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Exception From Informed Consent: How IRB Reviewers Assess Community Consultation and Public Disclosure.

ABSTRACT: Exception from Informed Consent (EFIC) regulations detail specific circumstances in which Institutional Review Boards (IRB) can approve studies where obtaining informed consent is not possible prior to subject enrollment. To better understand how IRB members evaluate community consultation (CC) and public disclosure (PD) processes and results, semi-structured interviews of EFIC-experienced IRB members were conducted and analyzed using thematic analysis. Interviews with 11 IRB members revealed similar approaches to reviewing EFIC studies. Most use summaries of CC activities to determine community members' attitudes; none reported using specific criteria nor recalled any CC reviews that resulted in modifications to or denials of EFIC studies. Most interviewees thought metrics based on Community VOICES's domains (feasibility, participant selection, quality of communication, community perceptions, investigator/IRB perceptions) would be helpful. IRB members had similar experiences and concerns about reviewing EFIC studies. Development of metrics to assess CC processes may be useful to IRBs reviewing EFIC studies.

SUBMITTER: Chisolm-Straker M

PROVIDER: S-EPMC7859882 | biostudies-literature | 2021 Jan-Mar

REPOSITORIES: biostudies-literature

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Exception From Informed Consent: How IRB Reviewers Assess Community Consultation and Public Disclosure.

Chisolm-Straker Makini M Nassisi Denise D Daya Mohamud R MR Cook Jennifer N B JNB Wilets Ilene F IF Clesca Cindy C Richardson Lynne D LD

AJOB empirical bioethics 20200929 1

Exception from Informed Consent (EFIC) regulations detail specific circumstances in which Institutional Review Boards (IRB) can approve studies where obtaining informed consent is not possible prior to subject enrollment. To better understand how IRB members evaluate community consultation (CC) and public disclosure (PD) processes and results, semi-structured interviews of EFIC-experienced IRB members were conducted and analyzed using thematic analysis. Interviews with 11 IRB members revealed si ...[more]

PMID: 32990501

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Project description:The US Food and Drug Administration and the Department of Health and Human Services outline regulations allowing an exception from informed consent (EFIC) for research conducted in an emergency setting. Acute care clinical trials using EFIC must include community consultation and public disclosure (CC/PD) activities. We describe our experience using social media to facilitate the CC/PD process in two trauma resuscitation clinical trials.We conducted local CC/PD activities for two multicenter trauma clinical trials, Pragmatic, Randomized Optimal Platelet and Plasma Ratios (PROPPR) and Prehospital Tranexamic Acid Use for Traumatic Brain Injury (ROC-TXA). As part of the CC/PD process, we developed research study advertisements using the social media Web site Facebook. The Facebook advertisements directed users to a regional study Web site that contained trial information. We targeted the advertisements to specific demographic users, in specific geographic areas. We analyzed the data using descriptive statistics.During the study periods, the PROPPR Facebook advertisement was displayed 5,001,520 times (12 displays per target population) with 374 individuals selecting the advertisement. The ROC-TXA Facebook advertisement was displayed 3,806,448 times (8 per target population) with 790 individuals selecting the advertisement. Respondents to both Facebook advertisements were mostly male (52.6%), with the highest proportion between the ages 15 years and 24 years (28.2%). Collectively, 26.9% of individuals that clicked on the Facebook advertisement spent more than 3 minutes on the study Web site (3-49 minutes). Commonly accessed Web pages were "contact us" (PROPPR, 5.5%; ROC-TXA, 7.7%), "study-specific FAQs" (PROPPR, 2.4%; ROC-TXA, 6.7%), and "opt out of research" (PROPPR, 2.5%; ROC-TXA, 3.8%). Of 51 total individuals viewing the opt out of research information (PROPPR, 19; ROC-TXA, 32), time spent on that specific page was modest (PROPPR, 62 seconds; ROC-TXA, 55 seconds), with no individuals requesting to opt out of either study participation.In clinical trauma trials using EFIC, social media may provide a viable option for facilitating the CC/PD process.

Project description:ImportanceThe US Food and Drug Administration (FDA) created the exception from informed consent (EFIC) pathway in 1996 to allow some emergency trials to enroll patients without informed consent. To protect individual autonomy and preserve public trust, the FDA requires that EFIC trial investigators consult with community members before a trial may begin.ObjectivesTo analyze data from surveys conducted as part of community consultation ahead of EFIC trials and assess levels of public approval.Data sourcesAll trials granted an EFIC must submit documentation of compliance with EFIC regulations to a publicly available docket at the FDA. Submissions between November 1, 1996, and October 23, 2017, were reviewed.Study selectionTrials with survey data were included.Data extraction and synthesisData were extracted between January 2018 and June 2018 and were analyzed between June 2018 and August 2018. The quality and validity of data were assessed according to Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. A random-effects metaregression was used to assess the association of demographic characteristics with EFIC approval.Main outcomes and measuresThe primary study outcome was EFIC approval.ResultsThe FDA docket contained 15 958 pages of material with survey data for 42 448 individuals submitted by 27 trials. Public approval of EFIC varied by question type, with more people willing to approve initiation of EFIC trials in their community (86.5%) than personal enrollment (73.0%), enrollment of a family member (68.6%), or the principle of enrollment without consent (58.4%) (P < .001 for all comparisons). In the United States, African American individuals made up 29.3% of those enrolled in EFIC trials that reported data on race (5064 of 17 302) but only 16.7% of those surveyed as part of community consultation. In the United States and Canada, men made up 42.9% of the surveyed population but 65.6% of those eventually enrolled in EFIC trials (29 961 of 45 694). Groups surveyed with higher proportions of African American and male respondents had lower rates of EFIC approval.Conclusions and relevancePublic approval of EFIC trials varied by question type and by the respondents' reported race and sex. The demographic characteristics of those surveyed did not match the demographic characteristics of EFIC enrollees. The FDA could strengthen community consultation by standardizing survey instruments and reporting, requiring broader inclusion of African American and male respondents, clarifying the function of surveys in the development and modification of trial protocols, and building more public consensus around the acceptable use of EFIC.

Project description:Research investigating the resuscitation and management of unstable trauma patients is necessary to improve care and save lives. Because informed consent for research is impossible in emergencies, the Federal Drug Administration has established an Exception from Informed Consent (EFIC) Policy that mandates "community consultation" as a means of protecting patient autonomy. We hypothesized that the trauma community represents a heterogeneous population whose attitudes regarding EFIC and willingness to participate in emergency research are influenced by status as a patient, family, or geographic community member.In the context of an upcoming trial, trauma patients as well as family and community members were asked to rank statements regarding EFIC and willingness to participate in emergency research using a 5-point Likert-type scale. Higher total scores reflected a more positive attitude regarding EFIC (range, 4-20; neutral = 12) and willingness (range, 21-105, neutral = 63). The influence of demographics, education, and interpersonal violence were evaluated by Kruskal-Wallis and Mann-Whitney U-tests (p < 0.05).Overall, the 309 participants (trauma patients, n = 172; family, n = 73; community, n = 64) were positive about EFIC (median, 16; interquartile range, [IQR], 14-18) and demonstrated high willingness scores (median, 82; IQR, 76-88.5). EFIC and willingness were not influenced by age, sex, race, or education. Victims of interpersonal violence and their family members had lower EFIC scores than those with other mechanisms (median [IQR], 16 [14-18] vs. 16 [13-16]; p = 0.04) but similar willingness. Although EFIC scores were similar between groups, trauma patients had significantly lower willingness than family (median [IQR], 74 [68-77] vs. 77 [70-85]; p = 0.03) or community members (median [IQR], 76 [70-84]; p = 0.01).Trauma patients, families, and the geographic community expressed a high degree of support for EFIC and willingness to participate in emergency research, although support was influenced by injury mechanism and group status. Consultation efforts for emergency research should extend beyond the geographic community to include trauma victims and their families.Epidemiologic, level III.

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Exception From Informed Consent: How IRB Reviewers Assess Community Consultation and Public Disclosure.

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Exception From Informed Consent: How IRB Reviewers Assess Community Consultation and Public Disclosure.

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