Regulatory Knowledge & Support

Program Description
The goal of the Regulatory Knowledge and Support (RKS) Program is to facilitate the safe, efficient and ethical conduct of clinical and translational research across SCTR. Our primary objective is to provide focused support for regulatory compliance and management through service and education.  Our efforts also intend to provide support navigating the regulatory enviornment, alleviate the bureaucratic barriers, streamline workflows and accelerate the learning curve while continuing to uphold the highest standards in the protection of human subjects. Specific aims include:
1. Providing access to Regulatory services.
2. Engaging stakeholders, including current and potential research subjects and health professionals.
3. Continue the SCTR-catalyzed efforts to streamline regulatory review and approval.
4. Expand the Research Subject Advocacy (RSA) Core to assist  in providing optimal human subject protection.
5. Provide regulatory training curriculum to promote Good Clinical Practice (GCP), medical ethics, and knowledge of federal and state regulations.

 

The RKS Program provides guidance
& consultations regarding:

Institutional Review Board Submissions
Informed Consent and HIPAA Writing
Regulatory Documentation
Federal Wide Assurances
IND and IDE
Certificates of Confidentiality

RequestService

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Highlights

- MUSC IRB Newsletter, Volume 3, Issue 1, February 2012: Get the latest news from IRB

- Western IRB (WIRB) submissions piloting: Find out if your study qualifies for WIRB review as the IRB of record.

Click Commerce eIRB now available at MUSC
All new IRB study applications must be submitted through eIRB.  Training and guidance materials are available for the research community.

Highlights will rotate frequently: please check back often!

 

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Contacts

Director:

Kathryn M Magruder, PhD, MPH
Professor
843-789-7280
magrudkm@musc.edu


Associate Director:

Susan C Sonne, PharmD
Research Associate Professor
843-792-5221
sonnesc@musc.edu

 

 


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Resources
Use this flow chart to determine what research review type your project may be considered.
Guidance to secure IRB approval of community engaged and multi-site research at MUSC.