1. 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

2. 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

3. 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

4. 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

5. IRB Purpose To ensure that all research lives up to the ethical principles articulated in the Belmont Report. –Respect for persons –Beneficence –Justice

6. Principle of Ethical Research: Respect for Persons Autonomy Vulnerable persons Privacy & Confidentiality Informed consent

7. Principle of Ethical Research: Beneficence Minimize risks and maximize benefits Human subjects should not be harmed

8. 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

9. Informed Consent Process of communication –Provides specific information –Answers questions –Gives subject time to consider –Obtains voluntary agreement to participate

10. 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

11. 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

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

13. 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

14. 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

15. 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.