Tips for IRB Submissions
15 Tips for Improving Interactions with the IRB
- Carefully plan the ethical aspects of your study from the very beginning—study the Belmont Report.
- Attach to your IRB application a cover letter summarizing your study, with special attention to human subject interactions.
- Examine university and Office of Human Research Protections (OHRP) Web sites for examples and specific directions.
- If you have questions, telephone and talk with your IRB administrator.
- Ask yourself if you would honestly want someone you love to participate in your study.
- Work hard to ensure that recruitment materials yield equitable and noncoercive results.
- Write consent forms at an eighth-grade reading level.
- Overestimate risks and underestimate benefits.
- Educate and debrief subjects on the nature, purpose, and findings of your study.
- Establish procedures to delink identifying information from main data sets and sources.
- Establish procedures to encrypt any and all identifying information and destroy it as soon as possible.
- If you disagree with an IRB decision, read the regulations and then ask for an in-person meeting to discuss things.
- Remember that research is not a right but a privilege and IRBs are peer review groups.
- Educate your local IRB and then volunteer for it.
- Never forget that IRBs did not spontaneously appear to frustrate scientists; they are a direct consequence of many documented violations of very basic ethical principles.
Excerpted from: Oakes, Michael J. (University of Minnesota) Risks and Wrongs in Social Science Research: An Evaluator’s Guide to the IRB; Evaluation Review, Vol. 26 No. 5, October 2002, 443-479.
Additional Resources
How can the investigator help the IRB in its scientific review? (Word Version)
Tips for Continuing Reviews:
- User guide for Investigators and Study Personnel
- IRB Requirements for Continuing Review After Enrollment and Data Collection are Completed
- IRB Continuing Review for Full Board Studies
- Reviewer Guidelines for Continuing Review Applications
IRB Reviewer Guidelines
The IRB Reviewer Guidelines can be used by IRB members and staff to aid in the review of applications. These guidelines serve as excellent resources when completing IRB applications.
- Exempt and Expedited Reviews of Human Subjects Research (Word Version)
- Reviewer Guidelines for New IRB Applications
- Reviewer Guidelines for Continuing Review Applications
- Reviewer Guidelines for Informed Consent
- Reviewer Guidelines for Research Involving Pregnant Women, Human Fetuses, and Neonates
- Reviewer Guidelines for Research Involving Prisoners
- Reviewer Guidelines for Research Involving Children
- Reviewer Guidelines for Research Funded by the Department of Defense
Checklist/Guidelines From Other Institutions