If you have an IRB-related question, others probably do too! This column is an opportunity to answer your questions. Check in each month to see the answers to some of the most common questions asked by the research community. To find more questions from previous months, click here to search the archive.
Please send your questions to crtimes@bu.edu.
Q. I’m thinking about broadening recruitment in my exempt survey study by sharing the link via LinkedIn and possibly on my personal website.
I just looked at INSPIR, and I’m not sure if I need to submit an amendment request, as it doesn’t seem like sharing in this new way will alter the Exempt status. The survey link will be the same one shared via email. Participation and answers will still be anonymous.
A: For an exempt study, the IRB does need to review new recruitment methods, as outlined in the HRPP Policies and Procedures below. Please submit an amendment to add these new recruitment avenues, and do not commence recruitment via these methods until the amendment is approved.
10.2.4.1 Request for Exempt Determination
For exempt determinations from the Boston Medical Center and Boston University Medical Campus IRB, changes to the research plan must be submitted as an amendment via the electronic system (see Section 7.4.1.2) for review and confirmation of continued exempt status or continued eligibility for a waiver of authorization prior to initiation of the change if the change could alter the IRB determinations, including changes in:
- protections for privacy and confidentiality; or
- funding; or
- recruitment procedures or recruitment materials; or
- information provided for a waiver of authorization for use and disclosure of Protected Health Information (see Section 8.5.2.2); or
- procedures related to the retention of data or samples for extra use (see Section 7.2.2.16.4) ; or
- procedures that involve the addition of a new study population, or proposed new types of procedures (such as new data collection methods) that were not previously reviewed; or
- relying sites or investigators; for example, the proposed addition of new external sites or new external individual investigators under a reliance agreement.