Ethics and psychiatric research: problems and justification.

The discussion of ethics in psychiatry continues to increase. Research in psychiatry, like all medical research, is of ethical concern because it often involves risks to subjects so that others may benefit. It also involves the allocation of monetary and human resources. In recent years these concerns have been brought to the forefront of professional and public attention. The authors consider the problem of justifying resource allocations and the risks involved in psychiatry research, survey some of the special problems faced by researchers in this field, and give a brief account of present government regulations that pertain to research ethics in psychiatry.

Research on the cognitively impaired: lessons and warnings from the emergency research debate.

OBJECTIVES: To demonstrate that the recent events in emergency research have broad implications for the conduct of human subjects research with the cognitively impaired. This essay illustrates the similarities between the two kinds of research and suggests how understanding these similarities might help to resolve issues in human subjects research on the cognitively impaired. METHODS: A review of pertinent journal articles, books, regulations, and court cases. RESULTS: The emergency research controversy resulted in large part because of conflicting interpretations of arguably inadequate research regulations. The proposed Food and Drug Administration (FDA) regulations include advance informed consent, a broad role for family in approving a subject's participation, replacement of a threshold of permissible risk, called minimal risk, with a more sensible balancing of risks and benefits, and a role for the community in research approval. The current state of research on the cognitively impaired suggests that many of the same problems exist now that existed in emergency research before the FDA issued its proposed regulations. The ongoing case of T.D. et al. vs N.Y. State Office of Mental Health suggest that unless steps are taken similar to those taken in emergency research, much of clinical research on the cognitively impaired could cease. CONCLUSION: Representatives of the government, medicine, and the public must recognize the unresolved issues and inadequate regulations relating to research on the cognitively impaired. The proposed FDA regulations for emergency research may provide guidance for a settlement of these issues.

Children as participants in medical research.

The use of children in research raises the questions about proper justification, assessment of benefit in relation to risk, ability to consent, compensation, and the just selection of subjects. Although substantive and procedural standards have evolved, subpopulations of vulnerable children created new challenges and concerns.

Human subjects in dental research: coping with the regulations. Council on Dental Research.

The rules and regulations pertaining to human subjects in research have evolved in response to ethical concerns for the protection of the rights and welfare of such subjects. However, investigators quite often are not well informed on what is required of them in the conduct of their clinical studies. Failure to be provided with sufficient information may be part of the problem, but the nature of such rules and regulations and their diversity and complexity certainly are sources of confusion. This article presents an overview of some of the major components and processes involved in the implementation of the federal regulations. It is hoped that this presentation will lead to a better understanding of the roles of the investigator, the institutional review boards, and the institutional and the federal agencies involved in the protection of human research subjects.

Exemption of certain research and demonstration projects from regulations for protection of human research subjects--DHHS. Notice of proposed rulemaking.

The Department of Health and Human Services (the Department or HHS) is proposing to include among the types of research specifically exempt from the application of the regulatory requirements of 45 CFR Part 46 (protection of human research subjects), research and demonstration projects conducted under the Social Security Act and other Federal statutory authority and designed to study certain public benefit or service programs, the procedures for obtaining benefits or services under those programs, and possible changes or alternatives to those programs or procedures, including changes in methods or levels of payment. This proposed amendment to the revised final regulations for protection of human research subjects (published January 26, 1981) would, in effect, restore to the regulations an exemption included in the initial notice of proposed rulemaking (NPRM) (published August 14, 1979). These demonstration and service projects are already subject to procedures which provide for extensive review by high level officials in various program administration offices. Review by an IRB would be duplicative and burdensome to state and local agencies and to other entities participating in demonstration projects. Removal of an unnecessary layer of review will not only reduce the cost of the projects but help to avoid unnecessary delays in project implementation.

U.S. prisoners' access to experimental HIV therapies.

PURPOSE: To examine Department of Corrections (DOC) policies prohibiting prisoner participation in research studies and to assess the variables associated with state policies and practices relating to access by inmates in U.S. prisons to HIV-related clinical studies and experimental therapies. METHODS: A telephone survey conducted in 1994-95 of DOC medical directors from 32 states throughout the United States to obtain information about state DOC policies and practices relating to HIV clinical studies. RESULTS: State policies governing prisoner participation in clinical trials and access to new therapies vary widely. States with high AIDS incidence rates, a large number of AIDS-related deaths in prison, and high concentrations of minorities in the correctional system were more likely to allow prisoners to enroll in clinical studies and to receive experimental medications. Overall, a relatively small number of prisoners in state prisons have enrolled in clinical studies. Participation of a prison representative on the board reviewing a clinical study was identified as an important factor in allowing prisoner participation in studies. CONCLUSIONS: Barriers to prisoner participation in clinical studies are numerous but not insurmountable. Results from this study have led to efforts in Minnesota to revise current policy in order to permit prisoner participation in studies if appropriate guidelines are followed.

Informed consent in emergency research. Prehospital thrombolytic therapy for acute myocardial infarction.

Can the conscious patient in the midst of a medical emergency provide adequate informed consent for a clinical research protocol? Adequate consent is crucial to the ethical conduct of clinical trials, including those performed in emergency settings. We examine the problem of emergency informed consent. As an illustrative case, we discuss a pilot trial of prehospital thrombolytic therapy for myocardial infarction. Federal regulations for clinical research do not provide clear guidelines on emergency research in the conscious patient. Clinical investigators currently approach emergency consent in four ways: (1) avoid such research, (2) omit the consent process, (3) obtain deferred consent, or (4) obtain customary consent. We suggest a fifth alternative, two-step consent, which permits the conduct of emergency research while protecting the rights of the emergency research subjects. Such a process may serve as an alternative solution for future studies faced with the problem of informed consent in emergencies.

KIE: The problem of informed consent to research in emergency care is examined, using as an example a pilot trial of prehospital administration of thrombolytic therapy for acute myocardial infarction. Current federal regulations governing emergency care research are reviewed, along with four ways in which investigators currently approach emergency consent. The authors' use of a two-step process to resolve the problem of emergency consent is described. This approach allows the conduct of emergency research while protecting the rights of research subjects, and may offer a solution to the the ethical conduct of other studies faced with the problem of consent to emergency care.

Philosophical, ethical, and legal aspects of resuscitation medicine. I. Deferred consent and justification of resuscitation research.

Informed prospective consent for clinical resuscitation research may not be possible. Deferred consent is an untenable notion. Consent to continue in research cannot be used to support a claim that there was, or would have been, consent to the initiation of research. The conditions for the justifiability of resuscitation research without informed consent are: a) patient is comatose; b) lifesaving treatment must be given immediately; c) given all available evidence, there is reason to believe that the probability of death or severe deficit with experimental or control therapy is not greater than the probability of death or severe deficit on usual therapy; d) given all available evidence, there is reason to believe that the probability of normal or near-normal outcome is greater on experimental or control therapy than on usual therapy; and e) the study can provide evidence on whether there is a significant difference between experimental and control therapies in the incidence of normal or near-normal survival.

Acting without asking: an ethical analysis of the Food and Drug Administration waiver of informed consent for emergency research.

This article summarizes the current requirements for a waiver of informed consent for emergency research and analyzes ethical issues that are involved. Researchers who intend to apply for a waiver of informed consent for emergency research must understand that they are asking for the major protector of human subjects, the informed consent process, to be removed. In its absence, other protections are required. These include communication with the community, family members, and others close to the patient. It is unlikely that even these additional protections can equal that afforded by an adequate consent process. With this understanding, investigators' actions must be in accordance with the highest ethical standards. It is therefore necessary for investigators to know the ethical implications of conducting controlled research without the subjects' consent.

On research on HIV infection and AIDS in correctional institutions.

AIDS presents unique problems and opportunities in jails and prisons for epidemiological research on HIV infection and its sequelae. If correctional institutions constrain inmates' access to social benefits, means exist to protect incarcerated people's rights in health studies. A reading of federal regulations indicates that research involving prisoners should be subject to scrutiny by an institutional review board (IRB); inmates participating in IRB-approved clinical trials on AIDS-related drugs should not receive placebos alone, moreover, given that some medications are partially effective against the syndrome. As in other domains of public health and public policy, HIV infection and AIDS in prisons compel new perspectives on justice and equity.