The American Journal of Medicine
Volume 119, Issue 3 , Pages 194-197 , March 2006

Informed Consent

References 

  1. Cardozo B . Schloendorff v Society of New York Hospital . 1914; 211 NY 125; 105 N.E.92
  2. Levine R . Informed consent (some challenges to the universal validity of the Western model) . In:  Beauchamp TL ,  Walters L editor. Contemporary Issues in Bioethics . Belmont, Calif: Wadsworth Pub. Co; 1999;p. 143–148
  3. Robinson WR . Canterbury v Spence . In:  Beauchamp TL ,  Walters L editor. Contemporary Issues in Bioethics . Belmont, Calif: Wadsworth Pub. Co; 1999;p. 133–134
  4. 21 CFR 50.24 (FDA); 45 CFR 46.011 waiver (OHRP).
  5. Kirsch J , Jungebliet A , Jenkins L , et al.   Adult Literacy in America (A First Look at the Results of the National Literacy Survey) . Washington, DC: US Department of Education; 1993;
  6. Miles S , Davis T . Patients who can’t read . JAMA . 1995;274:1719–1720
  7. Ingelfinger FJ . Informed (but uneducated) consent . N Engl J Med . 1972;287:465–466
  8. Ogloff J , Otto RK . Are research participants truly informed? Readability of informed consent forms used in research . Ethics Behav . 1991;1:239–252
  9. Hopper KD , TenHave TR , Hartzel J . Informed consent forms for clinical and research imaging procedures . AJR Am J Roentgenol . 1995;164:493–496
  10. Goldstein A , Frasier P , Curtis P , Reid A , Kreher N . Consent form readability in university-sponsored research . J Fam Pract . 1996;42:606–611
  11. Williams M , Parker R , Baker D , et al.   Inadequate functional health literacy among patients in two public hospitals . JAMA . 1995;274:1677–1682
  12. Yuval R , Halon D , Lewis BS . Patients’ point of view in heart failure trials . JAMA . 2001;285:883–884
  13. Gazmararian J , Baker D , Williams MV , et al.   Health literacy among Medicare enrollees in a managed care organization . JAMA . 1999;281:545–551
  14. Janofsky JS , McCarthy RJ , Folstein MF . The Hopkins Competency Assessment Test (a brief method for evaluating patients’ capacity to give informed consent) . Hosp Community Psychiatry . 1992;43:132–136
  15. Parikh NS , Parker RM , Nurss JR , Baker D , Williams M . Shame and health literacy (the unspoken connection) . Patient Educ Couns . 1996;27:33–39
  16. Joffe S , Cook EF , Cleary PD , Clark JW , Weeks JC . Quality of informed consent in cancer clinical trials (a cross sectional survey) . Lancet . 2001;358:1772–1777
  17. Tattersall M . Examining informed consent in cancer chemotherapy trials . Lancet . 2001;358:1742–1743
  18. Coyne C , Xu R , Raich P , et al.   Randomized controlled trial of an easy to read informed consent document . J Clin Oncol . 2003;21:836–842
  19. Lloyd AJ , Hayes PD , London NJM , Bell PRF , Naylor AR . Patients’ ability to recall risk-associated treatment options . Lancet . 1999;353:645
  20. Turner P , Williams C . Informed consent (patients listen and read and what information do they retain?) . N Z Med J . 2002;115:U218
  21. Heneghan C . Letter to the editor . Lancet . 1999;353:1713
  22. Gattellari M , Butow P , Tattersall M . Informed consent (what did the doctor say?) . Lancet . 1999;353:1713
  23. Williams AP . Malpractice Outcomes and Appropriateness of Care . Santa Monica, Calif: Rand Pub; 1988;
  24. Williams N , Ogden J . The impact of matching the patients vocabulary (a randomized clinical trial) . Fam Pract . 2004;21:630–635
  25. Kalawash JHT , Casarett DJ , James BD , Xie SX , Kim SYH . The ability of persons with Alzheimers Disease (AD) to make a decision about taking an AD treatment . Neurology . 2005;64:1514–1519
  26. Moye J , Karel MJ , Azar AR , Guerra RJ . Capacity to consent to treatment (empirical comparison of three instruments in older adults with and without dementia) . Gerontologist . 2004;44:166–175
  27. Edwards JL , Lilford RJ , Hewison J . The ethics of randomized clinical trials from the perspective of patients, the public and health care professionals . BMJ . 1998;317:1209–1212
  28. Diaz v Hillsborough County Hospital Authority : Ref 165 FRD 689 U S District Court, M D Florida, Tampa Div
  29. Dallas Morning News . 2005; July 3:1
  30. Rossi M , McClellan R , Chou L , Davis K . Informed consent for ankle fracture surgery (patient comprehension of verbal and videotape information) . Foot Ankle Int . 2004;25:756–762
  31. Abelson R . Hospitals see possible conflict on medical devices for doctors . New York Times; 2005;
  32. Eichenwald K , Kolata G . Drug trials hide conflicts for doctors . New York Times; 1999;
  33. McQuillan MP . Ethical lessons learned from the use of therapeutic plasma exchange in neurologic disease . Ther Apher . 2000;4:190–194
  34. Stossel T . Regulating academic-industrial research relationships—solving problems or stifling progress . N Engl J Med . 2005;353:1060–1065
  35. Brody B , McCullough L , Sharp R . Consensus and controversy in clinical research ethics . JAMA . 2005;294:1411–1414
  36. Marquis D . How to resolve an ethical dilemma concerning randomized clinical trials . N Engl J Med . 1999;341:691–693
  37. Butow P , Brown R , Tattersall M . Ethics of clinical trials . N Engl J Med . 2000;342:978–980
  38. Rosenzweig S . Letter to the editor . N Engl J Med . 2000;342:978–980
  39. Morris D . Letter to the editor . N Engl J Med . 2000;342:378–380
  40. Flory J , Emanuel E . Interventions to improve research participants understanding in informed consent for research . JAMA . 2004;292:1332–1342
  41. Moses H , Dorsey ER , Matheson DHM , Their S . Financial anatomy of biomedical research . JAMA . 2005;294:1333–1342
  42. Woolley M , Propst S . Public attitudes and perception about health-related research . JAMA . 2005;294:1380–1384
  43. De Angelis C , Drazen JM , Frizelle FA , et al.   Clinical trial registration (a statement from the International Committee of Medical Journal Editors) . N Engl J Med . 2004;351:1250–1251
  44. Kulynych J , Korn D . The effect of the new medical-privacy rule on research . N Engl J Med . 2002;346:201–204
  45. Sugarman J , Getz K , Speckman J , et al.   The cost of institutional review boards in academic medical centers . N Engl J Med . 2005;352:1825–1827
  46. Cassell EJ . Consent or obedience? Power and authority in medicine . N Engl J Med . 2005;352:328–330
  47. Markel H . “I swear by Apollo”—on taking the Hippocratic oath . N Engl J Med . 2004;350:2026–2029

PII: S0002-9343(05)01044-2

doi: 10.1016/j.amjmed.2005.10.040

The American Journal of Medicine
Volume 119, Issue 3 , Pages 194-197 , March 2006

Article Tools