The living will--are you for or against?

A lecturer in nursing discusses whether it is right to sustain life long beyond the dictates of nature merely because we have the medical technology to do so. He argues that nurses should become more involved in the national and legal debates about living wills and that ethics need to evolve and change along with changes in medical science.     

Biosecurity risks associated with vaccine platform technologies

Vaccine platforms have been critical for accelerating the timeline of COVID-19 vaccine development. Faster vaccine timelines demand further development of these technologies. Currently investigated platform approaches include virally vectored and RNA-based vaccines, as well as DNA vaccines and recombinant protein expression system platforms, each featuring different advantages and challenges. Viral vector-based and DNA vaccines in particular have received a large share of research funding to date. Platform vaccine technologies may feature dual-use potential through informing or enabling pathogen engineering, which may raise the risk for the occurrence of deliberate, anthropogenic biological events. Research on virally vectored vaccines exhibits relatively high dual-use potential for two reasons. First, development of virally vectored vaccines may generate insights of particular dual-use concern such as techniques for circumventing pre-existing anti-vector immunity. Second, while the amount of work on viral vectors for gene therapy exceeds that for vaccine research, work on virally vectored vaccines may increase the number of individuals capable of engineering viruses of particular concern, such as ones closely related to smallpox. Other platform vaccine approaches, such as RNA vaccines, feature relatively little dual-use potential. The biosecurity risk associated with platform advancement may be minimised by focusing preferentially on circumventing anti-vector immunity with non-genetic rather than genetic modifications, using vectors that are not based on viruses pathogenic to humans, or preferential investment into promising RNA-based vaccine approaches. To reduce the risk of anthropogenic pandemics, structures for the governance of biotechnology and life science research with dual-use potential need to be reworked. Scientists outside of the pathogen research community, for instance those who work on viral vectors or oncolytic viruses, need to become more aware of the dual-use risks associated with their research. Both public and private research-funding bodies need to prioritise the evaluation and reduction of biosecurity risks.     

The concept of governance in dual-use research

The rapid advance of life science within the context of increased international concern over the potential misuse of findings has resulted in the lack of agreement on the issues of responsibility, control and collaboration. This progress of knowledge outpaces the efforts of creating moral and legal guidelines for the detection and minimization of the risks in the research process. There is a need to identify and address normative aspects of dual-use research. This paper focuses on the issues of safety and global collaboration in life science research by highlighting the importance of openness, enabling policies and cooperative governance. These safeguards are believed to reduce the risks related to the misuse of science while enabling the important research to move forward. The paper addresses the need for a better definition of dual use concept and, based on the historical precedents, explores the moral concerns and governmental strategies of dual-use research. The three necessary moves in addressing the issue of security in life sciences are suggested: the move from constraining to enabling types of policies, the move from secrecy to openness, and the move from segregation to integration of the public voice.     

Coupled Ethical–Epistemic Analysis of Public Health Research and Practice: Categorizing Variables to Improve Population Health and Equity

The categorization of variables can stigmatize populations, which is ethically problematic and threatens the central purpose of public health: to improve population health and reduce health inequities. How social variables (e.g., behavioral risks for HIV) are categorized can reinforce stigma and cause unintended harms to the populations practitioners and researchers strive to serve.Although debates about the validity or ethical consequences of epidemiological variables are familiar for specific variables (e.g., ethnicity), these issues apply more widely.We argue that these tensions and debates regarding epidemiological variables should be analyzed simultaneously as ethical and epistemic challenges. We describe a framework derived from the philosophy of science that may be usefully applied to public health, and we illustrate its application.How epidemiological variables are categorized may result in real-world effects that reinforce stigma and cause unintended harms to the populations that public health professionals strive to serve. Debates about the validity or ethical consequences of variable choice are relatively familiar in the literature on ethnicity and race, but we suggest these problems apply more widely. We contend that stigmatizing vulnerable populations is ethically problematic, as has been previously established, and it more fundamentally undermines the purpose of public health research and practice: to improve population health and reduce health inequities.1 We outline some tensions that researchers face when categorizing variables and argue that these issues benefit from being approached as problems that are analyzed simultaneously as ethical challenges and as epistemic or evidentiary challenges. We present a framework, derived from the philosophy of science, as an approach that could be usefully applied to public health. We apply this framework to 2 examples: the use of men who have sex with men (MSM) as a variable in US blood bank policies and the use of the Scottish Index of Multiple Deprivation (SIMD) in health disparities policy.     

Beyond Bioethics: Reckoning With the Public Health Paradigm

In the wake of scandal over troubling research abuses, the 1970s witnessed the birth of a new system of ethical oversight. The bioethics framework, with its emphasis on autonomy, assumed a commanding role in debates regarding how to weigh the needs of society against the rights of individuals.Yet the history of resistance to oversight underscores that some domains of science hewed to a different paradigm of accountability—one that elevated the common good over individual rights.Federal officials have now proposed to dramatically limit the reach of ethical oversight. The Institute of Medicine has called for a rollback of the federal privacy rule. The changing emphasis makes it imperative to grapple with the history of the public interest paradigm.Only a few years ago, the business of ethical review seemed a juggernaut destined only to expand, inspiring increasingly bitter remonstrations about the “absurd demands” federal research regulation placed on scientists.1 It is remarkable, then, that the Department of Health and Human Services (DHHS) now stands poised to significantly scale back and streamline many institutional oversight procedures.2 In October 2011, DHHS closed the public comment period on a proposal that would expand the categories of social and behavioral research that can be “excused” from institutional review board approval, allow a single institutional review board to oversee multisite studies, and generally adjust the institutional review board system to avoid cases where low-risk studies are subjected to high levels of scrutiny. The pending overhaul comes in the wake of Institute of Medicine recommendations in 2009 to exempt all research from the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and absolve all “information-based” research from informed consent requirements.3 Taken together, these proposals suggest the regulatory pendulum is taking a swing to the permissive.Much debate around the DHHS proposal has centered on its identification of the HIPAA Privacy Rule as a potential framework for ensuring research data protection and security—an idea that has caused some researchers to fear that the new regime, designed to simplify the review process, will actually lead to even more red tape.4 Yet there are larger issues at stake than simply ensuring that important research can proceed without being slowed by administrative impediments. The prospect of change creates space to reckon with other ethical traditions and paradigms of accountability that might inform research regulation besides the reigning bioethical regime, which emphasizes autonomy and privacy. One such tradition, distinctly opposed to the current bioethics approach, stands out in the long history of the debate over research regulation and privacy protection.For more than a decade, professionals in history, journalism, the social sciences, and public health, which play essential roles in protecting the public from threats of disease and corporate and government misconduct, have argued that the purpose of scientific inquiry is to benefit society as a whole, even sometimes at the expense of individual interests. In debates over the mandate of institutional review boards, researchers in these fields have striven not simply to emancipate important nonmedical research from unnecessary fetters, but to underline an inherent tension between deeply conflicting paradigms of accountability in which very different conceptions of who and what require protection are at stake. We lay out 4 brief histories that bear on nonclinical research regulation and the arguments against it, focusing on fields that most forcefully resisted regulation by articulating a fundamentally different vision of accountability. Before turning to those specific cases, we lay out the broad backdrop against which the debates have unfolded.Following the Nuremberg Code of 1947, the principle of informed consent became the cardinal ethic for scientific research involving human participants. US federal regulations to prevent harm to individual research participants first arose in response to a series of exposés on shocking medical experiments in newspapers and medical journals, culminating in the 1972 revelations about the 40-year-long Tuskegee Syphilis Study. A new system of institutionally based ethical review intended to ensure the safety and voluntary consent of research participants was created.Initially, epidemiologists and social scientists grew alarmed that the new, individual rights–based bioethical framework that provided the moral architecture of the regulatory schema might make their research more difficult or even impossible to conduct. Some closure on these issues was reached in 1981, when social science and epidemiological research was explicitly exempted from institutional review board review if the risk to participants and their privacy was minimal. But before the 20th century closed, for many scholars the promise of streamlined oversight would be transformed into a stultifying specter, hovering over all scientific inquiry, no longer constrained within the boundaries of medicine.In the 1990s, activities that had long remained relatively free from ethical oversight began to be subjected to scrutiny following a spate of research-related incidents at high-profile institutions,5 including the death of an 18-year-old experimental gene therapy patient at the University of Pennsylvania in 1999.6 Federal regulators responded by cracking down, and risk-averse institutions began to apply conventional bioethical human participant protections with new muscle, suppressing alternative discourses, such as those that championed the common good, that struggled to resist such “ethical imperialism.”7 Yet even as the grip of bioethics as a regulatory regime tightened, it quickly became apparent that it was the wrong framework of accountability for some domains of inquiry.It was within this context that debates over research in different disciplines unfolded. For example, when in the early 1990s regulators sought to treat public health surveillance—the often compulsory reporting of the names of individuals diagnosed with certain infectious and chronic diseases by physicians and laboratories to city and state health departments—as research requiring federal ethical oversight, health officials countered that effective surveillance depended on universal reporting of names; it could not depend on informed consent. Such data collection was required by law, and the law reflected the will of the people.8 This was an old argument. As early as 1891, in the face of physician resistance to reporting, health officials argued that surveillance was based on a “contract.”9 It amounted to a public duty in which “the people had consented” in the name of the common good to what might otherwise seem like an “arbitrary” or even “authoritarian” regime.10 Surveillance could demand limitations not only of privacy but even of liberty if the disease in question required mandatory treatment or isolation.11 At stake were questions of what individuals in a civil society owed to one another.12Practitioners of quality assurance in health care, which involves the assessment of medical records to determine the adequacy of care, voiced similar arguments half a century later. The field of quality assurance originated in the 1960s as a response to poor clinical outcomes,13 and became one of the hallmarks of the provision of health care services under Medicare and Medicaid—two of the signature social welfare programs of President Lyndon Baines Johnson’s Great Society.14 By the 1990s, “quality improvement,” which originated as a proactive technique for regulating and improving the delivery of medical care, had become a “positive” watchword of a new era.15Beginning in 2000, after federal regulators received a complaint suggesting that a quality improvement study conducted among dialysis patients should have been classified as research,16 demand for bioethical review of all quality assurance activities escalated.17 But when federal panels began to develop recommendations for determining when quality assurance required ethical oversight,18 administrators at the Centers for Medicare and Medicaid Services resisted.19 “Fiduciary responsibility” served as their lodestar.20 Justified by the need to conserve taxpayer dollars while improving clinical outcomes, at the heart of their claim was an ethos similar to that of public health: those charged with administering the social welfare system bore a public duty to protect the interests of populations, not the rights of individuals.Giving full voice to this public-spirited paradigm were historians, journalists, and others engaged in social science inquiry, who argued that the purpose of research, at its best, was to illuminate critical social and political issues. The primary obligation was ensuring the public’s right to know. “Our job is to hold people accountable,” argued Columbia University historian Alice Kessler-Harris.21 Her point was that the primary commitment of historians was to the unfettered development of knowledge through historical interpretation—not to individual subjects who emerged as the subjects of inquiry. Historians viewed their research not through the lens of bioethics but as serving the “common good” and “vital to democratic debate and civic life.”22 They rested their claims on the centrality of freedom of speech.23 History’s villains could not be allowed to hide behind the regulations governing the protection of human participants.History also served the powerless. So much of social science research had sought to ensure that the perspectives of the socially and politically marginal—former slaves, women, the poor—came to light. Exposure in this context took on a different hue. Whether acting as watchdogs or giving voice to the voiceless, researchers drew on the Constitution for authority. “Simply put,” commented the University of Buffalo’s Michael Frisch, “the core purpose of oral history is to put named people into the historical record—not mask or anonymize them.”24Debate in the 1990s over medical privacy also provided occasion for making the case for the public good. President Bill Clinton’s 1993 proposal for universal health coverage, which raised the prospect of the centralized, computer-based management of medical care, sparked early calls to protect medical privacy. When the Clinton proposal failed, privacy concerns were taken up by Congress as part of HIPAA. From the outset, Congress envisioned shielding public health data from privacy regulations: health departments would not need consent to acquire and share personally identifiable information for the purpose of safeguarding the public’s health. As enacted, the DHHS Privacy Rule (45 CFR Part 160 and Subparts A and E of Part 164) contained what is known as a public health “carve-out.” Privacy advocates did not resist this exemption, and disease advocacy groups strongly supported it.25 The March of Dimes, for instance, noted that

While the individual has an interest in maintaining the privacy of his or her health information, public health authorities have an interest in the overall health and well being of the entire population.26

Thus, although the 2003 HIPAA Privacy Rule significantly enhanced medical privacy, it also formalized the notion that privacy rights are not always sacrosanct.As we debate the protections that must be in place for research participants today, it is essential to acknowledge the difference between social science inquiry and research performed in clinical settings. It goes without question that research with the potential to harm participants must be monitored by third parties. But blanket regulations designed to protect powerless clinical research participants may also inadvertently protect the powerful from necessary social and political scrutiny on the part of investigators in fields that define their mission in terms of the common good. This is not to say that a claim for the common good is always sufficient to justify a release from regulation.27 Our point, rather, is to emphasize that there is an important ethical framework, with a deep and varied history, that has justified affirmative duties to limit rights in the name of public interests.We agree that the time has come to recognize that social inquiry in areas like history, public health, and quality assurance requires an alternative framework of analysis. Yet we cannot let an obsession with rules allow us to overlook the fact that scientific research is guided by a number of different ethical frameworks that do not always agree. Bioethics asserts that individual rights such as privacy require protection; many other frameworks demand that we look past the individual and prioritize the common good. By embracing a new approach for research in public interest domains, the proposed changes implicitly acknowledge this tension. Indeed, there will always be issues where distinct paradigms hewing to different priorities collide. So although the ongoing debate over changes to ethical oversight procedures may resolve certain conflicts, it also sets the stage for the enduring contest between different paradigms of accountability.     

Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia

Public health interventions usually operate at the level of groups rather than individuals, and cluster randomized controlled trials (RCTs) are one means of evaluating their effectiveness. Using examples from six such trials in Bangladesh, India, Malawi and Nepal, we discuss our experience of the ethical issues that arise in their conduct. We set cluster RCTs in the broader context of public health research, highlighting debates about the need to reconcile individual autonomy with the common good and about the ethics of public health research in low-income settings in general. After a brief introduction to cluster RCTs, we discuss particular challenges we have faced. These include the nature of – and responsibility for – group consent, and the need for consent by individuals within groups to intervention and data collection. We discuss the timing of consent in relation to the implementation of public health strategies, and the problem of securing ethical review and approval in a complex domain. Finally, we consider the debate about benefits to control groups and the standard of care that they should receive, and the issue of post-trial adoption of the intervention under test.     

Integrating evolutionary aspects into dual-use discussion: the cases of influenza virus and enterohemorrhagic Escherichia coli

Research in infection biology aims to understand the complex nature of host–pathogen interactions. While this knowledge facilitates strategies for preventing and treating diseases, it can also be intentionally misused to cause harm. Such dual-use risk is potentially high for highly pathogenic microbes such as Risk Group-3 (RG3) bacteria and RG4 viruses, which could be used in bioterrorism attacks. However, other pathogens such as influenza virus (IV) and enterohemorrhagic Escherichia coli (EHEC), usually classified as RG2 pathogens, also demonstrate high dual-use risk. As the currently approved therapeutics against these pathogens are not satisfactorily effective, previous outbreaks of these pathogens caused enormous public fear, media attention and economic burden. In this interdisciplinary review, we summarize the current perspectives of dual-use research on IV and EHEC, and further highlight the dual-use risk associated with evolutionary experiments with these infectious pathogens. We support the need to carry out experiments pertaining to pathogen evolution, including to gain predictive insights on their evolutionary trajectories, which cannot be otherwise achieved with stand-alone theoretical models and epidemiological data. However, we also advocate for increased awareness and assessment strategies to better quantify the risks-versus-benefits associated with such evolutionary experiments. In addition to building public trust in dual-use research, we propose that these approaches can be extended to other pathogens currently classified as low risk, but bearing high dual-use potential, given the particular pressing nature of their rapid evolutionary potential.     

Qualitative science policy

Qualitative research struggles against a tide of quantitative methods. To assist in this struggle, it is useful to consider the historical and philosophical origins of quantitative methods as well as criticisms that have been raised against them. Although these criticisms have often been restricted to discussions in the philosophy of science, they have become increasingly prominent in debates regarding science policy. This article thus reviews current science policy debates concerning scientific autonomy and the linear model of science-society relationships. Then, having considered the multiple meanings of quality, it argues for a science policy reassessment of quantitative research, for deeper engagements between science policy and the social sciences, and finally, for a more explicit alliance between science policy and qualitative methods.     

Is my mum going to hear this? Methodological and ethical challenges in qualitative health research with young people

Ethical issues arise in all research settings. However, qualitative research with young people raises specific dilemmas that warrant special attention. In this paper we describe an ethical dilemma that arose during a qualitative project we carried out exploring self-management of chronic illness in adolescents. A participant disclosed details of poor adherence with medication, which had significant health implications. Prior to this disclosure he had been assured of confidentiality and thus we found ourselves unsure of how to proceed. Here, we analyse the case in detail, highlighting the ethically important moments, the options for action and the implications of these. We do this with the aim of facilitating ethical mindfulness and thus, ultimately, ethical research practice. As a backdrop to this case we consider the broader ethical context. We find that qualitative research is susceptible to ethical dilemmas because: (1) it is not always possible to predict all possible questions and responses; (2) the nature of the relationship between researchers and participants is amenable to sensitive disclosures; (3) the process of qualitative research can make it difficult for participants to voice concerns or withdraw; and (4) participants' identities are generally known to researchers, complicating boundary issues. Research with young people is susceptible to ethical dilemmas because: (1) young people have limited life experience; (2) consent is often required from both young people and parents; (3) issues of competence can complicate assumptions about informed consent; and (4) the power differential between researchers and participants is significant. When combining qualitative research methods and young participants, the scope for ethical risk is thus substantial.     

Hyped biomedical science or uncritical reporting? Press coverage of genomics (1992-2001) in Québec

Genomics integrates the promises and perils of modern biomedical science. Canada and the province of Québec embarked late but aggressively in genomics research based on the 'discourse of promise' in which genomics is embedded. This did not prevent the emergence of a 'discourse of concerns', and debates on the wider meaning of genomics and on the risks related to genomics applications such as gene therapy and gene testing. Given this context, this study aims to understand the evolution of genomics press coverage from the early days up to the publication of the draft sequence of the human genome. Accordingly, we performed a press content analysis on 749 articles reporting genomics research in Québec from 1992 to 2001. We focused on coverage of benefits and ethical issues, tone, and differences in reporting practices between press agencies and journalists. Results show an increasing number of articles, a general decline in the proportion of articles featuring ethical issues, an increased focus on the economy, and greater optimism from 1992 to 2001. In comparison to articles written by journalists, articles signed by press agencies are more optimistic and less often feature ethical issues. Results are discussed following two non-exclusive interpretations: (1) the successes of genomics and its institutionalization in Québec and Canada brought hype and greater social acceptance, and (2) uncritical reporting practices have emerged under pressures for expedient and consumable writing. We are left with two concerns: given worldwide media concentration movements, what are the challenges for the dissemination of diversified and critical information in print media? And, given limited coverage of ethical issues, and concerns about bioethics being too narrowly focused, should public debates on frontier biomedical science be promoted to broaden the scope of biomedical ethics?     

A consideration of the ethics of brain death--what are the ethical guidelines for physician, family and society in dealing with brain death?

There is at present considerable confusion with respect to ethical guidelines that should govern the behavior of society and the physician confronted by problems resulting from recent attainments of medicine and science. The use of life supporting devices raises the problem of determining when death has occurred and what is proper ethical procedure in dealing with the deficient half life caused by "Brain Death." Some guidance is obtained from a consideration of the nature of life, the nature of death, the nature of man, and the essence lost in death of man. A parallel consideration of the nature of ethics, the bases of ethics and of ethical decision can be helpful. An individual may have ideals which control behavior, even elevate ethical standards; others entertain concepts that destroy social ethics. Ethics control and direct social interactions; ethics determine the quality of social behavior--ethics are established by societies not by individuals. Numerous commissions have endeavored to define the requirements of physicians for diagnosing brain death and for appropriate subsequent actions. The rationales presented, however, are not invariably accepted by lay society. The problem is created by numerous trends. Among them are the "rightest" movement which, though possessing many virtues, has its excesses such as expressed in the "right to life movement." These have not been beneficial and have necessitated "right to death movements." Opposition is also due to the fact that society's concepts of the medical profession have changed. The practice of organ transplantation has created problems. Finally, the concept of death as other than evil is no longer generally accepted. As more biological manipulations are possible ever more difficult ethical problems will arise. It is a certainty, however, that when brain death has occurred life of man and that of the individual has ended. Although others might not agree, our ethic requires us to use life assist techniques to preserve the vegetative man, the individual who can still breathe spontaneously though lacking consciousness and behavioral ability. All the codes of medical ethics state that a physician shall not kill--this does not mean he cannot permit the terminal phases of death when the essence of human life is lost. A major question is the ethical responsibility of one society toward another. Can an affluent society squander its resources in the preservation of ineffectual life in the body after "brain death" when others are without the medical assistance which would permit total living?     

Ethics and the ethnography of medical research in Africa

The ethics of medical research have grown as an area of expertise and debate in recent years, with two broad approaches emerging in relation to transnational research: (1) the refinement of guidelines and strengthening of review, processes primarily to protect the right of individual research participants and strengthen interpersonal relations at the micro-level; and (2) considering more centrally, as crucial ethical concerns, the wider interests of whole populations, the functioning of research institutions, the processes of collaboration, and the ethics of inequitable international relations. We see the two areas of debate and action as complementary, and believe that social science conducted in and around transnational medical research environments can bring these two perspectives together in a more 'situated ethics' of research. To explore this idea for medical research in Africa, we organized a conference in December 2005 in Kilifi, Kenya. In this introduction we outline the two emerging approaches to medical ethics, summarise each of seven papers selected from the conference for inclusion in this special issue on ethics and ethnography, and finally highlight two areas of lively debate at the conference itself: the appropriateness and value of ethics guidelines and review boards for medical research; and the ethical review of social science research. Together, the papers and debates point to the importance of focusing on the ethics of relationships and on justice in both biomedicine and social science research, and on giving greater voice and visibility to the field staff who often play a crucial and under-supported role in 'doing ethics' in the field. They also point to the potential value of social science research on the range of relationships operating at different levels and time scales in medical research, including those surrounding community engagement activities, and the role and functioning of ethics review boards. We conclude by highlighting the ethical priority of capacity strengthening in medical research, social science and research ethics in Africa to ensure that local and national priorities and concerns are considered at both the micro and macro levels.     

Ethics and Childhood Vaccination Policy in the United States

Childhood immunization involves a balance between parents’ autonomy in deciding whether to immunize their children and the benefits to public health from mandating vaccines. Ethical concerns about pediatric vaccination span several public health domains, including those of policymakers, clinicians, and other professionals.In light of ongoing developments and debates, we discuss several key ethical issues concerning childhood immunization in the United States and describe how they affect policy development and clinical practice. We focus on ethical considerations pertaining to herd immunity as a community good, vaccine communication, dismissal of vaccine-refusing families from practice, and vaccine mandates.Clinicians and policymakers need to consider the nature and timing of vaccine-related discussions and invoke deliberative approaches to policymaking.Following the December 2014 measles outbreak at a popular amusement park in California,1,2 which spread to other states, Canada, and Mexico, there has been increased attention to US childhood immunization practices. A recent study attributed the outbreak to underimmunization,3 and several policymakers have called for an end to religious and philosophical (i.e., personal-belief) exemptions altogether, with the state of California passing legislation removing the option of personal-belief exemptions.4,5 Political candidates have expressed various viewpoints on vaccination.6 In light of these developments, we discuss several key ethical issues concerning childhood immunization in the United States and describe how they affect policy development and clinical practice. There are a myriad of ethical issues regarding such topics as vaccination development, administration, communication, and safety monitoring. We focus on a few key ethical issues concerning childhood immunization in the United States—what we refer to as a “vaccine ethics” approach—and describe how such an approach affects policy development and clinical immunization practice.     

From global bioethics to ethical governance of biomedical research collaborations

One of the features of advanced life sciences research in recent years has been its internationalisation, with countries such as China and South Korea considered ‘emerging biotech’ locations. As a result, cross-continental collaborations are becoming common generating moves towards ethical and legal standardisation under the rubric of ‘global bioethics’. Such a ‘global’, ‘Western’ or ‘universal’ bioethics has in turn been critiqued as an imposition upon resource-poor, non-Western or local medical settings. In this article, we propose that a different tack is necessary if we are to come to grips with the ethical challenges that inter-continental biomedical research collaborations generate. In particular we ask how national systems of ethical governance of life science research might cope with increasingly global research collaborations with a focus on Sino-European collaboration. We propose four ‘spheres’ – deliberation, regulation, oversight and interaction – as a helpful way to conceptualise national systems of ethical governance. Using a workshop-based mapping methodology (workshops held in Beijing, Shanghai, Changsha, Xian, Shenzen and London) we identified three specific ethical challenges arising from cross-continental research collaborations: (1) ambiguity as to which regulations are applicable; (2) lack of ethical review capacity not only among ethical review board members but also collaborating scientists; (3) already complex, researcher-research subject interaction is further complicated when many nationalities are involved.     

Operating from different premises: the ethics of inter‐disciplinarity in health promotion

The intersectoral and interdisciplinary nature of health promotion gives rise to ethical questions. This is because health promotion depends upon alliances between people who often have different perspectives on what matters in particular cases or different visions of the good society. This paper draws on the ambivalent relationship that health promoters can have with biomedicine to illustrate and explore the nature of these ethical questions. Examples from everyday life are used to underline the familiar nature of the kinds of coalitions and compromises that are needed to work alongside others with different values to oneself. It is suggested that analogous kinds of compromise are needed in health promotion and that this requires a form of ‘diplomatic ethics' for health promoters that, in turn, raises questions about their ethical integrity.     

Therapeutic Misconception: Hope,Trust and Misconception in Paediatric Research

Although the therapeutic misconception (TM) has been well described over a period of approximately 20 years, there has been disagreement about its implications for informed consent to research. In this paper we review some of the history and debate over the ethical implications of TM but also bring a new perspective to those debates. Drawing upon our experience of working in the context of translational research for rare childhood diseases such as Duchenne muscular dystrophy, we consider the ethical and legal implications of the TM for parental consent to research. In this situation, it is potentially the parent who is vulnerable to TM. In our analysis we not only consider the context of informed consent for research but also the wider environment in which the value of research is promoted, more broadly through the media but also more specifically through the communication strategies of patient organizations. All dissemination about developments in research for health runs the risk of portraying an overly optimistic view of the promise of biotechnological solutions and has the potential to encourage a ‘collective’ TM. In this paper we consider the challenge that TM presents to parents as well as explore the ethical and legal responsibilities of researchers to ensure an appropriately informed consent: compatible with a hopeful disposition of parents who consent for the their children whilst avoiding a blind and misleading optimism.     

The use of routinely collected patient data for research: a critical review

Over recent years in the UK there has been growing interest in the potential for routinely collected NHS (National Health Service) patient data to be used for secondary purposes, facilitated by the potential of increasingly sophisticated electronic databases. This article is based on a critically reflective literature review which analyses the key debates pertaining to this issue. The work arose in the context of a programme of research concerning routine patient data use in neonatal care. The article includes analysis of commentary (opinion and ethical inquiry) as well as empirically derived claims. It aims to deconstruct the knowledge assumptions on which relevant research studies have been based or are proposed and it also incorporates ontological position and moral argument. Results are presented according to three predominant debates: the prevailing claim that all health research benefits civic society; the varieties of informed consent and choices open to patients regarding secondary uses of their data; and the 'rights and responsibilities' of patients when it comes to their data being used for research purposes. It examines the relevance of these themes specifically to the neonatal context and the implications for our own research, concluding that employing an alternative ethical model to the traditional professional one might be useful in order to provide a further perspective on the issue.     

From Subject to Participant: Ethics and the Evolving Role of Community in Health Research

Belmont Report principles focus on the well-being of the research subject, yet community-engaged investigators often eschew the role of subject for that of participant. We conducted semistructured interviews with 29 community and academic investigators working on 10 community-engaged studies. Interviews elicited perspectives on ethical priorities and ethical challenges. Interviewees drew on the Belmont Report to describe 4 key principles of ethical community-engaged research (embodying ethical action, respecting participants, generalizing beneficence, and negotiating justice). However, novel aspects of the participant role were the source of most ethical challenges. We theorize that the shift in ethical focus from subject to participant will pose new ethical dilemmas for community-engaged investigators and for other constituents interested in increasing community involvement in health research.Patients, family members, health advocates, and health care agency leaders play substantially different roles in health services and public health research than they did just a few decades ago.1–3 Many major US health research funders today expect community involvement in research design, execution, or dissemination.4–7 For instance, engaging communities in research is a key goal of the National Center for Advancing Translational Science at the National Institutes of Health. The Patient-Centered Outcomes Research Institute prioritizes patient involvement in the development, governance, oversight, and dissemination of research.8 A report the Agency for Healthcare Research and Quality commissioned found that

stakeholder involvement . . . helps ensure that [Agency for Healthcare Research and Quality research] responds to relevant and important issues, . . . develops products that are accessible and user-friendly, and . . . ultimately reaches its intended audiences.9^(pi)

On the whole, community-engaged research asks community members with lived experience of the health problem under study—or with responsibility for populations with this lived experience (e.g., community-based agencies, advocates, payers)—to participate in planning, designing, conducting, interpreting, or disseminating research. Community engagement in research can take numerous forms, from limited advisory roles in early stages (e.g., input on research priorities) to key leadership responsibilities at every stage, as in community-based participatory research.10–13 Consensus-building activities, shared control of data, and long-term partnerships can be key elements of community-engaged projects. These research approaches reflect the growing prominence of patient advocacy groups and the concept of participatory science.1,14,15Until the latter decades of the 20th century, community members primarily participated in research as subjects. Indeed, the construction of the role of the research subject is inextricable from the historical development of the human sciences generally and health research specifically.16–19 Researchers defined the research situation with reference to 3 aspects of the subject role. First, the role of the subject is context dependent: an individual becomes a subject by consenting to provide data for a specific study (e.g., in a particular laboratory). Second, the role of the subject is task focused: it centers on completing activities that generate data, such as giving biological samples or completing tests. Third, the role of the subject is time limited: once data collection is complete, the subject role ends, as does, typically, the researcher’s relationship with the individual.Once specified, the subject position allowed researchers to elaborate and refine key intellectual assumptions about research rigor, reliability, and validity. Among these were that one can generalize from data on individuals (e.g., those with particular diseases) to larger populations (e.g., others with the same disease); that an individual can be studied in isolation from social context; and that abstract attributes (e.g., intelligence, conscientiousness) can be reliably measured in artificial experimental settings.The specification of the subject role also structured the concept of research ethics codified in the Belmont Report. The distinction between researcher and subject set the stage for “trust-based obligations” that are the foundation for what we understand as research ethics20^(p542) with the “protection of human subjects” as a core ethical goal.21^(p5) The experimental situation should maximize benefits and reduce risks to subjects as much as possible (the Belmont Report’s basic ethical principle of beneficence),22 individuals should participate voluntarily (principle of respect for persons), and risks and benefits to potential research subjects should be fairly distributed (principle of justice).To preserve the voluntarism at the heart of this relationship, both parties should expect the experiment to generate useful knowledge that could not be otherwise obtained,23 and they should expect this knowledge to be free of fabrication and falsehood.24 Institutional review boards (IRBs) assess whether subjects are adequately protected and insist on extra protections for those from vulnerable groups who may experience unusual constraints on voluntary decision-making or who may be less likely to receive the research benefits.25By contrast, community-engaged investigators enlist individuals in research as participants, advocating a transformation “from regarding individual community members as research subjects to engaging community members and the organizations that represent them as research partners.”10^(p1) Community-engaged investigators prefer the participant role because it “increases the possibility of overcoming the understandable distrust of research on the part of communities that have historically been the ‘subjects’ of such research.”26^(p181)To community-engaged investigators, words like “subject” and “researcher” can signal exploitation rather than ethical protection because the subject role is seen to require passive acquiescence to others’ agendas.27,28 Community-engaged investigators also eschew the sharp distinction between subject and researcher and seek to minimize the distance between community and academic participants through the mutual exchange of knowledge and skills.29 Community-engaged research is understood to be “‘with’ [the] community . . . rather than ‘for’ [the] community.”28^(p321) Community-engaged research participants may include enrolled individuals, research partners, social and constituent groups, funders and payers, study site staff, and others with some stake in the project.Many investigators recognize the ethical implications of these new research relationships, but the theory and practice of ethical community-engaged research remain inchoate.30 Although community-engaged investigators accept the continued relevance of the 3 Belmont principles,31 they articulate novel ethical priorities30 and encounter new ethical challenges.32–34 Community-engaged investigators have developed innovative approaches to support ethical conduct,35 yet investigators’ opinions about ethical priorities can vary.36 Although many investigators view community engagement as a means for achieving ethical ends,30 the field lacks objective criteria and shared guidelines for implementing ethical practices in community-engaged research.37 Conceptualizing ethics in community-engaged research is important for developing normative guidelines, educating investigators, and monitoring research conduct.38,39We used interview data from community and academic investigators working on community-engaged projects to describe the ethical priorities and dilemmas in community-engaged research. We compared projects to outline 4 principles of ethical community-engaged research and to advance theory that accounts for common ethical challenges. We have shown that most ethical challenges emerge as a result of the collapse of the subject position.Community-engaged investigators’ ethical focus on the participant—a role that is less time limited, setting dependent, and task focused than is that of the subject—raises ethical dilemmas that resist resolution through traditional ethical frameworks. By directing attention to this shift from subject to participant, we characterize sources of ethical challenge, propose strategies that can support ethics in research engaging community members, and raise a set of fundamental questions for further study.