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

• Definition: “A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”

Research

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

ReferencesBelmont 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.