Population-level biomedical research offers new opportunities to improve population health, but also raises new challenges to traditional systems of research governance and ethical oversight. Partly in response to these challenges, various models of public involvement in research are being introduced. Yet, the ways in which public involvement should meet governance challenges are not well understood. We conducted a qualitative study with 36 experts and stakeholders using the World Café method to identify key governance challenges and explore how public involvement can (...) meet these challenges. This brief report discusses four cross-cutting themes from the study: the need to move beyond individual consent; issues in benefit and data sharing; the challenge of delineating and understanding publics; and the goal of clarifying justifications for public involvement. The report aims to provide a starting point for making sense of the relationship between public involvement and the governance of population-level biomedical research, showing connections, potential solutions and issues arising at their intersection. We suggest that, in population-level biomedical research, there is a pressing need for a shift away from conventional governance frameworks focused on the individual and towards a focus on collectives, as well as to foreground ethical issues around social justice and develop ways to address cultural diversity, value pluralism and competing stakeholder interests. There are many unresolved questions around how this shift could be realised, but these unresolved questions should form the basis for developing justificatory accounts and frameworks for suitable collective models of public involvement in population-level biomedical research governance. (shrink)

Background: While employers are increasingly considering and implementing COVID-19 vaccination requirements, little is known about the reasons offered by employees seeking religious exemptions.Methods: We conducted a mixed methods analysis of all the requests for religious exemptions submitted during the initial implementation of a COVID-19 vaccination requirement at a single academic medical center in the United States.Results: Five hundred sixty-five (3.4%) employees requested religious exemptions. At least 305 (54.0%) requesters had job titles suggesting that they had direct patient contact. Four hundred (...) ninety-nine (88.3%) of requesters self-identified as Christian, of whom 120 (21.2%) identified as Roman Catholic. Requesters offered 0 to 8 (mean 2.7) categories of reasons for their request. The most frequently stated reasons pertained to the use of fetal cell lines in vaccine development and manufacturing (382, 67.6%), interest in maintaining purity (221, 39.1%), or belief in divine healing (172, 30.4%). Some requesters also volunteered evidence of the sincerity of their beliefs including examples of their religious practices (116, 20.5%), other practices (66, 11.7%), and emotional states (32, 5.7%). One hundred fifty-two applications (26.9%) contained text copied without attribution, primarily from sample religious exemption request letters available on the Internet.Conclusions: Most requesters focused on the use of fetal cell lines in the development or manufacturing of the vaccines as the justification for their request. The development of vaccines that are not reliant on fetal cell lines may increase vaccination rates. Understanding reasons for religious exemption requests may inform vaccine education and vaccination policies. (shrink)

Hastings Center Report, Volume 51, Issue 5, Page 8-11, September‐October 2021.