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Responsible Conduct of Research :
A Framework for Research Administrators and Organizations
Presented by:
Contributions from:
Denise McCartney, Washington University
Geoff Grant, Partners Health System
Lynne Chronister,Assistant Vice ProvostUniversity of WashingtonDenver, 2008
Conduct of ResearchPrinciple:
Ensures validity of results/Maximizes return on public investment
Conflict of InterestsResearch Integrity
Conflict of CommitmentData, Resource Sharing, Cyber Security (new)
Public Access to Publications (new)
Public Policy RequirementsPrinciple:
Meets National Social, Economic, Security InterestsSEVIS/Visas (new)
Export controls (new)Title IX
Lobbying DebarmentDrug Use
Protections/SafeguardsPrinciple:
Provides safety/welfare of subjects and environmentHuman SubjectsAnimal WelfareHIPAA (new)
Environmental Health & Safety Select Agents (new)
Cost Policy/Financial ManagementPrinciple:
Ensures fair and reasonable costs to the GovernmentReasonable Allocation of CostsSalary Charges/Effort Reporting
Indirect CostsCost Sharing
Geoff Grant, May, 2005
Ensuring Research Protections Principles and Ensuring Research Protections Principles and ResponsibilitiesResponsibilities
Research Compliance – Why?
Universities have an obligation to maintain the public’s trust by:
– Conducting research ethically and responsibly– Ensuring proper stewardship of research funds– Protecting animal and human subjects– Assuring compliance with federal regulations
Research Compliance – Why? Why is there so much emphasis on this topic
now?
1. The Academic Culture is at risk for compliance failures due to
• Decentralized organizations• Potential for conflicts of interest• Undefined roles and responsibilities• Lack of comprehensive training• Expanded Requirements
2. Recent, significant compliance failures at large, research institutions
Research Compliance – Why?
Why is there so much emphasis on this topic now?
3. Increased funding for biomedical research resulting
in greater scrutiny, increased inspections
4. Findings of liability on the part of universities have become more frequent in recent years
Research Compliance – Why? Why is there so much emphasis on this topic
now?
5. Successful Qui Tam Lawsuits
6. Federal Sentencing Guidelines reduce penalties if a fully-functioning corporate compliance program is in place. Corporate Integrity Agreements are onerous.
7. NIH Proactive Compliance Visits have helped set standards
Critical Components !!!
1. Instill a Culture of Compliance• Communication
• Policy development
2. Develop an Organizational Structure• RCR Committee
• Compliance/Integrity/Ethics Officer
3. Develop Comprehensive Education and Training
• RCR and Integrity/Ethics
1. Culture: How to Promote Research Integrity, or
Finding Your Voice, Ensuring Research Protections
Match Your Approach to Your CultureWhat Will Be Successful in Your Institution?
It’s all about the shared values in promoting outstanding science or research!
• Use language that appeals to the faculty
• Promote institutional core values first and foremost
– e.g. excellence in research, research protections, code of conduct, stewardship, research responsibilities
• Then find a balance between promoting research integrity and providing appropriate programs for compliance and accountability
– Requirements are increasingly complex– Faculty increasingly rely on internal expertise and
guidance– Research compliance programs are now an essential
element of institutional research infrastructure• every bit as important as research facilities and
instrumentation– Unfortunately, the institution and the research community
need safeguards against fraud and abuse
• Recovery from damage to the reputation or good name of the institution is a long term process!
Communication from the President or Provost Letter or Message to Faculty
– Be proactive, exert leadership
– Obviously a currency not be squandered or overused
– Time with announcement of a research integrity program, office, role, or an education program for faculty and/or administrators
– Reference to some other institutional case or event
One Example from Vanderbilt UniversityDivision of Sponsored ResearchOffice of Compliance
A Sample of One Institution’s Messages
The Principal Investigator (PI) role at Stanford University brings significant rewards and responsibilities. PIs are responsible for the intellectual direction of research and scholarship and for the education and training of students. In carrying out these critical tasks, PIs are also responsible for compliance with laws and regulations that touch on all aspects of the research enterprise.
John Hennessey, President, Stanford in a letter to the faculty 2000http://www.stanford.edu/dept/DoR/PIship/
Cite Respected Sources or Distinguished Scientists
“The scientific research enterprise, like other human activities, is built on a foundation of trust. Scientists trust that the results reported by others are valid. Society trusts that the results of research reflect an honest attempt by scientists to describe the world accurately and without bias. The level of trust that has characterized science and its relationship with society has contributed to a period of unparalleled scientific productivity. But this trust will endure only if the scientific community devotes itself to exemplifying and transmitting the values associated with ethical scientific conduct. ” [1]
[1] On Being a Scientist: Responsible Conduct in Research, Second Edition (1995) ,National Academy of Sciences
2. Consensus on Structure and Function
Who is responsible? What is our Structure? What RCR areas are critical?
How To Begin?
Draft Outline of plan Review of policies (COI, etc.) Extensive Survey of Education & Training Strategic Planning Session Engage a Compliance Officer Set up a committee Write Plan Design curriculum Teach and Train Commit Money!
Conduct an Institutional Risk Assessment
– Convene group of key faculty and administrators from departments and central offices
– Run consensus process by:• Appropriate Dean or academic official?• Associate VP for Research?• Compliance Officer?• Internal Audit?
Research Compliance Program Goals
Promote high standards of research integrity Effectively manage public funds to maximize
research outcomes Protect research subjects Assure coordination of compliance programs Avoid serious cases of fraud or mismanagement of
federal funds through self-monitoring Assure coordination of compliance programs
Compliance Program Elements
Written standards, policies and procedures Education, training and communication Monitoring Audits Appointment of a High Level Official Mechanism to report violations (e.g. hotline) Record Retention policy Defined roles and responsibilities
Compliance Program Models
Institutional Compliance Program– Single Compliance Office/Program with a
clearly identified Compliance Officer
Research Compliance Program– Separately established from other compliance
programs– Focused on oversight for research compliance
Compliance Program Models
Functional Compliance Model– Traditional organizational models building on
existing compliance structures– Increased clarity of roles and responsibilities– Increased focus on education– Oversight and/or coordination
Hybrid Models No Model No Program
Washington University Compliance Program
Roles and Responsibilities of Research Compliance
University Compliance
Research Compliance
Functional Areas
Research Compliance
•Support, assist and verify effectiveness of compliance activities
•Develop, revise & maintain the Code of Conduct
•Perform audits
•Receive & Respond to Allegations of Wrongdoing
•Communicate with the Board
•Develop and maintain Expertise on laws and regs
Develop and implement Policies and Procedures
•Develop and Provide Edcuational Programs
•Develop and implement methods to monitor compliance
•Respond to allegations of wrongdoing
•Develop & Promote Principles
•Develop & Coordinate Educational Programs
•Facilitate Monitoring
•Respond to allegations of wrongdoing
•Provide Necessary Infrastructure to facilitate compliance activities
Washington University Research Compliance Program
Research Compliance Accomplishments– Defined roles and responsibility of offices
accountable for Research Compliance– Began project to document roles and
responsibilities of other key offices and individuals involved in research
Washington University Research Compliance Program
Completed Inventory of Research Compliance functional areas– Policies– Educational Programs– Information Systems– Monitoring/Auditing Programs– Communication Tools
Developed, updated and revised polices based on inventory results
Washington University Research Compliance Program
Enhancing Educational Program– Research Administrators Forum
– Implemented Research News – a web-based communication tool targeted at specialized audience with associated library
– Hired Director of Research Education
– Departmental Educational Retreats
– Compliance Audit follow-ups
– Developing Administrators Financial Program
University of Utah
Began development in 2000 NIH Proactive Compliance Visit, August
2002 Increased concern on the part of
administration Increased concern expressed by faculty and
other researchers Concerted Effort in re-engineering clinical
studies including financial and regulatory
How Did Utah Begin?
Draft Outline of plan begun in 2001 Revision of numerous policies (COI, etc.) Extensive Survey of Educ. & Training Strategic Planning Session
– 35 participants (compliance admin & faculty)– 1 day– Strategic plan for structure and function of
compliance program– Plan for NIH visit incorporated
Compliance Mission
“The University of of Utah’s research compliance program is committed to the achievement of high ethical and legal standards of conduct through a culture of compliance and conscience that reflect our core values”.
Organization Chart
C o m p lian c e O ff ice r
S en io r V ice P re side n tH e a lth S c ien c es
C o m p lia nce C o m m ittee
A ss oc ia te V PR e se arch In te g r i ty
a ndC h a ir o f C om p lia nce C o m m ittee
R e s ea rchC o m p lian c e O ff ice r
V ice P res ide n tR e s ea rch
P res ide n t
Sample:Stanford Roles and Responsibilities
COGNIZANT POLICY OFFICE
OFFICER
FUNCTIONALLY RESPONSIBLE OFFICE
OFFICER
PRIMARY LOCUS OF RESPONSIBILITY
EH&S Dean of Research & Graduate Policy
EH&S PI’s
Medicare Billing VP for Medical Affairs SHC Compliance Office Medical Faculty SHC Compliance Office
Research/ Administration
Dean of Research & Graduate Policy, Assoc. VP for Research Admin.
Office of the Dean of Research
Office of Research Admin
PI’s/Departments
Scientific Misconduct
Dean of Research & Graduate Policy
Office of the Dean of Research
Schools
Human/Animal Subjects
Dean of Research & Graduate Policy
Administrative Panels, Compliance Office
PI’s
HR/EEOC VP for Business Affiars Human Resources Departments, Central HR
NCAA Provost DAPER Coaches
Fire and Bldg Safety VP for Land & Buildings EH&S/Fire Marshal EH&S/Schools/ Departments
IRS & CA Tax VP for Business Affiars Controller FAIR Group
Donor Gift Restrictions
President Office of Development SMC Schools/Departments/
Faculty Conflicts of Interest Provost Dean of Research &
Graduate Policy Business Affairs
Schools/Faculty, Controller,
Director of Procurement Immigration VP for Business Affairs Human Resources Departments,
Central HR Technology Licens’g/ Intellectual Property
Dean of Research & Graudate Policy
Office of Technology Licensing
OTL, Faculty
Land Use VP for Land & Buildings SMC/CP&M SMC/CP&M
Sample:Common Elements of an Institution-wide Compliance Program
Components of Compliance Program EH&SMedicare
Billing ResearchHR/
EEOC NCAA
Fire &Bldg
SafetyIRS &
CA TaxDonor Gift
Restrictions
Written code of business ethics and conduct
Expliciitly stated ethical and compliance policies and standards
Training for all employees on ethical and compliance policies and standards
Training for affected employees on laws and regulations related to their jobs
Designation of a compliance officer with appropriate powers and expertise
Adoption/provision of adequate procedures, resources, and systems to permit compliance
Maintenance of a process to allow anonymous reporting of alledged noncompliance
Protection for employees who lodge reports
Regular monitoring and auditing processes to test compliance
Mechanisms to enforce rules and discipline rule violators
Management commitment to take corrective actions and follow up
System to communicate corrective actions and follow up undertaken
Adequate Board-level oversight of compliance function
Mechanism to communicate the impact of rules to the creators and enforcers of the rules
UC Davis Gap Analysis Worksheet
3. Education and Training
NIH Training Grant Requirements NSF Training Grant Requirements America Competes Act Requirements:
– RCR training for ALL students and fellows
It is Right Thing to Do!!!
Establish Program Parameters
1. Comprehensive Programs?
2. Select RCR Modules?
Resources: Office of Research Integrity Responsible Conduct of Research Education
Consortium (http:/rcrec.org) PRIM&R (Public Responsibility in Medicine
and Research
It is not permitted to the most equitable of men to be a judge in his own cause.
Blaise Pascal (1670)
References and Resources Grant, Geoffrey, Guyton, Odell, Forrester,
Robert, Creating Effective Research Compliance Programs in Academic Institutions, Academic Medicine, vol. 74, No., September 1999.
Walsh, Barbara E., Moran, James, McDougall, Gerald, The Compliance Umbrella, Business Officer, January 2000,
American Association of Academic Medical Colleges website @ www.aamc.org/research/dbr/compliance/models.htm
Office of Research Integrity www.ori.dhhs.gov/
Kulakowski, Elliott, Chronister, Lynne, Research Administration and Management, Jones and Bartlett, 2007.
OMB Compliance Supplement, March 2008 www.whitehouse.gov/
Contact
Lynne ChronisterAssociate Vice Provost for Research
University of Washington,
206-543-4043