PMID- 27587446
OWN - NLM
STAT- MEDLINE
DCOM- 20180302
LR  - 20181202
IS  - 1748-720X (Electronic)
IS  - 1073-1105 (Linking)
VI  - 44
IP  - 3
DP  - 2016 Sep
TI  - Realizing Informed Consent in Times of Controversy: Lessons from the SUPPORT 
      Study.
PG  - 402-18
LID - 10.1177/1073110516667938 [doi]
AB  - This Essay examines the elegantly simple idea that consent to medical treatment 
      or participation in human research must be "informed" to be valid. It does so by 
      using as a case study the controversial clinical research trial known as the 
      Surfactant, Positive Pressure, and Oxygenation Randomized Trial ("SUPPORT"). The 
      Essay begins by charting, through case law and the adoption of the common rule, 
      the evolution of duties to secure fully informed consent in both research and 
      treatment. The Essay then utilizes the SUPPORT study, which sought to pinpoint 
      the level of saturated oxygen that should be provided to extremely low birth 
      weight infants to demonstrate modern complexities and shortcomings of the duty to 
      secure informed consent. This Essay shows how the duty is measured by 
      foreseeability of risks and benefits in human research and why federal regulators 
      believed the trade-offs in risk and benefits from differing oxygen levels 
      administered in the support study were foreseeable. It then explores the contours 
      of the duty to secure informed consent when applied to researchers who also serve 
      as treating physicians, highlighting how common law duties differ in 
      jurisdictions that apply the professional standard and those that apply the 
      patient-centered material risk standard. This Essay provides new insight into 
      what the law must do to make real the notion that [e]very human being of adult 
      years and sound mind has a right to determine what shall be done with his body."
CI  - (c) 2016 American Society of Law, Medicine & Ethics.
FAU - Morse, Robert J
AU  - Morse RJ
AD  - Robert J. Morse, J.D., is a graduate of the Class of 2016 at the University of 
      Illinois College of Law. Robin Fretwell Wilson, J.D., is the Roger and Stephany 
      Joslin Professor of Law and Co-Director of the Epstein Program in Health Law and 
      Policy at University of Illinois College of Law.
FAU - Wilson, Robin Fretwell
AU  - Wilson RF
AD  - Robert J. Morse, J.D., is a graduate of the Class of 2016 at the University of 
      Illinois College of Law. Robin Fretwell Wilson, J.D., is the Roger and Stephany 
      Joslin Professor of Law and Co-Director of the Epstein Program in Health Law and 
      Policy at University of Illinois College of Law.
LA  - eng
PT  - Journal Article
PL  - England
TA  - J Law Med Ethics
JT  - The Journal of law, medicine & ethics : a journal of the American Society of Law, 
      Medicine & Ethics
JID - 9315583
MH  - Humans
MH  - *Informed Consent
MH  - *Liability, Legal
MH  - Randomized Controlled Trials as Topic
MH  - Risk
EDAT- 2016/09/03 06:00
MHDA- 2018/03/03 06:00
CRDT- 2016/09/03 06:00
PHST- 2016/09/03 06:00 [entrez]
PHST- 2016/09/03 06:00 [pubmed]
PHST- 2018/03/03 06:00 [medline]
AID - 44/3/402 [pii]
AID - 10.1177/1073110516667938 [doi]
PST - ppublish
SO  - J Law Med Ethics. 2016 Sep;44(3):402-18. doi: 10.1177/1073110516667938.