Impact of Detailed Informed Consent on Research Subjects’ Participation: A Prospective, Randomized Trial

The Journal of Emergency Medicine - Tập 34 - Trang 269-275 - 2008
Catherine A. Marco1
1Department of Emergency Medicine, St. Vincent Mercy Medical Center, Toledo, Ohio

Tài liệu tham khảo

Meisel, 1996, Legal and ethical myths about informed consent, Arch Intern Med, 156, 2521, 10.1001/archinte.156.22.2521 In the Matter of Farrell, 108 N.J. 335, 529 A.2d 404 (1987). Prentice, 1999, Informed consent: the most important protector, Acad Emerg Med, 6, 774, 10.1111/j.1553-2712.1999.tb01204.x Moskop, 1999, Informed consent in the emergency department, Emerg Med Clin North Am, 17, 327, 10.1016/S0733-8627(05)70062-6 Hansson, 1998, Balancing the quality of consent, J Med Ethics, 24, 182, 10.1136/jme.24.3.182 Young, 1997, Informed consent, Ann Emerg Med, 30, 350, 10.1016/S0196-0644(97)70175-6 Etchells, 1996, Bioethics for clinicians: consent, CMAJ, 155, 177 Faden, 1998 Schmidt, 2004, ; SAEM Ethics Committee, Acad Emerg Med, 11, 1082 Crotar, 2004, Correlated of parental participation during informed consent for randomized clinical trials in the treatment of childhood leukemia, Ethics Behav, 14, 1, 10.1207/s15327019eb1401_1 Bentley, 2004, The influence of risk and monetary payment on the research participation decision making process, J Med Ethics, 30, 293, 10.1136/jme.2002.001594 Kim, 2004, Potential research participants’ views regarding researcher and institutional financial conflicts of interest, J Med Ethics, 30, 73, 10.1136/jme.2002.001461 Phipps, 2004, Investigation of ethnic differences in willingness to enroll in a rehabilitation research registry: a study of the Northeast Cognitive Rehabilitation Research Network, Am J Phys Med Rehabil, 83, 875, 10.1097/01.PHM.0000143436.57173.E1 Flory, 2004, Interventions to improve research participants’ understanding in informed consent for research: a systematic review, JAMA, 292, 1593, 10.1001/jama.292.13.1593 Biros, 1995, Informed consent in emergency research, JAMA, 273, 1283, 10.1001/jama.273.16.1283 Fish, 1999, Research ethics in emergency medicine, Emerg Med Clin North Am, 17, 461, 10.1016/S0733-8627(05)70072-9 Foex, 2001, The problem of informed consent in emergency medicine research, Emerg Med J, 18, 198, 10.1136/emj.18.3.198 World Medical Association. Declaration of Helsinki. Ethical principles for medical research involving human subjects. Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and amended by the 52nd WMA General Assembly, Edinburgh, Scotland, October 2000. Mader, 1997, Emergency medicine research consent form readability assessment, Ann Emerg Med, 29, 534, 10.1016/S0196-0644(97)70229-4 1996, Protection of human subjects: informed consent—FDA final rule, Fed Regist, 61, 51498 1979, Protection of human subjects: Belmont report—ethical principles and guidelines for the protection of human subjects of research, Fed Regist, 18, 23192 Paasche-Orlow, 2003, Readability standards for informed-consent forms as compared with actual readability, N Engl J Med, 348, 721, 10.1056/NEJMsa021212 Schmidt, 2004, Confronting the ethical challenges to informed consent in emergency medicine research, Acad Emerg Med, 11, 1082, 10.1197/j.aem.2004.05.028 Marco, 2004, The Society for Academic Emergency Medicine position on informed consent for emergency medicine research, Acad Emerg Med, 11, 1090, 10.1111/j.1553-2712.2004.tb00684.x Madsen, 2000, The extent of written trial information: preferences among potential and actual trial subjects, Bull Med Ethics, 159, 13 Kruse, 2000, A randomized trial assessing the impact of written information on outpatients’ knowledge about and attitude toward randomized clinical trials, Control Clin Trials, 21, 223, 10.1016/S0197-2456(00)00048-9 White, 1984, Informed consent: patient information forms in chemotherapy trials, Am J Clin Oncol, 7, 183, 10.1097/00000421-198404000-00012 White, 1996, Informed consent for medical research: common discrepancies and readability, Acad Emerg Med, 3, 745, 10.1111/j.1553-2712.1996.tb03509.x Mader, 1997, Emergency medicine research consent form readability assessment, Ann Emerg Med, 29, 534, 10.1016/S0196-0644(97)70229-4 David, 1998, Informed consent for clinical trials: a comparative study of standard versus simplified forms, J Natl Cancer Inst, 90, 668, 10.1093/jnci/90.9.668 Pesudovs, 2006, Recall from informed consent counseling for cataract surgery, J Law Med, 13, 496 Akkad, 2006, Patients’ perceptions of written consent: questionnaire study, BMJ, 333, 528, 10.1136/bmj.38922.516204.55 Dresden, 2001, Modifying a standard industry clinical trial consent form improves patient information retention as part of the informed consent process, Acad Emerg Med, 8, 246, 10.1111/j.1553-2712.2001.tb01300.x Wragg, 2000, Information presentation and decisions to enter clinical trials: a hypothetical trial of hormone replacement therapy, Soc Sci Med, 51, 453, 10.1016/S0277-9536(99)00477-3 Hama, 2006, Impact of written information consent on the number of intravenous contrast-enhanced CT and MR studies, Acad Radiol, 13, 258, 10.1016/j.acra.2005.10.013