The IRB frequently receives repository applications that lack sufficient detail for approval. This causes significant delays. Applications lacking sufficient details will be returned to pre-submission status without review.
Creation of a repository study requires a careful, detailed presentation of the study design. Below is a list of common problems that lengthen review time:
- Informed consent not addressed, including requests for waivers of informed consent for use of retrospective records;
- Misunderstanding the meaning of “prospective data” (see above for details);
- Sources of data/specimens are not clearly identified;
- Process for dissemination is not addressed.
Attempts to create both a repository and an umbrella application within one protocol frequently result in significant delays due to the complexity of both application types, along with missing and conflicting information. An umbrella application to conduct research using data from the repository should generally be submitted as a separate application from the repository.