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

Abstract

Background Exception from informed consent (EFIC) regulations for research in emergency settings contain unique requirements for community consultation and public disclosure. These requirements address ethical challenges intrinsic to this research context. Multiple approaches have evolved to accomplish these activities that may reflect and advance different aims. This scoping review was designed to identify areas of consensus and lingering uncertainty in the literature. Methods Scoping review methodology was used. Conceptual and empirical literature related to community consultation and public disclosure for EFIC research was included and identified through a structured search using Embase, HEIN Online, PubMed, and Web of Science. Data were extracted using a standardized tool with domains for major literature categories. Results Among 84 manuscripts, major domains included conceptual or policy issues, reports of community consultation processes and results, and reports of public disclosure processes and results. Areas of consensus related to community consultation included the need for a two‐way exchange of information and use of multiple methods. Public acceptance of personal EFIC enrollment is commonly 64% to 85%. There is less consensus regarding how to assess attitudes, what “communities” to prioritize, and how to determine adequacy for individual projects. Core goals of public disclosure are less well developed; no metrics exist for assessing adequacy. Conclusions Multiple methods are used to meet community consultation and public disclosure requirements. There remain no settled norms for assessing adequacy of public disclosure, and there is lingering debate about needed breadth and depth of community consultation.

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

“…In addition to the requirements above, additional special protections are afforded to persons unable to exercise their autonomy in deciding whether to participate in the trial 17 . These include: (1) community consultation, a process that provides the opportunity for discussions with and soliciting meaningful input from the community in which the study will take place and from which study subjects will be drawn 17–20 ; (2) public disclosure, a process by which information about the research and its results are disseminated to the affected communities 17,21 ; and (3) the requirement that there be a time‐limited effort to contact an LAR to give consent with appropriate documentation, or decline participation, and the opportunity for family members who are not LARs to opt out on behalf of the patient 17…”

Ethical Considerations in Clinical Trials for Disorders of Consciousness

“…Fins and colleagues describe an approach of “consensus consent” when considering enrolling persons with DoC in clinical trials, which requires involvement and agreement among four parties—the participant’s “legally authorized representative, the subject’s physician, the clinical investigator, and a lay subject advocate” [ 101 , 102 , 103 ]. Others contend that a model of interactive community consultation or public deliberation, whereby salient values and preferences of recovered patients and other key stakeholder groups are ascertained in advance of a planned study, could potentially supplant or supplement the traditional informed consent process in select circumstances [ 81 , 104 , 105 , 106 , 107 ]. Despite the proliferation of alternative models to informed consent, ethical debate still exists regarding the optimal form these approaches should take.…”

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

“…A recent review by Dickert et al 4 found that CC traditionally involved either interactive, discussion-based activities, such as town hall meetings, existing support group meetings, and in-person interviews or focus groups; or noninteractive, survey-based activities, such as random digit dialing telephone surveys, or web-based surveys. The PD methods, in contrast, typically included press releases; radio, TV, and public service announcements; social media advertisements; websites; individual communication; in-person disclosure; posters and brochures in hospitals; and meetings.…”

“…The PD methods, in contrast, typically included press releases; radio, TV, and public service announcements; social media advertisements; websites; individual communication; in-person disclosure; posters and brochures in hospitals; and meetings. The authors highlighted the clear conceptual distinction between CC and PD, whereas in practice, there is some overlap 4 . Both CC and PD involve the unidirectional provision of information, whereas only CC involves consultation—or bidirectional flow of information—between community members and investigators 4 .…”

“…As a result, there is growing interest in how to best conduct CC-regardless of whether conducted in-person, or using social media-and how effective they are. 4 A Pubmed search revealed more than 100 articles on CC and PD methodologies. Many of these relate to patients who have suffered injury, but the principles are equally applicable to patients who experience (non-traumatic) cardiac arrest, and certain neurological conditions.…”