Research Participant‐Centered Outcomes at NIH‐Supported Clinical Research Centers

Abstract

Background Although research participation is essential for clinical investigation, few quantitative outcome measures exist to assess participants’ experiences. To address this, we developed and deployed a survey at 15 NIH-supported clinical research centers to assess participant-centered outcomes; we report responses from 4,961 participants. Methods Survey questions addressed core aspects of the research participants’ experience, including their overall rating, motivation, trust, and informed consent. We describe participant characteristics, responses to individual questions, and correlations among responses. Results Respondents broadly represented the research population in sex, race, and ethnicity. Seventy-three percent awarded top ratings to their overall research experience and 94% reported no pressure to enroll. Top ratings correlated with feeling treated with respect, listened to, and having access to the research team (R2=0.80 - 0.96). White participants trusted researchers (88%) than did non-white participants collectively (80%) (p<0.0001). Many participants felt fully prepared by the informed consent process (67%) and wanted to receive research results (72%). Conclusions Our survey demonstrates that a majority of participants at NIH-supported clinical research centers rate their research experience very positively and that participant-centered outcome measures identify actionable items for improvement of participant’s experiences, research protections, and the conduct of clinical investigation.

Satisfaction and perceptions of research participants in clinical and translational studies: An urban multi-institution with CTSA

“…Several studies [1,3,[8][9][10] have focused on satisfaction as it relates to participation in research studies and retention of participants throughout the duration of the clinical study. Verheggen et al [8] conducted a survey in the Netherlands using personal interviews and telephone questionnaires and found that patient satisfaction was quite high.…”

“…Moreover, participants do not need to continue their participation once they have enrolled in a study but can withdraw without consequences for any reason. Kost et al [1,9,10] hypothesize that improved understanding on the part of the research participant can enhance human subjects' protection, enhance recruitment and retention, improve the quality of the research process, and increase public trust in the overall research enterprise. Thus, a participant-oriented approach to measuring satisfaction with the research process would be comparable to the current standard of evaluation of the clinical performance of hospitals and would be of use to clinical researchers.…”

“…Participation in research in general has been cited to be associated with satisfaction and their experiences while in a clinical trial [9,11]. Studies indicate that the major barriers to participation in clinical trials, particularly with respect to African Americans and other racial and ethnic minorities, include a lack of awareness about trials, low socioeconomic status, mistrust, lack of communication, and lack of disease education [2,12,13].…”

“…Reported barriers to participation have included length of the trial and the overall study design (e.g., randomization; chance of getting placebo instead of investigational drug) [15,16]. There is a growing interest among research investigators and clinical research staff to improve participants' study experiences [1,3,9,10,17] and to increase participation by minorities. The Center for Information and Study on Clinical Research Participation (CISCRP) argues that it is important to determine participant satisfaction as few studies have examined the role participant satisfaction may play with regard to cultural diversity [17].…”

“…The Center for Information and Study on Clinical Research Participation (CISCRP) argues that it is important to determine participant satisfaction as few studies have examined the role participant satisfaction may play with regard to cultural diversity [17]. In addition, many of the survey studies [9,10,17] that examined participant experience included only a small number of African American or other ethnic minority populations. It is, therefore, critical for researchers to find innovative ways to improve the overall study participant's experience, but more so with regard to African Americans and other racial and ethnic minority participants.…”