SBIR-STTR Award

The limitations of standard means of obtaining informed consent for psychiatric clinical trials have been well documented. Empirical data suggests that, aided by multimedia learning methods, psychiatric patients can be taught or"primed with"general knowledge about clinical trials and about the informed consent itself and that such priming facilitates each person's ability to efficiently and effectively participate in the consent process during and after review of consent forms for specific clinical trial protocols. The present application is being proposed through a partnership between Behavioral Tech Research, Inc., a small business concern with expertise in developing and marketing web-based multimedia health educational materials, and investigators at the University of California, San Diego (UCSD) who have expertise in issues of decisional capacity and enhancing informed consent for psychiatric research. Specific aims for the present Phase 1 application are as follows. Aim 1: to develop a web-based multimedia tool that can be used to educate subjects about research and informed consent prior to beginning review of protocol specific information. This tool will also incorporate standardized assessment of participant comprehension of disclosed information. Aim 2: to conduct a randomized controlled comparison of the consent aid prototype (versus routine consent) among 30 patients participating in phase III pharmacologic clinical trials for schizophrenia or bipolar disorder. Data on the effectiveness of consent aid, as well as participant opinions/reactions, and feedback from an expert advisory panel will inform further refinement of the prototype consent tool. Phase II (for which we will apply upon successful completion of Phase I) will focus on larger scale adaptation/refinement and testing for subsequent marketing and widespread dissemination.

Public Health Relevance:
There is a clear need for clinical trials to identify safer and more effective treatments for persons with serious mental illness. Yet, it is also critical from a humanitarian and ethical standpoint that those volunteering for participation in the clinical trials only be enrolled with their voluntary and capable informed consent to do so. This project will develop and validate a web-media consent tool designed to assess participant comprehension. It will also foster deeper comprehension among potential clinical trials participants about psychiatric clinical trials and the informed consent process itself, to aid each person in more actively and effectively engaging in the consent process for individual clinical trial protocols.