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 am co-investigator and site PI of a newly funded grant that involves specimens and data from deceased individuals. The responsibilities of the BUMC team are statistical analysis of data and manuscript-writing.
- Based on the helpful definition of human subjects research you have provided on your website, I have concluded that this study does not meet that definition. So seeking IRB approval is not needed. Is this correct?
- Data will be collected outside of BU at external institutions, so I assume we should proceed with a DUA. Do you agree?
A: If the project only involves data from deceased individuals, it does not meet the definition of human subjects research, as human subjects are by definition “living individuals”. Therefore, IRB oversight is not needed. The relevant HRPP Policy citation is here:
In regards to the need for a DUA, the IRB office does not oversee this process. As you are a BUMC investigator, please complete this form for assistance:
https://www.bu.edu/research/forms-policies/data-use-agreement-form/
BMC investigators should instead reach out to DUA.MTARequest@bmc.org for assistance with DUAs.