Paper: Discrepancy between participants' understanding and desire to know in informed consent: Are they informed about what they really want to know?

Journal of Medical Ethics

Volumn 38, Issue 2, 2012, Pages 102-106

  Koh, Jiwon ^a   Goh, Eurah ^b   Yu, Kyung Sang ^c   Cho, Belong ^c   Yang, Jeong Hee ^b  

^a Seoul National University   (South Korea)

^b Kangwon National University   (South Korea)

^c Seoul National University Hospital   (South Korea)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; AGED; ARTICLE; COMPREHENSION; CROSS-SECTIONAL STUDY; ETHICS; EVALUATION; FEMALE; HUMAN; INFORMED CONSENT; INTERPERSONAL COMMUNICATION; MALE; MEDICAL RESEARCH; MIDDLE AGED; QUESTIONNAIRE; STANDARD;

ADULT; AGED; BIOMEDICAL RESEARCH; COMMUNICATION; COMPREHENSION; CROSS-SECTIONAL STUDIES; DISCLOSURE; EVALUATION STUDIES AS TOPIC; FEMALE; HUMANS; INFORMED CONSENT; MALE; MIDDLE AGED; QUESTIONNAIRES; YOUNG ADULT;

EID: 84856787648     PISSN: 03066800     EISSN: 14734257     Source Type: Journal    
DOI: 10.1136/jme.2010.040972     Document Type: Article

References (24)

1. World Medical Association. WMA Declaration of HelsinkidEthical Principles for Medical Research Involving Human Subjects, 2008. http://www.wma.net/en/30publications/10policies/b3/index.html (accessed 7 May 2011).
2. Chanaud CM. Determination of required content of the informed consent process for human participants in biomedical research conducted in the U.S. A practical tool to assist clinical investigators. Contemp Clin Trials 2008;29:501-6.
3. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Guideline for Good Clinical Practice. 1996. http://ichgcp.net/ (accessed 17 Jun 2011).
4. US Department of Health and Human Services. 45 Code of Federal Regulations 46. Federal Register 1991 June 18;56:28012.
5. Fortun P, West J, Chalkley L, et al. Recall of informed consent information by healthy volunteers in clinical trials. QJM 2008;101:625-9.
6. Hereu P, Pérez E, Fuentes I, et al. Consent in clinical trials: what do patients know? Contemp Clin Trials 2010;30:443-6.
7. Joffe S, Cook EF, Cleary PD, et al. Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet 2001;358:1772-7.
8. 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;21:2589-96.
9. Bergenmar M, Molin C, Wilking N, et al. Knowledge and understanding among cancer patients consenting to participate in clinical trials. Eur J Cancer 2008;44:2627-33.
10. Han S, Yim DS. Current state of clinical trials in Korea. J Korean Med Sci 2010;53:745-52.
11. Korea Food and Drug Administration. Guideline for Korean Good Clinical Practice. Seoul, Korea: Korea Food and Drug Administration 2000.
12. Kim OJ, Park BJ, Sohn DR, et al. Current status of the institutional review boards in Korea: constitution, operation, and policy for protection of human research participants. J Korean Med Sci 2003;18:3-10.
13. Lim I, Rha SY. Clinical trials and ethics. J Korean Med Sci 2010;53:774.
14. Koh W, Sim J, Ahn W. Survey of institutional review board approval and informed consent in clinical research of Korean anesthetic society. Korean J Anesthesiol 2007;53:753-8.
15. Barrett R. Quality of informed consent: measuring understanding among participants in oncology clinical trials. Oncol Nurs Forum 2005;32:751-5.
16. Jefford M, Mileshkin L, Matthews J, et al. Satisfaction with the decision to participate in cancer clinical trials is high, but understanding is a problem. Support Care Cancer 2010;19:371-9.
17. Chappuy H, Baruchel A, Leverger G, et al. Parental comprehension and satisfaction in informed consent in paediatric clinical trials: a prospective study on childhood leukaemia. Arch Dis Child 2010;95:800-4.
18. Newton-Howes PA, Bedford ND, Dobbs BR, et al. Informed consent: what do patients want to know? NZ Med J 1998;111:340-2.
19. El-Wakeel H, Taylor GJ, Tate JJ. What do patients really want to know in an informed consent procedure? A questionnaire-based survey of patients in the Bath area, UK. J Med Ethics 2006;32:612-16.
20. Joffe S, Cook EF, Cleary PD, et al. Quality of informed consent: a new measure of understanding among research subjects. J Natl Cancer Inst 2001;93:139-47.
21. Henderson GE, Churchill LR, Davis AM, et al. Clinical trials and medical care: defining the therapeutic misconception. PLoS Med 2007;4:e324.
22. Beardsley E, Jefford M, Mileshkin L. Longer consent forms for clinical trials compromise patient understanding: so why are they lengthening? J Clin Oncol 2007;25:e13-14.
23. Freer Y, McIntosh N, Teunisse S, et al. More information, less understanding: a randomized study on consent issues in neonatal research. Pediatrics 2009;123:1301-5.
24. Kim DY, Kwon OD, Kim SG, et al. Recognitional study about patients and caregivers' understanding of clinical trial. Journal of the Korean Continence Society 2008;12:48-57.