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At least 19 recordsLinked to original sources
PubMed1990

Human gene therapy and congress.

Congress was the scene of conspicuous debate about human gene therapy during the 1980s. Congressional interest was sparked primarily by concerns about germ-line gene therapy expressed by clerics and public interest groups. The initial debate was provoked by Martin Cline's misadventures in 1980 and rekindled in 1983 by congressional resolution against germ-line intervention sponsored by Senator Mark Hatfield. The first hearing on gene therapy was held upon the release of the President's Commission report Splicing Life, in November, 1982, before a House subcommittee chaired by Congressman Albert Gore, Jr. Representative Gore later requested a report on gene therapy, which was released by the Office of Technology Assessment in December, 1984. He also sponsored the legislation that established the Biomedical Ethics Board and Biomedical Ethics Advisory Committee, Congress's abortive attempt to reestablish a federal bioethics commission. Implications of advances in human genetics, including gene therapy, were to be among the first topics addressed. Congress passed no substantive legislation affecting gene therapy research or clinical trials, but served principally as a national theater for debate. If and when germ-line gene therapy is contemplated, Congress will be faced with difficult choices, but will likely take no action to block trials that appear safe and are intended to produce clinical benefit for particular individuals.

Advisory Committees↗
PubMed1990

Legal regulation of human gene therapy.

The adequacy of existing legal mechanisms to regulate clinical trials of human gene therapy is examined. Existing legal controls include the federal Guidelines for Research Involving Recombinant DNA Molecules and federal regulations for the protection of human subjects. Another significant mechanism is provided by judicial oversight, i.e., judicial decisions involving recombinant DNA research. Human gene therapy does raise new issues that still must be resolved. At least two weaknesses exist in the present regulatory system: first, Recombinant DNA Advisory Committee (RAC) only has authority over federally funded research, not work done with private support, and second, RAC is not mandated to focus on difficult ethical issues, e.g., germ-line therapy, that arise from human genetic engineering technology.

Advisory Committees↗
PubMed2006

A biobank management model applicable to biomedical research.

BACKGROUND: The work of Research Ethics Boards (REBs), especially when involving genetics research and biobanks, has become more challenging with the growth of biotechnology and biomedical research. Some REBs have even rejected research projects where the use of a biobank with coded samples was an integral part of the study, the greatest fear being the lack of participant protection and uncontrolled use of biological samples or related genetic data. The risks of discrimination and stigmatization are a recurrent issue. In light of the increasing interest in biomedical research and the resulting benefits to the health of participants, it is imperative that practical solutions be found to the problems associated with the management of biobanks: namely, protecting the integrity of the research participants, as well as guaranteeing the security and confidentiality of the participant's information. METHODS: We aimed to devise a practical and efficient model for the management of biobanks in biomedical research where a medical archivist plays the pivotal role as a data-protection officer. The model had to reduce the burden placed on REBs responsible for the evaluation of genetics projects and, at the same time, maximize the protection of research participants. RESULTS: The proposed model includes the following: 1) a means of protecting the information in biobanks, 2) offers ways to provide follow-up information requested about the participants, 3) protects the participant's confidentiality and 4) adequately deals with the ethical issues at stake in biobanking. CONCLUSION: Until a governmental governance body is established in Quebec to guarantee the protection of research participants and establish harmonized guidelines for the management of biobanks in medical research, it is definitely up to REBs to find solutions that the present lack of guidelines poses. The model presented in this article offers a practical solution on a day-to-day basis for REBs, as well as researchers by promoting an archivist to a pivotal role in the process. It assures protection of all participants who altruistically donate their samples to generate and improve knowledge for better diagnosis and medical treatment.

Biological Specimen Banks↗
PubMed2004

Respect: or, how respect for persons became respect for autonomy.

This article provides an intellectual archeology of how the term "respect" has functioned in the field of bioethics. I argue that over time the function of the term has shifted, with a significant turning point occurring in 1979. Prior to 1979, the term "respect" connoted primarily the notion of "respect for persons" which functioned as an umbrella which conferred protection to autonomous persons and those with compromised autonomy. But in 1979, with the First Edition of Principles of Biomedical Ethics by Beauchamp and Childress, and the report of the Ethical Advisory Board (EAB) of the (then) Department of Health, Education, and Welfare entitled Research on In Vitro Fertilization, usage shifts from "respect for persons" to "respect for autonomy." Two results: 1) those with compromised autonomy are no longer protected by the canons of "respect" but rather the less overriding canons of beneficence; and 2) the term "respect" functions increasingly as a rhetorical device in public bioethics discourse.

Bioethical Issues↗
PubMed1989

The social control of human biomedical research: an overview and review of the literature.

Social control mechanisms have become an important element of human medical research in the United States. At first largely intraprofessional, controls over human experimentation have moved increasingly in the direction of externally developed, bureaucratically administered, and formally sanctioned rules. This paper examines intra- and extraprofessional methods of control over biomedical science and reviews available research assessing their effectiveness in promoting researcher adherence to high ethical standards concerning the use of human subjects. Research suggests that intraprofessional controls (including medical training, peer influence, ethical codes, and disciplinary boards), are, on their own, inadequate to ensure investigator ethicality. However, studies examining external controls over biomedical research (government regulations, institutional review boards, judicial and state law), also suggest that extraprofessional regulations are often ineffective. Further study of both forms of scientific social control is needed, as well as research examining their interactive effects on investigators' ethical attitudes and practices.

Education, Medical↗