A military exception to "informed consent": Doe v. Sullivan.

Consulting communities when patients cannot consent: a multicenter study of community consultation for research in emergency settings.

OBJECTIVES To assess the range of responses to community consultation efforts conducted within a large network and the impact of different consultation methods on acceptance of exception from informed consent research and understanding of the proposed study. DESIGN A cognitively pretested survey instrument was administered to 2,612 community consultation participants at 12 U.S. centers partic...

Public opinion of a stroke clinical trial using exception from informed consent

BACKGROUND Acute stroke is a leading cause of morbidity and mortality. Clinical trials in stroke are challenging because victims often do not have the capacity to provide informed consent, excluding those patients most likely to benefit from the research. AIM We evaluated patient willingness to participate in a hypothetical acute stroke trial using an exception from informed consent. METHOD...

The involuntarily confined mental patient and informed consent to psychiatric treatment.

The research on community consultation: an annotated bibliography.

Community consultation is a required element of research studies that use a waiver of or exception from informed consent. Its intent is to provide an additional patient safeguard in emergency research circumstances when prospective informed consent is not possible. Investigators have reported that community consultation may be the most difficult aspect in implementing research trials using a wa...

Ethical and regulatory challenges associated with the exception from informed consent requirements for emergency research: from experimental design to institutional review board approval.

Clinical research studies conducted in emergency settings under the waiver of consent provision outlined in federal regulations are uncommon, yet the importance of such research that may result in potentially lifesaving interventions is indisputable. Surgeons, as well as health care professionals in other disciplines of medicine, should be aware of the multiple challenges facing them if they co...