Interactive Media-Based Approach for an Exception From Informed Consent Trial Involving Patients With Trauma
Shannon W. Stephens, Christy Carroll-Ledbetter, Sarah Duckert, Tanner Coffman, Margaret Nelson, Karen N. Brown, Joel Rodgers, Russell L. Griffin, Amy Suen, Jeremy Casey, Steven R. Sloan, Brahm Goldstein, Adam Joseph McClintock, Sara F. Goldkind, Luke Gelinas, Amanda E. Higley, Bellal A. Joseph, John B. Holcomb, Jan O. Jansen
JAMA Surgery, 3 July 2024
Abstract
Importance
Exception From Informed Consent (EFIC) research requires community consultation (CC) and public disclosure (PD). Traditional methods of conducting CC and PD are slow, expensive, and labor intensive.
Objective
To describe the feasibility and reach of a novel interactive, media-based approach to CC and PD and to identify the similarities and differences between trial sites in website views, survey responses, online community forum attendance, and opt-out requests.
Design, Setting, and Participants
This survey study analyzed the CC and PD campaigns conducted for the TAP trial (Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival), an EFIC trial of the early administration of prothrombin complex concentrate in patients with trauma. The CC and PD campaigns consisted of social media advertisements, linked websites, community surveys, and online community forums. These activities were coordinated from a central site and approved by a central institutional review board. This study focused on the first 52 of 91 TAP trial sites (level I trauma centers) in the US to have completed their CC and PD campaigns. Community members in the catchment areas of the participating trauma centers were targeted. Data analysis was conducted between October 2023 and February 2024.
Exposure
Social media advertisements, surveys, and online community meetings conducted as part of the CC and PD campaign for the TAP trial.
Main Outcomes and Measures
Social media campaign reach and engagement, web page views, survey results, online community forum attendance, and opt-out requests.
Results
Fifty-two trial sites were approved for participant enrollment. Social media advertisements were displayed 92 million times, reaching 11.8 million individuals. The median (IQR) number of people reached in each location was 210 317 (172 068-276 968). Site-specific websites were viewed 144 197 times (median [IQR] viewings per site, 2984 [1267-4038]). A total of 17 206 fully or partly completed surveys were received, and survey respondents had a median (IQR) age of 40.1 (15-65) years and included 10 444 females (60.7%). Overall, 60.6% survey respondents said they would want to be entered into the trial even if they could not give consent, 87.7% agreed that emergency care research was necessary, and 88.0% agreed that the TAP trial should be conducted in their community. Online community forums were attended by a median (IQR) number of 38 (20-63) people. Four opt-out requests were received.
Conclusions and Relevance
The interactive media-based approach to CC and PD for the ongoing TAP trial showed the feasibility and benefits of executing an efficient, coordinated, centrally run series of locally branded and geographically targeted CC and PD campaigns for a large EFIC study.

Exception From Informed Consent—A Model for Donor Intervention Research
Invited Commentary
Anji E. Wall, Giuliano Testa
JAMA Surgery, 3 July 2024
Abstract
In their article “Interactive Media-Based Approach for an Exception From Informed Consent Trial Involving Patients With Trauma,” Stephens and colleagues demonstrate the feasibility of a multicenter community consultation and public disclosure campaign for exception for informed consent for the Trauma and Prothrombin Complex Concentrate (TAP) trial.1 The unique interactive media-based approach resulted in widespread reach to the community through social media and active community participation through surveys, virtual forums, and opt-out requests. Over 50 level 1 trauma centers adopted this approach, which demonstrated the feasibility of a centrally run, locally branded, and geographically targeted campaign.

The ethical value of consulting community members in non-emergency trials conducted with waivers of informed consent for research
Emily A Largent, Steven Joffe, Neal W Dickert, Stephanie R Morain
Clinical Trials, 25 June 2024
Abstract
There is growing interest in using embedded research methods, particularly pragmatic clinical trials, to address well-known evidentiary shortcomings afflicting the health care system. Reviews of pragmatic clinical trials published between 2014 and 2019 found that 8.8% were conducted with waivers of informed consent; furthermore, the number of trials where consent is not obtained is increasing with time. From a regulatory perspective, waivers of informed consent are permissible when certain conditions are met, including that the study involves no more than minimal risk, that it could not practicably be carried out without a waiver, and that waiving consent does not violate participants’ rights and welfare. Nevertheless, when research is conducted with a waiver of consent, several ethical challenges arise. We must consider how to: address empirical evidence showing that patients and members of the public generally prefer prospective consent, demonstrate respect for persons using tools other than consent, promote public trust and investigator integrity, and ensure an adequate level of participant protections. In this article, we use examples drawn from real pragmatic clinical trials to argue that prospective consultation with representatives of the target study population can address, or at least mitigate, many of the ethical challenges posed by waivers of informed consent. We also consider what consultation might involve to illustrate its feasibility and address potential objections.

Consent Form Reporting on ClinicalTrials.Gov, 2013-2023
Research Letter
Sydney A. Axson, Reshma Ramachandran, Alexa Lisenby, Nicholas A. Giordano
JAMA Open, 21 June 2024; 7(6)
Introduction
Informed consent documentation is legally, ethically, and scientifically imperative for research and provides prospective trial participants key study information. Historically, consent documents have been difficult to obtain and not consistently publicly available. As of July 21, 2019, and after a 2-year voluntary period, the revised Common Rule required select federally funded interventional trials to publicly post consent forms no later than 60 days after the last participant visit. The revision intends to increase research transparency and inform consent development. Although transparency efforts addressing trial registrations and results are well studied, less is known about public availability of consent forms in the context of the revised rule’s recent implementation. This cross-sectional analysis examined National Institutes of Health (NIH)–funded trial consent form availability on ClinicalTrials.gov.

Reshaping consent so we might improve participant choice (III) – How is the research participant’s understanding currently checked and how might we improve this process?
Research Article
Hugh Davies, Simon E Kolstoe, Anthony Lockett
Research Ethics, 24 February 2024
Open Access
Abstract
Valid consent requires the potential research participant understands the information provided. We examined current practice in 50 proposed Clinical Trials of Investigational Medicinal Products to determine how this understanding is checked. The majority of the proposals (n = 44) indicated confirmation of understanding would take place during an interactive conversation between the researcher and potential participant, containing questions to assess and establish understanding. Yet up until now, research design and review have not focused upon this, concentrating more on written material. We propose ways this interactive conversation can be documented, and the process of checking understanding improved.