1. Ethics in Research A class discussion

2. What is Ethics in Research? and Why is it Important?

3. Informed Consent Cases/Studies Tuskegee Syphilis Study (1932-1972) Patients left with untreated syphilis for decades Nazi Medical War Crimes (1935-1945) Physician-conducted experiments especially harmful to subjects Cold War Human Radiation Experiments (1944-1974) Radiation Experiments on US Citizens The Wichita Jury Study (1955) Audiotaped Jury Deliberation Milgram Studies of Obedience to Authority (1960s) People do cruel and unethical things when authority tells them to Thalidomide Experience (1962) Birth defects in pregnant women Jewish Chronic Disease Hospital Study (1963) Live cancer cells injected into chronically ill patients Willbrook Hepatitis Study (1963-1966) Infected mentally ill children with hepatitis without telling parents or children

4. Informed Consent Cases/Studies New England Journal of Medicine, Ethics of Clinical Research by Henry Beecher (1966) Described 22 trials that were unethical to focus attention to improve ethical standards. San Antonia Contraceptive Study (1970s) Indigent patients given a placebo without being told they were in a research study… so MANY unplanned pregnancies in control group Tearoom Trade Study (1970s) Gathered information about people interested in homosexual activity and breeched their confidentiality to families and in publications Albuquerque Tribunal publicizes Human Radiation Experiments (1993) Public newspaper acknowledges experiments Death of a Healthy Volunteer, Nicole Wan (1996) Lung Function study Apology to Tuskegee Experimental Subjects (1997) President Clinton issues a format apology. NBAC continues to investigate cases. Death of a healthy volulnteer, Jesse Gelsinger (1999) Lung Function study Death of a healthy volunteer, Ellen Roche (2001) Asthma Study

5. Informed Consent Laws Food and Drug Act (1938) Begins the need for human trials by requiring proof of safe drugs Nuremberg Code (1947) Voluntary & Informed Consent, Experiments must be scientifically necessary, Favorable risk/benefit analysis, Right to withdraw without penalty International Code of Medical Ethics of the World Medical Assembly (1949) Outlines duties of physicians First Federal Policy for Protection of Human Subjects (1953) Kefauver-Harris Bill – Expansion of Nuremberg Code (1962) Ban human trials until animal trials are conclusively safe FED Establishes Regulation 21 CFR130.3, later incorporated in 45 CFR 46 Certification of informed consent Helsinki Declaration signed by US (1964, expanded 1975, 1983, 1989) The interest of the subject has higher priority than society, Every subject should get the best known treatment, Requires independent review of all human subject research, Origin of Institutional Review Board (IRB) Congressional Hearings on Quality of Health Care and Human Experimentation (1973) Held in response to public concern about human subjects

6. Informed Consent Laws National Research Act (1974) Created National Commission for Protection of Human Subjects in Biomedical and Behavioral Research. Prompted establishment of IRBs at local level FDA Establishes Regulation 45 CFR 46 (1978) Protections for pregnant women, fetuses, and prisoners Belmont Report (1979) –Discussed further President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Commission (1980-1983) Recommends federal agencies adopt human subject regulation of Dept of Health & Human Services Human Radiation Experiments Report (1995) From President’s Advisory Committee – special care must be taken when research must be secret Catalyzed establishing the National Bioethics Advisory Committee NBAC Charter is not renewed under Pres. Bush (2002) Secretary’s Advisory Committee on Human Research Protection

7. The Belmont Report What is the Belmont Report? List & Describe the three basic principles associated with The Belmont Report List and Describe the three applications of The Belmont Report

8. Nazi War Crimes & Mengele Twin Study Describe Each

9. Nuremberg Code Describe the 10 parts of the Code 1.Voluntary Consent 2.Fruitful results for good of society, unprocurable by other means 3.Designed and based on results of animal experimentation and results will justify experiment 4.Avoid all unnecessary physical and mental suffering/injury 5.Death/Disablement not an acceptable result of experiment 6.Degree of risk should not exceed humanitarian importance 7.Proper prep and adequate facilities provided to protect subject against even remote possibilities of injury, disability, or death 8.Conducted by only scientifically qualified persons 9.Subject is free to end the experiment/ Freedom to Withdraw 10.Scientist must be prepared to terminate the experiment if continuation of the experiment is likely to result in injury, disability, or death

10. Tuskegee Syphilis Study Describe Study Describe Concerns Describe Results

11. Institutional Review Board What is the IRB? What is the purpose of the IRB? When is consent from the IRB necessary?