Tips to Speed Up Institutional Review Board (IRB) Approval
Review the Instructions
Always review the IRB protocol instructions when preparing a new submission to ensure you follow the latest instructions (see Forms, Instructions and Samples for Human Subjects Research). Submissions to the IRB must follow the format requested in the instructions. Submissions that do not follow the requested format will be returned to the Principal Investigator (PI) requiring that the requested format be followed before the IRB can review the submission.
Start Early!
While the IRB aims to provide a first review of submissions within 10 days of receipt, some protocols will require several rounds of revisions and reviews, while others may require Full Board Review. Applications proposing work with vulnerable populations, novel research, and/or international research (see International Human Subjects Research) often require lengthier reviews. Thus, there is no guarantee that you will receive IRB approval within 10 days of submission. It is always best to plan ahead and submit your protocol as soon as you have planned your research to ensure you have time to obtain the proper approval in advanced of your anticipated start date.
Complete the Required CITI Training
Make sure all personnel that will be listed on your IRB submission have completed the required Social & Behavioral Training through Collaborative Institutional Training Initiative (CITI). Depending on the nature of your research, additional courses may be required. Please review these training requirements on the Office of Research Compliance’s (ORC) Required Training for the Protection of Human Subjects webpage and remember that applications will not be approved until all PI’s and co-PI’s are up-to-date with required training.
Avoid the Most Common Issues for IRB Submissions
- Be sure to answer all questions on the form and provide clear and consistent responses throughout the submission. It is imperative to check for consistency throughout your written narrative and all appendices before submitting your application to the IRB. Common areas of inconsistencies include but are not limited to: time commitments of participants, data destruction dates, number of subjects, compensation amounts, procedures used, etc.
- Proofread your submission thoroughly for spelling errors, clarity, grammatical errors and missing details.
- Do not forget to include any required appendices with your submission. Missing appendices can result in incomplete submission that will be returned to the PI before a formal IRB review can be conducted. These can include recruitment scripts/flyers, requests to gatekeepers passively recruiting on your behalf, consent forms, Letters of Support from external institutions, all data collection instruments (focus group questions, interview scripts, surveys, etc.). This list is not inclusive and is dependent on the details of your specific research.
- All informed consent documents must follow the format provided in the informed consent templates on the IRB website (See Forms, Instructions, and Samples for Human Subjects Research). Applications with informed consents that do not follow this format will be returned to the PI requiring that the requested informed consent format be followed.
- The Confidentiality sections of both the narrative and the consent form(s) often receive the most comments requiring revisions. Be specific about your plans for data collection, storage, maintenance and destruction and convey this information consistently throughout the application. The IRB recommends taking extra care with these sections when preparing your submission.
- Materials that will be read/received by participants – recruitment documents, consent forms, etc. – should be written in a concise manner with relevant information that anyone can understand and should be tailored to your targeted research population (i.e., this language will read differently for adults with full capacity to consent vs. vulnerable populations; large font for those with decreased vision etc.). Consent forms should aim for a Flesch-Kincaid Level of 8th grade, though the IRB recognizes some studies require technical language that will prevent this score from being reached.
Student Applicants
Student applicants should work closely with their Faculty Sponsor (FS) while preparing their IRB submission. Please be sure to have your FS review your final application before submitting to the IRB.
New Researchers
The IRB recommends that PI’s who are new to the IRB submission process at UMaine reach out to someone in their field who is familiar with the process for review of their application prior to submission. New researchers are also encouraged to reach out to ORC for assistance while preparing their application.
Questions?
If you have any questions before or while preparing your application, please do not hesitate to reach out to contact the IRB. We are here to help and to ensure you have a smooth IRB approval process!