Learning From Experience: A Systematic Review of Community Consultation Acceptance Data Alexandra E. Fehr, MPH; Rebecca D. Pentz, PhD; Neal W. Dickert, MD, PhD* *Corresponding Author. E-mail: njr@emory.edu. Study objective: Federal regulations permitting an exception from informed consent for research in emergency settings require community consultation before study approval. Rates of acceptance of exception from informed consent in community consultation are often reported, but predictors of acceptance are not well understood, and investigators and institutional review boards struggle to interpret and use acceptance data. Methods: We systematically reviewed empirical literature on community consultation for exception from informed consent trials in the PubMed, EMBASE, and Web of Science databases. We included peer-reviewed articles reporting acceptance data from community consultation for US exception from informed consent trials. Questions were categorized by enrollment focus (eg, personal enrollment versus more general exception from informed consent acceptance), and observed acceptance was compared across studies. We also compared potential predictors of acceptance, including demographic factors, consultation method, and target community. Results: Nine studies (total n¼9,036 participants) were included in the final analysis. Personal acceptance of enrollment in the proposed exception from informed consent study ranged from 45% to 93% and clustered in the range of 64% to 80%. Acceptance of the exception from informed consent mechanism in general (without reference to personal inclusion) was lower (35% to 84%) than personal acceptance. The effect of demographic characteristics on acceptance was inconsistent, and meeting-based consultation methods were associated with greater acceptance than survey-based methods. Finally, acceptance rates varied substantially according to the phrasing of the question. Conclusion: Personal acceptance clustered between 64% and 80%. This range may be informative for institutional review boards and investigators evaluating community consultation results. However, numerous factors affect acceptance, and there is a need for considerable caution against overreliance on acceptance data. [Ann Emerg Med. 2015;65:162-171.] Please see page 163 for the Editor’s Capsule Summary of this article. A podcast for this article is available at www.annemergmed.com. 0196-0644/$-see front matter Copyright © 2014 by the American College of Emergency Physicians. http://dx.doi.org/10.1016/j.annemergmed.2014.06.023 INTRODUCTION Regulations permitting an exception from informed consent have facilitated an increasing number of pivotal clinical trials across a range of emergency cardiovascular, neurologic, and traumatic conditions. Although experience and comfort with exception from informed consent has increased among investigators, institutional review boards, and regulators, the requirement that investigators consult communities before approval and initiation of a proposed trial continues to pose challenges. 1,2 This is not surprising, especially because community consultation is not required by regulation for any other form of research. 2,3 Food and Drug Administration guidance enumerates 4 principal goals of community consultation: (1) to show respect for persons by informing the community in advance; (2) to inform community members in advance and facilitate meaningful input to the institutional review board; (3) to show respect for the community through allowing community members to identify potential concerns; and (4) to show respect for autonomy, particularly by inclusion of individuals expected to be similar to enrolled subjects. 3 Other proposed goals in the literature include fostering trust and sharing responsibility with the community. 3-6 Although these goals are laudable, putting them into operation and prioritizing among them has been challenging. One problem has been to ascertain the proper role of community consultation feedback in approval decisions. Food and Drug Administration guidance explicitly distinguishes community consultation from community consent, and the regulations do not require quantifying community acceptance. 3 However, quantitatively assessing community acceptance has been a focus of many consultation efforts, and analogies have been drawn between community consultation and democratic 162 Annals of Emergency Medicine Volume 65, no. 2 : February 2015 ETHICS/SYSTEMATIC REVIEW/META-ANALYSIS