Waiver of consent in noninterventional, observational emergency research: The PROMMTT experience

Erin E. Fox, Eileen M. Bulger, Aisha S. Dickerson, Deborah J. Del Junco, Patricia Klotz, Jeanette Podbielski, Nena Matijevic, Karen Brasel, John B. Holcomb, Martin Schreiber, Bryan A. Cotton, Herb A. Phelan, Mitchell J. Cohen, John G. Myers, Louis H. Alarcon, Peter Muskat, Charles E. Wade, Mohammad H. Rahbar

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    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 articlewas to examine the rationale and tradeoffs of using waiver of consent in PROMMTT. METHODS: PROMMTTenrolled 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 consentswere 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 awaiver 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.

    Original languageEnglish (US)
    JournalJournal of Trauma and Acute Care Surgery
    Volume75
    Issue number1 SUPPL1
    DOIs
    Publication statusPublished - 2013

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    Keywords

    • Massive transfusion
    • PROMMTT
    • Trauma
    • Waiver of consent

    ASJC Scopus subject areas

    • Critical Care and Intensive Care Medicine
    • Surgery

    Cite this

    Fox, E. E., Bulger, E. M., Dickerson, A. S., Del Junco, D. J., Klotz, P., Podbielski, J., ... Rahbar, M. H. (2013). Waiver of consent in noninterventional, observational emergency research: The PROMMTT experience. Journal of Trauma and Acute Care Surgery, 75(1 SUPPL1). https://doi.org/10.1097/TA.0b013e31828fa3a0