyrelationship that results in unfair treatment of employees orvolunteers; use of confidential or proprietary information forpersonal or potential gain, or against the organization’s bestinterests; and agreements with entities for the purpose ofreceiving favorite status and/or characterized by unethicalremuneration (e.g., kickbacks). Requiring particular atten-tion are highly remunerative relationships, such as thosewith publishers, exhibitors, and high-level supporters.Other mechanisms for the creation of conflicts includemisuse of organizational intellectual property, products, orreputation for personal gain or in conflict with the organi-zation’s best interests, and whenever demands of outsideactivities distract from optimal job performance by staffmembers.

Real or potential conflicts of interest can also be createdby industry or other benefactors of the ACCF or the AHA,including staff or volunteers as individuals, offers of researchand/or charitable funding accompanied by any actual, ap-parent, or potential restriction of use of funds or donationsthat inappropriately accrue to the benefit of donor and arenot in the best interests of the recipient (i.e., does notadvance the organization’s mission). Recognizing the partialfinancial dependence of the ACCF and the AHA onindustry support, situations such as the following should beavoided:

● undue influence, favoritism, or inappropriate recognitionof corporate donors,

● soliciting or directing donations to areas of personalgain,

● constraints on publication of research results,● premature release of scientific or guideline statements,● activities that involve violation of Accreditation Council for

Continuing Medical Education (ACCME) or PHARMAguidelines,

● unrealistic or unethical expectations as to gain, or● using organizational funds for personal or unauthorized

use.

Although intersocietal relationships are beneficial andfoster collaboration between organizations, they may alsocreate the potential for conflicts for members or staff whoare leaders of more than one related organization, or who

may be perceived as able to disclose confidential or propri-etary information.

Because senior officers, selected committee chairs, andjournal editors have a unique role in the organizations, theACCF and the AHA should have well-defined policiesregarding relationships that may represent potential orperceived conflicts of interest. These policies should con-sider which individuals are included and what relationships,if any, may be prohibited.

As avoidance of any real or potential conflict of interestrepresents an important ethical as well as operational man-date, the ACCF and the AHA should actively recognize thepotential problems and develop proactive policies for indi-viduals and the organizations, including codes of conduct,relationships with industry policies that include thresholdsfor disclosure based on level of financial interest, anddisclosure forms and procedures for assessing and ensuringcompliance. These should include a definition of conflicts toavoid and statement of principles to follow in staff andvolunteer appointments and assignments, regular monitor-ing of possible sources of conflicts, guidelines for dealingwith conflicts (e.g., disclosure, recusing oneself from discus-sion, non-voting), and procedures for dealing with viola-tions. A component of any policy should include recogni-tion of the obligation of staff and volunteer leadership to setan example by following and promulgating principles ofhigh ethical and moral behavior as well as the obligation ofthe organization to educate staff, volunteers, and memberson these important issues.

Recommendations

1. The organizations should have articulated their corevalues, which should be supported by a written code ofconduct.

2. Board members, staff, and volunteers should act inaccordance with their fiduciary, legal, and corporateresponsibilities.

3. The organizations should have policies and proceduresto protect their reputations/integrity, and to ensure legaland regulatory compliance and proper authority/deci-sion making.

4. The organizations should have conflict-of-interest pol-icies and procedures for both internal and externalrelationships.


1. Thier SO. 21st Bethesda conference: ethics in cardiovascular medicine.Keynote address. J Am Coll Cardiol 1990;16:5–6.

2. Business-Financial Desk. Operating Profits: Mining Medicare. HowOne Hospital Benefited from Questionable Surgery. New York Times,August 12, 2003.

3. Futter V. Nonprofit Governance and Management. Chicago, IL:American Bar Association (2002), 2004.

4. Independent Sector. Obedience to the Unenforceable, Ethics and theNation’s Voluntary and Philanthropic Community. Washington, DC:Independent Sector, 2002.




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Goldstein, Augustus O. Grant, David Faxon, Joao A. C. Lima and Rose Marie RobertsonRobert O. Bonow, Douglas P. Zipes, Jeffrey L. Anderson, Melvin D. Cheitlin, Larry B.

Task Force 5: Expert Testimony and Opinions

Print ISSN: 0009-7322. Online ISSN: 1524-4539 Copyright © 2004 American Heart Association, Inc. All rights reserved.

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Task force 5: Expert testimony and opinions

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