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Annals of Emergency Medicine
Volume 55, Issue 1
, Pages 9-14
, January 2010
Observed Behaviors of Subjects During Informed Consent for an Emergency Department Study
References
- . Informed consent for medical research: an ethical imperative. Regional Anesth Pain Med. 2006;31:353–357
- 21 CFR 50.24 and 45 CFR 46.101(i) Protection of human subjects: informed consent and waiver of informed consent requirements in certain emergency research; final rules. Fed Reg. 1996;61(192, Oct 2):51498-332
- Patients' perceptions of written consent: questionnaire study. BMJ. 2006;333:528
- . What makes clinical research ethical?. JAMA. 2000;283:2701–2711
- . Ethics and research in critical care. Intensive Care Med. 2006;32:1697–1705
- . Regulating clinical research: informed consent, privacy, and IRBs. Capital University Law Rev. 2003;31:71–91
- The effects of written informed consent on detection of violence in the home. Acad Emerg Med. 2001;8:974–979
- . Interventions to improve research participants' understanding in informed consent for research: a systematic review. JAMA. 2004;292:1593–1601
- Improving informed consent: the medium is not the message. IRB. 2003;25:S11–S19
- . Improving informed consent: a comparison of four consent tools. IRB. 2003;25:1–7
- Information disclosure, subject understanding, and informed consent in psychiatric research. Law Hum Behav. 1988;12:455–475
- Improving understanding of research consent in middle-aged and elderly patients with psychotic disorders. Am J Geriatr Psychiatry. 2002;10:142–150
- Evaluation of a video-supplement to informed consent: injection drug users and preventive HIV vaccine efficacy trials. AIDS Educ Prev. 1997;9:330–341
- Presenting clinical trial information: a comparison of methods. Patient Educ Couns. 1995;25:97–107
- . Evaluating the benefits of a patient information video during the informed consent process. Patient Educ Couns. 1997;30:239–245
- . Can the written information to research subjects be improved: an empirical study?. J Med Ethics. 1999;25:263–267
- 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;21:836–842
- Informed consent for clinical trials: a comparative study of standard versus simplified forms. J Natl Cancer Inst. 1998;90:668–674
- . Modifying a standard industry clinical trial consent form improves patient information retention as part of the informed consent process. Acad Emerg Med. 2001;8:246–252
- . Obtaining informed consent: form or substance. Arch Intern Med. 1969;123:682–688
- . Improving comprehension and recall of information for an HIV vaccine trial among women at risk for HIV: reading level simplification and inclusion of pictures to illustrate key concepts. AIDS Educ Prev. 1999;11:389–399
- Conventional consent with opting in versus simplified consent with opting out: an exploratory trial for studies that do not increase patient risk. J Pediatr. 1998;132:606–611
- Improving understanding of research consent disclosures among persons with mental illness. Psychiatr Serv. 2001;52:780–785
- . Informed consent, memory and age. Gerontologist. 1980;20:686–690
- . Informed consent for research: effects of readability, patient age, and education. J Am Geriatr Soc. 1986;34:601–606
- Comprehension of informed consent information by young-old through old-old volunteers. Exp Aging Res. 1987;13:173–178
- . Informed consent documents: increasing comprehension by reducing reading level. IRB. 1990;12:1–5
- Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials. J Clin Oncol. 1996;14:984–996
- Comprehension during informed consent in a less-developed country. Lancet. 2002;360:1301–1302
- . Is informed consent to clinical trials an “upside selective” process in acute coronary syndromes?. Am Heart J. 2000;140:94–97
- Effects of two formats of informed consent on knowledge amongst persons with advanced HIV disease in a clinical trial of didanosine. Patient Educ Couns. 1994;24:261–266
- Randomized, controlled evaluation of a prototype informed consent process for HIV vaccine efficacy trials. J Acquir Immune Defic Syndr. 2003;32:161–169
- . The elderly and informed consent: effects of vocabulary level and corrected feedback. Exp Aging Res. 1981;7:137–146
- . The effect of repeated testing upon comprehension of informed consent materials by elderly volunteers. Exp Aging Res. 1983;9:135–138
- Informed consent: assessment of comprehension. Am J Psychiatry. 1998;155:1508–1511
- . Resuscitation research involving vulnerable populations: are additional protections needed for emergency exception from informed consent?. Acad Emerg Med. 2005;12:1071–1077
- . Impact of detailed informed consent on research subjects' participation: a prospective, randomized trial. J Emerg Med. 2008;34:269–275
- . Feasibility and efficacy of verbal consents. Res Aging. 1990;12:364–372
- Use of a modified consent process among vulnerable patients: a descriptive study. J Gen Intern Med. 2006;21:867–873
- . Getting meaningful informed consent from older adults: a structures literature review of empirical research. J Am Geriatr Soc. 1998;46:517–524
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Supervising editors: Debra E. Houry, MD, MPH; Michael L. Callaham, MD
Dr. Houry and Dr. Callaham were the supervising editors on this article. Dr. Hollander did not participate in the editorial review or decision to publish this article.
Author contributions: JB was the principal investigator of the substudy. JB, RMS, FSS, EMD, and JEH were responsible for study design. JB, CFC, and JEH collected data. JB, CFC, RMS, FSS, EMD, and JEH analyzed and interpreted the data. JB, CFC, RMS, FSS, and EMD critically reviewed the article. JB supervised the first draft of the article. CFC and FSS wrote the article. FSS was overall statistician for the project. JEH was the overall study principal investigator, prepared the final article, and takes overall responsibility for the data. JEH takes responsibility for the paper as a whole.
Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article that might create any potential conflict of interest. The authors have stated that no such relationships exist. See the Manuscript Submission Agreement in this issue for examples of specific conflicts covered by this statement.
Publication date: Available online November 20, 2009.
Reprints not available from the authors.
Please see page 10 for the Editor's Capsule Summary of this article.
PII: S0196-0644(09)01561-3
doi: 10.1016/j.annemergmed.2009.09.023
© 2009 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.
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Annals of Emergency Medicine
Volume 55, Issue 1
, Pages 9-14
, January 2010
