The primary goal of the Regulatory and Ethics Knowledge Component (RKEC) is to reduce investigator compliance burdens and decrease institutional barriers while preserving the integrity of the research enterprise, protecting the rights of human subjects, advancing subjects’ and animals’ wellbeing, and preserving public trust. To achieve this goal the RKSC will take an innovative approach and explicitly integrate ethical and regulatory knowledge and facilitate institutional collaborations, provide ethical and regulatory support to CTSC researchers, and educate the research community in the ethical conduct of research.
- Integrate: Ethical and regulatory oversight of clinical and translational research ensures that the welfare and rights of human subjects and the wellbeing of animals are protected and advanced. Often, however, redundant and/or inefficient compliance mechanisms increase costs, discourage researchers and subjects’ participation, and ultimately delay transmission of the benefits of clinical and translational research to the public. Additionally, lack of attention to the ethical aspects that ground these regulations fails to serve the interests of the research community. The RKEC integrates ethics into the heart of regulatory assessments, incorporates ethics consultations within its activities, and contributes to the creation of strategies designed to limit unnecessary regulatory burdens and ensure the protection of human subjects and the welfare of animals.
- Support: An important source of delays in the research process is inadequate knowledge concerning regulatory and ethical knowledge and processes. The RKEC offers one-to-one support to CTSC participant researchers regarding regulatory aspects of research protocols, research consultation services to address ethical and regulatory issues arising at all stages of the research process, and a research subject advocacy service directed to assist researchers with informed consent documents and to monitor the consent process in some particularly high-risk clinical trials. In addition, research subject advocates are available to act as a liaison between research participants, investigators, IRB, and staff at each participating institution in addressing complaints or problems.
- Educate: Educating the research community as well as the general public about the ethical and regulatory aspects of clinical and translational research is indispensable to ensure competency and promote an environment of trust. The RKEC works with various partners to innovatively engage the public regarding ethical and regulatory aspects of research using theater and the arts as an effective teaching method. It also collaborates with the Clinical and Translational Education Program to provide ethical and regulatory training and mentorship to the research community of all partner institutions.
Accessing Regulatory Support