Impediments to Obtaining Informed Consent for Clinical Research in Trauma Patients

Dutton, Richard P.; Stansbury, Lynn G.; Hemlock, Bethany; Hess, John R.; Scalea, Thomas M.

doi:10.1097/ta.0b013e318165c15c

Cited by 39 publications

(47 citation statements)

References 27 publications

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“…We applied for a waiver of consent for the study on the basis that as an observational study, patients would be subject to no more than minimal risk and that the research could not be practicably carried out because we expected a 30–60% refusal rate based on previous studies. 18–22 …”

Section: Methodsmentioning

confidence: 99%

Coordination and management of multicenter clinical studies in trauma: Experience from the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study

et al. 2012

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Aim Early death due to hemorrhage is a major consequence of traumatic injury. Transfusion practices differ among hospitals and it is unknown which transfusion practices improve survival. This report describes the experience of the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study Data Coordination Center in designing and coordinating a study to examine transfusion practices at ten Level 1 trauma centers in the U.S. Methods PROMMTT was a multisite prospective observational study of severely injured transfused trauma patients. The clinical sites collected real-time information on the timing and amounts of blood product infusions as well as colloids and crystalloids, vital signs, initial diagnostic and clinical laboratory tests, life saving interventions and other clinical care data. Results Between July 2009 and October 2010, PROMMTT screened 12,561 trauma admissions and enrolled 1,245 patients who received one or more blood transfusions within 6 hours of ED admission. A total of 297 massive transfusions were observed over the course of the study at a combined rate of 5.0 massive transfusion patients/week. Conclusion PROMMTT is the first multisite study to collect real-time prospective data on trauma patients requiring transfusion. Support from the Department of Defense and collaborative expertise from the ten participating centers helped to demonstrate the feasibility of prospective trauma transfusion studies. The observational data collected from this study will be an invaluable resource for research in trauma surgery and it will guide the design and conduct of future randomized trials.

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Section: Methodsmentioning

confidence: 99%

Coordination and management of multicenter clinical studies in trauma: Experience from the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study

et al. 2012

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“…In a prospective study, Dutton et al 19 found that greater than 55% of patients with SBP<90mmHg could not be consented within 3 hours due to their own incapacitation and lack of an LAR or PDM. Similarly, only 7% of patients in the PROTECT trial of progesterone treatment for traumatic brain injury of patients could be enrolled within three hours using a proxy consent, and no consent could be obtained within two hours of the injury.…”

Section: Bioethical Principles and Er-eic Under Title 21 Section 5024mentioning

confidence: 99%

Exploring ethical conflicts in emergency trauma research: The COMBAT (Control of Major Bleeding after Trauma) study experience

Chin

Moore

Coors

et al. 2015

Surgery

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Background Up to 25% of severely injured patients develop trauma-induced coagulopathy. To study interventions for this vulnerable population for whom consent cannot be obtained easily, the Food and Drug Administration (FDA) issued regulations for emergency research with an exception from informed consent (ER-EIC). We describe the community consultation and public disclosure (CCPD) process in preparation an ER-EIC study namely the Control of Major Bleeding after Trauma (COMBAT) study. Methods The CCPD was guided by the four bioethical principles. We employed a multimedia approach including one-way communications (newspaper ads, brochures, television, radio, and web) and two-way communications (interactive in-person presentations at community meetings, printed and online feedback forms) to reach the trials catchment area (Denver County’s population: 643,000 and the Denver larger metro area where commuters reside: 2.9 million). Particular attention was given to special-interests groups (e.g., Jehovah Witnesses, homeless) and to Spanish-speaking communities (brochures and presentations in Spanish). Opt-out materials were available during on-site presentations or via the COMBAT website. Results 227 community organizations were contacted. Brochures were distributed to 11 medical clinics and 3 homeless shelters. The multimedia campaign had the potential to reach an estimated audience of 1.5 million individuals in large metro Denver area, the majority via one-way communication and 1900 in two-way communications. This resource intensive process cost over $84,000. Conclusions The CCPC process is resource-intensive, costly, and complex. While the multimedia CCPC reached a large audience, the effectiveness of this process remains elusive. The templates can be helpful to similar ER-EIC studies.

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“…Moreover, identifying potential subjects a priori or their legally authorized representatives (LARs) in a timely fashion may not be practical in most circumstances. 2,3 …”

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confidence: 99%

Exception from informed consent for emergency research

Sims

Isserman

Holena

et al. 2013

Journal of Trauma and Acute Care Surgery

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BACKGROUND Research investigating the resuscitation and management of unstable trauma patients is necessary to improve care and save lives. Because informed consent for research is impossible in emergencies, the Federal Drug Administration has established an Exception from Informed Consent (EFIC) Policy that mandates “community consultation” as a means of protecting patient autonomy. We hypothesized that the trauma community represents a heterogeneous population whose attitudes regarding EFIC and willingness to participate in emergency research are influenced by status as a patient, family, or geographic community member. METHODS In the context of an upcoming trial, trauma patients as well as family and community members were asked to rank statements regarding EFIC and willingness to participate in emergency research using a 5-point Likert-type scale. Higher total scores reflected a more positive attitude regarding EFIC (range, 4–20; neutral = 12) and willingness (range, 21–105, neutral = 63). The influence of demographics, education, and interpersonal violence were evaluated by Kruskal-Wallis and Mann-Whitney U-tests (p < 0.05). RESULTS Overall, the 309 participants (trauma patients, n = 172; family, n = 73; community, n = 64) were positive about EFIC (median, 16; interquartile range, [IQR], 14–18) and demonstrated high willingness scores (median, 82; IQR, 76–88.5). EFIC and willingness were not influenced by age, sex, race, or education. Victims of interpersonal violence and their family members had lower EFIC scores than those with other mechanisms (median [IQR], 16 [14–18] vs. 16 [13–16]; p = 0.04) but similar willingness. Although EFIC scores were similar between groups, trauma patients had significantly lower willingness than family (median [IQR], 74 [68–77] vs. 77 [70–85]; p = 0.03) or community members (median [IQR], 76 [70–84]; p = 0.01). CONCLUSION Trauma patients, families, and the geographic community expressed a high degree of support for EFIC and willingness to participate in emergency research, although support was influenced by injury mechanism and group status. Consultation efforts for emergency research should extend beyond the geographic community to include trauma victims and their families. LEVEL OF EVIDENCE Epidemiologic, level III.

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Impediments to Obtaining Informed Consent for Clinical Research in Trauma Patients

Abstract: Severely injured trauma patients can seldom provide consent for research studies, and LARs are often unavailable. Further efforts to develop workable mechanisms for exception from informed consent are justified.

Cited by 39 publications

References 27 publications

Coordination and management of multicenter clinical studies in trauma: Experience from the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study

Coordination and management of multicenter clinical studies in trauma: Experience from the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study

Exploring ethical conflicts in emergency trauma research: The COMBAT (Control of Major Bleeding after Trauma) study experience

Exception from informed consent for emergency research

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