Looking at research consent forms through a participant-centered lens: The PRISM Readability Toolkit

American Journal of Health Promotion

Volumn 23, Issue 6, 2009, Pages 371-375

  Ridpath, Jessica R ^a   Wiese, Cheryl J ^a   Greene, Sarah M ^a  

^a CENTER FOR HEALTH STUDIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL TRIAL; CULTURAL COMPETENCE; EDUCATIONAL STATUS; HUMAN; INFORMED CONSENT; METHODOLOGY; ORGANIZATION AND MANAGEMENT; RESEARCH SUBJECT;

CLINICAL TRIALS AS TOPIC; CONSENT FORMS; CULTURAL COMPETENCY; EDUCATIONAL STATUS; HUMANS; RESEARCH SUBJECTS;

EID: 68049114317     PISSN: 08901171     EISSN: None     Source Type: Journal    
DOI: 10.4278/ajhp.080613-CIT-94     Document Type: Article

References (29)

1. Ad Hoc Committee on Health Literacy for the Council on Scientific Affairs. Health literacy: report of the Council on Scientific Affairs. JAMA. 1995; 281: 552-557.
2. Weiss BD. Health Literacy: A Manual for Clinicians. Chicago, Ill: American Medical Association Foundation; 2003.
3. Berkman ND, DcWalt DA, Pignone MP, et al. Literacy and Health Outcomes: Summary Evidence Report/Technology Assessment No. 87. Rockville, Md: Agency for Healthcare Research and Quality; 2004. AHRQ Publication No. 04-E007-1.
4. Nielsen-Bohlman L, Panzer A, Kindig D, eds. Health Literacy: A Prescription to End Confusion. Washington, DC: National Academies Press; 2004.
5. Kutner M, Greenberg E, Jin Y, Paulsen C. The Health Literacy of America's Adults: Results from the 2003 National Assessment of Adult Literacy. Washington, DC: National Center for Education Statistics; 2006.
6. The Health Literacy and Patient Safety Roundtable. "What Did the Doctor Say?: " Improving Health Literacy to Protect Patient Safety. Oakbrook Terrace, Ill: The Joint Commission; 2007.
7. Vernon JA, Trujillo A, Rosenbaum S, DeBuono B. Low Health Literacy: Implications for National Health Policy. Storrs, Conn: University of Connecticut; 2007.
8. Kirsch I, Jungeblut A, Jenkins L, Kolstad A. Adult Literacy in America: A First Look at the Findings of the National Adult Literacy Survey. 3rd ed. Washington, DC: Office of Educational Research and Improvement; 2002.
9. Rudd RE, Moeykens BA, Colton TC. Health and literacy: a review of medical and public health literature. In: ComingsJ, Garners B, Smith C, eds. Annual lleview of Adult learning and Literacy. Vol 1. San Francisco, Calif: Jossey-Bass; 2000.
10. Protection of Human Subjects. Code of Federal Regulations, Title 45, §§46.109 and 50.20 (1993).
11. 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. (Pubitemid 28222140)
12. Morrow GR. How readable are subject consent forms? JAMA. 1980; 244: 56-58. (Pubitemid 10071578)
13. Taub HA. Comprehension of informed consent for research: issues and directions for future study. IRB. 1986; 8: 7-10.
14. LoVerda ME, Prochazka AV, Byyny RL. Research consent forms: continued unreadability and increasing length. J Gen Intern Med. 1989; 4: 410-412. (Pubitemid 19233782)
15. Young DR, Hooker DT, Freeberg FE. Informed consent documents: increasing comprehension by reducing reading level. IRB. 1990; 12: 1-6.
16. Tarnowski KJ, Allen DM, Mayhall C, Kelly PA. Readability of pediatric biomedical research informed consent forms. Pediatrics. 1990; 85: 58-63.
17. Hammerschmidt DE, Keane MA. Institutional Review Board (IRB) review lacks impact on the readability of consent forms for research. Am J Med Sci. 1992; 304: 348-351. (Pubitemid 23011307)
18. Hopper KD, TenHave TR, Hartzel J. Informed consent forms for clinical and research imaging procedures: how much do patients understand? Am J Roentgenol. 1995; 164: 493-496.
19. 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. (Pubitemid 36237042)
20. U.S. Department of Health and Human Services: Office of Disease Prevention and Health Promotion: Plain Language: A Promising Strategy for Clearly Communicating Health Information and Improving Health Literacy. Available at: http://www.health.gov/communication/literacy/plainlanguage/ IssueBrief.pdf. Accessed March 6, 2008.
21. Stableford S, Mettger W. Plain language: a strategic response to the health literacy challenge. J Public Health Policy. 2007; 28: 71-93.
22. Group Health Center for Health Studies: Readability Toolkit. Available at: http://centerforhealthstudies.org/capabilities/readability/readability-home. html. Accessed February 23, 2009.
23. Clinical Trials Networks Best Practices: Clinical Site Resources: Site Operations. Available at: https://www.ctnbestpractices.org/sites/siteoperations. Accessed February 23, 2009.
24. Wendler D. Can we ensure that all research subjects give valid consent? Arch Intern Med. 2004; 164: 2201-2204. (Pubitemid 39452979)
25. Cox K. Informed consent and decision-making: patients' experiences of the process of recruitment to phases I and II anti-cancer drug trials. Patient Educ Couns. 2002; 46: 31-38. (Pubitemid 34136106)
26. Coyne C, Ronghui X, 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. (Pubitemid 46606443)
27. Bjorn E, Rossel P, Holm S. Can the written information to research subjects be improved? - an empirical study. J Med Ethics. 1999; 25: 263-267. (Pubitemid 29273779)
28. Maslin A. A survey of the opinions on "informed consent" of women currently involved in clinical trials within a breast unit. Eur J Cancer Care. 1994; 3: 153-162.
29. Brock DW, Wartman S. When competent patients make irrational choices. New Engl J Med. 1990; 322: 1595-1599. (Pubitemid 20176702)