Dear IRB

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.


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Questions:


• Q: I am a BU SPH student. I am planning to work on an IRB-approved research protocol as a study coordinator at the Medical Campus of BU for the summer. What do I need to do, and what training do I need?

A: Based on the “Students in Research Guidance” on the IRB website you will need to be added to that protocol as an internal BUMC investigator. You will need to complete the BUMC human subjects protection training requirements, which includes the BUMC Privacy Module, just like any other investigator. If your work will involve direct access to patients' medical and/or dental records, then this may require an amendment to the IRB protocol.  In addition, you will also have to obtain privileges from the BMC Privacy Office before you can directly access patients' medical records.  More information about non-BMC investigators accessing BMC medical records  can be found in the BMC Privacy Module.

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• Q: I am a BU SPH student. I am planning to work on my thesis project this summer. As part of the project, I will be using data from an existing BUMC IRB-approved protocol. Can I just be added to that IRB protocol as an investigator?

A: It sounds like your research involves a unique study question that is being asked as part of your thesis project.  Based on the “Students in Research Guidance” on the IRB website you will need to submit a separate IRB application for your research.   Like all investigators, you will need to complete all the BUMC human subjects training requirements.

Note:  It is likely that your research may qualify for Exempt review.   We recommend that you consult the following CR TIMES articles because Exempt review allows you to complete a shorter IRB application.

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• Q: We have a graduate student from the University of Michigan who is going to join our study staff for the summer and work on our IRB-approved research project. How should this student be listed in INSPIR: As an internal or external investigator? What training will she need to do: BUMC or Michigan’s?

A: This answer is based on the information under “Students in Research Guidance” on the IRB website.

Assuming that the Michigan student is being hired (for pay or not) to conduct the research activities currently described in your IRB-approved protocol and not to answer her own separate research question, then she can be added as a BUMC internal study staff because she will be engaged in this research on behalf of BUMC (not Michigan). 

  • She will need to be added to INSPIR.  She will need to complete the BUMC Human Subjects Protection Training (including Privacy Module).
  • She will need to complete a BUMC COI disclosure form.
  • She will need to be supervised by a BUMC investigator and function as BUMC study staff (e.g., reporting unanticipated problems to BUMC IRB).
  • *** Even if she is added to the IRB protocol as an investigator, this does NOT grant her permission to access BMC medical records. If this will be necessary as part of her work on the research, then she will need to contact the BMC Privacy Office to obtain BMC privileges to access BMC medical records.

If the Michigan graduate student is coming to BUMC to collect data for her own research project (thesis) rather than to simply work on your existing project, then she should NOT be added as an investigator on your research.  Instead, she will need to submit her research to the Michigan IRB and obtain approval.  She will need to complete the human subjects training requirements of her own institution.

If your protocol is approved to release data/specimens to outside investigators who have obtained IRB approval, then the materials can be given to her (assuming all the HIPAA requirements have been met).   If your research is not approved as a repository to release data to external investigators, then you will need to submit an amendment to BUMC for your protocol.

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