Confronting the ethical challenges to informed consent in emergency medicine research.
The Society for Academic Emergency Medicine believes that protection of human subjects is vital in emergency medicine research and that, whenever feasible, informed consent is at the heart of that protection. At the same time, the emergency setting presents unique barriers to informed consent both because of the time frame in which the research is performed and because patients in the emergency department are a vulnerable population. This report reviews the concept of informed consent, empirical data on patients' cognitive abilities during an emergency, the federal rules allowing exemption from consent under certain circumstances, issues surrounding consent forms, and the new Health Insurance Portability and Accountability Act regulations as they relate to research. The authors conclude that, in many circumstances, informed consent is possible if the researcher is diligent and takes time to adequately explain the study to the potential subject. In cases in which it is possible to obtain consent, precautions must be taken to ensure that subjects have decision-making capacity and are offered time to have their questions answered and their needs met. Sometimes resuscitation and other emergency medicine research must be conducted without the ability to obtain consent. In these cases, special protections of subjects under the exception from consent guidelines must be followed. Protection of research subjects is the responsibility of every researcher in emergency medicine.
Department of Emergency Medicine, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97235, USA. schmidtt@ohsu.edu.
Terri A
TA
Schmidt
David
D
Salo
Jason A
JA
Hughes
Jean T
JT
Abbott
Joel M
JM
Geiderman
Catherine X
CX
Johnson
Katie B
KB
McClure
Mary Pat
MP
McKay
Junaid A
JA
Razzak
Raquel M
RM
Schears
Robert C
RC
Solomon
D004635:Emergency Medicine / Q000941:ethics* / Q000592:standards; D020408:Health Insurance Portability and Accountability Act; D006801:Humans; D007258:Informed Consent / Q000941:ethics* / Q000331:legislation & jurisprudence / Q000592:standards; D016743:Mental Competency / Q000331:legislation & jurisprudence; D017410:Practice Guidelines as Topic; D014481:United States