This is the third of three volumes containing a report from the International Panel on Social Progress. The IPSP is an independent association of top research scholars with the goal of assessing methods for improving the main institutions of modern societies. Written in accessible language by scholars across the social sciences and humanities, these volumes assess the achievements of world societies in past centuries, the current trends, the dangers that we are now facing, and the possible futures in the (...) twenty-first century. It covers the main socio-economic, political, and cultural dimensions of social progress, global as well as regional issues, and the diversity of challenges and their interplay around the world. This particular volume covers topics such as world cultures and religions, families, global health, education, and the contributions of social sciences to institutional change. (shrink)

The National Institutes of Health is the largest biomedical research institution in the world. It has become one of the world's most highly respected research centers in part because of its efforts over the years to provide the research community with leadership in both the ethical and scientific parameters of research involving humans. As its 113th birthday approaches at the turn of the century, its great legacy is providing an environment to stimulate and nourish the diversity and (...) creativity of ideas, and thereby enable science to progress. This research must continue to be guided and tempered by consistent and critical federally-supported ethical analyses. (shrink)

The consideration of racial differences in the biology of disease and treatment options is a hallmark of modern medicine. However, this time-honored medical tradition has no scientific basis, and the premise itself, that is, the existence of biological differences between the commonly known races, is false inasmuch as races are only sociocultural constructions. It is time to rid medical research of the highly damaging exercise of searching for supposed racial differences in the biological manifestations of disease. The practice not only (...) condoned but required by the National Institutes of Health of utilizing racial identification as a demographic characteristic with assumed biological implications is at best badly flawed, and at worst unintentionally contributes to perpetuating the fallacy of natural differences between persons of different skin color, which has been used in the past to advance the cause of racial discrimination. (shrink)

This paper is a critique of NIH guidelines for the care and protection of laboratory animals. It exposes four serious deficiencies in these guidelines: (1) failure to make it dear that the mere pursuit of knowledge does not justify using animals; (2) failure to give any guidance concerning what constitutes human benefit or well-being; (3) failure to countenance trade-offs between human benefit or well-being and animal well-being; (4) failure to clearly specify what constitutes keeping animals in an ‘environment appropriate to (...) the species and its life history.’ It concludes with the suggestion that the construction and revision of these guidelines is too important to be left to the professionals. Keywords: animals, benefit, NIH, research, trade-offs, well-being CiteULike Connotea Del.icio.us What's this? (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 15.2 (2005) 199-210 [Access article in PDF] Conflict-of-Interest Policy at the National Institutes of Health: The Pendulum Swings Wildly* Evan G. DeRenzo **This article addresses the National Institutes of Health (NIH) employee conflict-of-interest (COI) policy that went into effect February 2005. It is not, however, merely an account of another poorly crafted government policy that cries out for (...) revision. Instead, it is also a story about one of our nation's most important and prestigious institutions and its struggles to navigate the crosscurrents of scientific aspirations, power politics, public ambivalence toward capitalist economics in the biosciences, and the media's inclination to exaggerate problems and under report complicated facts. It is also a tale of greed, politics, purgatory, and redemption. The dramatic and abrupt change in the NIH COI policy demonstrates the difficulty of balancing the production of cutting-edge science with the demands for transparency resulting from work performed in the public interest on the public tab. It is an unhappy chapter in the life of a government agency that is also a national treasure. And, one hopes, it will be an example of how harmful and ill-conceived law can be revised and amended to advance national health and well-being. What is the New NIH COI Policy? The new NIH COI employee policy, more accurately referred to as the Interim Final Rule (Federal Register 2005), is a sweeping set of prohibitions on activities and holdings to reduce the possibility that NIH employees will have any actual [End Page 199] or apparent conflicts of interest. For the most part, the prohibitions are applied across-the-board—i.e., without distinction to employee category or function. The new policy includes prohibitions on outside activities, stock holdings, and awards. It prohibits all NIH employees from engaging in any compensated or uncompensated employment, including consulting, serving on advisory or other such boards, and compensated teaching, speaking, writing, or editing with certain kinds of entities. The first class of such entities is referred to as substantially affected organizations, defined as biotechnology, pharmaceutical, medical device companies, and others with similar interests. But these are not the only entities included in the prohibitions. Other organizations from which NIH employees now are cut off are hospitals, clinics, and other health care institutions; health, science, or health research-related professional associations and consumer and advocacy groups. Included also are educational institutions and not-for-profit independent research institutes that are, or were, recent NIH funding applicants, grantees, contractors, or cooperative research and development agreement (CRADA) partners. The only exemptions appear to be for health care institutions at which NIH employees provide clinical care and some forms of writing—e.g., an NIH physician who moonlights at her/his local hospital's emergency room or submits a manuscript to a peer-reviewed journal that receives only unrestricted funding from a prohibited entity. Prohibited and/or restricted holdings include stock in biotechnology, pharmaceutical, and medical device companies and others in research, development, or manufacture of medical devices, equipment, preparations, treatments, or products. The prohibitions apply to senior NIH employees; restrictions in the amount of such holdings apply to all remaining employees. Both apply to the spouses and minor children of NIH employees. If an NIH employee wins an award, the monetary allowance in most cases is limited to $200. In sum, the scope of this policy is vast, too vast to be reasonable. Too many employees are restricted in too many ways. Where appropriate restrictions have been placed on senior NIH employees, even these constructive aspects of the policy are overshadowed by the unfairness and destructiveness of other aspects. This policy far exceeds anything that could be considered sound. Fortunately, the policy has a built-in assessment process to begin at the end of the policy's first year of implementation. One can only hope that a fair and open evaluation will be conducted, the results of which surely must result in major revisions to what is now bad regulation. Why the Policy... (shrink)

The requirements of the UK Equality Act 2010 and some high profile criticism for using a potentially ageist methodology have prompted the National Institute for Health and Clinical Excellence (NICE) to assess the processes and methodology it uses to make appraisal decisions. This paper argues that NICE has established rigorous systems to protect against ageist decisions, has no track record of ageism and is well placed to meet the requirements of new UK equality legislation.

The now retired NIH Consensus Development Program has been used as a model for similar programs in other countries. However, the epistemic value of this kind of program has been disputed. This article provides an overview of the arguments levelled at Miriam Solomon by Laszlo Kosolosky and Jeroen Van Bouwel, who provide an opposing philosophical position on this issue. Here, I argue for a middle ground position that highlights the methodological interest of a retrospective analysis of the NIH consensus conferences (...) as a way to assess the impact of a public forum on guidelines ultimately relayed to healthcare professionals and citizens. (shrink)

Despite the international interest in priority setting as an important tool for health policy, there has been comparatively little interest in the setting of research priorities. One of the few places where there has been such an interest is at the National Institutes of Health (NIH) in the United States. Under pressure from Congress to explain its priority setting process, the NIH has tried to explain the criteria and process it uses. The NIH procedure is described, (...) and the problems created by the criteria it uses are analyzed. Although it uses the language of priority setting, it is uncertain whether it does have a real method of setting priorities. Nonetheless, despite the lack of a method, the results of its work are lauded. In the long run, however, NIH will need a more rigorous method of setting priorities. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 14.1 (2004) 47-54 [Access article in PDF] Ethical Guidelines for Human Embryonic Stem Cell Research*(A Recommended Manuscript) Adopted on 16 October 2001Revised on 20 August 2002 Ethics Committee of the Chinese National Human Genome Center at Shanghai, Shanghai 201203 Human embryonic stem cell (ES) research is a great project in the frontier of biomedical science for the twenty-first century. Be- cause the research (...) involves the use of human embryos, it triggers serious debate on ethical issues. Opponents consider the embryo to be an early form of human life that should be respected and not destroyed. However, the majority of scientists support embryonic stem cell research, believing that it offers good prospects for the treatment of diseases that have remained incurable until now and so will benefit humankind. The Ethics Committee of the Department of Ethical, Legal, and Social Implications of the Chinese National Human Genome Center at Shanghai seriously discussed the ethical debate initiated by embryonic stem cell research. We concluded that we should support the scientists of our country in actively carrying out human embryonic stem cell research for the noble cause of "medicine being a beneficent art." For the healthy and orderly development of human embryonic stem cell research in our country, we put forward the following recommended Ethical Guidelines for Human Embryonic Stem Cell Research as a reference for leaders, administrative departments, and related scientists. Preface Article 1. Human embryonic stem cells are the primitive cells that play the main role in the growth and development of a human body. These [End Page 47] primitive cells have the potential for infinite proliferation, self-renewal, and multi-directional differentiation. If scientists can discover the mechanism of differentiation of human embryonic stem cells, it will be possible to induce differentiation of human embryonic stem cells to form various types of human cells for clinical cell therapy. If human embryonic stem cell research can be integrated with modern biomedical engineering techniques, it also will be possible to make repair and replacement of human tissues and organs a reality. Article 2. There are two ways to classify human embryonic stem cells. One way is to classify them according to their potential for differentiation. There could be three kinds of stem cells: totipotent stem cells, pluripotent stem cells, and unipotent stem cells.A totipotent stem cell has the potential to develop into a whole individual. It can differentiate into the more than 200 cell types in the whole body, construct any tissue or organ of the body, and finally develop into a whole individual. The fertilized egg and the cleavage cells at the very early stage of embryonic development are totipotent stem cells.A pluripotent stem cell has the potential to differentiate into many cell types derived from the three embryonic layers. However, it has lost the capacity to develop into a complete organism.A unipotent stem cell is derived from the further differentiation of the pluripotent stem cell. It can differentiate only into one cell type such as a hematopoietic stem cell, neural stem cell, and others.The other way is to classify human stem cells according to their source. There could be two kinds of human stem cells: embryonic stem cells and tissue stem cells (also called adult stem cells). The former involves experimentation with embryos, which has serious ethical implications. Ethical issues associated with the latter are mainly expressed in the various opinions regarding the allocation of health resources. Article 3. Human embryonic stem cells are the group of cells called the blastocyst inner cell mass during the early stage of embryonic development. They are the main source of totipotent stem cells, and hence the focal and hot point in stem cell research. Studies on the clinical application of embryonic stem cells probably will involve use of the somatic cell nucleus transfer (SCNT) technique, which destroys the early human embryo. At present, the ethical and moral debate is very serious in human embryonic stem cell research regarding whether the research will develop... (shrink)

The National Institute for Health and Care Excellence (NICE) is the UK’s primary healthcare priority-setting body, responsible for advising the National Health Service in England on which technologies to fund and which to reject. Until recently, the normative approach underlying this advice was described in a 2008 document entitled ‘Social value judgements: Principles for the development of NICE guidance’ (SVJ). In January 2020, however, NICE replaced SVJ with a new articulation of its guiding principles. Given the (...) significant evolution of NICE’s methods between 2008 and 2020, this study examines whether this new document (‘Principles’) offers a transparent account of NICE’s current normative approach. It finds that it does not, deriving much of its content directly from SVJ and failing to fully acknowledge or explain how and why NICE’s approach has since changed. In particular, Principles is found to offer a largely procedural account of NICE decision-making, despite evidence of the increasing reliance of NICE’s methods on substantive decision-rules and ‘modifiers’ that cannot be justified in purely procedural terms. Thus, while Principles tells NICE’s stakeholders much about how the organisation goes about the process of decision-making, it tells them little about the substantive grounds on which its decisions are now based. It is therefore argued that Principles does not offer a transparent account of NICE’s normative approach (either alone, or alongside other documents) and that, given NICE’s reliance on transparency as a requirement of procedural justice, NICE does not in this respect satisfy its own specification of a just decision-maker. (shrink)

Democratic societies find it difficult to reach consensus concerning principles for healthcare distribution in the face of resource constraints. At the same time the need for legitimacy of allocation decisions has been recognised. Against this background, the National Institute for Health and Clinical Excellence (NICE) aspires to meet the principles of procedural justice, specifically the conditions of accountability for reasonableness as espoused by Daniels and Sabin, that is, publicity, relevance, revisions and appeal, and enforcement. Although NICE has adopted (...) a highly standardised approach and continuously publishes key documents on its website, its technology appraisal programme does not fulfil the publicity condition of accountability for reasonableness. Economic models are not made sufficiently transparent to enable public scrutiny, and decision criteria other than cost-effectiveness remain enigmatic. NICE’s reliance on cost-utility analysis and “plausible” cost-per-quality-adjusted life year (QALY) benchmarks further raises serious issues with regard to the relevance condition of accountability for reasonableness. This is illustrated by counterintuitive cost-per-QALY rankings that are difficult to justify using reflective equilibrium methods, and by the current debate surrounding expensive therapies for rare diseases (“orphan” treatments). In addition, an excessive focus on QALYs may stand in the way of exploiting the best available effectiveness evidence. The NICE mechanism for revision and appeals is also more restrictive than provided in accountability for reasonableness. As to the enforcement condition, no effective quality assurance processes are in place for technology assessments, and implementation of guidance remains imperfect. NICE, despite impressive efforts, appears to have a long way to go before meeting the conditions of accountability for reasonableness. (shrink)

In the United States, the National Institute of Mental Health is seeking to encourage researchers to move away from diagnostic tools like the Diagnostic and Statistical Manual of Mental Disorders. A key mechanism for this is the “Research Domain Criteria” initiative, closely associated with former NIMH Director Thomas Insel. This article examines how key figures in US psychiatry construct the purpose, nature, and implications of the ambiguous RDoC project; that is, how its novelty is constituted through discourse. In (...) this paper, I explore and analyze these actors’ accounts of what is new, important, or desirable about RDoC, demonstrating how they are constituted through institutional context and personal affects. In my interviews with mental health opinion leaders, RDoC is presented as overly reliant on neurobiological epistemologies, distant from clinical imaginaries and imperatives, and introduced in a top-down manner inconsistent with the professional norms of scientific research. Ultimately, the article aims to add empirical depth to current understandings about the epistemological and ontological politics of contemporary psychiatry and to contribute to science and technology studies debates about “the new” in technoscience. Accordingly, I use discussions about RDoC as a case study in the sociology of novelty. (shrink)

The UK’s National Institute for Health and Care Excellence is responsible for conducting health technology assessment on behalf of the National Health Service. In seeking to justify its recommendations to the NHS about which technologies to fund, NICE claims to adopt two complementary ethical frameworks, one procedural—accountability for reasonableness —and one substantive—an ‘ethics of opportunity costs’ that rests primarily on the notion of allocative efficiency. This study is the first to empirically examine normative changes to (...) NICE’s approach and to analyse whether these enhance or diminish the fairness of its decision-making, as judged against these frameworks. It finds that increasing formalisation of NICE’s approach and a weakening of the burden of proof laid on technologies undergoing HTA have together undermined its commitment to EOC. This implies a loss of allocative efficiency and a shift in the balance of how the interests of different NHS users are served, in favour of those who benefit directly from NICE’s recommendations. These changes also weaken NICE’s commitment to AfR by diminishing the publicity of its decision-making and by encouraging the adoption of rationales that cannot easily be shown to meet the relevance condition. This signals a need for either substantial reform of NICE’s approach, or more accurate communication of the ethical reasoning on which it is based. The study also highlights the need for further empirical work to explore the impact of these policy changes on NICE’s practice of HTA and to better understand how and why they have come about. (shrink)

The Rockefeller Foundation helpedestablish two health research institutes inFrance during the German occupation and Vichyrule. These institutes were the precursors ofthe Institut National de Santé et de laRecherche Médicale (INSERM), the Frenchequivalent of the National Institutes of Healthin the United States. This essay rescues theseinstitutes from oblivion, and examines theirorigins and their significance.

Child and adolescent researchers must balance increasingly complex sets of ethical, legal, and scientific standards when investigating child and adolescent mental disorders. Few guidelines are available. One mechanism that provides the investigator immunity from legally compelled disclosure of research records is described. However, discretion must be exercised in its use, especially with regard to abuse reporting, voluntary disclosure of abuse, and protection of research data. Examples of discretionary issues in the use of the certificate of confidentiality are provided.

On the morning of December 2, 1994, after a preceding afternoon of discussion, the Advisory Committee to the Director of the National Institutes of Health unanimously voted to approve the recommendations of the Report of the Human Embryo Research Panel. Panel members like myself who were present were elated. The vote marked the culmination of nearly a year of work. Approval of the report also represented a decisive step forward in bringing an end to a (...) 15-year long moratorium on federally funded research on the preimplantation human embryo and techniques of in vitro fertilization. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Convention for Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Biomedicine: Convention on Human Rights and BiomedicineCouncil of EuropePreambleThe Member States of the Council of Europe, the other States and the European Community signatories hereto,Bearing in mind the Universal Declaration of Human Rights proclaimed by the General Assembly of the United Nations on 10 December 1948;Bearing in mind the (...) Convention for the Protection of Human Rights and Fundamental Freedoms of 4 November 1950;Bearing in mind the European Social Charter of 18 October 1961;Bearing in mind the International Covenant on Civil and Political Rights and the International Covenant on Economic, Social and Cultural Rights of 16 December 1966;Bearing in mind the Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data of 28 January 1981;Bearing also in mind the Convention on the Rights of the Child of 20 November 1989;Considering that the aim of the Council of Europe is the achievement of a greater unity between its members and that one of the methods by which that aim is to be pursued is the maintenance and further realisation of human rights and fundamental freedoms;Conscious of the accelerating developments in biology and medicine;Convinced of the need to respect the human being both as an individual and as a member of the human species and recognising the importance of ensuring the dignity of the human being; [End Page 277]Conscious that the misuse of biology and medicine may lead to acts endangering human dignity;Affirming that progress in biology and medicine should be used for the benefit of present and future generations;Stressing the need for international co-operation so that all humanity may enjoy the benefits of biology and medicine;Recognising the importance of promoting a public debate on the questions posed by the application of biology and medicine and the responses to be given thereto;Wishing to remind all members of society of their rights and responsibilities;Taking account of the work of the Parliamentary Assembly in this field, including Recommendation 1160 (1991) on the preparation of a Convention on bioethics;Resolving to take such measures as are necessary to safeguard human dignity and the fundamental rights and freedoms of the individual with regard to the application of biology and medicine;Have agreed as follows:Chapter IGeneral provisionsArticle 1. (Purpose and object)Parties to this Convention shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine.Each Party shall take in its internal law the necessary measures to give effect to the provisions of this Convention.Article 2. (Primacy of the human being)The interests and welfare of the human being shall prevail over the sole interest of society or science.Article 3. (Equitable access to health care)Parties, taking into account health needs and available resources, shall take appropriate measures with a view to providing, within their jurisdiction, equitable access to health care of appropriate quality. [End Page 278]Article 4. (Professional standards)Any intervention in the health field, including research, must be carried out in accordance with relevant professional obligations and standards.Chapter IIConsentArticle 5. (General rule)An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it.This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks.The person concerned may freely withdraw consent at any time.Article 6. (Protection of persons not able to consent)1. Subject to Articles 17 and 20 below, an intervention may only be carried out on a person who does not have the capacity to consent, for his or her direct benefit.2. Where, according to law, a minor does not have the capacity to consent to an intervention, the intervention may only be carried out with the authorisation of his or her representative or an authority or a person or... (shrink)

Institutions in France are not yet well prepared to respond to allegations of scientific misconduct. Following a serious allegation in late 1997. INSERM,* the primary organization for medical and health-related research in France, began to reflect on this subject, aided by scientists and jurists. The conclusions have resulted in establishing a procedure to be followed in cases of alleged misconduct, and also in reinforcing the application of good laboratory practices within each laboratory. Guidelines for authorship practices and scientific assessment (...) must also be considered. Even though each institution must remain responsible for responding to allegations of scientific misconduct within its doors, INSERM would like to see national, European, and international co-ordination about the methods of such response. (shrink)

The International Panel on Social Progress is an independent association of top research scholars with the goal of assessing methods for improving the main institutions of modern societies. The IPSP has produced a report consisting of twenty-two chapters in three volumes that distills the research of these scholars and outlines what the best social science has to say about positive social change. Written in accessible language by scholars across the social sciences and humanities, these volumes assess the achievements of (...) world societies in past centuries, the current trends, the dangers that we are now facing, and the possible futures in the twenty-first century. It covers the main socio-economic, political, and cultural dimensions of social progress, global as well as regional issues, and the diversity of challenges and their interplay around the world. The authors offer a cautious optimistic conclusion: multiple ideas for social progress and better policies are already available and deserve to be tested and implemented. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Women and Health Research:A Report from the Institute of MedicineAnna C. Mastroianni (bio), Ruth Faden (bio), and Daniel Federman (bio)In recent years, claims have been made by segments of the research community and by women's health advocacy groups that clinical research practices and policies have not benefitted women's health to the same extent as men's health. Central to these claims has been an assertion that (...) women have been inadequately represented as subjects of clinical studies and that as a result neither health conditions unique to women—e.g., menopause—nor women's manifestations of health problems affecting both sexes—e.g., heart disease—have been investigated sufficiently.The scientific community, including federal agencies that sponsor and regulate clinical studies, is increasingly responsive to these claims and is taking steps to raise the level of women's participation in clinical studies. Controversy and concern have surrounded these actions, however. Two of the claims that have been made are: (1) that women are more difficult to study than men because of their cyclical hormonal changes; and (2) that conducting gender-specific subgroup analyses would increase the size of study populations, raise the cost of studies, and thereby reduce the number of studies that could be performed with the limited resources available. In addition, controversy over the inclusion of women of childbearing potential and pregnant women has been particularly salient. Concerns have been expressed about avoiding potential harm to existing or potential fetuses and about the possible legal and financial ramifications of such harm. A further concern involves the perceived difficulties in enrolling women in studies and retaining them for the duration of the studies.Against this backdrop, the Office of Research on Women's Health at the National Institutes of Health (NIH) asked the Institute of Medicine (IOM) in October 1992 to establish the Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies. The Committee's charge was to: (1) consider the ethical and legal implications of including women, particularly pregnant women and women of childbearing potential, in clinical studies; (2) examine known instances of litigation regarding injuries to research subjects [End Page 55] and describe existing legal liabilities and protections; and (3) provide practical advice on these issues for consideration by NIH, institutional review boards (IRBs), and clinical investigators.The 16 Committee members came from diverse backgrounds: bioethics, law, epidemiology and biostatistics, public health policy, obstetrics and gynecology, clinical research, pharmaceutical development, social and behavioral sciences, and clinical evaluative sciences.1 Chaired by two of the authors of this article, Ruth Faden and Daniel Federman, and coordinated by the third, IOM Study Director Anna Mastroianni, the Committee met five times over a fourteen-month period, convened a one-and-one-half day invitational workshop, and commissioned several background papers. The Committee's deliberations were complicated by the announcement of new federal policies late in its term. Specifically, the Food and Drug Administration (FDA) issued guidelines (FDA 1993) to replace its 1977 guidelines, which prohibited the inclusion of women of childbearing potential in early phases of most clinical drug trials. In addition, Congress passed the NIH Revitalization Act of 1993 (P.L. 103-43), which contains provisions mandating the inclusion of women and racial and ethnic minorities in NIH-sponsored clinical research. In February 1994, the IOM Committee publicly issued its final report and recommendations, Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, publishing the workshop presentations and commissioned papers in a separate volume.Deliberations of the CommitteeA number of issues arose at the outset as the Committee considered its charge. A few members initially believed that verification of the underrepresentation of women relative to men in clinical studies as a whole was a prerequisite to providing policy recommendations. Others believed that such an examination would be an important contribution to the knowledge base, but that it was not necessary for addressing the Committee's charge. As summarized in the Committee's report, the Committee's research indicated that firm conclusions about the relative underrepresentation of women could not be drawn from the available data because of the lack of systematic information... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 10.2 (2000) 171-174 [Access article in PDF] Bioethics Inside the Beltway The Oversight of Human Gene Transfer Research LeRoy Walters Jesse Gelsinger's death last September in a gene transfer study being conducted at the University of Pennsylvania has helped to spark a national debate. In part, this debate parallels the broader discussion of how human subjects research should be reviewed and regulated in (...) the United States. However, human gene transfer research is one of a handful of biomedical technologies that seem to deserve special attention, at least in the early years of their development.The major participants in the national debate on human gene transfer include the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the National Bioethics Advisory Commission, members of Congress, biotechnology and pharmaceutical companies, disease-oriented advocacy groups, reporters, and academics. At the December 1999 meeting of the NIH Recombinant DNA Advisory Committee (RAC), the protocol that involved Jesse Gelsinger was a central focus of discussion, but other topics emerged as well. One ad hoc panel reviewed adverse events that had occurred in other research protocols using adenovirus vectors, while a second proposed changes in the general system for reporting adverse events to NIH and the RAC.During the first several months of the year 2000, the United States Congress also became involved in the human gene transfer debate. In February, Senator Bill Frist (R-TN) convened a hearing to which Jesse Gelsinger's father, representatives of NIH and FDA, and several other witnesses were invited. At approximately the same time, the House Commerce Committee and its Subcommittee on Oversight and Investigations initiated their own inquiries, asking the Office of Inspector General at the Department of Health and Human Services to review the oversight roles of NIH and FDA. In March and April, the House committee also wrote directly to the NIH Director, the FDA Commissioner, and the President of the University of Pennsylvania, requesting extensive documentation on gene transfer, in general, and the trial in which Jesse Gelsinger was involved, in particular. Congressman Henry Waxman (D-CA) and Senator Edward Kennedy (D-MA) have also raised questions and proposed solutions in multiple letters to the NIH Director and the Secretary of Health and Human Services. [End Page 171]The major general questions that have emerged from this discussion are the following:(1) What kinds of information about adverse events should be reported by researchers or sponsors during the course of human gene transfer trials?(2) To what group or groups should adverse-event information be reported? How often and in what ways should the information be analyzed?(3) Should the information about adverse events remain confidential, or should it be discussed publicly?(4) How can the disclosure and consent process in gene transfer trials be improved?(5) Which federal agency should have primary responsibility for overseeing human gene transfer research, and how can it best fulfill its oversight role?How these questions are answered will have immediate relevance to the field of human gene transfer research as it enters into its next phase. At the same time, the models that are created for this important cutting-edge field also may be useful in other complex or controversial arenas of biomedical research, for example, xenotransplantation or human embryonic stem-cell research. In addition, the lessons learned from this one important area of human subjects research may suggest ways to improve protections for all the volunteers who make clinical research--and medical progress--possible.In the remainder of this article, I will turn from reporting, in as objective a way as possible, on the status of the public policy debate about human gene transfer research to suggesting measures for improving the current oversight system for such research. My initial general recommendation is that we should not expect a single regulatory agency to be solely responsible for a field as large and dynamic as human gene transfer research. Rather, there should be some helpful redundancy or, to change the metaphor, checks and balances in the public oversight of this field. Thus, an... (shrink)

Public funders of health research have been widely criticized on the grounds that their allocations of funding for disease-specific research do not reflect the relative burdens imposed by different diseases. For example, the US National Institutes of Health spends a much greater fraction of its budget on HIV/aids research and a much smaller fraction on migraine research than their relative contribution to the US burden of disease would suggest. Implicit in this criticism is a normative claim: (...) Insofar as the scientific opportunities are equal, each patient merits research into their condition proportional to the burden of disease for which that condition is responsible. This claim—the proportional view—is widely accepted but has never been fully specified or defended. In this paper, I explain what is required to specify the view, attempt to do so in the most charitable way, and then critically evaluate its normative underpinnings. I conclude that a severity-weighted proportional view is defensible. I close by drawing out five key lessons of my analysis for health research priority-setting. (shrink)

Although women have made important inroads in science and engineering since the early 1970s, their progress in these fields has stalled over the past several years. This study looks at women in science and engineering careers in the 1970s and 1980s, documenting differences in career outcomes between men and women and between women of different races and ethnic backgrounds. The panel presents what is known about the following questions and explores their policy implications: In what sectors are female Ph.D.s (...) employed? What salary disparities exist between men and women in these fields? How is marital status associated with career attainment? Does it help a career to have a postdoctoral appointment? How well are female scientists and engineers represented in management? Within the broader context of education and the labor market, the book provides detailed comparisons between men and women Ph.D.s in a number of measures: financial support for education, academic rank achieved, salary, and others. The study covers engineering; the mathematical, physical, life, and social and behavioral sciences; medical school faculty; and recipients of National Institutes of Health grants. Findings and recommendations in this volume will be of interest to practitioners, faculty, and students in science and engineering as well as education administrators, employers, and researchers in these fields. (shrink)

Background: The formulation and implementation of national ethical regulations to protect research participants is fundamental to ethical conduct of research. Ethics education and capacity are inadequate in developing African countries. This study was designed to develop a module for online training in research ethics based on the Nigerian National Code of Health Research Ethics and assess its ease of use and reliability among biomedical researchers in Nigeria.MethodologyThis was a three-phased evaluation study. Phase one involved development of an (...) online training module based on the Nigerian Code of Health Research Ethics (NCHRE) and uploading it to the Collaborative Institutional Training Initiative (CITI) website while the second phase entailed the evaluation of the module for comprehensibility, readability and ease of use by 45 Nigerian biomedical researchers. The third phase involved modification and re-evaluation of the module by 30 Nigerian biomedical researchers and determination of test-retest reliability of the module using Cronbach’s alpha. Results: The online module was easily accessible and comprehensible to 95% of study participants. There were significant differences in the pretest and posttest scores of study participants during the evaluation of the online module (p = 0.001) with correlation coefficients of 0.9 and 0.8 for the pretest and posttest scores respectively. The module also demonstrated excellent test-retest reliability and internal consistency as shown by Cronbach’s alpha coefficients of 0.92 and 0.84 for the pretest and posttest respectively. Conclusion: The module based on the Nigerian Code was developed, tested and made available online as a valuable tool for training in cultural and societal relevant ethical principles to orient national and international biomedical researchers working in Nigeria. It would complement other general research ethics and Good Clinical Practice modules. Participants suggested that awareness of the online module should be increased through seminars, advertisement on government websites and portals used by Nigerian biomedical researchers, and incorporation of the Code into the undergraduate medical training curriculum. (shrink)

This is the first of three volumes containing a report from the International Panel on Social Progress. The IPSP is an independent association of top research scholars with the goal of assessing methods for improving the main institutions of modern societies. Written in accessible language by scholars across the social sciences and humanities, these volumes assess the achievements of world societies in past centuries, the current trends, the dangers that we are now facing, and the possible futures in the (...) twenty-first century. It covers the main socio-economic, political, and cultural dimensions of social progress, global as well as regional issues, and the diversity of challenges and their interplay around the world. This particular volume covers topics such as economic inequality and growth, finance and corporations, labor, capitalism, and social justice. (shrink)

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

In lieu of an abstract, here is a brief excerpt of the content:The Office of Scientific IntegrityDavid P. Hamilton (bio)For most of the 1980s, the specter of scientific fraud popped into public view every few years, usually only to submerge again. Faced with several well-publicized cases of scientists who blatantly faked their data—among the best-known being Harvard cardiologist John Darsee (whose colleagues watched him forge data) (Broad and Wade 1982, p. 14) and Sloan-Kettering Institute immunologist William Summerlin (who painted black (...) spots on white mice to simulate tissue grafts) (Broad and Wade 1982, p. 155)—the scientific community as a whole tended to dismiss the phenomenon as the work of a few deviants. Called in 1981 to testify before then-Representative Albert Gore Jr.'s subcommittee on investigations and oversight, Philip Handler, then-president of the National Academy of Sciences, told the panel that science was perfectly capable of regulating itself, and that the problem of scientific fraud had been "grossly exaggerated" by the press (Broad and Wade 1982). The message was clear: Congress should stick to its knitting, and science would take care of itself.Now, however, scientists are faced with a very different situation: a permanent federal bureaucracy, known as the Office of Scientific Integrity (OSI), devoted to the investigation of alleged scientific wrongdoing. The transition from the days of laissez-faire, when universities were entrusted with all investigations unless they were handled so badly that the federal government was forced to take notice, has been an uncomfortable one for many researchers. Lately, this discomfort has taken shape as a vocal protest against OSI. Largely as a result of this protest, federal officials recently promoted a plan to restructure OSI and change some of its operating procedures, a move with unpredictable consequences for universities and researchers alike.OSI was born largely because of investigations by two influential congressmen: Representatives John Dingell of Michigan and Ted Weiss of New York. While both claimed they acted mainly to make sure taxpayer dollars were not spent on fraudulent research, both also maintained a strong interest in protecting "whistleblowers," the often vulnerable, and usually junior, scientists who first raise questions about bad research. And Dingell seemed to take special pleasure in pointing up the deficiencies of investigations run by universities and by the National Institutes of Health (NIH) itself. (For reasons that are not well understood, [End Page 171] biomedical research seems far more prone to fraud than any other field of science. As a result, NIH, which funds most biomedical research in the United States, has held ultimate responsibility for most prominent cases of fraud.) Plagued as they often were by conflicts of interest, shoddy methodologies, and, in some cases, a willingness to believe any excuse by the accused, no matter how far-fetched, these investigations made easy targets. And the notion that science could "govern itself" grew harder to sustain.In late 1988, Dingell and other congressmen began circulating draft bills that would have created a new office for investigating scientific fraud. Dingell would have placed such an office under the aegis of the Inspector General of the Department of Health and Human Services, raising the possibility that scientific fraud might be probed by the same criminal investigators who unravel Medicare fraud. Unsettled by this vision of the "science police," NIH officials moved quickly to pre-empt Congress. On March 16, 1989, they published a notice in the Federal Register announcing the creation of OSI, an office with responsibility for ensuring thorough university investigations of misconduct and the authority to conduct its own investigations when necessary.From the beginning, OSI took an unusual approach to its work. For one thing, the office had a broad mandate: Although located within NIH, it was responsible for research funded throughout the entire Public Health Service, including the Food and Drug Administration, the Alcohol, Drug, and Mental Health Administration, and the Centers for Disease Control. Furthermore, it was not restricted to scientific fraud. Departmental lawyers, wishing to avoid the legal connotations of the term "fraud"—in particular, a requirement that fraudulent actions not only mislead others but also cause them noticeable harm—decided instead to adopt the term "scientific misconduct," defined as "fabrication, falsification, plagiarism, or other practices that deviate... (shrink)