Perceived Challenges to Obtaining Informed Consent for a Time-sensitive Emergency Department Study of Pediatric Status Epilepticus: Results of Two Focus Groups
dc.contributor.author | Chamberlain, James M. | en_US |
dc.contributor.author | Lillis, Kathleen | en_US |
dc.contributor.author | Vance, Cheryl | en_US |
dc.contributor.author | Brown, Kathleen M. | en_US |
dc.contributor.author | Fawumi, Olubunmi | en_US |
dc.contributor.author | Nichols, Shari | en_US |
dc.contributor.author | Davis, Colleen O. | en_US |
dc.contributor.author | Singh, Tasmeen | en_US |
dc.contributor.author | Baren, Jill M. | en_US |
dc.date.accessioned | 2010-06-01T19:36:56Z | |
dc.date.available | 2010-06-01T19:36:56Z | |
dc.date.issued | 2009-08 | en_US |
dc.identifier.citation | Chamberlain, James M.; Lillis, Kathleen; Vance, Cheryl; Brown, Kathleen M.; Fawumi, Olubunmi; Nichols, Shari; Davis, Colleen O.; Singh, Tasmeen; Baren, Jill M. (2009). "Perceived Challenges to Obtaining Informed Consent for a Time-sensitive Emergency Department Study of Pediatric Status Epilepticus: Results of Two Focus Groups ." Academic Emergency Medicine 16(8): 763-770. <http://hdl.handle.net/2027.42/72751> | en_US |
dc.identifier.issn | 1069-6563 | en_US |
dc.identifier.issn | 1553-2712 | en_US |
dc.identifier.uri | https://hdl.handle.net/2027.42/72751 | |
dc.identifier.uri | http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=19673713&dopt=citation | en_US |
dc.format.extent | 193369 bytes | |
dc.format.extent | 3109 bytes | |
dc.format.mimetype | application/pdf | |
dc.format.mimetype | text/plain | |
dc.publisher | Blackwell Publishing Ltd | en_US |
dc.rights | © 2009 Society for Academic Emergency Medicine | en_US |
dc.subject.other | Informed Consent | en_US |
dc.subject.other | Clinical Research | en_US |
dc.subject.other | Consent Documents | en_US |
dc.subject.other | Research Ethics | en_US |
dc.title | Perceived Challenges to Obtaining Informed Consent for a Time-sensitive Emergency Department Study of Pediatric Status Epilepticus: Results of Two Focus Groups | en_US |
dc.type | Article | 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 | 19673713 | en_US |
dc.description.bitstreamurl | http://deepblue.lib.umich.edu/bitstream/2027.42/72751/1/j.1553-2712.2009.00455.x.pdf | |
dc.identifier.doi | 10.1111/j.1553-2712.2009.00455.x | en_US |
dc.identifier.source | Academic Emergency Medicine | en_US |
dc.identifier.citedreference | Biros MH, Lewis RJ, Olson CM, Runge JW, Cummins RO, Fost N. Informed consent in emergency research: consensus statement from the Coalition Conference of Acute Resuscitation and Critical Care Researchers. JAMA 1995; 273: 1283 – 7. | en_US |
dc.identifier.citedreference | Salzman JG, Frascone RJ, Godding BK, Provo TA, Gertner E. Implementing emergency research requiring exception from informed consent, community consultation, and public disclosure. Ann Emerg Med. 2007; 50: 448 – 55. | en_US |
dc.identifier.citedreference | Vaslef SN, Cairns CB, Falletta JM. Ethical and regulatory challenges associated with the exception from informed consent requirements for emergency research: from experimental design to institutional review board approval. Arch Surg. 2006; 141: 1019 – 23. | en_US |
dc.identifier.citedreference | Baren JM, Fish SS. Resuscitation research involving vulnerable populations: are additional protections needed for emergency exception from informed consent? Acad Emerg Med. 2005; 12: 1071 – 7. | en_US |
dc.identifier.citedreference | DeIorio NM, McClure KB. Does the emergency exception from informed consent process protect research subjects? Acad Emerg Med. 2005; 12: 1056 – 9. | en_US |
dc.identifier.citedreference | Watters D, Sayre MR, Silbergleit R. Research conditions that qualify for emergency exception from informed consent. Acad Emerg Med. 2005; 12: 1040 – 4. | en_US |
dc.identifier.citedreference | Schmidt TA, Salo D, Hughes JA, et al., SAEM Ethics Committee. Confronting the ethical challenges to informed consent in emergency medicine research. Acad Emerg Med. 2004; 11: 1082 – 9. | en_US |
dc.identifier.citedreference | Adams JG, Wegener J. Acting without asking: an ethical analysis of the Food and Drug Administration waiver of informed consent for emergency research. Ann Emerg Med. 1999; 33: 218 – 23. | en_US |
dc.identifier.citedreference | Biros MH, Fish SS, Lewis RJ. Implementing the Food and Drug Administration’s final rule for waiver of informed consent in certain emergency research circumstances. Acad Emerg Med. 1999; 6: 1272 – 82. | en_US |
dc.identifier.citedreference | Sloan EP, Nagy K, Barrett J. A proposed consent process in studies that use an exception to informed consent. Acad Emerg Med. 1999; 6: 1283 – 91. | en_US |
dc.identifier.citedreference | Mosesso VN Jr, Brown LH, Greene HL, et al. PAD Trial Investigators Conducting research using the emergency exception from informed consent: the Public Access Defibrillation (PAD) Trial experience. Resuscitation 2004; 61: 29 – 36. | en_US |
dc.identifier.citedreference | Dix ES, Esposito D, Spinosa F, Olson N, Chapman S. Implementation of community consultation for waiver of informed consent in emergency research: one institutional review board’s experience. J Invest Med. 2004; 52: 113 – 6. | en_US |
dc.identifier.citedreference | Sloan EP, Koenigsberg M, Houghton J, et al. The informed consent process and the use of the exception to informed consent in the clinical trial of diaspirin cross-linked hemoglobin (DCLHb) in severe traumatic hemorrhagic shock. DCLHb Traumatic Hemorrhagic Shock study group. Acad Emerg Med. 1999; 6: 1203 – 9. | en_US |
dc.identifier.citedreference | U.S. Food and Drug Administration. Exception from informed consent requirements for emergency research. Code of Federal Regulations 21CFR50.24. Available at: http://www.fda.gov/ora/compliance_ref/bimo/default.htm#emer. Accessed May 7, 2009. | en_US |
dc.identifier.citedreference | Triner W, Jacoby L, Shelton W, et al. Exception from informed consent enrollment in emergency medical research: attitudes and awareness. Acad Emerg Med. 2007; 14: 187 – 91. | 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 | Dresden GM, Levitt MA. Modifying a standard industry clinical trial consent form improves patient information retention as part of the informed consent process. Acad Emerg Med. 2001; 8: 246 – 52. | en_US |
dc.identifier.citedreference | Coyne CA, Xu R, Raich P, et al., Eastern Cooperative Oncology Group. Randomized, controlled trial of an easy-to-read informed consent statement for clinical trial participation: a study of the Eastern Cooperative Oncology Group. J Clin Oncol. 2003; 21: 836 – 42. | en_US |
dc.identifier.citedreference | Powers RD. Emergency department patient literacy and the readability of patient-directed materials. Ann Emerg Med. 1988; 17: 124 – 6. | en_US |
dc.identifier.citedreference | University of Illinois at Chicago. Institutional Review Board Policy “IRB Observation: Informed Consent Process/Ombudsman.” Version 1.0. October 15, 2008. Available at: http://tigger.uic.edu/depts/ovcr/research/protocolreview/irb/policies/0869.pdf. Accessed Mar 31, 2009. | en_US |
dc.identifier.citedreference | Kimmelman J. The therapeutic misconception at 25: treatment, research, and confusion. Hastings Cent Rep. 2007; 37: 36 – 42. | en_US |
dc.identifier.citedreference | Institute of Medicine. Crossing the Quality Chasm: A New Health System for the Twenty-first Century. Washington, DC: National Academy Press, 2001. | en_US |
dc.owningcollname | Interdisciplinary and Peer-Reviewed |
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