Exception From Informed Consent Research Articles

Design and implementation of community consultation for research conducted under exception from informed consent regulations for the PreVent and the PreVent 2 trials: Changes over time and during the COVID-19 pandemic.

Emergency clinical research has played an important role in improving outcomes for acutely ill patients. This is due in part to regulatory measures that allow Exception From Informed Consent (EFIC) trials. The Food and Drug Administration (FDA) requires sponsor-investigators to engage in community consultation and public disclosure activities prior to initiating an Exception From Informed Consent trial. Various approaches to community consultation and public disclosure have been described and adapted to local contexts and Institutional Review Board (IRB) interpretations. The COVID-19 pandemic has precluded the ability to engage local communities through direct, in-person public venues, requiring research teams to find alternative ways to inform communities about emergency research. The PreVent and PreVent 2 studies were two Exception From Informed Consent trials of emergency endotracheal intubation, conducted in one geographic location for the PreVent Study and in two geographic locations for the PreVent 2 Study. During the period of the two studies, there was a substantial shift in the methodological approach spanning across the periods before and after the pandemic from telephone, to in-person, to virtual settings. During the 10 years of implementation of Exception From Informed Consent activities for the two PreVent trials, there was overall favorable public support for the concept of Exception From Informed Consent trials and for the importance of emergency clinical research. Community concerns were few and also did not differ much by method of contact. Attendance was higher with the implementation of virtual technology to reach members of the community, and overall feedback was more positive compared with telephone contacts or in-person events. However, the proportion of survey responses received after completion of the remote, live event was substantially lower, with a greater proportion of respondents having higher education levels. This suggests less active engagement after completion of the synchronous activity and potentially higher selection bias among respondents. Importantly, we found that engagement with local community leaders was a key component to develop appropriate plans to connect with the public. The PreVent experience illustrated operational advantages and disadvantages to community consultation conducted primarily by telephone, in-person events, or online activities. Approaches to enhance community acceptance included partnering with community leaders to optimize the communication strategies and trust building with the involvement of Institutional Review Board representatives during community meetings. Researchers might need to pivot from in-person planning to virtual techniques while maintaining the ability to engage with the public with two-way communication approaches. Due to less active engagement, and potential for selection bias in the responders, further research is needed to address the costs and benefits of virtual community consultation and public disclosure activities compared to in-person events.

Public support for and concerns regarding pediatric dose optimization for seizures in emergency medical services: An exception from informed consent (EFIC) trial.

Federal regulations allow exception from informed consent (EFIC) to study emergent conditions when obtaining prospective consent is not feasible. Little is known about public views on including children in EFIC studies. The Pediatric Dose Optimization for Seizures in EMS (PediDOSE) trial implements age-based, standardized midazolam dosing for pediatric seizures. The primary objective of this study was to determine public support for and concerns about the PediDOSE EFIC trial. The secondary objective was to assess how support for PediDOSE varied by demographics. We conducted a mixed-methods study in 20 U.S. communities. Participants reviewed information about PediDOSE before completing an online survey. Descriptive data were generated. Univariable and multivariable logistic regression analysis identified factors associated with support for PediDOSE. Reviewers identified themes from free-text response data regarding participant concerns. Of 2450 respondents, 79% were parents/guardians, and 20% had a child with previous seizures. A total of 96% of respondents supported PediDOSE being conducted, and 70% approved of children being enrolled without prior consent. Non-Hispanic Black respondents were less likely than non-Hispanic White respondents to support PediDOSE with an adjusted odds ratio (aOR) of 0.57 (95% CI 0.42-0.75). Health care providers were more likely to support PediDOSE, with strongest support among prehospital emergency medicine clinicians (aOR 5.82, 95% CI 3.19-10.62). Age, gender, parental status, and level of education were not associated with support of PediDOSE. Common concerns about PediDOSE included adverse effects, legal and ethical concerns about enrolling without consent, and potential racial bias. In communities where this study will occur, most respondents supported PediDOSE being conducted with EFIC and most approved of children being enrolled without prior consent. Support was lowest among non-Hispanic Black respondents and highest among health care providers. Further research is needed to determine optimal ways to address the concerns of specific racial and ethnic groups when conducting EFIC trials.

Abstract 342: Willingness to Participate in an Active Pediatric Critical Care Interventional Trial Using Exception From Informed Consent

Introduction: Emergency interventional trials using Exception From Informed Consent (EFIC) are rare, but pooled survey data preceding 27 EFIC studies show that 73% of respondents were willing to be enrolled in the associated trial. However, given the hypothetical nature of these surveys, the actual rate of willingness to participate in an active EFIC trial and any associations with demographic characteristics are unknown. Aims: To 1) compare the actual rate of willingness to participate in an EFIC trial with that from previously published hypothetical surveys for the same trial; and 2) describe demographic characteristics associated with actual willingness rates. Hypothesis: We hypothesized that the actual rate of willingness to participate in an EFIC trial would be lower than the hypothetical survey rate. Methods: From April 13 to June 5, 2023, we attempted to notify all eligible patients/families of an active EFIC trial enrolling in our PICU and gave them the option to opt out from enrollment. Responses were recorded, and patient demographics were abstracted from the medical record. Major exclusion criteria were age over 25 years and state custody. Surveys were performed prior to trial initiation with a similar screening process. Likert scale responses for willingness to participate were dichotomized. Results: Of 207 families contacted, 149 (72%) were willing to participate in the trial which was similar to our pre-trial survey data (43/58 [74%]; p = 0.87). Willingness rates varied by race category (Asian 5/5, 100%; Black 8/18, 44%; Hispanic 22/33, 67%; White 66/84, 79%; Other 12/20 60%; Unknown 36/47, 77%; p = 0.03) but not patient age (willing, median 5 years [IQR 1, 13] vs not willing, median 7 years [IQR 1,4]; p=0.84). Conclusion: The actual rate of willingness to participate in an EFIC trial in the PICU was similar to the hypothetical rate reported in pre-trial survey data, suggesting surveys may reasonably reflect attitudes of potential participants. Willingness rates varied by race, though a significant proportion of data was missing. Reasons for racial differences in research engagement should be explored to better understand the consequences of long-standing structural racism in the US and the impact on future trial participation for these groups.

Randomized feasibility trial of remote ischemic conditioning to enhance resuscitation (RICE)

RationaleRestoration of blood flow after out-of-hospital cardiac arrest (OHCA) is associated with inflammation that causes cellular injury. The extent of this reperfusion injury (RI) is associated with the duration of ischemia and adequacy of resuscitation. Remote ischemic conditioning (RIC) consists of repeated application of non-lethal ischemia then reperfusion to a limb distal to the heart by inflating a blood pressure (BP) cuff. Trials in animal models in cardiac arrest and in humans with acute infarction show RIC reduces RI. ObjectiveWe sought to demonstrate the feasibility and safety of RIC in patients resuscitated from OHCA and transported to hospital. MethodsThis study was conducted under exception from informed consent (EFIC) for emergency research. Eligible subjects were randomized with masked allocation to control (standard care) versus intervention (standard care and RIC). Included were adults with non-traumatic OHCA. The primary outcome was attrition, the proportion of patients enrolled and not on allocated therapy for the study duration. Key secondary outcomes were survival to discharge, neurologic status at discharge, hospital-free survival, and adverse events. Results were summarized descriptively as recommended for pilot studies. ResultsN = 30 patients were enrolled (n = 14 control, n = 16 intervention). Mean age of enrolled patients was 52.5 ± 16.2 years. Eight (27%) were female gender and 7 (23%) had a shockable first recorded rhythm. 100% of enrolled patients completed their allocated study intervention (i.e., 0% attrition). The RIC group had 7 (44%) survival to discharge and median Rankin score of 6 (IQR 1, 6) at discharge as compared to the standard care group which had 6 (43%) survival to discharge and median Rankin score of 6 (IQR 1.5, 6) at discharge. A single patient (6%) in the intervention group had transient occlusion of their upper extremity intravenous line, which immediately resolved on repositioning of the blood pressure cuff. ConclusionApplication of RIC to patients resuscitated from CA and transported to an ED is feasible and safe. An adequately powered trial is required to assess whether RIC is effective at decreasing morbidity and mortality after CA.

Abstract TP50: Exception From Informed Consent (EFIC) In Emergency Research: Developing A Community Consultation Plan

Background: In emergent situations where patients are neurologically impaired, obtaining informed consent is a challenge. Research-related interventions that may optimize patient outcomes may be delayed or not given. Under the Final Rule, emergency research studies can proceed without informed consent granted that certain criteria are first met. One criteria is that researchers must conduct community consultation activities. Objective: We share the various mechanisms used in outreach to our catchment area and their respective views of EFIC research. Methods: As part of community consultation efforts for an emergent hemorrhagic stroke trial, our research team first developed a comprehensive plan to seek out the best platforms to disseminate study information and obtain diverse input (all while recognizing the heterogeneity of the community). A survey tool developed by the study’s sponsor National Institute of Health StrokeNet team was used to elicit feedback related to the value of the trial, participants’ understanding of EFIC, and trust in physician-investigators. Results: A total of 700 individuals participated across all the proposed community consultation events (e.g. focus groups, local support groups, forums). Two-hundred five participants completed the survey, with 96% agreeing that the trial is an important study to do; 80% were in favor of themselves or a loved one being included in the trial without consent. Community members responding included seniors, those at higher risk of suffering a stroke, and medical providers. Minority communities (i.e. Hispanic & African American populations) were contacted to ensure that their voice was heard. We used public disclosure to assist in reaching minority groups. Despite receiving only 22% turnout from these community members, the feedback received demonstrated the need to continue to make a collective effort in gaining the trust of these populations through community liaisons. Conclusion: Overall, community members expressed high levels of support for this EFIC trial. By incorporating a wide variety of mechanisms into a community consultation and public disclosure plan, maximal support for EFIC can be achieved.

A census of clinical trials conducted under the U.S. exception from informed consent rule.

The exception from informed consent (EFIC) rule was adopted in 1996, permitting waiver of informed consent for certain emergency research, including trials funded by the U.S. government. The rule requires prospective consent from patients or their legally authorized representative(s) (LAR) if practicable. For those enrolled without consent, the patient or their LAR must be given an opportunity to opt out from continued participation at the earliest opportunity. We sought to census the trials conducted under the EFIC rule to facilitate research to better understand how the rule is being used. We conducted a multipronged search to identify all trials conducted under the EFIC rule, drawing on reviews, database searches, examination of the FDA's docket, posting an inquiry on the institutional review board forum, and email requests to lead authors of all published EFIC trials and related review articles. We describe the trials, when they were started and completed, and whether they were terminated early. We identified a total of 110 trials as of the end of April 2022: 78 complete, 13 recruiting, seven registered on clinicaltrials.gov but not yet recruiting, five trials that were abandoned before enrolling any subjects, and seven trials in early planning. Nine of the 78 completed trials were pilot or feasibility trials. Of 69 completed full trials, 30 (43.5%) were terminated early. The most common reason for early termination was futility (15 trials, 25.0%) followed by poor recruitment (10 trials, 14.5%). The rate of conduct of trials has been remarkably constant since 2001, with roughly 18 trials started in each 5-year period. We have compiled a census of trials conducted under the U.S. FDA's EFIC rule, the availability of which we hope will stimulate further in-depth data collection and analysis of this set of trials.

Community consultation in the pediatric intensive care unit for an exception from informed consent Trial: A survey of patient caregivers

AimTo explore perspectives of families in the pediatric intensive care unit (PICU) about an emergency interventional trial on peri-arrest bolus epinephrine for acute hypotension using Exception From Informed Consent (EFIC). MethodsWe performed face-to-face interviews with families whose children were hospitalized in the PICU. A research team member provided an educational presentation about the planned trial and administered a survey with open- and closed-ended items. Analyses included descriptive statistics for quantitative data and thematic analysis for qualitative data. ResultsSixty-seven participants contributed to 60 survey responses (53 individuals and 7 families for whom 2 family members participated). Most participants answered favorably toward the planned trial: 55/58 (95%) reported that the trial seemed “somewhat” or “very important”; 52/57 (91%) felt the use of EFIC was “somewhat” or “completely acceptable”; and 43/58 (74%) said they would be “somewhat” or “very likely” to allow their child to participate. Five themes emerged supporting participation in the planned trial: 1) trust in the clinical team; 2) familiarity with the study intervention (epinephrine); 3) study protocol being similar to standard care; 4) informed consent during an emergency was not feasible; and 5) importance of research. Barriers to potential participation included requests for additional time to decide about participating and misconceptions about study elements, especially eligibility. ConclusionsFamilies of PICU patients generally supported plans for an emergency interventional trial using EFIC. Future inpatient EFIC studies may benefit from highlighting the themes identified here in their educational materials.

Community consultation for Exception from Informed consent (EFIC) before and during the COVID-19 pandemic

AimDescribe community consultation and surrogate consent rates for two Exception From Informed Consent (EFIC) trials for out-of-hospital cardiac arrest (OOHCA) - before and during the COVID-19 pandemic. MethodsThe PEARL study (2016–2018) randomized OOHCA patients without ST-elevation to early cardiac catheterization or not. Community consultation included flyers, radio announcements, newspaper advertisements, mailings, and in-person surveys at basketball games and ED waiting rooms. The PROTECT trial (2021-present) randomizes OOHCA survivors to prophylactic ceftriaxone or placebo; the community consultation plan during the pandemic included city council presentations, social media posts, outpatient flyers, but no in-person encounters. Demographics for PROTECT community consultation were compared to PEARL and INTCAR registry data, with p-value < 0.05 considered significant. ResultsPEARL surveyed 1,362 adults, including 64 % ≥60 years old, 96 % high school graduates or beyond; research acceptance rate was 92 % for the community and 76 % for personal level. PROTECT initially obtained 221 surveys from electronic media – including fewer males (28 % vs 72 %,p < 0.001) and those > 60 years old (14 % vs 53 %;p < 0.001) compared to INTCAR. These differences prompted a revised community consultation plan, targeting 79 adult in-patients with cardiac disease which better matched PEARL and INTCAR data: the majority were ≥ 60 years old (66 %) and male (54 %). Both PEARL and PROTECT enrolled more patients using surrogate consent vs EFIC (57 %, 61 %), including 71 % as remote electronic consents during PROTECT. ConclusionsCommunity consultation for EFIC studies changed with the COVID-19 pandemic, resulting in different demographic patterns. We describe effective adaptations to community consultation and surrogate consent during the pandemic.

Traumatic injury clinical trial evaluating tranexamic acid in children (TIC-TOC): a pilot randomized trial.

The antifibrinolytic drug tranexamic acid (TXA) improves survival in adults with traumatic hemorrhage; however, the drug has not been evaluated in a trial in injured children. We evaluated the feasibility of a large-scale trial evaluating the effects of TXA in children with severe hemorrhagic injuries. Severely injured children (0 up to 18th birthday) were randomized into a double-blind randomized trial of 1) TXA 15 mg/kg bolus dose, followed by 2 mg/kg/hr infusion over 8 hours, 2) TXA 30 mg/kg bolus dose, followed by 4 mg/kg/hr infusion over 8 hours, or 3) normal saline placebo bolus and infusion. The trial was conducted at 4 pediatric Level I trauma centers in the United States between June 2018 and March 2020. We enrolled patients under federal exception from informed consent (EFIC) procedures when parents were unable to provide informed consent. Feasibility outcomes included the rate of enrollment, adherence to intervention arms, and ability to measure the primary clinical outcome. Clinical outcomes included global functioning (primary), working memory, total amount of blood products transfused, intracranial hemorrhage progression, and adverse events. The target enrollment rate was at least 1.25 patients per site per month. A total of 31 patients were randomized with a mean age of 10.7 years (standard deviation [SD] 5.0 years) and 22 (71%) patients were male. The mean time from injury to randomization was 2.4 hours (SD 0.6 hours). Sixteen (52%) patients had isolated brain injuries and 15 (48%) patients had isolated torso injuries. The enrollment rate using EFIC was 1.34 patients per site per month. All eligible enrolled patients received study intervention (9 patients TXA 15 mg/kg bolus dose, 10 patients TXA 30 mg/kg bolus dose, and 12 patients placebo) and had the primary outcome measured. No statistically significant differences in any of the clinical outcomes were identified. Based on enrollment rate, protocol adherence, and measurement of the primary outcome in this pilot trial, we confirmed the feasibility of conducting a large-scale, randomized trial evaluating the efficacy of TXA in severely injured children with hemorrhagic brain and/or torso injuries using EFIC.

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

Community consultation (CC) is a requirement for exception from informed consent (EFIC) research. This article explores the issue of how representative such consultations can and should be, with particular reference to the use of media-based activities. Interactive, media-based CC strategies are gaining traction, because they have much greater reach than traditional methods, but the increasing use of such methods has also led to calls to ensure that those contacted are representative of the community at risk. However, this is more complex than at first apparent. This article examines the question of how the "trauma community" should be defined, and what characteristics might be used to assess whether a sample of this community is representative. It also considers what data are actually available in order to satisfy such requirements.

Exception from informed consent for biomedical research in emergency settings: A study from Jordan

BackgroundResearch conduction in emergency settings is of paramount importance to promote knowledge and experiences related to treating acutely ill patients. However, the complexity of situations creates a considerable ethical challenge facing researchers who basically deal with emergent cases. This study aimed to determine attitudes of healthcare providers (HCPs) towards exception from informed consent (EFIC) and enrollment willingness in emergency research in Jordan. MethodsA quantitative research with face-to-face questionnaire was conducted by an interviewer during 6-month period in 2019. Survey measures included items related to EFIC policy and overall willingness of HCPs to participate or support their family members’ participation in emergency research. ResultsA total of 151 HCPs in the emergency departments (EDs) in Jordan was recruited. Positive attitude toward emergency research dominated among participants; about 21.9% of participants reported previous experience in the conduction of emergency research and 12.3% had related publications. Regarding EFIC policy, there was a general consensus of disagreement to most of the examined items. There was a trend for little support of EFIC policy when questioned about the enrollment of family members or public in emergency research, however, the application of EFIC was accepted for self-enrollment of respondents in emergency research. No significant differences (P = 0.37), among participants from different disciplines, were reported regarding the attitudes towards EFIC items or willingness to enroll in emergency research. ConclusionsGenerally, HCPs reported an overall positive support to emergency research despite a consensus of disagreement related to EFIC terms. Therefore, it is recommended to pursue future studies to compare well-informed subjects; recruited from well-developed institutions in regard to emergency research potentials; with the present basic attitudinal surveillance in order to dissipate the effect of such confounder and to get better insight of the actual attitudes related to emergency research and EFIC. In addition, efficient multidisciplinary communication channels between researchers and policy makers can lather the way to collaborative research with simultaneous innovative delivery of quality emergency care.

An Approach to Reviewing Local Context for Exception from Informed Consent Trials Using a Single IRB.

In the context of emergency research, researchers can ask the institutional review board (IRB) to waive the regulatory requirement that individuals provide informed consent when enrolling in research studies. A requirement of the waiver of informed consent is that the reviewing IRB must review and approve a community consultation and public disclosure plan. It is critical that an IRB serving as the single IRB (sIRB) for multisite research be thoroughly versed in the local context concerns for each participating site to determine whether the site's community is being adequately consulted about the research in which individuals will be enrolled under an exception to the informed consent requirement. We designed an sIRB review model for evaluating site-specific community consultation plans that included a local evaluation and feedback step, and we piloted the model with a four-site, pediatric exception from informed consent (EFIC) clinical trial. We identified three key roles for the model: the sIRB, the investigators, and the representative of the institution's human research protection program (HRPP). We successfully collected the information and local input needed to evaluate each site's community consultation plan and applied the information to a thorough IRB review, despite the geographic distance between the study site and the sIRB.

Integration of social media with targeted emails and in-person outreach for exception from informed consent community consultation.

Exception from informed consent (EFIC) enables the enrollment of research subjects with emergent conditions to clinical trials without prior consent. EFIC study approval requires community consultation and public disclosure. We hypothesized that the integration of social media with targeted emails and in-person outreach is an effective community consultation strategy. We utilized social media with targeted emails and in-person outreach for the community consultation of the ACCESS cardiac arrest trial. Study advertisements were disseminated using Facebook and Instagram, and targeted emails were sent to emergency medicine, prehospital, and cardiology providers. We also interviewed at-risk individuals with cardiac conditions, their caretakers, and patient advocacy groups. Participants were asked to complete a survey about their opinions about the study. We collected 559surveys over an 8-week period, and 70.5% of the surveys were obtained using social media. The median (IQR) age of survey respondents was 44 (33-57)years; 89.9% were White and 60.1% were women. A total of 91.3% believed ACCESS was an important study. Compared to the in-person group, more from social media (81.8% vs. 63.3%, p<0.05) and targeted email (77.4% vs. 63.3%, p<0.05) groups said they would include their loved ones in the study. More from the in-person group believed that their opinion would be considered seriously compared to the social media (75.9% vs. 62.6%, p<0.05) and targeted email (75.9% vs. 54.5%, p<0.05) groups. The incorporation of social media and targeted emails for community consultation reduced the cost per survey by fourfold compared to an in-person-only strategy. The integration of social media with targeted emails and in-person outreach was a feasible and cost-saving approach for EFIC community consultation. Future work is necessary to determine the perception and best utilization of social media for community consultation.

Variation in time to notification of enrollment and rates of withdrawal in resuscitation trials conducted under exception from informed consent

ImportanceEmergency research is challenging to do well as it involves time sensitive interventions in unstable patients. There is limited time to obtain informed consent from the patient or their legally authorized representative (LAR). Such research is permitted under exception from informed consent (EFIC) if specific criteria are met, including notification after enrollment. Some question whether the risks of EFIC outweighs its benefits. To date, there is limited empiric information about time to notification (TTN) and rates of withdrawal in such trials. ObjectiveTo describe variation in TTN and rates of withdrawal among that patients enrolled in EFIC trials over a twelve-year period. DesignWe performed post hoc descriptive analyses of data from five trials conducted under EFIC. SettingEmergency medical services and receiving hospitals participating in the Resuscitation Outcomes Consortium in the United States and Canada. ParticipantsPatients with out-of-hospital cardiac arrest or life-threatening traumatic injury. ExposuresNotification strategies were specified at each site before initiation of enrollment by a local institutional review board. We monitored TTN within each site centrally throughout each study’s enrollment period. OutcomesTTN was defined as time from randomization to first-reported notification of patient or LAR of enrollment. Withdrawal was defined as patient or LAR opt out of ongoing participation at the time of notification. ResultsOf 35,442 patients enrolled in five trials, 33,805 had cardiac arrest; and 1636 had traumatic injury. TTN varied overall and by patient outcome. Among those with cardiac arrest, TTN ranged from median (5%ile, 95%ile) of 6 (1,27) days to 28 (2, 53) days across sites. 0.3% of notified patients with cardiac arrest withdrew. Among those with traumatic injury, TTN ranged from 0 (0, 5) days to 36 (5, 68) days across sites. 7.7% of notified patients with traumatic injury withdrew. Conclusions and RelevanceThere is large variation in TTN in trials conducted under EFIC for emergency research. This may be due to several factors. It may or may not be modifiable. Overall rates of withdrawal are low, which suggests current practices related to EFIC are acceptable to those who have participated in emergency research.

Enrollment with and without exception from informed consent in a pilot trial of tranexamic acid in children with hemorrhagic injuries.

Federal exception from informed consent (EFIC) procedures allow studies to enroll patients with time-sensitive, life-threatening conditions when written consent is not feasible. Our objective was to compare enrollment rates with and without EFIC in a trial of tranexamic acid (TXA) for children with hemorrhagic injuries. We conducted a four-center randomized controlled pilot and feasibility trial evaluating TXA in children with severe hemorrhagic brain and/or torso injuries. We initiated the trial enrolling patients without EFIC. After 3months of enrollment, we met our a priori futility threshold and paused the trial to incorporate EFIC procedures and obtain regulatory approval. We then restarted the trial allowing EFIC if the guardian was unable to provide timely written consent. We used descriptive statistics to compare characteristics of eligible patients approached with and without EFIC procedures. We also calculated the time delay to restart the trial using EFIC. We enrolled one of 15 (6.7%) eligible patients (0.17 per site per month) prior to using EFIC procedures. Of the 14 missed eligible patients, seven (50%) were not enrolled because guardians were not present or were injured and unable to provide written consent. After obtaining approval for EFIC, we enrolled 30 of 48 (62.5%) eligible patients (1.34 per site per month). Of these 30 patients, 22 (73.3%) were enrolled with EFIC. Of the 22, no guardians refused written consent after randomization. There were no significant differences in the eligibility rate and patient characteristics enrolled with and without EFIC procedures. Across all sites, the mean delay to restart the trial using EFIC procedures was 12months. In a multicenter trial of severely injured children, the use of EFIC procedures greatly increased the enrollment rate and was well accepted by guardians. Initiating the trial without EFIC procedures led to a significant delay in enrollment.

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

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. 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. 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. 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.

Model Operational Procedures for the Implementation and Review of NIH Sponsored Multicenter Clinical Trials with Exception from Informed Consent (EFIC) for Emergency Research, Version 1 - January 2021

Model Operational Procedures for the Implementation and Review of NIH Sponsored Multicenter Clinical Trials with Exception from Informed Consent (EFIC) for Emergency Research, Version 1 - January 2021

Exception from informed consent in the era of social media: The SEGA stroke trial experience.

INTRODUCTION:Patients with acute ischemic stroke (AIS) and neurologic deficits are often unable to provide consent and excluded from emergency research participation. Experiences with exception from informed consent (EFIC) to facilitate research on potentially life-saving emergency interventions are limited. Here, we describe our multifaceted approach to EFIC approval for an ongoing randomized clinical trial that compares sedation versus general anesthesia (SEGA) approaches for endovascular thrombectomy during AIS.METHODS:We published a university clinical trial website with EFIC information. We initiated a social media campaign on Facebook within a 50 mile radius of Texas Medical Center. Advertisements were linked to our website, and a press release was issued with information about the trial. In-person community consultations were performed, and voluntary survey information was collected.RESULTS:A total of 193 individuals (65% female, age 46.7 ± 16.6 years) participated in seven focus group community consultations. Of the 144 (75%) that completed surveys, 88.7% agreed that they would be willing to have themselves or family enrolled in this trial under EFIC. Facebook advertisements had 134,481 (52% females; 60% ≥45 years old) views followed by 1,630 clicks to learn more. The website had 1130 views (56% regional and 44% national) with an average of 3.85 min spent. Our Institutional Review Board received zero e-mails requesting additional information or to optout.CONCLUSION:Our social media campaign and community consultation methods provide a significant outreach to potential stroke patients. We hope that our experience will inform and help future efforts for trials seeking EFIC.

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

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.

Abstract 391: Variation in Time to Notification After Enrollment in Trials Conducted Under Exception From Informed Consent for Emergency Research

Context: Research in an emergency setting is challenging because the window of opportunity to treat may be short, and preclude time to obtain informed consent from the patient or their representative. Such research can be conducted under exception from informed consent (EFIC) if specific criteria are met. In the United States, this includes notification of an enrolled subject or their representative as soon as feasible after enrollment so that they have autonomy to opt out from ongoing study participation. To date, there is limited empiric information about time to notification (TTN). Objective: To describe variation in TTN among sites participating in randomized trials conducted under exception from informed consent for emergency research. Methods: Notification strategies were determined at each site prior to initiation of subject enrollment, and approved by a local institutional review board or equivalent. TTN was summarized overall, as well as stratified by site and clinical outcome among patients enrolled in multiple trials conducted by the Resuscitation Outcomes Consortium (ROC). Results: Included were 34,868 patients enrolled in four trials. Of these, 33,805 had with out-of-hospital cardiac arrest; and 1,063 had life-threatening traumatic injury. TTN varied (Table). Conclusions: There is large variation in TTN in trials conducted under EFIC for emergency research. Early notification is difficult; delayed notification may reduce the autonomy of patients or their representative.