The IRB Review Process & Types of Review
Pre-submission is when the researcher designs the research, completes IRB templates and forms, obtains approvals from communities, proposes to thesis or dissertation committee, etc. This part of the process is done by the researcher typically without involvement of the OIRB or IRB. As you develop your paperwork, please consider the IRB guidance and policies that may apply to your research. If during this phase you have any questions, you can schedule a consult to meet with an IRB Analyst to talk about IRB expectations, completing the paperwork, or any other questions that you have. Once the paperwork is complete and ready, you will upload the documents and submit using IRBNet.
Once the package is submitted, the first step is the pre-review. This phase involves an IRB Analyst examining the submitted documents for completeness, consistency, and other administrative components. If there are any issues, then the analyst will unlock the package and you will get an email listing the issues that needs to be addressed, which is known as Clarifications. Once all of the issues have been addressed, you will need to upload edited documents and "Mark Revisions Complete" so the analyst can complete the pre-review. Please note that you have 30 days to respond to clarifications; if there is no response, the submission will be withdrawn.
Once pre-review is complete, the submission will be reviewed. The types of review are described below. When writing your study documents, don't focus on trying to get one review type or another, just write the documents from the perspective of what you need to conduct successful research.
After the review has been completed, a determination letter will be available in IRBNet. There are three determinations: Approve, which means you can start your research; Disapprove, which means that you are not able to do your research; and Modifications Required, which means that there are specific changes that need to be made or more information that is required before it can be approved. If you get a modifications required letter, you CANNOT begin the research. The specific issues to address will be listed in the letter. Once those issues have been addressed, you will create a new package for that exisiting project in IRBNet to upload edited documents. When you upload edited documents, make sure to create a version trail (see IRBNet Submission Instructions for specific steps).
What are the types of IRB review?
Activities that meet the institutional definition of Human Subjects Research (HSR) require IRB review. Activities that do not meet the definition of HSR (e.g. program evaluation, oral history, etc.) do not require IRB review. If you want a written determination from the IRB of whether a project is HSR, you must submit documentation via IRBNet as described in the IRB Submission Checklist.
Certain categories of HSR can be determined to be exempt from the federal regulations as long as they meet prescribed ethical criteria including the requirement for informed consent, minimal risk study procedures and considerations for participant privacy and data confidentiality. An exempt determination means that the study is exempt from the federal regulations and does not need to be submitted for continuing review. However, any significant changes to an exempt project will need to be submitted to the IRB to ensure that the exempt determination still applies. This is a determination made by the OIRB or IRB; researchers are not permitted to make exempt determinations.
Examples of exempt studies include online anonymous surveys, classroom curriculum evaluations, interviews on non-sensitive topics, review of existing academic, medical or other records without recording identifiers, etc.; See SOP 302 “Exempt Review” for a complete list of exemption categories.
Certain research that involves no greater than minimal risk and only includes procedures listed in the Federal Register expedited review categories can undergo expedited review. This is a determination made by the IRB upon review of the study. Expedited review procedures allow an individual IRB member to review and approve studies on behalf of the full IRB. Studies that qualify for expedited review are reviewed on a weekly basis. These studies are subject to continuing review by the IRB. Some full board studies may eventually qualify for expedited review once the study is limited to data analysis or if no participants have been enrolled in the study.
Examples of expedited studies include identifiable surveys, interviews and focus groups on potentially sensitive topics, studies that access identifiable health or educational records, studies collecting biological specimens by noninvasive means, etc.
Full Board Review
Studies that do not qualify for exempt or expedited review and/or present greater than minimal risk to participants must be reviewed at a fully convened IRB meeting. The full board meets once per month. Due to the frequency of full board meetings, the OIRB website lists deadlines for submission in order for items to be on the meeting agenda. Submissions that complete pre-review after the deadline will be reviewed at the following month’s meeting. A majority of the board including at least one non-scientific member must be present at the meeting in order for quorum to be established. If protocols include research with children or prisoners, then an IRB member with that expertise must be present in full board meetings that review such research protocols.
Examples of full board studies include research in prisons, studies administering drugs or alcohol, research involving invasive interventions (e.g. biopsies, tDCS), or research including high risk or vulnerable populations (e.g. maximal aerobic capacity testing on frail populations), etc.
Minor changes to study documents such as grammar corrections, addition or removal of project team members, phone number changes, etc. and study closures are reviewed administratively by OIRB staff. Submissions that qualify for administrative review are done on a daily, first come first serve basis.