David Resnik

This study presents the results of a survey of student satisfaction with electronic discussion boards in a course on the responsible conduct of research (RCR). On a 1–5 scale, the respondents stated that the use of the electronic discussion board was an effective teaching tool (4.71), that it enabled them to get feedback from their peers (4.43), that it helped promote discussion and debate (4.36), that it helped them learn how to analyze ethical dilemmas in research (4.36), and that they would consider using an electronic discussion board, if they ever taught a course themselves (4.76). In their written comments, the respondents indicated that electronic discussion boards are a convenient way of promoting debate and in-depth discussion. These results suggest, but do not prove, that discussion boards can promote debate and discussion in courses on research ethics. Instructors who teach RCR should consider using electronic discussion boards in regular or online courses, and they should consider studying the effectiveness of electronic discussion boards in research ethics education. Although electronic discussion boards cannot replace the face-to-face interaction that occurs in a classroom setting, they may provide a useful medium for the exchange of ideas and opinions online.

This article examines conflicts of interest in the context of scientific research related to regulation or litigation. The article defines conflicts of interest, considers how conflicts of interest can impact research, and discusses different strategies for dealing with conflicts of interest. While it is not realistic to expect that scientific research related to regulation or litigation will ever be free from conflicts of interest, society should consider taking some practical steps to minimize the impact of these conflicts, such as requiring full disclosure of information required for independent evaluation of research, prohibiting financial relationships between regulatory agencies and the companies they regulate, and banning payments to expert witnesses for specific research results, testimony or legal outcomes.

Very few people who read Carl Schneider's The Censor's Hand: The Misregulation of Human-Subject Research will have a neutral opinion of his book. Schneider defends the radical thesis that the system of regulating human subjects research is not just broken but deeply misguided and therefore needs to be abolished. While some researchers who are frustrated with the current regime will welcome Schneider's scathing critiques of institutional review boards and the regulations they enforce, those who view the status quo as a necessary, though perhaps flawed, means of protecting human subjects will recoil from his arguments and conclusions. Schneider rejects reform efforts, such as the proposed revisions to the Common Rule, as likely to be short-lived and ineffective. He argues that professional self-regulation and tort law can do a better job of protecting human subjects and advancing research than government regulation

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.

What the Doctor Didn’t Say: The Hidden Truth About Medical Research, by Jerry Menikoff , is an insightful, clear, and engaging overview of some of the ethical and legal challenges of clinical research. The book contains thoughtful discussions of legal protections for research subjects, medical malpractice law, informed consent, pediatric research, emergency research, research on decisionally incapacitated adults, payment to research subjects, and other important topics. It also makes a number of stunning revelations concerning the practice of clinical research and provocative proposals for legal and policy reform

Openness is one of science’s fundamental ethical norms, but it should not take precedence over the obligation to protect the confidentiality of data. Deidentifying the data obtained from human genomic research as a condition of providing open access to research data is a strategy to promote scientific openness while protecting research participants’ confidentiality interests. However, given recent advances in methods of reidentifying individuals whose deidentified data are in genomic databases, the best way to balance scientific openness and protection of human subjects in genomic research is to permit access to genomic data on a restricted basis

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 study discusses the results of a survey of 1,800 articles published in American medical journals from 1985--1996. The study finds 9% of these articles reported research that uses only male subjects to examine medical conditions that affect both sexes; the ratio of research on female to male conditions among these articles was greater than 5:1; but 76.5% of the articles reported research that includes both male and female subjects. The study also discusses evidence that sex biases against women (and men) are decreasing. This study also offers some possible psychological, institutional, medical, and economic explanations of the sex biases in medical research published in American journals, and discusses some policy implications of sex biases in medical research. The study concludes by urging others to conduct more empirical research on sex biases in medical research.

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

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

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 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?

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

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

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

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

The Common Rule is a set of regulations for protecting human participants in research funded by the Department of Health and Human Services, which has been adopted in part by 17 federal agencies. It includes four different subparts: Subpart A, Subpart B, Subpart C, and Subpart D. The Common Rule has not been significantly revised since 1981 although some significant changes may be forthcoming. The Food and Drug Administration has adopted its own regulations for the protection of human participants, which are similar to the Common Rule in many key areas, such as the structure and function of the Institutional Review Board, and the criteria for approving research.

: 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

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'.