Clinical Research Policy

The National Institutes of Health (NIH) provides leadership and direction to programs designed to improve the health of the nation by conducting and supporting research.  Research support requires directing and disseminating effective clinical research policy that provides guidance to the research community, while protecting the rights and welfare of research subjects.

The Clinical Research (CR) Policy program began as the Clinical Research Policy Analysis and Coordination (CRpac) Program, which was originally part of the NIH Roadmap. The program focuses on improving the efficiency, organization and advancement of clinical research.  It serves as a nexus for ongoing harmonization, streamlining, and optimization of policies and requirements concerning the conduct and oversight of clinical research, and addresses a wide range of topics including:

  • Adverse Event Reporting
  • Bioethics and NIH-funded research
  • Clinical Trials
  • Ethical Issues in International Research
  • IRB review
  • NIH Data and Safety Monitoring
  • Privacy and Confidentiality in Research
  • Research Involving Human Subjects