John Yanagida & Carl Evensen

1. UH employees and students who conduct research involving human subjects are required to obtain approval from the Committee on Human Studies (CHS). John Yanagida & Carl Evensen

2. Responsibility The Committee on Human Studies (CHS) is primarily responsible to ensure that • the rights, safety and welfare of human subjects are protected, • that human subject research is conducted ethically • and in compliance with all Federal regulations, the requirements of State law and the UH’s policies

3. What is the Committee on Human Studies? • The Committee on Human Studies (CHS) is the unit designated to function as the federally mandated Institutional Review Board (IRB) for the University of Hawaii System.

4. Committees under CHS Overview CHS has 3 separate IRB committees. (i). Biomedical Committee: For projects that involve direct medical intervention or interaction, clinical trials for new drugs/devices (FDA regulated activities), invasive or non-invasive procedures for research purposes and other activities involving research purposes in the biomedical arena.

5. Other IRB committees (ii). Social Science/Behavioral Science Committee: For projects involving the intervention or interaction with participants excluding medical procedures, treatment, physical sensors, exercise activities or the collection of medical specimens. (iii).Multi Institutional Cooperative Committee: For only federally funded, multicenter and multisite projects affiliated with UH, Queen’s Medical Center, Hawaii Pacific Health and St. Francis Medical Center.

6. Some history… • International concerns about the ethical treatment of human research subjects can be traced back to the Nuremberg Military Tribunal which was convened to investigate the “research” performed under Nazi Germany during World War II. • During the Nuremberg trials, fundamental ethical principles for conducting research involving human subjects were written in the Nuremberg Code of 1947. The Nuremberg Code became the first international standard for conducting research.

7. History of scandals: Nuremberg Third Reich medical experiments

8. International response Nuremberg War Criminal Trials 1947

9. “The voluntary informed consent of the human subject is absolutely essential.” • Legal capacity to give consent • Free of force, fraud, deceit, duress, constraint or coercion • Sufficient comprehension to make an enlightened decision

10. Infamous Human Subjects Cases in the United States • The Tuskegee Syphilis Study • The Jewish Chronic Disease Hospital Study • The Willowbrook Study • Fernald State School in Massachusetts

11. Tuskegee Syphilis Study:1932 - 1972 • 400 African American sharecroppers became part of study • Study did not give informed consent and participants were not informed of their diagnosis • Participants told that they had “bad blood” and could receive free treatment • By 1947, penicillin was available

12. A history of abuse, 1932 – 1974, US US Public Health Service syphilis study, Tuskegee, AL

13. The Jewish Chronic Disease Hospital Study • In 1963, studies were undertaken at New York City’s Jewish Chronic Disease Hospital to develop information on the nature of the human transplant rejection process • Patients hospitalized with various chronic debilitating diseases were injected with live cancer cells

14. The Willowbrook Study • From 1963 -1966, studies were carried out at the Willowbrook State School , a New York State Institution for “mentally defective persons”. • The subjects, all children, were deliberately infected with the hepatitis virus. Testing whether it was better for them to be infected under carefully controlled research conditions.

15. Fernald State School in Massachusetts • From 1946 to 1956, 19 boys who thought they were participating in a science club were fed radioactive milk by researchers who wanted to learn about the digestive system.

16. Human Subjects Reform in the United States • Following the Nuremberg Code of 1947, the U.S. passed the National Research Act in 1974 establishing the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. • This national Commission eventually published the Belmont Report and the Code of Federal Regulations

17. The National Commission (1974-78) • National Commission for the Protection of Subjects of Biomedical and Behavioral Research Charge Recommend guidelines to protect the rights and welfare of human subjects of research, particularly those with disabilities and develop principles to govern the ethical conduct of research Reports Fetal research, children, prisoners, institutionalized mentally infirm, psychosurgery, IRBs, The Belmont Report

18. US response, 1979

19. The Belmont Report Ethical principles to protect human subjects: 1. Respect for persons 2. Beneficence 3. Justice

20. 1. Respect for persons Each human being is an autonomous individual. Each should be free to make decisions about their own welfare.

21. 2. Beneficence Researchers have a social duty to do good and improve the world by maximizing the ratio of good research consequences over bad consequences.

22. 3. Justice Researchers are bound by considerations of fairness to distribute the risks and benefits of research justly.

23. Belmont emphasis • Protect humans from exploitation • Special protection for most vulnerable (children, pregnant women, prisoners)

24. Code of Federal Regulations • Uses the basic principles of the Belmont Report • Mandates that Institutional Review Boards (IRBs) protect the rights and safeguard the welfare of human research subjects.

25. Research Ethics Internet Coursehttp://openseminar.org/ethics/modules/1/index/screen.do