Office of Human Subjects Research, National Institutes of Health
FAQs
1. Who is required to submit an application to the IRB?
Anyone on campus (including administrators, faculty, staff, students, etc.) who plans to do research involving human participants is required to submit a proposal.
2. What is the definition of research?
“Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” (Definition of Research, Office for Human Subjects Research, National Institutes of Health)
3. Do all projects require a formal review?
No, some projects qualify for an expedited review (refer to http://www.hhs.gov/ohrp/); however, that determination is made by the IRB. The researcher may request an expedited review and state their reasons.
4. Do I need to use a specific form?
Yes. The Application Form is available here.
5. Can I submit the application by e-mail?
No. This document is considered a formal application and needs to be signed.
6. Why do I need to submit so many copies?
Each member of the IRB committee needs a copy.
7. What kind of time course can I expect for a review?
If your project qualifies for an expedited review, you can usually receive an answer in three days. If your project needs a full review, it may be longer. The full IRB review requires a submission no later than 5 p.m. on the Monday before the last Friday of September, October, November, January, February, March, and April. The full committee then meets on those last Fridays.
8. When can I begin my research?
As soon as you receive a signed approval form from the IRB, you may begin.
9. How long does the approval last?
One year from the date of approval.
10. If I want to renew, do I need to go through the entire process again?
If substantial changes have not been made to the original proposal, and no untoward results occurred in the original study, you may be able to go through an expedited review.
11. What if I have an entire class that is doing research?
First of all, make sure that what you are doing is research (see question #2 above) and not an in-class exercise. If you are doing research, you may receive a faster review if you submit one application form as a template and then attach examples. Also, certain research methods (e.g. anonymous surveys) may qualify for an expedited review (see #3).
12. If one of my students does a research project, am I responsible?
Yes, you are considered the responsible project investigator.
13. What if my proposal is not approved?
The IRB committee will provide you with feedback to modify your proposal to increase its chances of approval.
14. If I have any questions about the process, whom should I contact?
Kathy Dillon, 782-1726, Box S5009, 303 Sleith


