Dana-Farber Cancer Institute, Boston, MA
Submitted by: Steven Joffe, MD MPH, Attending Physician, Hospital Ethicist

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 innovation 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 validated questionnaire called the Quality of Informed Consent (QuIC), for measuring understanding of clinical trials among prospective or actual research participants. It is usable across a wide range of clinical trials.

Significance/contribution: The questionnaire constitutes a generic research tool that can be used to assess informed consent across multiple contexts and clinical trials. The development of a generic informed consent questionnaire is an essential step towards improving the quality and utility of the evidence base about research informed consent. Also since the questionnaire is validated it can facilitate the development of a prospective monitoring function by IRB’s.

Impact: The QuIC has already shown its utility as a research tool. The Institute has published the innovators’ work using the instrument to assess understanding in an observational study involving over 200 cancer clinical trial participants. Their work has also received attention in the popular press. For example, U.S. News and World Report, in its January 14, 2002 issue, highlighted their study using the QuIC in an article on cancer clinical trials.

Innovators: Five individuals collaborated to design, evaluate and disseminate the QuIC:
Steven Joffe, MD, MPH; Jane C. Weeks, MD, MSc; E. Francis Cook, ScD; Paul D Cleary, Ph.D.; Jeffrey W. Clark, MD.

Applicant’s justification for award: Based on the experience and interest to date, the QuIC successfully addresses a critical need in the effort to improve the study and conduct of consent to biomedical research during the coming years.

For additional information:
Steven Joffe, MD, MPH
Tel: 617-632-5295
Fax: 617-632-2270
Email: steven_joffe@dfci.harvard.edu