Regulation and the social licence for medical research

Regulation and governance of medical research is frequently criticised by researchers. In this paper, we draw on Everett Hughes’ concepts of professional licence and professional mandate, and on contemporary sociological theory on risk regulation, to explain the emergence of research governance and the kinds of criticism it receives. We offer explanations for researcher criticism of the rules and practices of research governance, suggesting that these are perceived as interference in their mandate. We argue that, in spite of their complaints, researchers benefit from the institutions of governance and regulation, in particular by the ways in which regulation secures the social licence for research. While it is difficult to answer questions such as: “Is medical research over-regulated?” and “Does the regulation of medical research successfully protect patients or promote ethical conduct?”, a close analysis of the social functions of research governance and its relationship to risk, trust, and confidence permits us to pose these questions in a more illuminating way.     

Institutional context: What elements shape how community occupational therapists think about their clients’ care?

Clinical reasoning (CR) is the cognitive process that therapists use to plan, direct, perform and reflect on client care. Linked to intervention efficiency and quality, CR is a core competency that occurs within an institutional context (legal, regulatory, administrative and organisational elements). Because this context can shape how community therapists think about their clients’ care, its involvement in their CR could have a major impact on the interventions delivered. However, little is known about this involvement. Our study thus aimed to describe the elements of the institutional context involved in community therapists’ CR. From March 2012 to June 2014, we conducted an institutional ethnography (IE) inquiry in three Health and Social Services Centres in Québec (Canada). We observed participants and conducted semi‐structured interviews with 10 occupational therapists. We also interviewed 12 secondary key informants (colleagues and managers) and collected administrative documents (n = 50). We analysed data using the IE process. Of the 13 elements of the institutional context identified, we found that four are almost constantly involved in participants’ CR. These four elements, that is, institutional procedures, organisation's basket of services, occupational therapists’ mandate and wait times for their services, restrictively shape CR. Specifically, occupational therapists restrict their representation of the client's situation and exploration of potential solutions to what is possible within the bounds of these four elements. In light of such restrictions on the way they think about their clients’ care, therapists should pay close attention to the elements of their own institutional context and how they are involved in their CR. Because of its potentially important impact on the future of professions (e.g. further restrictions on professionals’ role, reduced contribution to population health and well‐being), this involvement of the institutional context in CR concerns all professionals, be they clinicians, educators, researchers or regulatory college officers.     

Ethical review from the inside: repertoires of evaluation in Research Ethics Committee meetings

Evaluating the practice of ethical review by Research Ethics Committees (REC) could help protect the interests of human participants and promote scientific progress. To facilitate such evaluations, we conducted an ethnographic study of how an REC reviews research proposals during its meetings. We observed 13 meetings of a Dutch REC and studied REC documents. We coded this material inductively and categorised these codes in two repertoires of evaluation: a repertoire of rules and a repertoire of production. In the repertoire of rules the REC applies rules, weighs scientific value and burdens to the participants and makes a final judgment on a research proposal in a meeting. In the repertoire of production, REC members check documents and forms and advise researchers on how to improve their proposals and can use informal communication. Based on these findings, we think that evaluations of the practice of ethical review should take into account the fact that RECs can use a repertoire of rules and a repertoire of production to evaluate research proposals. Combining these two repertoires can be a viable option so that the REC gives researchers advice on how to improve their proposals to prevent rejection of valuable research.     

Community governance in primary health care: towards an international Ideal Type

Against a global background of increased resource management responsibilities for primary health care agencies, general medical practices, in particular, are increasingly being required to demonstrate the legitimacy of their decision making in market oriented environments. In this context a scoping review explores the potential utility for health managers in primary health care of community governance as a policy concept. The review of recent research suggests that applied learning from international health systems with enhanced approaches to public and patient involvement may contribute to meeting this requirement. Such approaches often characterise local health systems in Latin America and North West Europe where innovative models are beginning to respond effectively to the growing demands on general practice. The study design draws on documentary and secondary data analyses to identify common components of community governance from the countries in these regions, supplemented by other relevant international studies and sources where appropriate. Within a comprehensive framework of collaborative governance the components are aggregated in an Ideal Type format to provide a point of reference for possible adaptation and transferable learning across market oriented health systems. Each component is illustrated with international exemplars from recent organisational practices in primary health care. The application of community governance is considered for the particular contexts of GP led Clinical Commissioning Groups in England and Primary Health Networks in Australia. Some components of the Ideal Type possess potentially powerful negative as well as positive motivational effects, with PPI at practice levels sometimes hindering the development of effective local governance. This highlights the importance of careful and competent management of the growing resources attributed to primary health care agencies, which possess an increasingly diverse range of non‐governmental status. Future policy and research priorities are outlined. Copyright © 2016 John Wiley & Sons, Ltd.     

Dirty questions: Indigenous health and 'Western research'

OBJECTIVE: This paper explores both Indigenous and non-indigenous critiques of 'Western' research frameworks in an Aboriginal health context. It also discusses the 'reform' of Aboriginal health research practices since the 1980s, particularly in relation to the development of ethical guidelines. METHOD: The text is based on both archival research and a critical review of secondary literature. CONCLUSIONS AND IMPLICATIONS: It is argued here that efforts to reform the practices of mainstream Indigenous health research since the 1980s have oscillated between taking concrete steps towards actually changing research practice and placing too great a reliance on written guidelines and positive rhetoric. In offering this analysis, the paper argues for a more challenging conception of reforming mainstream research, involving an emphasis on shifts in institutional arrangements as well local research practices.     

Community involvement in the ethical review of genetic research: lessons from American Indian and Alaska Native populations

The National Bioethics Advisory Commission has proposed that regulatory oversight for research with human subjects be extended beyond the protection of individual research participants to include the protection of social groups. To accomplish this, the commission recommends that investigators and ethics review boards a) work directly with community representatives to develop study methods that minimize potential group harms, b) discuss group implications as part of the informed consent process, and c) consider group harms in reporting research results. We examine the utility of these recommendations in the context of research with American Indian and Alaska Native communities. Because much attention has been given to the question of how best to consult with members of these communities in the design and conduct of research, we believe it behooves investigators to consider the lessons to be learned from research involving American Indians and Alaska Natives. After describing several difficulties surrounding the application of the commission's approach to these research contexts, we propose a research agenda to develop best practices for working with local communities in the ethical assessment of epidemiologic and environmental health research.     

Written work: the social functions of Research Ethics Committee letters

Research Ethics Committees (RECs) are increasingly institutionalised as a feature of research practice, but have remained strangely neglected by social scientists. In this paper, we argue that analysis of letters from RECs to researchers offers important insights into how RECs operate. We report a traditional content analysis and an ethnographic content analysis of 141 letters to researchers, together with an analysis of the organisational and institutional arrangements for RECs in the UK. We show that REC letters perform three important social functions. First, they define what is deemed by a REC to be ethical practice for any particular application, and confer authority on that definition. They do this actively, through comments on particular aspects of proposals, and passively, through silences about other aspects. Second, they provide an account of the work of the REC, and function as a form of institutional display. Third, they specify the nature of the relationship between the REC and the applicant, casting the applicant in a supplicant role and requiring forms of docility. Writing and reading REC letters require highly specific competences, and engage both parties in a Bourdieusian "game" that discourages challenges from researchers. The authority of RECs' decisions derives not from their appeal to the moral superiority of any ethical position, but through their place in the organisational structure and the social positioning of the parties to the process thus implied. Letters are the critical point at which RECs act on researchers and their projects.     

Institutional ethics policies on medical end-of-life decisions: a literature review

OBJECTIVES: The responsibility of healthcare administrators for handling ethically sensitive medical practices, such as medical end-of-life decisions (MELDs), within an institutional setting has been receiving more attention. The overall aim of this paper is to thoroughly examine the prevalence, content, communication, and implementation of written institutional ethics policies on MELDs by means of a literature review. METHODS: Major databases (Pubmed, Cinahl, PsycINFO, Cochrane Library, FRANCIS, and Philosopher's Index) and reference lists were systematically searched for all relevant papers. Inclusion criteria for relevance were that the study was empirically based and that it focused on the prevalence, content, communication, or implementation of written institutional ethics policies concerning MELDs. RESULTS: Our search yielded 19 studies of American, Canadian, Dutch and Belgian origin. The majority of studies dealt with do-not-resuscitate (DNR) policies (prevalence: 10-89%). Only Dutch and Belgian studies dealt with policies on pain and symptom control (prevalence: 15-19%) and policies on euthanasia (prevalence: 30-79%). Procedural and technical aspects were a prime focus, while the defining of the specific roles of involved parties was unclear. Little attention was given to exploring ethical principles that question the ethical function of policies. In ethics policies on euthanasia, significant consideration was given to procedures that dealt with conscientious objections of physicians and nurses. Empirical studies about the implementation of ethics policies are scarce. CONCLUSIONS: With regard to providing support for physicians and nurses, DNR and euthanasia policies expressed support by primarily providing technical and procedural guidelines. Further research is needed whether and in which way written institutional ethics policies on MELDs could contribute to better end-of-life care.     

Involving citizens in the ethics of biobank research: Informing institutional policy through structured public deliberation

This paper reports on the design, implementation, and results of a structured public deliberation on human tissue biobanking conducted in Vancouver, Canada, in 2009. This study builds on previous work on the use of deliberative democratic principles and methods to engage publics on the social and ethical implications of human tissue biobanking. In a significant refinement of methods, we focus on providing public input to institutional practice and governance of biobanks using a tailored workbook structure to guide participants' discussion. Our focus is on the local context and practices of a particular institution, the BC BioLibrary. However, elements of both the methodological innovations and the ethical guidance implied by our findings are generalisable for biobanking internationally. Recommendations from the deliberative forum include issues of informed consent, privacy protections, collection of biospecimens, governance of biobanks, and how to manage the process of introduction between biobanks and potential donors. Notable findings include public support for research use of anonymised un-consented tissue samples when these come from archived collections, but lack of support when they are collected prospectively.     

Cultural models of diarrheal illness: conceptual framework and review

Health planning for diarrheal diseases must be responsive to both epidemiological patterns and local perceptions of health, illness and need. A conceptual framework that relates patterns of distress, explanatory models, help seeking and treatment practices to knowledge and use of oral rehydration therapy (ORT), dietary management, other specific treatments and health policy issues provides the basis for our review of research on diarrheal illness-related beliefs and practices. The ethnomedical model asserts that efforts to secure the compliance of target populations are likely to be inadequate without an alliance between health professionals and communities to identify and address mutually comprehensible objectives that are perceived locally as meaningful and relevant. An appreciation of local cultural models and the diversity of cultural contexts enables health professionals to (1) recognize the significance of local perceptions of diarrheal illness with respect to pertinent outcomes and perceived needs, (2) develop ways to introduce recommendations that communities will accept, and (3) make appropriate use of existing community resources representing local traditions. An agenda for needed research concludes the review.     

Understanding the linkages between informal and formal care for people living with HIV in sub-Saharan Africa

Abstract

In response to the human resource challenges facing African health systems, there is increasing involvement of informal care providers in HIV care. Through social and institutional interactions that occur in the delivery of HIV care, linkages between formal and informal systems of care often emerge. Based on a review of studies documenting the relationships between formal and informal HIV care in sub-Saharan Africa, we suggest that linkages can be conceptualised as either ‘actor-oriented’ or ‘systems-oriented’. Studies adopting an actor-oriented focus examine hierarchical working relationships and communication practices among health systems actors, while studies focusing on systems-oriented linkages document the presence, absence or impact of formal inter-institutional partnership agreements. For linkages to be effective, the institutional frameworks within which linkages are formalised, as well as the ground-level interactions of those engaged in care, ought to be considered. However, to date, both actor- and system-oriented linkages appear to be poorly utilised by policy makers to improve HIV care. We suggest that linkages between formal and informal systems of care be considered across health systems, including governance, human resources, health information and service delivery in order to improve access to HIV services, enable knowledge transfer and strengthen health systems.     

Supplementing the traditional institutional review board with an environmental health and community review board

BACKGROUND: Community-based research often involves additional ethical, legal, and social considerations beyond those of the specific individuals involved in the study. The traditional institutional review board (IRB) typically focuses on protecting the rights and ensuring the safety of the individuals involved. For projects involving community members, IRBs should be more sensitive to issues related to the broader community concerns. OBJECTIVES: The objective of this article is to discuss the concept of community-based participatory research and the shortcomings of the traditional IRBs in dealing with ethical issues associated with broader community concerns such as implications for family members, neighborhood groups, and local businesses. I examine the rationale and benefits for expanding the roles and responsibilities of review boards related to community-based issues. DISCUSSION: I propose the development of environmental health and community review boards (EHCRBs) that combine the fundamental responsibilities and ethical concept of the traditional review boards with an expanded ethical construct of dignity, veracity, sustainability, and justice, with an added emphasis on community. CONCLUSIONS: Only by acknowledging the needs of and working with the community can we ensure ethically based and socially responsible research. An EHCRB will allow researchers and community members to more fully address their mutual interest in conducting scientific, ethical, and socially responsible research.     

Doctors as moral pioneers: Negotiated boundaries of assisted conception in Colombia

New biotechnologies such as assisted conception are socially embedded artefacts that raise context‐specific ethical, moral and social anxieties. In contexts where the regulations of these profitable developments are limited or ambiguous, and competition between private facilities is high, individual doctors become morally and socially responsible for determining the parameters of administering such therapies. Ethnographic research at two private fertility centres in Colombia reveals that doctors do not determine boundaries based on monetary gain but rather personal morals, social norms and professional obligations. Medical professionals hold diverse perceptions of assisted conception, and often struggle to make decisions regarding who should access such therapies, who are ideal gamete donors and the fate of extra embryos. The complexity of these perceptions applied in a context of limited regulation and the competition of private medicine impacts the praxis of assisted conception. As doctors determine the boundaries of their practice they not only create variation between clinical practices, but also make moral decisions regarding who should be parents, how families should be formed and the significance of embryos. Thus, in navigating their everyday practices, doctors also shape the social world.     

Ethics review of COVID-19 human challenge studies: A joint HRA/WHO workshop

This report of a joint World Health Organization (WHO) and United Kingdom (UK) Health Research Authority (HRA) workshop discusses the ethics review of the first COVID-19 human challenge studies, undertaken in the midst of the pandemic. It reviews the early efforts of international and national institutions to define the ethical standards required for COVID-19 human challenge studies and create the frameworks to ensure rigorous and timely review of these studies.This report evaluates the utility of the WHO’s international guidance document Key criteria for the ethical acceptability of COVID-19 human challenge studies (WHO Key Criteria) as a practical resource for the ethics review of COVID-19 human challenge studies. It also assesses the UK HRA’s approach to these complex ethics reviews, including the formation of a Specialist Ad-Hoc Research Ethics Committee (REC) for COVID-19 Human Challenge Studies to review all current and future COVID-19 human challenge studies. In addition, the report outlines the reflections of REC members and researchers regarding the ethics review process of the first COVID-19 human challenge studies. Finally, it considers the potential ongoing scientific justification for COVID-19 human challenge studies, particularly in relation to next-generation vaccines and optimisation of vaccination schedules.Overall, there was broad agreement that the WHO Key Criteria represented an international consensus document that played a powerful role in setting norms and delineating the necessary conditions for the ethical acceptability of COVID-19 human challenge studies. Workshop members suggested that the WHO Key Criteria could be practically implemented to support researchers and ethics reviewers, including in the training of ethics committee members. In future, a wider audience may be engaged by the original document and potential additional materials, informed by the experiences of those involved in the first COVID-19 human challenge studies outlined in this document.     

Genetic testing,governance, and the family in the People’s Republic of China

In western countries the rise of genetic testing has been accompanied by ethical arrangements like autonomy and informed consent that help to dissociate genetics from eugenic policies. However, critics have argued that this trend to increase individual choice should be considered as a neoliberal governance strategy to promote bio-citizenship. These western concepts are often used to discuss genetic testing in the Peoples Republic of China as well. China’s population policy has a reputation for condoning eugenic practices and for ruthless one-child and family planning policies, but there have been many reforms recently, which, together with the revival and development of traditional religions and beliefs, have complicated the discussion about the meaning of the Chinese family. In this context, the introduction of genetic testing in China has been linked to state eugenics as well as post-reform neo-liberalist governance. Based on fieldwork and various archival and literature studies it explores genetic testing in five different Chinese contexts. The analysis makes clear that, although population planning in China proceeds from the idea that the planning of family health leads to a healthier population, traditional beliefs, individual initiative, group pressure, commercial organisations and state policies make for an amalgam of genetic testing practices that cannot be understood in terms of eugenics or liberal governance.     

Long‐term ill health and the social embeddedness of work: a study in a post‐industrial,multi‐ethnic locality in the UK

Against the background of an increasingly individualising welfare‐to‐work regime, sociological studies of incapacity and health‐related worklessness have called for an appreciation of the role of history and context in patterning individual experience. This article responds to that call by exploring the work experiences of long‐term sick people in East London, a post‐industrial, multi‐ethnic locality. It demonstrates how the individual experiences of long‐term sickness and work are embedded in social relations of class, generation, ethnicity and gender, which shape people's formal and informal routes to work protection, work‐seeking practices and responses to worklessness. We argue that this social embeddedness requires greater attention in welfare‐to‐work policy.     

Capacity and transparency of potable water regulation in Tijuana, Mexico: challenges for ensuring water quality at community level

The ability of public institutions to provide efficient and equitable potable water services is key to reducing water-borne diseases, one of the leading causes of morbidity and mortality in the developing world. In this article, a case study of potable water and public health programs in Tijuana, Mexico, is used to direct attention to practical examples of policy and institutional incapacities. A qualitative methodology was used to gain access to local context and the formal and informal actions of the key informants. This paper concludes that public health agencies are creating the illusion of program action through disease surveillance, however capacity gaps demonstrate that institutional policy is not pragmatically reflected on the local community level. Political client-patron relationships are used to circumvent bureaucratic barriers and distribute resources at the local level. This raises the question of whether further accountability will bring the much-expected equitable distribution of public goods in the developing world.     

"It's like Tuskegee in reverse": a case study of ethical tensions in institutional review board review of community-based participatory research

Community-based participatory research (CBPR) addresses the social justice dimensions of health disparities by engaging marginalized communities, building capacity for action, and encouraging more egalitarian relationships between researchers and communities. CBPR may challenge institutionalized academic practices and the understandings that inform institutional review board deliberations and, indirectly, prioritize particular kinds of research. We present our attempt to study, as part of a CBPR partnership, cigarette sales practices in an inner-city community. We use critical and communitarian perspectives to examine the implications of the refusal of the university institutional review board (in this case, the University of California, San Francisco) to approve the study. CBPR requires expanding ethical discourse beyond the procedural, principle-based approaches common in biomedical research settings. The current ethics culture of academia may sometimes serve to protect institutional power at the expense of community empowerment.     

A national snapshot of local school wellness policies

Background: The federal mandate for local wellness policies (LWP) provides an unprecedented opportunity to improve schools’ practices that support student health, which, in turn, supports academic achievement. With a full agenda and budget challenges, districts need resources and support to turn policies into sustainable practices. The purpose of this study was to assess district policy goals and compare them to the federal mandate and benchmarks of best practices. It is hoped that this information will lead to development of specific assistance in the areas of policy implementation, evaluation, and revision. Methods: Action for Healthy Kids (AFHK) collected a convenience sample of 256 approved LWP. The sample included districts with small, medium, and large student enrollment from every state (except Hawaii). Policies were compared to federal requirements and the AFHK Wellness Policy Fundamentals, a tool which documents best practices for nutrition and physical activity in schools. Results: Sixty‐eight percent of policies sampled were consistent with the mandates set forth in the law. Thirty‐two percent did not address 1 or more goal areas set by the federal mandate with 15% not addressing goals for evaluation and monitoring. None of the policies addressed all components of AFHK’s Fundamentals. Less than 1% addressed all 4 of the evaluation components. Teacher requirements and training for nutrition and physical education were addressed by 43% and 45% of policies, respectively. Conclusions: This study’s findings indicate schools will need assistance to meet each of the mandates provided by the federal mandate. Areas lacking attention in policies, yet essential for sustaining wellness practices, include assurances of qualified staff, opportunities for staff development, and implementation, evaluation, and revision of the policy.