IRB Submission Checklist
IRB Submission Checklist
Please review this checklist to ensure your human-subject submission is complete before you submit it for IRB review. These guidelines apply no matter the level of review.
- The principal investigator has either a paid UC Merced faculty appointment greater than or equal to 50 percent, or is a staff member or student at UC Merced. Each student applicant must have a faculty sponsor/advisor.
- If needed, all school, research unit, or other compliance committee approvals have been secured before submitting the IRB study.
- If using an experimental drug/device, the IND or IDE number and filing date is provided in the IRB submission.
- All potential co-investigators and research personnel are listed as appropriate in the submission, and on consent forms if involved in the informed-consent process. Each research team member's role on the project is clearly defined in the narrative.
- All personnel listed in the submission, including the principal investigator have completed human-subject training at the time of submission.
- The purpose of the research is explained adequately.
- The subject population and size is justified in the context of the proposed research (Consider providing a power analysis, if appropriate).
- Equitable inclusion of women and minorities is assured.
- The proposed recruitment and consent methods guarantee voluntary participation. If the proposed subject population might be vulnerable to coercion, explain how this will be minimized.
- Subject inclusion/exclusion criteria is explained in sufficient detail.
- Adverse event reporting and treatment is addressed.
- All activities involving subjects are thoroughly explained.
- Probable risks to participants and potential benefits to participant and society are adequately explained.
- The consent form addresses all areas required by federal regulations and is written at an eighth-grade reading level or lower.
- Data collection instruments and/or citations are provided.
- If research will take place off site, proper documentation (permission letter, Federalwide Assurance for off-site entity, off-site research agreement, etc.) has been obtained or is in progress.
- If research will be funded by an external sponsor (grant, contract, or gift), proposal paperwork has been filed with the Office of Sponsored Projects.
- All other applicable approvals have been obtained (GAC, CRFA, DSRC, CTPMRC) or are in process (IBC, Radiation Safety Committee).