1. Scientific Ethics and Ethical Decision Making
Leonard Ortmann
Renee Ross
Natalie Brown
Betty Wong
Office of the Director
Office of the Associate Director for Science

2. 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? 2

3. Ethics Is About …
Avoiding wrong doing, doing the right thing, doing what is best, doing what we should do
Establishing ethical principles of action
Reflectively analyzing and evaluating the rightness or wrongness of actions
Practically making decisions often in the context of conflicting values or competing stakeholders
Prioritizing and integrating diverse values in crafting decisions, policies or recommendations 3

4. 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

5. Office of the Associate Director Office of Science Integrity
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 process
Privacy Unit
Privacy legislation and regulations, HIPAA, FERPA
Confidentiality Unit
Certificates and Assurances of Confidentiality
Information Collection Review Office
Paperwork Reduction Act
Public financial disclosure
Outside activity requests
Official duty requests
Award approvals
Advice 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 5

6. Public Health Ethics: Addressing ethical issues in the practice of public health
Leonard Ortmann, Ph.D.
Public Health Ethicist
Public Health Ethics Unit
Office of Science Integrity
Office of the Associate Director for Science

7. Common Ethical Challenges in 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

8. 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

9. Clinical vs. Public Health Ethics
Clinical 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

10. 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

11. 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
IDENTIFY
ANALYZE
RESOLVE

12. 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?

13. Employee Ethics Renee Ross Ethics Program Specialist
Ethics Program Activity Office
Office of the Chief Operating Officer

14. 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

15. 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

16. 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.

17. Confidential Financial Disclosure Reports OGE 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, 2011

18. 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

19. 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

20. 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. 20 20

21. Letter of Support Permanent 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

22. Letter of Support Grant Application
Letter should be:
General in nature
Outline importance of the work or subject matter, not the application
Straightforward and factual
5 CFR (b)(8) – Impartiality
5 CFR (c) - Endorsement

23. Conflict of Interest Statutes
5 CFR (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 (b)(8) – Impartiality
Provides that an employee “shall act impartially and not give preferential treatment to any private organization or individual.”

24. Gifts Question: Answer - Yes: 2635.204(a) – An exception to gift rule:
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
(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.

25. Hatch Act Permitted 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

26. Hatch Act Presidential 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)

27. Advice and Guidance
The Ethics Program Activity Office offers individual counseling on:
Conflicts of Interest
Political Activities
Post Employment Restrictions
Recusals

28. Human Research Ethics Natalie Brown, MPH, Senior IRB Administrator and
Betty Wong, MPH, CHES, IRB Administrator
Human Research Protection Office
Office of Science Integrity
Office of the Associate Director for Science

29. Overview Regulatory overview
Public health research or public health practice
Research involving human subjects
CDC’s institutional review board (IRB) process 29

30. 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 30

31. Public Health Practice Public Health Research
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 31

32. References, Policies, and Guidance
Code of Federal Regulations, 45 CFR 46
45 CFR (d)
CDC’s policy on Distinguishing Public Health Research and Public Health Nonresearch, July 2010
CSTE’s Public Health Practice vs. Research: A Report for Public Health Practitioners, May 2004 32

33. The Belmont Report
1979 report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (
Guide the resolution of the ethical problems based on 3 principles
Respect for persons
Beneficence
Justice 33

34. 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? 34

35. What is Research Involving Human Subjects?
Code of Federal Regulations, 45 CFR 46
45 CFR (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 35

36. Engagement of Institutions in Human 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 36

37. 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 37

38. 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 )
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 38

39. 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 39

40. 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? 40

42. Public Health Ethics Unit
Drue Barrett, Lead or
Telephone:
FAX:
Website:

43. Ethics Program Activity Office
Teresa Walker-Mason, Ethics Program Officer
Telephone:
Fax:
Website:

44. Human Research Protection Office
Barbara R. DeCausey, Chief
Telephone:
Fax:
Website: