Additional Resources on Informed Consent

Koyfman SA, McCabe MS, Emanuel EJ, Grady C. A Consent Template for Phase 1 Oncology Trials. IRB 2009; 31:1-8.

Ryan RE, Prictor MJ, McLaughlin KJ, Hill SJ. Audio-visual presentation of information for informed consent for participation in clinical trials . Cochrane Database Syst Rev 2008 Jan 23;(1): CD003717.

Jefford M, Moore R. Improvement of informed consent and the quality of consent documents. Lancet Oncol. 2008; 9: 485-93.

Friedman Ross L. Chapter 5: Informed Consent in Pediatric Research. In: Children in Medical Research Access versus Protection. New York: Oxford University Press (2006).

Kodish E, Eder M, Noll RB, et al. Communication of randomization in childhood leukemia trials. JAMA 2004; 291: 470-5.

King NM, Henderson GE, Churchill LR, et al. Consent forms and the therapeutic misconception: the example of gene transfer research. IRB. 2005; 27: 1-8.

National Institues of Health. Points to Consider Research Involving Individuals with Questionable Capacity to Consent (http://oba.od.nih.gov/policy/NIH%20Points% 20to%20Consider%20Research%20Involving%20Individuals%20With%20 Questionable%20Capacity%20to%20Consent%2011-2009.pdf)

Flory J, Emanuel E. Interventions to improve research participants' understanding in informed consent for research: a systematic review. JAMA 2004; 292: 1593-601.

ISSCR Guidelines for the Clinical Translation of Stem Cells (www.isscr.org/clinical_trans/pdfs/ISSCRGLClinicalTrans.pdf)

Deciding Whether to Enroll in Gene Transfer Research?
http://oba.od.nih.gov/oba/brochure/decide_gene_transfer.pdf