Journal of the American College of Radiology
Volume 3, Issue 12 , Pages 932-939 , December 2006

Ethical Conduct of Radiology Research With Human Participants

  • Ingrid Burger, BS

      Affiliations

    • Corresponding Author InformationCorresponding author and reprints: Ingrid Burger, BS, The Johns Hopkins Bloomberg School of Public Health, Department of Health Policy and Management, 624 N Broadway, Hampton House 344, Baltimore, MD 21205
    • ,
  • Nancy Kass, ScD

References 

  1. National Commission for the Protections of Human Subjects of Biomedical and Behavioral Research. The Belmont report: ethical principles and guidelines for the protection of human subjects of research. Washington, DC: National Commission for the Protections of Human Subjects of Biomedical and Behavioral Research; 1979;
  2. Protection of human subjects: federal policy for the protection of human subjects. Code of Federal Regulations (Title 45, Part 46). 1991.
  3. Advisory Committee on Human Radiation Experiments. The human radiation experiments: final report of the President’s Advisory Committee on Human Radiation Experiments. New York, NY: Oxford University Press; 1996;
  4. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical?. JAMA. 2000;283:2701–2711
  5. Wadey V, Frank C. The effectiveness of patient verbalization on informed consent. Can J Surg. 1997;40:124–128
  6. Sorrell JM. Effects of writing/speaking on comprehension of information for informed consent. West J Nurs Res. 1991;13:110–122
  7. Combs DR, Adams SD, Wood TD, Basso MR, Gouvier WD. Informed consent in schizophrenia: the use of cues in the assessment of understanding. Schizophr Res. 2005;77:59–63
  8. Protection of human subjects. Code of Federal Regulations (Title 21, Part 50). 2002.
  9. IRB review of research: institutional review boards. Code of Federal Regulations (Title 21, Part 56). 2002.
  10. Cooper JA. Responsible conduct of radiology research: part I (The regulatory framework for human research). Radiology. 2005;236:379–381
  11. Cooper JA. Responsible conduct of radiology research: part II (Regulatory requirements for human research). Radiology. 2005;236:748–752
  12. Cooper JA. Responsible conduct of radiology research: part III (Exemptions from regulatory requirements for human research). Radiology. 2005;237:3–7
  13. Vick CC, Finan KR, Kiefe C, Neumayer L, Hawn MT. Variation in institutional review processes for a multisite observational study. Am J Surg. 2005;190:805–809
  14. Christian MC, Goldberg JL, Killen J, et al. A central institutional review board for multi-institutional trials. N Engl J Med. 2002;346:1405–1408
  15. Cobb L, Thomas G, Dillard D. An evaluation of internal-mammary-artery ligation by a double-blind technic. N Engl J Med. 1959;260:1115–1118
  16. Dimond EG, Kittle F, Crockett J. Comparison of internal mammary artery ligation and sham operations for angina pectoris. Am J Cardiol. 1960;5:483–486
  17. The EC/IC Bypass Study Group. Failure of extracranial-intracranial arterial bypass to reduce the risk of ischemic stroke: results of an international randomized trial. N Engl J Med. 1985;313:1191–1200
  18. Mello MM, Brennan TA. The controversy over high-dose chemotherapy with autologous bone marrow transplant for breast cancer. Health Aff (Millwood). 2001;20:101–117
  19. Levine R. Ethics and regulation of clinical research. 2nd ed. Baltimore, Md: Urban & Scharzenberg; 1986;
  20. Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 1987;317:141–145
  21. Hellman S, Hellman DS. Of mice but not men (Problems of the randomized clinical trial). N Engl J Med. 1991;324:1585–1589
  22. Miller PB, Weijer C. Rehabilitating equipoise. Kennedy Inst Ethics J. 2003;13:93–118
  23. Ellenberg SS, Temple R. Placebo-controlled trials and active-control trials in the evaluation of new treatments (Part 2: practical issues and specific cases). Ann Intern Med. 2000;133:464–470
  24. Fried C. Medical experimentation: personal integrity and social policy. the Netherlands: Amsterdam; 1974;
  25. Tcheng JE, Madan M, O’Shea JC, et al. Ethics and equipoise: rationale for a placebo-controlled study design of platelet glycoprotein IIb/IIIa inhibition in coronary intervention. J Interv Cardiol. 2003;16:97–105
  26. Pelletier G, Ducreux M, Gay F, et al. Treatment of unresectable hepatocellular carcinoma with lipiodol chemoembolization: a multicenter randomized trial (Groupe CHC). J Hepatol. 1998;29:129–134
  27. Llovet JM, Real MI, Montana X, et al. Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial. Lancet. 2002;359:1734–1739
  28. Yuen MF, Chan AO, Wong BC, et al. Transarterial chemoembolization for inoperable, early stage hepatocellular carcinoma in patients with Child-Pugh grade A and B: results of a comparative study in 96 Chinese patients. Am J Gastroenterol. 2003;98:1181–1185
  29. Temple R, Ellenberg SS. Placebo-controlled trials and active-control trials in the evaluation of new treatments (Part 1: ethical and scientific issues). Ann Intern Med. 2000;133:455–463
  30. Emanuel EJ, Miller FG. The ethics of placebo-controlled trials—a middle ground. N Engl J Med. 2001;345:915–919
  31. Appelbaum PS, Rothe L, Lidz C, Benson P, Winslade W. False hopes and best data. Hastings Cent Rep. 1987;17:20–24
  32. Daugherty C, Ratain MJ, Grochowski E, et al. Perceptions of cancer patients and their physicians involved in phase I trials. J Clin Oncol. 1995;13:1062–1072
  33. Sugarman J, Kass NE, Goodman SN, Perentesis P, Fernandes P, Faden RR. What patients say about medical research. IRB. 1998;20:1–7
  34. Meropol NJ, Weinfurt KP, Burnett CB, et al. Perceptions of patients and physicians regarding phase I cancer clinical trials: implications for physician-patient communication. J Clin Oncol. 2003;21:2589–2596
  35. Weinfurt KP, Sulmasy DP, Schulman KA, Meropol NJ. Patient expectations of benefit from phase I clinical trials: linguistic considerations in diagnosing a therapeutic misconception. Theor Med Bioeth. 2003;24:329–344
  36. National Bioethics Advisory Commission. Research involving human biological materials: ethical issues and policy guidance, vol 1. Washington, DC: National Bioethics Advisory Commission; 1999;
  37. Johns Hopkins Bloomberg School of Public Health, Committee on Human Research. Disclosure of test results to subjects. Available at: http://www.jhsph.edu/chr/PolicyGuidelines/pandp/OTT-9.pdf.
  38. Furman R. Genetic test results and the duty to disclose: can medical researchers control liability?. Seattle Univ Law Rev. 1999;23:391–429
  39. Katzman GL, Dagher AP, Patronas NJ. Incidental findings on brain magnetic resonance imaging from 1000 asymptomatic volunteers. JAMA. 1999;282:36–39
  40. Kim BS, Illes J, Kaplan RT, Reiss A, Atlas SW. Incidental findings on pediatric MR images of the brain. Am J Neuroradiol. 2002;23:1674–1677
  41. Illes J, Desmond JE, Huang LF, Raffin TA, Atlas SW. Ethical and practical considerations in managing incidental findings in functional magnetic resonance imaging. Brain Cogn. 2002;50:358–365
  42. Illes J, Kirschen MP, Karetsky K, et al. Discovery and disclosure of incidental findings in neuroimaging research. J Magn Reson Imaging. 2004;20:743–747
  43. Partridge AH, Wong JS, Knudsen K, et al. Offering participants results of a clinical trial: sharing results of a negative study. Lancet. 2005;365:963–964
  44. Partridge AH, Burstein HJ, Gelman RS, Marcom PK, Winer EP. Do patients participating in clinical trials want to know study results?. J Natl Cancer Inst. 2003;95:491–492
  45. Kirschen MP, Jaworska A, Illes J. Subjects’ expectations in neuroimaging research. J Magn Reson Imaging. 2006;23:205–209

PII: S1546-1440(06)00340-1

doi: 10.1016/j.jacr.2006.06.010

Journal of the American College of Radiology
Volume 3, Issue 12 , Pages 932-939 , December 2006

Article Tools