David Resnik

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

Scientists and policy‐makers have long understood that the products of research can often be used for good or evil. Nuclear fission research can be used to generate electricity or create a powerful bomb. Studies on the genetics of human populations can be used to understand relationships between different groups or to perpetuate racist ideologies. While the notion that scientific research often has beneficial and harmful uses has been discussed before, the threat of bioterrorism—a concern that has only grown since 2001—has led to increased awareness about the need to prevent the misuse of biomedical research, particularly when it involves dangerous pathogens or toxins. In 2012, the concern was ratcheted up another notch by two papers reporting the results of research on genetically engineered strains of the H5N1 avian influenza virus. Although the H5N1 papers have potential scientific and social value, some scientists and policy‐makers opposed their publication because they feared that terrorists (or others with nefarious motives) could use the research to create a bioweapon that could trigger a global pandemic. The H5N1 papers raise difficult questions concerning the ethics of knowledge. Should scientific research with dangerous applications be published? Should some types of research be kept secret or not be conducted at all? What type of government oversight of dangerous research is appropriate? In this essay, I will develop a framework for thinking about the ethics of knowledge and apply it to the H5N1 controversy, focusing on issues related to publication. I will argue that redacted publication would have been a reasonable response to the dilemmas posed by the H5N1 papers if not for practical and legal problems with this option. Given these problems, full publication seems appropriate.

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

The idea that research with human participants should benefit society has become firmly entrenched in various regulations, policies, and guidelines, but there has been little in-depth analysis of this ethical principle in the bioethics literature. In this paper, I distinguish between strong and weak versions and the social benefits principle and examine six arguments for it. I argue that while it is always ethically desirable for research with human subjects to offer important benefits to society, the reasonable expectation of substantial public benefit should be a necessary condition for regarding research as ethical only when it imposes more than minimal risks on non-consenting subjects; or it is supported by public resources.

The genetic diversity argument (GDA) is one of the most commonly voiced objections to advances in reproductive and genetic technologies. According to the argument, scientific and technological developments in the realm of genetics and human reproduction will lead to lower genetic diversity, which will threaten the health and survivability of the human population. This discussion explicates and analyzes the GDA and challenges its empirical assumptions. It also discusses the possible significance of the GDA in our overall thinking about genetics and human reproduction and examines two proposals for preserving "useful" genes.

Healthy volunteers in biomedical research often face significant risks in studies that offer them no medical benefits. The U.S. federal research regulations and laws adopted by other countries place no limits on the risks that these participants face. In this essay, I argue that there should be some limits on the risks for biomedical research involving healthy volunteers. Limits on risk are necessary to protect human participants, institutions, and the scientific community from harm. With the exception of self-experimentation, limits on research risks faced by healthy volunteers constitute a type of soft, impure paternalism because participants usually do not fully understand the risks they are taking. I consider some approaches to limiting research risks and propose that healthy volunteers in biomedical research should not be exposed to greater than a 1% chance of serious harm, such as death, permanent disability, or severe illness or injury. While this guideline would restrict research risks, the limits would not be so low that they would prevent investigators from conducting valuable research. They would, however, set a clear upper boundary for investigators and signal to the scientific community and the public that there are limits on the risks that healthy participants may face in research. This standard provides guidance for decisions made by oversight bodies, but it is not an absolute rule. Investigators can enroll healthy volunteers in studies involving a greater than 1% chance of serious harm if they show that the research addresses a compelling public health or social problem and that the risk of serious harm is only slightly more than 1%. The committee reviewing the research should use outside experts to assess these risks.

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.

In September 2012, Gilles-Eric Séralini and seven coauthors published an article in Food and Chemical Toxicology claiming that rats fed Roundup©-resistant genetically modified maize alone, genetically modified maize with Roundup©, or Roundup© for 2 years had a higher percentage of tumors and kidney and liver damage than normal controls. Shortly after this study was published, numerous scientists and several scientific organizations criticized the research as methodologically and ethically flawed. In January 2014, the journal retracted the article without the authors’ consent on the grounds that the research was inconclusive. In June 2014, Environmental Sciences Europe published a slightly modified version of the retracted paper. The publication, retraction and subsequent republication of the Séralini study raise important scientific and ethical issues for journal editors. Decisions to retract an article should be made on the basis of well-established policies. Articles should be retracted only for serious errors that undermine the reliability of the data or results, or for serious ethical lapses, such as research misconduct or mistreatment of animal or human subjects. Inconclusiveness, by itself, is not a sufficient reason for retracting an article, though a flawed study design might be. Retracted articles that are submitted for republication should undergo scientific review to ensure that they meet appropriate standards. Republished articles should be linked to the original, retracted publication. Journals that are reviewing studies with significant scientific and social implications should take special care to ensure that peer review is rigorous and fair

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

Health policy frameworks usually construe environmental protection and human health as harmonious values. Policies that protect the environment, such as pollution control and pesticide regulation, also benefit human health. In recent years, however, it has become apparent that promoting human health sometimes undermines environmental protection. Some actions, policies, or technologies that reduce human morbidity, mortality, and disease can have detrimental effects on the environment. Since human health and environmental protection are sometimes at odds, political leaders, citizens, and government officials need a way to mediate and resolve conflicts between these values. Unfortunately, few approaches to applied bioethics have the conceptual tools to do accomplish this task. Theories of health care ethics have little to say about the environment, and theories of environmental ethics don’t say much about human health. In this essay, I defend an approach to ethical decision-making that gives policy-makers some tools for balancing promotion of human health and protection of the environment

In this article we examine four objections to the genetic modification of human beings: the freedom argument, the giftedness argument, the authenticity argument, and the uniqueness argument. We then demonstrate that each of these arguments against genetic modification assumes a strong version of genetic determinism. Since these strong deterministic assumptions are false, the arguments against genetic modification, which assume and depend upon these assumptions, are therefore unsound. Serious discussion of the morality of genetic modification, and the development of sound science policy, should be driven by arguments that address the actual consequences of genetic modification for individuals and society, not by ones propped up by false or misleading biological assumptions

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.

Mosquito-borne diseases take a tremendous toll on human populations, especially in developing nations. In the last decade, scientists have developed mosquitoes that have been genetically modified to prevent transmission of mosquito-borne diseases, and field trials have been conducted. Some mosquitoes have been rendered infertile, some have been equipped with a vaccine they transmit to humans, and some have been designed to resist diseases. This article focuses on ethical issues raised by field trials of disease-resistant, genetically modified mosquitoes. Some of these issues include: protecting the public and the environment from harm, balancing benefits and risks, collaborating with the local community, avoiding exploitation, and safeguarding the rights and welfare of research subjects. One of the most difficult problems involves protecting the welfare of community members who will be impacted by the release of mosquitoes but who are not enrolled in the study as research subjects. To address this concern, field trials should take place only when the targeted disease is a significant public health problem in an isolated area, the benefits of the trial for the community are likely to outweigh the risks, community leaders approve of the trial, and there are measures in place to protect the welfare of un-enrolled community members, such as informing the community about the study and offering free treatment to people who contract mosquito-borne diseases. Since the justification of any field trial depends on a careful examination of the scientific and ethical issues, proposed studies should be evaluated on a case-by-case basis

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

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.