Learning from experience: a systematic review of community consultation acceptance data

Area of Science:

• Clinical Research Ethics
• Public Health Policy
• Emergency Medicine Research

Background:

• Federal regulations mandate community consultation for research exceptions to informed consent in emergencies.
• Understanding predictors of community acceptance is crucial for study approval and data interpretation by investigators and IRBs.

Purpose of the Study:

• To systematically review empirical literature on community consultation acceptance for exception from informed consent trials.
• To identify predictors of acceptance and compare acceptance rates across different consultation methods and question phrasings.

Main Methods:

• Systematic review of peer-reviewed articles from PubMed, EMBASE, and Web of Science.
• Inclusion of US-based exception from informed consent trials reporting community consultation acceptance data.
• Categorization of questions by enrollment focus and comparison of acceptance predictors (demographics, consultation method, community).

Main Results:

• Nine studies (n=9,036) reported acceptance rates.
• Personal acceptance ranged from 45% to 93%, clustering between 64% and 80%.
• General acceptance (35%-84%) was lower than personal acceptance; meeting-based consultations showed higher acceptance than survey-based ones, and question phrasing significantly impacted rates.

Conclusions:

• Personal acceptance rates for exception from informed consent research in emergencies often fall between 64% and 80%.
• This range can inform institutional review boards and investigators, but acceptance is influenced by multiple factors.
• Caution is advised against over-reliance on acceptance data due to variability and influencing factors.