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)

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)

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)

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)

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)

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)

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 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)

In this set of contributions to the Kennedy Institute of Ethics Journal celebrating the significant work and contributions of LeRoy Walters, we aim to bring new perspectives to topics that Dr. Walters helped to pioneer and continue his tradition of bringing moral insights and arguments to bear on the development of practical public and professional policies. Dr. Walters is well known for his invaluable service as member and chair of the Recombinant DNA Advisory Committee at the National Institutes of (...) Health. He also made major contributions to a variety of other committees responsible for the oversight of research and science, and to the development and implementation of influential... (shrink)

BackgroundCommunity Advisory Boards 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 members in Tanzania. We conducted In-depth Interviews (...) with ten participants and three Focus Group Discussions 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)

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)

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)

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.

BackgroundCommunity engagement is a key component in health research. One of the ways health researchers ensure community engagement is through Community Advisory Boards. 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 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, 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)

We have national guidelines for the responsible conduct of research and procedures for handling allegations of misconduct in Finland. The guidelines have been formulated and updated by the Finnish Advisory Board on Research Integrity. In this article, we introduce and evaluate the national RCR guidelines. We also present statistics of alleged and proven RCR violation cases and frequency of appeals to TENK on the decisions or procedures of the primary institutions. In addition, we analyze the available data on (...) seven investigated cases in more detail. Positive aspects in the Finnish system are a fairly good infrastructure to investigate suspected RCR violations and a wide concept of RCR violations, which consists of fabrication, falsification, plagiarism, misappropriation, and other misbehaviors. However, the guidelines contain poorly elaborated definitions, do not treat the complainant and the suspect in an equal way, and need to be revised. Confusion about the concepts and criteria of the RCR violations seems to be common in primary institutions and among the complainants. Even if research institutions and universities have officially adhered to the national RCR guidelines, slipping from the guidelines occurs quite commonly. All these factors lead to frequent dissatisfaction with the decisions or procedures applied, high rate of appeals to TENK, and far from optimal functionality of the system. (shrink)

Genomic biobanking research is undergoing exponential growth in Africa raising a host of legal, ethical and social issues. Given the scientific complexity associated with genomics, there is a growing recognition globally of the importance of science translation and community engagement for this type of research, as it creates the potential to build relationships, increase trust, improve consent processes and empower local communities. Despite this level of recognition, there is a lack of empirical evidence of the practise and processes for effective (...) CE in genomic biobanking in Africa. To begin to address this vacuum, 17 in-depth face to face interviews were conducted with South African experts in genomic biobanking research and CE to provide insight into the process, benefits and challenges of CE in South Africa. Emerging themes were analysed using a contextualised thematic approach. Several themes emerged concerning the conduct of CE in genomic biobanking research in Africa. Although the literature tends to focus on the local community in CE, respondents in this study described three different layers of stakeholder engagement: community level, peer level and high level. Community level engagement includes potential participants, community advisory boards and field workers; peer level engagement includes researchers, biobankers and scientists, while high level engagement includes government officials, funders and policy makers. Although education of each stakeholder layer is important, education of the community layer can be most challenging, due to the complexity of the research and educational levels of stakeholders in this layer. CE is time-consuming and often requires an interdisciplinary research team approach. However careful planning of the engagement strategy, including an understanding of the differing layers of stakeholder engagement, and the specific educational needs at each layer, can help in the development of a relationship based on trust between the research team and various stakeholder groups. Since the community layer often comprises vulnerable populations in low and middle income countries, co-development of innovative educational tools on genomic biobanking is essential. CE is clearly a component of a broader process best described as stakeholder engagement. (shrink)

New techniques for the genetic modification of organisms are creating new strategies for addressing persistent public health challenges. For example, the company Oxitec has conducted field trials internationally—and has attempted to conduct field trials in the United States—of a genetically modified mosquito that can be used to control dengue, Zika, and some other mosquito-borne diseases. In 2016, a report commissioned by the National Academies of Sciences, Engineering, and Medicine discussed the potential benefits and risks of another strategy, using gene drives. (...) Driving a desired genotype through a population of wild animals or insects could lead to irreversible genetic modification of an entire species. The NASEM report recommends community, stakeholder, and public engagement about potential uses of the technology, and it argues that the engagement should occur as research advances, well before gene drives are deployed. Yet what “engagement” means in practice is unclear. This article seeks clarity on this problem by offering a justification for community engagement and drawing out implications of this argument for the implementation and desired outcomes of community engagement. Community engagement is essential when it comes to research that would release genetically modified insects or animals into the environment. By contrast, obtaining informed consent from people who live near such a proposed field trial is neither necessary nor sufficient. Drawing on the epistemic and moral arguments for deliberative democracy, I propose two discrete mechanisms of community engagement: community advisory boards and deliberative forums, neither of which has been systematically incorporated into research governance. The proposed mechanisms would engender respect for persons who live near field trials, even when the results of deliberation override some individuals’ preferences. Community engagement foregrounds the community in our thinking about humans’ relationship to nature, and it implies that deciding to release genetically modified insects or animals into the wild ought to be a collective decision, not one made by product developers, policy-makers, private companies, research funders, or scientists alone. (shrink)

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)

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)

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 (...) class='Hi'>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)

The last 12 years have seen historically high levels of interest in biosecurity among life scientists, science policymakers, and academic experts on science and security policy. This interest was triggered by the 9/11 terrorist attacks, the ‘anthrax letters’ attack of the same year, and two virology papers, published early last decade, that were thought to raise serious biosecurity concerns.1 Ethicists have come relatively late to the game, but, in recent years, a lively debate has developed on ethical issues raised (...) by biosecurity policy, and, more generally, on the ethics of producing and disseminating ‘dangerous’ biomedical knowledge. Unsurprisingly, this debate has taken on increased sense of urgency over the last 18 months as the journals Science and Nature, the United States National Science Advisory Board for Biosecurity, and the World Health Organization, among others, have been considering whether and how to publish two academic papers reporting means of enhancing the transmissibility of H5N1 influenza, or ‘bird flu’ .We hope that this issue of the Journal of Medical Ethics will substantially advance the emerging ethical debate in this area. The issue features five articles on the ethics of biosecurity: a feature article, by Allen Buchanan and Maureen Kelley ; three brief replies to this article, by Michael Selgelid , Thomas May , and Nicholas King ; and a stand-alone paper by Nicholas Evans , which discusses the recent H5N1 controversy and analyses the appeals to scientific freedom that have been made by some of its protagonists. In this ‘concise argument’, I can, regrettably, comment only on the Buchanan and Kelley piece.Buchanan and Kelley on the framing of the biosecurity debateBuchanan and Kelley aim to broaden and reframe the existing debate on biosecurity. They begin by noting that "science policy … ". (shrink)

O texto interpreta a atuação de organizações militares e diplomáticas estadunidenses dedicadas à América Latina. O contexto é o da transição da Segunda Guerra Mundial à Guerra Fria. A base empírica é composta por diferentes documentos mantidos nos Arquivos Nacionais dos EUA do acervo do Comitê Consultivo Conjunto das Repúblicas Americanas, cobrindo o período 1940-1945. O comitê estava encarregado de propor e executar políticas ligadas à Defesa Hemisférica a serem desenvolvidas em conjunto com os países da América Latina na guerra (...) e no pós-guerra.From World War II to the Cold War: US military policies for Latin America The text interprets the performance of US military and diplomatic organizations dedicated to Latin America. The context is that of the transition from World War II to the Cold War. The empirical basis is composed of different documents maintained in the US National Archives of the collection of the Joint Advisory Board of the American Republics covering the period 1940-1945. The committee was charged with proposing and implementing policies related to Hemispheric Defense to be developed jointly with the Latin American countries in war and postwar. Resumen De la Segunda Guerra Mundial a la Guerra Fría: políticas militares estadounidenses para América Latina El texto interpreta la actuación de las organizaciones militares y diplomáticas estadounidenses dedicadas a América Latina. El contexto es el de la transición de la Segunda Guerra Mundial a la Guerra Fría. La base empírica está compuesta por diferentes documentos mantenidos en los Archivos Nacionales de los Estados Unidos del acervo del Comité Consultivo Conjunto de las Repúblicas Americanas cubriendo el período 1940-1945. El comité estaba encargado de proponer y ejecutar políticas vinculadas a la Defensa Hemisférica a ser desarrolladas en conjunto con los países de América Latina en la guerra y en la posguerra. (shrink)

Artikkelen undersøker hvordan NIPT ble vedtatt implementert i det norske fosterdiagnostiske systemet gjennom en fagligpolitisk prosess mellom 2012 og 2017. Prosessen innebar at Nasjonalt kunnskapssenter for helsetjenesten, Helsedirektoratet, Bioteknologirådet og Helse- og Omsorgsdepartementet ga sine vurderinger av testen og sine råd omkring en eventuell innføring. Artikkelen viser at det i denne prosessen foregikk en forsiktig tilnærming eller sammensmelting mellom de tradisjonelt helt ulike måtene å forstå og å ramme inn fosterdiagnostikk på i Norge, dvs. i en ‘autonomi/ behandlingsramme’ og en (...) ‘sorteringsramme’. Artikkelen argumenterer videre for at denne tilnærmingen eller konvergensen var mulig fordi prosessen ble holdt innenfor de fagligpolitiske byråkratiene, og de ulike etatene var innstilt på å ‘samarbeide’ om å inkludere både kunnskap og verdier fra begge rammene i sine tilrådninger. Politikk for fosterdiagnostikk er imidlertid et svært politisk betent område i Norge, og denne konvergensen var et skjørt byggverk. Den sprakk da også opp i løpet av tre uker i mai 2020, da Fremskrittspartiet plutselig inngikk et ‘bioteknologiforlik’ med Arbeiderpartiet og SV etter at de hadde gått ut av Solbergregjeringen. Dermed endte spørsmålet om implementeringen av NIPT i Stortinget, hvor konvergensen i den fagpolitiske prosessen ble erstattet av de tradisjonelle frontene, og de gamle innrammingene igjen ble ‘satt i arbeid’. Artikkelen diskuterer avslutningsvis kort de bortimot uløselige dilemmaene disse innrammingene både representerer og produserer. Nøkkelord: NIPT, fosterdiagnostikk, humanmedisinsk bioteknologi, regulering English Title: Fetal diagnostics between medicine and ethics: Implementation of Prenatal Invasive Testing in a turbulent policy area: The article examines how the decision to implement Prenatal Invasive Testing in the Norwegian Fetal Diagnostic System was reached through a professional policy process between 2012 and 2017. The process involved the Norwegian Research Centre for Health Services, the Norwegian Directorate of Health, the Norwegian Biotechnology Advisory Board and the Ministry of Health and Care Services, which provided their individual assessments and advice regarding the potential implementation of the test. The article finds that a careful convergence took place between traditionally opposing ways to understand and frame fetal diagnostics in Norway – either as a ‘treatment frame’ or a ‘sorting frame’. The article further argues that this convergence was possible because the process was kept within these bureaucracies, and that the different agencies were willing to collaborate to include knowledge and values from both frames in their recommendations. However, policy for fetal diagnostics is a very turbulent political area in Norway, and this convergence was a fragile construction. During three weeks in May 2020, the convergence collapsed when the Norwegian Progress Party suddenly entered a “biotechnology settlement” with the Labour Party and the Socialist Left Party after exiting the conservative Government coalition. Hence, the question of implementing NIPT ended up in the Norwegian Parliament, where the convergence from the professional policy process was replaced by the traditional fronts, and the old framings were again set in motion. Lastly, the article briefly discusses the almost unsolvable dilemmas these framings both produce and represent. Keywords: NIPT, non-invasive prenatal testing, fetal diagnostics, medical biotechnology, regulation. (shrink)

Details goverment, private, and international response to the policy recommendations of the National Bioethics Advisory Commission.

A romance with the concept of community has long characterized activist healthcare movements and has more recently been taken up by academic medical centers as a sign of virtuous civic engagement. During the late 1960s, the word community, as deployed by administrators at prestigious AMCs, became increasingly politicized, commodified and racialized. Here, we analyze how the concept of community was initially framed in the 1963 Community Mental Health Centers Act, the first legislation to establish community mental health centers in America. (...) We then examine the Health Policy Advisory Center’s analysis of the proposed Washington Heights Community Mental Health Center to be run by Columbia University’s College of Physicians and Surgeons, an institution that had historically neglected residents’ health needs. Community pushback against Columbia’s plan to build a multi-block center, amplified by medical students and residents critical of the professionalized community mental health movement, escalated in the late 1960s, leading the city’s planning board to reject Columbia and approve a community council’s plan for preventive and rehabilitative local services. These conflicting overtones of “community” still inform understandings of the word in medicine today; thus, a critical historical analysis of “community” is warranted. (shrink)

ABSTRACT Objections to the current EU regulatory system on genetically modified organisms in terms of high cost and lack of consistency, speed and scientific underpinning have prompted proposals for a more technology-neutral system. We sketch the conceptual background of the notion of ‘technology neutrality’ and propose a refined definition of the term. The proposed definition implies that technology neutrality of a regulatory system is a gradual and multidimensional feature. We use the definition to analyze two regulatory reform proposals: One proposal (...) from the Netherlands for improving the exemption mechanism for GMOs under Directive 2001/18/ec, and one from the Norwegian Biotechnology Advisory Board, outlining a new stratified risk assessment procedure. While both proposals offer some degree of improved technology neutrality in some dimensions compared to current EU regulation, in some extents and dimensions, they do not. We conclude that proposals for more technology-neutral regulation of GMOs need, first, to make explicit to what extent and in what dimensions the proposal improves neutrality and, second, to present arguments supporting that these specific improvements constitute desirable policy change against the background of objections to current policy. (shrink)

In the past decade, the philosophical scene in Russia has changed dramatically: it has become much more diverse, lively, and interesting. As a result, it is more difficult, but at the same time more important, to keep abreast of significant developments in Russian philosophy. As a journal of translations, Russian Studies in Philosophy plays a unique role in giving the English-language reader direct access to at least some of the serious philosophical work currently being done in Russia. I endorse the (...) editorial policy set forth by my predecessor, James P. Scanlan, in his first issue . With the help of the new advisory board, I shall try to make the journal reflect, as it has done in the past, the state of Russian philosophy. To achieve this, the journal will cover various branches of philosophy and publish materials from different sources—articles from the long-established as well as new specialized journals, chapters or sections from books, book reviews, roundtable discussions, and conference papers. As the Russian philosophical community becomes increasingly diversified, the journal will try to focus on the most controversial issues and present the conflicting viewpoints in a fair and balanced way. It is particularly important to follow Russia's changing view of itself, its revaluation of the Soviet and pre-Soviet philosophical heritage, and its increasing involvement in the world dialogue of the various philosophical traditions. The current issue of the journal presents a discussion of the importance and merits of one doctrine of Marxism-Leninism. (shrink)