International Ethical Guidelines Research Articles

BOOK REVIEWS

Book Reviews in this Article: The Uses of Philosophy, by Mary Warnock Issues in Reproductive Technology, by Helen Bequaert Holmes (ed) Life Before Birth: The Moral and Legal Status of Embryos and Fetuses, by Bonnie Steinbock The Ethics of Diagnosis, edited by Jose Luis Peset and Diego Gracia. Gene Mapping: Using Law and Ethics as Guides, edited by George J. Annas and Sherman Elias. Creation and Abortion: A Study in Moral and Legal Philosophy, by F.M. Kamm. Wonderwoman and Superman: The Ethics of Human Biotechnology, by John Harris International Ethical Guidelines for Biomedical Research Involving Human Subjects, by Council for International Organizations of Medical Sciences (CIOMS)

Research on Human Populations: National and International Ethical Guidelines

Research on Human Populations: National and International Ethical Guidelines

Existing International Ethical Guidelines for Human Subjects Research: Some Open Questions

International guidelines regarding ethics, and in particular the ethics of clinical research, are problematic on two broad levels. First, by asserting their universality, “international” guidelines obscure real and legitimate crosscultural differences in ethical expectations. International guidelines seek to make homogeneous something which is not necessarily so. Second, existing guidelines are ambiguous about their objectives and purposes. On the one hand, guidelines are structured as a set of goals, largely aspirational in language and content. But on the other hand, such guidelines also suggest a normative function, providing a set of standards by which to judge and, if appropriate, sanction investigators’ conduct.These criticisms are not intended to argue that international guidelines are useless. Nor are they intended to question the good faith under which such guidelines are developed. Rather, we wish to suggest that the role of present international guidelines is somewhat more limited than is ordinarily appreciated.

Human experimentation in historical and ethical perspectives

During the past two decades there has been an extraordinary proliferation of articles, books, reports, laws and regulations, and meetings concerned with the ethical aspects of biomedical interventions on human beings and, in particular, those of an experimental nature. Such writings, the vast majority of which are in the English language, necessarily tend to become more and more repetitive in the sense that they bring to light no new facts, or even ideas, but are variations on the same themes according to the cultural and professional backgrounds of their authors. For some of the older problems of medical ethics, particularly those linked to human reproduction— such as induced abortion, sterilization, and artificial insemination from a donor—it would be illusory to expect a consensus at the national, far less the international, level, for religious dogma or deeply-felt personal convictions may render discussion sterile. However, for the increasingly important subject of biomedical experimentation involving human subjects it might well be possible to arrive at an international consensus, as has already been done in very broad terms by the World Medical Association in the Tokyo (1975) revision of the Declaration of Helsinki (Helsinki II). It was in the belief that a more comprehensive consensus might be achieved that the World Health Organization and the Council for International Organizations of Medical Sciences embarked in 1978 on a joint project for the establishment of international ethical guidelines for biomedical research involving human subjects, taking Helsinki II as their starting point. In some of the existing literature on bioethics there are brief historical introductions, but these are usually very rudimentary. It was therefore decided that, in order to place the WHO/CIOMS project in the broadest possible perspective, an attempt should be made to provide a further, if not comprehensive, account of the historical aspects of human experimentation and of the circumtances in which formal ethical codes evolved.

Dangers of Oxytocin-induced Labour to Fetuses

Clinician gate-keeping is the process whereby healthcare providers prevent access to eligible patients for research recruitment. This paper contends that clinician gate-keeping violates three principles that underpin international ethical guidelines: respect for persons or autonomy; beneficence or a favourable balance of risks and potential benefits; and justice or a fair distribution of the benefits and burdens of research. In order to stimulate further research and debate, three possible strategies are also presented to eliminate gate-keeping: partnership with professional researchers; collaborative research design and clinician education.

Justification of participation of human subjects in Phase 1 clinical trials: an ethical analysis

In the process of clinical trials, after ascertaining the safety of drugs or other therapeutic interventions in animals or in vivo, phase I clinical trials are conducted as initial step on healthy human volunteers (or patients with specific disease) to observe pharmacokinetics, safety and side effects associated with escalating doses of the drugs. Participation of human subjects having different biological system than animals is not without risks in these trials; this fact raises some important ethical issues. In the light of international research ethics guidelines, this paper analyses moral justification of use of humans as research subjects in phase I clinical trials, discusses what groups of participants should be involved, their economic status, questionable coercive effect of monetary remuneration on the subjects and soundness of informed consent obtained for the trials. These issues are also discussed in the perspective of four founding principles of bioethics i.e. autonomy, justice, beneficence and non-maleficence. DOI: http://dx.doi.org/10.3329/bioethics.v2i2.9543 Bangladesh Journal of Bioethics 2011; 2(2): 26-29

Revised CIOMS International Ethical Guidelines for Biomedical Research

The revised CIOMS 2002 International Ethical Guidelines for Biomedical Research Involving Human Subjects supersede the previous 1993 Guidelines and consist of a statement of general ethical principles, a preamble and 21 guidelines with extensive commentaries. The Guidelines provide advice on the implementation in practice of the World Medical Association (WMA) Declaration of Helsinki and are designed to be of use, particularly to low-resource countries, in defining national policies and regulations on the ethics of biomedical research. The Guidelines are available on the CIOMS website.