The Ethics of Withdrawal from Study Participation

References

• 21 C.F.R. 50 (1991).
   Google Scholar
• 45 C.F.R. 46 (2005).
   Google Scholar
• Advisory Committee on Human Radiation Experiments . 1995 . Final Report , Washington, DC : U.S. Government Printing Office .
   Google Scholar
• Agrawal , M. 2003 . Voluntariness in clinical research at the end of life . Journal of Pain and Symptom Management , 25 ( 4 ) : S25 – S32 . [INFOTRIEVE] [CSA]
   Web of Science ®Google Scholar
• Ainsworth-Vaughn , N. 1998 . Claiming Power: Doctor-Patient Talk , New York : Oxford University Press .
   Google Scholar
• Beauchamp , T. L. and Childress , J. F. 1994 . Principles of Biomedical Ethics , 4th , New York : Oxford University Press .
   Google Scholar
• Bender , B. G. , Ellison , M. C. , Gleason , M. , Murphy , J. R. , Sundstrom , D. A. and Szefler , S. J. 2003 . Minimizing attrition in a long-term clinical trial of pediatric asthma . Annals of Allergy and Asthma Immunology , 91 ( 2 ) : 168 – 76 . [CSA]
   Google Scholar
• Bennett , C. L. , Nebeker , J. R. , Lyons , E. A. , Samore , M. H. , Feldman , M. D. , McKoy , J. M. , Carson , K. R. , Belknap , S. M. , Trifilio , S. M. , Schumock , G. T. , Yarnold , P. R. , Davidson , C. J. , Evens , A. M. , Kuzel , T. M. , Parada , J. P. , Cournoyer , D. , West , D. P. , Sartor , O. , Tallman , M. S. and Raisch , D. W. 2001 . The research on adverse drug events and reports (RADAR) project . Journal of the American Medical Association , 293 ( 17 ) : 2131 – 2140 . [CSA] [CROSSREF]
   Google Scholar
• Brody , B. 2001 . Making informed consent meaningful . IRB: Ethics & Human Research , 23 ( 5 ) : 1 – 5 . [INFOTRIEVE] [CSA]
   PubMedGoogle Scholar
• Brody , H. 1992 . The Healer's Power , New Haven, CT : Yale University Press .
   Google Scholar
• Churchill , L. R. , Collins , M. L. , King , N. M. , Pemberton , S. G. and Wailoo , K. A. 1998 . Genetic research as therapy: Implications of ‘gene therapy’ for informed consent . Journal of Law, Medicine, & Ethics , 26 : 38 – 47 . [INFOTRIEVE] [CSA]
   PubMed Web of Science ®Google Scholar
• Edwards , S. J. 2005 . Research participation and the right to withdraw . Bioethics , 19 ( 2 ) : 112 – 130 . [INFOTRIEVE] [CSA] [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Gailey , C.W. 1998 . “ Feminist methods ” . In Handbook of Methods in Cultural Anthropology , Edited by: Bernard , H. R. 203 – 233 . Walnut Creek, CA : Alta Mira Press .
   Google Scholar
• Gotay , C.C. 2001 . Perceptions of informed consent by participants in a prostate cancer prevention study . Cancer Epidemiology Biomarkers Prevention , 10 ( 10 ) : 1097 – 1099 . [CSA]
   Google Scholar
• Graham , P. 2003 . Type of consent does not influence patient recall of serious potential radiation toxicity of adjuvant breast radiotherapy . Australas Radiology , 47 ( 4 ) : 416 – 421 . [CSA] [CROSSREF]
   Google Scholar
• Henderson , G. E. and King , N. M. P. 2001 . Studying benefit in gene transfer research . IRB: Ethics & Human Research , 23 ( 2 ) : 13 – 15 . [INFOTRIEVE] [CSA]
   Google Scholar
• Hougham , G. W. , Sachs , G. A. , Danner , D. , Mintz , J. , Patterson , M. , Roberts , L.W. , Siminoff , L.A. , Sugarman , J. , Whitehouse , P. J. and Wirshing , D. 2003 . Empirical research on informed consent with the cognitively impaired . IRB: Ethics and Human Research , 25 ( 5 ) : S26 – S32 . [INFOTRIEVE] [CSA] [CROSSREF]
   Google Scholar
• Huberman , A. M. and Miles , M. B. 1994 . “ Data management and analysis methods ” . In Handbook of Qualitative Research , Edited by: Denzin , N.K. and Lincoln , Y.S. 413 – 427 . Thousand Oaks, CA : Sage Publications .
   Google Scholar
• Jaffe , S. , Cook , E. F. , Cleary , P. D. , Clark , J. W. and Weeks , J. C. 2001 . Quality of informed consent in cancer clinical trials: A cross-sectional survey . The Lancet , 358 ( 24 ) : 1772 – 1777 . [CSA] [CROSSREF]
   Google Scholar
• Jonas, H. (1969). Philosophical reflections on experimenting on human subjects. Daedalus 98: 219–247 http://falcon.tamucc.edu/~philosophy/pmwiki/pmwiki.php/ProfEthicsS05Sections/BerkichReadingsJonas
   Google Scholar
• Kass , N. E. , Sugarman , J. , Faden , R. and Schoch-Spana , M. 1996 . Trust: The fragile foundation of contemporary biomedical research . Hastings Center Report , 26 ( 5 ) : 25 – 29 . [INFOTRIEVE] [CSA]
   PubMed Web of Science ®Google Scholar
• Keller , C. S. , Gonzales , A. and Fleuriet , K. J. 2005 . Retention of Minority Participants in Clinical Research Studies . Western Journal of Nursing Research , 27 ( 3 ) : 292 – 306 . [INFOTRIEVE] [CSA] [CROSSREF]
   PubMed Web of Science ®Google Scholar
• King , N. M. P. , Henderson , G. E. , Churchill , L. R. , Davis , A. M. , Hull , S. C. , Nelson , D. K. , Parham-Vetter , P. C. , Rothschild , B. B. , Easter , M. M. and Wilfond , B. S. 2005 . Consent forms and the therapeutic misconception: The example of gene transfer research . IRB: Ethics and Human Research , 27 ( 1 ) : 1 – 8 . [INFOTRIEVE] [CSA]
   PubMedGoogle Scholar
• King , N.M.P. , Henderson , G. E. and Stein , J. , eds. 1999 . Beyond Regulations: Ethics in Human Subjects Research , Chapel Hill, NC : North Carolina University Press .
   Google Scholar
• Kodish , E. 2005 . “ Ethics and Research with Children: An Introduction ” . In Ethics and Research with Children: A Case-Based Approach , Edited by: Kodish , E. 3 – 28 . New York : Oxford University Press .
   Google Scholar
• Luborsky , M. 1994 . “ The identification and analysis of themes and patterns ” . In Qualitative Methods in Aging Research , Edited by: Gubrium , J. F. and Sankar , A. 189 – 210 . Thousand Oaks, CA : Sage Publications .
   Google Scholar
• Levine , R. J. 1986 . Ethics and Regulation of Clinical Research , 2nd , New Haven : Yale University Press .
   Google Scholar
• Lewis , J. H. 1984 . An IRB's consent form survey . IRB: Ethics and Human Research , 6 ( 4 ) : 10 [INFOTRIEVE] [CSA] [CROSSREF]
   Google Scholar
• Lidz , C. W. , Appelbaum , P. S. and Meisel , A. 1988 . Two models of implementing informed consent . Archives of Internal Medicine , 148 ( 6 ) : 1385 – 1389 . [INFOTRIEVE] [CSA] [CROSSREF]
   Google Scholar
• Macrina , F. L. 2005 . Scientific Integrity: Text and Cases in Responsible Conduct of Research , 3rd , Washington, DC : ASM Press .
   Google Scholar
• Meade , C. D. 1999 . Improving understanding of the informed consent process and document . Seminars in Oncological Nursing , 15 : 124 – 137 . [CSA] [CROSSREF]
   Google Scholar
• Meisel , A. and Kuczewski , M. 1996 . Legal and ethical myths about informed consent . Archives of Internal Medicine , 156 : 2521 – 2525 . [INFOTRIEVE] [CSA] [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Mishler , E. 1984 . The Discourse of Medicine , Norwood, NJ : Ablex .
   Google Scholar
• Montogomery , C. , Lydon , A. and Lloyd , K. 1999 . Psychological distress among cancer patients and informed consent . Journal of psychosomatic Research , 46 : 241 – 245 . [CSA] [CROSSREF]
   Google Scholar
• Nelson , R. M. and Merz , J. F. 2002 . Voluntariness of consent for research: an empirical and conceptual review . Medical Care , 40 : V69 – 80 . [INFOTRIEVE] [CSA]
   Web of Science ®Google Scholar
• Newton , L. H. 1984 . Agreement to participate in research: Is that a promise? . IRB: Ethics and Human Research , 6 ( 2 ) : 7 – 9 . [INFOTRIEVE] [CSA] [CROSSREF]
   Google Scholar
• Nurgat , Z. A. , Craig , W. , Campbell , N. C. , Bissett , J. D. , Cassidy , J. and Nicholson , M.C. 2005 . Patient motivations surrounding participation in phase I and phase II clinical trials of cancer chemotherapy . British Journal of Cancer , 92 ( 6 ) : 1001 – 1005 . [INFOTRIEVE] [CSA] [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Rogers , A. S. , Schwartz , D. F. , Weissman , G. and English , A. 1999 . A case study in adolescent participation in clinical research: Eleven clinical sites, one common protocol, and eleven IRBs . IRB: Ethics and Human Research , 21 : 6 – 10 . [INFOTRIEVE] [CSA] [CROSSREF]
   Google Scholar
• Scales , R. and Miller , J. H. 2003 . Motivational techniques for improving compliance with an exercise program: skills for primary care clinicians . Current Sports Medicine Reports , 2 ( 3 ) : 166 – 172 . [INFOTRIEVE] [CSA]
   PubMedGoogle Scholar
• Schaeffer , M. H. , Krantz , D. S. , Wichman , A. , Masur , H. and Reed , E. 1996 . The impact of disease severity on the informed consent process in clinical research . The American Journal of Medicine , 100 : 261 – 268 . [INFOTRIEVE] [CSA] [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Shamoo , A. E. and Dunigan , C. D. 2000 . Ethics in research . Proceedings of the Society for Experimental Biology and Medicine , 224 ( 4 ) : 205 – 210 . [INFOTRIEVE] [CSA] [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Silverman , H. , Hull , S. C. and Sugarman , J. 2001 . Variability among institutional review boards' decisions within the context of a multicenter trial . Critical Care Medicine , 29 ( 2 ) : 235 – 241 . [INFOTRIEVE] [CSA] [CROSSREF]
   PubMed Web of Science ®Google Scholar
• The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Office of the Secretary. April 18, 1979 http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm (Accessed: 2 November 2005 ).
   Google Scholar
• Vick , C. C. , Finan , K. R. , Kiefe , C. , Neumayer , L. and Hawn , M. T. 2005 . Variation in institutional review processes for a multisite observational study . The American Journal of Surgery , 190 : 805 – 809 . [CSA] [CROSSREF]
   PubMed Web of Science ®Google Scholar