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

ResponsibilityThe 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

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.

Committees under CHS OverviewCHS 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.

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.

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.

History of scandals: Nuremberg

Third Reich medical experiments

International response

Nuremberg War Criminal Trials 1947

• Legal capacity to give consent

• Free of force, fraud, deceit, duress, constraint or coercion• Sufficient comprehension to make an

enlightened decision

“The voluntary informed consent of the human subject is absolutely essential.”

Infamous Human Subjects Cases in the United StatesThe Tuskegee Syphilis StudyThe Jewish Chronic Disease Hospital StudyThe Willowbrook StudyFernald State School in Massachusetts

Tuskegee Syphilis Study:1932 - 1972400 African American sharecroppers became

part of studyStudy 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

US Public Health Service syphilis study, Tuskegee, AL

A history of abuse, 1932 – 1974, US

The Jewish Chronic Disease Hospital StudyIn 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

The Willowbrook StudyFrom 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.

Fernald State School in MassachusettsFrom 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.

Human Subjects Reform in the United StatesFollowing 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

The National Commission (1974-78)• National Commission for the Protection of

Subjects of Biomedical and Behavioral Research

ChargeRecommend 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

ReportsFetal research, children, prisoners, institutionalized mentally infirm, psychosurgery, IRBs, The Belmont Report

US response, 1979

The Belmont Report

Ethical principles to protect human subjects:

1. Respect for persons2. Beneficence3. Justice

1. Respect for persons

Each human being is an autonomous individual.

Each should be free to make decisions about their own welfare.

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.

3. Justice

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

Belmont emphasis

Protect humans from exploitation

Special protection for most vulnerable (children, pregnant women, prisoners)

Code of Federal RegulationsUses the basic principles of the Belmont

Report

Mandates that Institutional Review Boards (IRBs) protect the rights and safeguard the welfare of human research subjects.

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