Frequently Asked Questions

An IRB is an independent committee that reviews and oversees research involving human participants. Its primary role is to protect the rights, safety, and well-being of people who take part in research studies. Every U.S. institution conducting federally-funded research must have an IRB.

Our board includes physicians, scientists, nurses, ethicists, and community members who don't have other affiliation with RUHS. This mix ensures research is reviewed from multiple perspectives: scientific, ethical, and community.

The full board meets monthly, on the third Thursday. Expedited and exempt reviews happen on a rolling basis and don't require a convened meeting.

The RUHS IRB follows the Common Rule (45 CFR 46), FDA regulations (21 CFR 50 and 56), HIPAA Privacy Rule, and California state research regulations.

Email [email protected] or call (951) 486-4000. Office hours are Monday through Friday, 8:00 AM to 5:00 PM Pacific.

No. Participation is always voluntary. Choosing not to take part will not affect the medical care you receive or your relationship with your doctor.

Yes. You can withdraw from a study at any time, for any reason, without explanation. Let the research team know, and they'll tell you about any follow-up needed for your safety.

Yes. Researchers must follow strict rules under HIPAA and federal research regulations about how your information is stored, used, and shared. Most published research uses de-identified data.

You can contact the IRB directly at (951) 486-4000 or [email protected]. We're independent of the research team and exist to advocate for participants. You can also submit concerns anonymously.

Expedited reviews (chart reviews, minimal-risk studies) move on a rolling basis once the submission is complete. Full board reviews align with the monthly meeting schedule, so submissions are due before the submission deadline for the meeting you want your study reviewed at.

Yes. All study personnel must complete the appropriate CITI Program human-subjects research training before submission. Training certificates expire every 3 years.

It depends on study type and risk level. Chart reviews and minimal-risk studies usually qualify for expedited review. Studies involving direct intervention or special populations require full board review. Take our pathway quiz or contact the IRB office for guidance.

Any change to your approved protocol (including changes to study personnel, procedures, recruitment, consent forms, or data collection) requires an amendment before implementation.

Any unanticipated problem involving risks to participants or others must be reported to the IRB within 10 business days. Serious adverse events that are both unexpected and related to the research are reported within 5 business days.

Under the revised Common Rule, many expedited and minimal-risk studies no longer require annual continuing review. Full board studies typically require continuing review at intervals determined by the board (usually annually).

Submit a study closure report (Form I) when all research activities are complete, including data analysis and publication.