Research Ethics

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

History Leading up to IRB’s Nazi War Crimes 1942-46 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

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

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)

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

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

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

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)

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…

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

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

Radioactive Milk Research 1946-1956, 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

The Willowbrook Study 1963-1966, 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

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

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

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

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

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

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

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

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

WOU Sponsored Research Office http://www.wou.edu/provost/oirsp/index.php Training: Protecting Human Research Participants (PHRP) http://phrp.nihtraining.com/users/login.php Institutional Review Board (IRB) http://www.wou.edu/provost/irb/Application_IRB.pdf

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.

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 http://www.wou.edu/provost/irb/DecisionTree.php