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

  • Jill Baren, MD, MBE

      Affiliations

    • Department of Emergency Medicine, University of Pennsylvania School of Medicine, Philadelphia, PA
    • Corresponding Author InformationAddress for correspondence: Jill Baren, MD, MBE, Department of Emergency Medicine, University of Pennsylvania School of Medicine, Ground floor Ravdin Building, 3400 Spruce Street, Philadelphia, PA 19104-4283; 215-662-6917, fax 215-662-3953
  • ,
  • Caren F. Campbell, BA

      Affiliations

    • Department of Emergency Medicine, University of Pennsylvania School of Medicine, Philadelphia, PA
  • ,
  • Raquel M. Schears, MD

      Affiliations

    • Mayo Clinic, Saint Marys Hospital, Rochester, MN
  • ,
  • Frances S. Shofer, PhD

      Affiliations

    • Department of Emergency Medicine, University of Pennsylvania School of Medicine, Philadelphia, PA
  • ,
  • Elizabeth M. Datner, MD

      Affiliations

    • Department of Emergency Medicine, University of Pennsylvania School of Medicine, Philadelphia, PA
  • ,
  • Judd E. Hollander, MD

      Affiliations

    • Department of Emergency Medicine, University of Pennsylvania School of Medicine, Philadelphia, PA

Received 15 June 2009 ,Revised 24 August 2009 ,Accepted 16 September 2009.

References 

  1. Ilfeld B. Informed consent for medical research: an ethical imperative. Regional Anesth Pain Med. 2006;31:353–357
  2. 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
  3. Akkad A, Jackson C, Kenyon S, et al. Patients' perceptions of written consent: questionnaire study. BMJ. 2006;333:528
  4. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical?. JAMA. 2000;283:2701–2711
  5. Silverman HJ, Lemaire F. Ethics and research in critical care. Intensive Care Med. 2006;32:1697–1705
  6. Hoffman S. Regulating clinical research: informed consent, privacy, and IRBs. Capital University Law Rev. 2003;31:71–91
  7. Hollander J, Schears RM, Shofer FS, et al. The effects of written informed consent on detection of violence in the home. Acad Emerg Med. 2001;8:974–979
  8. Flory J, Emanuel E. Interventions to improve research participants' understanding in informed consent for research: a systematic review. JAMA. 2004;292:1593–1601
  9. Agre P, Campbell FA, Goldman BD, et al. Improving informed consent: the medium is not the message. IRB. 2003;25:S11–S19
  10. Agre P, Rapkin B. Improving informed consent: a comparison of four consent tools. IRB. 2003;25:1–7
  11. Benson PR, Roth LH, Appelbaum PS, et al. Information disclosure, subject understanding, and informed consent in psychiatric research. Law Hum Behav. 1988;12:455–475
  12. Dunn LB, Lindamer LA, Palmer BW, et al. Improving understanding of research consent in middle-aged and elderly patients with psychotic disorders. Am J Geriatr Psychiatry. 2002;10:142–150
  13. Fureman I, Meyers K, McLellan AT, et al. Evaluation of a video-supplement to informed consent: injection drug users and preventive HIV vaccine efficacy trials. AIDS Educ Prev. 1997;9:330–341
  14. Llewellyn-Thomas HA, Thiel EC, Sem FW, et al. Presenting clinical trial information: a comparison of methods. Patient Educ Couns. 1995;25:97–107
  15. Weston J, Hannah M, Downes J. Evaluating the benefits of a patient information video during the informed consent process. Patient Educ Couns. 1997;30:239–245
  16. Bjorn E, Rossel P, Holm S. Can the written information to research subjects be improved: an empirical study?. J Med Ethics. 1999;25:263–267
  17. Coyne CA, Xu R, Raich P, et al. 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
  18. Davis TC, Holcombe RF, Berkel HJ, et al. Informed consent for clinical trials: a comparative study of standard versus simplified forms. J Natl Cancer Inst. 1998;90:668–674
  19. 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;8:246–252
  20. Epstein LC, Lasagna L. Obtaining informed consent: form or substance. Arch Intern Med. 1969;123:682–688
  21. Murphy DA, O'Keefe ZH, Kaufman AH. 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
  22. Rogers CG, Tyson JE, Kennedy KA, et al. 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
  23. Stiles PG, Poythress NG, Hall A, et al. Improving understanding of research consent disclosures among persons with mental illness. Psychiatr Serv. 2001;52:780–785
  24. Taub HA. Informed consent, memory and age. Gerontologist. 1980;20:686–690
  25. Taub HA, Baker MT, Sturr JF. Informed consent for research: effects of readability, patient age, and education. J Am Geriatr Soc. 1986;34:601–606
  26. Taub HA, Baker MT, Kline GE, et al. Comprehension of informed consent information by young-old through old-old volunteers. Exp Aging Res. 1987;13:173–178
  27. Young DR, Hooker DT, Freeberg FE. Informed consent documents: increasing comprehension by reducing reading level. IRB. 1990;12:1–5
  28. Aaronson NK, Visser-Pol E, Leenhouts GH, et al. Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials. J Clin Oncol. 1996;14:984–996
  29. Fitzgerald DW, Marotte C, Verdier RI, et al. Comprehension during informed consent in a less-developed country. Lancet. 2002;360:1301–1302
  30. Kucia AM, Horowitz JD. Is informed consent to clinical trials an “upside selective” process in acute coronary syndromes?. Am Heart J. 2000;140:94–97
  31. Tindall B, Forde S, Ross MW, et al. 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
  32. Coletti AS, Heagerty P, Sheon AR, et al. Randomized, controlled evaluation of a prototype informed consent process for HIV vaccine efficacy trials. J Acquir Immune Defic Syndr. 2003;32:161–169
  33. Taub HA, Kline GE, Baker MT. The elderly and informed consent: effects of vocabulary level and corrected feedback. Exp Aging Res. 1981;7:137–146
  34. Taub HA, Baker MT. The effect of repeated testing upon comprehension of informed consent materials by elderly volunteers. Exp Aging Res. 1983;9:135–138
  35. Wirshing DA, Wirshing WC, Marder SR, et al. Informed consent: assessment of comprehension. Am J Psychiatry. 1998;155:1508–1511
  36. Baren JM, Fish SS. Resuscitation research involving vulnerable populations: are additional protections needed for emergency exception from informed consent?. Acad Emerg Med. 2005;12:1071–1077
  37. Marco CA. Impact of detailed informed consent on research subjects' participation: a prospective, randomized trial. J Emerg Med. 2008;34:269–275
  38. Brod MS, Feinbloom RI. Feasibility and efficacy of verbal consents. Res Aging. 1990;12:364–372
  39. Sudore R, Landefeld CS, Williams BA, et al. Use of a modified consent process among vulnerable patients: a descriptive study. J Gen Intern Med. 2006;21:867–873
  40. Sugarman J, McCrory DC, Hubal RC. 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

Annals of Emergency Medicine
Volume 55, Issue 1 , Pages 9-14 , January 2010