1. What and why an IRB?
The institutional review board (IRB) is a committee of faculty and community members who review the involvement/participation of individuals in research programs/projects conducted by any Trinity College researcher, faculty, student or staff. The IRB is mandated by federal regulations for any federally funded research. Federal regulations on the protection of human subjects and the Trinity College IRB manual were enacted to protect research participants from violation of their human rights.
2. Is what I am doing research?
Research is any activity which gathers information on individuals participating in any activity. Research means any systematic investigation designed to develop or contribute to knowledge or understanding about a question. It includes surveys, testing, program evaluation, interviews, and focus groups. Research is collecting information (data) on people and using that data in reports presented, published, or reported outside of the activity. If the data are only for program/activity improvement and not reported to anyone or anywhere else ever, then it is not research and does not have to go to the IRB. If after conducting the program/activity, the findings are so exciting or insightful or ground-breaking that they need to be disseminated or communicated to a larger audience, then those findings become research and the IRB must be consulted.
3. When is research exempt?
Consult the HHS regulations for the protection of human subjects, Title 45 CFR, Part 46. The Department of Health and Human Services’ Office for Human Research Protections (OHRP) provides a decision tree on human subjects research as a guide for IRBs, investigators, and others, including one on whether human subjects research is eligible for exemption (see http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html).
4. If I think my research is exempt, why should I go through Human Subjects training?
If your research involves Human Subjects (HS), even if you think your project will be exempt, you must complete HS training. Trinity College believes all research should be governed by ethical research methodology and concern for Human Subjects. The Trinity College IRB requires all Investigators to complete HS protections training. The National Institutes of Health’s Office of External Research has an online training module, “Protecting Human Research Participants,” which the Trinity College IRB strongly recommends to all researchers involved in research with human subjects. As noted in Appendix 5, student researchers are required to show proof of completion of this training if submitting a research protocol to the IRB.
5. If I think my research is exempt, why should I submit my determination for IRB review?
You must submit your determination to the IRB to have your research proposal approved as exempt unless your research is clearly excluded from needing any IRB review. Otherwise only the IRB can finally decide if your research project will be exempt from further review.
6. All I'm doing is a survey; do I have to apply to the IRB?
The IRB has three levels of review: exempt, expedited, and full review. Some things are clearly excluded from IRB review such as administrative research and classroom tests. Much of what takes place at Trinity College, such as surveys and questionnaires, may fall under the "exempt" status, which will require submission to IRB review. [LINK TO EXEMPT APPLICATION]
7. Are evaluations research?
Evaluations are considered research when the findings of the evaluation are reported or going to be reported outside the program. Findings can be data from surveys, focus groups, interviews, questionnaires (such as attitude or knowledge questionnaires), or observations. If a program is evaluated solely for the purpose of education or program improvement, and NOT EVER reported to any one or any group outside the program, the evaluation protocol does not need IRB approval. However, if after conducting the program, the findings will be disseminated or communicated to a larger audience, then IRB approval is needed to do that. It is easier to get IRB approval at the beginning of a program than to go back after a program is completed and try to track down all the participants.
8. Is my Oral History Project subject to IRB review?
Often it is. Because of concerns about confidentiality, Trinity College requires oral history research to be reviewed.
9. I'm submitting a grant proposal to an outside funding agency. What do I have to do regarding the IRB?
All sponsored programs/projects involving human subjects need Trinity IRB approval. Some funding agencies will not even review a proposal without IRB assurances. Almost all government funding agencies require an IRB assurance and some agencies and government departments have their own human research protection requirements. Some funding agencies will conduct a proposal review with the assurance that the IRB review will follow by the time the award is made. This is called a pending review. Trinity College requires all grant proposals involving human subjects to have a Trinity IRB review. No research may be done under the auspices of Trinity College without IRB review. The principal investigator/program director is responsible for completing and filing the IRB review.
10. What are IRB reviewers looking for in my application?
See the Reviewer Checklist, Appendix 8.
11. What is minimal risk?
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
12. What is an FWA?
FWA stands for Federalwide Assurance. An institution must obtain an FWA in order to conduct any human subjects research that is supported by the US Department of Health and Human Services. The FWA is essentially the legal permission to do such research. The Office for Human Research Protections (OHRP) is authorized to restrict, suspend or revoke an FWA if it finds that the institution, its IRB or an investigator using the IRB failed to comply with regulations. Each institution that receives an FWA from OHRP is assigned a unique FWA number.
13. My data collection is complete, but the project itself is not yet complete. The IRB approval for the data collection has expired. Do I need to apply to the IRB for approval to continue the project even though I am no longer collecting data?
Yes, you need IRB review because according to 45CFR46.102(f) you are still conducting research that involves human subjects (you are still using their identifiable private information).
14. Where can I find out more?
Trinity IRB Links page [identify & provide link]
If you have questions or examples you think might benefit others by being on this page, please contact the IRB Office Administrator.