Interactive media-based community consultation for exception from informed consent trials: How representative should (and can) it be?

Abstract

R esearch in emergency care has been facilitated by an exception from the requirements for obtaining and documenting informed consent. This exception only applies to a strictly limited class of research, involving activities that may be carried out in human subjects who are in need of emergency therapy and for whom, because of the participants' medical condition, and the unavailability of legally authorized representatives of the subjects, no legally effective informed consent can be obtained. 1 These regulations (21 CFR 50.24 for Food and Drug Administration [FDA] regulated studies and/or a Secretarial Waiver in 45 CFR Part 46 for the Department of Health and Human Services sponsored, funded or conducted studies) were introduced in 1996, and have allowed many key clinical trialswhich would otherwise not have been possible-to proceed and to positively transform emergency care in the process. This article explores the issue of how representative community consultation (CC), a requirement for such studies, can and should be, with particular reference to the use of interactive mediabased activities. While focused on trauma trials, the issues addressed are equally applicable to other emergent conditions associated with loss of capacity, such as cardiac arrest, stroke, or status epilepticus. 2

Interactive Media-Based Approach for an Exception From Informed Consent Trial Involving Patients With Trauma

“…11 Our results are consistent with findings of studies that demonstrate the wide reach of social media and the ability to engage community members in defined geographic areas. 7,[12][13][14] The trial advertisements were displayed 92 million times; 11.8 million unique individuals were reached, and 17 206 people completed surveys about this trial. This type of broad PD is critical because it allows interested individuals to engage further.…”

“…The interactive media-based approach we developed is more comprehensive than a previous method, which relied on social media alone. 7 In particular, with the new approach, there is a greater opportunity for individuals to convey their views, which is one of the tenets of CC.…”

“…The eFigure in Supplement 1 shows the number of views that the main landing pages, FAQ pages, EFIC description pages, and opt-out information pages received by site. The main landing pages were viewed most frequently (median [IQR] viewings, 2936 [1250-3924]), followed by the community meeting pages (median [IQR] viewings, 13 ), opt-out information pages (median [IQR] viewings, 12 [7][8][9][10][11][12][13][14][15][16][17][18][19]), FAQ pages (median [IQR] viewings, 10 [5-20]), and EFIC description pages (median [IQR] viewings, 9 [4][5][6][7][8][9][10][11][12][13][14][15][16]). There was a discernible temporal pattern, in that websites that have been active and able to be accessed for longer were viewed by more people.…”

“…This method, developed in consultation with an ethics consultant and the central Advarra Institutional Review Board (IRB), is the interactive, media-based approach. 7 In this study, we applied this approach to the CC and PD campaigns for the TAP trial (Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival), 8 an 8000-patient, 120-center, international randomized clinical trial that evaluates the early use of 4-factor prothrombin complex concentrate in patients with trauma who are expected to require a largevolume blood transfusion. 9 Approximately 90 of the TAP trial sites are located in the US, thus requiring CC and PD and making these CC and PD campaigns the largest to date.…”

An adaptive platform trial for evaluating treatments in patients with life‐threatening hemorrhage from traumatic injuries: Ethical and US regulatory considerations

“…Just as trial designs have evolved over the past decade, so have approaches to meaningful community consultation 18–20,48 . The FDA has accepted the use of electronic outreach for community consultation 49 . These include providing information via social media sites and the development of interactive study websites that allow investigators to reach larger audiences and employ creative educational tools.…”