Do Public Involvement Activities in Biomedical Research and Innovation Recruit Representatively? A Systematic Qualitative Review

Abstract

Background: Public involvement activities (PIAs) may contribute to the governance of ethically challenging biomedical research and innovation by informing, consulting with and engaging the public in developments and decision-making processes. For PIAs to capture a population's preferences (e.g. on issues in whole genome sequencing, biobanks or genome editing), a central methodological requirement is to involve a sufficiently representative subgroup of the general public. While the existing literature focusses on theoretical and normative aspects of ‘representation', this study assesses empirically how such considerations are implemented in practice. It evaluates how PIA reports describe representation objectives, the recruitment process and levels of representation achieved. Methods: PIA reports were included from a systematic literature search if they directly reported a PIA conducted in a relevant discipline such as genomics, biobanks, biotechnology or others. PIA reports were analyzed with thematic text analysis. The text analysis was guided by an assessment matrix based on PIA-specific guidelines and frameworks. Results: We included 46 relevant reports, most focusing on issues in genomics. 27 reports (59%) explicitly described representation objectives, though mostly without adjusting eligibility criteria and recruiting methods to the specific objective. 11 reports (24%) explicitly reported to have achieved the intended representation; the rest either reported failure or were silent on this issue. Conclusion: Representation of study samples in PIAs in biomedical research and innovation is currently not reported systematically. Improved reporting on representation would not only improve the validity and value of PIAs, but could also contribute to PIA results being used more often in relevant policy and decision-making processes.

Practice evaluation of biobank ethics and governance: current needs and future perspectives

“…They found that the way biobank employees understand and practice engagement activities differed across biobanks and between people working in the same institution 24. Lander et al evaluated how issues of representativeness in public involvement activities were reported in publications 25. Although their study was not restricted to biobanks, 18 (39%) out of 46 analysed publications focused on public involvement in biobank research.…”

Involving patients and publics in medical and health care research studies: an exploratory survey on participant recruiting and representativeness from the perspective of study authors

“…The latter aspects became evident in particular from the survey respondents' open answers (Q. 19). Also, while (some) guidance on planning and conducting PPI is available from research and PPI institutions, a considerable number of survey respondents mentioned the need for more guidance and a better understanding of "PPI".…”

“…Further assessment of PPI activities could be done for instance by contacting research groups leaders either from a specific area of research or more broadly and interviewing them regarding non-published PPI activities. This may also reveal insights about whether reporting/publishing on PPI and particular aspects such as participant recruiting is lacking so far [19] because authors simply do not consider reporting about PPI relevant, or because of actual difficulties with PPI conduct in practice.…”

“…Various previous studies assess and debate PPI terminology and the challenges it entails [2,13,14], different types of representativeness and how they are used [17,19], and current PPI practices more broadly [20][21][22][23], using for instance debates, framework developments, and literature reviews. Few studies take a more practice-oriented approach by conducting interviews with professionals on PPI in general [24,25], and with small sample sizes [17,22].…”

Public Deliberation and Biomedical Enhancements

“…Even if reasonable disagreements persist after discussion has been conducted, public deliberation will nevertheless have contributed to legitimacy and fairness because it is based on an aspiration to offer justification for a certain decision. Similarly to developments within deliberative democratic theory, from the first stage which was mostly characterized by normative considerations, the discussion has largely moved towards practice of public deliberation regarding various bioethical issues [3][4][5].…”