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.
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).