1. What is an IRB?
The acronym IRB refers to an Institutional Review Board. Institutions receiving any kind of federal funding for research, must establish an Institutional Review Board to establish human research policies and review all research involving human participants.
2. What federal policies govern human subjects research?
Human subjects research is governed by United States Department of Health and Human Services policy 45 CFR 46.
3. When must research proposals involving human subjects be submitted to the IRB?
Research proposals involving human subjects must be submitted for review and receive approval before the research begins. Graduate student action research that involves protected/vulnerable populations or proposals identified as a risk through the pre-screening
4. What documentation is required for an IRB submission?
- A signed Administrator Consent form for each research site
- Completed HSAR-I
- Completed HSAR-II for all studies involving minors or other protected populations.
- Copies of appropriate informed consent forms (templates available under "Resources & Forms")
- Copies of all survey instruments
- Debriefing Form (templates available under "Resources & Forms")
*Absence of any of these documents upon initial submission may delay the review
**The IRB reserves the right to seek clarification or additional materials from the researcher.
All IRB Proposals should be submitted to firstname.lastname@example.org
5. What are the review categories?
6. How long does IRB review typically take?
- Exempt from IRB Consideration: For projects associated with university courses, if the identity of a research subject is sufficiently protected and the subject is at minimal risk, an exception may be granted. All submissions for exempt status will receive special attention by the Chair if a protected population is included in the study.
- Expedited Review: An expedited review is a review by a subcommittee of the IRB consisting of the chair of the IRB and two other members of the IRB for research that involves no more than minimal risk, protected populations, or to review minor revisions in previously approved research, or review revisions for proposals that were approved with contingencies. This review is conducted electronically and is typically completed within seven to ten working days. An initial discussion of a project proposal with the IRB chair will determine whether an expedited or full review is necessary.
- Full Review: A full review is a review of a project proposal by the entire IRB. This will be conducted for research that involves greater than minimal risk, or when the research is of a psychological nature.
7. What are the possible committee decisions.
- Exempt reviews are typically completed within 1-3 business days.
- Expedited reviews are distributed with a goal of completion within 7-10 business days, though reviews may take longer in periods such as semester breaks or over the summer session.
- Full board reviews are contingent upon the ability to schedule a meeting of all board members and thus may take a considerable time to schedule.
8. Are there additional reporting requirements for researchers after obtaining initial Approval?
- Approved: Researcher can begin his/her project.
- Revise and Resubmit: More information is needed or revisions are needed before proposal is reconsidered.
- Not Approved: Research should not be started.
Yes, pursuant to federal requirements, researchers must report the research status to the IRB Chair, at least once every 12 months until the project is complete.9. Why is there a population minimum of 15? Can smaller populations be used?
The smallest population in which random sampling can be used and retain a 95% level of certainty on research results is 15. Populations smaller than 15 tend to pose challenges for research analysis, including reductions in validity, reliability, and statistical significance.
10. I am not collecting any identifying information; do I need to file for IRB approval?
Yes. Proposals will be evaluated as Exempt, Expedited, or Full Board review based upon the criteria outlined on this site.