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Related (The Gonzalez Protocol): Borror KC. Office for Human Research Protections. Determination Letter to Columbia University Health Sciences. 2003-05-13. Accessed on 2006-02-07 at: http://www.hhs.gov/ohrp/detrm_letrs/YR03/may03a.pdf
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Chen XP, Xiao B, Shi W, Xu H, Gao K, Rao J, Zhang Z. Impact of acute vivax malaria on the immune system and viral load of HIV-positive subjects. Chin Med J. 2003;116(12):1810-1820. Accessed on 2006-05-18 at: http://www.cmj.org/Periodical/PDF/2003/2003121810.pdf
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Clause SL, Triller DM, Bornhorst CPH, Hamilton RA, Cosler LE. Conforming to HIPAA Regulations and Compilation of Research Data. Am J Health-Syst Pharm. 2004;61(10):1025-1031. Accessed on 2006-01-14 at: http://www.medscape.com/viewarticle/478848_1 (Requires free registration.)
Cleaton-Jones P. The First Randomised Trial of Male Circumcision for Preventing HIV: What Were the Ethical Issues? PLoS Med. 2005;2(11):e287. Accessed on 2006-02-14 at: http://medicine.plosjournals.org/archive/1549-1676/2/11/pdf/10.1371_journal.pmed.0020287-p-S.pdf
Cleaton-Jones P. Research injury in clinical trials in South Africa. Lancet. 2006;367:458-459. Accessed on 2006-02-10 at: http://www.thelancet.com/journals/lancet/article/PIIS0140673606681580/fulltextprinter (Requires free registration.)
Coffey MJ, Wilfond B, Freedman Ross L. Ethical Assessment of Clinical Asthma Trials Including Children Subjects. Pediatrics. 2004; 113: 87-94. Accessed on 2006-09-04 at: http://pediatrics.aappublications.org/cgi/reprint/113/1/87
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Concar D. A Bitter Pill: Exporting Drug Trials to the Developing World. Amnesty International Magazine. Summer 2003. Accessed on 2008-03-29 at: http://www.amnestyusa.org/Summer_/A_Bitter_Pill_Exporting_Drug_Trials_to_the_Developing_World/page.do?id=1105438&n1=2&n2=19&n3=409
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Emanuel, EJ, Wood A, Fleischman A, Bowen A, Getz KA, Grady C, Levine C, Hammerschmidt DE, Faden R, Eckenwiler L, Tucker Muse C, Sugarman J. Oversight of Human Participants Research: Identifying Problems To Evaluate Reform Proposals. Ann Intern Med. 2004;141(4):282-91. Accessed on 2006-03-02 at: http://www.annals.org/cgi/reprint/141/4/282.pdf
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Emanuel EJ, Lemmens T, Elliot C. Should Society Allow Research Ethics Boards to Be Run As For-Profit Enterprises? PLoS Med. 2006;3(7):e309. Accessed on 2006-07-29 at: http://medicine.plosjournals.org/archive/1549-1676/3/7/pdf/10.1371_journal.pmed.0030309-S.pdf
Related: eLetters responding to: Emanuel EJ, Lemmens T, Elliot C. Should Society Allow Research Ethics Boards to Be Run As For–Profit Enterprises? PLoS Med. 2006;3(7):e309. Accessed on 2007-12-25 at: http://medicine.plosjournals.org/perlserv/?request=read-response&doi=10.1371/journal.pmed.0030309
Epstein M, Wingate DL. Is the NHS Research Ethics Committees System to Be Outsourced to a Low-Cost Offshore Call Centre? J Med. Ethics. 2006. (Pre-Publication) Accessed on 2006-05-10 at: http://jme.bmjjournals.com/preprint/epsteinandwingate.pdf
Ernst E. Winnowing the Chaff of Charlatanism from the Wheat of Science. eCAM Advance Access published online on 2009-02-06. Accessed on 2009-03-09 at: http://ecam.oxfordjournals.org/cgi/content/full/nen089v1
Fernandez CV, Kodish E, Taweel S, Shurin S, Weijer C. Disclosure of the right of research participants to receive research results: An analysis of consent forms in the Children's Oncology Group. Cancer. 2003;97:2904-2909. Accessed on 2006-04-30 at: http://www3.interscience.wiley.com/cgi-bin/fulltext/104532672/PDFSTART (Free registration required.)
Fisher B, Redmond CK. Fraud in Breast-Cancer Trials. N Engl J Med. 1994;330(20):1458-1462. Accessed on 2006-05-10 at: http://content.nejm.org/cgi/content/full/330/20/1458 (Free registration required.)
Fisk NM, Roberts IA, Markwald R, Mironov V. Can Routine Commercial Cord Blood Banking Be Scientifically and Ethically Justified? PLoS Med. 2005;2(2):e44. Accessed on 2006-03-02 at: http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0020044
Fraser HE, Martlew AE, Frew DJ. Model for a single ethical and scientific review of multicentre research in New South Wales. MJA 2007;187 (1): 7-8. Accessed on 2007-08-20 at: http://www.mja.com.au/public/issues/187_01_020707/fra10429_fm.html
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Frisch M, Schwartz BS. The Pitfalls of Hair Analysis for Toxicants in Clinical Practice: Three Case Reports. Environ Health Perspect. 2002;110(4):433-436 [Online 2002-04-12]. Accessed on 2006-06-30 at: http://www.ehponline.org/members/2002/110p433-436frisch/EHP110p433PDF.PDF
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Fugh-Berman AJ, 2010 The Haunting of Medical Journals: How Ghostwriting Sold HRT
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Glickman SW, McHutchison JG, Peterson ED, Cairns CB, Harrington RA, Califf RM, Schulman KA. Ethical and Scientific Implications of the Globalization of Clinical Research. N Engl J Med. 2009;360(8): 816-823. Accessed on 2009-02-17 at: http://content.nejm.org/cgi/content/full/360/8/816
Goldfarb NM. The Tranquil World of IND Safety Reports. Journal of Clinical Research Best Practices 2008;4(2). Accessed on 2009-02-18 at: http://www.firstclinical.com/journal/2008/0802_IND_Reports.pdf
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Gross CP, Krumholz HM, Van Wye G, Emanuel EJ, Wendler D. Does Random Treatment Assignment Cause Harm to Research Participants? PLoS Med. 2006;3(6):e188. Accessed on 2006-06-09 at: http://medicine.plosjournals.org/archive/1549-1676/3/6/pdf/10.1371_journal.pmed.0030188-p-S.pdf
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Hill TP. Phase 0 Trials: Are They Ethically Challenged? Clin Cancer Res. 2007;13:783-784. Accessed on 2008-03-05 at: http://clincancerres.aacrjournals.org/cgi/content/full/13/3/783
Hoffman SL. Experimental Challenge of Volunteers with Malaria. Ann Intern Med. 1997;127(3):233-235. Accessed on 2006-09-30 at: http://www.annals.org/cgi/content/full/127/3/233
Holloway KFC. Accidental Communities: race, emergency medicine, and the problem of Polyheme. AJOB. 2006;15:10. Accessed on 2006-03-10 at: http://www.bioethics.net/journal/pdf/UAJB_A_166839.pdf
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Horstmann E, McCabe MS, Grochow L, Yamamoto S, Rubinstein L, Budd T, Shoemaker D, Emanuel EJ, Grady C. Risks and Benefits of Phase 1 Oncology Trials, 1991 through 2002. N Engl J Med. 2005;352:895-904. Accessed on 2006-03-02 at: http://content.nejm.org/cgi/reprint/352/9/895.pdf (Free registration required.)
Huijer M, Van Leeuwen E. Personal values and cancer treatment refusal. J Med Ethics 2000;26:358-62. Accessed on 2006-09-19 at: http://jme.bmjjournals.com/cgi/content/full/26/5/358
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Kimmelman J, Palmour N. Therapeutic optimism in the consent forms of phase 1 gene transfer trials: an empirical analysis. J Med. Ethics. 2005;31:209-214. Accessed on 2006-05-10 at: http://jme.bmjjournals.com/cgi/content/full/31/4/209
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Kipnis K, King NMP, Nelson RM. An open letter to IRBs considering Northfield Laboratories' Polyheme trial. AJOB. 2006;15:34. Accessed on 2006-03-10 at: http://www.bioethics.net/journal/pdf/UAJB_A_166837.pdf
Kipnis K, King NMP, Nelson RM. Trials and errors: barriers to oversight of research conducted under the emergency research consent waiver. IRB: Ethics and Human Research. 2006;28(2):16-19. Accessed on 2006-03-10 at: http://www.thehastingscenter.org/publications/irb/irb.asp (Free registration required.)
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Kruszewski SP, Paczynski RP, Bialy M. State Medical Board Responses to an Inquiry on Physician Researcher Misconduct. Journal of Medical Licensure and Discipline 2008;94(1):16-22. Accessed on 2009-02-01 at: http://psychrights.org/Research/Digest/Science4Sale/MdResearcherMisconductKruszewski2008.pdf
Anomalous Citations Awaiting Correction
The Antineoplaston Anomaly: How A Drug Was Used For Decades In Thousands Of Patients, With No Safety, Efficacy Data. The Cancer Letter. 1998;24(36):1. Available from http://www.cancerletter.com/vol24n36.html. Accessibility verified 2006-04-25.
Enhancing the Accountability of Alternative Medicine. The Millbank Memorial Fund. 1998. Accessed on 2006-03-10 at: http://www.milbank.org/mraltmed.html
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