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 J. Brasel, John B. Holcomb, Martin A. Schreiber, Bryan A. Cotton, Herb A. Phelan, Mitchell J. Cohen, John G. Myers, Louis H. Alarcon, Peter Muskat, Charles E. Wade, Mohammad H. Rahbar

Research output: Contribution to journalArticle

6 Citations (Scopus)

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
StatePublished - 2013

Fingerprint

Research Ethics Committees
Emergencies
Wounds and Injuries
Research
Trauma Centers
Erythrocytes

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

Waiver of consent in noninterventional, observational emergency research : The PROMMTT experience. / Fox, Erin E.; Bulger, Eileen M.; Dickerson, Aisha S.; Del Junco, Deborah J.; Klotz, Patricia; Podbielski, Jeanette; Matijevic, Nena; Brasel, Karen J.; Holcomb, John B.; Schreiber, Martin A.; Cotton, Bryan A.; Phelan, Herb A.; Cohen, Mitchell J.; Myers, John G.; Alarcon, Louis H.; Muskat, Peter; Wade, Charles E.; Rahbar, Mohammad H.

In: Journal of Trauma and Acute Care Surgery, Vol. 75, No. 1 SUPPL1, 2013.

Research output: Contribution to journalArticle

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 2013, 'Waiver of consent in noninterventional, observational emergency research: The PROMMTT experience', Journal of Trauma and Acute Care Surgery, vol. 75, no. 1 SUPPL1. https://doi.org/10.1097/TA.0b013e31828fa3a0
Fox, Erin E. ; Bulger, Eileen M. ; Dickerson, Aisha S. ; Del Junco, Deborah J. ; Klotz, Patricia ; Podbielski, Jeanette ; Matijevic, Nena ; Brasel, Karen J. ; Holcomb, John B. ; Schreiber, Martin A. ; Cotton, Bryan A. ; Phelan, Herb A. ; Cohen, Mitchell J. ; Myers, John G. ; Alarcon, Louis H. ; Muskat, Peter ; Wade, Charles E. ; Rahbar, Mohammad H. / Waiver of consent in noninterventional, observational emergency research : The PROMMTT experience. In: Journal of Trauma and Acute Care Surgery. 2013 ; Vol. 75, No. 1 SUPPL1.
@article{50139310786d4351bef896058a650fe0,
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 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.",
keywords = "Massive transfusion, PROMMTT, Trauma, Waiver of consent",
author = "Fox, {Erin E.} and Bulger, {Eileen M.} and Dickerson, {Aisha S.} and {Del Junco}, {Deborah J.} and Patricia Klotz and Jeanette Podbielski and Nena Matijevic and Brasel, {Karen J.} and Holcomb, {John B.} and Schreiber, {Martin A.} and Cotton, {Bryan A.} and Phelan, {Herb A.} and Cohen, {Mitchell J.} and Myers, {John G.} and Alarcon, {Louis H.} and Peter Muskat and Wade, {Charles E.} and Rahbar, {Mohammad H.}",
year = "2013",
doi = "10.1097/TA.0b013e31828fa3a0",
language = "English (US)",
volume = "75",
journal = "Journal of Trauma and Acute Care Surgery",
issn = "2163-0755",
publisher = "Lippincott Williams and Wilkins",
number = "1 SUPPL1",

}

TY - JOUR

T1 - Waiver of consent in noninterventional, observational emergency research

T2 - The PROMMTT experience

AU - Fox, Erin E.

AU - Bulger, Eileen M.

AU - Dickerson, Aisha S.

AU - Del Junco, Deborah J.

AU - Klotz, Patricia

AU - Podbielski, Jeanette

AU - Matijevic, Nena

AU - Brasel, Karen J.

AU - Holcomb, John B.

AU - Schreiber, Martin A.

AU - Cotton, Bryan A.

AU - Phelan, Herb A.

AU - Cohen, Mitchell J.

AU - Myers, John G.

AU - Alarcon, Louis H.

AU - Muskat, Peter

AU - Wade, Charles E.

AU - Rahbar, Mohammad H.

PY - 2013

Y1 - 2013

N2 - 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.

AB - 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.

KW - Massive transfusion

KW - PROMMTT

KW - Trauma

KW - Waiver of consent

UR - http://www.scopus.com/inward/record.url?scp=84880439889&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84880439889&partnerID=8YFLogxK

U2 - 10.1097/TA.0b013e31828fa3a0

DO - 10.1097/TA.0b013e31828fa3a0

M3 - Article

VL - 75

JO - Journal of Trauma and Acute Care Surgery

JF - Journal of Trauma and Acute Care Surgery

SN - 2163-0755

IS - 1 SUPPL1

ER -