What is the difference between the CARAS Human Research Protections Program (HRPP) and the CARAS Research Support Program (RSP)?
The CARAS Human Research Protections Program (HRPP) and CARAS Research Support Program (RSP) are complementary, but the two programs are different in mission and scope.
The HRPP is focused on oversight of regulated research projects, including management of the CARAS IRB and formal regulatory determinations. The CARAS HRPP provides oversight of human subjects research under the jurisdiction of United States law and regulation. The CARAS HRPP also works with external organizations to help them to build infrastructure to support U.S. federally regulated research. Services provided by the HRPP are subject to fees, consistent with industry rates, billed to the investigator or client organization.
The RSP is focused on assisting researchers and students in the planning and execution of their research, and ensuring that communities affected by research have a voice in the proposed research. The RSP provides a variety of services including research review through the CARAS community advisory board, and consulting and educational services to assist investigators and students. The RSP provides outreach and presentations to community members addressing research and clinical topics. Projects addressed by the RSP are international in scope and include the biomedical, social and behavioral sciences, but also scholarship in the arts and humanities. RSP activities may reference regulatory requirements if applicable, but in a consulting and advisory role. Services provided by the RSP generally do not involve additional fees and require only active CARAS membership.
What is the difference between the CARAS Institutional Review Board (IRB) and the CARAS Research Advisory Committee (RAC)?
The IRB provides oversight of particular human subjects research projects that must comply with federal regulations and other U.S. legal requirements.
The RAC, as a community advisory board, is not a regulated activity and the RAC does not make formal regulatory determinations. While criteria for RAC endorsement are largely consistent with U.S. federal (and international) requirements for the approval of human subjects research, RAC criteria for endorsement emphasize concerns of the communities supported by CARAS that go beyond regulatory requirements. Examples include the evaluation of potential community-level benefits and harms, including the potential long-range effects of research, that are not a part of federal requirements. Also, participation of community representatives in RAC deliberations go beyond federal requirements related to IRB membership and the approval of human subjects research. The RAC reviews projects such as educational activities and scholarship in the arts and humanities that are not classified as human subjects research under U.S. regulations, and thus do not require IRB review.