Community consultation methods in a study using exception to informed consent.

Objective: The most effective means of community consultation is unknown. We evaluated differences in community opinion elicited by varying means of consultation.

Methods: We compared responses with a cross-sectional, standardized survey administered as part of the community consultation for the Resuscitation Outcomes Consortium (ROC) hypertonic saline trial.

Ethics committee experience with emergency exception from informed consent protocols.

SINCE 1996, U.S. FEDERAL REGULATIONS allow research without informed consent to study emergency conditions, if there is currently no satisfactory treatment for the condition, no time to obtain advance consent from the patient or representative, and if there is community involvement through a public disclosure and community consultation process.

A qualitative study of institutional review board members' experience reviewing research proposals using emergency exception from informed consent.

Background: Emergency exception to informed consent regulation was introduced to provide a venue to perform research on subjects in emergency situations before obtaining informed consent. For a study to proceed, institutional review boards (IRBs) need to determine if the regulations have been met.

Aim: To determine IRB members' experience reviewing research protocols using emergency exception to informed consent.

Does the emergency exception from informed consent process protect research subjects?

Although subject protection is the cornerstone of medical ethics, when considered in the context of research using emergency exception from informed consent, its success is debatable. The participants of a breakout session at the 2005 Academic Emergency Medicine Consensus Conference discussed the issues surrounding subject protection and advanced the following recommendations. 1) There are no outcome measures that define "protection"; therefore, it is not currently known whether or not subjects are protected under the current rules.

Confronting the ethical challenges to informed consent in emergency medicine research.

The Society for Academic Emergency Medicine believes that protection of human subjects is vital in emergency medicine research and that, whenever feasible, informed consent is at the heart of that protection. At the same time, the emergency setting presents unique barriers to informed consent both because of the time frame in which the research is performed and because patients in the emergency department are a vulnerable population. This report reviews the concept of informed consent, empirical data on patients' cognitive abilities during an emergency, the federal rules allowing exemption from consent under certain circumstances, issues surrounding consent forms, and the new Health Insurance Portability and Accountability Act regulations as they relate to research.

Ethics seminars: the ethical debate on practicing procedures on the newly dead.

Emergency medicine and its academic teaching programs face an ethical dilemma surrounding the question of practicing procedures on the newly dead. For many years, procedures have been practiced on the newly dead, but few institutions have had policies addressing the practice. This article considers the ethical arguments both for and against practicing procedures on the newly dead without consent, reviews the empirical studies on the subject, and presents the positions of other professional societies, before concluding with the position of the Society for Academic Emergency Medicine (SAEM).

Attitudes of emergency department patients and visitors regarding emergency exception from informed consent in resuscitation research, community consultation, and public notification.

Objective: To assess public views on emergency exception to informed consent in resuscitation research, public awareness of such studies, and effective methods of community consultation and public notification.

Methods: A face-to-face survey was conducted in two academic Level I trauma center emergency departments (EDs) in Oregon and Minnesota from June through August 2001.

Results: Five hundred thirty people completed the survey, with an 82% response rate.