Ethics & Regulatory Program
Program Goals:
- Sponsor quality improvement activities to improve the efficiency of regulatory review and approval, study conduct, and participant safety;
- Foster new collaborations between regulatory and compliance activities within and between ACTSI programs and partner institutions;
- Support research participant safety within the ACTSI Clinical Research Network; and
- Provide enhanced opportunities and resources for research ethics education and regulatory knowledge education and training for clinical and translational researchers.
The ACTSI Ethics & Regulatory program supports the conduct of clinical and translational science within ACTSI partners by providing regulatory resources needed to enable investigators to engage in the responsible conduct of clinical and translational research activities. It also offers a novel program in research ethics including the analysis of ethical dilemmas in research. Ethics & Regulatory provides specialized training for investigators in research ethics and regulatory knowledge to meet the challenges of the increasing complexity of biomedical research, particularly in the setting of intellectual property issues, conflict of interest, and multicenter clinical trials. Ethical issues also permeate research with human subjects. Collaborations between ethicists and investigators are necessary for the development of a culture of compliance based on ethical principles, rather than relying on excessive regulatory activity that may slow the pace of innovation without improving protocol performance or participant safety.