Regulatory challenges in conducting human subjects research in emergency settings: the National Trauma Research Action Plan (NTRAP) scoping review

Cynthia Lizette Villarreal; Michelle A Price; Ashley N Moreno; Alfonso Zenteno; Christine Saenz; Alexander Toppo; Juan Pablo Herrera-Escobar; Carrie A Sims; Eileen M Bulger; (NTRAP) Investigators Group National Trauma Research Action Plan

doi:10.1136/tsaco-2022-001044

Regulatory challenges in conducting human subjects research in emergency settings: the National Trauma Research Action Plan (NTRAP) scoping review

Trauma Surg Acute Care Open. 2023 Mar 2;8(1):e001044. doi: 10.1136/tsaco-2022-001044. eCollection 2023.

Authors

Cynthia Lizette Villarreal¹, Michelle A Price¹, Ashley N Moreno¹, Alfonso Zenteno¹, Christine Saenz¹, Alexander Toppo¹, Juan Pablo Herrera-Escobar², Carrie A Sims³, Eileen M Bulger⁴; (NTRAP) Investigators Group National Trauma Research Action Plan

Collaborators

(NTRAP) Investigators Group National Trauma Research Action Plan:
Jeffrey A Bailey, Pamela J Bixby, Karen J Brasel, Maxwell Braverman, Eileen M Bulger, Zara R Cooper, Todd W Costantini, James R Ficke, Nicole S Gibran, Jonathan I Groner, Adil H Haider, Bellal A Joseph, Craig D Newgard, Michelle A Price, Deborah M Stein

Affiliations

¹ Coalition for National Trauma Research, San Antonio, Texas, USA.
² Center for Surgery and Public Health, Brigham and Women's Hospital, Boston, Massachusetts, USA.
³ Division of Trauma, Critical Care, and Burn, The Ohio State University, Columbus, Ohio, USA.
⁴ Department of Surgery, University of Washington, Seattle, Washington, USA.

Abstract

The complexity of the care environment, the emergent nature, and the severity of patient injury make conducting clinical trauma research challenging. These challenges hamper the ability to investigate potentially life-saving research that aims to deliver pharmacotherapeutics, test medical devices, and develop technologies that may improve patient survival and recovery. Regulations intended to protect research subjects impede scientific advancements needed to treat the critically ill and injured and balancing these regulatory priorities is challenging in the acute setting. This scoping review attempted to systematically identify what regulations are challenging in conducting trauma and emergency research. A systematic search of PubMed was performed to identify studies published between 2007 and 2020, from which 289 articles that address regulatory challenges in conducting research in emergency settings were included. Data were extracted and summarized using descriptive statistics and a narrative synthesis of the results. The review is reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. Most articles identified were editorial/commentary (31%) and published in the USA (49%). Regulatory factors addressed in the papers were categorized under 15 regulatory challenge areas: informed consent (78%), research ethics (65%), institutional review board (55%), human subjects protection (54%), enrollment (53%), exception from informed consent (51%), legally authorized representative (50%), patient safety (41%), community consultation (40%), waiver of informed consent (40%), recruitment challenges (39%), patient perception (30%), liability (15%), participant incentives (13%), and common rule (11%). We identified several regulatory barriers to conducting trauma and emergency research. This summary will support the development of best practices for investigators and funding agencies.

Keywords: informed consent; policy; research; vulnerable populations.

Publication types

Review