David Resnik

Most of the discussion in bioethics and health policy concerning social responsibility for health has focused on society’s obligation to provide access to healthcare. While ensuring access to healthcare is an important social responsibility, societies can promote health in many other ways, such as through sanitation, pollution control, food and drug safety, health education, disease surveillance, urban planning and occupational health. Greater attention should be paid to strategies for health promotion other than access to healthcare, such as environmental and public health and health research.Lifestyle plays a major role in most of the illnesses in industrialised nations.1 Six of the 10 leading factors contributing to the global burden of disease are lifestyle related: unsafe sex, high blood pressure, tobacco use, alcohol use, high cholesterol and obesity.2 Lifestyle-related illnesses also contribute to the rising costs of healthcare. Spending on healthcare accounts for about 16% of the gross domestic product in the USA, or US$1.9 trillion.3 Although smoking has declined steadily there since the 1960s, smoking-related medical expenses are still about US$75.5 billion per year.4 Obesity, which has been climbing in the past two decades, accounts for about US$75 billion in healthcare costs there each year.5 Alcoholism and drug addiction in the USA account for annual healthcare costs of about US$22.5 billion and US$12 billion, respectively.6,7 Federal government spending on healthcare relating to HIV/AIDS is over US$13 billion per year.8Given the well-documented relationship between lifestyle, disease burden and healthcare costs, it makes economic and medical sense to hold individuals morally responsible for their health-related choices. While this view has a great deal of intuitive appeal, it also faces numerous objections.9–12 First, holding individuals entirely responsible for their own health conflicts with medicine’s obligation to treat the sick and society’s obligation …

Informed consent is one of the foundational ethical and legal requirements of research with human subjects. The Nuremberg Code, the Helsinki Declaration, the Belmont Report, the Common Rule and many other laws and codes require that research subjects make a voluntary, informed choice to participate in research.12345 Informed consent is based on the moral principle of respect for autonomy, which holds that rational individuals have a right to make decisions and take actions that reflect their values and preferences. 6 Whereas most guidelines and codes also require that informed consent be properly documented, informed consent is much more than signing a piece of paper: It is a continuous process of communication between the investigator and the research subject. 7 Because the body of knowledge impacting a study frequently changes, subjects should receive information from investigators after they have enrolled in a study, such as significant new findings that may affect their decision to participate in research or clinically useful tests results. 8910 In large studies, some investigators use newsletters to update subjects on the progress of research and other developments.11Most of the ongoing communications between investigators and subjects involve little more than information sharing, without revisiting the decision to participate in research or signing any additional documents. Sometimes, however, it may be necessary for subjects to reaffirm their decision to participate, to re-consent, or to sign or re-sign a document. 8 Re-consent can be defined as an action in which a subject makes the decision to participate in research once again. Re-consent is different from reaffirming a commitment to participate in a study, because in re-consent one actually reconsiders the information necessary to make decision, whereas in reaffirmation one simply expresses ….

The phrase “minimal risk,” as defined in the United States’ federal research regulations, is ambiguous and poorly defined. This article argues that most of the ambiguity that one finds in the phrase stems from the “daily life risks” standard in the definition of minimal risk. In this article, the author argues that the daily life risks standard should be dropped and that “minimal risk” should be defined as simply “the probability and magnitude of the harm or discomfort anticipated in research are not greater than those encountered during the performance of routine physical or psychological examinations or tests”

Multiple authorship is becoming increasingly common in bioethics research. There are well-established criteria for authorship in empirical bioethics research but not for conceptual research. It is important to develop criteria for authorship in conceptual publications to prevent undeserved authorship and uphold standards of fairness and accountability. This article explores the issue of multiple authorship in bioethics and develops criteria for determining who should be an author on a conceptual publication in bioethics. Authorship in conceptual research should be based on contributing substantially to: (1) identifying a topic, problem, or issue to study; (2) reviewing and interpreting the relevant literature; (3) formulating, analyzing, and evaluating arguments that support one or more theses; (4) responding to objections and counterarguments; and (5) drafting the manuscript and approving the final version. Authors of conceptual publications should participate substantially in at least two of areas (1)?(5)

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.

In a recent issue of Biology and Philosophy, Kenneth Waters argues that the principle of survival of the fittest should be eliminated from the theory of natural selection, because it is an untestable law of probability, and as such, has no place in evolutionary theory. His argument is impressive, but it does not do justice to the practice of biology. The principle of survival of the fittest should not be eliminated from the theory of natural selection because it is important to biological practice: it plays an essential role in explanation and discovery, and in unffying the theory of natural selection.

Government food and beverage policies can play an important role in promoting public health. Few people would question this assumption. Difficult questions can arise, however, when policymakers, public health officials, citizens, and businesses deliberate about food and beverage policies, because competing values may be at stake, such as public health, individual autonomy, personal responsibility, economic prosperity, and fairness. An ethically justified policy strikes a reasonable among competing values by meeting the following criteria: the policy serves important social goal; the policy is likely to be effective at achieving those goal; less burdensome options are not likely to be effective at achieving the goals; the policy is fair

This article reports the results of an anonymous survey of researchers at a government research institution concerning their perceptions about ethical problems with journal peer review. Incompetent review was the most common ethical problem reported by the respondents, with 61.8% (SE = 3.3%) claiming to have experienced this at some point during peer review. Bias (50.5%, SE = 3.4%) was the next most common problem. About 22.7% (SE = 2.8%) of respondents said that a reviewer had required them to include unnecessary references to his/her publication(s), 17.7% (SE = 2.6%) said that comments from reviewers had included personal attacks, and 9.6% (SE = 2.0%) stated that reviewers had delayed publication to publish a paper on the same topic. Two of the most serious violations of peer review ethics, breach of confidentiality (6.8%, SE = 1.7%) and using ideas, data, or methods without permission (5%, SE = 1.5%) were perceived less often than the other problems. We recommend that other investigators follow up on our exploratory research with additional studies on the ethics of peer review.

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

Elliott Sober (1987, 1993) and Orzack and Sober (forthcoming) argue that adaptationism is a very general hypothesis that can be tested by testing various particular hypotheses that invoke natural selection to explain the presence of traits in populations of organisms. In this paper, I challenge Sobers claim that adaptationism is an hypothesis and I argue that it is best viewed as a heuristic (or research strategy). Biologists would still have good reasons for employing this research strategy even if it turns out that natural selection is not the most important cause of evolution.

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.

This paper argues that clinicians are sometimes justified in not testing diagnoses or in not subjecting them to a full battery of tests. In deciding whether to conduct a test, a clinician may consider and weigh several different factors, including her confidence in her initial diagnosis, the specificity and sensitivity of the test, the consequences of making a false diagnosis, the pain, harm, and inconvenience caused by the test, and the costs of the test to the patient and society. This view suggests that diagnoses are fundamentally different from scientific hypotheses in that they are not always subjected to the same evidential standards

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.

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

: 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

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.

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

The first stage of the human embryonic stem(ES) cell research debate revolved aroundfundamental questions, such as whether theresearch should be done at all, what types ofresearch may be done, who should do theresearch, and how the research should befunded. Now that some of these questions arebeing answered, we are beginning to see thenext stage of the debate: the battle forproperty rights relating to human ES cells. The reason why property rights will be a keyissue in this debate is simple and easy tounderstand: it costs a great deal of money todo this research, to develop new products, andto implement therapies; and private companies,researchers, and health professionals requirereturns on investments and reimbursements forgoods and services. This paper considersarguments for and against property rightsrelating to ES cells defends the followingpoints: (1) It should be legal to buy and sellES cells and products. (2) It should be legalto patent ES cells, products, and relatedtechnologies. (3) It should not be legal tobuy, sell, or patent human embryos. (4) Patentson ES cells, products, and related technologiesshould not be excessively broad. (5) Patents onES cells, products, and related technologiesshould be granted only when applicants statedefinite, plausible uses for their inventions. (6) There should be a research exemption in EScell patenting to allow academic scientists toconduct research in regenerative medicine. (7)It may be appropriate to take steps to preventcompanies from using patents in ES cells,products, and related technologies only toblock competitors. (8) As the field ofregenerative medicine continues to develop,societies should revisit issues relating toproperty rights on a continuing basis in orderto develop policies and develop regulations tomaximize the social, medical, economic, andscientific benefits of ES cell research andproduct development