My IRB approval has an expiration date. What must I do if my research is continuing beyond the expiration date?
If your research will continue beyond the IRB approval's expiration date, you must submit a continuation request. Your request must be approved before the initial/former approval form's expiration date or your research must cease until IRB approval of your continuation request. Be sure to submit your continuation request with this in mind.
If you continue to recruit subjects, collect data or analyze data after the expiration date and before your request has been approved, you will be out of compliance.
What happens if I am making changes to my research plan as outlined in my approved protocol?
If you plan to make changes to your research plan as outlined in your approved protocol, you must submit a modification request. This request must be approved before the implementation of the changes (except where changes are necessary to eliminate apparent immediate hazards to subjects). Be sure to submit your modification request with this in mind. If you implement changes before IRB approval, you will be out of compliance.
What are examples of changes to my research plan (as outlined in my approved protocol) that require IRB approval?
Some examples of changes include (note that this list is by no means exhaustive):
Change in principal investigator.
Addition or removal of personnel.
Change in number of enrolled participants.
Changes to the procedures or study design.
Changes to the study instruments (surveys, questionnaires, etc.).
Changes to the informed consent documents or procedures.
Changes to recruitment materials.
Changes in location of research or agency.
Changes in funding sources.
If my modification request is approved by the IRB, is my expiration date automatically extended?
No. You must still submit a continuation request by the expiration date noted on the approval of your initial protocol or most recent continuation approval.
What do I do if issues arise that increase the risks to my research subjects?
If a serious problem occurs while conducting your research, you must report it to the Institutional Review Board administrator promptly after becoming aware of the problem.
I have concluded all research-related activities. Must I inform the IRB?
Yes. When your research is complete (when all participants have completed all research related interventions, all analysis of identifiable data is completed and all funding and contracting issues have been completed) you must complete a termination report. This report must be submitted regardless of review level.
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Still Have Questions?
- Lara Kuhn, Director of Research Integrity and Compliance.
- Gail Goldman, Senior Research Integrity Administrator.
- Eric Taft, Research Integrity Administrator.
- Kevin Dardik, Research Integrity Administrator.
Human Research Protection Program
Bernstein-Marcus 2nd floor, MS 116
415 South Street
Waltham, MA 02453