Leonard OrtmannRenee Ross

Natalie BrownBetty Wong

Scientific Ethics and Ethical Decision Making

Office of the Director

Office of the Associate Director for Science

Who You Gonna Call?

An investigator has worked with his Center ADS and Human Subject Contact to determine that the activity he proposes is classified as non-exempt research involving human subjects. Which office facilitates the work of the IRB?

You are attending a conference hosted by a pharmaceutical company and are asked to go to lunch with the organizer. They have agreed to pay. Which office can give you advice on whether you can accept the lunch?

Your program is developing recommendations relating to a public health policy and you want to ensure that you have considered all of the ethical ramifications. Which office would you turn to for assistance?

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Ethics Is About …

1. Avoiding wrong doing, doing the right thing, doing what is best, doing what we should do

2. Establishing ethical principles of action

3. Reflectively analyzing and evaluating the rightness or wrongness of actions

4. Practically making decisions often in the context of conflicting values or competing stakeholders

5. Prioritizing and integrating diverse values in crafting decisions, policies or recommendations

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Stop Sign Versus Green Light Ethics

Observe caution in order to comply with relevant legal codes

Series of either/or compliance determinations made in unbiased manner

Based on legal statutes informed by ethical principles

Expedite practical decision making in context of multiple stakeholders

Choice of best option among alternatives

Based on the decision-maker’s prioritization of values, which align with ethical principles and the law

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Office of the Associate Director for Science

Office of Science Integrity

Ethics Program Activity Office

Stop Animal Care and Use Office • Animal research Human Research Protection Office• Protecting human subjects in

research• IRB processPrivacy Unit • Privacy legislation and regulations,

HIPAA, FERPAConfidentiality Unit• Certificates and Assurances of

ConfidentialityInformation Collection Review Office• Paperwork Reduction Act

Public financial disclosureOutside activity requestsOfficial duty requestsAward approvalsAdvice and counseling• Seeking employment

and post-employment restrictions

• Gifts• Hatch Act

Go Public Health Ethics Unit• Public health ethics consults and

training for public health practice• Ethics desk activities in the

Emergency Operation Center

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Public Health EthicistPublic Health Ethics Unit

Office of Science IntegrityOffice of the Associate Director for Science

Public Health Ethics:

Addressing ethical issues in the practice of

public healthLeonard Ortmann, Ph.D.

Common Ethical Challengesin Public Health Practice

• Allocating scarce resources fairly: in regard to undocumented aliens, in emergencies, etc.

• Respecting individual rights and freedom while protecting the public good

• Protecting underserved and marginalized populations and building trust with them

• Engaging and sharing information with communities in a transparent manner

• Protecting data confidentiality and individual privacy while conducting surveillance activities

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Code of Ethics for Public Health• Sets a standard of

accountability to ethically orient public health institutions and practitioners

• Lays out 12 key principles for analyzing ethical challenges and practicing public health

• Key concept: interdependence of community members

http://www.apha.org/NR/rdonlyres/1CED3CEA-287E-4185-9CBD-BD405FC60856/0/ethicsbrochure.pdf

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Clinical vs. Public Health EthicsClinical Emphasis Public Health Emphasis

• Focus on patient-provider interactions

• Biomedical determinants• Respect for autonomy,

privacy, liberty• Informed consent • Beneficence and non-

maleficence• Justice

• Focus on institutions and populations

• Social determinants• Interdependence and

interrelatedness• Public engagement• Social good and avoiding

social harm• Social justice

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Focus of Activities• Development of ethics guidance on

specific program areas

• Development of capacity of CDC staff to address ethical issues– Training – Center level public health ethics teams– Consultation procedures– Support of state and local health

departments

CDC Ethics Consult Procedure

• The process of a public health ethics consult can be categorized into three actions - to identify, analyze, and resolve.

• 9-step framework provides a systematic step-wise approach to ethical decision making

http://intranet.cdc.gov/od/oads/osi/phethics/startConsultation.htm

IDENTIFY ANALYZE RESOLVE

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Example of Public Health Ethics Question

• Your program is developing recommendations relating to a public health policy and you want to ensure that you have considered all of the ethical ramifications. Which office would you turn to for assistance?

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Ethics Program SpecialistEthics Program Activity Office

Office of the Chief Operating Officer

Employee Ethics

Renee Ross

Responsibilities

• Public Financial Disclosure• Outside Activity Requests• Official Duty Requests• Award Approvals• Advice and Counseling– Seeking Employment and Post Employment

Restrictions– Letters of Support– Hatch Act

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14 General Principles of Ethical Conduct

• Public Service is a Public Trust• Requires employees to place loyalty to the

Constitution, the laws and ethical principals above private gain

• Employees have a responsibility to the United States Government and its citizens, and shall respect and adhere to the principles of ethical conduct

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Misuse of Position

• You should never use your public office for your private gain. • Employees are not to use their position, title or any authority associated with their office to coerce or induce a benefit for themselves or others. • Employees also are not to use or allow the improper use of nonpublic information to further a private interest, either their own or another's.

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Confidential Financial Disclosure ReportsOGE 450

• Annual Requirement used to determine if an employee has a potential conflict of interest with their investments and activities as those issues relate to their official duties

• Criminal Conflict of Interest Statute– 18 U.S.C. § 208– This means that employees must not

participate in any official matter that would have a direct and predictable effect on their own or imputed financial interests.

• Annual Ethics Training – due December 30, 201117

Outside Activity Requests

• Employees must obtain approval before engaging in an outside activity which requires the use of professional qualifications readily identified with CDC employment.• Employees shall not engage in any outside activity that conflicts with his/her official duties.• Employees are prohibited from participating in activities that create an appearance of using public office for private gain, or create the appearance that the employee’s official position was used to obtain an outside business opportunity.• Employees may receive compensation

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Official Duty Requests

• What are official duty activities?– Federal Liaison; Advisory Board/Committee or Editorial Board; Voluntary Consensus Standard Organization (standards setting body); and Officer, Director, or Trustee

• Approval is granted:– If the activity is related to employee’s official duties– If the activity is consistent with the authority and mission of the agency

• The employee may not receive compensation

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Awards from Outside Sources

• Awards may be accepted for meritorious public service or achievement, including work performed at CDC/ATSDR.

• Awards that have a market value of more than $200 requires prior written determination by the Deputy Ethics Counselor.

• Awards may not be accepted from entities that have interests that may be substantially affected by the performance or non-performance of the employees official duties.

Letter of SupportPermanent Residency

• Can I use CDC Letterhead using my official title?– Must have personal knowledge of the ability or character

of the individual, and– Must be a person you have dealt with in the course of

your Federal employment, OR– This person is seeking a Federal job.

• 18 USC 205 (Appearing on behalf of another before a Federal Agency)– Employee must write the letter based on his own

knowledge– Letter must not be written by applicant or by the

applicant’s direction

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Letter of SupportGrant Application

• Letter should be:– General in nature– Outline importance of the work or subject

matter, not the application– Straightforward and factual

• 5 CFR 2635.101(b)(8) – Impartiality• 5 CFR 2635.702(c) - Endorsement

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Conflict of InterestStatutes

• 5 CFR 2635.702(c) – Endorsement– Provides that an “employee shall not use or

permit the use of his Government position or title or any authority associated with his public office to endorse any product, service, or enterprise.”

• 5 CFR 2635.101 (b)(8) – Impartiality– Provides that an employee “shall act

impartially and not give preferential treatment to any private organization or individual.”

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Gifts

• Question:– I am attending a conference hosted by a pharmaceutical

company and I’m asked to go to lunch with the organizer. They have agreed to pay – can I accept the lunch?

• Answer - Yes:– As long as the gift was not given because of your official

position– As long as the value of the lunch does not exceed $20

• 2635.204(a) – An exception to gift rule:– allows that federal employees may accept unsolicited

gifts with an aggregate value of $20 or less per source per occasion, not to exceed $50 from that same source in a calendar year.

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Hatch ActPermitted Activities

• Employees may:– Register and vote– Contribute money to political candidates or organizations– Assist in nonpartisan voter registration drives– Participate in nonpartisan campaigns (such as most school board

elections)– Campaign for or against referendum questions, constitutional

amendments, etc.

• Employees may not:– Run for public office in a partisan election– Use official authority or influence to interfere with or affect the

result of an election– Use official title in connection with any partisan political activity– Solicit or discourage the political activity of anyone having

business before the Department– Engage in political fundraising 25

Hatch ActPresidential Photographs

• Can I display a picture of a candidate for partisan political office in my workspace? • No, as a general rule, employees may not display

pictures of candidates for partisan public office in the federal workplace.

• Exception to the rule - All of the following must apply:• Photo was on display in advance of election season• The employee is in the photograph with the

candidate• The photograph is a personal one (i.e., the

employee has personal relationship with the candidate and photo is taken at personal event)

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Advice and Guidance

• The Ethics Program Activity Office offers individual counseling on:– Conflicts of Interest– Political Activities– Post Employment Restrictions– Recusals

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Human Research Protection OfficeOffice of Science Integrity

Office of the Associate Director for Science

Human Research Ethics

Natalie Brown, MPH, Senior IRB Administratorand

Betty Wong, MPH, CHES, IRB Administrator

Overview

Regulatory overview Public health research or public health

practice Research involving human subjects CDC’s institutional review board (IRB)

process

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CDC Policy Considerations

CDC has ethical and legal obligation to ensure individuals are protected in all public health activities

All CDC activities must be reviewed to determine if they are research involving human subjects CDC and collaborators must comply with 45 CFR part 46

and 21 CFR parts 50 and 56 to assure the protection of human subjects

Prevention and control of disease or injury to improve public health programs, clearly without a research component, is deemed nonresearch Incorporating a research component is a possibility

during emergency situations, but the appropriate approvals must be obtained prior to the commencement of the research

http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf30

Distinguishing Public Health Research and

Public Health Practice: A CDC Perspective

Public Health Practice Public Health Research

Purpose is to identify and control a health problem or improve a public health program or service

Purpose is to develop or contribute to generalizable knowledge

Benefits of the project are primarily or exclusively for the participants or their community

Benefits may or may not include study participants, always extend beyond the study participants

Data collected are needed to assess or improve the program or service, the health of the participants, or their community

Data collected exceed requirements for care of study participants or extend beyond scope of activity

http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf

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References, Policies, and Guidance

Code of Federal Regulations, 45 CFR 46 45 CFR 46.102(d) http://www.hhs.gov/ohrp/humansubjects/guidance/

45cfr46.html CDC’s policy on Distinguishing Public Health

Research and Public Health Nonresearch, July 2010 http://www.cdc.gov/od/science/integrity/docs/cdc-policy-

distinguishing-public-health-research-nonresearch.pdf CSTE’s Public Health Practice vs. Research:

A Report for Public Health Practitioners, May 2004 http://www.cste.org/pdffiles/newpdffiles/

CSTEPHResRptHodgeFinal.5.24.04.pdf32

The Belmont Report

1979 report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (http://intranet.cdc.gov/od/oads/osi/hrpo/codes/belm-eng.pdf)

Guide the resolution of the ethical problems based on 3 principles Respect for persons Beneficence Justice

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Additional Determinations for Research

Once an activity is classified as research, three additional determinations must be made: Is the activity research involving human subjects? If the activity is nonexempt research involving human

subjects, which institutions are engaged in research and are required to certify IRB approval?

If the activity is research involving human subjects, does the research meet the criteria for exemption from 45 CFR 46?

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What is Research Involving Human Subjects?

Code of Federal Regulations, 45 CFR 46 45 CFR 46.102(f) – Human subject means a living

individual about whom an investigator conducting research obtains• Data through intervention or interaction with the individual,

or• Identifiable private information

Excludes research that uses existing anonymous data and data about deceased individuals

Once the project is determined to be research involving human subjects, 45 CFR 46 applies Except that there are a few exemptions for certain

activities that generally carry negligible risk There are special considerations for

vulnerable persons

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Engagement of Institutions inHuman Subjects Research

Institutions are considered engaged in human subjects research when its employees or agents for the purposes of the research project obtain Data about the subjects of the research through

intervention or interaction with them Identifiable private information about the subjects of the

research The informed consent for research

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Determination for Review

All projects undergo a formal review by the Associate Director for Science in each CIO

Projects that are determined to be research involving human subjects where CDC is engaged are routed to HRPO Nonexempt human subjects research is reviewed by an

IRB Exempt human subjects research is reviewed by the

Chief of HRPO or designee

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CDC Options for IRB Review

CDC IRB: Convened Board (Quorum) Expedited review not permitted May meet the criteria for expedited review, but the

research project is controversial or includes sensitive topics or issues

CDC IRB: Expedited Review (45 CFR 46.110) Permissible categories Experienced reviewer outside convened meeting

Non-CDC IRB: Reliance Request Reliance on an outside IRB Limited criteria primarily based on CDC’s role

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CDC IRB Review

HRPO provides worksheets and guidance to all IRB members to ensure that all regulatory requirements are met; standard operating procedures are also available

HRPO utilizes the primary IRB reviewer system An expert reviewer reviews protocol, consent form, and

all supporting documentation A less experienced reviewer will review with concurrence

from an expert reviewer IRB reports are issued to the principal

investigator upon completion of the review Once all regulatory requirements are met,

the study is approved for no more than one year

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Example of Human Research Protection Question

An investigator has worked with his Center ADS and Human Subject Contact to determine that the activity he proposes is classified as non-exempt research involving human subjects. Which office facilitates the work of the IRB?

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Public Health Ethics Unit

• Drue Barrett, Lead• Email: DBarrett@cdc.gov or phethics@cdc.gov • Telephone: 404-639-4690• FAX: 404-639-7341• Website: http://intranet.cdc.gov/od/oads/osi/phethics/

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Ethics Program Activity Office

• Teresa Walker-Mason, Ethics Program Officer• Email: Ethics@cdc.gov• Telephone: 770-488-8970• Fax: 770-488-0265• Website: http://intranet.cdc.gov/od/ethics/

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Human Research Protection Office

• Barbara R. DeCausey, Chief• Email: huma@cdc.gov• Telephone: 404-639-7570• Fax: 404-639-3249• Website: http://intranet.cdc.gov/od/oads/osi/hrpo/

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