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

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 issued regulations for emergency research with an exception from informed consent...

Full description

Saved in:

Bibliographic Details
Published in:	Surgery 2015-01, Vol.157 (1), p.10-19
Main Authors:	Chin, Theresa L., MD, Moore, Ernest E., MD, Coors, Marilyn E., PhD, Chandler, James G., MD, Ghasabyan, Arsen, MPH, Harr, Jeffrey N., MD, MPH, Stringham, John R., MD, Ramos, Christopher R., MD, Ammons, Sarah, BS, Banerjee, Anirban, PhD, Sauaia, Angela, MD, PhD
Format:	Article
Language:	eng
Subjects:	Blood Coagulation Disorders - etiology Blood Coagulation Disorders - prevention & control Community-Based Participatory Research Emergency Medical Services - ethics Humans Information Dissemination Informed Consent Surgery Wounds and Injuries - etiology Wounds and Injuries - therapy
Online Access:	Get full text
Tags:	Add Tag No Tags, Be the first to tag this record!

Description
Summary:	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 issued regulations for emergency research with an exception from informed consent (ER-EIC). We describe the community consultation and public disclosure (CC/PD) process in preparation for an ER-EIC study, namely the Control Of Major Bleeding After Trauma (COMBAT) study. Methods The CC/PD was guided by the four bioethical principles. We used 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 (eg, 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 study website. Results A total of 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 more than $84,000. Conclusion The CC/PD process is resource-intensive, costly, and complex. Although the multimedia CC/PD reached a large audience, the effectiveness of this process remains elusive. The templates can be helpful to similar ER-EIC studies.
ISSN:	0039-6060 1532-7361