PMID- 28186529
OWN - NLM
STAT- MEDLINE
DCOM- 20180405
LR  - 20181202
IS  - 1744-5019 (Electronic)
IS  - 0360-5310 (Linking)
VI  - 42
IP  - 2
DP  - 2017 Apr 1
TI  - Defining Research Risk in Standard of Care Trials: Lessons from SUPPORT.
PG  - 184-198
LID - 10.1093/jmp/jhw065 [doi]
AB  - Recent controversy surrounding the Surfactant Positive Airway Pressure and Pulse 
      Oximetry Trial (SUPPORT) and the Office for Human Resource Protection's (OHRP) 
      judgment that its informed consent procedures were inadequate has unmasked 
      considerable confusion about OHRP's definition of research risks. The controversy 
      concerns application of that definition to trials comparing multiple treatments 
      within the existing standard of care. Some have argued that it is impossible for 
      such trials to pose research risks on the grounds that all risks associated with 
      a standard-of-care treatment should instead be considered risks of treatment. 
      However, analysis of OHRP's definition demonstrates that some risks in such 
      trials can be research risks.
CI  - (c) The Author 2017. Published by Oxford University Press, on behalf of the Journal 
      of Medicine and Philosophy Inc. All rights reserved. For permissions, please 
      e-mail: journals.permissions@oup.com.
FAU - Press, Joel K
AU  - Press JK
AD  - California University of Pennsylvania, California, Pennsylvania, USA.
FAU - Rogers, Caryn J
AU  - Rogers CJ
LA  - eng
PT  - Journal Article
PL  - United States
TA  - J Med Philos
JT  - The Journal of medicine and philosophy
JID - 7610512
RN  - S88TT14065 (Oxygen)
SB  - IM
MH  - Blindness/*prevention & control
MH  - Humans
MH  - Infant, Newborn
MH  - Infant, Premature
MH  - Multicenter Studies as Topic
MH  - Oxygen/administration & dosage
MH  - Parental Consent
MH  - *Randomized Controlled Trials as Topic
MH  - Research
MH  - *Risk
MH  - *Standard of Care
OTO - NOTNLM
OT  - informed consent
OT  - research risk
OT  - standard of care
EDAT- 2017/02/12 06:00
MHDA- 2018/04/06 06:00
CRDT- 2017/02/11 06:00
PHST- 2017/02/12 06:00 [pubmed]
PHST- 2018/04/06 06:00 [medline]
PHST- 2017/02/11 06:00 [entrez]
AID - 2982823 [pii]
AID - 10.1093/jmp/jhw065 [doi]
PST - ppublish
SO  - J Med Philos. 2017 Apr 1;42(2):184-198. doi: 10.1093/jmp/jhw065.