Blog
October 17, 2024
Best Practices for IRB Protocol Submission Timing
As Research Administrators, we have all experienced the age-old conundrum of when the Institutional Review Board (IRB) protocol should be submitted for review and approval.
The IRB review process is guided by federal rules and regulations. It is based on the Federal Policy for the Protection of Human Subjects (“Common Rule”), the Belmont Report, and provisions of 45CFR46 — “Protection of Human Subjects” requiring institutions that receive federal funds to have all research involving human participants approved by an IRB.
For the National Institutes of Health (NIH) at least, we know that the approved IRB protocol is not typically required at proposal submission but one should always check the Funding Opportunity Announcement (FOA). However, if we wait until Just-In-Time (JIT) is requested, there may not be enough turnaround time for protocol submission, review, and Full Board approval before NIH requires compliance approvals in order to prepare the award. This delay may potentially result in a prolonged period of time before NIH issues the Notice of Award (NOA) or it is issued with a restriction on human subjects. So, what should we do and when?
Note: Please refer to your institutional policies and the Association for Accreditation of Human Research Protection Programs, Inc. (AAHRPP) guidelines.
Step 1: Complete the Required Training
This often includes Good Clinical Practice (GCP) and Human Subject Protection (HSP) training but other training may be required for all senior/key personnel on the project involved in the human subjects research of the proposed project.
When? If you are in a lab or position where human subjects research is expected at some point, it is best to complete the training as early as possible, during new employee onboarding.
Step 2: Request Access to the Software Needed
Request a login and password to your institution’s protocol submission software and complete the software training as well.
When? This can also be done very early on in the process, either at New Employee On-boarding or once a funding opportunity has been identified.
Step 3: Complete and Submit the Initial Review Application
Review the sponsor guidelines and your institution’s policies for what is considered “not human subjects research,” “exempt,” or considered eligible for “expedited review.”
When? Since these studies do not require a Full Board Review, it is best to submit them right away, while you are in the proposal development stage or when the PI has received their summary statement with the score. There is no reason to wait on these. If you can get them approved before the proposal is submitted, it would be ideal to include the approval letter with your application.
Step 4: Complete and Submit the Full Research Protocol
With studies that are not considered nonexempt, exempt, or eligible for expedited review, there is often not enough information to complete the protocol at the proposal development stage.
When? The best practice would be to prepare the required documents and complete the IRB protocol in the protocol submission system before JIT is requested, but not submit the protocol for review. This could be any time as soon as you know enough about the research to complete the protocol application at your university. Oftentimes, PIs are in contact with their Program Officers, and they might have an idea the grant proposal is being considered for funding or that they received a potentially fundable score. Once the PI receives the JIT notice or an indication the grant proposal is being considered for funding the IRB protocol should be submitted for IRB full board review.
Step 5: Submit Additional Documents
These could include items such as:
- Any/all subject-facing documents
- Recruitment Materials (e.g., flyers, advertisements)
- Screening Scripts
- Consent Form(s)
- Surveys/Interview Questions/Focus Group Prompts
When? Again, ideally, these should be prepared before JIT is requested. In practice, these documents should be submitted along with or soon after the research protocol is submitted, depending on the institution’s guidelines.
Step 6: Signatures and IRB Committee Review
Often signatures are required in the institution’s protocol submission software. Once everything has been submitted and approved through the software, the protocol will be ready for Full Board Review. Each institution has their own meeting schedule, but this meeting is often held once a month. So, if the protocol is not ready in time for the current month’s meeting, it will have to wait another month.
When? If the protocol is submitted for IRB review prior to receiving the JIT request, it’s possible the approval letter may be available by the time JIT documents are submitted.
Note: Revisions may be required before the protocol can be approved. However, if the next meeting is past the JIT deadline, you may provide the protocol number even if it is not yet approved. You can provide a letter that this protocol is slated for IRB review. If the project is funded, this may result in a delayed issue of the NOA or in the NOA being issued with a restriction on human subjects research until proof of an approved protocol is provided. Also, please note, many federal funding agencies will only issue a restricted award notice towards the end (August/September) of the federal fiscal year which is September 30.
Step 7: Prepare Post-Approval Submissions
Amendments or modifications may be needed after the protocol is approved.
When? This varies as needed. The best practice is to submit these documents as soon as you are aware that they are needed. If a new study site is to be added, this must be approved before they can begin any work.
When each of these steps are completed as early as possible as discussed above, we, as Research Administrators, can put our PIs in the best position for IRB protocol approval before JIT is requested.
Attain Partners – IRB Protocol Experts
Attain Partners’ research professionals can assist your organization in submitting its IRB Protocol for review and approval. Contact us today to learn more and get connected directly with one of our experts.
About the Authors
Melanie Bourghol is a Senior Associate at Attain Partners. She completed her Master’s in Health Administration program at Cornell University in NY. She has been working in Research Administration for almost 20 years in central pre-award and post-award administration at multiple NYC institutions, including New York University and Albert Einstein College of Medicine. For a few years, she specialized in Award Set Up, where her interest in IRB administrative matters grew. After joining Attain Partners over two years ago, she’s had the opportunity to round out her experience in AR, cash management, and closeouts through her work with prestigious research institutions.
Mindy Solivan is a Senior Consultant for Attain Partners. She completed her Masters in Industrial Chemistry-Forensic Science program at the University of Central Florida. She has been working in research administration for almost 20 years in central pre-award, post award and research compliance at multiple institutions including the University of Central Florida and the University of the Virgin Islands. For many years, she specialized in pre-award, including proposal submission and contract negotiation, and non-financial post-award. Over the last 6 years she has expanded her experience and oversight to research compliance including IRB administration. After joining Attain Partners this year she continues to expand her experiences in all areas of research administration including system integrations, assessments and training through her opportunity to work with diverse research institutions.
