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Biomedical subjects

Jonathan D Moreno

Publications and source records attributed to Jonathan D Moreno.

At least 19 recordsLinked to original sources
PubMed2003

Maternal-fetal research and human research protections policy.

It may be that the current system of formal definitions, ethical theories, and voluntary professional guidelines to protect patients from unwittingly becoming subjects of research is inadequate to meet the challenge of surgical innovation. Important questions, such as when surgical innovation becomes research involving human subjects or how to distinguish between variations on an existing technique and true innovations, are key. These questions also apply to MFS as an innovative surgical therapy. Now that MFS has been recognized as experimental and formal clinical trials will be conducted, it is important to ensure adequate protection of the pregnant women and fetuses involved as human research subjects. This issue is even more pertinent in light of the new regulations regarding fetuses as research subjects. Those responsible for reviewing study protocols will have to be especially careful when examining the new version of DHHS regulations as they apply to future studies in the field of MFS.

Biomedical Research↗
PubMed2002

Ethical regulations for innovative surgery: the last frontier?

BACKGROUND: There are no clear federal regulations governing innovative surgery, even though general guidelines regulating research with human subjects do exist. We hypothesized that US surgeons are unaware of Department of Health and Human Services regulations, rarely seek IRB review, generally oppose outside regulation of innovative surgery, and are uncertain what constitutes innovation and research. These circumstances, if true, would pose a significant ethical problem and present potential harm to patients as unwitting subjects of research. STUDY DESIGN: In a pilot study we reviewed 527 issues of US surgical and medical journals, selecting 59 articles published between 1992 and 2000, that described innovative surgery. Corresponding authors from university hospitals (71%) and other facilities (29%) were sent an anonymous questionnaire. RESULTS: The survey was conducted between November 2000 and May 2001. Twenty-one questionnaires were returned, completed with responses, constituting a 35% overall response rate. Fourteen authors confirmed their work was research, yet only six had sought prior IRB review. The majority of authors (15 of 21) did not submit their protocol to IRB. Only seven authors had mentioned the innovative nature of the procedure in the informed consent form. Seven authors claimed familiarity with Office for Human Research Protections definitions of research and human subject. Two-thirds of the respondents stated that government regulations for the protection of human subjects of innovative surgery would not be appropriate. CONCLUSIONS: The current system of definitions, ethical theories, and voluntary professional guidelines may be inadequate to meet the challenge of surgical innovation. Further research is proposed to examine the adequacy of the existing guidelines.

Ethical Review↗
PubMed2002

Bioethics after the terror.

Bioethics as a field has been fortunate that its values and concerns have mirrored the values and concerns of society. In light of the September 11th attacks, it is possible that we are witnessing the beginning of a transition in American culture, one fraught with implications for bioethics. The emphasis on autonomy and individual rights may come to be tempered by greater concern over the collective good. Increased emphasis on solidarity over autonomy could greatly alter public response to research abuses aimed at defense from bioterrorism, to privacy of genetic information, and to control of private medical resources to protect the public health.

Bioethics↗
PubMed1996

Revising the history of Cold War research ethics.

President Clinton's charge to the Advisory Committee on Human Radiation Experiments included the identification of ethical and legal standards for evaluating government-sponsored radiation experiments conducted during the Cold War. In this paper, we review the traditional account of the history of American research ethics, and then highlight and explain the significance of a number of the Committee's historical findings as they relate to this account. These findings include both the national defense establishment's struggles with legal and insurance issues concerning human experiments, and the medical profession's perspective on human experimentation in the years following the Nuremberg Medical Trials. We conclude that the Committee's work both enriches the traditional view of the history of research ethics and opens important new areas for study.

Advisory Committees↗
PubMed1992

The social individual in clinical ethics.

Except for several provocative final sentences, Sigrid Fry-Revere's "A Libertarian Critique of H. Tristram Engelhardt, Jr.'s The Foundations of Bioethics" is not a libertarian so much as it is a philosophical critique. Engelhardt's work has been widely reviewed, and its arguments have been discussed in Fry-Revere's article and elsewhere. Although it would be impractical in this context to undertake the development of a full-scale, philosophical alternative to libertarianism in bioethics, some recent work in philosophy and clinical ethics bears strongly on the challenge that Engelhardt's work represents. In this commentary I will focus on the implications of a certain alternative philosophy -- and by comparison the limitations of Engelhardt's libertarianism -- for one important aspect of clinical ethics: our understanding of the nature of individuality, with special reference to the situation of the patient. I write as an admiring critic of Engelhardt's work, from which I have learned and drawn inspiration....

Bioethics↗
PubMed1991

Call me Doctor? Confessions of a hospital philosopher.

Accustomed as many of us have become in the era of clinical bioethics to the idea of a "hospital philosopher", on reflection the historical novelty of the role is astonishing, as are its ambiguities. As a result of considering my own experience I found myself writing this miniature intellectual autobiography. In the course of this essay I raise two specific questions: what can the Western philosophical tradition contribute to the clinical setting; and (a question that is rarely asked), what are the implications of this experience for that tradition?

Bioethics↗
PubMed1991

Ethics consultation as moral engagement.

I will begin by presenting some doubts about what might be called the "received view" of the role of the moral expert as a health care consultant. Then I will review the literature on moral experts and moral expertise and proceed to apply the results of that review to the notion that there are some who are expert in ethical decision making in health care. I will try to show that certain conclusions that can be drawn from this rather circumscribed topic have implications for the very conception of the relationship between moral theory and clinical ethics.

Bioethical Issues↗