DEAR IRB
Question(s):
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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.
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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.
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THE CRRO CORNER
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The BMC/BUMC IRB has released translated Spanish versions of the Adult Consent Form template and the Exempt Information Sheet template. As an accompaniment to the release of these translated consent form templates, this month’s Feature Article discusses the inclusion of individuals with limited English proficiency (LEP); and how to ensure that these individuals are given the opportunity to make a fully informed and autonomous decision about whether participating in a research study is right for them. 