Learning From Experience: A Systematic Review of Community Consultation Acceptance Data

Approaches to community consultation in exception from informed consent: Analysis of scope, efficiency, and cost at two centers

“…Surveys, both online and in person, have been included in many EFIC trials, and compare favorably to community meetings and random-digit-dialing [6][7][8][9][10][11][14][15][16][17][18][19][20][21] . Survey data exist in the literature for comparison, its costs are substantially lower, and the public is more likely to participate since it takes less time than a community meeting 14 and is less personally disruptive than random digit dialing.…”

“…5 This puts investigators and IRBs in the position of developing their own process for each trial, and continuously defining standards of acceptance, which can be quite variable from community to community. For example, one review of nine IRB-approved EFIC trials 6 found that surveyed community members' personal acceptance rates (the respondent theoretically accepts the possibility of 4 being enrolled in the trial without consent if they fall ill) varied from 45% of the survey population to 93%, with a mean of 68% (±12.9%, n = 9,036). Community acceptances (the respondent theoretically accepts that the research trial be conducted in their community) ranged from 74% to 100% with a mean of 78% (SD 10.3%, n = 3,797).…”

Protecting study participants in emergency research: is community consultation before trial commencement enough?

“…This is comparable with results reported in a 2014 systematic review of studies undertaken in the USA, where personal acceptance rates for emergency research using EFIC clustered in the 64% to 80% ranges. 11 However, simply comparing reported CC results between sites is challenging, given the various types of CC processes actually used, as well as the different types of populations that were engaged (ie, a general community response vs responses from specific and highly affected communities). CCs can be undertaken using a variety of methods: researchers attending standing committee meetings, presentation at special public meeting, the use of social media and interactive websites, face-to-face interviews, focus groups, as well as the RDD surveys used in our study.…”

Ethical and regulatory challenges in advancing prehospital research: focus on sepsis

“…Examples of such efforts might include a randomized trial of a novel drug that appears promising in early-phase trials but is associated with a defined increase in risk of bleeding. Well-described challenges exist regarding how best to conduct public engagement activities for EFIC studies and how, particularly, to use community consultation feedback 15–17 . However, the EFIC mechanism is an established route for conducting important studies like this in the prehospital setting.…”