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In two recent papers, a radical change of the review system for medical ethics review committees was proposed. The current systems in Great Britain and Australia were described and it was suggested that the extended roles and responsibilities of the medical ethics review committees could not be fulfilled by the present committees. It was proposed that professional medical ethics committees be established with full time members who would receive an appropriate honorarium. The Netherlands has a decentralised system of medical ethics review, which is based on peer review. A radical change of the current system of medical ethics review is not warranted. There is however a need for further improvements to the current peer-review system. An important aspect of this improvement is an honorarium for the members as well as a budget for training and for the adequate scientific and administrative support of the committee by a secretariat. The fees levied for reviewing each protocol could in part finance the committee and its secretariat. However, these fees will probably not meet all of the costs. Therefore the centres involved in medical research should consider supporting their committees. It is in their interest to demonstrate their wish to protect those persons who consent to participate as research subjects. This will maintain the confidence of both the public and future participants in clinical trials. Furthermore, an efficient and adequate system of ethical review will support a balanced view towards medical research with human subjects and will also contribute to a positive image of the centre also as an attractive environment for medical professionals.

Purpose: To create a more meaningful understanding of the informed consent process as it has come to be practiced and regulated in clinical trials, this discussion uses the experience gained from the conduct of therapeutic research that involves cancer patients., Design: After an introduction of the ethical tenets of the consent process in clinical research that involves potentially vulnerable patients as research subjects, background that details the use of written consent documents and of the term "informed consent" is provided. Studies from the cancer setting that examine the inadequacies of written consent documents, and the outcome of the consent process itself, are reviewed. Two ethically challenging areas of cancer clinical research, the phase I trial and the randomized controlled trial, are discussed briefly as a means of highlighting many dilemmas present in clinical trials. Before concluding, areas for future research are discussed., Results: Through an exclusive cancer research perspective, many current deficiencies in the informed consent process for therapeutic clinical trials can be critically examined. Also, new directions for improvements and areas of further research can be outlined and discussed objectively. The goals of such improvements and research should be prevention of further misguided or ineffective efforts to regulate the informed consent process., Conclusion: To ignore this rich and interesting perspective potentially contributes to continued misunderstanding and apathy toward fulfilling the regulatory and ethically obligatory requirements involved in an essential communication process between a clinician-investigator and a potentially vulnerable patient who is considering clinical trial participation.

Objective: To monitor the conduct of medical research projects that have already been approved by the local medical research ethics committee., Design: Follow up study of ethically approved studies (randomly selected from all the studies approved in the previous year) by examination of patients' case notes, consent forms, and research records and by interview of the researchers at their workplace., Setting: Tayside, Scotland (mixed rural and urban population)., Subjects: 30 research projects approved by Tayside local medical research ethics committee., Main Outcome Measures: Adherence to the agreed protocol, particularly for recruitment (obtaining and recording informed consent) and for specific requirements of the ethics committee, including notification of changes to the protocol and of adverse events., Results: In one project only oral consent had been obtained, and in a quarter of the studies one or more consent forms were incorrectly completed. Inadequate filing of case notes in five studies and of consent forms in six made them unavailable for scrutiny. Adverse events were reported, but there was a general failure to report the abandoning or non-starting of projects in two studies the investigators failed to notify a change in the responsible researcher., Conclusions: Monitoring of medical research by local medical research ethics committees promotes and preserves ethical standards, protects subjects and researchers, discourages fraud, and has the support of investigators. We recommend that 10% of projects should undergo on-site review, with all others monitored by questionnaire. This would require about six person hours of time and a salary bill of 120 pounds per study monitored.

Ethical decision making in clinical trials has become increasingly emphasized at many levels of the review process. Ethical concepts applicable to Neuroclinical Trials (NCT) are reviewed. The discussion is directed towards ethical concerns that investigators must consider and justify prior to Institutional Review Board (IRB) submission. Risk-benefit analysis, methodology (randomization: placebo; design) and consent (informed; deferred; waived) are reviewed and Office for Protection from Research Risk (OPRR) guidelines are described. Our conclusions: Investigators proposing NCT face increasing ethical scrutiny by IRBs. Attention to ethical issues early in trial planning process is recommended.

Objective: To establish the frequency of informed consent and review by institutional review boards in Mexican medical journals., Design: Retrospective review of prospective medical research published in seven Mexican medical journals between 1990-1993., Measurements and Main Results: 391 prospective studies were analyzed: 259 (66%) were cross-sectional and 132 (34%) longitudinal; 197 (51%) descriptive and 194 (49%) comparative; 277 (71%) observational and 114 (29%) experimental. In general, the informed consent was reported in 123 studies (31%), and its institutional review board approval in 41 (10%). In the 114 experimental articles the informed consent was reported in 53 (46%) and the review board approval in 28 (25%)., Conclusions: Most Mexican researchers do not report or do not obtain informed consent nor review board approval in the articles we reviewed. This suggests the presence of legal and ethical flaws which should be overcome.

Much of today's medical care relies on experience unsupported by investigation, and emergency medical care is no exception; research is necessary to improve this care. Critically ill and injured patients are the patients who will benefit the most from improvements in emergency medical diagnostic and treatment methods. Yet, the federal bureaucracy has effectively banned research on these patients, since they cannot generally give "informed consent." We argue that, with the proper safeguards, research on critically ill and injured patients should be performed in the emergency medicine (EDs and EMS) settings without informed consent. To require such consent when not obtainable compromises both the researchers who must get such consent and the patients who must continue to endure old, and often untested therapies.

The author focuses the question of hospital infection, analysing the background on which the control committees were created. The hospital infection is discussed under bioethical principles and the Medical Ethics Code, examining the aspects related to the government, the Hospital Directorship, the Committee and the Control Service of Hospital Infection, and the assisting physician. A closer integration between the activities of the Program of Control of Hospital Infections and those of the Medical Ethics Committee is proposed, aiming at the patient and at the community, "targets of total medical attention".

Purpose: Phase I research trials assess the safety of agents never before administered to humans. In the field of oncology, this practice raises several important ethical questions. We examined the ethics of these trials by surveying phase I oncology investigators and institutional review board (IRB) chairpersons at major cancer research centers around the country., Methods: Questionnaires were mailed to 78 investigators and 47 chairpersons to obtain their views on the ethical propriety of conducting phase I oncology research, and on institutional practice regarding these trials. The response rate was 68% in each group., Results: The majority of each group reported that phase I oncology trials face no more scrutiny or resistance in their institution's IRB process than other research protocols. Nevertheless, IRB chairpersons were more likely than investigators to favor special procedural safeguards to protect subjects in phase I oncology trials. Nearly all respondents agreed that although actual medical benefit was very uncommon, most patients entered for a chance at a therapeutic effect. Investigators were more likely than chairpersons to report that patients obtained psychologic benefit from participation in phase I trials., Conclusion: Although individual IRB chairpersons and oncology investigators may have important differences of opinion concerning the ethics of phase I trials, these disagreements do not represent a widespread area of ethical conflict in clinical research.

Background: Research in acute care is a troubling area for Institutional Review Board (IRB) approval and informed consent. Confusion about ethical and legal requirements has hampered research efforts and subsequent patient benefits., Analysis: Acute care patients are the relatively few critical care patients who have suffered unexpected events that carry a high probability of mortality or severe morbidity unless immediate medical intervention is provided. We argue that acute care research is justified if the usual ethical requirements for research are modified to reflect the uniqueness of the situation., Conclusions: Our recommendations are to: a) use an explicit definition of acute care as distinct from other modes of critical care; b) eliminate the requirement for informed consent (as it is usually understood); and c) require stringent IRB oversight, regarding the unique ethical problems raised by this area of research. We further suggest that IRB oversight includes review of the protocol by a panel of individuals who represent possible enrollees in the proposed study.

Inherent in the dual role of physician-researcher is a conflict of interest arising out of the competing objectives of research and medical practice. Most commentary and policy recommendations on this conflict of interest have focused on the problems that arise in negotiations for informed consent. These are not, however, the only problems presented by this conflict; they are not necessarily even the most important. In order to deal with these problems, several commentators have suggested various procedural safeguards to protect the interests of the patient-subject--for example, separating the roles of physician and researcher, or introducing third parties into the relationship in order to assist in the initial or continuing negotiations for informed consent. In my view, the necessity for special procedural protections of patient-subject interests should be a discretionary judgment of the Institutional Review Board (IRB). In determining the need for special procedural protections for any research protocol, the IRB should consider three factors. To the extent that any one of these or a combination of two or more seems to present a problem, the IRB should consider it increasingly important to recommend special procedural protections: 1. There are serious impairments of the prospective subjects' capacities to consent. 2. The risk of physical or psychological injury presented by procedures done in the interests of research exceeds the threshold of "a minor increment above minimal risk." 3. The protocol is designed to introduce, test, evaluate, or compare therapeutic, diagnostic, or prophylactic maneuvers.

Present features and functions of ethics committees in 80 Japanese medical schools were surveyed through inquiries to those institutes by the author. Seventy nine schools have already started their own committees in each campus by the end of 1990, and the remaining one is preparing for its start in near future. The major role of the ethics committee may be said to roughly correspond to that of the Institutional Review Boards (IRB) in the USA, although a role of the hospital ethics committee has been played in addition to its proper functions in many schools. Among many problems two major drawbacks seem necessary to be removed urgently. The first one is an inappropriate composition of the committee in the majority of schools. More members from the outside of the campus, younger generations, and female reviewers should be added to the committee. The second point is the essentially closed review systems in most schools. The process of the review has not been effectively opened to the public yet, even in case in which no privacy of the patients or volunteers appears in the discussion. Several schools are preparing for opening now and the situation will be improved gradually. It was fortunate that the ethics committees in Japanese medical schools were founded by wills and efforts of members of each campus without having any suggestions, recommendations, or orders from the national government or other officials.

During the 1990s medical ethics will undergo changes. Individual clinical issues, especially those related to death and dying, will continue to create conflict and preoccupy hospital staffs. But professional ethicists will focus on social concerns more frequently than they have in the past. Following are some of the most crucial ethical issues and directions they are likely to take in this decade: Clinical practice and the law will move toward less demanding standards of proof regarding the withdrawal of treatment from patients who are no longer competent. Public policy will set more lenient standards for judging whether a person would refuse artificial nutrition and hydration if he or she were able. Unless sensible people strengthen the distinction between active and passive euthanasia, more physicians and legislatures will move toward physician-assisted suicide. Those proposing a higher-brain definition of death, as opposed to whole-brain definitions, will gain ground with the general public, but not with legislators. New transplantation technologies will increase medical options but create more problems with paying for the procedures. As techniques are perfected, ethical questions will focus more on financing than on the source of transplantable material. AIDS treatment priorities will clash with other medical demands (e.g., treatment for breast cancer), and concerns about protecting both providers and patients from contracting AIDS will move policy toward routine testing. Progress in public argument will be made on the abortion issue. Members of ethics committees will have to be trained to address financing issues. Some medical schools and residency programs will add courses on the concept of character and on character development to their ethics programs.(ABSTRACT TRUNCATED AT 250 WORDS)