Center for Clinical and Translational Science

Surprisingly, in the otherwise data-rich environment of translational research, we know very little about what research participants think about their research experiences. Three decades of research into the design and use of patient-centered surveys to assess the hospital care experience-- now routinely required by federal funding agencies and accrediting agencies—has demonstrated that collecting and analyzing patient perceptions improves patient care and clinical outcomes, and reveals unexpected patient priorities and perceptions.  Applying similar rigorous methodology to understand research participants’ perceptions has the potential to: identify motivations to participate in research protocols, assess how well the informed consent procedure prepare participants for their actual research experiences; provide information on the quality of the participants’ experience, including their interactions with the research team, and provide data to improve participant recruitment, the research experience, and the provision of ethical protections.
Under the leadership of Dr. Rhonda, Kost, the multi-center Research Participant Perception Survey Project, a collaboration between the Rockefeller Center for Clinical and Translational Science (CCTS) and the NIH Clinical Center, has made significant progress, including the creation and initial fielding of a validated questionnaire to measure research participant experiences.

Supported by the Rockefeller CTSA grant, the project is designed to find out how participants view their experiences in clinical research, provide national benchmarks for the conduct of clinical research, and generate data for evidence-based performance improvement of human research protections and research conduct. The initial phase focused on using rigorous qualitative methods to define the aspects of research participation that are important to research participants so as to inform the creation of a questionnaire.  The second phase was designed validate the questionnaire, obtain national benchmarks for performance, and provide local performance data to clinical research centers. 

A paper describing the results of the initial phase, including the results of 18 focus groups of participants and research professionals that were conducted at 8 academic research centers, was recently accepted for publication (Kost, et al.; CTS 2011, in press). In brief, research participants most commonly rated altruism, access to treatment, and learning about health as important factors in joining research projects; of particular note, financial compensation was rated a less important motivation to join or stay in a research study than many professionals predicted.

Participants varied widely in the way they reacted to potential risks of participation and other study details, but almost universally participants rated being treated with respect by the research team as essential to a positive experience. Reinforcing this last theme was the finding that when participants felt that they were not being treated with respect, they were likely to decline to participate or leave a protocol before it ended.  Survey questions were developed based on data from the focus group work. The questions spanned the entire process of research participation, from initial recruitment, through enrollment and study conduct, to completion or withdrawal.  The questionnaire was finalized in collaboration with the NRC Picker company, a leader in the creation, validation, and analysis of hospital patients’ surveys. The questionnaire was mailed to 18,980 research participants at 15 academic research institutions (including 13 CTSAs) across the country, and 4,961 responses (29%) were returned. Several methods were used to analyze both the validity of the questions and the five conceptual groupings of questions, namely, trust, informed consent, respect for patient preferences, information-education-communication, and coordination of care.

Questionnaires were sent to more than 1200 Rockefeller participants, and 384 responded, split nearly evenly between healthy volunteers and participants with specific disorders.. The group responding included 15% Hispanic/Latino, 21% Black African-Americans, 72% Caucasians, and 8% Asians participants. Overall, participants were very positive about their experiences at Rockefeller. Thus, 79% rated their research experience as “Best’ (9 – 10 on 0 – 10 scale), and 72% indicated they would recommend participation to their friends and family.

A detailed analysis of all of the questions is currently underway and several manuscripts describing the results are in preparation. Future e-Newsletters will contain articles that provide detailed discussions of specific themes. NRC Picker will make the survey available as part of their survey offerings in early 2012. If it is adopted broadly, the survey has the potential to establish national standards and encourage data-driven performance improvement across CTSA institutions and beyond!