title: Ethical and regulatory challenges associated with the exception from informed consent requirements for emergency research: from experimental design to institutional review board approval.
abstract: 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 contemplate conducting a research trial without the prospective informed consent of enrolled subjects. The challenges associated with conducting research studies using the exception from informed consent requirements for emergency research are numerous, beginning with ensuring an appropriate study design, understanding state and federal regulations that govern such emergency research studies, and continuing through a complicated and sometimes arduous institutional review board (IRB) process that is unique to these studies. This article will describe the challenges encountered when implementing the exception from informed consent requirements for emergency research and will provide surgeon researchers with an understanding of the ethical controversies surrounding such studies.
authors.affiliation: Division of General Surgery, Department of Surgery, Division of Emergency Medicine, and the Institutional Review Board, Duke University Medical Center, Durham, NC 27710, USA. vasle001@mc.duke.edu
authors.forename: Steven N
authors.initials: SN
authors.lastname: Vaslef
authors.forename: Charles B
authors.initials: CB
authors.lastname: Cairns
authors.forename: John M
authors.initials: JM
authors.lastname: Falletta
mesh_terms: D016638:Critical Illness / Q000628:therapy; D004638:Emergency Treatment / Q000941:ethics*; D028744:Ethics Committees, Research; D026690:Ethics, Clinical; D035082:Federal Government; D033161:Government Regulation; D006801:Humans; D007258:Informed Consent / Q000941:ethics* / Q000331:legislation & jurisprudence*; D018570:Risk Assessment; D013219:State Government; D036302:Therapeutic Human Experimentation / Q000941:ethics* / Q000331:legislation & jurisprudence*; D014481:United States