Variation of community consultation and public disclosure for a pediatric multi-centered “Exception from Informed Consent” trial

Abstract

Background The U.S. federal regulation “Exception from Informed Consent (EFIC) for Emergency Research,” 21 Code of Federal Regulations 50.24, permits emergency research without informed consent under limited conditions. Additional safeguards to protect human subjects include requirements for community consultation and public disclosure prior to starting the research. Because the regulations are vague about these requirements, Institutional Review Boards (IRBs) determine the adequacy of these activities at a local level. Thus there is potential for broad interpretation and practice variation. Aim To describe the variation of community consultation and public disclosure activities approved by IRBs, and the effectiveness of this process for a multi-center, EFIC, pediatric status epilepticus clinical research trial. Methods: Community consultation and public disclosure activities were analyzed for each of 15 participating sites. Surveys were conducted with participants enrolled in the status epilepticus trial to assess the effectiveness of public disclosure dissemination prior to study enrollment. Results Every IRB, among the 15 participating sites, had a varied interpretation of EFIC regulations for community consultation and public disclosure activities. IRBs required various combinations of focus groups, interviews, surveys, and meetings for community consultation; news releases, mailings, and public service announcements for public disclosure. At least 4,335 patients received information about the study from these efforts. 158 chose to be included in the “Opt Out” list. Of the 304 participants who were enrolled under EFIC, 12 (5%) had heard about the study through community consultation or public disclosure activities. The activities reaching the highest number of participants were surveys and focus groups associated with existing meetings. Public disclosure activities were more efficient and cost-effective if they were part of an in-hospital resource for patients and families. Conclusion There is substantial variation in IRBs' interpretations of the federal regulations for community consultation and public disclosure. One of the goals of community consultation and public disclosure efforts for emergency research is to provide community members an opportunity to opt-out of EFIC research; however, rarely do patients or their legally authorized representatives report having learned about a study prior to enrollment.

A comprehensive systematic review of stakeholder attitudes to alternatives to prospective informed consent in paediatric acute care research

“… Families approached for DC 1178/1358 (87%) of emergency admissions (remaining 180 (13%) not included analysis). Inclusion rates differed according to whether the child died or survived Holsti, 2015[ 32 ] 15 sites in U.S and Canada. Academic paediatric emergency departments Effectiveness of community consultation and public disclosure activities Mixed methods.…”

“…Two studies explored other issues around community consultation including cost, value and variability in implementation [ 26 , 32 ]. Requirements of community consultation are at the discretion of local institutional review boards (IRBs) and variability in requirements was evident, particularly when involving multiple centres and different jurisdictions [ 26 , 32 ]. Methods of community consultation included focus groups, interviews, surveys, town meetings, and public disclosure involving news releases, mailings and public service announcements.…”

“…Another study with various modalities found focus groups were not well attended, with a quarter having no attendees. Only 5% of research participants had heard about the trial from community consultation and public disclosure activities [ 32 ]. The cost of community consultation was reported in two studies.…”

“…The phone surveys conducted by one large multicentre study averaged US$15,000 per site [ 26 ]. Another study utilising various modalities calculated the median cost of activities was about US$7000 [ 32 ]. The median additional time of this process was 10 months.…”

Impact of Social Media on Community Consultation in Exception From Informed Consent Clinical Trials

“…2 The specific mechanisms by which institutions grant EFIC are varied and poorly reported, leading to wide variation in institutional perceptions regarding EFIC across the United States. 3 At our institution, the process to obtain EFIC, including the specification of the number of community meetings required, was developed by our institutional review board (IRB) decades ago without significant changes since. That process traditionally involved 12-15 consultative meetings with community groups and public notification via advertisements and other traditional media.…”