Regulatory Advisory Unit (RAU)
About Regulatory Advising
The Regulatory Advisory Unit (RAU) serves as a central resource for researchers proposing to conduct biomedical, social or behavioral research involving human subjects. Regulatory Advising provides expertise to researchers on research protocol design with a focus on proactively supporting efficient and streamlined regulatory approvals and compliance. The Regulatory Advisors work closely with Brown’s HRPP/IRB and have a deep knowledge and familiarity with NIH, GCP, OHRP, FDA, and other applicable federal regulations for human subject participation in clinical, social, and behavioral research.
Unit Services
Protocol Preparation
Working closely with researchers, the Regulatory Advisor assists in the preparation, completion and submission of protocols and other required documentation to the Institutional Review Board (IRB). With the vision of reducing the timelines on the protocol review process the goals of the RAU include:
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Help researchers build a fundamental understanding of the ethical and legal frameworks underlying human subjects’ research.
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Advise on requirements related to investigational new drugs or devices as applicable.
- Assure protocols have complete, consistent language throughout, including proper SAE reporting requirements, and any other study specific regulatory or sponsor requirements that apply.
Regulatory Support
Assists clinical researchers in setting up regulatory requirements, documentation’ good practices and self-assessing compliance during the study life as needed for clinical trials.
When to contact the RAU
RAU can provide assistance at different time points during a protocol lifecycle:
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At the time of working on a project idea. At this time, the RAU will provide input on feasibility from the ethical and compliance perspective of the project.
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Before initial submission of protocols to the IRB: The RAU will work with the PI on incorporating all the regulatory requirements to the protocol to be submitted.
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After receiving “modifications required” communication from the IRB, researchers can work with the regulatory advisors to address these IRB requests and/or work on modifications and renewals of studies to ensure timely, accurate submission to the IRB.
How to contact RAU?
To request protocol advising and regulatory support services, please schedule an appointment using this meeting calendar or contact Dr. Ximena Levy, Director of Regulatory Advising, at RegulatoryAdvising@brown.edu or [email protected].
