Working with Human Subjects in Research

1. Working with Human Subjects in Research Shawn J Riley October 2010

2. Overview • Why me? • Human Research Protection Program Online Application System • MSU’s Institutional Review Boards (IRBs) • Review Process • Review Criteria • Question and Answers

3. Why is approval important? • You may not obtain your degree since the University may not allow you to use your data. • They will check in your final draft of dissertation… • Data may not be publishable (most journals require proof of IRB approval)

4. Institutional Review Boards (IRBs) Protect the rights and welfare of human subjects Purpose Michigan State University’s IRBs: • Human Research Protection Program • Social Science/Behavioral/Educational Research IRB (SIRB) • Community Research IRB (CRIRB) • Biomedical and Health IRB (BIRB)

5. MSU Requirements All research projects involving human subjects must be either: • reviewed and approved by an Institutional Review Board (IRB) before initiation or • reviewed and determined to be Exempt by the IRB staff before initiation. In either situation, you need an approval letter or determination letter before you can start your research.

6. MSU Requirement • Responsible Project Investigator = only faculty members • Students listed as the secondary investigators. • Data are the property of the faculty member and a copy must be retained by her/him • Must obtain participants’ informed consent Responsible Project Investigators assume responsibility for the oversight and conduct of the project.

7. Online Application System • The IRB office will onlyaccept applications for initial review submitted through the online application system.

8. Online Application System • To log on: • Go to www.humanresearch.msu.edu • Click on “Investigator Login” in the menu on the left

9. MSU Training Requirement Investigators and research staff on the project must complete the online tutorial available at: www.humanresearch.msu.edu/training/training_index.htm

10. Initial Review Types • The initial review process depends on the type of review: • Exempt • Expedited • Full Board • To determine the review level: • Check the lists available on website • Analyze the level of risk

11. IRB Considerations Criteria for IRB Approval • Risks to subjects are minimized • Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects Considerations • Risks include possible harm or injury occurring as a result of participation in the research study. Potential risks may be physical, psychological, social, legal, and/or economic in nature • Benefits are valued or desired outcomes, advantages occurring as a result of the research study Clearly explain risks and benefits in the initial application and in the consent Tip

12. Consent content • Brief summary of project, with title and “consent” at top • It’s voluntary - you can withdraw at any time • Risks and benefits of participation • Who investigators are and their contact information • How to contact IRB • Participant’s signature Consult template available on the IRB website to be sure you cover all of the necessary information Tip

13. IRB Considerations Criteria for IRB Approval • Informed consent will be appropriately documented Considerations • The subject is required to sign the consent document • A waiver of documentation may be requested Requirements • Informed consent is a process, not just a form. • Subjects must be provided a copy of the consent document.

14. IRB Considerations Criteria for IRB Approval • When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data Considerations • Privacy vs. confidentiality • Anonymity vs. confidentiality • Reporting of data

15. Example As part of her master’s research, Susan Creel is going to be interviewing 20-30 people about their satisfaction with fishing. • What are some potential risks? • Are there additional risks posed because of her association with the subjects?

16. Example On her IRB application, she states that she plans to interview subjects “in the field.” • Are there any privacy concerns?

17. Initial Application: Tips for Completion • Questions for IRB? • Email if not urgent • Visit or call if question is urgent • When in doubt, including more information in your application is better than less information • Use the help information and templates online to check your application • Send all appropriate attachments • Be sure your training is up-to-date • Small things can lead to big delays - apply as early as you can!

18. Continuing Responsibilities The researcher’s obligation to protect human research participants does not end with initial approval of the study or signed consent document. The commitment to participants is to safeguard their interests throughout the study, and beyond.

19. Continuing Responsibilities • Revisions • obtain approval for changes before implementing them • Renewals • obtain renewal for your study before approval expires • Unanticipated Problems and Adverse Events • report unanticipated problems immediately to the IRB • Closures • communicate the completion of your study to the IRB IMPORTANT... • Forms available at www.humanresearch.msu.edu • Completed forms can be submitted through mail or the Responsible Investigator’s MSU email account