Bioethics and Regulatory Knowledge

Ethics and Regulation of scientific research are inextricably linked. The CTSC has made the strategic decision to couple these components in a distinct program that will ensure that the relationship between ethics and regulation is consistently at the forefront of our clinical research enterprise. Many regulations governing research are derived from key ethical values articulated in the Belmont Report::

  • respect for persons
  • beneficence
  • justice

In addition to these guiding principles that serve as the foundation of human subject protections, all clinical and translational research include the following types of review:

  • ethical (e.g., protection of research participants, humane treatment of animals)
  • regulatory (e.g., conflicts of interest, compliance with federal and state regulations)
  • legal (e.g., indemnification, subject rights and researcher responsibilities)
  • fiscal (e.g., budgeting, accounting, billing and reporting)
  • scientific (e.g., validity, accuracy, and integrity of research)
  • intellectual property (e.g., ownership of research products)

These core reviews help to ensure responsible research conduct throughout the design, implementation, and dissemination of all aspects of clinical and translational research.

The ethical principles articulated in the Belmont Report represent the enduring values upon which the research enterprise is based. Research regulations and institutional policies express these values through specific requirements and standards. This program combines regulatory and ethical perspectives to facilitate clinical and translational research, the protection of human participants, and promotion of public trust. Central to the mission of the Bioethics and Regulatory Knowledge Program is the early integration of ethical considerations in the design of CTSC research, education and community outreach activities.

Leadership
Mission
  • Ensure ethical and regulatory integrity in clinical and translational research
  • Enable responsible research conduct
  • Assist investigators and research personnel in understanding and meeting ethical and regulatory responsibilities
How we support investigators
  • Provide a Research Ethics Consultation Service (RECS) to help investigators, participants, and communities address ethical issues in clinical and translational research
  • Address regulatory knowledge in the context of the ethical values that form their basis
  • Streamline processes for investigators where possible
  • Provide individual guidance to investigators on regulatory requirements
  • Data and safety monitoring review planning and implementation
  • Conflict resolution among members of the research community including research participants
How to Contact Us
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