Ethical and Legal Issues in Emergency Research: Barriers to Conducting Prospective Randomized Trials in an Emergency Setting

Morrison, C. Anne; Horwitz, Irwin B.; Carrick, Matthew M.

doi:10.1016/j.jss.2009.03.051

Cited by 38 publications

(33 citation statements)

References 43 publications

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“…1,2,5,10 This variability allows for local IRBs to tailor federal recommendations to their community and patient population. 14 Previous EFIC studies of adult subjects outline suggestions for community consultation and public disclosure.…”

Section: Discussionmentioning

confidence: 99%

Variation of community consultation and public disclosure for a pediatric multi-centered “Exception from Informed Consent” trial

et al. 2014

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Background The U.S. federal regulation “Exception from Informed Consent (EFIC) for Emergency Research,” 21 Code of Federal Regulations 50.24, permits emergency research without informed consent under limited conditions. Additional safeguards to protect human subjects include requirements for community consultation and public disclosure prior to starting the research. Because the regulations are vague about these requirements, Institutional Review Boards (IRBs) determine the adequacy of these activities at a local level. Thus there is potential for broad interpretation and practice variation. Aim To describe the variation of community consultation and public disclosure activities approved by IRBs, and the effectiveness of this process for a multi-center, EFIC, pediatric status epilepticus clinical research trial. Methods: Community consultation and public disclosure activities were analyzed for each of 15 participating sites. Surveys were conducted with participants enrolled in the status epilepticus trial to assess the effectiveness of public disclosure dissemination prior to study enrollment. Results Every IRB, among the 15 participating sites, had a varied interpretation of EFIC regulations for community consultation and public disclosure activities. IRBs required various combinations of focus groups, interviews, surveys, and meetings for community consultation; news releases, mailings, and public service announcements for public disclosure. At least 4,335 patients received information about the study from these efforts. 158 chose to be included in the “Opt Out” list. Of the 304 participants who were enrolled under EFIC, 12 (5%) had heard about the study through community consultation or public disclosure activities. The activities reaching the highest number of participants were surveys and focus groups associated with existing meetings. Public disclosure activities were more efficient and cost-effective if they were part of an in-hospital resource for patients and families. Conclusion There is substantial variation in IRBs' interpretations of the federal regulations for community consultation and public disclosure. One of the goals of community consultation and public disclosure efforts for emergency research is to provide community members an opportunity to opt-out of EFIC research; however, rarely do patients or their legally authorized representatives report having learned about a study prior to enrollment.

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Section: Discussionmentioning

confidence: 99%

Variation of community consultation and public disclosure for a pediatric multi-centered “Exception from Informed Consent” trial

et al. 2014

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“…New strategies to treat emergent conditions, such as trauma resuscitation 1 and trauma-induced coagulopathy (TIC) 2 have become a major research priority. Cohort studies in trauma resuscitation have been shown to be weakened by methodologic issues such as survivor and intervention biases.…”

Section: Need For Emergency Researchmentioning

confidence: 99%

Exploring ethical conflicts in emergency trauma research: The COMBAT (Control of Major Bleeding after Trauma) study experience

Chin

Moore

Coors

et al. 2015

Surgery

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Background Up to 25% of severely injured patients develop trauma-induced coagulopathy. To study interventions for this vulnerable population for whom consent cannot be obtained easily, the Food and Drug Administration (FDA) issued regulations for emergency research with an exception from informed consent (ER-EIC). We describe the community consultation and public disclosure (CCPD) process in preparation an ER-EIC study namely the Control of Major Bleeding after Trauma (COMBAT) study. Methods The CCPD was guided by the four bioethical principles. We employed a multimedia approach including one-way communications (newspaper ads, brochures, television, radio, and web) and two-way communications (interactive in-person presentations at community meetings, printed and online feedback forms) to reach the trials catchment area (Denver County’s population: 643,000 and the Denver larger metro area where commuters reside: 2.9 million). Particular attention was given to special-interests groups (e.g., Jehovah Witnesses, homeless) and to Spanish-speaking communities (brochures and presentations in Spanish). Opt-out materials were available during on-site presentations or via the COMBAT website. Results 227 community organizations were contacted. Brochures were distributed to 11 medical clinics and 3 homeless shelters. The multimedia campaign had the potential to reach an estimated audience of 1.5 million individuals in large metro Denver area, the majority via one-way communication and 1900 in two-way communications. This resource intensive process cost over $84,000. Conclusions The CCPC process is resource-intensive, costly, and complex. While the multimedia CCPC reached a large audience, the effectiveness of this process remains elusive. The templates can be helpful to similar ER-EIC studies.

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“…Various barriers to undertaking prehospital clinical trials have been identified, such as regulations and difficulties obtaining appropriate consent 6 7. Problems have been encountered in the few prehospital trials undertaken to date in the UK.…”

Section: Introductionmentioning

confidence: 99%

Paramedic perceptions of the feasibility and practicalities of prehospital clinical trials: a questionnaire survey

2013

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Ethical and Legal Issues in Emergency Research: Barriers to Conducting Prospective Randomized Trials in an Emergency Setting

Cited by 38 publications

References 43 publications

Variation of community consultation and public disclosure for a pediatric multi-centered “Exception from Informed Consent” trial

Variation of community consultation and public disclosure for a pediatric multi-centered “Exception from Informed Consent” trial

Exploring ethical conflicts in emergency trauma research: The COMBAT (Control of Major Bleeding after Trauma) study experience

Paramedic perceptions of the feasibility and practicalities of prehospital clinical trials: a questionnaire survey

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