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Biomedical subjects

David B Resnik

Publications and source records attributed to David B Resnik.

At least 37 records · Page 2Linked to original sources
PubMed2003

Exploitation in biomedical research.

This essay analyzes exploitation in biomedical research in terms of three basic elements: harm, disrespect, or injustice. There are also degrees of exploitation, ranging from highly exploitative to minimally exploitative. Although exploitation is prima facie wrongful, some exploitative research studies are morally justified, all things considered. The reason an exploitative study can still be ethical is that other moral considerations, such as the autonomy of the research subject or the social benefits of research, may sometimes justify studies that are minimally exploitative. Calling a research project exploitative does not end the debate about the merits of the study but invites one to ask additional questions about how the study is exploitative, and whether the study is justifiable nevertheless.

Biomedical Research↗
PubMed2003

Genetic testing and primary care: a new ethic for a new setting.

For several decades, clinical geneticists have espoused two key ethical principles, nondirectiveness and confidentiality. These principles made a great deal of sense in the highly personal and controversial setting of reproductive genetics. Now that clinical genetics has entered the primary care setting, clinicians are rethinking the strength of their commitment to these traditional norms and they are revamping their ethical priorities. Patients increasingly need advice about whether they should take genetic tests and whether and how they should respond to the test results. Patients also need to know about how this information will impact family members and whether other members of their family should be tested. Clinical geneticists may even consider breaking individual confidentiality in order to prevent harms to family members. Although clinical geneticists do not need to abandon nondirectiveness and confidentiality in this new setting, they may not strictly adhere to these principles in some circumstances in order to benefit patients and their families.

Confidentiality↗
PubMed2002

The commercialization of human stem cells: ethical and policy issues.

The first stage of the human embryonic stem (ES) cell research debate revolved around fundamental questions, such as whether the research should be done at all, what types of research may be done, who should do the research, and how the research should be funded. Now that some of these questions are being answered, we are beginning to see the next stage of the debate: the battle for property rights relating to human ES cells. The reason why property rights will be a key issue in this debate is simple and easy to understand: it costs a great deal of money to do this research, to develop new products, and to implement therapies; and private companies, researchers, and health professionals require returns on investments and reimbursements for goods and services. This paper considers arguments for and against property rights relating to ES cells defends the following points: (1) It should be legal to buy and sell ES cells and products. (2) It should be legal to patent ES cells, products, and related technologies. (3) It should not be legal to buy, sell, or patent human embryos. (4) Patents on ES cells, products, and related technologies should not be excessively broad. (5) Patents on ES cells, products, and related technologies should be granted only when applicants state definite, plausible uses for their inventions. (6) There should be a research exemption in ES cell patenting to allow academic scientists to conduct research in regenerative medicine. (7) It may be appropriate to take steps to prevent companies from using patents in ES cells, products, and related technologies only to block competitors. (8) As the field of regenerative medicine continues to develop, societies should revisit issues relating to property rights on a continuing basis in order to develop policies and develop regulations to maximize the social, medical, economic, and scientific benefits of ES cell research and product development.

Biotechnology↗
PubMed1998

The ethics of HIV research in developing nations.

This paper discusses a dispute concerning the ethics of research on preventing the perinatal transmission of HIV in developing nations. Critics of this research argue that it is unethical because it denies a proven treatment to placebo-control groups. Since studies conducted in developed nations would not deny this treatment to subjects, the critics maintain that these experiments manifest a double standard for ethical research and that a single standard of ethics should apply to all research on human subjects. Proponents of the research, however, argue that these charges fail to understand the ethical complexities of research in developing nations, and that study designs can vary according to the social, economic, and scientific conditions of research. This essay explores some of the ethical issues raised by this controversial case in order to shed some light on the deeper, meta-ethical questions. The paper argues that standards of ethical research on human subjects are universal but not absolute: there are some general ethical principles that apply to all cases of human subjects research but the application of these principles must take into account factors inherent in particular situations.

Acquired Immunodeficiency Syndrome↗
PubMed1997

The morality of human gene patents.

This paper discusses the morality of patenting human genes and genetic technologies. After examining arguments on different sides of the issue, the paper concludes that there are, at present, no compelling reasons to prohibit the extension of current patent laws to the realm of human genetics. However, since advances in genetics are likely to have profound social implications, the most prudent course of action demands a continual reexamination of genetics laws and policies in light of ongoing developments in science and technology.

Commodification↗
PubMedDate not supplied

Disclosing conflicts of interest to research subjects: an ethical and legal analysis.

In this article, I examine the ethical and legal issues related to disclosure of conflicts of interest to research subjects, and discuss some empirical studies related to the topic. I argue that researchers have an ethical obligation to disclose conflicts of interest to research subjects, provided that they take steps to help subjects understand information about conflicts of interest and how to interpret it. Researchers also may have a legal duty to disclose conflicts of interests to subjects, depending on the facts of the case and the court's interpretation of the law. To reinforce and clarify the legal obligation to disclose conflicts of interest, the federal regulations should be amended to include disclosure of conflicts of interest as one of the informed consent requirements. Institutional review boards play a key role in helping researchers to disclose conflicts of interest to subjects in an appropriate manner. Institutional review boards should approve the disclosure language in informed consent documents, and they should require researchers to disclose financial interests to research subjects, if they have any, as a condition of approval.

Beneficence↗
PubMedDate not supplied

Conflict of interest and the university.

This essay provides an analysis of conflicts of interest (COIs) that arise in university relationships with private industry and articulates the concept of an "institutional" COI. It compares personal and institutional COIs in order to shed some light on the difficulties universities face in managing their own COIs. The essay discusses some proposed strategies for responding to institutional COIs, such as developing independent boards to monitor and oversee the university's COIs, building firewalls between various parts of the university to prevent financial interests from affecting university functions, creating independent research institutes, and prohibiting some types of university investments.

Conflict of Interest↗
PubMedDate not supplied

The misuse of statistics: concepts, tools, and a research agenda.

This paper presents concerns regarding misuse of statistics in scientific work, especially in biomedical research. The paper discusses what is meant by "misuse." It appears that misuse arises from various sources: degrees of competence in statistical theory and methods, honest error in the application of methods, egregious negligence, and deliberate deception (misconduct.) The incidence of error is partly due to a perceived need to meet artificial statistical criteria for acceptance of research reports for publication by journals. There has been no systematic research into the prevalence of misuse or its breakdown by type. Nonetheless, there are ways to encourage, or even to enforce, good statistical practice. These can be greatly supported by use of available statistical ethics documents. This article suggests lines of further research that could define the problem more explicitly and that might lead to additional corrective measures.

Biomedical Research↗
PubMedDate not supplied

From Baltimore to Bell Labs: reflections on two decades of debate about scientific misconduct.

This essay proposes a new definition of scientific "misconduct," which is broader than the definition recently adopted by the U.S. government. According to the proposed definition, misconduct is a serious and intentional violation of accepted scientific practices, commonsense ethical norms, or research regulations in proposing, designing, conducting, reviewing, or reporting research. Punishable misconduct includes fabrication of data or experiments, falsification of data, plagiarism, or interference with a misconduct investigation. Misconduct does not include honest errors, differences of opinion, or ethically questionable research practices.

Biomedical Research↗
PubMedDate not supplied

Research on environmental health interventions: ethical problems and solutions.

This article reviews a variety of ethical issues one must consider when conducting research on environmental health interventions on human subjects. The paper uses the Kennedy Krieger Institute lead abatement study as well as a hypothetical asthma study to discuss questions concerning benefits and risks, risk minimization, safety monitoring, the duty to warn, the duty to report, the use of control groups, informed consent, equitable subject selection, privacy, conflicts of interest, and community consultation. Research on environmental health interventions can make an important contribution to our understanding of human health and disease prevention, provided it is conducted in a manner that meets prevailing scientific, ethical, and legal standards for research on human subjects.

Asthma↗