Washington University School of Medicine Human Studies Committee, St Louis, MO
Submitted by: Sarah Frankel, Ph.D.

The following information was submitted by the applicant 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 information for any purpose. Institutions interested in adopting or adapting the practice would be well-advised to contact the person who submitted the application and to evaluate this and any additional information for their purposes.

Description: A comprehensive education program geared toward anyone conducting or reviewing research at the University. This includes approximately 300 committee members, 20 Human Studies Committee (HSC) staff members, and all faculty and staff vital in the conduct of the 3500 new and on-going human subjects protocols seen yearly by the HSC.

Genesis: The practice began 15 years ago when the current Director and Chair took their positions.

Experience: The premise for the current education program comes out of adult education theory. A teamwork approach with the adult educator as facilitator works best in most adult education programs. In 2001, an assessment of the current education program was made and goals were set for its expansion, and, by June 2001, the expanded program was implemented.

Compliance: The education program satisfies human studies protection regulations, Good Clinical Practice 3.1.3, and meets the terms of the Federal Wide Assurance for Institutions within the United States.

Protection of human subjects: Mandating that all research faculty and staff be educated in the protection of human subjects shows a strong commitment towards protection of human subjects.

Monitoring and evaluation/outcomes: Evaluation of the program involves qualitative questionnaires distributed at the end of educational sessions. Informally, the HSC receives feedback from its committee members and researchers.

Innovation: Education has become an area of emphasis in human subjects’ protection due to the fact that the conduct of research is a specialty unto itself and requires training as well as education.

Replicability: This is a highly replicable and adaptable program for any institution that is receptive and supporting of research education.

Applicant’s justification for award: This is a model program for working professionals in the area of human subjects research. It differs from other programs that predominately target students.

For additional information:
Sarah Frankel, PhD
Tel: 314-633-7456
Fax: 314-367-3041
Email: frankels@msnotes.wustl.edu