Award for Excellence in Human Research Protection
Innovation 2005
National Institutes of Health, Department of Clinical
Bioethics, Bethesda, MD
Submitted by: Ezekiel J. Emanuel, Chair, Department of Clinical Bioethics, The Clinical Center, National Institutes of Health, Bethesda,
MD
The following
information was submitted by the candidate for the award. The Institute may
have edited the text for presentation purposes. Health Improvement Institute
has not verified, and does not guarantee, the completeness or accuracy of the
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Description: The
Department of Clinical Bioethics has created a systematic and comprehensive
framework to assist researchers, IRB members and others in evaluating the
ethics of research protocols. Existing guidance on the ethics of
biomedical research is frequently the response to particular scandals and
crises and is often haphazard. To provide an organized and systematic
approach to evaluating a research protocol, the Department delineated 8 ethical
principles and then specified 32 benchmarks to determine how well the 8
principles are fulfilled.
Significance/contribution: The framework provides an organized, systematic,
comprehensive, and practical mechanism for researchers, IRB members, and others
to evaluate the ethics of a clinical research protocol. These 8 principles and
32 benchmarks are necessary for the ethical evaluation of all biomedical
research; they are also universal, applying in both developed and developing
countries.
Impact: This framework has been widely adopted. The papers that
outlined this framework have been cited 204 times in 5 years. In
addition, these principles have been explicitly incorporated into the newly
revised guidelines for research in
Innovators: The innovators are Ezekiel Emanuel, David Wendler, and
Christine Grady who worked together as a team to articulate and specify these
principles and the benchmarks. They run a course each year at the National
institutes of Health that educates researchers, grant officials, IRB members,
and others about this framework. Attendees have come from NIH, FDA, ORHP, EPA,
Walter Reed Army Hospital, Bethesda Naval Hospital, for-profit IRBs, several
medical research institutions in Peru, and other developing countries, and many
other organizations.
Applicant’s justification for award: The protection of research
participants requires conscientious researchers as well as proper IRB
evaluation of research studies. Researchers need to know how to design studies
in an ethical manner, including factors they must consider and issues they must
address. IRB members need to know how to systematically evaluate whether a
research protocol fulfills ethical requirements. The framework developed by
Emanuel, Wendler, and Grady provides a systematic, comprehensive, and coherent
guide, as well as specific considerations that must be addressed, for both
researchers and IRB members. While many guidelines have been developed for
research with human subjects, none is useful for systematically and thoroughly
evaluating the ethical aspects of research protocols. This framework, with its
principles and benchmarks, addressed an unmet need as shown by its widespread
adoption in national guidelines and IRB practices, and by citations in other
articles.
For additional information:
Ezekiel
J. Emanuel, M.D., Ph.D.
Tel:
Bethesda 301-435-8706
Chicago 847-424-9018
Fax: Bethesda 301-496-0760
Chicago 847-424-9017
Email: eemanuel@cc.nih.gov