National Institutes of Health Clinical Center

Research

Ethics of Clinical Research

Human Subjects Protections

Despite an extensive literature on ethical principles in clinical research, their application to particular studies, and oversight protections, theoretical and practical limitations attenuate the ethical analysis of issues in clinical research. Ethical norms and guidance have been based on an assumption that research is exceptional, different in ethically important ways from other social activities. Additionally, ethical norms and principles pertinent to patient care have been uncritically applied to clinical research without appreciating ethically significant differences. Third, the oversight mechanisms in place for clinical research are criticized for adding burden and delay without necessarily enhancing the protection of human participants, yet oversight mechanisms have not been critically evaluated or updated. Finally, ethical guidance has been promulgated without sufficient attention to the relevance of differences in the type of research, design, and methodology or the practical contexts in which studies are conducted.

The NIH Clinical Center Department of Bioethics has close proximity to the design, review, and conduct of clinical investigation and therefore a unique opportunity to advance the understanding of the ethics of clinical research. Department members who serve on NIH Intramural Institutional Review Boards (IRB) and on the Bioethics Consultation Service have access to cutting edge research, familiarity with scientific methodology, willing collaborators, and the opportunity to engage in complex ethical issues in the design, review, and conduct of research.

The Department's conceptual and empirical work related to the ethics of clinical research over the last several years has focused primarily on the following areas:

Department members have published several books and book chapters about human subjects protections, including The Oxford Textbook of Clinical Research Ethics (2008); Rethinking the Ethics of Clinical Research: Widening the Lens (Oxford 2011); and Research Ethics Consultation: a Casebook (Oxford 2012). Department members also created a novel and unique educational pamphlet entitled Research Ethics: How to Treat People who Participate in Research for use by high school students and undergraduates to learn about the ethics of clinical research.

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