David Resnik

Inappropriate authorship is a common problem in biomedical research and may be becoming one in bioethics, due to the increase in multiple authorship. This paper investigates the authorship policies of bioethics journals to determine whether they provide adequate guidance for researchers who submit articles for publication, which can help deter inappropriate authorship. It was found that 63.3% of bioethics journals provide no guidance on authorship; 36.7% provide guidance on which contributions merit authorship, 23.3% provide guidance on which contributions do not merit authorship, 23.3% require authors to take responsibility for their contributions or for the article as a whole, 20% provide guidance on which contributions merit an acknowledgement but not authorship, 6.7% require authors to describe their contributions, and only 3.3% distinguish between authorship in empirical and conceptual research. To provide authors with effective guidance and promote integrity in bioethics research, bioethics journals should adopt authorship policies that address several important topics, such as the qualifications for authorship, describing authorship contributions, taking responsibility for the research and the difference between authorship in empirical and conceptual research

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”

Sarah Conly defends paternalistic public health policies, such as New York City’s soft drink ban, on the grounds that they promote values that people accept but have difficulty realizing, owing to their cognitive biases. In this commentary, I criticize Conly’s defense of the soft drink ban and offer my own view of the justification for paternalistic food and beverage policies. I propose that paternalistic government restrictions on food and beverage choices should address a significant health problem pertaining to a specific type or class of food or beverage. There should also be substantial evidence that the restrictions are likely to be effective at dealing with the problem and that alternative ways of dealing with it, which do not involve coercion, are likely to be ineffective

Patient counseling is a cornerstone of ethical pharmacy practice and high quality pharmaceutical care. Counseling promotes patient compliance with prescription regimens and prevents dangerous drug interactions and medication errors. Counseling also promotes informed consent and protects pharmacists against legal risks. However, economic, social, and technological changes in pharmacy practice often force community pharmacists to choose between their professional obligations to counsel patients and business objectives. State and federal legislatures have enacted laws that require pharmacists to counsel patients, but these laws have had mixed results. This essay argues that community pharmacy's patient counseling conundrum can be solved through additional moral education and moral persuasion, not through additional legal mandates.

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

The objective of this study was to determine whether consent forms in oncology clinical trials of commercially available treatments inform subjects that they may be able to obtain the treatments being investigated without participating in research. We acquired consent forms from a random sample of U.S. oncology clinical trials in the ClinicalTrials.gov database. We then examined a subgroup of the sample consisting of studies in which the treatments under investigations were commercially available. Less than 20% of the consent forms in that group disclosed to subjects that they may be able to obtain the treatment being investigated without participating in the study . Our results suggest that potential research subjects are frequently not informed about important alternatives to research participation in studies involving commercially available treatments, which is a violation of both ethical and regulatory standards

When scientific research collides with social values, science's right to self-governance becomes an issue of paramount concern. In this article, I develop an account of scientific autonomy within a framework of public oversight. I argue that scientific autonomy is justified because it promotes the progress of science, which benefits society, but that restrictions on autonomy can also be justified to prevent harm to people, society, or the environment, and to encourage beneficial research. I also distinguish between different ways of limiting scientific autonomy, and I argue that government involvement in scientific decision-making should usually occur through policies that control the process of science, rather than policies that control the content of science

This paper attempts to debunk the slippery-slope argument against human germ-line gene therapy by showing that the downside of the slope – genetic enhancement – need not be as unethical or unjust as some people have supposed. It argues that if genetic enhancement is governed by proper regulations and is accompanied by adequate education, then it need not violate recognized principles of morality or social justice. Keywords: germ-line therapy, slippery slope argument, future generations, social justice CiteULike Connotea Del.icio.us What's this?

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.

Scientists have rules pertaining to data fabrication and falsification that are enforced with significant punishments, such as loss of funding, termination of employment, or imprisonment. These rules pertain to data that describe observable and unobservable entities. In this commentary I argue that scientists would not adopt rules that impose harsh penalties on researchers for data fabrication or falsification unless they believed that an aim of scientific research is to develop true theories and hypotheses about entities that exist, including unobservable ones. This argument presents a challenge for constructive empiricists, such as van Fraassen. Constructive empiricists need to be able to explain why rules pertaining to data fabrication and falsification do not threaten their philosophy of science

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'.

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)

This paper provides an explication and defense of a view that many philosophers and biologists have accepted though few have understood, the idea that functional language can play an important role in biological discovery. I defend four theses in support of this view: (1) functional statements can serve as background assumptions that produce research problems; (2) functional questions can be important parts of research problems; (3) functional concepts can provide a framework for developing general theories; (4) functional statements can serve as heuristics for generating hypotheses. I develop and defend these four claims by describing a taxonomy of functional discourse, providing an account of scientific discovery, and by applying this framework to some cases of successful research in biology

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.

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.

This paper develops an instrumentalistic argumentagainst an eliminativist approach to using the folkconcept of pain in clinical medicine and draws someimplications for biomedical theories of pain. Thepaper argues that the folk concept of pain plays afundamental role in several aspects of clinicalmedicine, including the diagnosis and treatment ofdiseases and symptoms, relieving human suffering, andthe doctor-patient relationship. Since clinicians mustbe able to apply biomedical theories of pain inmedical practice, these theories should not stray toofar from pain's clinical realities. Biomedicaltheories of pain should at least incorporate an analogof the folk concept of pain, even if this concept isrevised in light of scientific advances

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.

This essay analyzesexploitation in biomedical research in terms ofthree basic elements: harm, disrespect, orinjustice. There are also degrees ofexploitation, ranging from highly exploitationto minimally exploitation. Althoughexploitation is prima facie wrongful,some exploitative research studies are morallyjustified, all things considered. The reasonan exploitative study can still be ethical isthat other moral considerations, such as theautonomy of the research subject or the socialbenefits of research, may sometimes justifystudies that are minimally exploitative. Calling a research project exploitative doesnot end the debate about the merits of thestudy but invites one to ask additionalquestions about how the study is exploitative,and whether the study is justifiablenevertheless.