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

Abstract

BackgroundThis article presents the results of a community consultation (CC) process completed in Toronto, Ontario, using a random digit dialling technique, on the attitudes and perceptions of the public toward the use of exception from informed consent when conducting emergency research involving the use of massive blood transfusions.MethodsIn 2012, our hospital conducted a CC, using a random digit dialling technique, to elicit the attitudes and perceptions of the public toward the use of an exemption from informed consent for an upcoming clinical trial. A total of 500 participants from high violent crime areas were interviewed as part of this consultation.ResultsThe response rate for the telephone survey was 54%. Participants indicated a personal acceptance rate of 76%, acceptance of the justification for the exception to consent at 81%, thatthe study would meet the best interest of patients and the community at 81% and that youth (between 15 and 18 years) could be enrolled at 71%. When offered, no participant requested an opt-out wrist band to avoid being enrolled in this study.DiscussionThe use of violent crime neighborhoods to locate at risk communities was not effective in identifying the appropriate community of interest for this study. Though only representing a small subpopulation from a large Canadian city, the attitudes noted here is suggestive that Canadians may have a similar level of acceptance as the US based on published studies. However, given the resources needed to undertake this process and that in the end it did not elicit any useful feedback or recommendations for enhancing the safety of participants, the future use of phone surveys as a means of engaging communities should be reconsidered.Level of evidence (Level V)This is a retrospective subanalysis of a CC using a randomized phone dialling technique from a site prior to the start of the Pragmatic Randomized Optimal Platelet and Plasma Ratios Trial. The CC was not designed specifically for research purposes and as such reflect only a case study from a single center.Trial registration numberPre-result, NCT01545232.

The acceptability of delayed consent for prehospital emergency care research in the Western Cape province of South Africa

“…Delayed consent was generally acceptable to respondents if the interventions offered direct benefit to the research participant, if the participant's condition was life-threatening and the work held the prospect of benefit for future patients, and if the protocol for delayed consent was approved by a human research ethics committee. Our findings on the acceptability of delayed consent for EC research are comparable to research done in other settings, such as Australia (62%) [33], Canada (76%) [34], and the United States (70%) [35]. A recent systematic review also showed comparable results in pediatric EC research (68%) [36].…”

Public Approval of Exception From Informed Consent in Emergency Clinical Trials

“…Several trials have published survey data from 1 or more sites, but these studies capture only isolated snapshots of community attitudes regarding EFIC. [7][8][9][10][11][12][13][14][15][16][17][18] To our knowledge, the largest systematic review of EFIC survey data to date examined 9 trials with 9036 respondents but included only published data and did not quantitatively assess the demographic characteristics of those surveyed. 19 To comprehensively evaluate public attitudes regarding EFIC trials and avoid publication bias, we conducted a systematic review of all EFIC survey data submitted directly to the FDA since initiation of the EFIC pathway in November 1996 through October 2017.…”

“…There is limited literature on community consultation surveys in EFIC trials. Several trials have published survey data from 1 or more sites, but these studies capture only isolated snapshots of community attitudes regarding EFIC . To our knowledge, the largest systematic review of EFIC survey data to date examined 9 trials with 9036 respondents but included only published data and did not quantitatively assess the demographic characteristics of those surveyed .…”

Meeting unique requirements: Community consultation and public disclosure for research in emergency setting using exception from informed consent

“…Two types of value for community consultation were frequently emphasized: 1) the ability to clarify impact of trial enrollment on potential enrollees and ways to refine the study and 2) the potential to promote trust, provide transparency, and demonstrate respect 5–13 . There were questions raised about the extent to which community consultation accomplishes these goals, especially identifying changes 14–19 . A key theme was the reiteration that community consultation is not intended to be a “consent” process or vote, although acceptance is relevant 6,9,20,21 .…”