Improving Community Understanding of Medical Research: Audience Response Technology for Community Consultation for Exception to Informed Consent

Abstract

IntroductionThe Department of Health and Human Services and Food and Drug Administration described guidelines for exception from informed consent (EFIC) research. These guidelines require community consultation (CC) events, which allow members of the community to understand the study, provide feedback and give advice. A real-time gauge of audience understanding would allow the speaker to modify the discussion. The objective of the study is to describe the use of audience response survey (ARS) technology in EFIC CCs.MethodsAs part of the Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART), 13 CC events were conducted. We prepared a PowerPoint™ presentation with 4 embedded ARS questions,according to specific IRB guidelines to ensure that the pertinent information would reach our targeted audience. During 6 CCs, an ARS was used to gauge audience comprehension. Participants completed paper surveys regarding their opinion of the study following each CC.ResultsThe ARS was used with minimal explanation and only one ARS was lost. Greater than 80% of the participants correctly answered 3 of the 4 ARS questions with 61% correctly answering the question regarding EFIC. A total of 105 participants answered the paper survey; 80–90% of the responses to the paper survey were either strongly agree or agree. The average scores on the paper survey in the ARS sites compared to the non-ARS sites were significantly more positive.ConclusionThe use of an audience response system during the community consultation aspects of EFIC is feasible and provides a real-time assessment of audience comprehension of the study and EFIC process. It may improve the community’s opinion and support of the study.

A Novel Emergency Department‐based Community Notification Method for Clinical Research Without Consent

“…were frequently not targeted to lay people and involved on average fewer than 15 participants . Two‐way communication, when implemented, results in effective information delivery and community understanding of the EFIC research …”

“…One of the most recent, largest, and best‐described efforts at community consultation was the RAMPART study . The researchers' exhaustive efforts to meet with members of the community and collect opinion data regarding willingness to participate were disappointing given the effort and expense.…”

“…The researchers' exhaustive efforts to meet with members of the community and collect opinion data regarding willingness to participate were disappointing given the effort and expense. A total of 105 people participated in audience response surveys during 13 community consultation efforts at one site . Another paper from the RAMPART study describes additional community consultation efforts in two other sites with participation ranging from seven individuals at two meetings to a high of 151 people attending another meeting .…”

Approach and Methods of the 2016 Alaska Native Research Forum

“…Audience response systems (ARS) are an innovative way to involve community members in presentations by posing questions to audience members during the presentation. Various ARS have been used to obtain data in community-based participatory research initiatives and have been well received by AN/AI people (Gamito, Burhansstipanov, Krebs, Bemis, & Bradley, 2005; Subrahmanian et al, 2011) and other diverse community groups (Boscardin & Penuel, 2012; Cain & Robinson, 2008; Davis et al, 2012; Rodriguez, Torres, & Erwin, 2013; Vohra et al, 2014). The ARS is a computer-assisted tool that includes handheld keypads linked wirelessly to a computer system and an audiovisual display (Cain & Robinson, 2008).…”

Lessons learned from using an audience response system in a community setting for research data collection

“…After an extensive literature search using CINAHL, Google Scholar, PubMed, MEDLINE, and PsycINFO, few research manuscripts were identified that describe the use of ARS as a data collection method in research. The research studies that did incorporate ARS used it most often as an assessment tool to analyze research participants comprehension of the consent process or to simply collect demographic data and were conducted by academic researchers (Gamito, Burhansstipanov, Krebs, Bemis, & Bradley, 2005;Keifer, Reyes, Liebman, & Juarez-Carrillo, 2014;Vohra et al, 2014). Gray et al (2016) did use ARS as a means to test the validity and reliability of the Food, Health, and Choices Questionnaire (FHC-Q) administered with ARS technology.…”