The contents and readability of informed consent forms for oncology clinical trials

American Journal of Clinical Oncology: Cancer Clinical Trials

Volumn 33, Issue 4, 2010, Pages 387-392

  Cheung, Winson Y ^a,b   Pond, Gregory R ^b   Heslegrave, Ronald J ^c   Enright, Katherine ^b   Potanina, Larissa ^c   Siu, Lillian L ^b  

^a HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^b UNIVERSITY OF TORONTO   (Canada)

^c UNIVERSITY HEALTH NETWORK   (Canada)

Author keywords

Cancer; Clinical trials; Content; Informed consent; Oncology; Quality; Readability

Indexed keywords

ARTICLE; CANCER THERAPY; CONFIDENTIALITY; DEATH; FUNDING; GOVERNMENT; HEMATOLOGY; HOSPITALIZATION; INFORMED CONSENT; INTERVENTION STUDY; RISK BENEFIT ANALYSIS; SCORING SYSTEM; SURVIVAL; CANADA; CLASSIFICATION; CLINICAL TRIAL; COMPREHENSION; HUMAN; INFORMATION PROCESSING; INTERPERSONAL COMMUNICATION; METHODOLOGY; NEOPLASM; PATIENT SELECTION; REPRODUCIBILITY; RESEARCH; RISK ASSESSMENT; RISK FACTOR; STANDARD;

CLINICAL TRIALS AS TOPIC; COMPREHENSION; CONSENT FORMS; DATA COLLECTION; HUMANS; INFORMED CONSENT; NEOPLASMS; ONTARIO; PATIENT SELECTION; REPRODUCIBILITY OF RESULTS; RESEARCH; RISK ASSESSMENT; RISK FACTORS; TRUTH DISCLOSURE;

EID: 77956644767     PISSN: 02773732     EISSN: 1537453X     Source Type: Journal    
DOI: 10.1097/COC.0b013e3181b20641     Document Type: Article

References (33)

1. American Society of Clinical Oncology. American Society of Clinical Oncology policy statement: Oversight of clinical research. J Clin Oncol. 2003; 21:2377-2386.
2. World Medical Association. Declaration of Helsinki (1964). Ethical principles for medical research involving human subjects. Available at: Http:// www.wma.net/e/policy/pdf/17c.pdf. Accessed September 22, 2008.
3. US National Institutes of Health. Guidelines for the conduct of research involving human subjects at the NIH (2004). Available at: Http://ohsr.od. nih.gov/guidelines/GrayBooklet82404.pdf. Accessed September 22, 2008.
4. Joffe S, Cook EF, Cleary PD, et al. Quality of informed consent in cancer clinical trials: A cross-sectional survey. Lancet. 2001;358:1772-1777.
5. Daugherty CK, 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.
6. Meropol NJ, Weinfurt KP, Burnett CB, et al. Perceptions of patients and physicians regarding phase I cancer clinical trials: Implications for physicianpatient communication. J Clin Oncol. 2003;21:2589-2596.
7. Grossman SA, Piantadosi S, Covahey C. Are informed consent forms that describe clinical oncology research protocols readable by most patients and their families? J Clin Oncol. 1994;12:2211-2215.
8. Paasche-Orlow MK, Taylor HA, Brancati FL. Readability standards for informed consent forms as compared with actual readability. N Engl J Med. 2003;348:721-726.
9. Brown RF, Butow PN, Boyle F, et al. Seeking informed consent to cancer clinical trials: Evaluating the efficacy of doctor communication skills training. Psychooncology. 2007;16:507-516.
10. Sorensen JB, Rossel P, Holm S. Patient-physician communication concerning participation in cancer chemotherapy trials. Br J Cancer. 2004;90:328-332.
11. Horng S, Emanuel EJ, Wilfond B, et al. Descriptions of benefits and risks in consent forms for phase I oncology trials. N Engl J Med. 2002;26:2134-2140.
12. Pentz RD, Flamm AL, Sugarman J, et al. Study of the media's potential influence on prospective research participants' understanding of and motivations for participation in a high-profile phase I trial. J Clin Oncol. 2002;20:3785-3791.
13. Tomamichel M, Jaime H, Degrate A, et al. Proposing phase I studies: Patients', relatives', nurses', and specialists' perceptions. Ann Oncol. 2000; 11:289-294.
14. Daugherty CK, Ratain MJ, Minami H, et al. Study of cohort-specific consent and patient control in phase I cancer trials. J Clin Oncol. 1998;16:2305-2312.
15. Itoh K, Sasaki Y, Fujii H, et al. Patients in phase I trials of anti-cancer agents in Japan: Motivation, comprehension, and expectations. Br J Cancer. 1997; 76:107-113.
16. Tomamichel M, Sessa C, Herzig S, et al. Informed consent for phase I studies: Evaluation of quantity and quality of information provided to patients. Ann Oncol. 1995;6:363-369.
17. Pond GR, Siu LL, Moore M, et al. Nomograms to predict serious adverse events in phase II clinical trials of molecularly targeted agents. J Clin Oncol. 2008;26:1324-1330.
18. Bentzen SM, Trotti A. Evaluation of early and late toxicities in chemoradiation trials. J Clin Oncol. 2007;25:4096-4103.
19. National Cancer Institute. Recommendations for the development of informed consent documents for cancer clinical trials (1998). Available at: Http://www.cancer.gov/clinicaltrials/understanding/simplification-ofinformed- consent-docs. Accessed February 12, 2009.
20. Sharp SM. Consent documents for oncology trials: Does anybody read these things? Am J Clin Oncol. 2004;27:570-575.
21. Goldstein AO, Frasier P, Curtis P, et al. Consent form readability in university- sponsored research. J Fam Pract. 1996;42:606-611.
22. Kimmelman J, Palmour N. Therapeutic optimism in the consent forms of phase 1 gene transfer trials: An empirical analysis. J Med Ethics. 2005;31:209-214. (Pubitemid 40542132)
23. Kimmelman J, Levenstadt A. Elements of style: Consent form language and the therapeutic misconception in phase 1 gene transfer trials. Hum Gene Ther. 2005;16:502-508.
24. Italiano A, Massard C, Bahleda R, et al. Treatment outcome and survival in participants of phase I oncology trials carried out from 2003 to 2006 at Institut Gustave Roussy. Ann Oncol. 2008;19:787-792.
25. Horstmann E, McCabe MS, Grochow L, et al. Risks and benefits of phase 1 oncology trials, 1991 through 2002. N Engl J Med. 2005;352:895-904.
26. Davis TC, Williams MV, Marin E, et al. Health literacy and cancer communication. CA Cancer J Clin. 2002;53:134-149.
27. Davis TC, Crouch MA, Wills G, et al. The gap between patient reading comprehension and the readability of patient education materials. J Fam Pract. 1990;31:533-538.
28. 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-e14.
29. 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.
30. 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.
31. Flory J, Emanuel E. Interventions to improve research participants' understanding in informed consent for research: A systematic review. JAMA. 2004;292:1593-1601.
32. Bhatia S, Francisco L, Carter A, et al. Late mortality after allogeneic hematopoietic cell transplantation and functional status of long-term survivors: Report from the Bone Marrow Transplant Survivor Study. Blood. 2007;110:3784-3792. (Pubitemid 350159650)
33. Bhatia S, Robinson LL, Francisco L, et al. Late mortality in survivors of autologous hematopoietic cell transplantation: Report from the Bone Marrow Transplant Survivor Study. Blood. 2005;105:4215-4222.