Ethical Principles Human Subjects Research

1. NTR 629 - Week 7A Ethical Principles Human Subjects Research

2. What is Ethical Research? • Ethical behavior is defined as conforming to the standards of conduct of a given profession or group (Webster’s New World Dictionary). • Ethics refers to the question(s) of right and wrong. • An agreement among researchers dictates what is considered right and wrong. • The question to ask is: “Will any physical or psychological harm result from this particular research?” • By practicing ethical procedures, the researcher is doing “what is right”.

3. Protecting from Harm • It is the responsibility of all researchers to ensure that participants are protected from physical or psychological harm, discomfort, or danger due to research procedures. • The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment. • Three important questions to ask about harm in a study are: • Could people be harmed? • If so, could the study be changed to determine the same results? • Are the results important enough to cause possible harm? • Subject must be informed of risks of study not “exempt” – obtain consent.

4. Ethical Issues in Research • When using humans or animals for research, important ethical issues must be addressed • Historically, these issues were addressed by the professional code of ethics • Codes of conduct have evolved and now have been codified into law.

5. The Nuremburg Trial • World War II—The Nuremburg Trial • Joseph Mengele and unethical experiments performed by Nazi doctors • 20 doctors were charged with War Crimes and Crimes against humanity • Joseph Mengele fled and was not tried • Lead to Nuremburg Code of 10 Principles

6. Nuremburg Code • Requires voluntary consent • Experiments must be rational • Experiments must be based on animal studies and knowledge of the disease • Experiments should avoid suffering • No experiment should involve excessive risks, except in those studies where physical experimental physicians also serve as subjects • Degree of risks should be determined by importance of the problem • Precautions should be taken to avoid against even remote possibilities of injury, disability, or death • Experiment should be conducted only by scientifically qualified persons • Subjects should be able to end experiment at any time • The scientist in charge must be prepared to terminate the experiment at any stage, if they believe the experiment is likely to result in injury, disability, or death to the subject

7. Continuing Ethical Issues Unfortunately, codes were not always followed: Willowbrook State Hospital-1970 Retarded injected with viral hepatitis US Department of Energy-1950s-60s Studies on radioactive fallout University of Iowa-1940s Research on stuttering in orphans home • Tuskegee Syphilis Study-USPHS-1930’s • Not treated even after penicillin discovered • Jewish Chronic Disease Hospital • Patients injected with cancer cells • Midgeville State Hospital • Investigational drugs used without consent

8. National Research Act • Increased Public concern led to congressional action and National Research Act of 1974 • President Nixon then established National Commission for the Protection of Human Subjects of Biomedical and Behavioral research • Commission charged to consider: • Boundaries between practice and research • Assessment of role of risk vs. benefit in research • Guidelines for selection of subjects • Informed Consent

9. Belmont Report • National Commission submitted the Belmont Report to President in 1979 • Led to 1981 revision of 1974 guidance (45 CFR 46) for human research committees • 45 CFR 46-has become the bible for reviewing research funded by DHHS • Required appointment of Institutional Review Boards or IRB’s to review human subject studies • Provided standards for appointment of IRBs, record-keeping and oversight in research

10. 45 CFR 46 • Revised in 1983 and 1991 • In 1991 revisions referred to as Common Rule • Adopted by 15 federal agencies, not just DHHS • Institutions with NIH funding must submit assurance of compliance to OHRP, DHHS • After February 28, 2001-assurances must cover all research at institution, not just NIH