Perceptions and Experiences of Community Members Serving on Institutional Review Boards: A Questionnaire Based Study

Abstract

The community representative plays a very important role in an institutional review board (IRB) but there is sparse data about their understanding of their role in an IRB. This study was conducted to assess perceptions of community members serving on IRBs of one region in India. A validated questionnaire (Cohen's kappa coefficient of 0.84) was administered to community members of IRBs in a prospective cross-sectional study. The questions related to demography, perceptions of their role in the IRB, experiences while serving on the IRBs, difficulties faced by them, and suggestions to improve their contributions. Of the 56 IRBs contacted, all 15 of the public institutions shared details of their community members, while only 26 of the 41 IRBs of private institutions responded. When questioned about why they joined the IRB, one third of the respondents said either that there was "no specific reason" for joining or that they accepted the invitation to serve on the insistence of other members of the IRBs or the head of their institution. All except one felt that community members were needed for optimal functioning. Six participants said that they did not review informed consent documents (ICD), and 10 were unaware that their presence was vital for quorum to be met. Twenty-eight said they participated actively in meetings and did not feel intimidated by the presence of clinicians. Twelve reported difficulties in understanding medical terminologies in ICDs. Although the majority of participants were aware about their role in an IRB, some did not review important documents such as ICDs. Restricted participation by private hospital IRBs was a striking observation in our study. There is a need to define eligibility criteria and develop targeted training modules for community members to ensure their effective contribution to effective oversight of clinical research.

Perspectives of non-specialists on the potential to serve as ethics committee members

“…These findings emphasize the need for an increase in basic training with development of modules including those available online. 10…”

“…Additionally, in a study of Indian board members, Kuyare et al. 10 suggested that being experienced may actually be counterproductive to the role of non-specialist members as participant/community representatives. That is, the more experience they gain, the more knowledgeable they become and therefore the less able they are to represent the community.…”

“…The role of ethics committee members outside the institution (non-affiliated members) and/or members whose primary concerns are non-scientific (non-scientist members) have also been discussed and emphasized. 5–10 Non-affiliated members are often referred to as community members. 9 In the present study, the term “non-specialists” refers to those who have no involvement with clinical research.…”

Ethics Committees in India: Past, present and future

“…A survey among laypersons serving on ECs revealed several of them did not review informed consent documents (ICDs), those who said they did not understand technical terms in the ICDs, and one-third were unaware that their presence was vital for quorum to be met. [ 21 ] Other papers have also identified the lack of active participation of nonmedical members in the Committee's deliberations, as well as the fact that they lack training and are diffident. [ 22 23 ]…”

Experiencia de los miembros de la comunidad en los comités de ética en investigación en Colombia

“…Introducción L a figura del representante en la comunidad (RC), en los Comités de Ética en Investigación o Comités Institucionales de Ética (CEI) o juntas de revisión institucional (IRB en sus siglas en inglés) ha sido, en general, poco comprendida (Kuyare 2015). Muchos CEI tienen a esas personas solo porque es una exigencia de la reglamentación vigente y por tanto su elección, capacitación y funcionamiento no están en las prioridades de los directivos de las instituciones o de los CEI 1 .…”