Confronting Ethical and Regulatory Challenges of Emergency Care Research With Conscious Patients.

Barriers to informed consent are ubiquitous in the conduct of emergency care research across a wide range of conditions and clinical contexts. They are largely unavoidable; can be related to time constraints, physical symptoms, emotional stress, and cognitive impairment; and affect patients and surrogates. US regulations permit an exception from informed consent for certain clinical trials in emergency settings, but these regulations have generally been used to facilitate trials in which patients are unconscious and no surrogate is available.

Open disclosure of adverse events: transparency and safety in health care.

Many patients suffering adverse events in health care turn to the legal system to learn what happened to them and to seek compensation. Health care providers have ethical, professional, and legal duties to disclose the harmful effects of care to the patient, regardless of how small the risk. The purpose of open disclosure is to explain what happened to the patient and to seek a just outcome for patient and provider.