The IRB system treats all types of submissions—studies, sites, and follow-on submissions—very similarly. You perform the similar types of activities and follow the same process for each, with small exceptions. The questions asked are different for each type of submission, but the workflow follows a similar path.
At the highest level, all non-ceded studies and follow-on submissions use the following general IRB process workflow:
At the highest level, all non-ceded sites (participating sites/pSites) use the following general IRB process workflow:
The system shows the diagram above when you view an individual study and shows the current state of the study in orange
ESTR accepts these types of submissions:
- Initial submissions (new studies)
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Follow-on submissions:
- Modification/Updates for approved studies (Modification scope includes options to change ‘Other parts of the study’ and/or ‘Study team member information’)
- Continuing Reviews for approved studies
- Study Closure requests for approved studies
- New information reports (often called RNI for reportable new information) for approved studies or active research in general
- Sites for both when other engaged institutions or organizations that will rely on Harvard review or when associated with an initial External IRB submission.
- Site Modifications to change a feature of an active site
- For External IRB projects only related Study Updates for a modification or update on the status of a study where Harvard relies on the review of another institution
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All submission types follow a very similar workflow. Some differences include:
- Each type of follow-on submission has its own set of determinations that differs from the study determinations.
- Studies, modifications, and continuing reviews include optional ancillary reviews that can be conducted concurrently with the IRB's reviews. Site and RNI submissions do not include ancillary review.
- RNI submissions may skip certain states or require committee review after designated review has been completed.