Updating Protections for Human Subjects Involved in Research
Caplan, Arthur L.
Wolpe, Paul Root
JAMA. 1998 Dec 9; 280(22): 1951-1958.
For decades, all federally funded research involving human subjects has been subject to regulations that require the informed consent of the subject and oversight by the local institution. These regulations last underwent major revision in 1981 and have remained unchanged despite significant changes in the nature of clinical science, the financial sources of research support, and the institutional environment in which clinical research is conducted. In the intervening years, doubt has evolved as to whether the regulations currently in place adequately protect the welfare and rights of research subjects in today's clinical research environment and whether the costs, in terms of time, bureaucracy, and delay, are justified by the level of protection afforded. The Human Research Ethics Group, administered by the Center for Bioethics at the University of Pennsylvania Health System, extensively reviewed the status of existing human subjects protections with the aim of making recommendations to improve and reform the regulations. Here, we present recommendations constituting a consensus of the group members for reform in 3 key areas: protecting subject populations with special needs and vulnerabilities, oversight by institutional review boards, and regulatory policy.
Advance Directives; Advisory Committees; Bioethics; Biomedical Research; Children; Committee Membership; Compensation; Competence; Consensus; Consent Forms; Clinical Research; Consent; Dementia; Drugs; Emergency Care; Environment; Ethical Review; Ethics; Ethics Committees; Evaluation; Federal Government; Females; Financial Support; Food; Forms; Government; Guidelines; Health; Human Experimentation; Information Dissemination; Informed Consent; Injuries; Investigational Drugs; Institutional Review Boards; Investigators; Nature; Nontherapeutic Research; Organization and Administration; Property Rights; Public Policy; Public Sector; Property; Regulation; Research; Research Ethics; Research Subjects; Research Support; Review; Rights; Risks and Benefits; Science; Selection of Subjects; State Government; Students; Therapeutic Research; Third Party Consent; Vulnerable Populations;
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Moreno, Jonathan; Caplan, Arthur L.; Wolpe, Paul Root (Human Research Ethics Group. (University of Pennsylvania Health Systems, Center for Bioethics. Project on Informed Consent), 1998-12-09)