References
- Advisory Committee on Human Radiation Experiments, (ACHRE) . 1996 . “ Research Proposal Review Project. ” . In Final Report of the Advisory Committee on Human Radiation Experiments , New York : Oxford University Press .
- Advisory Committee on Human Radiation Experiments (ACHRE). 1996 . “ Subject Interview Study. ” . In Final Report of the Advisory Committee on Human Radiation Experiments , New York : Oxford University Press .
- Appelbaum , P. S. , Lidz , C. W. and Meisel , A. 1987 . Informed Consent: Legal Theory and Clinical Practice , New York : Oxford University Press .
- Council for International Organizations of Medical Sciences (CIOMS). 2002 . International Ethical Guidelines for Biomedical Research Involving Human Subjects , Geneva : Author .
- Daugherty , C. K. , Banik , D. M. , Janish , L. and Ratain , M. J. 2000 . Quantitative Analysis of Ethical Issues in Phase I Trials: A Survey Interview Study of 144 Advanced Cancer Patients . IRB , 22 ( 3 ) : 6 – 14 . [PUBMED] [INFOTRIEVE] [CSA]
- Flory , J. S. and Emanuel , E. J. 2004 . Interventions to Improve Research Participants’ Understanding in Informed Consent for Research . Journal of the American Medical Association , 292 : 1593 – 1601 . [PUBMED] [INFOTRIEVE] [CROSSREF]
- Horng , S. 2002 . Descriptions of Benefits and Risks in Consent Forms for Phase 1 Oncology Trials . New England Journal of Medicine , 347 ( 26 ) : 2134 – 2140 . [PUBMED] [INFOTRIEVE] [CROSSREF]
- Joffe , S. 2001 . Quality of Informed Consent in Cancer Clinical Trials: A Cross-Sectional Survey . Lancet , 358 ( 9295 ) : 1772 – 1777 . [PUBMED] [INFOTRIEVE] [CROSSREF]
- Kass , N. E , Maman , S. and Atkinson , J. Is “Informed Choice” a Reality for Research Participation in Developing Countries? The Experience in Three International Research Studies . in review
- Layton , S. and Korsen , J. 1994 . Informed Consent in Oral and Maxillofacial Surgery: A Study of the Value of Written Warnings . British Journal of Oral and Maxillofacial Surgery , 32 : 34 – 46 . [CSA]
- Levine , R. J. 1986 . Ethics and Regulation of Clinical Research , New Haven, CT : Yale University Press .
- Macklin , R. 1999 . Understanding Informed Consent . Acta Oncologica , 38 : 83 – 87 . [PUBMED] [INFOTRIEVE] [CROSSREF]
- Meisel , A. and Kuczewski , M. 1996 . Legal Myths About Informed Consent . Archives of Internal Medicine , 156 : 2521 – 2526 . [PUBMED] [INFOTRIEVE] [CROSSREF] [CSA]
- Morrow , G. , Gootnick , J. and Scmale , A. 1978 . A Simple Technique for Increasing Cancer Patients Knowledge of Informed Consent to Treatment . Cancer , 42 : 793 – 799 . [PUBMED] [INFOTRIEVE]
- Murray , T. H. 1980 . Commentary: Was This Deception Really Necessary? . IRB , 2 ( 10 ) : 7 – 8 . [PUBMED] [INFOTRIEVE]
- National Bioethics Advisory Commission (NBAC). 2001 . Ethical and Policy Issues in Research Involving Human Participants: Report and Recommendations of the National Bioethics Advisory Commision , Bethesda : U.S. Government .
- Neptune , S. M. 1996 . Take-Home Informed Consent for Intravenous Contrast Media . Investigative Radiology , 31 ( 2 ) : 109 – 113 . [PUBMED] [INFOTRIEVE] [CROSSREF] [CSA]
- Paasche-Orlow , M. K. , Taylor , H. A. and Brancati , F. L. 2003 . Readability Standards for Informed-Consent Forms as Compared with Actual Readability . New England Journal of Medicine , 348 ( 8 ) : 721 – 726 . [PUBMED] [INFOTRIEVE] [CROSSREF]
- Puglisi , T . 2000 . “ IRB Knowledge of Local Research Context ” . Accessed on 8/10/04.
- Rodenhuis , S. 1984 . Patient Motivation and Informed Consent in a Phase I Study of an Anticancer Agent . European Journal of Cancer Clinical Oncology , 20 : 457 – 462 . [PUBMED] [INFOTRIEVE] [CROSSREF] [CSA]
- Silva , M. C. and Sorrell , J.M. 1988 . Enhancing Comprehension of Information for Informed Consent . IRB , 10 ( 1 ) : 1 – 5 . [PUBMED] [INFOTRIEVE]
- Sugarman , J. 1999 . Empirical Research on Informed Consent: An Annotated Bibliography . Hastings Center Report , 29 ( 1 ) : S1 – 42 . [PUBMED] [INFOTRIEVE] [CSA]
- Titus , S. L. and Keane , M. A. 1996 . Do You Understand? An Ethical Assessment of Researchers’ Description of the Consenting Process . Journal of Clinical Ethics , 7 ( 1 ) : 60 – 68 . [PUBMED] [INFOTRIEVE] [CSA]
- U.S. Food and Drug Administration. (1998). Information Sheets: A Guide to Informed Consent http://www.fda.gov/oc/ohrt/irbs/informedconsent.html (http://www.fda.gov/oc/ohrt/irbs/informedconsent.html) (Accessed: 8/23/04 ).
- Wendler , D. 1996 . Deception in Medical and Behavioral Research: Is It Ever Acceptable? . The Milbank Quarterly , 74 ( 1 ) : 87 – 114 . [PUBMED] [INFOTRIEVE] [CSA]
- Wendler , D. and Rackoff , J. E. 2001 . Informed Consent and Respecting Autonomy: What’s a Signature Got to Do With It? . IRB , 23 ( 3 ) : 1 – 4 . [PUBMED] [INFOTRIEVE] [CSA]