Valid Consent/Refusal: A Core Competency for Research

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DESCRIPTION (provided by applicant): Curricula in research ethics typically teach the rationale and requirements for acquiring valid consent from potential volunteers; IRB's require investigators to describe how they will obtain and document consent. Valid consent, however, is a process; the practice of consent requires more than knowledge of its rationale, or what should be included in documents. Traditional content-based methods fail to teach those who recruit research participants how to obtain consent, and investigators also need to know how to recognize and disclose conflicts of interest. We aim to develop, implement and evaluate a course designed to improve knowledge and skills of investigators for obtaining consent. The course is based on principles of adult learning, experience teaching clinical consent using similar methods, and needs assessments by the PI. The course begins with written and didactic material on the rationale and components of consent, the components of and process for evaluating competence, principles and practices for surrogate decision making, types of and examples of conflicts of interest, and how to "do" consent, including how to disclose conflicts of interest. Next, small groups of learners' role-play evaluating competence, disclosing conflicts and obtaining consent in differing scenarios (e.g., questionable competence, need for interpreter). Finally, learners demonstrate skills as they ask a "patient" to participate in research and disclose a conflict of interest. Simulated patient instructors (SPIs) are trained to play the part of the patient, assess the learner's ability to complete the task using a checklist, and provide feedback to the learner. A randomized controlled evaluation of the course in n>310 learners will compare knowledge gains, self-efficacy and outcome expectations. A second randomized controlled evaluation on the same learners (n>310) of the non-SPI components of the course uses the SPI as an evaluation tool. All participants (n=500/year for 3 years) complete questionnaires measuring satisfaction with and usefulness of the course. With over 1000 faculty investigators who relied on human volunteers in 2002, the population of learners at this institution is large. We plan to offer the course to researchers from other institutions beginning in the third year. Replication of the SPI is also easily accomplished at the many universities in the U.S. and Canada that have SPI programs, and we will disseminate evaluation findings in scholarly publications.