17 Nov What Works: Ten Tips to Improve IRB Submissions
Has getting institutional review board (IRB) approval ever taken longer than you expected? Have delays cost you time or money you didn’t have? If so, you’re not the only one.
Understanding the IRB’s needs and knowing how to meet them can improve IRB turnaround time.
Karen Adams and Adrienne Meyer, Regulatory Specialists for the Institute of Translational Health Sciences, offer the following 10 tips to help reduce delays in getting IRB approval:
- Identify the appropriate level of IRB review or exempt determination for your study before you prepare your application. Submitting your application for the wrong level of review can waste valuable time.
- Once you pinpoint the type of review required, always complete the current version of the appropriate application form from the IRB’s website.
- Consider the reviewer a reasonably educated person, NOT a clinician. Write using simple lay language and well-described concepts. Be sure to define scientific and clinical terminology.
- Separate research procedures from routine clinical care. Use the “Background and Purpose” section to provide the clinical context for your study. Use the “Research Procedures” section to tell the participant’s experience of being in your study.
- Include well-defined inclusion and exclusion criteria, and explain how determinations of eligibility will be made (e.g., medical records, participant self-report, participant’s physician).
- Ask colleagues to share recently IRB-approved consent forms as a model for your forms.
- Include copies of all study documents (e.g., data collection instruments, recruitment materials, waiver requests).
- Have someone else proofread your submission. Ask them to look for inconsistencies.
- Be ready to quickly respond in full to requests during the review process. Know the submission deadlines for the next IRB meeting.
- Foster a constructive working relationship with your IRB contact person through polite and professional communication.
Requesting RCC IRB Support
The RCC employs Regulatory Specialists with firsthand knowledge of how to write and submit successful IRB applications. Experienced RCC Regulatory Specialists can help your team:
- Obtain prompt IRB approval
- Discern the level of IRB review and anticipate other regulatory requirements that might impact IRB review
- Facilitate collaboration between investigators and IRB staff
To discuss hiring a part-time or project-based Regulatory Specialist to help with your IRB applications, please contact Laura Baker via email or by phone at (206) 616-8752. You can also visit the ITHS website to learn about other services offered by the RCC.
Research Bioethics Consultations
Need guidance or suggestions on how to address an ethical issue with the development, implementation, or analysis of clinical and translational research? ITHS offers bioethics consultations to support researchers in working through these challenges. Learn more by visiting the ITHS website or contacting the ITHS Research Navigator.