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Results for “Committee Membership”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

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At least 271 records · Page 15Linked to original sources
PubMed1996

Ethics consultation.

This article comprehensively addresses the composition, role, and functions of a hospital ethics committee (HEC). HECs are of particular interest to critical care specialists because they often participate in or lead such committees, extending their commitment to communication and caring beyond the borders of the intensive care unit (ICU). This article also demonstrates that a well-run ICU in a hospital with a strong HEC automatically will include many of the services that the HEC normally would provide, without the need for HEC assistance.

Committee Membership↗
PubMed2004

Valuing risk: the ethical review of clinical trial safety.

Despite its mandate on minimizing harms in clinical trials, the Common Rule provides little guidance as to how IRBs should evaluate risk. The Common Rule and derivative commentaries tend to conceptualize risk review as an expert-based endeavor aimed at an objective and universal evaluation of possible harm; they also have tended to locate risk in the research activity itself rather than in the context of research. These views of risk conflict with scholarship showing that risk evaluations are socially determined even among experts, that the context of harms can influence how persons evaluate risks, and that forums that approach risk assessment as a technical endeavor bracket from discussion the numerous values that ground risk judgments. Possible reforms are proposed for clinical trial risk review that would render it more inclusive of the different types of risk encountered and more attuned to the priorities of trial subjects.

Academic Medical Centers↗
PubMed1997

A new role for institutional ethics committees: organizational ethics.

New methods for financing and managing healthcare organizations have caused concerns regarding how these changes will affect the ethics of the care of patients. To address these concerns, the JCAHO has, for the first time, promulgated a standard requiring that each HCO develop and operate under a code of organizational ethics. This standard is now a part of the requirements that JCAHO will consider in its accreditation of HCOs. Development of the required code is mandatory for JCAHO subscribers and will, by necessity, need to be addressed by each institution. An IEC is the proper forum for undertaking this work.

Codes of Ethics↗
PubMed1998

Updating protections for human subjects involved in research. Project on Informed Consent, Human Research Ethics Group.

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.

Advisory Committees↗