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 firstname.lastname@example.org.
Q. I have some questions about setting up a new biobank and about distributing samples from the biobank to outside groups. It would probably be easier to have an initial discussion. Who should I contact?
A: From the IRB standpoint, the principal issue is that the consent form signed by individuals who contribute samples include that the samples will be shared, to whom (i.e., other academic researchers, commercial entities) and what will be shared (i.e., limited non-identifying clinical data). The IRB application should describe the stewardship of the biobank, specifically what the process is for deciding with whom to share. If the samples are not identifiable to the recipient, then the research with the samples is not considered human subjects research. It has been a common mistake in the past to state in the consent form, that the researchers who receive these specimens will have IRB approval for their study. If this is stated in the consent, then this becomes a requirement that you must adhere to.
If you need more information about the mechanics of Material Transfer Agreements (MTAs), then these all originate with the BU Office of Technology Development (http://www.bu.edu/researchsupport/profile/technology-development/). Depending upon an algorithm, some of these transfers by BMC investigators are routed to the BMC CTO office. The Director of the BU Office is Michael Pratt. email@example.com; 617-353-4569. If there are other questions, contact John F. Ennever MD, PhD, Director, Human Research Protection Program, Boston Medical Center and Boston University Medical Campus, 617-358-5377, firstname.lastname@example.org.