Research Involving Human Subjects

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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).
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
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 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.
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
“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
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
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
A history of abuse, 1932 – 1974, US
US Public Health Service syphilis study, Tuskegee, AL
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
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.
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.
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
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
US response, 1979
Ethical principles to protect human subjects:
1. Respect for persons
2. Beneficence
3. Justice
The Belmont Report
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 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.
Research Ethics Internet Course
http://openseminar.org/ethics/modules/1/index/screen.do
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