David Resnik

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

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

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.

InExplaining Science: A Cognitive Approach, Ronald Giere (1988), proposes what he calls a cognitive theory of science (p. 2). Giere intends his view to be a broadly scientific account employing the resources of the cognitive sciences (Giere, 1988, p. 2). This paper argues that Giere does not secure a firm foundation for a cognitive theory of science because he leaves the door wide open for social constructivist interpretations of his views. In order to avoid social constructivism, Giere needs to adopt or develop an objective (i.e. non-conventionalist) concept of similarity.

This article examines the ethical basis for the patient's duty to adhere to the physician's treatment prescriptions. The article argues that patients have a moral duty to adhere to the physician's treatment prescriptions, once they have accepted treatment. Since patients still retain the right to refuse medical treatment, their duty to adhere to treatment prescriptions is a prima facie duty, which can be overridden by their other ethical duties. However, patients do not have the right to refuse to adhere to treatment prescriptions if their non-adherence poses a significant threat to other people. This paper also discusses the use of written agreements between physicians and patients as a strategy for promoting patient adherence.

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.

It is widely recognized that endocrine disrupting compounds, such as Bisphenol A, pose challenges for traditional paradigms in toxicology, insofar as these substances appear to have a wider range of low-dose effects than previously recognized. These compounds also pose challenges for ethics and policymaking. When a chemical does not have significant low-dose effects, regulators can allow it to be introduced into commerce or the environment, provided that procedures and rules are in place to keep exposures below an acceptable level. This option allows society to maximize the benefits from the use of the chemical while minimizing risks to human health or the environment, and it represents a compromise between competing values. When it is not possible to establish acceptable exposure levels for chemicals that pose significant health or environmental risks, the most reasonable options for risk management may be to enact either partial or complete bans on their use. These options create greater moral conflict than other risk management strategies, leaving policymakers difficult choices between competing values

This paper discusses a dispute concerning the ethics of research on preventing the perinatal transmission of HIV in developing nations. Critics of this research argue that it is unethical because it denies a proven treatment to placebo‐control groups. Since studies conducted in developed nations would not deny this treatment to subjects, the critics maintain that these experiments manifest a double standard for ethical research and that a single standard of ethics should apply to all research on human subjects. Proponents of the research, however, argue that these charges fail to understand the ethical complexities of research in developing nations, and that study designs can vary according to the social, economic, and scientific conditions of research. This essay explores some of the ethical issues raised by this controversial case in order to shed some light on the deeper, meta‐ethical questions. The paper argues that standards of ethical research on human subjects are universal but not absolute: there are some general ethical principles that apply to all cases of human subjects research but the application of these principles must take into account factors inherent in particular situations.

: In the last two decades, scientists, government officials, and science policy experts have expressed concerns about the increasing role of financial interests in research. Many believe that these interests are undermining research by causing bias and error, suppression of results, and even outright fraud. This paper seeks to shed some light on this view by (1) explicating the concept research bias, (2) describing some ways that financial interests can cause research biases, and (3) discussing some strategies for mitigating or managing the influence of financial interests. These strategies include (a) using government funds to counter-balance privately funded research, (b) increasing public input into government funding decisions, (c) disclosing and managing conflicts of interest in research, (d) auditing data, (e) expanding access to data. Since it is neither possible nor desirable to eliminate financial interests from research, the wisest policy is to manage and counter-balance these interests for the good of science and society

When environmental health researchers study hazards in the home, they often discover information that may be relevant to protecting the health and safety of the research subjects and occupants. This article describes the ethical and legal basis for a duty to warn research subjects and occupants about hazards in the home and explores the extent of this duty. Investigators should inform research subjects and occupants about the results of tests conducted as part of the research protocol only if the information is likely to be accurate, reliable, and medically useful. Investigators should warn subjects and occupants about hazards they happen to discover while they are in the home, if a reasonable person would warn the subjects and occupants about those hazards. Investigators should not report illegal hazards discovered in the home to the authorities, unless those hazards constitute abuse or neglect of children or mentally disabled people living in the home. When investigators decide to warn research subjects and occupants about hazards in the home, they should take some steps to help them make effective use of this information, such as providing additional counselling or making a referral for remediation or medical treatment. Investigators should discuss these issues with research subjects during the informed consent process.

Openness is one of the most important principles in scientifi c inquiry, but there are many good reasons for maintaining secrecy in research, ranging from the desire to protect priority, credit, and intellectual property, to the need to safeguard the privacy of research participants or minimize threats to national or international security. This article examines the clash between openness and secrecy in science in light of some recent developments in information technology, business, and politics, and makes some practical suggestions for resolving confl icts between openness and secrecy

This paper discusses the idea of forming a patent pool in order to address some of the licensing problems in the biotechnology industry. The pool would be an independent, non-profit corporation that would manage patents and have the authority to grant licenses. The patent pool would not be a purely altruistic venture, since it would charge licensing fees. The pool would charge the market price for licensing services and reimburse patent holders for licensing activities. The pool would also provide patent holders with a minimum income based on a percentage of royalties generated from the pool. The pool would include patents on a variety of materials and methods that play an important role in biotechnology. It would also be international in scope, with the power to grant licenses in different countries.

This paper focuses on the question of whether DNA patents help or hinder scientific discovery and innovation. While DNA patents create a wide variety of possible benefits and harms for science and technology, the evidence we have at this point in time supports the conclusion that they will probably promote rather than hamper scientific discovery and innovation. However, since DNA patenting is a relatively recent phenomena and the biotechnology industry is in its infancy, we should continue to gather evidence about the effects of DNA patenting on scientific innovation and discovery as well the economic, social, and legal conditions relating to intellectual property in biotechnology. We should give the free market, the courts, researchers, and patent offices a chance to settle issues related to innovation and discovery, before we seek legislative remedies, since new laws proposed at this point would lack adequate foresight and could do more harm than good. However, we should be open to new laws or regulations on DNA patents if they are required to in order to deal with some of the biases and limitations of the free market.

Most of the literature on phase one trials has focused on ethical and safety issues in research on patients with advanced cancer, but this article focuses on healthy, adult subjects. The article makes six specific recommendations for protecting the rights and welfare of healthy subjects in phase one trials: 1) because phase one trials are short in duaration (usually 1 to 3 months), researchers should gather more data on the short-term and long-term risks of participation in phase one studies by healthy subjects; 2) researchers should develop strict inclusion/exclusion criteria that exclude unhealthy or vulnerable subjects, such as decisionally impaired people, in phase one studies; 3) subjects should not participate in more than one phase one study at the same time and should wait at least 30 days between participating in different studies; 4) researchers should develop a database to keep track of phase one participants; 5) subjects should be guaranteed a minimum wage equivalent to the equivalent type of unskilled labor, but there should be no upper limits on wages; and 6) subjects should be allowed to engage in collective bargaining with research sponsors. *Disclaimer: The ideas and opinions expressed in this article are the authors' personal views and do not represent the views of the National Institute of Environmental Health Sciences, the National Institutes of Health, or the United States government