This essay will address the ethical issues that have emerged in the first considerations of the newly emerging stem cell technology. Many of us in the field of bioethics were deliberating related issues as we first learned of the new science and confronted the ethical issues it raised. In this essay, I will draw on the work of colleagues who were asked to reflect on early stages of the research (members of the IRBs, the Geron Ethicist Advisory (...) class='Hi'>Board, and the National Bioethics Advisory Commission) as the field debated the issues of consent, moral status, use of animal tissues, abortion, use of fetal tissue, and the nature and goals of entrepreneurial research. In this new capacity, ethicists weighed the problem of privacy, the role of justice considerations, and the issues of the marketplace in science. At this point, it is clear that far more issues remain unresolved than are settled, that there is largely unexplored territory ahead, and that the single most important task that faces us as a field is a steady call for ongoing conversation and public debate. (shrink)

Background Community advisory boards have expanded beyond high-income countries and play an increasing role in low- and middle-income country research. Much research has examined CABs in HICs, but less is known about CABs in LMICs. The purposes of this scoping review are to examine the creation and implementation of CABs in LMICs, including identifying frequently reported challenges, and to discuss implications for research ethics. Methods We searched five databases for publications describing or evaluating CABs in LMICs. Two researchers (...) independently reviewed articles for inclusion. Data related to the following aspects of CABs were extracted from included publications: time, country, financial support, research focus, responsibilities, and challenges. Thematic analyses were used to summarize textual data describing challenges. Results Our search yielded 2005 citations, 83 of which were deemed eligible for inclusion. Most studies were published between 2010 and 2017. Upper-middle-income countries were more likely to have studies describing CABs, with South Africa, China, and Thailand having the greatest numbers. The United States National Institutes of Health was the main source of financial support for CABs. Many CABs focused on HIV research. Thirty-four studies reported how CABs influenced the informed consent process for clinical trials or other aspects of research ethics. CAB responsibilities were related to clinical trials, including reviewing study protocols, educating local communities about research activities, and promoting the ethical conduct of research. Challenges faced by CABs included the following: incomplete ethical regulations and guidance; limited knowledge of science among members of communities and CABs; unstable and unbalanced power relationships between researchers and local communities; poor CAB management, including lack of formal participation structures and absence of CAB leadership; competing demands for time that limited participation in CAB activities; and language barriers between research staff and community members. Several challenges reflected shortcomings within the research team. Conclusions Our findings examine the formation and implementation of CABs in LMICs and identify several ethical challenges. These findings suggest the need for further ethics training among CAB members and researchers in LMICs. (shrink)

BackgroundThe use of a Community Advisory Board is one method of ensuring community engagement in community based research. To identify the process used to constitute CABs in Zambia, this paper draws on the perspectives of both research team members and CAB members from research groups who used CABs in Lusaka. Enabling and restricting factors impacting on the functioning of the CAB were identified.MethodsAll studies approved by the University of Zambia Bioethics Research Committee from 2008 – 2012 were reviewed (...) to identify those studies that were likely to include a CAB. Eight teams with studies that included a CAB were identified. For each of these studies, consent was obtained to conduct an informal interview with a research team member and to obtain contact details for one CAB member. In total 14 interviews were conducted with 8 research team members and 6 CAB members from 12–30 August 2013.ResultsIdentification of potential CAB members from the community and their participation in developing the terms of reference for CABs was perceived to have contributed to the success of the CAB. Due to the trust that the community had in members of their community the CABs were then in a stronger position to influence community participation in the research. Training of CAB members was identified as a factor that enhanced the functioning of a CAB. Lack of commitment and low literacy levels of CAB members posed a threat to the role of the CAB. Although compensation in the form of a stipend was not provided, CAB members were provided with transport reimbursements for attending meetings.ConclusionsSelection of CAB members from within the community contributed to community confidence in the CAB, enhancing its ability to act as an effective link between study team and community. This contributed positively to the conduct of the study and enhanced community awareness and acceptance of the research. However, establishment of study specific CABs has the potential to compromise CAB independence due to support provided by the research team in the form of transport reimbursements and other forms of support. Consideration should be given to establishing community wide Community Advisory Boards that could function across a range of studies to increase independent objective decision-making. (shrink)

BackgroundCommunity engagement is increasingly promoted as a marker of good, ethical practice in the context of international collaborative research in low-income countries. There is, however, no widely agreed definition of community engagement or of approaches adopted. Justifications given for its use also vary. Community engagement is, for example, variously seen to be of value in: the development of more effective and appropriate consent processes; improved understanding of the aims and forms of research; higher recruitment rates; the identification of important ethical (...) issues; the building of better relationships between the community and researchers; the obtaining of community permission to approach potential research participants; and, the provision of better health care. Despite these diverse and potentially competing claims made for the importance of community engagement, there is very little published evidence on effective models of engagement or their evaluation.MethodsIn this paper, drawing upon interviews with the members of a Community Advisory Board on the Thai-Myanmar border, we describe and critically reflect upon an approach to community engagement which was developed in the context of international collaborative research in the border region.Results and conclusionsDrawing on our analysis, we identify a number of considerations relevant to the development of an approach to evaluating community engagement in this complex research setting. The paper also identifies a range of important ways in which the Community Advisory Board is in practice understood by its members to have morally significant roles and responsibilities beyond those usually associated with the successful and appropriate conduct of research. (shrink)

It has been suggested that community advisory boards can play a role in minimising exploitation in international research. To get a better idea of what this requires and whether it might be achievable, the paper first describes core elements that we suggest must be in place for a CAB to reduce the potential for exploitation. The paper then examines a CAB established by the Shoklo Malaria Research Unit under conditions common in resource-poor settings – namely, where individuals join with (...) a very limited understanding of disease and medical research and where an existing organisational structure is not relied upon to serve as the CAB. Using the Tak Province Border Community Ethics Advisory Board as a case study, we assess the extent to which it might be able to take on a role minimising exploitation were it to decide to do so. We investigate whether, after two years in operation, T-CAB is capable of assessing clinical trials for exploitative features and addressing those found to have them. The findings show that, although T-CAB members have gained knowledge and developed capacities that are foundational for one-day taking on a role to reduce exploitation, their ability to critically evaluate studies for the presence of exploitative elements has not yet been strongly demonstrated. In light of this example, we argue that CABs may not be able to perform such a role for a number of years after initial formation, making it an unsuitable responsibility for many short-term CABs. (shrink)

BackgroundCommunity Advisory Boards (CAB) have become essential organs of involving communities in HIV clinical trials especially in developing countries. However, limited empirical evidence exists on the role of CABs in low and middle-income countries including Tanzania. This study aims at exploring the role of CABs in community-based HIV clinical trials conducted in Tanzania.MethodologyWe adopted a phenomenological approach to purposefully select HIV clinical trial stakeholders. These included CAB members, researchers and Institutional Review Board (IRB) members in Tanzania. We conducted (...) In-depth Interviews (IDIs) with ten participants and three Focus Group Discussions (FGDs) with eighteen participants. The data were thematically analyzed with the aid of MAXQDA software version 20.2.1.ResultsThe findings indicate that at every stage of implementation of a community-based HIV clinical trial, a functioning CAB is important for its success. This importance is based on contextualization of the informed consent process and protocol, managing rumours in the community, weighing trial risks and benefits, sensitizing the community, assisting participant recruitment, tracing and retention. However, being perceived as financial beneficiaries than community representatives emerged as a challenge to CAB members. ConclusionThe study empirically indicates the need for functioning CABs in every stage of implementation of community-based HIV clinical trials. The roles of which are interwoven in serving research goals and protecting the interests of the community and that of trial participants. (shrink)

Engaging communities in community-based health research is increasingly being adopted in low- and middle-income countries. The use of community advisory boards is one method of practicing community involvement in health research. To date, few studies provide in-depth accounts of the strategies that CAB members use to practice community engagement. We assessed the perspectives, experiences and practices of the first local CAB in Eswatini, which was implemented as part of the MaxART Early Access to ART for All study. Trained Swazi (...) research assistants conducted two focus group discussions and 13 semi-structured interviews with CAB members who had been part of the MaxART study for at least 2.5 years. Interviews explored CAB composition and recruitment, the activities of CAB members, the mechanisms used to engage with communities and the challenges they faced in their role. The MaxART CAB played an active role in the implementation of the Early Access to Art for All study, and activities mainly focused on: promoting ethical conduct, in particular privacy, consent and confidentiality; communication and education, communicating about the study and educating the community on the benefits of HIV testing and early access to HIV treatment; and liaising between the community and the research team. Strategies for interacting with communities were varied and included attending general community meetings, visiting health facilities and visiting public places such as cattle dipping tanks, buses, bars and churches. Differences in the approach to community engagement between CAB members living in the study areas and those residing outside were identified. The experiences of the first CAB in Eswatini demonstrate that community engagement using CABs is a valuable mechanism for engaging communities in implementation studies. Considerations that could impact CAB functioning include clearly defining the scope of the CAB, addressing issues of CAB independence, the CAB budget, providing emotional support for CAB members, and providing continuous training and capacity building. These issues should be addressed during the early stages of CAB formation in order to optimize functioning. (shrink)

Engaging communities in community-based health research is increasingly being adopted in low- and middle-income countries. The use of community advisory boards is one method of practicing community involvement in health research. To date, few studies provide in-depth accounts of the strategies that CAB members use to practice community engagement. We assessed the perspectives, experiences and practices of the first local CAB in Eswatini, which was implemented as part of the MaxART Early Access to ART for All study. Trained Swazi (...) research assistants conducted two focus group discussions and 13 semi-structured interviews with CAB members who had been part of the MaxART study for at least 2.5 years. Interviews explored CAB composition and recruitment, the activities of CAB members, the mechanisms used to engage with communities and the challenges they faced in their role. The MaxART CAB played an active role in the implementation of the Early Access to Art for All study, and activities mainly focused on: promoting ethical conduct, in particular privacy, consent and confidentiality; communication and education, communicating about the study and educating the community on the benefits of HIV testing and early access to HIV treatment; and liaising between the community and the research team. Strategies for interacting with communities were varied and included attending general community meetings, visiting health facilities and visiting public places such as cattle dipping tanks, buses, bars and churches. Differences in the approach to community engagement between CAB members living in the study areas and those residing outside were identified. The experiences of the first CAB in Eswatini demonstrate that community engagement using CABs is a valuable mechanism for engaging communities in implementation studies. Considerations that could impact CAB functioning include clearly defining the scope of the CAB, addressing issues of CAB independence, the CAB budget, providing emotional support for CAB members, and providing continuous training and capacity building. These issues should be addressed during the early stages of CAB formation in order to optimize functioning. (shrink)

Community engagement is increasingly promoted as a marker of good, ethical practice in the context of international collaborative research in low-income countries. There is, however, no widely agreed definition of community engagement or of approaches adopted. Justifications given for its use also vary. Community engagement is, for example, variously seen to be of value in: the development of more effective and appropriate consent processes; improved understanding of the aims and forms of research; higher recruitment rates; the identification of important ethical (...) issues; the building of better relationships between the community and researchers; the obtaining of community permission to approach potential research participants; and, the provision of better health care. Despite these diverse and potentially competing claims made for the importance of community engagement, there is very little published evidence on effective models of engagement or their evaluation. (shrink)

The Hanford Advisory Board (HAB) is a broadly representative, deliberative body that provides formal policy advice on Department of Energy (DOE) proposals and decisions at the Hanford nuclear cleanup site near Richland, Washington. Despite considerable skepticism about the effectiveness of citizen advisory boards, we contend that the HAB offers promising institutional innovations. Drawing on our analysis of the HAB’s formal advice as well as our interviews with board members and agency officials, we explore the HAB’s unique (...) design, outline a normative framework for evaluating participatory institutions, and assess the HAB’s effectiveness in rendering the DOE accountable to the local public. (shrink)

BackgroundCommunity engagement within biomedical research is broadly defined as a collaborative relationship between a research team and a group of individuals targeted for research. A Community Advisory Board is one mechanism of engaging the community. Within genomics research CABs may be particularly relevant due to the potential implications of research findings drawn from individual participants on the larger communities they represent. Within such research, CABs seek to meet instrumental goals such as protecting research participants and their community from (...) research-related risks, as well as intrinsic goals such as promoting the respect of participants and their community. However, successful community engagement depends on the degree to which CABs legitimately represent and engage with communities targeted for research. Currently, there is little literature describing the use of CABs in genomics research taking place in developing countries, and even less in the field of genomics research relating to mental illness. The aim of this article is to describe and consider the contributions made by a researcher-driven, population-specific CAB in a genomics of schizophrenia research project taking place in South Africa, from the perspective of the research team.DiscussionFour broad discussion topics emerged during the CAB meetings namely: 1) informed consent procedures, 2) recruitment strategies, 3) patient illness beliefs and stigma experiences, and 4) specific ethical concerns relating to the project. The authors consider these discussions in terms of their contributions to instrumental and intrinsic goals of community engagement.SummaryThe CAB gave valuable input on the consent processes and materials, recruitment strategies and suggested ways of minimizing the potential for stigma and discrimination. All of these contributions were of an instrumental nature, and helped improve the way in which the research took place. In addition, and perhaps more importantly, the CAB made a unique and important contribution relating to intrinsic functions such as promoting the respect and dignity of research participants and their community. This was particularly evident in ensuring sensitivity and respect of the community’s traditional beliefs about schizophrenia and its treatment, and in this way promoting a respectful relationship between the research team and the participants. (shrink)

BackgroundCommunity engagement is a key component in health research. One of the ways health researchers ensure community engagement is through Community Advisory Boards (CABs). The capacity of CABs to properly perform their role in clinical research has not been well described in many resource limited settings. In this study, we assessed the capacity of CABs for effective community engagement in Uganda.MethodsWe conducted a cross sectional study with mixed methods. We used structured questionnaires and key informant interviews (KII) to collect (...) data from CAB members, trial investigators, and community liaison officers. For quantitative data, we used descriptive statistics while for qualitative data we used content analysis.ResultsSeventy three CAB members were interviewed using structured questionnaires; 58.9% males, median age 49 years (IQR 24–70), 71.2% had attained tertiary education, 42.5% never attended any research ethics training, only 26% had a training in human subject protection, 30.1% had training in health research, 50.7% never attended any training about the role of CABs, and 72.6% had no guidelines for their operation. On the qualitative aspect, 24 KIIs cited CAB members to have some skills and ability to understand and review study documents, offer guidance on community norms and expectations and give valuable feedback to the investigators. However, challenges like limited resources, lack of independence and guidelines, and knowledge gaps about research ethics were cited as hindrances of CABs capacity.ConclusionThough CABs have some capacity to perform their role in the Ugandan setting, their functionality is limited by lack of resources to facilitate their work, lack of independence, lack of guidelines for their operations and limited knowledge regarding issues of research ethics and protection of the rights of trial participants. (shrink)

In 2005 the new Governor of Puerto Rico appointed a panel of experts to evaluate the healthcare system of Puerto Rico and make recommendations. Among other things, the panel recommended the creation of an advisory board on bioethics for the commonwealth of Puerto Rico.

Advanced Cell Technology's Ethics Advisory Board has been called window dressing for a corporate marketing plan. But the scientists and managers have paid attention, and the lawyers have gone along.

The European Medical Information Framework project, funded through the IMI programme, has designed and implemented a federated platform to connect health data from a variety of sources across Europe, to facilitate large scale clinical and life sciences research. It enables approved users to analyse securely multiple, diverse, data via a single portal, thereby mediating research opportunities across a large quantity of research data. EMIF developed a code of practice to ensure the privacy protection of data subjects, protect the interests of (...) data sharing parties, comply with legislation and various organisational policies on data protection, uphold best practices in the protection of personal privacy and information governance, and eventually promote these best practices more widely. EMIF convened an Ethics Advisory Board, to provide feedback on its approach, platform, and the EcoP. The most important challenges the ECoP team faced were: how to define, control and monitor the purposes for which federated health data are used; the kinds of organisation that should be permitted to conduct permitted research; and how to monitor this. This manuscript explores those issues, offering the combined insights of the EAB and EMIF core ECoP team. For some issues, a consensus on how to approach them is proposed. For other issues, a singular approach may be premature but the challenges are summarised to help the community to debate the topic further. Arguably, the issues and their analyses have application beyond EMIF, to many research infrastructures connected to health data sources. (shrink)

This book is the first systematic, detailed treatment of the approaches to ethical issues taken by biotech and pharmaceutical companies. The application of genetic/genomic technologies raises a whole spectrum of ethical questions affecting global health that must be addressed. Topics covered in this comprehensive survey include considerations for bioprospecting in transgenics, genomics, drug discovery, and nutrigenomics, as well as how to improve stakeholder relations, design ethical clinical trials, avoid conflicts of interest, and establish ethics advisory boards. The expert (...) authors represent multiple disciplines including law, medicine, bioinformatics, pharmaceutics, business, and ethics. (shrink)

The pandemic significantly raised the stakes for the translation of bioethics insights into policy. The novelty, range and sheer quantity of the ethical problems that needed to be addressed urgently within public policy were unprecedented and required high‐bandwidth two‐way transfer of insights between academic bioethics and policy. Countries such as the United Kingdom, which do not have a National Ethics Committee, faced particular challenges in how to facilitate this. This paper takes as a case study the brief career of (...) the Ethics Advisory Board (EAB) for the NHS Covid‐19 App, which shows both the difficulty and the political complexity of policy‐relevant bioethics in a pandemic and how this was exacerbated by the transience and informality of the structures through which ethics advice was delivered. It analyses how and why, after EAB's demise, the Westminster government increasingly sought to either take its ethics advice in private or to evade ethical scrutiny of its policies altogether. In reflecting on EAB, and these later ethics advice contexts, the article provides a novel framework for analysing ethics advice within democracies, defining four idealised stances: the pure ethicist, the advocate, the ethics arbiter and the critical friend. (shrink)

EDITOR’S NOTE: Business Ethics Quarterly invited a number of scholars involved with BEQ over its first twenty years (especially in its early years, as editors or editorial board members) to offer their reflections on the past, present, and future of business ethics. The resulting comments, which appear below, are as diverse and eclectic as the group of scholars who have given their energies to BEQ over the years.

Background Intensive and critical care nurses need to demonstrate ethical sensitivity especially in recognizing and dealing with ethical dilemmas particularly as they often care for patients living with life-threatening conditions. Theories suggest that there is a convergence between nurses’ empathy and ethical sensitivity. Evidence in the literature indicates that nurses’ emotional, demographic, and work characteristics are associated with their level of empathy and ethical sensitivity. Aim To investigate the relationship between nurses’ empathy and ethical sensitivity, considering their emotional states (depression, (...) anxiety, and stress), demographic and work characteristics, and test an empirical model describing potential predictors of empathy (as a mediator) and ethical sensitivity using path analysis. Research design Using a cross-sectional design, the philosophical theory of care ethics and empathy was extended and adopted as a conceptual framework for this study and tested by path analysis. Participants and research context Data were collected from 347 intensive care nurses recruited by ten educational-medical hospitals in Iran using a questionnaire between February and March 2021. Ethical considerations The study was reviewed by the Ethical Advisory Board in Iran and conducted according to the Declaration of Helsinki. Findings Study participants demonstrated a mild level of stress, anxiety, and depression, alongside a relatively high level of empathy and ethical sensitivity. Nurses with good socioeconomic status had higher empathetic behavior with patients than those with weak status. Nurses aged over 40 who had received ethics training and had higher work experience were associated with higher ethical sensitivity compared to nurses under 20 years of age. Empathy directly affected ethical sensitivity; however, anxiety had an indirect effect on ethical sensitivity through empathy. Among demographic factors, age had a positive direct effect on ethical sensitivity. Conclusions Less anxiety and a high level of empathy contribute to higher levels of ethical sensitivity among intensive and critical care nurses. (shrink)

Background Institutional review board (IRB) expertise is necessarily limited by maintaining a manageable board size. IRBs are therefore permitted by regulation to rely on outside experts for review. However, little is known about whether, when, why, and how IRBs use outside experts.Methods We conducted a national survey of U.S. IRBs to characterize utilization of outside experts. Our study uses a descriptive, cross-sectional design to understand how IRBs engage with such experts and to identify areas where outside expertise is (...) most frequently requested.Results The survey response rate was 18.4%, with 55.4% of respondents reporting their institution’s IRB uses outside experts. Nearly all respondents who reported using outside experts indicated they do so less than once a month, but occasionally each year (95%). The most common method of identifying an outside expert was securing a previously known subject matter expert (83.3%). Most frequently, respondents sought consultation for scientific expertise not held by current members (69.6%). Almost all respondents whose IRBs had used outside experts reported an overall positive impact on the IRB review process (91.5%).Conclusions Just over half of the IRBs in our sample report use of outside experts; among them, outside experts were described as helpful, but their use was infrequent overall. Many IRBs report not relying on outside experts at all. This raises important questions about what type of engagement with outside experts should be viewed as optimal to promote the highest quality review. For example, few respondents sought assistance from a Community Advisory Board, which could address expertise gaps in community perspectives. Further exploration is needed to understand how to optimize IRB use of outside experts, including how to recognize when expertise is lacking, what barriers IRBs face in using outside experts, and perspectives on how outside expert review impacts IRB decision-making and review quality. (shrink)

Community engagement to protect and empower participating individuals and communities is an ethical requirement in research. There is however limited evidence on effectiveness or relevance of some of the approaches used to improve ethical practice. We conducted a study to understand the rationale, relevance and benefits of community engagement in health research. This paper draws from this wider study and focuses on factors that shaped Community Advisory Group members’ selection processes and functions in Malawi. A qualitative research design was (...) used; two participatory workshops were conducted with CAG members to understand their roles in research. Workshop findings were triangulated with insights from ethnographic field notes, key informant interviews with stakeholders, focus group discussions with community members and document reviews. Data were coded manually and thematic content analysis was used to identify main issues. Results have shown that democratic selection of CAG members presented challenges in both urban and rural settings. We also noted that CAG members perceived their role as a form of employment which potentially led to ineffective representation of community interests. We conclude that democratic voting is not enough to ensure effective representation of community's interests of ethical relevance. CAG members’ abilities to understand research ethics, identify potential harms to community and communicate feedback to researchers is critical to optimise engagement of lay community and avoid tokenistic engagement. (shrink)

The governance structures of state public health systems vary as much as the states themselves, including the existence and role of state boards of health. Understanding these differences is essential to a complete understanding of the governmental public health enterprise. State boards of health are obvious vehicles for public health policy development in some states, where they work closely with or oversee state health agencies. In other states they do not exist or serve only in a non-binding advisory capacity.In (...) this article, we distinguish and identify state boards of health and state public health advisory boards, examine state boards of health in practice, and discuss their role in advocacy and policy development in the context of state politics. We used a set of mixed qualitative methods, including a literature review, online research of state statutes establishing state board of health authorities, and key informant interviews. Informants were five current and former state board of health members, four current and former state health officers, and nine state health agency senior policy staff, spanning 13 states. (shrink)

The governance structures of state public health systems vary as much as the states themselves, including the existence and role of state boards of health. Understanding these differences is essential to a complete understanding of the governmental public health enterprise. State boards of health are obvious vehicles for public health policy development in some states, where they work closely with or oversee state health agencies. In other states they do not exist or serve only in a non-binding advisory capacity.In (...) this article, we distinguish and identify state boards of health and state public health advisory boards, examine state boards of health in practice, and discuss their role in advocacy and policy development in the context of state politics. We used a set of mixed qualitative methods, including a literature review, online research of state statutes establishing state board of health authorities, and key informant interviews. Informants were five current and former state board of health members, four current and former state health officers, and nine state health agency senior policy staff, spanning 13 states. (shrink)

Although the first human embryonic stem cells were produced in 1998, the direction of U.S. policy on stem cell research was set nearly 20 years earlier when the recommendations of a congressionally established Ethics Advisory Board were ignored by the Reagan administration. Thus began an unprecedented and unparalleled 30-year-long history of political intrusions in an area of scientific and biomedical research that has measurable impacts on the health of Americans. Driving these intrusions were religiously informed public policy (...) positions that have usually escaped critical ethical analysis. Here I record my own encounters with this history of intrusions and the thinking behind them.My most abrupt encounter with the politics of stem cell research occurred on September 6, 2006, at a hearing of the Senate Subcommittee on Labor, Health and Human Services and Related Agencies, chaired by Senator Arlen Specter. Just a week before, scientists at Advanced Cell Technology, a small Massachusetts biotech company, had published a paper in the journal Nature in which they described a method for extracting stem cells from early human embryos while leaving the embryos intact and viable. As head of ACT’s Ethics Advisory Board, I had supported this research. (shrink)

On 8th August 2019, Secretary of State for Health and Social Care, Matt Hancock, announced the creation of a £250 million NHS AI Lab. This significant investment is justified on the belief that transforming the UK’s National Health Service (NHS) into a more informationally mature and heterogeneous organisation, reliant on data-based and algorithmically-driven interactions, will offer significant benefit to patients, clinicians, and the overall system. These opportunities are realistic and should not be wasted. However, they may be missed (one may (...) recall the troubled Care.data programme) if the ethical challenges posed by this transformation are not carefully considered from the start, and then addressed thoroughly, systematically, and in a socially participatory way. To deal with this serious risk, the NHS AI Lab should create an Ethics Advisory Board and monitor, analyse, and address the normative and overarching ethical issues that arise at the individual, interpersonal, group, institutional and societal levels in AI for healthcare. (shrink)

As members of the fetal surgery advisory board at a large tertiary care center, we read with great interest Hendriks’ et al. target article proposing a new ethical framework for fetal therap...

Background:Ethics in nursing care are traditionally discussed in terms of moral norms or principles. When taking an ontological approach to ethics, ethics is about ethos. Ethos involves both an internal and an external side of ethics. Considering ethics and health from an ontological perspective can provide a different understanding of ethics and health in caring and nursing.Aim and research question:The aim of this study is to deepen the ontological understanding of ethics and health (...) in caring and nursing. The research question is as follows: What is the ontology of health and ethics in caring and nursing?Research design:The study follows a hermeneutical design inspired by Gadamer. Participants and research context: essays about ethics and health were gathered from PhD students in nursing and caring sciences.Ethical considerations:The research follows Responsible conduct of research guidelines provided by the Finnish Advisory Board on Research Integrity.Findings:An ethos with the values of freedom and responsibility seem to ontologically be important for ethics and health. These values allow a movement between the internal and the external sides of ethics that is important for health.Discussion:The ethos of freedom and responsibility that is essential for ethics and health can provide the current ethical debate a new starting point that previous research asks for.Conclusion:Ontologically, an ethos of freedom and responsibility is essential for ethics and health in nursing and caring. (shrink)

Background With an increasing older population, the pressure on home care resources is growing, which makes it important to ensure the maintenance of quality care. It is known that compassion and ethical sensitivity can improve the quality of care, but little is known about care leaders’ perceptions on ethical sensitivity and compassion in home care and how it is associated with staff competence and thus quality of care. Aim The aim of the study was to explore home care leaders’ perceptions (...) of ethical sensitivity and compassion associated with care quality in home care. Research design, participants, and research context A hermeneutical approach with a qualitative explorative design was used. The data consists of texts from 10 in-depth interviews with home care leaders. Content analysis was used as a method. Ethical considerations The study was conducted following the ethical guidelines of the Declaration of Helsinki and the Finnish Advisory Board of Research Ethics. Research ethics permission was applied for from a Research Ethics Board. Findings One overall theme and four subthemes were found. The overall theme was: “Compassion provides deeper meaning and ethical sensitivity provides means for knowing how to act”. Discussion If nurses fail to be sensitive and compassionate with patients, good and high qualitative home care cannot be achieved. Ethical sensitivity and compassion can be seen as resources in home care but the organization and the care leaders need to provide the support for these to develop. Conclusion This study provides an understanding of the meaning of ethical sensitivity and compassion as sources of strength and their link to quality of care in a home care context. Further studies could focus on how to build compassion and ethical sensitivity into home-based care and how to ensure adequate support for healthcare professionals’ compassion and ethical sensitivity. (shrink)

Instead of another federal advisory panel to identify ethical principles governing human subjects research, it is time we had a national board with authority to regulate and review such research.

Many medical‐ethics advisory boards have concluded that human embryonic stem cell research can be conducted in an ethical manner. Yet, almost all the recommendations of the ethics advisory boards have included a rather obscure requirement: the embryos that are to be destroyed for stem cell research must be treated with profound respect. In none of these recommendations, however, do we see an adequate explanation of what proper respect for human embryos actually entails. In this essay I (...) argue that showing proper respect for human embryos, on the one hand, and simultaneously destroying them for stem cell research, on the other hand, are not mutually exclusive. In addition, I maintain that given current U.S. in vitro fertilization practices, which deliberately produce more embryos than will be implanted, proper respect for surplus embryos requires their use in embryonic stem cell research. (shrink)

Gain-of-function research involves experimentation that aims or is expected to increase the transmissibility and/or virulence of pathogens. Such research, when conducted by responsible scientists, usually aims to improve understanding of disease causing agents, their interaction with human hosts, and/or their potential to cause pandemics. The ultimate objective of such research is to better inform public health and preparedness efforts and/or development of medical countermeasures. Despite these important potential benefits, GOF research can pose risks regarding biosecurity and biosafety. In 2014 the (...) administration of US President Barack Obama called for a “pause” on funding of GOF experiments involving influenza, SARS, and MERS viruses in particular. With announcement of this pause, the US Government launched a “deliberative process” regarding risks and benefits of GOFR to inform future funding decisions—and the US National Science Advisory Board for Biosecurity was tasked with making recommendations to the US Government on this matter. As part of this deliberative process the National Institutes of Health commissioned this Ethical Analysis White Paper, requesting that it provide review and summary of ethical literature on GOFR, identification and analysis of existing ethical and decision-making frameworks relevant to the evaluation of risks and benefits of GOFR, decision-making about the conduct of GOF studies, and the development of US policy regarding GOFR, and development of an ethical and decision-making framework that may be considered by NSABB when analyzing information provided by GOFR risk-benefit assessment, and when crafting its final recommendations. The ethical and decision-making framework ultimately developed is based on the idea that there are numerous ethically relevant dimensions upon which any given case of GOFR can fare better or worse : research imperative, proportionality, minimization of risks, manageability of risks, justice, good governance, evidence, and international outlook and engagement. Rather than drawing a sharp bright line between GOFR studies that are ethically acceptable and those that are ethically unacceptable, this framework is designed to indicate where any given study would fall on an ethical spectrum—where imaginable cases of GOFR might range from those that are most ethically acceptable, at one end of the spectrum, to those that are most ethically problematic or unacceptable, at the other. The aim should be that any GOFR pursued should be as far as possible towards the former end of the spectrum. (shrink)

A recent controversy over the US National Science Advisory Board for Biosecurity's recommendation to censor two publications on genetically modified H5N1 avian influenza has generated concern over the threat to scientific freedom such censorship presents. In this paper, I argue that in the case of these studies, appeals to scientific freedom are not sufficient to motivate a rejection of censorship. I then use this conclusion to draw broader concerns about the ethics of dual-use research.

There is wide agreement that community engagement is important for many research types and settings, often including interaction with ‘representatives’ of communities. There is relatively little published experience of community engagement in international research settings, with available information focusing on Community Advisory Boards or Groups (CAB/CAGs), or variants of these, where CAB/G members often advise researchers on behalf of the communities they represent. In this paper we describe a network of community members (‘KEMRI Community Representatives’, or ‘KCRs’) linked to (...) a large multi-disciplinary research programme on the Kenyan Coast. Unlike many CAB/Gs, the intention with the KCR network has evolved to be for members to represent the geographical areas in which a diverse range of health studies are conducted through being typical of those communities. We draw on routine reports, self-administered questionnaires and interviews to: 1) document how typical KCR members are of the local communities in terms of basic characteristics, and 2) explore KCR's perceptions of their roles, and of the benefits and challenges of undertaking these roles. We conclude that this evolving network is a potentially valuable way of strengthening interactions between a research institution and a local geographic community, through contributing to meeting intrinsic ethical values such as showing respect, and instrumental values such as improving consent processes. However, there are numerous challenges involved. Other ways of interacting with members of local communities, including community leaders, and the most vulnerable groups least likely to be vocal in representative groups, have always been, and remain, essential. (shrink)

Background Older patients in emergency care often have complex needs and may have limited ability to make their voices heard. Hence, there are ethical challenges for healthcare professionals in establishing a trustful relationship to determine the patient’s preferences and then decide and act based on these preferences. With this comes further challenges regarding how the patient’s autonomy can be protected and promoted. Aim To describe nurses’ experiences of dealing with older patients’ autonomy when cared for in emergency departments (EDs). Research (...) design This study adopted reflective lifeworld theory and a phenomenological design. Participants and research context A total of 13 open-ended interviews were performed with nurses working at two EDs in Sweden. Ethical considerations The study was reviewed by the Ethical Advisory Board in South East Sweden and conducted according to the Declaration of Helsinki. All participants gave consent. Findings Nurses’ experiences of dealing with older patients’ autonomy in EDs are characterized by moving in a conflicting uphill struggle, indicating obscure thoughts on how patient autonomy can be protected in an ethically challenging context. The phenomenon is further described with its meaning constituents: ‘Being hampered by prioritization under stress’, ‘Balancing paternalism and patient autonomy’, ‘Making decisions without consent in the patient’s best interests’ and ‘Being trapped by notions of legitimate care needs’. Conclusion Stressful work conditions and lacking organizational strategies in EDs contribute to nurses maintaining unjustified paternalistic care, regardless of the patient’s ability and medical condition, and questioning who has legitimacy for participating in decisions about care. The nurses’ protection and promotion of older patients’ autonomy is dependent on the opportunity, ability and willingness to create a patient relationship where the patient’s voice and preferences are valued as important. Consequently, strategies are needed to improve patient autonomy in EDs based on the idea of ‘relational autonomy’. (shrink)

Background Decision-making competence is a complex concept in the care for transgender and gender diverse adolescents, since this type of care concerns one’s developing gender identity and involves treatment options that often lack international consensus. Even despite competence assessments, moral challenges arise in the decision-making process. Here, traditional forms of clinical ethics support such as moral case deliberation might not fit as these do not provide thematic guidance. This study therefore aimed to develop a practice-oriented ethics support tool (...) to assist care providers when dealing with moral challenges around decision-making competence in transgender adolescent care. Methods The study followed a participatory design to develop a tool in close collaboration with care providers; they had a say in all phases of development and dissemination. Firstly, nine care providers were interviewed about experienced moral challenges and needs for ethics support. Based on this, the structure and content of the tool was constructed and discussed in two focus group meetings, after which four care providers tested the tool and additional feedback was collected from the team and an advisory board. The final tool was presented to all Dutch care providers in transgender adolescent care. Results Care providers expressed a need for guidance in defining and assessing decision-making competence. Main moral challenges concerned discussing fertility options with young clients, dealing with co-occurring mental health difficulties and the decision-making role of parents. The final tool, named the Competence Consultant, is an interactive pdf containing four parts: (1) Clarify information; (2) Identify doubts and moral questions; (3) Guidance for conversations and (4) Overview and Conclusions. Discussion Developing an ethics support tool in a controversial care setting is highly relevant as it aims to help individual care providers in defining, discussing and dealing with their moral challenges in actual practice. The ‘Competence Consultant’ for transgender care providers contributes to their moral sensitivity and moral competence. It is an example of the development of innovative and integrative forms of thematic ethics support. (shrink)

There are six national ethics commissions in Finland. The National Advisory Board on Research Ethics was first established in 1991, followed by the National Advisory Board on Biotechnology and the Board on Gene Technology in 1995. The National Advisory Board on Health Care Ethics was established in 1998, followed by its Sub‐Committee on Medical Research Ethics in 1999. The Co‐operation Group for Laboratory Animal Sciences was established in 2001. Only (...) the Board on Gene Technology works as a national authority and gives binding opinions and recommendations about the use of genetically modified organisms. The Sub‐Committee on Medical Research Ethics acts as a national research ethics committee and gives opinions about research projects. Other advisory boards do not make legally binding decisions, but their expertise gives a lot of power to their opinions and statements. The commissions work in close collaboration with each other, having regular meetings. They arrange seminars and conferences, and share information with each other. The commissions also share duties and information in international collaboration. How the voice and opinions of these commissions is heard in society lies in the wide, multi‐professional expertise of their members. Large commissions and wide expertise may make it difficult to find consensus in their opinions and statements, although wide expertise may, more than discussion in a small expert group, help to further process difficult ethical issues. Collaboration between different bodies is important in order to share duties, and also to add more emphasis to the statements and opinions where different bodies share interests. In our country, the interest that national commissions share is research ethics, where the advisory boards and their members have discharged collaborative activities for years. (shrink)

The study reports on the results of an empirical investigation of the education and recruitment processes used in HIV vaccine trials conducted in South Africa. Interviews were conducted with 21 key informants involved in HIV vaccine research in South Africa and three focus groups of community advisory board members. Data analysis identified seven major themes on the relationship between education and recruitment: the process of recruitment, the combined dual role of educators and recruiters, conflicts perceived by field staff, (...) pressure to achieve recruitment targets, problems in achieving comprehension, accountability and education as capacity building. The results raise ethical concerns about the adequacy of current informed consent processes in these settings. The study findings bear directly on current debates about issues of exploitation and the scope of moral responsibilities of researchers and funding agencies to assure that HIV clinical prevention research is conducted ethically. (shrink)

Questions concerning moral problems caused by the lifesciences and concerning the adequate methods and instruments to solve these are timely and urgent; especially in the face of intense debates on the acceptability of research on human embryonic stem cells and preimplantation diagnostics, to name only two applications developed from research in the life-sciences. Unfortunately, the constant and accusing demand that life-scientists must behave morally does not give us a clue on how ethics may help in establishing guidelines for moral (...) behaviour. In this heated situation the foundation of ethics-committees seems to be the motto of the day. But instead of functioning as necessary and fruitful scientific advisory boards, these committees run the risk of being misused as a fashionable (and soon forgotten) weapon in the battle for political opinion-leadership. In the following article, the view is defended that ethics is a scientific enterprise and has an important role to play in political decision making on lifesciences issues. Content Type Journal Article Pages 29-31 Authors Felix Thiele, Bad Neuenahr-Ahrweiler GmbH, Wilhelmstrasse 56, D-53474 Bad Neuenahr-Ahrweiler, Germany Journal Human Reproduction & Genetic Ethics Online ISSN 2043-0469 Print ISSN 1028-7825 Journal Volume Volume 8 Journal Issue Volume 8, Number 2 / 2002. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:An Egg Takes Flight: The Once and Future Life of the National Bioethics Advisory Commission*Alexander Morgan Capron (bio)Attempting to describe the National Bioethics Advisory Commission (NBAC) is comparable to the surreal feat performed by the artist in a famous painting by René Magritte. The artist (Magritte himself) sits with his back to the viewer, a palette in his left hand. The brush in his right hand is (...) raised to a canvas, blank except for a bird in flight that he is in the process of painting. The artist is looking to his left at a tabletop, bare except for a single, plain egg.Having held its second formal meeting in mid-January, NBAC is certainly still embryonic, its future mysterious within its shell. Yet answers to four major questions that will determine not just what kind of bird the Commission turns out to be but the heights to which it will fly should be evident by April or May 1997. First, will the White House take the sort of interest in NBAC that is needed if it is to succeed? Second, will the Commission’s term be extended beyond October 1997—and will the decision come early enough to allow it to start soon on projects that will take more than a single year to complete? Third, will the Commission take a broad view of the issues it addresses, reexamining widely accepted assumptions and going back to basic premises, or will it respond primarily in bureaucratic terms, guided by its charter’s focus on improving the policies and practices of federal departments and agencies? Fourth, will the Commission move beyond its initially mandated topics—the rights and welfare of human research subjects and the management and use of genetic information—and become what its name promises, the nation’s advisory body on the full range of bioethical issues that arise in the organization and management of health services and research?The Origins of the Egg: NBAC’s PredecessorsThe creation of a national bioethics commission has been demanded for years, at the least since its most recent predecessor, the Biomedical Ethics [End Page 63] Advisory Committee (BEAC) finally expired in 1990. BEAC’s statutory authority lapsed after the hapless committee had spent several years itself like an in vitro embryo in a vat of liquid nitrogen. BEAC’s opponents in Congress froze its appropriation and forbad it to meet until the Biomedical Ethics Board of six senators and six representatives to which it was supposed to report resolved the chaos resulting from the Board members’ ideological differences and personal distrust; this never occurred, and the Board proved unable even to choose its chairman. 1 BEAC, which met only twice, had laid preliminary plans to study the issues raised by the new genetics, but the politics of abortion—which had greatly complicated and slowed the Board’s naming of the BEAC members—was strong enough to interfere even with the topic of genetics, on which the difference among committee members actually gave no sign of dividing on pro-life/pro-choice grounds.The disappearance of BEAC left the nation without a mechanism for “public bioethics,” and several efforts were undertaken in the early 1990s to generate a new commission that could carry on in the tradition of the two previous, successful bioethics commissions. (The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research operated under a Congressional mandate in the Department of Health, Education, and Welfare from 1974 to 1978, and the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, which had been authorized by Congress in 1978, actually operated as an independent body with government-wide purview from January 1980 to March 1983.) The Institute of Medicine established a committee to assess the mechanisms available not only to the federal government but also to states, professional bodies, and the public for deliberating about and resolving ethical issues stemming from developments in biomedicine (Bulger, Bobby, and Fineberg 1995). In September 1992, Senators Mark O. Hatfield (R-OR), Edward M. Kennedy (D-MA), and Dennis DeConcini (D-AZ) requested that the Office of Technology Assessment (OTA) evaluate the... (shrink)

Developers and designers make all sorts of moral decisions throughout an innovation project. In this article, we describe how teams of developers and designers engaged with ethics in the early phases of innovation based on case studies in the SUBCOP project. For that purpose, Value Sensitive Design will be used as a reference. Specifically, we focus on the following two research questions: How can researchers/developers learn about users’ perspectives and values during the innovation process? and How can researchers/developers take (...) into account these values, and related design criteria, in their decision-making during the innovation process? Based on a case study of several innovation processes in this project, we conclude the researchers/developers involved are able to do something similar to VSD, supported by relatively simple exercises in the project, e.g., meetings with potential end-users and discussions with members of the Ethical Advisory Board of the project. Furthermore, we also found—possibly somewhat counterintuitively—that a commercial, with its focus on understanding and satisfying customers’ needs, can promote VSD. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 12.1 (2002) 95-102 [Access article in PDF] Bioethics Inside the Beltway Some Initial Reflections on NBAC Eric M. Meslin and Harold T. Shapiro On 3 October 2001, Executive Order 12975 expired, and with it so too did the National Bioethics Advisory Commission (NBAC). Established by President Bill Clinton in 1995, NBAC was the fifth national committee since 1974 created to advise the (...) U.S. government on bioethics policy. In the long political tradition in this country that national bioethics policy advice should use temporary rather than permanent bodies, NBAC followed in the footsteps of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-78); the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (1980-83); the Ethics Advisory Board (1978-80); and the Biomedical Ethics Advisory Committee (1988-89). Arguably, other distinguished panels could lay claim to recognition as a "national bioethics committee" including the Advisory Committee on Human Radiation Experiments (ACHRE) (1994-95); the Fetal Tissue Transplantation Research Panel (1988); the Human Embryo Research Panel (1994); and the National Institutes of Health (NIH) Recombinant DNA Advisory Committee (RAC), which continues to function.These committees and commissions form a kind of a continuum, albeit occasionally interrupted by periods during which no such bodies existed. Each arose from a particular confluence of events and circumstances. NBAC was no different; its history can be traced both to a series of discussions within the White House Office of Science and Technology Policy beginning in 1993 (NBAC 1998a, p. 3), and to a specific recommendation from ACHRE that called for a national committee to address ethical issues in human subjects research (ACHRE 1995, p. 817). Nbac's Impact In his useful comparison of the accomplishments of the National Commission and the President's Commission, Brad Gray concluded that seven lessons were learned, the sixth of which was that "nothing substitutes for having a perceptible impact on either policy or practice" (Gray 1995, p. 304). Assessing NBAC's [End Page 95] impact on "policy or practice" is difficult, particularly given the fact that it so recently completed its work. More time may be needed before a full assessment can be undertaken of the impact of its six reports (and their total of 120 recommendations). Instead, in this essay we offer some reflections on NBAC's initial impact, using some specific examples of how bioethics gets done Inside the Beltway. Eliciting Reaction If immediate reaction by the White House is any measure of impact, then Cloning Human Beings (NBAC 1997) had a significant one. The day after he received this report in a Rose Garden ceremony, President Clinton submitted a bill to Congress that would have extended the moratorium on federal funding to create a child using somatic cell nuclear transfer. This bill never passed, nor has any other bill emerged that has enjoyed the support of the House and the Senate. Five states have enacted legislation to date, but these vary in their permissibility from bans on all forms of cloning to bans similar to the one proposed by NBAC, which recommended a time-limited prohibition only on somatic cell transfer to create a child (reproductive cloning).If the Cloning report elicited speedy action from the White House, this paled in comparison to the reaction that led to and, in turn, was created by Ethical Issues in Human Stem Cell Research (NBAC 1999a). Those who believe that government moves slowly need only be reminded of the events of 8-14 November 1998 (and, as we shall mention below, the further events of 14 July 1999). Some will recall that early in the second week of November 1998, James Thomson and his colleagues published in Nature and John Gearhart and his colleagues published in the Proceedings of the National Academy of Sciences that they had isolated and cultured human primordial stem cells and germ cells respectively. Within days of these remarkable reports, Advanced Cell Technology (ACT) announced via an article written by Nicholas Wade in the... (shrink)

Background: Increasing collaboration between industrialised and developing countries in human research studies has led to concerns regarding the potential exploitation of resource deprived countries. This study, commissioned by the former National Bioethics Advisory Commission of the United States, surveyed developing country researchers about their concerns and opinions regarding ethical review processes and the performance of developing country and US international review boards .Methods: Contact lists from four international organisations were used to identify and survey 670 health researchers in developing (...) countries. A questionnaire with 169 questions explored issues of IRB review, informed consent, and recommendations.Results: The majority of the developing country researchers were middle aged males who were physicians and were employed by educational institutions, carrying out research on part time basis. Forty four percent of the respondents reported that their studies were not reviewed by a developing country IRB or Ministry of Health and one third of these studies were funded by the US. During the review process issues such as the need for local language consent forms and letters for approval, and confidentiality protection of participants were raised by US IRBs in significantly higher proportions than by host country IRBs.Conclusion: This survey indicates the need for the ethical review of collaborative research in both US and host countries. It also reflects a desire for focused capacity development in supporting ethical review of research. (shrink)

The year 2018 was the 40th anniversary of the birth of Louise Joy Brown, marking four decades of clinical in vitro fertilization and embryo transfer. Though this milestone, reached first by Steptoe and Edwards in the United Kingdom, is well acknowledged through Nobel accolade, the achievement was not entirely celebrated at the time. Global contention was not just moral, but political and legislative. In the United States, the achievement led in 1978 to the freezing of federal funds by the National (...) Institute of Health for research on human embryos and oocytes.A report published on May 4, 1979, by the Ethics Advisory Board of the Department of Health... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:At the Vortex of Controversy:Developing Guidelines for Human Embryo ResearchRonald M. Green (bio)Because of the unavoidable time delay between the submission and publication of this article, its readers will have a significant advantage over its writer: You will know whether the recommendations of the Report of the Human Embryo Research Panel, on which I have served as a member since its inception in January of this year, are progressing (...) smoothly as the basis for evaluating future, federally-funded embryo research—or whether any of the recommendations has become stalled in controversy and political dispute. Staid journals like Science already are predicting that the Panel's Report is likely to create a stormy autumn for the National Institutes of Health.The Panel formally presented its Report to NIH Director Harold Varmus on September 27. The Panel's recommendations will be reviewed by the Advisory Committee to the Director (ACD) until the ACD's next meeting in early December. At that time, the ACD will make formal recommendations to Dr. Varmus, who then will initiate the process of drafting federal regulations that could go into effect by Spring 1995.Historical BackgroundControversy is not new to the area of human embryo research. In the United States, federal regulations enacted in the mid-1970s required any research on the human embryo to be approved by a federally mandated Ethics Advisory Board (EAB). The EAB drafted a significant report that provided ethical guidelines for research on the early, ex utero, human embryo. However, before the report could be acted upon, a new administration, which was opposed to abortion and anything remotely viewed as threatening to prenatal life, came to office, and when the EAB's charter expired in 1980, it was not renewed. In this manner, the Reagan and Bush administrations forestalled any federal support for embryo research in the United States. The next 13 years saw a significant expansion of infertility services in this country, but in the absence of federal funding and [End Page 345] review, there was very little systematic research on either infertility procedures or the human embryo.In January 1993, the U.S. political environment changed again when the Clinton administration fulfilled a campaign promise to remove a nearly five-year-old ban on fetal tissue transplantation research. Although fetal tissue research, which uses the remains of an aborted fetus, significantly differs from embryo research, which involves the developing conceptus ex utero before its transfer to and implantation in a womb, the changed political environment stimulated public discussion of embryo research as well. As a result, in June 1993, Congress nullified the federal regulations requiring EAB review for embryo research. Although this presumably left NIH free to fund embryo research without restrictions, NIH officials felt that guidelines were needed to ensure that such research was conducted in an ethically and socially responsible manner. Accordingly, in January 1994, NIH formed the Human Embryo Research Panel to propose such guidelines.The Panel Begins its WorkChaired by Steven Muller, President emeritus of the Johns Hopkins University, the Panel's 19 members included 7 basic and clinical scientists, 4 ethicists, 2 lawyers, and 6 individuals representing various backgrounds relevant to the making of public policy. Patricia King of the Georgetown University Law Center and Brigid Hogan, a cell biologist at Vanderbilt University, were appointed policy and science co-chairs respectively. Meeting for the first time in early February, the Panel was told by its chair and co-chairs that NIH's need for guidance in the face of pending proposals meant that it had approximately six months—including five one- to two-day meetings each month in Washington—in which to complete its work.In his charge, Dr. Varmus asked the Panel to place the possible areas of research into three categories: (1) acceptable for federal funding; (2) warranting additional review; and (3) unacceptable for federal support. In addition, he asked the Panel to draft guidelines for the review and conduct of the research deemed acceptable.Looking back after months of work, I vividly recall a sense of the enormity of the task facing us. We were being asked, in a short period of time, not only to master... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Private Bioethics Forums:Counterpoint to Government BodiesCynthia B. Cohen (bio) and Elizabeth Leibold McCloskey (bio)Ethical issues associated with reproductive technologies quickly gain public attention. The front pages of newspapers have featured stories about grandmothers giving birth to their own grandchildren, couples "renting" wombs from surrogates, and researchers prepared to transplant fetal ovaries into women unable to produce viable eggs. With each new and bolder foray into reproductive realms, the question (...) of whether to set limits on the use of such technologies surfaces. An ancillary debate inevitably ensues about the proper forum for discussing and deciding such limits. The recent announcement of human embryo splitting or cloning research is no exception to this pattern. Articles in both the popular press and academic circles in the wake of the reported research contain lamentations about the absence of a national ethics body that could address the ethical issues raised by the cloning experiment. This research also breathed new life into congressional calls to create a government bioethics commission.1At times, it appears that the substantive questions raised by a procedure like cloning are subsumed under the debate about whether this ethics group or that should be convened to study the matter. But the forum in which options are discussed is as crucial to the development of sound ethical thought and public policy as are the conclusions themselves. Thus, we address the question of whether a private, as opposed to a public, bioethics body provides a distinctively useful forum for reaching an understanding of issues such as cloning that have significant ethical and public policy implications.A 1993 Office of Technology Assessment report, in which the authors suggest that a new federal bioethics commission might be useful, has helped to frame recent discussions about the value of government-sponsored bioethics bodies (Office of Technology Assessment 1993). To most people, the question of whether a national forum for bioethics is needed is synonymous with the question of whether a new federal body should be convened. Yet the existence of the National Advisory Board on Ethics in Reproduction (NABER) suggests that the scope of the question should be broadened. [End Page 283]NABER was born in 1992, in part as a response to an Institute of Medicine report on infertility. That document endorsed the formation of a nongovernment body to develop guidelines for assisted reproductive measures and fetal research in the event that a government body was not forthcoming (Institute of Medicine 1989). NABER, which was founded by the American College of Obstetricians and Gynecologists and the American Fertility Society, now functions wholly independently of those groups and is supported by private foundations including the Ford, Greenwall, and Josiah Macy, Jr., Foundations and the Walter and Elise Haas Fund. NABER has issued a report on ethical issues related to the use of fetal tissue (Cohen and Jonsen 1993), is about to publish a report and background papers on oocyte donation, and presents a report on human cloning in this issue of the Kennedy Institute of Ethics Journal. In addition, it has developed a protocol for NABER review of research proposals from federal agencies subject to federal guidelines on the use of human subjects in research.Thus, in function and form, NABER was envisioned as a substitute for a government body, and it now functions in a manner similar to several types of government bioethics groups. Like the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission) and the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (President's Commission), NABER functions primarily through the publication of reports intended for a broad audience of practitioners, patients, policymakers, and the general public. Just as the Ethics Advisory Board of the late 1970s examined ethical issues related to specific protocols or types of research as they arose, NABER's purposes include scrutinizing the ethics of various research efforts in the reproductive area.NABER also parallels past government bodies in form. Like these groups, NABER is a multidisciplinary board that meets regularly and is supplemented by consultants and staff who provide research and writing for the board. Its members are nationally recognized in... (shrink)

United States ethicist Ronald M Green approaches the issue of embryo research (ER) in the very accessible form of a “philosophical memoir” (xv). Reporting in detail from his experience of serving on several high level ethics advisory boards, focusing mostly on his membership of the National Institutes of Health’s (NIH) 1994 human embryo research panel, Green portrays both the functioning of this increasingly more influential form of institutionalised ethics, as well as the social and political dynamics governing (...) its (in)effectiveness. The author also covers extensive ground regarding the subject matter of ER itself and familiarises the reader with the technical issues and conceptual conundrums (potentiality, moral status, harming future persons) involved. Green states in the title of The Human Embryo Research Debates: Bioethics in the Vortex of Controversy, that he is concerned with a plurality of debates. Examining the discourse in the US, he first deals with the different areas in which ER is debated: of the book’s eight chapters, chapters one and four stress the relevance of ER for the fields of in vitro fertilisation (IVF) research, the study of birth defects, and the development of contraceptive methods. Chapter 6 deals with the relation of ER to reproductive cloning; Green formulates a comprehensive …. (shrink)