1. Institutional Review Board for Human Subject Research: Does Your Research Need One? Merle Rosenzweig oriley@umich.edu oriley@umich.edu Michael Unsworth unsworth@msu.edu

2. OUTLINE IRB Background  Definitions & Concepts  History – matter of ethics  IRB process Case Studies

3. Definitions & Concepts

4. Institutional Review Board (IRB) A group that reviews and approves any type of research to protect the people who take part in it. IRBs check to see that the research is well designed, legal, ethical, does not involve unneccesary risks, and includes safeguards for people taking part.

5. AS DEFINED BY FEDERAL REGULATIONS

6. A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Studies that involve interviews, follow-up contact to determine the effectiveness of a program. Marketing surveys and surveys to assess user satisfaction often do not require IRB review and approval because contracts with member groups specifically allow members to be contacted without such approval and because these surveys do not contribute to generalizable knowledge. If information from a project will be published in a scientific journal or presented at a scientific meeting, the project is considered research by the federal definition and requires IRB review and approval. Publication or presentation implies an intention to contribute to generalizable knowledge. Additionally, many medical journals require documentation of review by a human subjects committee as a condition of publication.

7. Human Subjects Research Involves Wide variety of biomedical and clinical research Behavioral research Survey research

8. A fundamental ethical requirement in connection with research involving human subjects A basic principle of respect for persons Respect for persons requires that subjects, to the degree they are capable, be given the opportunity to choose what shall or shall not happen to them

9. (45 CFR 46) Most Research Receiving Federal Funding Must Follow “The Common Rule.“(45 CFR 46) Elements:  requirements for assuring compliance by research institutions;  requirements for researchers obtaining and documenting informed consent;  requirements for Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping.  additional protections for certain vulnerable research subjects-- pregnant women, prisoners, and children

10. IRBs Are the Result of 20 th Century Research Misconduct or Dilemmas

11. The IRB Process

12. Title of the Study Principle Investigator,Study Team Members (Roles,Conflict of Interest information, & Credentials) Project Summary Estimated start and end dates Performance Site(s) and Details Research Design: Objective, Specific Aim(s)/Hypothesis, Background Information, Interactions (e.g., information gathering, survey, interview, focus groups), Statistical Design Benefits and Risks Subject participation (number and age) Recruitment (may include screening) Informed Consent Confidentiality/Security Retention of Data

13. An IRB then reviews the application to insure that: Risks to subjects are minimized. Risks to subjects are reasonable in relation to anticipated benefits, if any. Selection of subjects is equitable. Informed consent will be sought from each prospective subject. The possibility of coercion or undue influence is minimized. Require that additional information be given to subjects “when in the IRB's judgment the information would meaningfully add to protection of the rights and welfare of subjects”.

14. IRBs are also responsible for ensuring that members who review research have no conflicting interest.

15. Research that meets the categories set forth by the federal regulations (45 CFR 46) that expose participants to no more than minimal risk.

16. Research limited to the following activities may qualify for an exemption determination by an IRB: Studying educational methods Interviewing public figures Use of publicly available data sets Use of existing data and/or specimens stripped of identifiers

17. HOW AN IRB DETERMINES AN EXEMPTION:

18. TO GET AN IRB EXEMPTION, ONE MUST STILL DO A LOT OF PAPERWORK!

19. CONCLUSION: ACCEPT THE IRP PROCEDURES AS PART OF THE RESEARCH PROCESS AND FOLLOW THEM

20. CASE STUDIES