FREE NEJM E-TOC    HOME   |   SUBSCRIBE   |   CURRENT ISSUE   |   PAST ISSUES   |   COLLECTIONS   |   Search Term  Advanced Search

Sign in | Get NEJM's E-Mail Table of Contents — Free | Subscribe

Previous Volume 348:721-726 February 20, 2003 Number 8 Next

	Full Text PDF PDA Full Text Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

Background Institutional review boards (IRBs) are charged with safeguarding potential research subjects with limited literacy but may have an inadvertent role in promulgating unreadable consent forms. We hypothesized that text provided by IRBs in informed-consent forms falls short of the IRBs' own readability standards and that readability is influenced by the level of research activity, local literacy rates, and federal oversight.

Methods To test these hypotheses, we conducted a cross-sectional study linking data from several public-use sources. A total of 114 Web sites of U.S. medical schools were surveyed for IRB readability standards and informed-consent-form templates. Actual readability was measured with the Flesch–Kincaid scale, which assigns a score on the basis of the minimal grade level required to read and understand English text (range, 0 to 12). Data on the level of research activity, local literacy rates, and federal oversight were obtained from organizational Web sites.

Results The average readability score for text provided by IRBs was 10.6 (95 percent confidence interval, 10.3 to 10.8) on the Flesch–Kincaid scale. Specific readability standards, found on 61 Web sites (54 percent), ranged from a 5th-grade reading level to a 10th-grade reading level. The mean Flesch–Kincaid scores for the readability of sample text provided by IRBs exceeded the stated standard by 2.8 grade levels (95 percent confidence interval, 2.4 to 3.2; P<0.001). Readability was not associated with either the level of research funding (P=0.89) or local rates of literacy (P=0.92). However, the 52 schools that had been made subject to oversight by the Office for Human Research Protections (46 percent) had lower Flesch–Kincaid scores than the other schools (10.2 vs. 10.9, P=0.005).

Conclusions IRBs commonly provide text for informed-consent forms that falls short of their own readability standards. Federal oversight is associated with better readability.

Source Information

From the Departments of Medicine (M.K.P.-O., F.L.B.), Health Policy and Management (H.A.T.), and Epidemiology (F.L.B.) and the Phoebe R. Berman Bioethics Institute (M.K.P.-O., H.A.T.), Johns Hopkins University, Baltimore.

Address reprint requests to Dr. Paasche-Orlow at the Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins Medical Institutions, 2024 E. Monument St., Suite 2-600, Baltimore, MD 21205, or at mpaasche{at}jhmi.edu.

Full Text of this Article

Related Letters:

Readability of Informed-Consent Forms
Beyer D. R., Lauer M. S., Davis S., Mayo D. J., Paasche-Orlow M. K., Taylor H. A., Brancati F. L.
Extract | Full Text | PDF  
N Engl J Med 2003; 348:2262-2263, May 29, 2003. Correspondence

This article has been cited by other articles:

• Granero-Molina, J., Fernandez-Sola, C., Aguilera-Manrique, G. (2009). Applying a Sociolinguistic Model to the Analysis of Informed Consent Documents. Nurs Ethics 16: 797-812 [Abstract]  
• Rogers, E. S., Spalding, S. L., Eckard, A. A., Wallace, L. S. (2009). Are Patient-Administered Attention Deficit Hyperactivity Disorder Scales Suitable for Adults?. J Atten Disord 13: 168-174 [Abstract]  
• Knapp, P, Raynor, D K, Silcock, J, Parkinson, B (2009). Performance-based readability testing of participant materials for a phase I trial: TGN1412. J. Med. Ethics 35: 573-578 [Abstract] [Full Text]  
• Obermeyer, C. M., Osborn, M. (2007). The Utilization of Testing and Counseling for HIV: A Review of the Social and Behavioral Evidence. AJPH 97: 1762-1774 [Abstract] [Full Text]  
• Merlo, D F, Knudsen, L E, Matusiewicz, K, Niebroj, L, Vahakangas, K H (2007). Ethics in studies on children and environmental health. J. Med. Ethics 33: 408-413 [Abstract] [Full Text]  
• Ha, A. T., Gansky, S. A. (2007). HIPAA Notice of Privacy Practices Used in U.S. Dental Schools: Factors Related to Readability or Lack Thereof. J Dent Educ 71: 419-429 [Abstract] [Full Text]  
• Ford, K., Sankey, J., Crisp, J. (2007). Development of children's assent documents using a child-centred approach. J Child Health Care 11: 19-28 [Abstract]  
• Christopher, P. P., Foti, M. E., Roy-Bujnowski, K., Appelbaum, P. S. (2007). Consent Form Readability and Educational Levels of Potential Participants in Mental Health Research. Psychiatr. Serv. 58: 227-232 [Abstract] [Full Text]  
• Jaspers, P., van der Arend, A., Wanders, R. (2006). Inclusion Practice in Lung Cancer Trials. Nurs Ethics 13: 649-660 [Abstract]  
• Shalowitz, D., Wendler, D. (2006). Informed Consent for Research and Authorization under the Health Insurance Portability and Accountability Act Privacy Rule: An Integrated Approach. ANN INTERN MED 144: 685-688 [Abstract] [Full Text]  
• Chappuy, H, Doz, F, Blanche, S, Gentet, J-C, Pons, G, Treluyer, J-M (2006). Parental consent in paediatric clinical research. Arch. Dis. Child. 91: 112-116 [Abstract] [Full Text]  
• Dunn, L. B, Candilis, P. J, Roberts, L. W. (2006). Emerging Empirical Evidence on the Ethics of Schizophrenia Research. Schizophr Bull 32: 47-68 [Abstract] [Full Text]  
• Dunn, L. B, Palmer, B. W, Keehan, M. (2006). Understanding of Placebo Controls Among Older People With Schizophrenia. Schizophr Bull 32: 137-146 [Abstract] [Full Text]  
• Walfish, S., Watkins, K. M. (2005). Readability Level of Health Insurance Portability and Accountability Act Notices of Privacy Practices Utilized by Academic Medical Centers. Eval Health Prof 28: 479-486 [Abstract]  
• Moodley, K, Pather, M, Myer, L (2005). Informed consent and participant perceptions of influenza vaccine trials in South Africa. J. Med. Ethics 31: 727-732 [Abstract] [Full Text]  
• Weiss, B. D., Mays, M. Z., Martz, W., Castro, K. M., DeWalt, D. A., Pignone, M. P., Mockbee, J., Hale, F. A. (2005). Quick Assessment of Literacy in Primary Care: The Newest Vital Sign. Ann Fam Med 3: 514-522 [Abstract] [Full Text]  
• Eriksson, S, Helgesson, G (2005). Keep people informed or leave them alone? A suggested tool for identifying research participants who rightly want only limited information. J. Med. Ethics 31: 674-678 [Abstract] [Full Text]  
• Young, J. L. (2005). Commentary: Refusing to Give up on Forensic Research. J Am Acad Psychiatry Law 33: 368-370 [Abstract] [Full Text]  
• Cooper, J. A. (2005). Responsible Conduct of Radiology Research: Part II. Regulatory Requirements for Human Research. Radiology 236: 748-752 [Abstract] [Full Text]  
• Breese, P., Burman, W. (2005). Readability of Notice of Privacy Forms Used by Major Health Care Institutions. JAMA 293: 1593-1594 [Full Text]  
• McCray, A. T. (2005). Promoting Health Literacy. J. Am. Med. Inform. Assoc. 12: 152-163 [Abstract] [Full Text]  
• Dunn, L. B., Gordon, N. E. (2005). Improving Informed Consent and Enhancing Recruitment for Research by Understanding Economic Behavior. JAMA 293: 609-612 [Full Text]  
• Holtzman, J. M., Elliot, N., Biber, C. L., Sanders, R. M. (2005). Computerized Assessment of Dental Student Writing Skills. J Dent Educ 69: 285-295 [Abstract] [Full Text]  
• Breese, P., Burman, W., Rietmeijer, C., Lezotte, D. (2004). The Health Insurance Portability and Accountability Act and the Informed Consent Process. ANN INTERN MED 141: 897-898 [Full Text]  
• Hamvas, A., Madden, K. K., Nogee, L. M., Trusgnich, M. A., Wegner, D. J., Heins, H. B., Cole, F. S. (2004). Informed Consent for Genetic Research. Arch Pediatr Adolesc Med 158: 551-555 [Abstract] [Full Text]  
• Vahakangas, K. (2004). Ethical aspects of molecular epidemiology of cancer. Carcinogenesis 25: 465-471 [Abstract] [Full Text]  
• Beyer, D. R., Lauer, M. S., Davis, S., Mayo, D. J., Paasche-Orlow, M. K., Taylor, H. A., Brancati, F. L. (2003). Readability of Informed-Consent Forms. NEJM 348: 2262-2263 [Full Text]  
• Martyn, C. (2003). The ethical bureaucracy. QJM 96: 323-324 [Full Text]  
• (2003). Minerva. BMJ 326: 508-508 [Full Text]