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D. Strategies and Tools for Sharing Best Practices in Regulatory Support and Advocacy

The Rockefeller University Center for Clinical and Translational Research is committed to sharing and adopting Best Practices in collaboration with the National CTSA Consortium Steering Committee. A Proposal to develop the Picker Clinical Research Perception of care Survey as a validated tool to benchmark outcomes of Clinical Research Regulatory Support, Education, Research Subject Safety and other programs across the CTSAs is in its pilot stage of development. Project pilot and outcome data will be submitted to the National CTSA Consortium Steering Committee Initiative for consideration as it becomes available.

The original Picker survey instrument was used by general hospitals and academic medical centers to assess overall hospital performance and identify areas for improvement. Additional elements were developed by the NIH Clinical Center to incorporate questions aimed at measuring key aspects of clinical research human protections, focusing on the quality of the informed consent process and other aspects of subjects' rights. In collaboration with the Clinical Center, the survey was adopted by the Rockefeller University Hospital and GCRC and has been used continuously at RUH since 2003. One example of the value of the instrument as an outcome assessment tool can be gleaned from the responses to the participant question, "When can you stop participation in the study." 84.5% of respondents answered correctly, "At any time for any reason", but 11.5% answered "Only when the protocol is over." and 3.8% answered that they "Do not know" when they could stop. Even though the percentage of individuals who did not know the correct answer in our sample (15%) is much lower than the 55% reported by a study of Informed Consent comprehension at Johns Hopkins University (Sugarman et. al 2005), the survey outcome measures still helped to focus our education initiatives for investigators and research nurses on insuring that all participants understood that they could leave a study at any time for any reason. The Picker Survey has also provided useful feedback for the design of Informed Consent Forms. Thus, the pressure to make Informed Consent forms shorter and simpler has led to recommendations to minimize the description of mild or common side effects in favor of conveying the most severe albeit rare expected adverse events. Interestingly, our Picker survey results showed that 50% of participants wanted to know more about common but not serious risks of the study. These results, over time, inform CRSO advocacy policies and actions. We have also used the companion Employee Survey, which provides added and complementary information about areas in need of performance improvement. For instance, participant responses indicating a desire for improved discharge instructions complemented responses from research nurses requesting more information from research teams on discharge instructions. In response to these findings, new initiatives were developed to improve communication and harmonize written procedures.

An Advisory Committee is being assembled to assist in the further development of the Picker Clinical Research Perception of Care Survey, guiding revision and validation of the questions, and adding questions to evaluate the process of recruitment (patient survey) and the effects of educational programs in our Center and a selected sample of CTSA Centers and GCRCs. Properly validated, the survey may be a very valuable tool for assessing outcome measures in clinical research, and for benchmarking those findings. Findings will be shared with the National Consortium Steering committee for consideration or development of best practices.

Sugarman J, Lavori PW, Boeger M, Cain C, Edson R, Morrison V, Yeh SS. "Evaluating the quality of informed consent." Clinical Trials 2005;2:1-8.