Transcript Institutional Review Board Update

What Institutional Researchers
Should Know about the IRB
Susan Thompson
Senior Research Analyst
Office of Institutional Research
Presented at the Texas Association of Institutional Research
Annual Conference, March 3, 2009
Overview
• What is an Institutional Review Board?
• History of human subjects research
• Ethical principles of human subjects
research
• Defining key terms: “human subject”
and “research”
• When are IRB reviews necessary
What is an IRB?
• Definition: An independent administrative body established
to protect the rights and welfare of human research
subjects recruited to participate in research activities
conducted under the auspices of the institution with which it
is affiliated.
• Requirements specified in 45 CFR 46:
– at least five members
– sufficiently qualified through experience and expertise
– diversity of the members, including consideration of race, gender, and
cultural backgrounds and sensitivity to such issues as community attitudes
Why Do We Need IRBs?
A (Very) Brief History
•
•
•
•
•
•
•
1947 Nuremberg Trials
1948 Nuremberg Code
1955 Wichita Jury Study
1962 Thalidomide Testing
1963 Milgram Studies of Obedience to Authority
1970s Tearoom Trade Study
1932-1972 Tuskegee Syphilis Study
• 1974 National Research Act/National Commission for the
Protection of Human Subjects of Biomedical & Behavioral
Research
• 1974 45 CFR 46 (Common Rule)
• 1979 Belmont Report
IRB Purpose
• To ensure that all research lives up
to the ethical principles articulated in
the Belmont Report.
– Respect for persons
– Beneficence
– Justice
Principle of Ethical Research:
Respect for Persons
•
•
•
•
Autonomy
Vulnerable persons
Privacy & Confidentiality
Informed consent
Principle of Ethical Research:
Beneficence
• Minimize risks and maximize
benefits
• Human subjects should not
be harmed
Principle of Ethical Research:
Justice
• Benefits and risks must be
distributed fairly
• Human subjects should not be
selected because of easy
availability rather than for reasons
related to research
Informed Consent
• Process of communication
–
–
–
–
Provides specific information
Answers questions
Gives subject time to consider
Obtains voluntary agreement to
participate
Required Elements of
Informed Consent
•
•
•
•
•
•
Statement of research, purposes and procedures
Description of risks
Description of benefits
Disclosure of alternative procedures or courses of treatment
Statement about confidentiality of records
For research involving more than minimal risk, an
explanation of the availability and nature of any
compensation or medical treatment if injury occurs
• Identification of whom to contact for further information
• A statement that participation is voluntary
Human Subject
• Definition: “…a living individual about
whom an investigator… conducting
research obtains data through:
– Intervention or interaction with the
individual OR
– Identifiable private information.”
• Information about behavior that is
usually not observed or recorded
• Information that is provided for a
specific purpose that is usually not
public
Research
• Definition: “A systematic
investigation, including research
development, testing and
evaluation, designed to develop or
contribute to generalizable
knowledge.”
IRB Review is
Necessary When:
• The study is a systematic investigation about
individuals OR
• The study involves interaction with persons
OR
• The person is identifiable (includes use of
database contents)
AND
• The findings will be published or shared
publicly outside the institution
Protecting Human
Subjects in Research
• Risks are reasonable in relation to
benefits
• Subject selection is fair and equitable
• Informed consent is ongoing, clear and
documented
• Data are collected in a way that ensures
safety and privacy
References
Belmont Report:
Ethical Principles and Guidelines for the protection of
human subjects of research. The National Commission
for the Protection of Human Subjects of Biomedical and
Behavioral Research, April 1979.
http://ohsr.od.nih.gov/guidelines/belmont.html.
Common Rule:
45 Code of Federal Regulations Part 46 Protection of
Human Subjects.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.