Informed Consent in Acute Stroke

To the Editor:The process of informed consent is an integral component in the daily practice of medicine. Ongoing debate reflecting varying societal issues across wide geographical locales, medicolegal sophistication and evolving regulations have shaped this process. Increasingly complex medical decisions are formulated through this interaction between patients and doctors, opting for established surgical procedures, concocting medication regimens for off-label use, or choosing investigational approaches. Although a dedicated document may not be used in every scenario, the process embodies a universal doctrine designed to protect the patient. Elaborate algorithms or language considerations are often devoted to protect specific populations, yet this process also protects the doctor by noting patient consent. When consent is not established, many providers now document informed refusal.1 Discussions of risks, benefits, and alternatives have culminated in informed consent or refusal documents spanning up to 20 pages. Such documentation may not be feasible and the process may be entirely waived under specific emergency circumstances. The US Food and Drug Administration recently held public hearings to update stipulations for waiver of consent in emergency research. Clinical trialists have actively engaged in these forums, yet paradoxically, public interest and participation in these discussions that may decisively influence their future …