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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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).

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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

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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.

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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.

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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.

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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.

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History of scandals Nuremberg Third Reich
medical experiments
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International response Nuremberg War
Criminal Trials 1947
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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

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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

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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

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

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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.

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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.

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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

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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

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US response, 1979
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The Belmont Report

• Ethical principles to protect human subjects
• 1. Respect for persons
• 2. Beneficence
• 3. Justice

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

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• 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.

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

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Belmont emphasis

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

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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.

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