Clinical Research Support Office/CRSO
D. Developing and sharing strategies, tools and Best Practices in Regulatory Support and Advocacy
The Rockefeller University Center for Clinical and Translational Research is committed to developing, demonstrating, and disseminating, Best Practices for clinical research, in alignment with the mission of CTSA Consortium.
The Research Participant Experience: The CRSO has sustained a research program devoted to understanding participants' experiences in research as one of the keys to accelerating translational research.
Why study research participants' experiences? The value of engaging research volunteers in talking about their experiences in clinical research is increasingly recognized as a critical to understanding how to improve recruitment and retention in research studies, assure that informed consent process is working, and enrolled cohorts that fully represent the affected populations.
What was the goal? To make sure we could ask the questions that mattered most to research participants, we used a rigorous approach to develop standard valid research participant-centered measures of the research experience. We started a multi-site collaboration 2006, to develop and validate participant-centered measures of the research experience, including measures of the quality of the informed consent process, aspects of research participant's autonomy and rights, the degree of alignment between expectations and experiences during study participation, and drivers of decisions to join, leave or stay in a research study. We also wanted to understand the drivers of positive research experiences, and to demonstrate the value of using participant feedback to improve the research process.
What was done? We collaborated with 15 NIH-funded research institutions to conduct a series of studies to develop a standard questionnaire. We conducted focus groups with research participants from different research centers, and also with investigators, research coordinators and nurses, and Institutional Review Board members to gain broad perspective, as well as participant-centered insights about the research experience. We used qualitative methods to develop the questions addressing many aspects of research participation, and quantitative psychometric methods to test their validity. We fielded the survey to thousands of participants and analyzed their responses.
What did the research accomplish? We used response data from more than 8,000 research participants to to develop a suite of Ultrashort, Short and Long versions of the Research Participant Perception Survey (RPPS). The RPPS surveys are validated, which means that the have passed tests of reliability and reproducibility in collecting the information. The surveys are also available in broadcast Spanish.
The RPPS offered insights into research participants' experiences that had not previously been collected at scale or using a valid tool:
Among the results from close to 5,0000 research participants in the largest group tested,
- A majority (73%) gave their research experience the highest rating,
- Many valued a feeling of being treated as a partner in the research endeavor.
- Basic values, such as being treated with respect, feeling listened to, and having consent discussions conducted understandably impacted overall study rating
- 72% of participants would have liked to receive the results of their research study.
When the ultrashort, short and long RPPS versions were tested together, we learned: the shorter the survey, the more people completed it; inclusion of a financial incentive shifted the demographics of responders to a slighter younger group, and slightly lowered response reliability.
How are the results used? The real value of the RPPS surveys extends beyond the results of a single assessment. The surveys give researchers the tools to empirically test to find the best approaches to recruitment, consent, study conduct, compensation, return of results, and more from the perspective of the participants. The surveys can be used over time to test different approaches to enhance informed consent, outreach, recruitment, return of results and other aspects of research.
We offer the RPPS survey to all of our research participants on a rolling basis, confidentially administered by a third party and use the results to improve our consent forms, patient flow, and provide valuable feedback to research teams. We share the surveys freely with other institutions, numerous of which have adopted the shorter versions of the survey for local use. The full suite of RPPS surveys are available for download, free of charge in the REDCap library.
What's next? Through a new 4-year grant to the Rockefeller University from the National Center for Accelerating Science (U01TR003026) PI, Dr. Rhonda Kost is leading a collaboration with investigators at Johns Hopkins University Vanderbilt University, Wake Forest University and, University of Rochester, and Duke University to develop, demonstrate and disseminate a new streamlined electronic platform and analytics dashboard for the RPPS tools. The new infrastructure will enable broader uptake and use of the RPPS-Short, and support local and national benchmarking to enhance participants' research experiences.