1. Research Ethics

2. Review Boards IRB – Institutional Review Board
Human subject protection
IACUC – Institutional Animal Care and Use Committee
Animal subject regulations

3. History Leading up to IRB’s
Nazi War Crimes
Sterilization experiments-wanted to find ways to sterilize large populations to ensure supremacy of the Aryan race
Dried plant juice was put into flour that was fed to the general population which was supposed to sterilize women.
Intra-uterine injections of a silver nitrate solution were given to women without their consent during routine physical examinations
Men stood at a counter to complete forms while being exposed, without their knowledge, to sterilizing doses of X-radiation

4. Nazi War Crimes 1942-46 Typhus fever vaccine experiments
Nazi physicians were under great pressure to develop an effective vaccine for typhus fever to administer to German troops
Buchenwald concentration camps: prisoners were used in experiments to test the vaccine
Between 1942 & 1943, over 700 prisoners were subjected to these experiments and 154 died

5. Nazi War Crimes Tribunal (1947)
Fundamental ethical principles for the conduct of research involving human subjects were codified into the Nuremberg Code
10 conditions that must be met before research involving human subjects is ethically permissible
First internationally recognized code of research ethics (not a law)

6. Nuremberg Code: 1) Voluntary consent of human subjects
Legal capacity to give consent
Ability to exercise free choice
Should have knowledge of research to make informed decision
Nature, duration, purpose of the project
Method and means by which it is conducted
All inconveniences and hazards to subject
Effects upon subjects health or person that may come from participation

7. Code cont.
2) No study permitted if reason to believe death or disabling injury will occur
3) Degree of risk should not exceed importance of problem
4) Adequate protection for human subjects to avoid, even remove, possibilities of injury, disability, or death

8. Code cont.
5) Study shall yield fruitful results that cannot be obtained from other methods 6) The scientific design must be sound so that anticipated results justifies the study 7) Study should avoid unnecessary physical and mental suffering and injury

9. Code cont.
8) Study conducted by scientifically qualified persons 9) Subjects can discontinue at any time 10) Investigator should terminate study if continuation of experiment is likely to result in injury, disability, or death to subject (including mental harm)

10. Declaration of Helsinki, 1964
Adopted by the World Medical Assembly, Helsinki, Finland
Recommendations guiding physicians in biomedical research involving human subjects
Included a principle that stated: in case of physical or mental incapacity for subject to give informed consent or in case of a minor, responsible relative or legal guardian…

11. Historically abused populations
Mentally ill
Developmentally challenged
Children
Active military
Prisoners
Immigrants
Minority populations
Uneducated or minimally educated
Elderly

12. Tuskegee Syphilis Study
Began in 1932 to study the natural history or progression of syphilis
400 black men with syphilis, 200 not infected
Recruited without informed consent
Study continued until 1972 when news reached public via the national press
Formal presidential apology 1997

13. Radioactive Milk Research
, experiments performed on 19 boys (mentally impaired) at a state school in Massachusetts by Harvard and MIT researchers
Boys thought they were participating in a science club
Fed radioactive forms of iron and calcium in their milk by researchers who wanted to learn about the digestive system and the body’s ability to digest minerals

14. The Willowbrook Study
, studies carried out at the Willowbrook State School (mentally handicapped children)
Gain understanding of the natural history of infectious hepatitis and test the effectiveness of an agent for inoculating against hepatitis
Parents were provided information describing drug administration as vaccinations.
Children were deliberately infected with hepatitis virus

15. U.S. Government Regulations
1974 Congress passed the National Research Act
Establishment of IRB’s to review all US Dept. of HHS funded research involving human subjects
Established National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Belmont Report issued in 1979

16. Three basic ethical principles
Belmont Report 1979 Ethical Principles and Guidelines for the Protection of Human Subjects
Three basic ethical principles
Respect for persons
Beneficence
Justice

17. Respect for Persons
Individuals treated as autonomous agents and that persons with diminished autonomy are entitled to protection
Implement respect for persons through informed consent
Information
Comprehension
Voluntary nature

18. Beneficence Assessment of risks and benefits Do not harm
Maximize possible benefits and minimize possible harms

19. Justice Fairness or distribution Are risks distributed equitably?
Who should bear the burdens?
Who receives benefits?
Important in the consideration of research subjects
Tuskegee, Nazi experiments

20. Applications: Informed Consent Assessment of Risks and Benefits
Selection of Subjects

21. U.S. Government Regulations 1981-2000
1981: Title 45 Code of Federal Regulations, Part 46: Protection of Human Subjects
Belmont Report embodied in this regulation
1983 Subparts B-D added to 45 CFR 46
1991 Common Rule
17 Federal agencies adopted 45 CFR 46
2000 Educational Requirement on the Protection of Human Subjects

22. The Common Rule (Federal Policy) is also codified at:
Department of Agriculture
Department of Energy
National Aeronautics and Space Administration
Department of Commerce
Consumer Product Safety Commission
International Development Cooperation Agency, Agency for International Development
Department of Housing and Urban Development
Department of Justice
Department of Defense
Department of Education
Department of Veterans Affairs
Environmental Protection Agency
National Science Foundation
Department of Transportation

23. WOU Sponsored Research Office
Training: Protecting Human Research Participants (PHRP)
Institutional Review Board (IRB)

24. What needs to be reviewed?
If the proposed research activity involves human participants and may contribute (e.g., through publication, presentation, or dissemination outside the WOU community) to "generalizable knowledge", then the activity will require review and approval by the WOU Institutional Review Board before any recruitment or research involving human participants may begin.
IRB review and approval is required for ALL research projects involving human participants, regardless of the source of funding for the project or the level of risk posed to participants.

25. Research Review Categories
Faculty completing an IRB application designate a prediction of the type of review needed, (Exempt, Expedited, Full Board). ALL Review categories require IRB approval.
Only an IRB member can determine actual review necessary.
Exempt from Full Board Review
Expedited Review
Full Board Review