Regulatory Knowledge and Support Core

$117,170U54FY2017MDNIH

Morehouse School Of Medicine, Atlanta GA

Investigators

Linked publications & trials

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Abstract

A Human Research Protection Program (HRPP) is comprised of the units or groups that provide support to any research project that contains human participants. It functions to advocate for the rights and welfare of the participants in these research projects, and to promote high quality, ethical research. The Association for the Accreditation of Human Research Protection Programs (AAHRPP) is the body that reviews HRPPs and has the authority to grant accreditation. HRPP accreditation is regarded as the gold standard and indicates a high quality research program. It is also an indication that the institution has effective policies and procedures, keeps better records, has efficient operations, provides comprehensive protections and produces high quality data. MSM has made the commitment to become AAHRPP accredited, and to participate in procedures and processes that enhance the HRPP such as developing and providing educational resources, as well as evaluation of the HRPP units. The first aim of the Regulatory Knowledge and Support core is to become accredited by AAHRPP. The initial application which includes a self-study of the program has been submitted. Modifications to the program will be implemented in response to written critiques and site visit recommendations. All programs and personnel, including administration will have to prepare for a site visit. This will include an institution-wide roll-out of the program and educating the MSM community about the program: The second aim is to design and implement an HRPP quality improvement plan. This plan is necessary to improve the protections of human participants in research, help researchers become more knowledgeable about protections and ensure that the program is operating to the highest standards. The final aim is to enhance inter-institutional collaborations. Reciprocity agreements have been signed by most of the RCMI Translational Research Network institutions, but details for their implementation and use are still vague. Standard operating procedures are in the process of being developed.

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