100 - Development and Implementation of a Human Rights Committee to Facilitate a Participant-Centered Approach to Research

Background:  Participant recruitment and retention presents a time-consuming and costly challenge to the conduct and completion of clinical trials. A participant-centered approach has proved to be an effective quality improvement strategy to mitigate this universal problem through the inclusion of and engagement with the community as members of the study team.

Program

Description:  A Center-based Program-wide Human Rights Committee (HRC) has been established and implemented as a quality assurance initiative to foster community engagement and participation in research. It provides independent guidance relative to human rights and ethics in the design, planning, and conduct of IRB-approved clinical trials from the participant perspective. Membership at each Center comprises employees and non-employees and includes community members, patients, scientists, and clinicians appointed by the Center Director. During the planning phase of a new trial, the HRC reviews the protocol and informed consent process focusing on human rights, study feasibility, participant experience, and ethical issues. Once a study is active, non-employee HRC members conduct participant interviews to assess their experiences and interactions with the study team. Feedback is communicated to the local site study team, medical center administration, and research leadership. The Plan Do Study Act method is the framework used to determine the success of this program in meeting its goals to identify and mitigate issues including but not limited to recruitment and retention from the perspective of the research participant.

Program

Assessment:  The HRC has effectively facilitated participant advocacy, engagement, and trust in the research process. Participant trust is essential to mitigate any inherent distrust of research in general and site staff trust in research leadership fosters teamwork toward the common goal of creating a participant-centered approach in a non-threatening manner. Bi-directional communication and education are also strengthened by HRC contributions. All study participants report their involvement in research as positive and meaningful. Discussions with site staff reveal the benefit of genuine connections with participants to positively impact recruitment and retention. HRC visits and interviews have been well received by all. Gaps in understanding of the concept of randomization during the informed consent process were identified during HRC interviews with participants. Feedback provided to research leadership led to quality improvement initiatives. Accomplishments as well as challenges related to logistics, resources, and environmental limitations are also communicated to medical center leadership at individual sites. HRC activities provide participants a voice, and the sites, medical center leadership, and research leadership a better understanding of the participant experience in research.

Limitations: In-person participant interviews have been difficult to arrange despite efforts to coordinate with previously scheduled visits, therefore many have been conducted by phone. Participant selection bias for those interviewed may have hampered potential opportunities for improvement. Financial challenges continue to impact the ability of HRC members to travel. Restrictions due to the COVID pandemic have also challenged this program. A relatively low but increasing number of site visits has impaired our ability to generalize conclusions.

Discussion:  This HRC, at one research center within a program, has demonstrated value and plays an important role in developing and conducting studies by connecting research to the community. There is evidence of an increase in trust, engagement, and continuous improvement. HRC membership is being expanded to broaden the implementation of this program to include more participants and more sites. There is also a plan to combine our data with other similar programs. With more data, specific metrics will become available for more meaningful analysis to facilitate the formulation of generalizable conclusions about the true impact of this unique participant-centered program.