The precautionary principle holds that we should not allow scientific uncertainty to prevent us from taking precautionary measures in response to potential threats that are irreversible and potentially disastrous. Critics of the principle claim that it deters progress and development, is excessively risk-aversive and is unscientific. This paper argues that the principle can be scientific provided that the threats addressed by the principle are plausible threats, and the precautionary measures adopted are reasonable. The paper also argues that one may use (...) epistemic criteria, such as consistency, coherence and explanatory power, to determine whether a threat is plausible, and that one may use practical considerations, such as effectiveness, proportionality, cost-effectiveness, realism and consistency, to determine whether a response to a threat is reasonable. (shrink)

Modern science is big business. Governments, universities, and corporations have invested billions of dollars in scientific and technological research in the hope of obtaining power and profit. In The Price of Truth, David B. Resnik examines some of the important and difficult questions resulting from the financial and economic aspects of modern science.

The therapy-enhancement distinction occupies a central place in contemporary discussions of human genetics and has been the subject of much debate. At a recent conference on gene therapy policy, scientists predicted that within a few years researchers will develop techniques that can be used to enhance human traits. In thinking about the morality of genetic interventions, many writers have defended somatic gene therapy, and some have defended germline gene therapy, but only a handful of writers defend genetic enhancement, or even (...) give it a fair hearing. The mere mention of genetic enhancement makes many people cringe and brings to mind the Nazi eugenics programs, Aldous Huxley's BraveNewWorld, or the recent movie Although many people believe that gene therapy has morally legitimate medical uses, others regard genetic enhancement as morally problematic or decidedly evil. (shrink)

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. (shrink)

During the past decade scientists, public policy analysts, politicians, and laypeople, have become increasingly aware of the importance of ethical conduct in scientific research. In this timely book, David B. Resnik introduces the reader to the ethical dilemmas and questions that arise in scientific research. Some of the issues addressed in the book include ethical decision-making, the goals and methods of science, and misconduct in science. The Ethics of Science also discusses significant case studies such as human and (...) animal cloning, the Challenger accident and Tobacco research. This is essential reading for anyone who wishes to understand the importance of ethics in science. (shrink)

According to some estimates, less than 10% of the world's biomedical research funds are dedicated to addressing problems that are responsible for 90% of the world's burden of disease. This paper explains why this disparity exists and what should be done about it. It argues that the disparity exists because: 1) multinational pharmaceutical and biotechnology companies do not regard research and development investments on the health problems of developing nations to be economically lucrative; and 2) governmental agencies that sponsor biomedical (...) research face little political pressure to allocate funds for the problems of developing nations. This paper argues that developed nations have an obligation to address disparities related to biomedical research funding. To facilitate this effort, developed countries should establish a trust fund dedicated to research on the health problems of developing nations similar to the Global AIDS Fund. (shrink)

Modern science is big business. Governments, universities, and corporations have invested billions of dollars in scientific and technological research in the hope of obtaining power and profit. For the most part, this investment has benefited science and society, leading to new discoveries, inventions, disciplines, specialties, jobs, and career opportunities. However, there is a dark side to the influx of money into science. Unbridled pursuit of financial gain in science can undermine scientific norms, such as objectivity, honesty, openness, respect for research (...) participants, and social responsibility. In The Price of Truth, David B. Resnik examines some of the important and difficult questions resulting from the financial and economic aspects of modern science. How does money affect scientific research? Have scientists become entrepreneurs bent on making money instead of investigators searching for the truth? How does the commercialization of research affect the public's perception of science? Can scientists prevent money from corrupting the research enterprise? What types of rules, polices, and guidelines should scientists adopt to prevent financial interests from adversely affecting research and the public's opinion of science? (shrink)

This book provides a framework for approaching ethical and policy dilemmas in research with human subjects from the perspective of trust. It explains how trust is important not only between investigators and subjects but also between and among other stakeholders involved in the research enterprise, including research staff, sponsors, institutions, communities, oversight committees, government agencies, and the general public. The book argues that trust should be viewed as a distinct ethical principle for research with human subjects that complements other principles, (...) such as autonomy, beneficence, non-maleficence, and justice. The book applies the principle of trust to numerous issues, including informed consent, confidentiality, risk minimization, risks and benefits, protection of vulnerable subjects, experimental design, research integrity, and research oversight.This work also includes discussions of the history of research involving human subjects, moral theories and principles, contemporary cases, and proposed regulatory reforms. The book is useful for undergraduate and graduate students studying ethical policy issues related to research with human subjects, as well as for scientists and scholars who are interested in thinking about this topic from the perspective of trust. (shrink)

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. (shrink)

BackgroundThe nature of the relationship between a clinical investigator and a research subject has generated considerable debate because the investigator occupies two distinct roles: clinician and scientist. As a clinician, the investigator has duties to provide the patient with optimal care and undivided loyalty. As a scientist, the investigator has duties to follow the rules, procedures and methods described in the protocol.Results and conclusionIn this article, I present a contextual approach to the investigator-subject relationship. The extent of the investigator's duty (...) to provide the patient/subject with clinical care can vary from one situation to the next, as a function of several factors, including: the research design, benefits and risks of the research; the subject's reasonable expectations, motivations, and vulnerabilities; the investigator's ability to benefit the subject; and the investigator's prior relationship with the subject. These and other factors need to be considered when determining the clinical investigator's obligations to provide clinical care to human research subjects. In some research contexts, the investigator has extensive clinical obligations to the patient/subject; in others, the investigator has minimal ones. (shrink)

During a prostate exam, Mr. Watson, age 65, learns that his prostate appears to be abnormal. The family physician conducting the exam, Dr. Kleinman, informs Mr. Watson that he may have prostate cancer. Mr. Watson agrees to a variety of tests, including blood tests, bone scans, ultrasound scanning, and a biopsy. After learning about this possible diagnosis and these tests, Mr. Watson surfs the Web for information about prostate cancer and gathers data from many different sources, including the National Cancer (...) Society, the National Institutes of Health, Johns Hopkins University, the Mayo Clinic, and medicine sites. He also searches for information from medical journals using MEDLINE, visits several chat rooms on prostate cancer, and joins some e-mail lists. He arrives in Dr. Kleinman's office for a follow-up appointment with a stack of material and many questions. Dr. Kleinman is surprised, irritated, and offended. He recommends that Mr. Watson have a prostatectomy followed by radiation, but Mr. Watson does not want this operation. He would rather receive a form of radiation therapy recently approved by the FDA that he learned about through his own research. Dr. Kleinman admits that he does not know much about this new treatment, but he says that he would read up on it and consult an oncologist. (shrink)

Environmental Health Ethics illuminates the conflicts between protecting the environment and promoting human health. In this study, David B. Resnik develops a method for making ethical decisions on environmental health issues. He applies this method to various issues, including pesticide use, antibiotic resistance, nutrition policy, vegetarianism, urban development, occupational safety, disaster preparedness and global climate change. Resnik provides readers with the scientific and technical background necessary to understand these issues. He explains that environmental health controversies cannot simply (...) be reduced to humanity versus environment and explores the ways in which human values and concerns - health, economic development, rights and justice - interact with environmental protection. (shrink)

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. (shrink)

A growing body of evidence has linked consumption of trans fatty acids to cardiovascular disease. To promote public health, numerous state and local governments in the United States have banned the use of artificial trans fats in restaurant foods, and additional bans may follow. Although these policies may have a positive impact on human health, they open the door to excessive government control over food, which could restrict dietary choices, interfere with cultural, ethnic, and religious traditions, and exacerbate socioeconomic inequalities. (...) These slippery slope concerns cannot be dismissed as far-fetched, because the social and political pressures are place to induce additional food regulations. To protect human freedom and other values, policies that significantly restrict food choices, such as bans on types of food, should be adopted only when they are supported by substantial scientific evidence, and when policies that impose fewer restrictions on freedom, such as educational campaigns and product labeling, are likely to be ineffective. (shrink)

The question of how to distinguish between science and non-science, the so-called ‘demarcation problem’, is one of the most high-profile, perennial, and intractable issues in the philosophy of science. It is not merely a philosophical issue, however, since it has a significant bearing on practical policy questions and practical decisions. This essay develops a pragmatic approach to the demarcation problem: it argues that while there are some core principles that we can use in distinguishing between science and non-science, particular judgments (...) and decisions about something's scientific status depend, in part, on practical goals and concerns. (shrink)

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. (shrink)

This essay discusses some of the problems with current authorship practices and puts forward a proposal for a new system of credit allocation: in published works, scientists should more clearly define the responsibilities and contributions of members of research teams and should distinguish between different roles, such as author, statistican, technician, grant writer, data collector, and so forth.

A clear, introductory overview of the issues surrounding gene patenting.

The precautionary principle is a useful strategy for decision-making when physicians and patients lack evidence relating to the potential outcomes associated with various choices. According to a version of the principle defended here, one should take reasonable measures to avoid threats that are serious and plausible. The reasonableness of a response to a threat depends on several factors, including benefit vs. harm, realism, proportionality, and consistency. Since a concept of reasonableness plays an essential role in applying the precautionary principle, this (...) principle gives physicians and patients a decision-making strategy that encourages the careful weighing and balancing of different values that one finds in humanistic approaches to clinical reasoning. Properly understood, the principle presents a worthwhile alternative to approaches to clinical reasoning that apply expected utility theory to decision problems. (shrink)

This paper uses John Rawls' theory of justice to defend the patent system against charges that it has an unfair effect on access to medications, from the perspective of national and international justice. The paper argues that the patent system is fair in a national context because it respects intellectual property rights and it benefits the least advantaged members of society by providing incentives for inventors, investors, and entrepreneurs. The paper also argues that the patent system is fair in an (...) international context, provided that developed nations take steps to help disease-stricken countries secure internal justice. Fairness in a national or international context also requires that the patent system should include emergency exceptions to deal with short-term inequities. (shrink)

Artificial intelligence (AI), large language models (LLMs), such as Open AI’s ChatGPT, have a remarkable ability to process and generate human language but have also raised complex and novel ethica...

In Playing Politics with Science, David B. Resnik explores the philosophical, political, and ethical issues related to the politicalization of science and ...

This book fills a gap in the literature on the Precautionary Principle by placing the principle within the wider context of precautionary reasoning and uses philosophical arguments and case studies to demonstrate when it does—and does not—apply. The book invites the reader to take a step back from the controversy surrounding the Precautionary Principle and consider the overarching rationales for responding to threats to the environment or public health. It provides practical guidance and probing insight for the intended audience, including (...) scholars, students, journalists, and policymakers. (shrink)

Green bioethics is an area of research and scholarship that examines the impact of healthcare practices and policies on the environment and emphasises environmental values, such as ecological sustainability and stewardship. Some green bioethicists have argued that healthcare providers should inform patients about the environmental impacts of treatments and advocate for options that minimise adverse impacts. While disclosure of information pertaining to the environmental impacts of treatments could facilitate autonomous decision-making and strengthen the patient–provider relationship in situations where patients have (...) clearly expressed environmental concerns, it may have the opposite effect in other situations if makes patients feel like they are being judged or manipulated. We argue, therefore, that there is not a generalisable duty to disclose environmental impact information to all patients during the consent process. Providers who practice green bioethics should focus on advocating for system-level changes in healthcare financing, organisation and delivery and use discretion when bringing up environmental concerns in their encounters with patients. (shrink)

According to some estimates, less than 10% of the world's biomedical research funds are dedicated to addressing problems that are responsible for 90% of the world's burden of disease. This paper explains why this disparity exists and what should be done about it. It argues that the disparity exists because: 1) multinational pharmaceutical and biotechnology companies do not regard research and development investments on the health problems of developing nations to be economically lucrative; and 2) governmental agencies that sponsor biomedical (...) research face little political pressure to allocate funds for the problems of developing nations. This paper argues that developed nations have an obligation to address disparities related to biomedical research funding. To facilitate this effort, developed countries should establish a trust fund dedicated to research on the health problems of developing nations similar to the Global AIDS Fund. (shrink)

Social scientists have begun elucidating the variables that influence public trust in science, yet little is known about hype in biotechnology and its effects on public trust. Many scholars claim that hyping biotechnology results in a loss of public trust, and possibly public enthusiasm or support for science, because public expectations of the biotechnological promises will be unmet. We argue for the need for empirical research that examines the relationships between hype, public trust, and public enthusiasm/support. We discuss the complexities (...) in designing empirical studies that provide evidence for a causal link between hype, public trust, and public enthusiasm/support, but also illustrate how this may be remedied. Further empirical research on hype and public trust is needed in order to improve public communication of science and to design evidence-based education on the responsible conduct of research for scientists. We conclude that conceptual arguments made on hype and public trust must be nuanced to reflect our current understanding of this relationship. (shrink)

Various U.S. laws, such as the Clean Air Act and the Food Quality Protection Act, require additional protections for susceptible subpopulations who face greater environmental health risks. The main ethical rationale for providing these protections is to ensure that environmental health risks are distributed fairly. In this article, we (1) consider how several influential theories of justice deal with issues related to the distribution of environmental health risks; (2) show that these theories often fail to provide specific guidance concerning policy (...) choices; and (3) argue that an approach to public decision making known as accountability for reasonableness can complement theories of justice in establishing acceptable environmental health risks for the general population and susceptible subpopulations. Since accountability for reasonableness focuses on the fairness of the decision-making process, not the outcome, it does not guarantee that susceptible subpopulations will receive a maximum level of protection, regardless of costs or other morally relevant considerations. (shrink)

This essay analyzes the concept of public trust in science and offers some guidance for ethicists, scientists, and policymakers who use this idea defend ethical rules or policies pertaining to the conduct of research. While the notion that public trusts science makes sense in the abstract, it may not be sufficiently focused to support the various rules and policies that authors have tried to derive from it, because the public is not a uniform body with a common set of interests. (...) Well-focused arguments that use public trust to support rules or policies for the conduct of research should specify (a) which public is being referred to (e.g. the general public or a specific public, such as a particular community or group); (b) what this public expects from scientists; (c) how the rule or policy will ensure that these expectations are met; and (d) why is it important to meet these expectations. (shrink)

Two articles published in Bioethics recently have explored the ways that bioethics can contribute to the climate change debate. Cheryl Cox Macpherson argues that bioethicists can play an important role in the climate change debate by helping the public to better understand the values at stake and the trade-offs that must be made in individual and social choices, and Sean Valles claims that bioethicists can contribute to the debate by framing the issues in terms of the public health impacts of (...) climate change. While Macpherson and Valles make valid points concerning a potential role for bioethics in the climate change debate, it is important to recognize that much more than ethical analysis and reflection will be needed to significantly impact public attitudes and government policies. (shrink)

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.

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. (shrink)

Editor's Note: On February 2, 2005, the National Institutes of Health changed course on conflicts of interest and prohibited its scientists from owning stock in or working as consultants with pharmaceutical or biotechnology companies. The following essay, sent to press before the new policy was announced, recommends a very different approach. The author stands by the recommendations.

In this article, we discuss ethical issues related to using and disclosing artificial intelligence (AI) tools, such as ChatGPT and other systems based on large language models (LLMs), to write or edit scholarly manuscripts. Some journals, such as Science, have banned the use of LLMs because of the ethical problems they raise concerning responsible authorship. We argue that this is not a reasonable response to the moral conundrums created by the use of LLMs because bans are unenforceable and would encourage (...) undisclosed use of LLMs. Furthermore, LLMs can be useful in writing, reviewing and editing text, and promote equity in science. Others have argued that LLMs should be mentioned in the acknowledgments since they do not meet all the authorship criteria. We argue that naming LLMs as authors or mentioning them in the acknowledgments are both inappropriate forms of recognition because LLMs do not have free will and therefore cannot be held morally or legally responsible for what they do. Tools in general, and software in particular, are usually cited in-text, followed by being mentioned in the references. We provide suggestions to improve APA Style for referencing ChatGPT to specifically indicate the contributor who used LLMs (because interactions are stored on personal user accounts), the used version and model (because the same version could use different language models and generate dissimilar responses, e.g., ChatGPT May 12 Version GPT3.5 or GPT4), and the time of usage (because LLMs evolve fast and generate dissimilar responses over time). We recommend that researchers who use LLMs: (1) disclose their use in the introduction or methods section to transparently describe details such as used prompts and note which parts of the text are affected, (2) use in-text citations and references (to recognize their used applications and improve findability and indexing), and (3) record and submit their relevant interactions with LLMs as supplementary material or appendices. (shrink)

In recent years, many philosophers of science have rejected the “value-free ideal” for science, arguing that non-epistemic values have a legitimate role to play in scientific inquiry. However, this philosophical position raises the question of how to distinguish between legitimate and illegitimate influences of values in science. In this paper, we argue that those seeking to address this “new” demarcation problem can benefit by drawing lessons from the “old” demarcation problem, in which philosophers tried to find a way of distinguishing (...) between science and non-science. Many of those who worked on this problem ultimately found that efforts to provide necessary and sufficient conditions for defining science failed, and most concluded that the best solution to the problem was to characterize scientific hypotheses, theories, and research programs in terms of some common norms. We suggest that those seeking to distinguish between legitimate and illegitimate value influences on science would do well to adopt a similar approach. Rather than attempting to establish necessary and sufficient conditions for identifying appropriate value influences, it will be more fruitful to evaluate scientific activities based on their adherence to a set of epistemic and ethical norms that can be implemented in scientific practice by means of rules, conventions, policies, and procedures. (shrink)

Bioethics, Volume 36, Issue 7, Page 735-741, September 2022.

Valid Informed consent to medical treatment or research participation has traditionally been viewed as consisting of the following requirements: the person has t...

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. (shrink)

: This paper discusses the morality of patenting human genes and genetic technologies. After examining arguments on different sides of the issue, the paper concludes that there are, at present, no compelling reasons to prohibit the extension of current patent laws to the realm of human genetics. However, since advances in genetics are likely to have profound social implications, the most prudent course of action demands a continual reexamination of genetics laws and policies in light of ongoing developments in science (...) and technology. (shrink)

Traditional debates about scientific realism tend to focus on issues concerning scientific representation and de-emphasize issues concerning scientific intervention. Questions about the relation between theories and the world, the nature of scientific inference, and the structure of scientific explanations have occupied a central place in the realism debate, while questions about experimentation and technology have not. Ian Hacking's experimental realism attempts to reverse this trend by shifting the defense of realism away from representation to intervention. Experimental realism, according to Hacking, (...) does not require us to believe that our theories are true, nor does its defense depend on inference to the best explanation. For Hacking, the strongest proof for realism is that we can manipulate objects: 'So far as I'm concerned, if you can spray them, then they are real'. (shrink)

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. (shrink)

A growing body of literature has identified potential problems that can compromise the quality, fairness, and integrity of journal peer review, including inadequate review, inconsistent reviewer reports, reviewer biases, and ethical transgressions by reviewers. We examine the evidence concerning these problems and discuss proposed reforms, including double-blind and open review. Regardless of the outcome of additional research or attempts at reforming the system, it is clear that editors are the linchpin of peer review, since they make decisions that have a (...) significant impact on the process and its outcome. We consider some of the steps editors should take to promote quality, fairness and integrity in different stages of the peer review process and make some recommendations for editorial conduct and decision-making. (shrink)