We examined institutional review board policies from the top U.S. research universities to determine how many have policies that define or provide examples of what constitutes a “minor change” to previously approved research. We sought to describe differences among definitions and to ascertain whether funding level, accreditation, public versus private status, and geographic region impact the inclusion of a definition or example of this term. Of the 184 universities that we obtained policies from, 52.2% defined “minor change,” 43.5% gave examples (...) of what would constitute one, and 67.9% provided either a definition or examples. We found that higher funding and accreditation were positively associated with having a definition or giving examples of minor changes, but that public versus private status and geographic region had no significant impact. While our study indicates that most of the top U.S. research institutions define the term “minor change” to previously approved research, we found that the definitions vary considerably. Additional guidance from federal agencies could help promote consistency in institutional policies and ensure uniformity in protections for human research participants. (shrink)

The concept of athleticism seems, at first glance, to be a minor component of Deleuze's analysis in Francis Bacon, appearing by name in the text only six times. In this article, I draw out the close link between athleticism and Deleuze's fundamental concept of intensity, arguing that this ostensibly minor term is in fact central to his account of the ‘clear and durable sensation’ produced by Bacon's painting. In tracing links between athleticism, Deleuze's aesthetic concept of ‘the fall’, and his (...) reliance on and critique of Kant's theory of intensive magnitudes, I show that athleticism in Francis Bacon names the form of intensity proper to painting. (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.

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)

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)

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)

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. (shrink)

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

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

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)

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)

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. (shrink)

This book expounds a system of ideas about the nature of mathematics which Michael Resnik has been elaborating for a number of years. In calling mathematics a science he implies that it has a factual subject-matter and that mathematical knowledge is on a par with other scientific knowledge; in calling it a science of patterns he expresses his commitment to a structuralist philosophy of mathematics. He links this to a defense of realism about the metaphysics of mathematics--the view that (...) mathematics is about things that really exist. (shrink)

The Ethics and Regulation of Research with Human Subjects, edited by Professors Carl Coleman of Seton Hall, Jerry Menikoff of the University of Kansas, Jesse Goldner of Saint Louis University, and Nancy Dubler of the Albert Einstein College of Medicine, is an up-to-date and authoritative collection of readings on ethical, legal, and policy issues in research with human subjects. The authors have modeled their text on the casebook style commonly used in law schools. At 746 pages, plus front matter and (...) an appendix, this book contains just about everything one needs to know for a thorough grasp on human subjects research, including federal and state regulations governing this research, interpretive guidance from federal agencies, international guidelines and codes, court decisions, historical documents and case studies, and selected readings from scholarly articles and books. The book includes written comments and questions to help students understand and interpret the readings. (shrink)

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. (shrink)

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. (shrink)

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. (shrink)

The idea that the degree of infringement public health interventions have on individual rights should be proportional to the degree of expected benefits has emerged as an influential principle in public health ethics and policy. While proportionality makes sense in theory, it may be difficult to implement in practice, due to the inherent conflict between individual rights and the common good underlying the principle. To apply the proportionality principle to a decision of policy, one must still find a reasonable way (...) of balancing these competing values in light of the available options and empirical evidence. In this article, I consider how the proportionality principle applies to the regulation of dietary supplements and examine some critiques of the current oversight system. I argue that it may be difficult maintain proportional oversight because the risks of dietary supplements vary considerably. Strengthening the regulations may therefore promote an appropriate level of regulation in some cases but lead to overregulation in others. (shrink)

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. (shrink)

In this note I shall make some observations concerning both the original and repaired systems presented by Frege in his Grundgesetze der Arithmetik . These in tum lead to general considerations con- cerning related axáom systems and contemporary comparative set theory. I hope that my remarks will be useful to others - as they were to me - for obtaining some insight into Frege's and current systems.

There has recently been a flurry of activity in the philosophy of language on how to best account for the unique features of epithets. One of these features is that epithets can be appropriated (that is, the offense-grounding potential of a term can be removed). We argue that attempts to appropriate an epithet fundamentally involve a violation of language-governing rules. We suggest that the other conditions that make something an attempt at appropriation are the same conditions that characterize acts of (...) civil disobedience. Accounting for attempts at appropriation is thus both a linguistic and socio-political endeavor. We demonstrate how these two facets of attempts at appropriation also help us understand the communicative features of civil disobedience. (shrink)

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)

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. (shrink)

This article explores the impact of the Copernican and Darwinian revolutions on our view of human-kind’s place in the universe and locates the current debates about stem cell research within this larger sociohistorical context. The article argues that the past 500 years of science support the idea that the morally significant features of human beings reside in the unique cognitive, emotive, and social traits that are often described as the “soul,” not in any special features of human physiology, anatomy, or (...) genetics. (shrink)

This letter responds to the article “The Social Risks of Science,” by Jonathan Herington and Scott Tanona, published in the November‐December 2020 issue of the Hastings Center Report.

The US federal research regulations prohibit informed consent, whether written or oral, from including provisions in which human subjects waive or appear to waive legal rights. We argue that policies that prevent human subjects from waiving legal rights in research can be ethically justified under the rationale of group, soft paternalism. These policies protect competent adults from making adverse decisions about health and legal matters that they may not understand fully. However, this rationale is less defensible if there is a (...) comprehensive compensation for injury programme available in which subjects are asked to waive some legal rights in order to participate in the programme. In this situation, subjects should be allowed to waive some legal rights to obtain the benefits of the programme. (shrink)

In little more than 30 years, China has recovered from the intellectual stagnation brought about by the Cultural Revolution to become a global leader in science and technology. Like other leading countries in science and technology, China has encountered some ethical problems related to the conduct of research. China 's leaders have taken some steps to respond to these problems, such as developing ethics policies and establishing oversight committees. To keep moving forward, China needs to continue to take effective action (...) to promote research integrity. Some of the challenges China faces include additional policy development, promoting education in responsible conduct of research, protecting whistle-blowers, and cultivating an ethical research environment. (shrink)

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)