Within and beyond the communal turn to informed consent in industry-sponsored pharmacogenetics research: merits and challenges of community advisory boards

Abstract

The one-size-fits-all paradigm of drug development fails to address inter-individual variability in drug response. Pharmacogenetics research aims at studying the role of genotypic differences in drug response. Recently, the pharmaceutical industry has shown interest to embed pharmacogenetics studies in the process of drug development. Nevertheless, population-based and commercial aspects of such futureoriented studies pose challenges for individually based informed consent (IC). As an exemplar of the communal turn to IC procedures, community advisory boards (CABs) have been integrated into different types of medical research. CABs hold the promise of organizing the relationship between participants and researchers in a more reciprocal and participatory way, offering possible means of overcoming the lapses of individualistic IC. However, the involvement of CABs with pharmacogenetics research might be rife with difficulties, uncertainties, and challenges. The current study first reviews the existing literature to discuss added values and challenges of relying on CABs as a supplement to individually based IC. Then, the particular moral and regulatory landscape of pharmacogenetics research will be delineated to argue that community engagement is both necessary and promising beyond the communal turn to IC processes. Three main features of the landscape include (1) new supportive stances that some regulatory bodies have adopted toward pharmacogenetics research, (2) the motivation of the industry to draw reception and trust from the subpopulations, and (3) the important role of the society in generating and embedding pharmacogenetics knowledge. Finally, some points to consider will be discussed to contextualize relying on CABs within this landscape.

Perspectives and ethical considerations for return of genetics and genomics research results: a qualitative study of genomics researchers in Uganda

“…The need for meaningful community engagement is increasingly being promoted in global health research with the aim of protecting communities from exploitation and harm while promoting research that is beneficial [28]. Community Advisory Boards have been employed mainly by clinical trials but different methods could be used based on the nature and setting of the study [29,30]. Community engagement is essential if communities are to understand the ethical and social implications of the study particularly the findings.…”

Perspectives and ethical considerations for return of genetics and genomics research results: a qualitative study of genomics researchers in Uganda

“…Community engagement was considered an important requirement for return of results particularly when returning aggregate results associated with the community.The need for meaningful community engagement is increasingly being promoted in international research guidelines with the aim of protecting communities from exploitation and harm while promoting research that is bene cial [24]. Community advisory boards have been employed mainly by clinical trials but different methods could be used based on the nature and setting of the study [25,27]. Community engagement is essential because it facilitates the study community to appreciate the research and understand implications of its participation, while also helping researchers to contextualize their research to the study community by, among other things, taking into account local values and preferences [28].…”

The Application of Bioethical Principles in the Use of Pharmacogenomics in Person-Centered Medicine

“…Indigenous participation may be enhanced by several approaches that may help: collaboration with community leaders, cultural competency, a process of deliberation with the community for the way of receiving results, improving research transparency, and supporting the community with capacity building 13 , 14 . Community advisory boards may also help to support pharmacogenetic tests in vulnerable populations 15 .…”