An IRB is a review committee established by an institution, in accordance with federal regulations, to protect the rights and welfare of human subjects who have volunteered to participate in research studies.
The Children's Hospital & Research Center Oakland (CHRCO) IRB has agreed to comply with Federal regulations to protect the rights and welfare of human research subjects.
Both the Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) have regulatory responsibilities. Some study protocols may be subject to review by both agencies for regulatory compliance.
The fundamental responsibility of the IRB is to ensure that all ethical and regulatory issues have been addressed in the protection of human subjects. Research protocols are reviewed to consider ethical issues, such as subject coercion by excessive monetary inducements, investigators’ financial conflict of interest, potential benefits versus risks, and assurance that appropriate consent procedures are used.
Review Procedures and Criteria for Approval
Special Protections for Vulnerable Populations
Checklist for Protocol Submissions
Instructions for Protocol Submissions
Required CITI Human Subjects Training Certification