David Resnik

The US federal research regulations prohibit informed consent, whether written or oral, from including provisions in which human subjects waive or appear to waive legal rights. We argue that policies that prevent human subjects from waiving legal rights in research can be ethically justified under the rationale of group, soft paternalism. These policies protect competent adults from making adverse decisions about health and legal matters that they may not understand fully. However, this rationale is less defensible if there is a comprehensive compensation for injury programme available in which subjects are asked to waive some legal rights in order to participate in the programme. In this situation, subjects should be allowed to waive some legal rights to obtain the benefits of the programme

This paper defends two principles of methodological conservatism on the grounds that they help to promote an effective social structure for a knowledge‐seeking community. Conservatism has some prima facie justification because it provides for an effective division of cognitive labor, it promotes the effective use of scientific resources, and it provides for a certain amount of stability. However, the principles I defend in this paper should not be treated as absolute or unconditional criteria of theory‐choice, since they can be overridden by other rules or maxims. Since the decision to override a principle of conservatism depends on various contextual factors, the appropriateness of conservatism can vary from context to context.

This essay provides an explanation and interpretation of the undertreatment of pain by discussing some of the scientific, clinical, cultural, and philosophical aspects of this problem. One reason why pain continues to be a problem for medicine is that pain does not conform to the scientific approach to health and disease, a philosophy adopted by most health care professionals. Pain does not fit this philosophical perspective because (1) pain is subjective, not objective; (2) the causal basis of pain is often poorly understood; (3) pain is often regarded as a mere symptom, not as a disease; (4) there often are no magic bullets for pain; (5) pain does not fit the expert knowledge model. In order for health care professionals to do a better job of treating pain, some changes need to occur in medical philosophy, education, and practice.

In his book The Evolution of Individuality, Leo Buss attacks a central dogma of the neo-Darwinian (or synthetic) theory of evolution, the idea that the individual is the sole unit of selection, by arguing that individuals themselves emerged as the result of selective forces that regulated the replication of cell lineages for the benefit of the whole organism. Buss also argues that metazoan developmental patterns and life cycles are the products of selection operating on different units of selection, and that there have been transitions between different units of selection during the history of life. Despite the revolutionary character of this book, The Evolution of Individuality in many ways reflects the adaptationist thinking often associated with the synthetic theory. Buss' framework could be improved by giving further consideration to chance factors in the evolution of development, and examining the details of the evolution of ontogeny in more depth.

In this article, we argue that the scope of bioethical debate concerning justice in health should expand beyond the topic of access to health care and cover such issues as occupational hazards, safe housing, air pollution, water quality, food and drug safety, pest control, public health, childhood nutrition, disaster preparedness, literacy, and many other environmental factors that can cause differences in health. Since society does not have sufficient resources to address all of these environmental factors at one time, it is important to set priorities for bioethical theorizing and policy formation. Two considerations should be used to set these priorities: (1) the impact of the environmental factor on health inequality, and (2) the practicality of addressing the factor.

This paper discusses the economic, legal, moral, and political difficulties in developing drugs for the developing world. It argues that large, global pharmaceutical companies have social responsibilities to the developing world, and that they may exercise these responsibilities by investing in research and development related to diseases that affect developing nations, offering discounts on drug prices, and initiating drug giveaways. However, these social responsibilities are not absolute requirements and may be balanced against other obligations and commitments in light of economic, social, legal, political, and other conditions. How a company decides to exercise its social responsibilities to the developing world depends on the prospects for a reasonable profit and the prospects for a productive business environment. Developing nations can either help or hinder the pharmaceutical industry’s efforts to exercise social responsibility through various policies and practices. To insure that companies can make a reasonable profit, developing nations should honor pharmaceutical product patents and adhere to international intellectual property treaties, such as the Trade‐Related Aspects of Intellectual Property Rights agreement. To insure the companies have a good business environment, developing nations should try to promote the rule of law, ethical business practices, stable currencies, reliable banking systems, free and open markets, democracy, and other conditions conducive to business. Overall, this paper advocates for reciprocity and cooperation between pharmaceutical companies and developing nations to address the problem of developing drugs for the developing world. In pursuing this cooperative approach, developing nations may use a variety of other techniques to encourage pharmaceutical companies to act responsibly, such as subsidizing pharmaceutical research, helping to design and implement research protocols, providing a guaranteed market, and bulk buying.

: This essay provides an analysis of conflicts of interest in science. It gives an overview of some current conflict of interest policies and distinguishes between real, apparent, and potential conflicts of interest. The essay argues that scientists should disclose real, apparent, and potential conflicts of interest and that they should avoid conflicts that threaten scientific objectivity or trustworthiness. The essay also uses several hypothetical scenarios to illustrate some of the key points made in the analysis and suggests some strategies for buffering the impact of conflicts of interest in science

This paper examines a new challenge to neo-Darwinism, a movement known as process structuralism. The process structuralist critique of neo-Darwinism holds 1) that there are general laws in biology and that biologists should search for these laws; 2) that there are general forms of morphology and development and that biologists should attempt to uncover these forms; 3) that organisms are unified wholes that cannot be understood without adopting a holistic perspective; and 4) that no special, causal primacy should be given to the genes in development and morphology. This paper places process structuralism in its historical context, examines the philosophical underpinnings of the movement, and discusses some of the evidence used to support its claims.

In this article I defend a rule utilitarian approach to paternalistic policies in research with human participants. Some rules that restrict individual autonomy can be justified on the grounds that they help to maximize the overall balance of benefits over risks in research. The consequences that should be considered when formulating policy include not only likely impacts on research participants, but also impacts on investigators, institutions, sponsors, and the scientific community. The public reaction to adverse events in research (such as significant injury to participants or death) is a crucial concern that must be taken into account when assessing the consequences of different policy options, because public backlash can lead to outcomes that have a negative impact on science, such as cuts in funding, overly restrictive regulation and oversight, and reduced willingness of individuals to participate in research. I argue that concern about the public reaction to adverse events justifies some restrictions on the risks that competent, adult volunteers can face in research that offers them no significant benefits. The paternalism defended here is not pure, because it involves restrictions on the rights of investigators in order to protect participants. It also has a mixed rationale, because individual autonomy may be restricted not only to protect participants from harm but also to protect other stakeholders. Utility is not the sole justification for paternalistic research policies, since other considerations, such as justice and respect for individual rights/autonomy, must also be taken into account

This discussion adjudicates a dispute between Larry Laudan and Gerald Doppelt over the nature of methodological rules. Laudan holds that all methodological rules are hypothetical imperatives, while Doppelt argues that a subset of those rules, basic methodological standards, are not hypothetical imperatives. I argue that neither writer offers a satisfactory account of methodological rules and that their reliance on the hypothetical/nonhypothetical distinction does not advance our understanding of methodological rules. I propose that we dispense with this dubious distinction and develop an alternative account of scientific norms

This paper develops three arguments for increasing the strength of database protection under U.S. law. First, stronger protections would encourage private investment in database development, and private databases have many potential benefits for science and industry. Second, stronger protections would discourage extensive use of private licenses to protect databases and would allow for greater public control over database laws and policies. Third, stronger database protections in the U.S. would harmonize U.S. and E.U. laws and would thus enhance international trade, commerce, and research. The U.S. should therefore follow the European example and develop two tiers of protection for databases: 1) protection for creative databases under copyright law; 2) protection for non-creative databases through a special type of sui generis protection. In order to balance private control of data and public access to data, sui generis protections should define a “fair use” exemption that permits some unauthorized extraction of data for private, educational, and research purposes, provided that such extraction does not adversely impact the economic value of the database.

This article examines the assertion that human embryonic stem cells patents are immoral because they violate human dignity. After analyzing the concept of human dignity and its role in bioethics debates, this article argues that patents on human embryos or totipotent embryonic stem cells violate human dignity, but that patents on pluripotent or multipotent stem cells do not. Since patents on pluripotent or multipotent stem cells may still threaten human dignity by encouraging people to treat embryos as property, patent agencies should carefully monitor and control these patents to ensure that patents are not inadvertently awarded on embryos or totipotent stem cells

InScience and Values (1984) and other, more recent, works, e.g. (1987a, 1987b, 1989a, 1989b, 1990), Larry Laudan proposes a theory of scientific debate he dubs the reticulated model of scientific rationality (Laudan, 1984, pp. 50–66). The model stands in sharp contrast to hierarchical approaches to rationality exemplified by Popper (1959), Hempel (1965), and Reichenbach (1938), as well as the conventionalist views of rationality defended by Carnap (1950), Popper (1959), Kuhn (1962), and Lakatos (1978). Ironically, the model commits some of the same errors Laudan finds in hierarchicalist and conventionalists approaches to scientific rationality. This paper will show that the model can be fixed by recognizing that criteria of goal assessment have no privileged status. These rules are best viewed as simply rules of rationality (or rules of scientific method) by another name.

This paper addresses the appropriate role for public input into priority setting for federal funding of biomedical research and development. The public should be involved in priority setting because researchers should be publicly accountable, because the public has a right to oversee government activities, and because public input is needed to assess normative questions related to the burden of disease and health care needs. On the other hand, political factors arising from public input can also hamper the governmentÕs ability to allocate funds according to the burden of disease or to promote the progress of biomedical science. When it comes to public input into R & D priority setting, more is not necessarily better. What is needed is the right balance of public and expert decision making with respect to the setting of biomedical R & D priorities.

Biologists in many different fields of research give how-possibly explanations of the phenomena they study. Although such explanations lack empirical support, and might be regarded by some as unscientific, they play an important heuristic role in biology by helping biologists develop theories and concepts and suggesting new areas of research. How-possibly explanations serve as a useful framework for conducting research in the absence of adequate empiri cal data, and they can even become how-actually explanations if they gain enough empirical support.