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.
Unlike our usual Dear IRB questions, this includes an important follow-up question. Please read along for the follow-up question and answer.
Initial Question:
Q. Our team ceded review to an external IRB.
The external site has asked us to post flyers at BMC to help them recruit control group participants for this study. We will not be interacting at all with people interested in participating; we will exclusively be posting the flyers in approved locations, such as the clinic waiting room. The flyers include the phone number of the external site study coordinator, who will be handling all interactions with potential control participants. The flyer for control participants has been approved by the external reviewing IRB, but since this is a new participant group, I wanted to confirm whether we need to submit a local IRB amendment.
Initial Answer:
A: As I understand it, for this group, you will post the flyers in BMC space, but participate in no active recruitment. Instead, patients who see the flyer and are interested are expected to call the external site team directly. If this is correct, then you do not need to submit this to the BMC/BUMC IRB. You just need permission from whomever controls the space to post the flyer, and you need to obtain approval for the flyer from BMC Marketing and Communications. Here is info on how to submit to them:
Follow-Up Question:
Q. Thank you for your response. In the 2023 CR Times article, “Recruitment Help Update: When is Marketing/Communications Review Now Required?“ it says:
“Moving forward, printed materials such as flyers, brochures, and postcards that are only physically disseminated at Boston Medical Center or on the Medical Campus do not require Mar/Comm approval. Instead, these offices recommend that studies use the branded templates for printed materials like flyers and postcards. Regardless of whether you choose to use the professional templates or create your own materials, you do not need Mar/Comm approval if they will only be posted or handed out at Boston Medical Center or in another Medical Campus location.”
Based on this language, I am wondering why this flyer would still need Marketing/Communications approval. I hesitate to create a new version using branded BMC materials as I didn’t make the original version, and that one already has approval from the external site IRB. If we are distributing a new version, then the external site may need to request approval from their IRB for it.
Follow-Up Answer:
A: Thanks for the excellent question, and for referencing the CR TIMES!
The policy you reference applies to recruitment materials that have been reviewed and approved by the BMC/BUMC IRB. The reason that this one requires Mar/Comm review is because it is wholly created/reviewed by the external site. Mar/Comm wants to ensure that there is a formal review for all materials that are publicly posted; and in this case, since the BMC/BUMC IRB does not need to review, then it needs to be reviewed by Mar/Comm.
An alternate option would be to, instead, submit to the BMC/BUMC IRB for review via a Change Request and Amendment form.
Apologies that the article didn’t explain this in detail – this is a rare situation.