Does experience matter? Implications for community consultation for research in emergency settings

ABSTRACT

Background: Community consultation (CC) is required for research in emergency settings using an exception from informed consent (EFIC) in the United States, but uncertainty persists regarding best CC practices. There is ongoing debate about whom to include in CC, specifically, whether to prioritize geographically defined communities or individuals with connections to the condition. Understanding the impact of personal disease experience on views of EFIC research is important for designing CC and interpreting its results. Methods: This study was a secondary analysis of surveys administered to 2612 participants at 12 sites in CC events conducted for ProTECT III: Progesterone for Traumatic Brain Injury, a Phase III, randomized trial conducted using EFIC. Key survey domains included personal traumatic brain injury (TBI) experience, demographic information, and acceptance of both hypothetical personal enrollment under EFIC and the use of EFIC in general in ProTECT III. Descriptive statistics and multivariable regression models were used to explore relationships between key domains. Results: TBI patients, those with family members/loved ones with TBI, and those who knew someone else with TBI were slightly more accepting of hypothetical personal enrollment under EFIC (adjusted odds ratio [OR] 1.14 [0.78–1.67], 1.54 [1.17–2.02], and 1.51 [1.19–1.92], respectively) and use of EFIC in general (adjusted OR 1.17 [0.83–1.64], 1.39 [1.08–1.77], and 1.06 [0.86–1.31], respectively) than those without this. In a subgroup analysis based on race, white participants with any disease experience had higher levels of acceptance of EFIC, as expected. However, there was numerically lower acceptance of personal and general EFIC enrollment among black participants with closer TBI connections. Conclusions: Personal TBI experience was associated with increased acceptance of EFIC research for that condition, except among black participants. Heterogeneity of the effect of personal disease experience on EFIC views further supports inclusion of individuals with relevant disease experience in CC and highlights the importance of engaging minority participants.

KEYWORDS:

• bioethics
• empirical research
• informed consent
• research ethics
• emergency medicine
• traumatic brain injury

Acknowledgments

We thank the members of the NETT Human Subjects Working Group for their contributions to the development of the initial survey instrument and the findings from this analysis.

Author contributions

All authors participated in the conception and design of this study. VM and ND were primarily responsible for data analysis. All authors participated in interpretation of the data. VM had primary responsibility for the drafting of the article. All authors participated in the revision of the article and approve of its submission.

Funding

The initial study was funded by the ProTECT III grant from NINDS (5U01NS062778). Dr. Dickert received support from the National Heart, Lung, and Blood Institute (NHLBI; F32HL095358-01A1) and the Greenwall Foundation Faculty Scholars Program during the study period.

Conflicts of interest

Emory University and Dr. Wright have a patent on the use of progesterone for traumatic brain injury. No other authors report any significant conflicts of interest related to this article.

Ethical approval

This study was approved by the institutional review board at Emory University, and the survey was approved at each of the 12 participating sites as part of their plans for community consultation.