UH employees and students who conduct research involving human subjects are required to obtain approval from the Committee on Human Studies (CHS). - PowerPoint PPT Presentation

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

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Title: UH employees and students who conduct research involving human subjects are required to obtain approval from the Committee on Human Studies (CHS).


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

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 UHs
    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, Queens
    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 Study1932 - 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
    Citys 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
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