Reviewers should read the Trinity IRB definitions, learning tools, and policy manual, and also complete the CITI training module for reviewers. Note that local Trinity policies and procedures may differ from those suggested in the CITI training, which was designed for a national audience.
The Trinity IRB Administrator manages the online application tracker, conducts a preliminary review for completeness and glaring errors, and assigns applications to individual IRB Faculty Reviewers. Your response is expected within 10 days for typical low-risk applications, so notify the administrators if problems arise.
The majority of applications received by the Trinity IRB are lower-risk studies. Each is assigned to one Trinity IRB Reviewer, who acts on behalf of the entire committee. If you are unsure how to respond to a particular application, contact the IRB administrators and/or the chair. If a Reviewer believes that the application is higher risk, s/he may call for a full review by the entire committee by notifying the IRB Administrator. Higher-risk proposals undergo a full review by all IRB voting members, and require a majority vote of the quorum to be approved.
When reviewing an IRB application, read all of the materials, and go to the Submit page to check the review criteria boxes. In the drop-down menu, select either:
– Approved (which automatically notifies the applicant and the administrator)
– Revise and Resubmit (and then Add a Comment to explain what is needed)
In either case, the applicant and the administrator will be notified automatically. But the applicant will not see the name of the reviewer. Use “public” comments whenever possible, since these are visible to the applicant, research supervisor, etc. Note that “Denied” can be selected only by the Administrator upon a vote of the full IRB.
Avoid IRB “mission creep” by focusing on our primary criteria: “Does this application for human participants research meet our ethical standards?” Reviewers are NOT required to comment on other aspects of the study. However, if you wish to offer helpful suggestions, consider splitting your comments into two categories. For example, you might format your comments like this:
Revisions required to meet Trinity IRB ethical standards:
1) In Methods Q4, include an interview guide to show us the types of questions you plan to ask.
2) In Privacy Q2, explain how individually-identifiable data will be kept on a password-protected computer or in a locked room.
Recommended suggestions to improve the clarity of your research and communication:
3) In Background, correct spelling is “Principal investigator.”
4) In Methods Q5, consider rewording your consent form sentence X…. to Y…. to be clearer.
Other common examples of reviewer comments (feel free to copy and paste)
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- When the applicant unnecessarily fills out the entire IRB form:
This IRB application is approved, but for future reference, please note that filling out the entire application was not necessary in this case. See Trinity IRB definitions (http://commons.trincoll.edu/irb/definitions) for question 2: “Will you obtain or use identifiable private information about living humans?” Part B-6 states: “If you interview a government official or candidate for public office, this is not ‘private’ information.” Since this study conducts interviews only with elected officials, this is not ‘private’ information. The applicant should have answered IRB question 2 as “No,” which would have exempted them from filling out the entire form.
2. When materials intended for research participants (such as parental consent forms) are too complex:
Please revise the parental consent form to use simpler language, especially for parents with lower levels of English literacy. See the templates in the Learning Tools section (http://commons.trincoll.edu/irb/learning-tools).