As of June 1, 2006, all studies will be closed on their expiration date in INSPIR. This involves all studies that may have lapsed or their Renewals have not received final approval due to outstanding conditions of approval or deferral.
The Office of Research Protection Guidance on Continuing Review states “If an investigator has failed to provide continuing review information to the IRB or the IRB has not reviewed and approved a research study by the continuing review date specified by the IRB, the research must stop, unless the IRB finds that it is in the best interests of individual subjects to continue participating in the research interventions or interactions. Enrollment of new subjects cannot occur after the expiration of IRB approval.”
This guidance also indicates, “The regulations make no provision for any grace period extending the conduct of research beyond the expiration date of IRB approval. “
Therefore, once a study has lapsed or is closed in INSPIR, all research related activities including recruitment, enrollment, interventions, follow-up and data analysis must cease as of the expiration date of the study until full approval of the study has been granted. Conditional approval does NOT constitute full IRB approval.
If we want to re-open our study, what should we do?
A Protocol DEVIATION report will need to be submitted PRIOR to re-opening or
resubmitting a lapsed study. The protocol deviation report will need to address:
-Whether all research related activities stopped as of the expiration date or
whether research activities continued after expiration (If yes, then include
an explanation as to which research activities continued. Please be specific
i.e. number of subjects, amount of times, etc.)
-An explanation of why the study expired without renewal
-A description of your plan of correction to prevent this from occurring in
the future (Again, please be specific.)
-Whether you wish to use any data collected during the period of expiration
(If yes, then please present your request, along with the justification.)
- The IRB will review this report to determine whether the corrective action
plan is appropriate and how the study can be processed.
Once the above protocol deviation process has occured, you can do one of two things:
(1) If a draft or pending version of the renewal is already under letters/protocol
history, that version will be able to be processed.
(2) If there is no draft or pending version, then a research staff member will
need to call the IRB at 617-638-7207 to re-open the study. The protocol will
only remain open until midnight on the day the study is opened, so a renewal
draft should be created before INSPIR automatically closes the study again.
Will my study lapse be considered serious or continuing non-compliance?
Please see the recent CR Times article, “Dodging New Potholes on the Research Superhighway” for details about this. This article did cite “Research conducted after the expiration date of a research protocol” and “Investigator frequently allowing studies to lapse” as examples of serious or continuing non-compliance.
What if it is in the “best interests of individual subjects to continue participating in the research interventions or interactions”?
If it is in the subject's best interest for study activities to continue, you must submit a protocol EXCEPTION and have it approved by the IRB. If continuation is time sensitive, then please also call the IRB. The IRB will review this information on a case-by-case basis to determine whether individual subjects will be allowed to continue to participate in the research interventions or interactions.