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Biomedical subjects

David B Resnik

Publications and source records attributed to David B Resnik.

At least 19 recordsLinked to original sources

Ethical issues in clinical trials involving nanomedicine.

Nanomedicine shows tremendous promise for improving medical diagnosis, treatment, and prevention, but it also raises a variety of ethical concerns. Because of the paucity of data on the physicochemical properties of nanoscale materials in biological systems, clinical trials of nanomedicine products present some unique challenges related to risk minimization, management and communication involving human subjects. Although these clinical trials do not raise any truly novel ethical issues, the rapid development of nanotechnology and its potentially profound social and environmental impacts, add a sense of urgency to the problems that arise.

Clinical Trials as Topic↗

Genetic modification and genetic determinism.

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.

Genetic Determinism↗

Using electronic discussion boards to teach responsible conduct of research.

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.

Attitude of Health Personnel↗

The patient's duty to adhere to prescribed treatment: an ethical analysis.

This article examines the ethical basis for the patient's duty to adhere to the physician's treatment prescriptions. The article argues that patients have a moral duty to adhere to the physician's treatment prescriptions, once they have accepted treatment. Since patients still retain the right to refuse medical treatment, their duty to adhere to treatment prescriptions is a prima facie duty, which can be overridden by their other ethical duties. However, patients do not have the right to refuse to adhere to treatment prescriptions if their non-adherence poses a significant threat to other people. This paper also discusses the use of written agreements between physicians and patients as a strategy for promoting patient adherence.

Adult↗

Pesticide testing on human subjects: weighing benefits and risks.

In the debate surrounding testing pesticides on human subjects, two distinct positions have emerged. The first position holds that pesticide experiments on human subjects should be allowed, but only under stringent scientific and ethical standards. The second position asserts that these experiments should never be allowed. In this article, we evaluate what we consider to be the strongest argument for the second position--namely, that the benefits of the experiments are not significant enough to justify the risks posed to healthy subjects. We challenge this argument by examining the benefits and risks of testing pesticides on human subjects. We argue that a study that intentionally exposes humans subjects to pesticides should be permitted if a) the knowledge gained from the study is expected to promote human health; b) the knowledge cannot be reasonably obtained by other means; c) the study is not expected to cause serious or irreversible harm to the subjects; and d) appropriate safeguards are in place to minimize harm to the subjects.

Humans↗

Fair drug prices and the patent system.

This paper uses John Rawls' theory of justice to defend the patent system against charges that it has an unfair effect on access to medications,from the perspective of national and international justice. The paper argues that the patent system is fair in a national context because it respects intellectual property rights and it benefits the least advantaged members of society by providing incentives for inventors, investors, and entrepreneurs. The paper also argues that the patent system is fair in an international context, provided that developed nations take steps to help disease-stricken countries secure internal justice. Fairness in a national or international context also requires that the patent system should include emergency exceptions to deal with short-term inequities.

Drug Industry↗

The precautionary principle and medical decision making.

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.

Decision Making↗

The distribution of biomedical research resources and international justice.

According to some estimates, less than 10% of the world's biomedical research funds are dedicated to addressing problems that are responsible for 90% of the world's burden of disease. This paper explains why this disparity exists and what should be done about it. It argues that the disparity exists because: 1) multinational pharmaceutical and biotechnology companies do not regard research and development investments on the health problems of developing nations to be economically lucrative; and 2) governmental agencies that sponsor biomedical research face little political pressure to allocate funds for the problems of developing nations. This paper argues that developed nations have an obligation to address disparities related to biomedical research funding. To facilitate this effort, developed countries should establish a trust fund dedicated to research on the health problems of developing nations similar to the Global AIDS Fund.

Biomedical Research↗

Strengthening the United States' database protection laws: balancing public access and private control.

This paper develops three arguments for increasing the strength of database protection under U.S. law. First, stronger protections would encourage private investment in database development, and private databases have many potential benefits for science and industry. Second, stronger protections would discourage extensive use of private licenses to protect databases and would allow for greater public control over database laws and policies. Third, stronger database protections in the U.S. would harmonize U.S. and E.U. laws and would thus enhance international trade, commerce, and research. The U.S. should therefore follow the European example and develop two tiers of protection for databases: 1) protection for creative databases under copyright law; 2) protection for non-creative databases through a special type of sui generis protection. In order to balance private control of data and public access to data, sui generis protections should define a "fair use" exemption that permits some unauthorized extraction of data for private, educational, and research purposes, provided that such extraction does not adversely impact the economic value of the database.

Access to Information↗

Are DNA patents bad for medicine?

This paper considers the potential benefits and harms of DNA patenting for biomedical research and medical practice. It argues that, all things considered, the benefits of patenting DNA outweigh the harms, although societies should adopt policies designed to prevent or mitigate the harms associated with patenting. Some of these policies include: (1) reinforcing the research exemption for academic researchers, (2) raising the "bar" for the criteria of patentability, (3) restricting the scope of patents, (4) disclosing conflicts of interest related to DNA patents, (5) sharing the economic benefits of patenting with patients, and (6) providing insurance coverage for some types of genetic tests.

Biomedical Research↗