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.
MUSC has a
long-standing human research protection program and human subjects'
research program that includes our Clinical and Translational Research Center (CTRC)
that was first funded by the National Institutes of Health in
1977. The human subjects' research program at MUSC includes
corporate-sponsored and federally supported clinical trails in a
variety of health-related areas.
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
former 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 the SCTR Center for Community Health Partnerships.
To
build upon our excellence and commitment to human research protection,
MUSC has received full accreditation from The
Association for the Accreditation of Human Research Protection Programs
(AAHRPP)*.
*
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.
To
build upon our excellence and commitment to human research protection,
MUSC has received full accreditation from The
Association for the Accreditation of Human Research Protection Programs
(AAHRPP)*. 
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