Understanding the IRB Process

1. Understanding the IRB Process Dr. Cheryl Peters, Evaluation Specialist cpeters@anr.msu.edu

2. Is it research? • Does our Extension project require IRB review? • 3 Questions

3. Is it research? • MSUE IRB differentiates between program evaluation (with intent to inform or improve program implementation), quality assurance or quality improvement (is the program implemented as intended and with fidelity) and research.

4. Is it research? Question #1 • Is the activity a systematic investigation designed to develop or contribute to generalizableknowledge? • If yes, the activity is defined as research. Next question to consider:

5. Is it research? Question #1 • Generalizableknowledge? • Contributes to theoretical framework • Primary beneficiaries are other researchers/filed practitioners • Publications, presentations intended for professional purpose • Results intended for replication

6. Is it research? Question #2 • Does the research involve obtaining information about living individuals? • If yes, the research involves human subjects. Next question to consider:

7. Is it research? Question #2 • Living individuals? • A human subject • Data through investigation or interaction with the individual • Identifiable private information • De-identified data may not require IRB review

8. Is it research? Question #3 • Does the research involve intervention or interaction with the individuals? • If yes, an IRB application is warranted.

9. 3 Questions = 3 yes • If yes, an IRB application is warranted. • Most Extension program evaluations fall under the category of exempt because the evaluation plan involves research conducted in established or commonly accepted educational settings, involving normal education practices (use of surveys, interviews, observations, or tests).

10. Exempt, because…. • Presents minimal risk. • Often the consent document would be the only record linking the subject and the research. • Note: Keeping your Extension survey voluntary and confidential can support the allowance of waived consent.

11. Waived Consent • Most Extension program evaluation is approved by the IRB under the exempt category & can waive collecting a signed informed consent document.

12. Informed Consent • All Extension program evaluations should include the elements of voluntary involvement, confidentiality, and notifying participants regarding the intent of the research or evaluation. The consent process should be informative and empowering. Templates of consent forms are available on the MSU IRB website. http://www.humanresearch.msu.edu/

13. Types of irb approval • Exempt is still a type of IRB approval. • Expedited and Full Board, VERY RARE. • IRB website: humanresearch.msu.edu • Form descriptions • Reference documents/ Forms

14. PI Status • Updated March 2012 • If Masters degree – no longer require special permission • If do not currently hold a Master’s or higher-level degree, special permission still required for PI status before beginning work on a grant or project • If Ph.D. research, must apply through Faculty Advisor

15. Required IRB training • Individuals listed on an IRB proposal as PI, or staff assisting in the collection of data, are required to have IRB training. The IRB training is online and has a test. Once you complete the training, it is good for 2 years. Instructions and links for the required IRB training are here: http://www.humanresearch.msu.edu/requiredtraining.html

16. Online IRB applications only • Investigator Login • Faculty/Staff need Z-PID

17. What you will need ready • Title • Review category • Resources • Research sites • Project description and procedures (200 words)

18. What you will need ready • Subject population characteristics • Subject risks • Subject privacy/confidentiality • Conflict of interest • Timeline • Consent document (possibly) • Survey instrument (or questions)

19. Last thoughts • Program Evaluation vs. Research. • Intend to Publish Externally. • Have your project stabilized and well-described before seeking application. • Sometimes a call or email will help flesh out the “three questions”. • Sometimes funders “want” IRB.