IRB Protocol

Student Research Flow Chart: Figure out how to proceed depending on your roles in any research projects

Resources and Notes About Submitting to the IRB

  • Students can obtain assistance with regulatory questions from the Clinical Research Resources Office (Director Mary Tara Roth) at (617) 638-8873 or www.bumc.bu.edu/crro.   The CRRO will conduct pre-reviews of IRB protocols before they are submitted to the IRB. This is usually very helpful especially for those who are submitting their first IRB protocols and prevent a lot of back and forth with the IRB.
  • Each student must have a Faculty Advisor as a co-investigator on the protocol who is responsible, along with the student, for the ethical conduct of the research.  The Faculty Advisor is responsible for helping students to design the research and write their overall research protocol etc. as the CRRO cannot take on this mentoring responsibility.
  • It is not too soon for students to start submitting their summer projects to the IRB. The IRB frequently gets deluged with student projects prior to summer and must review them on a first come, first serve basis.  This means that it could take a month or so for IRB approval – especially if the protocol needs to be sent back for questions to be answered or issues to be addressed. Since students cannot start their projects until they have received full IRB approval it is best to not wait until the last minute.
  • Students must have completed the required Human Subjects Research Training requirements before their protocols can be approved. They must submit the documentation to the IRB office via FAX at  (617) 638-7234.  They should NOT attach the certifications to their IRB protocols.  Details about certification and recertification training can be found at http://www.bumc.bu.edu/ocr/certification/ .
  • The Clinical Research Times  (CR Times) at www.bu.edu/crtimes is an excellent resource with about 10 years worth of articles in the archives on various research topics.  This information can be very helpful for students who are working on research protocols.  Click on Archives link and then search under Feature Articles topics.
  • Specific information about how to complete an INSPIR application, how to gain access to INSPIR, etc. can be found on the IRB website at http://www.bumc.bu.edu/irb/inspir-ii/ .

Quality Improvement/Assurance Projects that Don’t Involve Research

For quality improvement (not research) projects the IRB does not have any jurisdiction. The IRB is frequently asked to review projects to make a determination as to whether some or all of the project meets the definition of human subjects research.   Many times a project can involve QA/QI  and research – in those cases IRB review is required and human subjects regulations apply.

For projects that are ONLY  QA/QI and don’t involve research

  • No human subjects research training is required
  • No IRB submission and approval is Required *
    • *If there is Federal or foundation /industry funding, an IRB review may be required in order to release the funds (even if it is only for the IRB to make a determination that it is not human subjects research)
  • If the research involves the collection of research data from medical records or collection of data under HIPAA then IRB review may be needed to ensure HIPAA compliance.
  • Recommendations for a alternate/parallel review for QA – committee/someone at the institution to review QA/QI projects to ensure that they are ethical, are compliant with institutional policies,  confidentiality/HIPAA issues are addressed, that they haven’t crossed the line into research.

Projects that Might Qualify for Exempt Review

For projects that might qualify for EXEMPT review under the IRB regulations

  • Will require IRB submission and approval- IRB makes the Exempt determination
  • May require approval under HIPAA

Dear IRB Q & A

(As appeared in February 2013′s CR Times)

Q: Dear IRB, I am writing an IRB protocol and I would like to use a list serve as a source of recruitment.   Is this possible?  If so, what do I need to put into the IRB protocol?
A:  It depends on the study.  For many studies, it would be appropriate to use a list serve as a way of informing subjects about the research.  The IRB protocol needs to include, in the recruitment section, the name of the list serve, the exact text that will be included in the message and you will need to confirm that you have the permission of the administrator of the specific list serve to use it for this purpose (recruitment of research subjects).    IMPORTANT POINT: Obtaining appropriate permission from the owners of the list serve is also necessary. IRB approval to use a list serve as a recruitment strategy is NOT the same thing as having the permission of the “owners” of the list serve to use their list serve to recruit for your study.    Both IRB approval AND appropriate permissions are needed.    This is no different than obtaining IRB approval for use of a flier for recruitment.  The IRB approves the use of the flier but you must also obtain appropriate permission to post the flier in a physician’s waiting room,  public transportation,  or a church hall.   Additional assistance with addressing recruitment questions can be obtained from the BUMC CRRO.

Q. Dear IRB,  I would like to recruit subjects for my research study by sending out a “blast” email to every member of the BU/BMC faculty staff with the specific recruitment materials about my study.  Is this ok?
A. The IRB will not ordinarily approve this recruitment plan because the Institutions’ policies are to not use their email systems in this way.  There is, however, an alternative option.   There is a weekly email that goes out to medical campus faculty /staff /students called Weekly Events on the Medical Campus.    Once the IRB protocol is approved you can send the approved recruitment text to BU Corporate Communications.  They will post the recruitment information about the study in this “Weekly Events” email along with information about other events and studies.   Again, your IRB protocol should indicate that this recruitment method will be used and should specify the text that will be used.  The contact about posting recruitment information in this newsletter is bumccorporatecomm@bu.edu.

Q. Dear IRB,   I would like to recruit BU medical students into my research study.   Specifically I would like to send out recruitment information for the study directly to med students via the BU medical student list serve.  Is this ok?
A. As a rule, using the medical student list serve for research recruitment of individual protocols is not allowed.    However, depending on the nature of the research it might be considered.   If medical students will be targeted you will need to have approval of Dean Antman.  This would be obtained by listing Dean Antman as a sign-off in Section 3.5 of the IRB application.  (If this was a study of dental students you would need the approval of Dean Jeffrey W. Hutter, DMD  and for the School of Public Health you would need the permission of Dean Robert Meenan, MD).   Secondly, the IRB protocol would need to specify that these students were being targeted for recruitment and why.  The recruitment section of the protocol would need to state that the student list serve would be used and the specific recruitment language must be provided.  As stated in the first section above, the permission of the administrator of the each list serve to use the list serve in this way would also be needed.  In the case of the med student list serve the contact person is  Douglas Hughes MD, Associate Dean of Academic Affairs, dhughes@bu.edu .