Human Research Protection Program
Human Research Protection Program
A Message from the Director of the Office of Research Integrity
The mission of the Medical University of South Carolina (MUSC) is to provide excellence in patient care, teaching, and research, in an environment that is respectful of others, adaptive to change and accountable for outcomes. Human subjects' research is an important elements in meeting this mission. The University has established policies, procedures, and programs for the oversight of human subject research to ensure the continued support of this mission, to promote the ethical conduct of research, safeguard the integrity in the protection of human subjects and maintain stringent compliance with regulatory standards. MUSC investigators are granted the privilege of using human subjects under assurance to the government that research conducted at MUSC complies with regulations protecting human subjects.
All human research studies operate under the auspices of a campus-wide Human Research Protection Program (HRPP) with oversight and management from the Office of the President of MUSC through the Associate Provost and the Vice President for Academic Affairs/Provost as the responsible organizational officials for its operation.
MUSC has been proactive in providing the operational structure required for an effective HRPP and its oversight. Leadership places high priority on compliance and regulatory monitoring to ensure that all aspects of research integrity are valued and that the proper mechanisms are in place for education, training and continuing review. While the Associate Chief of Staff/Research and Development at the VAMC, the current Vice President for Academic Affairs/Provost at MUSC appointed a monitor for post-approval review of all human subjects research, which made the Ralph H. Johnson VAMC among the first in the country to do so. A similar office was established at MUSC in 2002 under the Office of Compliance.
The ongoing improvement and quality of our HRPP is initiated through multiple mechanisms including the continuing education, external advisors and consultants, ongoing monitoring by the Office of Compliance, ongoing review of best practices, regularly scheduled reviews of the IRB operations and weekly discussions among the multiple offices involved in our HRPP.
We consider the ongoing review of educational and training requirements for all individuals involved in human research to be another important vehicle for quality improvement and have training requirements in place for individuals just beginning in research and for continuing education through the CITI. In addition, the Office of Research Integrity developed a course “Core Clinical Research Training” that is now offered through our South Carolina Clinical and Translational Research Institute (SCTR) for all research teams and coordinators involved in human research. In addition, many centers and institutes on campus have training and mentoring opportunities in place to assist in education and awareness. Finally, we have active community-based outreach and education programs to increase awareness in the community for human subjects’ research, as noted in our Human Research Protection Brochure (in English and Spanish), and our Healthy South Carolina Initiative, both linked below.
To build upon our excellence and commitment to human research protection, MUSC is in the process of applying for accreditation from The Association for the Accreditation of Human Research Protection Programs (AAHRPP)*. Our goal is to receive accreditation in 2009.
* AAHRPP accredits high-quality human research protection programs in order to promote excellent, ethically sound research. Through partnerships with research organizations, researchers, sponsors, and the public, AAHRPP encourages effective, efficient, and innovative systems of protection for human research participants.