Committee Responsibilities
The Research & Development Committee entrusts the Institutional Review Board (IRB) of the Medical University of South Carolina (MUSC) for the review of studies involving human subjects. The Research and Development Committee and the IRB have the responsibility of insuring that research involving human subjects is conducted under the most rigorous ethical standards that assure the protection of the rights, welfare, and safety of the veteran patients.
Approval of a project by the IRB indicates conformity with the Federal Guidelines for Studies Involving Human Subjects known as VHA Handbook 1200.05, Requirements for Protection of Human Subjects in Research.
For more information, please contact any of the following:
Shelley Coleman , Ralph H. Johnson VAMC Acting Research Compliance Officer, 843-789-6769
Beth Gibbs , VISN 7 Compliance Officer, 843-789-7399.
Additional information on MUSC's website
Quality Assurance / Standard Operating Procedures
Human Research Review Applications
All Human Research Review Applications must contain the elements listed below. These are the minimal components that are required for submission:
Requirements for R&D Committee Review
Request to Review Research Proposal-Project (VA R&D form)
Investigational Drug Information Record, if applicable (9012 form)
Protocol or grant application describing studies involving human subjects
Letter of IRB approval VA consent forms must be submitted to the Research Office before final R&D Committee approval is granted
Requirements for IRB Review
Request to Review Research Proposal-Project (VA R&D form)
Request to involve himan subjects in research (Non-VA website: by clicking this link, you are leaving the VA domain and going to the domain of the Medical University of South Carolina)
VA Informed Consent for ERMA submissions
(guideline and template attached; updated July 2, 2012)
VA Informed Consent for eIRB submissions
(guideline and template attached; updated July 2, 2012)
VA Consent to use Picture and/or Voice Recordings (form attached)
VA HIPAA Authorization Form for ERMA submissions (guideline and template attached)
VA HIPAA Authorization Form for eIRB submissions (guideline and template attached)
or
HIPPAA Waiver of Authorization Form
Protocol or grant application describing studies involving human subjects
Dates for submissions of human research review applications
Mandatory Training for Conductin Studies Involving Human Subjects
Training is required for all individuals who will be involved in research pertaining to human subjects. Any new staff in a study must obtain the required training before initiating any study activities. Training involves completion of the Miami CITI course (by clicking this link, you will leave the VA web domain and go to the domain of MUSC) plus the Good Clinical Practices course. Please note: to have access to the VA training modules, you must register on the CITI website as a member of the local VA Medical Center. Copies of the training certificates should be submitted to Shelley Coleman in the VA Research Office.
Links to Additional Information
(these links contain important information, although they may take you out of the VA domain)
VHA Handbook 1200.05, Requirements for Protection of Human Subjects in Research.
VHA Hardbook 1058.01, Research Compliance Reporting Requirements
Human Research Protections Program - This is the Ralph H. Johnson VAMC Human Rights Protection Program (HRPP). It is important that all those who are involved in human studies research be fully familiar with our HRPP.
Federal-Wide Assurance - Available through this link is the Ralph H. Johnson VAMC Federal-Wide Assurance, which assures compliance with DHHS regulations for the protection of human subjects (approved 8/15/2012).
Office for Human Research Protections / U.S. Department of Health and Human Services
Food and Drug Administration / U.S. Department of Health and Human Services
Belmont Report
Helsinki Declaration
Nuremberg Code
M. Rita I. Young, Ph.D.
Associate Chief of Staff for Research
E-mail: rita.young@va.gov
Phone: (843) 789-6707; Fax: (478) 274-5761
Research Service
Ralph H. Johnson VA Medical Center
109 Bee Street
Charleston, SC 29401
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