title: Waiver of consent in noninterventional, observational emergency research: the PROMMTT experience.
abstract: BACKGROUND
  In the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) study, waiver of consent was used because previous literature reported low response rates and subsequent bias. The goal of this article was to examine the rationale and tradeoffs of using waiver of consent in PROMMTT.
  
  
  METHODS
  PROMMTT enrolled trauma patients receiving at least 1 U of red blood cells within 6 hours after admission at 10 US Level 1 trauma centers. Local institutional review boards (IRBs) from all sites approved the study. Site 8 was required by their IRB to attempt consent but was allowed to retain data on patients unable to be consented.
  
  
  RESULTS
  Of 121 subjects enrolled at Site 8, 55 consents were obtained (46%), and no patient or legally authorized representative refused to give consent. Of the patients, 36 (30%) died, and 6 (5%) were discharged before consent could be attempted. Consent was attempted but not possible among 24 patients (20%). Of the 10 clinical sites, 6 of the local IRBs approved collection of residual blood samples, 1 had previous approval to collect timed blood samples under a separate protocol, and 3 reported that their local IRBs would not approve collection of residual blood under a waiver of consent.
  
  
  CONCLUSIONS
  Waiver of consent was used in PROMMTT because of the potential adverse impact of consent refusals; however, there were no refusals. If the IRB for Site 8 had required withdrawal of patients unable to consent and destruction of their data, a serious bias would likely have been introduced. Other tradeoffs included a reduction in sites participating in residual blood collection and a smaller than expected amount of residual blood collected among sites operating under a waiver of consent. Noninterventional emergency research studies should consider these potential tradeoffs carefully before deciding whether waiver of consent would best achieve the goals of a study.
authors.affiliation: Biostatistics/Epidemiology/Research Design Core, Center for Clinical and Translational Sciences, University of Texas Health Science Center at Houston, Houston, TX 77030, USA. erin.e.fox@uth.tmc.edu
authors.forename: Erin E
authors.initials: EE
authors.lastname: Fox
authors.forename: Eileen M
authors.initials: EM
authors.lastname: Bulger
authors.forename: Aisha S
authors.initials: AS
authors.lastname: Dickerson
authors.forename: Deborah J
authors.initials: DJ
authors.lastname: del Junco
authors.forename: Patricia
authors.initials: P
authors.lastname: Klotz
authors.forename: Jeanette
authors.initials: J
authors.lastname: Podbielski
authors.forename: Nena
authors.initials: N
authors.lastname: Matijevic
authors.forename: Karen J
authors.initials: KJ
authors.lastname: Brasel
authors.forename: John B
authors.initials: JB
authors.lastname: Holcomb
authors.forename: Martin A
authors.initials: MA
authors.lastname: Schreiber
authors.forename: Bryan A
authors.initials: BA
authors.lastname: Cotton
authors.forename: Herb A
authors.initials: HA
authors.lastname: Phelan
authors.forename: Mitchell J
authors.initials: MJ
authors.lastname: Cohen
authors.forename: John G
authors.initials: JG
authors.lastname: Myers
authors.forename: Louis H
authors.initials: LH
authors.lastname: Alarcon
authors.forename: Peter
authors.initials: P
authors.lastname: Muskat
authors.forename: Charles E
authors.initials: CE
authors.lastname: Wade
authors.forename: Mohammad H
authors.initials: MH
authors.lastname: Rahbar
mesh_terms: D000328:Adult; D001803:Blood Transfusion / Q000941:ethics* / Q000379:methods*; D004635:Emergency Medicine / Q000941:ethics*; D028744:Ethics Committees, Research / Q000941:ethics*; D005260:Female; D006470:Hemorrhage / Q000401:mortality / Q000628:therapy*; D017052:Hospital Mortality; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012107:Research Design; D012151:Resuscitation / Q000379:methods*; D014193:Trauma Centers; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D014947:Wounds and Injuries / Q000401:mortality / Q000628:therapy*