Clinical Research Ethics for Critically Ill Patients: A Pandemic Proposal
Sprung, Charles L
Critical Care Medicine 2010 April; 38(4 Suppl): e138-e142
Pandemic H1N1 influenza is projected to be unprecedented in its scope, causing acute critical illness among thousands of young otherwise healthy adults, who will need advanced life support. Rigorous, relevant, timely, and ethical clinical and health services research is crucial to improve their care and outcomes. Studies designed and conducted during a pandemic should be held to the same high methodologic and implementation standards as during other times. However, unique challenges arise with the need to conduct investigations as efficiently as possible, focused on the optimal outcome for the individual patient, while balancing the need for maximal societal benefit. We believe that clinical critical care research during a pandemic must be approached differently from research undertaken under nonemergent circumstances. We propose recommendations to clinical investigators and research ethics committees regarding clinical and health services research on pandemic-related critical illness. We also propose strategies such as expedited and centralized research ethics committee reviews and alternate consent models.
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Adults; Critically Ill; Clinical Investigators; Clinical Research; Consent; Ethics; Ethics Committees; Health; Health Services; Health Services Research; Influenza; Illness; Investigators; Life; Patients; Research; Research Ethics; Research Ethics Committees; Standards; Health Care; Human Experimentation Policy Guidelines / Institutional Review Boards; Informed Consent or Human Experimentation; Social Control of Human Experimentation; International and Political Dimensions of Biology and Medicine; Research on Special Populations;
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