Emergency Research: Using Exception from Informed Consent, Evaluation of Community Consultations
dc.contributor.author | Govindarajan, Prasanthi | en_US |
dc.contributor.author | Dickert, Neal W. | en_US |
dc.contributor.author | Meeker, Michele | en_US |
dc.contributor.author | Souza, Natalie | en_US |
dc.contributor.author | Harney, Deneil | en_US |
dc.contributor.author | Hemphill, Claude J. | en_US |
dc.contributor.author | Pentz, Rebecca | en_US |
dc.contributor.author | Adams, James | en_US |
dc.date.accessioned | 2013-02-12T19:00:19Z | |
dc.date.available | 2014-03-03T15:09:24Z | en_US |
dc.date.issued | 2013-01 | en_US |
dc.identifier.citation | Govindarajan, Prasanthi; Dickert, Neal W.; Meeker, Michele; Souza, Natalie; Harney, Deneil; Hemphill, Claude J.; Pentz, Rebecca; Adams, James (2013). "Emergency Research: Using Exception from Informed Consent, Evaluation of Community Consultations." Academic Emergency Medicine (1): 98-103. <http://hdl.handle.net/2027.42/96243> | en_US |
dc.identifier.issn | 1069-6563 | en_US |
dc.identifier.issn | 1553-2712 | en_US |
dc.identifier.uri | https://hdl.handle.net/2027.42/96243 | |
dc.description.abstract | Background In 1996, the U.S. Food and Drug Administration approved regulations authorizing an exception from informed consent (EFIC) for research conducted in emergency settings when obtaining prospective informed consent is not possible due to the potential subject's critical illness or injury. The regulations require that investigators conduct community consultation (CC) efforts before initiating a study and require that institutional review boards review the results of CC prior to approving a study. However, little is known about how communities view EFIC research or the CC process. Objectives The objective was to assess the views of CC meeting attendees regarding the CC process, their understanding and views of EFIC research relating to the specific research trial under discussion, and their level of trust in physician‐investigators. Methods Following CC meetings at two study sites (San Francisco and Atlanta) for the Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART), an active comparison, randomized trial of prehospital treatment for status epilepticus, the authors administered a pair of surveys to participants. One survey focused on CC experiences (CC survey) and trust in physician‐investigators; the second assessed participants' understanding of EFIC and the RAMPART clinical trial design (EFIC survey). Results A total of 317 individuals participated in one of the two most popular types of CC meetings (group meetings and focus group sessions) at both sites. A total of 189 participants (59%) completed the CC survey and trust questions, and 297 (92%) completed the EFIC survey. Of those who completed the CC survey, 173 of 189 (92%) were very satisfied with the meeting, and 174 of 189 (92%) felt that they learned a lot about research at the meeting. A total of 169 of 189 participants (88%) felt that researchers heard the community's concerns, while only 106 of 189 (56%) said researchers would be willing to make changes to the study based on their concerns. Of those who completed the EFIC survey, 261 of 297 (88%) supported the study, 207 of 297 (70%) said they would agree to participate in the study, and 203 of 297 (68%) reported that they would agree to consent a loved one into the study. On a recently validated scale measuring trust in physician‐investigators, participants at both sites seemed to have higher levels of trust in physician‐investigators than the validation study population. Conclusions Overall, members of these two communities expressed satisfaction with the CC session and had relatively high levels of support for the study and trust in physician‐investigators. Resumen La Excepción del Consentimiento Informado en la Investigación en Medicina de Urgencias y Emergencias ‐ Evaluación de las Consultas a la Comunidad Introducción En 1996, la United States Food and Drug Administration aprobó las regulaciones que autorizaban la excepción del consentimiento informado (EDCI) para la investigación llevada a cabo en el ámbito de la medicina de urgencias y emergencias cuando la obtención del consentimiento informado de forma prospectiva no era posible debido a enfermedad o lesión potencialmente crítica del sujeto. Las regulaciones requieren que los investigadores hagan el esfuerzo de llevar a cabo una consulta comunitaria (CC) antes del inicio de un estudio, y requieren que el comité de revisores de la institución revise los resultados de la CC previamente a aprobación. Sin embargo, existe escasa información del punto de vista de las comunidades sobre la investigación con EDCI o el proceso de CC. Objetivos Valorar los puntos de vista de los asistentes a una reunión de CC respecto al proceso de CC, su grado de comprensión, su parecer respecto a la investigación con EDCI en relación al ensayo clínico en discusión y su nivel de confianza en los médicos investigadores. Método Tras las reuniones de CC en dos lugares (San Francisco y Atlanta) para evaluar el estudio Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART), un ensayo clínico con comparación activa y asignación aleatorizada del tratamiento prehospitalario para el estatus epiléptico, los autores administraron un par de encuestas a los participantes de la CC. Una encuesta se enfocó a las experiencias de CC (encuesta CC) y la confianza en los médicos investigadores; la segunda valoró el grado de comprensión de los participantes acerca de la EDCI y el diseño del ensayo clínico RAMPART (encuesta EDCI). Resultados Un total de 317 sujetos participaron en una de las dos sesiones de CC más populares (reuniones de grupo y sesiones de grupo dirigidas) en ambos lugares. Ciento ochenta y nueve participantes (59%) completaron la encuesta CC y las preguntas sobre el grado de confianza, y 297 (92%) completaron la encuesta EDCI. De aquéllos que completaron la encuesta CC, 173 de 189 (92%) estaban muy satisfechos con la reunión, y 174 de 189 (92%) expresaron que habían aprendido mucho sobre la investigación en la reunión. Ciento sesenta y seis de 189 participantes (88%) sintieron que los investigadores escucharon las inquietudes de la comunidad, mientras que sólo 106 de 189 (56%) afirmaron que los investigadores desearían realizar cambios en el estudio basándose en sus inquietudes. De aquéllos que completaron la encuesta EDCI, 261 de 297 (88%) apoyaron el estudio, 207 de 297(70%) dijeron que estarían de acuerdo en participar en el estudio, y 203 de 297 (68%) expresaron que estarían de acuerdo en dar el consentimiento de un ser querido para el estudio. Según una escala para medir la confianza en los médicos investigadores validada recientemente, los participantes de ambos lugares parecían tener mayores niveles de confianza en los médicos investigadores que la población de validación del estudio. Conclusiones En definitiva, los miembros de estas dos comunidades expresaron satisfacción con la sesión de CC y tuvieron niveles relativamente altos de aprobación del estudio y de confianza en los médicos investigadores. | en_US |
dc.publisher | Wiley Periodicals, Inc. | en_US |
dc.title | Emergency Research: Using Exception from Informed Consent, Evaluation of Community Consultations | en_US |
dc.type | Article | en_US |
dc.rights.robots | IndexNoFollow | en_US |
dc.subject.hlbsecondlevel | Medicine (General) | en_US |
dc.subject.hlbtoplevel | Health Sciences | en_US |
dc.description.peerreviewed | Peer Reviewed | en_US |
dc.identifier.pmid | 23570483 | en_US |
dc.description.bitstreamurl | http://deepblue.lib.umich.edu/bitstream/2027.42/96243/1/acem12039-sup-0003-DataSupplementS3.pdf | |
dc.description.bitstreamurl | http://deepblue.lib.umich.edu/bitstream/2027.42/96243/2/acem12039-sup-0001-DataSupplementS1.pdf | |
dc.description.bitstreamurl | http://deepblue.lib.umich.edu/bitstream/2027.42/96243/3/acem12039.pdf | |
dc.description.bitstreamurl | http://deepblue.lib.umich.edu/bitstream/2027.42/96243/4/acem12039-sup-0002-DataSupplementS2.pdf | |
dc.identifier.doi | 10.1111/acem.12039 | en_US |
dc.identifier.source | Academic Emergency Medicine | en_US |
dc.identifier.citedreference | Majority Opinion Research. Research Tools and Techniques. Available at: http://majorityopinionresearch.com/about/tools/tools.htm. Accessed Jul 13, 2012. | en_US |
dc.identifier.citedreference | Bulger EM, Schmidt TA, Cook AJ, et al. The random dialing survey as a tool for community consultation for research involving the emergency medicine exception from informed consent. Ann Emerg Med. 2009; 53: 341 – 50. | en_US |
dc.identifier.citedreference | McClure KB, DeIorio NM, Gunnels MD, Ochsner MJ, Biros MH, Schmidt TA. Attitudes of emergency department patients and visitors regarding emergency exception from informed consent in resuscitation research, community consultation, and public notification. Acad Emerg Med. 2003; 10: 352 – 9. | en_US |
dc.identifier.citedreference | Longfield JN, Morris MJ, Moran KA, Kragh JF Jr, Wolf R, Baskin TW. Community meetings for emergency research community consultation. Crit Care Med. 2008; 36: 731 – 6. | en_US |
dc.identifier.citedreference | Biros MH, Sargent C, Miller K. Community attitudes towards emergency research and exception from informed consent. Resuscitation. 2009; 80: 1382 – 7. | en_US |
dc.identifier.citedreference | Contant C, McCullough LB, Mangus L, Robertson C, Valadka A, Brody B. Community consultation in emergency research. Crit Care Med. 2006; 34: 2049 – 52. | en_US |
dc.identifier.citedreference | Department of Health and Human Services/U.S. Food and Drug Administration. Protection of Human Subjects: Informed Consent and Waiver of Informed Consent Requirements in Certain Emergency Research; Final Rules. 21 CFR part 50.24. Federal Registrar. 1996; 61: 51497 – 531. | en_US |
dc.identifier.citedreference | Department of Health and Human Resources/U.S. Food and Drug Administration. Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors. Exception from Informed Consent Requirements for Emergency Research. Draft Guidance, 2006. Available at: http://www.fda.gov/ohrms/dockets/98fr/06d-0331-gdl0001.pdf. Accessed Jul 13, 2012. | en_US |
dc.identifier.citedreference | Richardson LD, Quest TE, Birnbaum S. Communicating with communities about emergency research. Acad Emerg Med. 2005; 12: 1064 – 70. | en_US |
dc.identifier.citedreference | Silbergleit R, Lowenstein D, Durkalski V, Conwit R; Neurological Emergency Treatment Trials (NETT) Investigators. RAMPART (Rapid anticonvulsant Medication Prior to Arrival Trial): a double‐blind randomized clinical trial of the efficacy of intramuscular midazolam versus intravenous lorazepam in the prehospital treatment of status epilepticus by paramedics. Epilepsia. 2011; 52 ( Suppl 8 ): 45 – 7. | en_US |
dc.identifier.citedreference | Hall MA, Camacho F, Lawlor JS, Depuy V, Sugarman J, Weinfurt K. Measuring trust in medical researchers. Med Care. 2006; 44: 1048 – 53. | en_US |
dc.owningcollname | Interdisciplinary and Peer-Reviewed |
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