Waiver of consent in noninterventional, observational emergency research: the PROMMTT experience. J Trauma Acute Care Surg 2013 Jul;75(1 Suppl 1):S3-8
Date
08/13/2013Pubmed ID
23778508Pubmed Central ID
PMC3744180DOI
10.1097/TA.0b013e31828fa3a0Scopus ID
2-s2.0-84880439889 (requires institutional sign-in at Scopus site) 13 CitationsAbstract
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.
CONCLUSION: 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.
Author List
Fox EE, Bulger EM, Dickerson AS, del Junco DJ, Klotz P, Podbielski J, Matijevic N, Brasel KJ, Holcomb JB, Schreiber MA, Cotton BA, Phelan HA, Cohen MJ, Myers JG, Alarcon LH, Muskat P, Wade CE, Rahbar MH, PROMMTT Study GroupMESH terms used to index this publication - Major topics in bold
AdultBlood Transfusion
Emergency Medicine
Ethics Committees, Research
Female
Hemorrhage
Hospital Mortality
Humans
Informed Consent
Male
Middle Aged
Prospective Studies
Research Design
Resuscitation
Trauma Centers
Treatment Outcome
United States
Wounds and Injuries