In their self-understanding, expert committees solely draw on scientific knowledge to provide policy advice. However, we try to show, first, on the basis of material related to the German Radiation Protection Commission that much of their work consists in active model building. Second, expert advice is judged by criteria that diverge from standards used for judging epistemic research. In particular, the commitment to generality or universality is replaced by the criterion of specificity, and the value of precision (...) gives way to epistemic robustness. Third, non-epistemic considerations are included in the reasoning—albeit hesitantly. Manageability and social robustness, understood as compatibility with widespread value attitudes in society, affect the content of the recommendations. (shrink)

In order to implement cost-benefit analysis of protective actions to reduce radiological exposures, one needs to attribute a monetary value to the avoided exposure. Recently, the International Commission on Radiological Protection has stressed the need to take into consideration not only the collective exposure to ionising radiation but also its dispersion in the population. In this paper, by using some well known and some recent results in the economics of uncertainty, we discuss how to integrate these recommendations (...) in the valuation of the benefit of protection. (shrink)

The International Commission on Radiological Protection — whose regularly updated recommendations are routinely adopted as law throughout the globe — recently issued the first-ever ICRP protections for the environment. These draft 2005 proposals are significant both because they offer the commission’s first radiation protections for any non-human parts of the planet and because they will influence both the quality of radiation risk assessment and environmental protection, as well as the global costs of nuclear-weapons cleanup, (...) reactor decommissioning and radioactive waste management. This piece argues that the 2005 recommendations are scientifically and ethically flawed, or gray, in at least three respects: first, in largely ignoring scientific journals while employing mainly “gray literature;” second, in relying on non-transparent dose estimates and models, rather than on actual radiation measurements; and third, in ignoring classical ethical constraints on acceptable radiation risk. (shrink)

The main international standard-setting agencies for ionizing radiation, the International Atomic Energy Agency (IAEA) and the International Commission on Radiological Protection (ICRP) both subscribe to principles which (they claim) lead to equitable protection for all generations exposed to radioactive pollution. Yet, when one examines the practices both groups support, it is clear that these practices discriminate against future generations with respect to radioactive pollution. After showing (I) that the IAEA and ICRP rhetoric of equity does not (...) match their policies and practices, the essay argues (2) that current people ought to try to treat members of future generations equitably with respect to protection from radioactive pollution. The essay also argues (3) that current policies of permanent disposal of high-level radioactive waste do not meet the second criterion, and therefore (4) that society ought to investigate whether another strategy for managing the waste would provide better equal protection among all generations. (shrink)

Ionizing radiation is present in various situations in the contemporary world. Defining the quantities and units for this field is a complex scientific task, especially the quantities used in radiological protection (RP) to estimate the damage caused to individuals exposed to radiation (detriment). This article highlights the lack of consensus in the scientific RP community regarding the quantities and units employed in practice from the perspective of the philosophy of science. The basic concepts related to the system (...) of quantities are presented, followed by the problems and criticisms addressed by experts in the field. Several reasons for these problems are identified. The article discusses the scant interest on the part of philosophy of science in RP. The philosophy of science is still dominated by an analytical–conceptual perspective that pays little attention to the actual influence of certain structures better understood when considered from the institutional viewpoint, which is here exemplified by the International Commission on Radiological Protection (ICRP) and the International Atomic Energy Agency (IAEA). (shrink)

After WWII, global concerns about the uses of nuclear energy and radiation sources in agriculture, medicine, and industry brought about calls for radiation protection. At the beginning of the 1960s radiation protection involved the identification and measurement of all sources of radiation to which a population was exposed, and the evaluation and assessment of populations in terms of the biological hazard their exposure posed. Mexico was not an exception to this international trend. This paper (...) goes back to the origins of the first studies on the effects of radiation and on radioprotective compounds in the Genetics and Radiobiology Program of the National Commission of Nuclear Energy founded in 1960, at a time when the effects of radiation on living beings and radiation protection demanded the attention of highly localized groups of scientists and the creation of international as well as national institutions, and its connection to dosimetry and radiation protection until the 1990s. This historical reconstruction examines the circulation of knowledge, scientists, and their material and cognitive resources, to show that radiobiology, with dosimetry and radiation protection as cases in point, not only were carried out with high international standards in parallel with international agencies, but also reflected local material needs, including the standardization of new experimental techniques. (shrink)

Ionizing radiation is present in various situations in the contemporary world. Defining the quantities and units for this field is a complex scientific task, especially the quantities used in radiological protection (RP) to estimate the damage caused to individuals exposed to radiation (detriment). This article highlights the lack of consensus in the scientific RP community regarding the quantities and units employed in practice from the perspective of the philosophy of science. The basic concepts related to the system (...) of quantities are presented, followed by the problems and criticisms addressed by experts in the field. Several reasons for these problems are identified. The article discusses the scant interest on the part of philosophy of science in RP. The philosophy of science is still dominated by an analytical–conceptual perspective that pays little attention to the actual influence of certain structures better understood when considered from the institutional viewpoint, which is here exemplified by the International Commission on Radiological Protection (ICRP) and the International Atomic Energy Agency (IAEA). (shrink)

There is uncertainty and disagreement about the question which preventive actions are rationally justified with regard to moderately elevated levels of nuclear radiation. This may have at least four causes: ignorance, insufficient information, inconclusiveness and indeterminability. After the nuclear disaster with the Fukushima nuclear power plant the advice, given by some authorities, to leave Tokyo was largely based on the former two factors: ignorance and insufficient information. By contrast, the uncertainty and disagreement amongst experts about the size of the (...) area to be evacuated was mainly caused by the latter two factors: inconclusiveness and indeterminability. Inconclusiveness concerns the question whether moderately elevated radiation levels cause real and significant health risks that require drastic measures. Indeterminability concerns the problem of rationally weighing disparate benefits and costs of the preventive measures, to wit, expected health benefits versus the costs and burdens of mass evacuation. The International Commission on Radiological Protection (ICRP) recommends that no measures should be taken unless they produce a positive net benefit. Exposure to moderately increased levels of radiation may increase the risk of fatal cancer in the future, while mass evacuation has burdensome and disruptive consequences for the society and for the persons who have to leave their residential and/or working area for a long time. Ordering of mass evacuation seems rationally and ethically justified only if the expected future benefits outweigh the present and future burdens. Small or uncertain future health benefit may be outweighed by large costs and burdens of mass evacuation. Because we have to take into consideration not only public but also individual costs and benefits, it is important to take into account the personal absolute increase in health risk of elevated radiation in addition to relative risk. Unlike relative risk, absolute risk reveals the individual chance of getting a radiation-based disease. The increase in absolute risk – that is, the difference between the chances of getting the disease with and without the exposure to the increased level of radiation – is a useful measure to reveal the personal chance of health benefit from evacuation. This personal benefit must be balanced against the personal costs and burdens. The key question is which levels of radiation absorption and health risks outweigh the burdens of mass evacuation. There seems consensus amongst experts about the justification of mass evacuation in cases of expected individual radiation absorption > 500 mSv over a year. Similarly, experts agree that expected extra radiation absorption < 10 mSv does not justify mass evacuation. But between these two extremes there is a wide range of 50-fold increasing radiation levels in which it is not clear whether the personal and public benefits from mass evacuation outweigh the personal and public costs. This may partly explain why experts and authorities gave conflicting advice about the radius of the area around the Fukushima nuclear power plant within which people had to be evacuated. The uncertainty about the right thing to do with respect to a wide range of moderately elevated levels of radiation seems to be caused not only by inconclusiveness but also by indeterminability, that is, impossibility of determinately weighing disparate costs and benefits. (shrink)

With new technologies come new ethical challenges. Often, we can apply previously established principles, even though it may take some time to fully understand the detail of the new technology - or the questions that arise from it. The International Commission on Radiological Protection, for example, was founded in 1928 and has based its advice on balancing the radiation exposure associated with X-rays and CT scans with the diagnostic benefits of the new investigations. They have regularly updated (...) their advice as evidence has accumulated and technologies have changed,1 and have been able to extrapolate from well-established ethical principles. Other new technologies lend themselves less well to off-the-peg ethical solutions. In several articles in this edition the ethical challenges associated with the use of artificial intelligence in medicine are addressed. Although multiple ethical codes and guidelines have been written on the use and development of AI, Hagendorf noted that many of them reiterated a ‘ deontologically oriented, action-restricting ethic based on universal abidance of principles and rules’. 2 Applying pre-existing ethical frameworks to artificial intelligence is problematic for several reasons. In particular, AI has two characteristics which are very different from the current clinical practice on which traditional medical ethics are based: 1. The so called ‘black box’ of deep learning, whereby a deep neural network is trained to iteratively adapt to make …. (shrink)

This is a response to an article by Wade Allison in which he argues that we should accept drastically higher doses of ionizing radiation than what we currently do. He employs four arguments in defence of his position: comparisons with background radiation, the positive experiences of radiotherapy, the presence of biological defence mechanisms against radiation, and a concession by Swedish authorities that their approach to reindeer meat after the Chernobyl fallout was unnecessarily strict. It is shown that (...) each of the four arguments is fallacious. In conclusion, the traditional weighing of risks against benefits in radiation protection is defended. (shrink)

United States Atomic Energy Commission (USAEC) and UN agencies utilized techniques of power and negotiation to implement radiation exposure regulations. USAEC affiliated scientists’ expertise was cultivated while establishing a radiation protection regime based on classified experiments. World Health Organization (WHO) leadership sought to manifest a human right to health, including a right to protection from radiation contamination. The careers of a few technical experts and interagency UN correspondence shows how American risk models of (...) class='Hi'>radiation regulation traveled and ultimately inhibited WHO attempts to frame radiation as a public health threat. The USAEC and the International Atomic Energy Agency (IAEA) navigated WHO’s way of perceiving radiation with technical experts and bureaucratic and legislative means. This paper shows the underpinning at the UN of competing models of radiation regulation, one state centric and the other, an individual right to health. This narrative provides insights into the nature of the UN’s current conceptualization of radiation regulation and argues for further research into UN, radiation, and human rights history. (shrink)

During the fall of 2001 (October 22–25), The Norwegian Radiation Protection Authority (NRPA) and the Agricultural University of Norway arranged a consensus conference on the protection of the environment against ionising radiation. The motive for the conference was the need to study the ethical and philosophical basis for protection of nature in its own right. The conference was funded by Nordic Nuclear Safety Research (NKS), in cooperation with the International Union of Radioecology (IUR). The National (...) Committee for Research Ethics in Science and Technology (NENT) was hired as facilitators for the consensus process. This paper will give a brief outline of the aims and method of the conference, distinguishing these from other kinds of consensus conferences. The paper ends with some general reflections on the appropriateness of seeking consensus on ethics-related issues among experts. (shrink)

Some of the major problems in radiation protection are closely connected to issues that have a long, independent tradition in moral philosophy. This contribution focuses on two of these issues. One is the relationship between the protection of individuals and optimisation on the collective level, and the other is the relative valuation of future versus immediate damage. Some of the intellectual tools that have been developed by philosophers can be useful in radiation protection. On the (...) other hand, philosophers have much to learn from radiation protectors, not least when it comes to finding pragmatic solutions to problems that may be intractable in principle. (shrink)

In order to investigate the relationship between scientific evidence and social commitments this article addresses three questions: does low dose ionizing radiation cause cancer? Is the answer to this question different in a social setting than in a scientific context? What are the consequences of the answers of 1 and 2 for the relationship between epistemology and ethics as played out in radiation protection? Conceptual analysis with basis in the philosophy of science, in particular traditional theories of (...) causality. Whether low dose ionizing radiation causes cancer deeply depends on what we mean by causality. According to traditional scientific conceptions of causality it is not warranted to say that low dose ionizing radiation causes cancer. Standard approaches in radiation protection, however, imply that there is a causal connection, which is due to the strong social commitment in the field. There is a close relationship between social and scientific conceptions of causality, posing a series of challenges: one being that scientists covertly become moral experts, another one that the general public can be misinformed. There is a difference between causality in science and in policy making. Mixing these conceptions, as sometimes is done in radiation protection, can be misleading. Whether low dose ionizing radiation causes cancer is a social and not only a scientific issue. As such those who are warranted to have a say. (shrink)

It seems likely that there is no threshold for the induction of cancer by ionising radiation. Hence even small radiation doses may result in a finite number of premature deaths if a large number of people are exposed. Various arguments are used to demonstrate that such deaths, if they occur, are acceptable; these arguments are shown to be flawed. Many of the arguments, and the ICRP's principle of justification, appear rooted in a utilitarian system of moral philosophy. Such (...) a system is superficially attractive as it appears objective and rational; however, the objectivity may be an illusion masking the underlying aims of the interested parties. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Examining the Ethics of Human Subjects ResearchPaul S. Appelbaum (bio)The work of the Advisory Committee on Human Radiation Experiments confirms once again the value of combining empirical and normative approaches to problems in clinical and research ethics. The Committee, like its predecessor, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, spent relatively modest sums of money gathering targeted data (...) to inform its deliberations. The results of the Committee’s research, which are discussed by Nancy Kass and Jeremy Sugarman in this issue of the Kennedy Institute of Ethics Journal, enhance our understanding of the current ethical status of human subjects research, helping to focus attention on areas of particular concern, and lay the basis for future research and policy development.My comments here focus on the two major empirical studies conducted by the Committee—the Research Proposal Review Project and the Subject Interview Study. I will underscore just a few of the primary findings from these studies, consider their limitations, and explore their implications. Readers interested in the details of the studies should consult the Committee’s Final Report (ACHRE 1995), on which I rely in part and which provides additional information on the methodology and findings of the studies.Research Proposal Review ProjectWhat can be learned from the Committee’s review of 125 federally-funded human research studies? In answering that question, one cannot ignore the irony inherent in the Committee’s decision to review documents related to institutional review board (IRB) consideration of the selected protocols. The single most frequent complaint about the current system for protecting human subjects is that IRBs focus almost exclusively on review of consent forms and other research documents, as if they bore some close relationship to what actually transpires between investigators and potential research subjects. Only a small number of studies examine the research consent process. Nevertheless, existing data strongly [End Page 283] suggest that subject recruitment often involves an extended process of courtship, during which the information contained in consent forms is only a small part of the information passed between investigators and subjects (Benson, Roth, and Winslade 1985; Lidz et al. 1984).Indeed, the second of the Committee’s studies—the Subject Interview Study, which is discussed below—appears to confirm these findings. In-depth interviews with 99 individuals who reported that they were former or current research subjects suggest that “[f]or many, the decision to participate seemed to have been made before the consent form was given to them, and they signed it almost as a formality” (ACHRE 1995 [GPO, p. 742; Oxford, p. 471]). 1 Why, then, did the Committee focus its attention on documents that in many cases seem to play only a tangential role in the consent process? As is the case with IRBs around the country, the answer appears to be that consent forms and related documents are the only easily available window on consent transactions. In addition, under the current system, consent forms constitute the part of the process that IRBs can influence most easily. Consequently, it suits almost everyone’s needs—except perhaps those of the research subjects—to pretend that they reflect what actually transpires in the recruitment process. To the Committee’s credit, it was well aware of this dilemma. Nonetheless, it struggled to wring valid lessons from these limited data in its Final Report.Perhaps the most interesting finding from the Research Proposal Review Project is just how poor so many consent forms are. Given the disproportionate emphasis that many IRBs place on the content of the forms, one would expect that investigators by now would have learned to design documents that meet objective standards of adequacy, such as those applied by the Committee. Indeed, except in the most unusual circumstances, doing so would virtually guarantee that the IRB will ask no further questions about subject recruitment procedures. Although the data justify the inference that many investigators do not yet understand which information is essential to communicate to potential subjects, nor have learned how to do so effectively, they also force us to a still more radical conclusion. If the IRBs were doing their jobs, the Committee... (shrink)

Many people argue that uncertain science -- or controversial policies based on science -- can be clarified primarily by greater attention to the social and ethical values influencing the science and the policy and by greater attention to the vested, economic interests involved. This paper argues that while such clarification is necessary, it is neither a sufficient condition, nor even the primary means, by which to achieve better science and better policy. Using a case study involving the current, highly politicized (...) controversy over the shape of dose-response curves for biological effects of ionizing radiation in both the protective action levels (PALS) and the International Commission on Radiological Protection (ICRP) environmental proposals, the paper argues that the conflict could be resolved largely through five specific methodological improvements in the areas of metascience and philosophy of science. (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)

Despite previous political efforts, AGW (IPCC, 2013) remains one of the present century’s primary political issues, with major economic expenditure required for mitigation and adaptation (Stern, 20...

In lieu of an abstract, here is a brief excerpt of the content:IntroductionAnna Mastroianni (bio) and Jeffrey Kahn (bio)In this issue of the Kennedy Institute of Ethics Journal, we subject the work of the Advisory Committee on Human Radiation Experiments to examination from many angles. Nearly one year has passed since the release of the Committee’s final report and recommendations, and it seems an appropriate time to invite discourse and reflection on the influence and impact of the Committee and (...) its efforts. Our intent is to advance understanding of the Committee and its work, its place in the evolution of bioethics and public policy, as well as the broader legacy of restoring trust in the conduct of human subjects research.In 1993, President Clinton and Secretary of Energy Hazel O’Leary initiated an investigation of America’s involvement in radiation experiments on its citizens during the Cold War. The investigation resulted in the appointment of the Committee in January 1994. Some issues raised by these radiation experiments were brought to the attention of the nation by revelations contained in a Pulitzer Prize-winning series of newspaper stories about plutonium injections carried out by the government on allegedly unsuspecting subjects during the Cold War. The Committee faced a broad mandate, which included piecing together the history of Cold War radiation experiments and human subjects research, as well as recommending remedies for past wrongs and mechanisms to ensure that such wrongs could not be repeated in the future.This issue of the Journal consists of articles and accompanying commentaries on historical, philosophical, policy, and political aspects of the Committee’s work that are important to bioethics. This collection of articles, authored by Committee members, staff, and leading scholars, is designed to paint a picture of the breadth and complexity of the Committee’s efforts and to provide context and to stimulate discussion of significant issues.In the first article, Ruth Faden provides her unique perspective as chair of the Committee. She goes beyond the necessary overview and background of the Committee to reflect on the impact and meaning of the Committee’s work to bioethics and public policy.Much of the Committee’s effort was directed at gathering and uncovering information about the history of Cold War radiation experiments, an endeavor fairly foreign to bioethics but critically important to understanding the context in which to make moral judgments about the past. Jonathan Moreno and Susan Lederer discuss how the Committee’s work changed some of the traditional views of the history of research ethics. The commentary by Allan Brandt and Lara Freidenfelds further illuminates the value of understanding this recovered history. [End Page ix]In making moral judgments about the past, the Committee confronted complex questions about how to assess wrongdoing and the culpability of the government and its agents. Allen Buchanan explains why this was such a difficult but crucial task and how the Committee worked through some of the answers to these questions. His discussion illustrates the challenges to consensus in the committee decision-making process described in Ruth Macklin’s article in this issue on committees and consensus. Tom Beauchamp analyzes the frameworks for making retrospective moral judgments developed by two committees, the Advisory Committee and the University of California at San Francisco Ad Hoc Fact Finding Committee on World War II Human Radiation Experiments, and critiques their applications of the frameworks in the case of the plutonium injection experiments.The Committee recognized that in order to prevent wrongs seen in the past from occurring in the future, it would be necessary to understand the human subjects protections now in place. Nancy Kass and Jeremy Sugarman discuss the results of the Committee’s attempts to measure the operation and effectiveness of the current system for protection of human subjects. Paul Appelbaum comments on the relevance and value of the Committee’s empirical projects to contemporary human subjects research.The Committee’s work, and the products of any commission’s work, must be viewed partly in light of the place of commissions in bioethics scholarship and policymaking. Appointed commissions can have significant impacts on scholarly and public thinking, policymaking, and future direction, and bring high visibility to issues. It is important to realize that the conclusions of the Committee... (shrink)

The Federal Trade Commission has an important role to play in the governmental oversight of mobile health apps, ensuring consumer protections from unfair and deceptive trade practices and curtailing anti-competitive methods. The FTC’s consumer protection structure and authority is outlined before reviewing the recent FTC enforcement activities taken on behalf of consumers and against developers of mhealth apps. The article concludes with identification of some challenges for the FTC and modest recommendations for strengthening the consumer protections it provides.

The acquisition of a nuclear power reactor from the North American company Westinghouse in 1964 not only brought atomic practices and knowledge to Spain but also introduced new methods of industrial organization and management, as well as regulations created by organizations such as the US Atomic Energy Commission and the International Atomic Energy Agency. This article analyzes the history of the knowledge, regulations and experimental practices relating to radiation safety and protection that traveled with this reactor to (...) an industrial space: the Zorita nuclear power plant. Within this space, the appropriation, use, and coproduction of knowledge and practices were conditioned by political, economic, industrial and social factors, and by the engineers, researchers and other professionals who contributed expert knowledge. Material held in the Tecnatom Historical Archive—the engineering company that coordinated construction of the plant—is the main source for this work, which delves into the history of knowledge and atomic technologies and adds to the historiography of radiological protection in Spain.ZusammenfassungMit dem Kauf des ersten Kernreaktors von der nordamerikanischen Firma Westinghouse im Jahre 1964 gelangten neue atomare Praktiken und Kenntnisse nach Spanien, ebenso wie neue Formen der Organisation und des Managements dieses Industriezweigs und bis dahin in Spanien unbekannte Regelungen, wie z. B. die der US Atomenergiekommission und der Internationalen Atomenergiebehörde. Der vorliegende Artikel analysiert die Geschichte des – angeeigneten, genutzten und koproduzierten – Wissens, der Vorschriften und der experimentellen Praktiken hinsichtlich der Strahlensicherheit und des Strahlenschutzes, die mit der Inbetriebnahme des Reaktors im industriellen Komplex des Kernkraftwerks Zorita einhergingen. Dort, wo Wissen und Praktiken durch politische, wirtschaftliche, industrielle und soziale Faktoren bedingt waren, waren neben den Ingenieuren und Forschern auch andere Fachleute beteiligt, die gleichermaßen kompetentes Wissen beisteuerten. Das Material, das im Historischen Archiv von Tecnatom, dem Ingenieurbüro, das den Bau der Anlage koordinierte, aufbewahrt wird, ist die Hauptquelle dieser Arbeit, die versucht, die Geschichte des Atomwissens und der Atomtechnologien zu vertiefen und die Darstellungen zur Geschichte des Strahlenschutzes in Spanien zu erweitern. (shrink)

: In light of information uncovered about human radiation experiments conducted during the Cold War, an important charge for the Advisory Committee on Human Radiation Experiments was to assess the current state of protections for human research subjects. This assessment was designed to enhance the Committee's ability to make informed recommendations for the improvement of future policies and practices for the protection of research subjects. The Committee's examination of current protections revealed great improvement over those from the (...) past, yet some problems remain. Although the data collected by the Committee highlight specific areas in need of attention, the Committee's work should be viewed in part as the beginning of a series of ongoing assessments of the adequacy and effectiveness of the protections afforded to human subjects. (shrink)

Like the National Commission and the President's Commission, the Advisory Committee on Human Radiation Experiments was formed to carry out specific ethical tasks. Yet the committee also had an “openness” mission, a charge to investigate allegations that the U.S. government secretly exposed Americans to environmental releases of radiation. Eighteen months later—and after sixteen public meetings, more than 200 interviews, and the review of about 400,000 documents—the committee delivered a 925‐page report to the president.

In this paper, I discuss from a philosophical viewpoint the so-called radiation problem that resulted from the Fukushima Daiichi Nuclear Power Station accident after the Great East Japan Earthquake in 2011. The starting point lies in the conceptual distinction between “damage due to radiation” and “damage caused by avoiding radiation.” We can recognize the direct “damage due to radiation” in Fukushima as not serious based on the empirical data so that I focus upon the problem of (...) the “damage caused by avoiding radiation,” particularly the damage due to evacuation actions. Actually, evacuation actions caused more refugees to die of suicide and diseases than supposed. Obviously, there is a practical problem on whether the forceful and emergent evacuationwas needed. In addition, I will point out that some people psychologically had negative feelings about the radiation problem altogether, for example, absurdity, discomfort, anxiety, or distrust, where some of them tend to twistedly solve those by giving moral censure to people and the product in affected areas. This brought about serious harm to people in Fukushima. I will interpret some people’s careless adoption of precautionary principle and their misunderstanding of the legal standard in radiation protection as being latent in this tragedy. (shrink)

This paper is about human rights and policing in Bangladesh, with special focus on the role of National Human Rights Commission. The protection and promotion of human rights in Bangladesh has become difficult as the law enforcement agencies, particularly the police and the Rapid Action Battalion, are involved in human rights violations. An overall culture of impunity for human rights violations exists in Bangladesh. The National Human Rights Commission appears to have failed to break the culture of (...) impunity in Bangladeshi politics. This paper explains the reasons why the National Human Rights Commission in Bangladesh largely fails to make the political system in particular law enforcement agencies accountable. (shrink)

Are cures for cancer being suppressed by the mainstream medical profession to protect corporate profits? Is what we are being told about global warming true, or is there a hidden agenda? How many alternative scientific theories and 'fringe' practitioners have been suppressed by the power elite to maintain their stranglehold on what, and what not, the American public is allowed to know?In Suppressed Science: Radiation, Global Warming, Alzheimer's, Grizzly Bears, Crop Circles and More, chemical engineer, amateur climatologist, author, AMERICAN (...) FREE PRESS columnist, USAF major (Retired) and, yes, rocket scientist Jack Phillips delves into these questions and many more as he uncovers the facts behind the facade of lies that fronts for modern science. (shrink)

The National Academy of Science's 1956 study on the Biological Effects of Atomic Radiation was designed to provide an objective analysis to assess conflicting statements by leading geneticists and by officials in the Atomic Energy Commission. Largely because of its status as a detached, non-governmental evaluation by eminent scientists, no studies have had a broader impact on the development of biological thinking in regard to nuclear policies. This paper demonstrates that despite the first BEAR study's reputation as an (...) objective and independent study, it was the product of careful negotiation between Academy scientists, the Atomic Energy Commission, and Britain's Medical Research Council. This paper also reveals the fragility of the consensus that produced the Academy's report, the range of political uses of the report, and the subsequent disaffection of the scientists who took part in it. (shrink)

The National Commission for the Protection of Human Subjects of Bio-medical and Behavioral Research ended its work by substantially endorsing the status quo which places primary reliance on local Institutional Review Boards for subject protection. This was predictable because of the commission's researcher-dominated composition which permitted it to assume that research is good; experimentation is almost never harmful to subjects; and researcher-dominated IRBs can adequately protect the interests of human subjects. The successor Presidential Commission can (...) learn much by reexamining these premises. (shrink)

Medical doctors are commissioned by the migration authorities and/or border police to assist in decision making about asylum seeker’s requests for residency permits in Sweden. They are asked to: (i) assess the formal written medical opinions made by physicians in support of asylum or humanitarian narratives in the asylum process and/or (ii) to make medical assessments of persons considered for deportation. This arrangement raises questions such as: How is the decision making process carried out? How is medical knowledge used, and (...) who ought to make decisions about medical evidence in the asylum process? Does this approach effect public health overall? There are longstanding concerns that medical assessments to certify whether a person is fit for transport or not, can have a direct, negative impact on persons in need of care and protection. A separate structure of doctors commissioned by the immigration authority seems to raise professional tensions, politicizes medical constructs and contributes to moral disengagement. Empirical data are used to illustrate this discussion with reference to medical issues, medical ethics, public health and legal discourses. I then reflect on key value conflicts using public health ethics theory and conclude with implications for public health ethic theory, policy and practice. (shrink)

Succession of states regains its importance in current geopolitical situation as now we are witnessing a possible new wave of state succession: South Sudan has been accepted to the United Nations, Kosovo’s independence has been recognized by many countries, Palestine has gained new status in the United Nations, etc. This would lead to the necessity to resolve questions related to succession of states, which might, among other subjects, include issues of diplomatic protection which was subject to international legislation – (...) International Law Commission has prepared the Draft Articles on Diplomatic Protection. However, General Assembly is still not ready to adopt this document as a convention, therefore the term to consider possible ways of handling the issues on diplomatic protection within the UN was extended till 2013. Draft articles give the definition of diplomatic protection, indicating the main features of this institute. However, sometimes the difference among the institutes being called the same name with diplomatic protection might cause misunderstandings when analyzing the issue both in general and in the context of succession of states. One of the main prerequisites for diplomatic protection recognized in the jurisprudence of International Court of Justice is the Mavrommatis rule, which indicates that when protecting the citizen’s rights, state in reality is asserting its own right. This rule has been cited in other cases, however, especially now, when individuals already have quite a number of measures to protect their individual rights independently from the actions of state, it has been acknowledged that the rule is fictitious. This recognition, reflected in the Draft Articles and indicated in the commentary of it, is most welcomed as it helps to resolve questions related to the succession of states. There is a need to understand that there is a difference between international obligations under which state is entitled to diplomatic protection and those under which it really asserts its own rights, despite the fact that the latter might also be related to the rights of individuals. This difference is also important in the context of the succession of states, as the consequences arising out of the breach of these obligations in the context of state succession might differ. The last but not least issue addressed in the article is the question of the succession to treaties, which indicate individual rights, but does not form a customary international law. The question is whether the successor state is entitled to diplomatic protection on behalf of its succeeded citizen in a case of a breach of international treaty which was not subject to succession by the successor state. Taking everything into account, there are issues which are not addressed in the Draft Articles on Diplomatic Protection. Herewith there are issues of diplomatic protection which should be addressed in a case of state succession. Nonetheless, it should be reminded that diplomatic protection is always subject to the decision of the state itself, it is just important that newly created states understand and know the possibility to invoke international responsibility of the third state using the means of diplomatic protection, even if the injury was made to its national before the moment of state succession. (shrink)

The use of experimental animals, mostly rodents, in biomedical research and especially in oncology and immunology should be acknowledged with respect, recognizing the contribution of animal experimentation in the fascinating scientific progress in these disciplines of research. It is an obligation of the investigator to justify the scientific and ethical aspects of each study requiring the use of animals. The international guiding principles for using animals in biomedical research are well defined and have been distributed worldwide by the International Council (...) for Laboratory Animal Science (ICLAS) since 1956, when this Organization was founded. In Poland the ICLAS philosophy and principles are highly respected and were implemented firstly by the members of the Commission on Biology of Experimental Animals appointed in 1962 by the Department of Medical Science of the Polish Academy of Science in Warsaw. Animal Protection Acts, first proclaimed in 1928 were gradually modified and improved. Actual legislation (enacted in 1997, 2003 and 2005) is consistent with EU Directives (86/609/EEC) and follows the internationally recommended principles that include ICLAS guidelines concerning animal welfare and care condition in biomedical research. The problem of “alternative methods” is briefly discussed. Dr. Donald Boisvert, CCAC — Canadian Council on Animal Care. (shrink)

This article looks at the human rights protection in transitional post-uprising Tunisia, from 2011 to 2017, offering insights into the willingness to both protect human rights and build capacity in Tunisia. It focuses on the establishment of an adequate legal framework in Tunisia, with particular attention being paid to the constitution-making process and, on the establishment, the strengthening of certain institutional capacities, such as the constitutional court and the Truth and Dignity Commission. The article first gives a brief (...) historical overview of the human rights situation in Tunisia. This is followed by an analysis of the willingness and capacity to protect human rights in post-uprising transitional Tunisia, in both the 2011–2014 and 2014–2017 periods.This article is based on evidence from a series of semi-structured interviews I conducted with the key political actors from various political parties, and actors from NGOs working on human rights, during field research in Tunisia in October-November 2017, supplemented by secondary literature. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Protecting Human Research SubjectsThe Office for Protection from Research RisksJoan Paine Porter (bio)The office for Protection from Research Risks (OPRR), located within the National Institutes of Health, has two divisions: Human Subject Protections and Animal Welfare. This article will address the overall responsibilities and current projects relating to human subject protections.OPRR implements the Department of Health and Human Services' (HHS) regulations for the protection of human (...) subjects (45 CFR 46 (1991)). These regulations fulfill the responsibilities set forth in the Public Health Service (PHS) Act with regard to institutional review boards (IRB) and other protections for human subjects involved in biomedical and behavioral research conducted or supported by HHS. The PHS Act also mandates a program to clarify ethical issues in biomedical research involving human subjects and to address violations of the rights of human subjects of research (P.L. 99-158 (1985)).OPRR staff negotiate assurances of compliance with institutions conducting Federally-supported research involving human subjects. The assurances describe the policies and procedures each institution will follow to fulfill the requirements of the regulations, including specific IRB composition and functions.In addition, OPRR cosponsors with the Food and Drug Administration and awardee institutions a series of regional workshops that address human subject protections issues. These are attended by IRB members, institutional officials, research investigators, and others involved with human subject protections.Current ActivitiesNumerous activities are underway in OPRR. The following describes only a few of the initiatives and studies aimed at helping develop policies and procedures to protect human subjects of research."Points to Consider" DocumentsOPRR is currently working with the National Center for Human Genome Research (NCHGR) to develop a "points to consider" document for IRBs and others involved in large genetic pedigree studies. Many questions have emerged [End Page 279] on topics such as how subjects should be recruited, with whom information should be shared about others in the family, social risks of disclosure in employment and insurance, the circumstances and timing of informing subjects about study results, and involvement of children. OPRR and NCHGR hope to assemble a group this fall to review and refine the points that are now being developed jointly. A conference in South Carolina organized by the American Association for Advancement in the Sciences entitled "Project on the Ethical and Legal Implications of Genetic Testing," helped generate advice, and identified some of the more controversial issues in design and conduct of genetic research that involves large groups of family members.Another "points to consider" effort concerns enrollment of women and minorities in research. The PHS has established a policy that members of these groups must be included in research projects unless there are valid scientific justifications for their exclusion which can be made on a project by project basis (ADAMHA/NIH Policy 1990; NIH/ADAMHA Policy 1990). OPRR has commissioned several scholarly papers to help in developing "points to consider" for IRBs as they balance issues of equitable selection of subjects and protection of these selected individuals. Concerns about enrolling women of childbearing age in research that may be harmful to a fetus, and liability issues frequently dominate discussion in this area. The papers will address ethical, legal, and statistical aspects of enrollment of minorities and women as well as provide a description of various practices and roles of IRBs in addressing goals of fair selection of participants and appropriate protections.OPRR is also working with the PHS Panel on Women, Adolescents and Children to produce a document, also in the form of "points to consider" guidance, concerning enrollment of children who are wards of the state in HIV-related research. Subpart D of the regulations for the protection of human subjects (45 CFR 46) specifically addresses research involving children who are wards of the state, including the special protections that must be provided. State and local officials who have authority to enroll foster care children in research have indicated a desire to obtain advice in this area.The IRB GuidebookA major project that is now being completed under contract to the Poynter Center at Indiana University is the IRB Guidebook. It will revise and expand the current IRB Guidebook produced in the 1980s... (shrink)

20 years ago, the Report of the Commission on Research Integrity was submitted to the Secretary of the Department of Health and Human Services and to House and Senate Committees. As directed in enabling legislation, the Commission had provided recommendations on a new definition of research misconduct, oversight of scientific practices, and development of a regulation to protect whistleblowers. Reflecting the ethos of the time, the Commission recommended that institutions receiving Public Health Service research funding should provide (...) oversight of all but the most egregious misconduct. The suggested definition of research misconduct was organized around misappropriation, interference and misrepresentation, which would have addressed collaborative/authorship disputes and sabotage in scientific laboratories, both of which remain unaddressed in current policy. The Commission also recommended the Whistleblower Bill of Rights and Responsibilities which would have authorized remedies for whistleblowers who experienced retaliation and sanctions against retaliators. Response from the scientific community was highly critical, and none of the Commission’s recommendations was accepted. No new body has examined issues within the Commission’s charge, there has been no significant Congressional or public pressure to do so, institutions have not been able to sustain standards that would have avoided current concerns about bias and irreproducibility in research, and there is still no entity in science capable of addressing issues assigned to the Commission and other urgent issues. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Another Bioethics Commission?Renie Schapiro (bio)Ever Since the Ill-Fated Biomedical Ethics Advisory Committee (BEAC) ended almost before it began a few years ago, bioethicists and the members of Congress who take an interest in them have wondered whether a governmental commission is still a feasible way to address bioethics issues.The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in the 1970s, (...) and the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research in the early 1980s, have generally received high marks for their work. But since the expiration of the President's Commission in 1983, no federal body has been able to sustain the momentum.Tempers around the abortion issue couldn't be tamed enough even to elect a board chairman for the BEAC, or for the body to begin studying the issues. From its inception, abortion politics threatened to dog its work.Both the National Commission and the President's Commission studied issues touching on the abortion question. The President's Commission reported on genetic screening. The National Commission looked at fetal research. Both were able to produce respected reports that largely steered clear of the abortion acrimony.But that was then. The question facing policy makers inside the Beltway is how we can learn from the past experiences to make some new body work now. The question extends far beyond the abortion issue, of course.When certain people in Washington start asking questions, the answer usually comes by way of a study. Sometimes, as in this case, more than one study.In the March 1992 issue, this Journal reported on an Institute of Medicine study on ethics commissions. That study is still underway. It is scheduled to be completed in January 1994.More recently, the Office of Technology Assessment (OTA), an arm of Congress, also took on the issue. The OTA project is intended to be a quicker, more confined study. It began last fall and a final report is expected later this month.The primary force behind the OTA study is Senator Mark Hatfield. In a September 8, 1992 letter, co-signed by Senators Edward Kennedy and Dennis DeConcini, he asked OTA to prepare a background report to assist Congress in [End Page 77] "determining what is the best approach to explaining policy problems with biomedical and ethical dimensions."The letter noted: "As the 21st Century approaches, Congress will face policy dilemmas for which an informed decision can only be made through understanding not just the legal or economic dimensions of the questions, but the ethical considerations as well."Hatfield's interest in bioethics issues over the past few years has centered largely on biotechnology, and particularly patent rights. He had planned to introduce legislation to put a moratorium on patenting of genetically altered organisms, which according to Hatfield staffer Douglas Pahl caused a "firestorm" in the biotechnology community.As a result, Kennedy and DeConcini said they would hold hearings on the issue if Hatfield would withdraw the amendment. The three agreed to request a short-term OTA report on possible governmental structures for dealing with bioethics issues and a longer report looking at patenting issues.In their letter, the three senators asked OTA to prepare a history of bioethics in public policy. Referring specifically to the past commissions, they asked, "What lessons can we learn from each of these—or similar—entities? What worked, or did not work, and why?" The request also asked OTA to examine international institutions.In response to the request, OTA held a workshop entitled "Biomedical Ethics in U.S. Public Policy" on December 4, 1992. It brought together 15 people who had participated in commissions—from local to international—as well as observers of these bodies and health professionals who used their products.1According to project director Robyn Nishimi, the workshop was meant to be a free-wheeling discussion. Although there was no total consensus, the focus of the discussion tended to be on how to make a commission function effectively, rather than on whether there should be one. That workshop will be part of a report of about 40-60 pages OTA hopes to... (shrink)

Presidential commissions come and go by design, and it is reasonable to wonder about the impact of their recommendations. I have been involved in the work of two presidential commissions: as a member of the Advisory Committee on Human Radiation Experiments (from 1994 to 1995) and as senior consultant to the National Bioethics Advisory Commission (from 1999 to 2000) for its report on multinational research. I continue to reflect on and look for the impact of both these commissions.ACHRE's (...) charter included the review of experiments with ionizing radiation sponsored or conducted by the United States government since the 1940s. The committee was also charged with investigating specific intentional releases of radiation into the environment. ACHRE had a somewhat unique difficulty built into its work: the need to make retrospective ethical judgments. With the National Bioethics Advisory Commission, my main role as senior consultant consisted of writing chapters of the report on multinational research for the commissioners’ approval. A more important concern for me as a hired consultant was how to maintain intellectual and moral integrity. Unlike when writing scholarly papers, where I can express my own views, when I was drafting text for a presidential commission, the commissioners’ views took precedence over my own when we disagreed. I wondered, how much could I comply with the commissioners’ positions without compromising my own integrity? (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Fallout from Government-Sponsored Radiation ResearchCarol Mason Spicer (bio)On December 28, 1993, Energy Secretary Hazel R. O'Leary publicly appealed to both the executive and legislative branches of the United States Government to consider compensation for individuals who were harmed by their exposure to ionizing radiation while enrolled in government-sponsored studies conducted between 1940 and the early 1970s.1 The call for compensation was issued three weeks after Secretary O'Leary (...) disclosed that radiation experiments involving humans, sometimes without their consent, had occurred under the auspices of the Atomic Energy Commission (AEC), a forerunner of the Department of Energy (DOE). Secretary O'Leary directed her department to investigate the nature and extent of the experiments, report on their medical and ethical acceptability, and locate the research subjects or their families.Background to the Federal Advisory CommitteeDespite the fact that the existence of many government-sponsored radiation experiments was not a secret—much of the research was reported at the time in scientific journals, and in 1986, Representative Edward J. Markey (D-MA) conducted congressional hearings on such radiation research—Secretary O'Leary's disclosure of the AEC experiments and her call for compensation made the experiments common knowledge and sparked a swift and complex governmental response involving both the executive and legislative branches.It is curious that the "radiation experiments" have garnered so much attention now, since they were virtually ignored in the wake of the 1986 hearings. Secretary O'Leary's disclosure of the radiation studies grew out of a general reassessment of secrecy in government. In April 1993, the Clinton administration set out to review the system of government secrecy that evolved during the Cold War, and in May 1993, DOE began reviewing and declassifying files pertaining to nuclear weapons research. When Dan Reicher, a top aide to Secretary O'Leary, informed her in November of the impending publication of an Albuquerque Tribune investigative report (Welsome 1993) on an experiment conducted between 1945 and 1947 in which 18 subjects were injected with plutonium, [End Page 147] the topic of questionable research involving the exposure of human subjects to radiation was added to the DOE list of information to be disclosed. At the time, it was thought to be but one small part of a massive quantity of DOE information to be made public.As part of its effort to investigate the radiation experiments, DOE established a toll-free telephone hot line for individuals who thought they might have been the subjects of radiation exposure experiments. The hot line, originally staffed by three people to handle the anticipated few dozen calls per day, received more than 2,000 calls in the first week. By early January the hot line was flooded with 6,000 to 10,000 calls daily, and its staff had increased more than ten-fold. Although many of the calls were deemed not to be candidates for further investigation, the extent of the radiation-related experiments, sponsored not only by AEC, but also by the military and other government departments and agencies, took officials by surprise.On December 30, the Department of Defense, the Department of Veterans Affairs, and the National Aeronautics and Space Administration all announced that they were initiating thorough reviews of their files to determine the extent and nature of any radiation experiments conducted under their auspices.2 In January, the CIA and the Department of Health and Human Services, including the National Institutes of Health, followed suit.The White House publicly entered the arena in late December announcing that it would hold a meeting on January 3, 1994, to help coordinate the government's investigative effort. At the same time, Senator Edward M. Kennedy (D-MA) called for a mid-January congressional hearing to investigate experiments conducted between 1946 and 1956 in which mentally retarded boys at the Fernald State School in Massachusetts were fed radioactive iron supplements or milk containing radioactive calcium to enable researchers to trace the absorption of those nutrients. Senator Kennedy's hearing, conducted by the Subcommittee on Health of the Senate Committee on Labor and Human Resources, was the first of a number of congressional hearings held earlier this year to investigate the... (shrink)

The aim of the Directive 2005/29 on unfair commercial practices is to contribute to the proper functioning of the internal market and achieve a high level of consumer protection by way of approximation of the laws, regulations and administrative provisions of Member States relating to the elimination of these practices. As announced to the European Commission’s Green Paper, the Commission felt that the existing regulations in the Member States in that the regard to show significant differences causes (...) legal uncertainty and barriers to the operation of the internal market, including building consumer confidence in cross-border transactions. The advantage of the full unification of the law is to strengthen the autonomy of Community law, the achievement of effectiveness. It is questionable whether it is due to the subject matter which is the maximum harmonization discussed act will actually serve to protect economic interests of the consumer. In particular, it undermines the treaty-legal basis, which clearly is aimed at strengthening the single market. Also changes in the Lisbon Treaty, particularly Article 3 TEU, are aimed at establishing the internal market. In the last judgments, like on 9 November 2010 we find that Directive 2005/29 must be interpreted as precluding a national provision, which lays down a general prohibition on sales with bonuses and is not only designed to protect consumers but also pursues other objectives. Does the new act in consequence of the implementation of the national member states give great scope for the flexible operation and may become an effective instrument of pressure to improve business practices? (shrink)

The International Commission on Intervention and State Sovereignty's report, The Responsibility to Protect, argues that when a state is unable or unwilling to uphold its citizens? basic human rights, such as in cases of genocide, ethnic cleansing, and crimes against humanity, the international community has a responsibility to protect these citizens by undertaking humanitarian intervention. An essential issue, however, remains unresolved: which particular agent in the international community has the duty to intervene? In this article, I critically examine four (...) ways of assigning this duty. Although I highlight the benefits of institutionalising the responsibility to protect, I argue that we should adopt, in the short term at least, a consequentialist solution: humanitarian intervention should be the responsibility of the intervener that will be the most effective. (shrink)