1 LoVerde ME, Prochazka AV, Byyny RL. Research consent forms: continued unreadability and increasing length. J Gen Intern Med 1989;4(5):410-2.
2 Paasche-Orlow MK, Taylor HA, Brancati FL. Readability standards for informed-consent forms as compared with actual readability. N Engl J Med 2003;20;348(8):721-6.
3 Joffe S, Cook EF, Cleary PD, et al. Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet 2001;358(9295):1772-7.
4 Coletti AS, Heagerty P, Sheon AR, et al. Randomized, controlled evaluation of a prototype informed consent process for HIV vaccine efficacy trials. J Acquir Immune Defic Syndr 2003;32(2):161-9.
5 Sudore RL, Landefeld CS, Williams BA, et al. Use of a modified informed consent process among vulnerable patients: a descriptive study. J Gen Intern Med 2006;21(8):867-73.
6 Raich PC, Plomer KD, Coyne CA. Literacy, comprehension, and informed consent in clinical research. Cancer Invest 2001;19(4):437-45.
7 DeWalt DA, Berkman ND, Sheridan S, et al. Literacy and health outcomes: a systematic review of the literature. J Gen Intern Med 2004;19(12):1228-39.
8 Kutner, M., Greenberg, E., Jin,Y., et al. The Health Literacy of America's Adults: Results From the 2003 National Assessment of Adult Literacy. Washington, DC: U.S. Department of Education, National Center for Education Statistics; 2006. NCES Publication No. 2006-483. Available at: http://nces.ed.gov/pubs2006/2006483.pdf (PDF File, 1.2 MB; Plugin Software Help).
9 Krousel-Wood M, Muntner P, Jannu A, et al. Does waiver of written informed consent from the institutional review board affect response rate in a low-risk research study? J Investig Med 2006 May;54(4):174-9.
10 Wendler D, Grady C. What should research participants understand to understand they are participants in research? Bioethics 2008 May;22(4):203-8.
11 Kripalani S, Bengtzen R, Henderson LE, et al. Clinical research in low-literacy populations: using teach-back to assess comprehension of informed consent and privacy information. IRB 2008 Mar-Apr;30(2):13-9.
12 Sudore RL, Landefeld CS, Williams BA, et al. Use of a modified informed consent process among vulnerable patients: a descriptive study. J Gen Intern Med. 2006 Aug;21(8):867-73.
13 Levine C, Faden R, Grady C, et al. Consortium to Examine Clinical Research Ethics. "Special scrutiny": a targeted form of research protocol review. Ann Intern Med 2004 Feb 3;140(3):220-3.
14 Diaz v. Hillsborough County Hospital Authority. Plaintiffs' Brief in Support of Order Finally Approving Consent Decree. Case No. 8:90-cv-00120 (Doc. 450, 07/31/2000) and see Final Order Approving Consent Decree (Doc. 457, 08/09/2000). U.S. District Court for the Middle District of Florida, Tampa Division.
15 Go to 45 CFR 46.
16 Waggoner WC, Mayo DM. Who understands? A survey of 25 words or phrases commonly used in proposed clinical research consent forms. IRB 1995 Jan-Feb;17(1):6-9.
17 Waggoner WC, Sherman BB. Who understands? II: A survey of 27 words, phrases, or symbols used in proposed clinical research consent forms. IRB 1996 May-Jun;18(3):8-10.
18 Flory J, Emanuel E. Interventions to improve research participants' understanding in informed consent for research: a systematic review. JAMA 2004 Oct 6;292(13):1593-601.
19 Go to 45 CFR 164.508(b)(3)(iii) (PDF File, 32 KB; Plugin Software Help).
Return to Contents
Current as of September 2009
The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research. September 2009, Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/fund/informedconsent/