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Articles on Human Research Protections and Related Topics Authors A — K

A | B | C | D | E | F | G | H | I | J | K
L | M | N | O | R | S | T | V | W | Y | Z

U.S. Food and Drug Administration. Clinical Testing Synopsis of the New Drug Regulations. FDA Papers March 1967: 21-25. http://www.circare.org/fda/clinicaltesting_fdapapers_031967.pdf

U.S. Food and Drug Administration. Use of approved drugs for unlabeled indications. FDA Drug Bulletin. 1982;12(1):4-5: http://www.circare.org/fda/fdadrugbulletin_041982.pdf

Agrawal M, Emanuel EJ. Ethics of phase 1 oncology studies: reexamining the arguments and data. JAMA. 2003;290:1075-1082. Accessed on 2006-01-14 at: http://jama.ama-assn.org/cgi/content/abstract/290/8/1075

Amariglio N, Hirshberg A, Scheithauer BW, Cohen Y, Loewenthal R, et al. Donor-Derived Brain Tumor Following Neural Stem Cell Transplantation in an Ataxia Telangiectasia Patient. PLoS Medicine 2009;6(2): e29. Accessed on 2009-02-18 at: http://dx.doi.org/10.1371/journal.pmed.1000029

Angers RC, Seward TS, Napier D, Green M, Hoover E, Spraker T, et al. Chronic wasting disease prions in elk antler velvet. Emerg Infect Dis. 2009 May; [Epub ahead of print]. Accessed on 2009-03-30 at: http://www.cdc.gov/eid/content/15/5/pdfs/08-1458.pdf

Antonuccio DO, Healy D. The researcher's credo. BMJ;2008;336:629-629. Accessed on 2008-03-21 at: http://www.bmj.com/cgi/content/full/336/7645/629

Asser SM, Swan R. Child Fatalities From Religion-motivated Medical Neglect. Pediatrics. 1998;101:625-629. Accessed on 2006-01-14 at: http://www.pediatrics.org/cgi/content/full/101/4/625

Atlas MC. Retraction policies of high-impact biomedical journals. J Med Libr Assoc. 2004;92(2):242-250. Accessed on 2006-01-14 at: http://www.pubmedcentral.gov/picrender.fcgi?artid=385306&action=stream&blobtype=pdf

Atwood KC. The National Center for Complementary and Alternative Medicine: Ongoing Problems. Skeptical Inquirer. 2003;27(5). Accessed on 2006-02-07 at: http://www.csicop.org/si/2003-09/alternative-medicine.html

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

Borror KC. Office for Human Research Protections. Determination Letter to Columbia University Health Sciences. 2002-12-02. Accessed on 2006-02-07 at: http://www.hhs.gov/ohrp/detrm_letrs/YR02/dec02d.pdf

Atwood KC, Woeckner E, Baratz RS, Sampson WI. Why the NIH Trial to Assess Chelation Therapy (TACT) Should Be Abandoned. Medscape J Med 2008;10(5):115. Accessed on 2008-06-11 at: http://journal.medscape.com/viewarticle/570625 (Requires free registration)

TACT Trial Website: http://www.chelationwatch.org/s/tact/index.html. For additional information see: Atwood KA. The TACT is at least as Bad as We Predicted. Science Based Medicine. Accessed on 2008-06-11 at: http://www.sciencebasedmedicine.org/?p=132


Beauchamp TL. Methods and principles in biomedical ethics. J Med Ethics. 2003;29:269-274. Accessed on 2006-05-10 at: http://jme.bmjjournals.com/cgi/content/full/29/5/269

Beecher HK. Ethics and clinical research. N Engl J Med. 1966;274(24):1354-1360. Accessed on 2006-05-01 at: http://web.archive.org/web/20100409100343/http://www.hhs.gov/ohrp/documents/BeecherArticle.pdf

Bero L, Oostvogel F, Bacchetti P, Lee K. Factors Associated with Findings of Published Trials of Drug–Drug Comparisons: Why Some Statins Appear More Efficacious than Others. PLoS Med 2007;4(6): e184. Accessed on 2007-06-10 at: http://dx.doi.org/10.1371/journal.pmed.0040184

Beyerstein BL. Distinguishing science from pseudoscience. Center for Curriculum and Professional Development, Simon Frasier University. 1996-10. Accessed on 2006-02-07 at: http://www.sfu.ca/~beyerste/research/articles/02SciencevsPseudoscience.pdf

Beyerstein BL. Alternative medicine and common errors of reasoning. Acad Med 2001;76:230-237. Accessed on 2006-03-10 at: http://www.academicmedicine.org/cgi/reprint/76/3/230

Beck JM, Azari E. FDA, Off-Label Use, and Informed Consent: Debunking Myths and Misconceptions. Food & Drug L. J. 2001;53:71-104. Accessed on 2006-01-14 at: http://web.archive.org/web/20040623021551/http://library.lp.findlaw.com/articles/00081/001502.pdf

Bentley JP, Thacker PG. The influence of risk and monetary payment on the research participation decision making process. J Med Ethics. 2004;30:293-298. Accessed on 2006-02-10 at: http://jme.bmjjournals.com/cgi/content/full/30/3/293

Black N, Barker M, Payne M. Cross sectional survey of multicentre clinical databases in the United Kingdom. BMJ 2004;328:1478. Accessed on 2006-02-10 at: http://bmj.bmjjournals.com/cgi/content/full/328/7454/1478

Boozang KM et al. Conflicts of Interest in Clinical Trial Recruitment & Enrollment: A Call for Increased Oversight. The Center for Health & Pharmaceutical Law & Policy, Seton Hall University School of Law. 2009-11: http://law.shu.edu/ProgramsCenters/HealthTechIP/upload/health_center_whitepaper_nov2009.pdf

Bradford GE, Elben CC. The Drug Package Insert and the PDR as Establishing the Standard of Care in Prescription Drug Liability Cases. J Mo Bar. 2001;57(5). Accessed on 2006-02-10 at: http://www.mobar.org/journal/2001/sepoct/bradford.htm

Bramstedt KA. A study of warning letters issued to clinical investigators by the United States Food and Drug Administration. Clin Invest Med. 2004;27(3):129-34. Accessed on 2006-02-10 at: http://www.cma.ca/multimedia/staticContent/HTML/N0/l2/cim/vol-27/issue-3/pdf/pg129.pdf

Bramstedt KA, Kassimatis K. A study of warning letters issued to institutional review boards by the United States Food and Drug Administration. Clin Invest Med 2004;27(6):316-23. Accessed on 2006-02-10 at: http://www.cma.ca/multimedia/staticContent/HTML/N0/l2/cim/vol-27/issue-6/pdf/pg316.pdf

Bramstedt KA. Recruiting Healthy Volunteers for Research Participation via Internet Advertising. Clin Med Res. 2007 Jun;5(2):91-7. Accessed on 2007-08-22: http://www.clinmedres.org/cgi/content/full/5/2/91

Brazier M. Exploitation and enrichment: the paradox of medical experimentation. J Med Ethics. 2008;34:180-183. Accessed on 2008-03-05 at: http://jme.bmj.com/cgi/content/full/34/3/180

Brody BA, McCullough LB, Sharp RR. Consensus and Controversy in Clinical Research Ethics. JAMA. 2005;294:1411-1414. Accessed on 2006-04-30 at: http://jama.ama-assn.org/cgi/content/full/294/11/1411 (Free registration required.)

Brown P, Morello-Frosch R, Brody JG, Altman RG, Rudel RA, Senier L, Pérez C, Simpson R. Institutional review board challenges related to community-based participatory research on human exposure to environmental toxins: a case study. Environ Health. 2010 Jul 16;9:39. Accessed on 2010-08-16 at: http://dx.doi.org/10.1186/1476-069X-9-39

Carome M. Is Informed Consent Always Necessary for Randomized, Controlled Trials? N Engl J Med 1999;341:448-449. Accessed on 2006-04-30 at: http://content.nejm.org/cgi/content/full/341/6/448 (Free registration required.)

Cave E, Holm S. New governance arrangements for research ethics committees: is facilitating research achieved at the cost of participants' interest. J Med. Ethics. 2002;28:318-321. Accessed on 2006-05-10 at: http://jme.bmjjournals.com/cgi/content/full/28/5/318

de Castro LC, Sy PA, Alvarez AAA, Mendez RV, Rasco JK. Bioethics in the Asia-Pacific Region: Issues and Concerns: Proceedings of Regional Meeting on Ethics of Science and Technology. 2003-11-07. Accessed on 2006-04-27 at: http://web.archive.org/web/20050228001323/http://www.unescobkk.org/ips/ebooks/documents/ethic_in_asia_pacific/1_109BIOTHICS.PDF


Centers for Disease Control. Deaths Associated with Hypocalcemia from Chelation Therapy — Texas, Pennsylvania, and Oregon, 2003–2005. MMWR Weekly March 3, 2006 / 55(08);204-207. Accessed on 2006-03-02 at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5508a3.htm?s_cid=mm5508a3_e

Centers for Disease Control. Outbreak of Mesotherapy-Associated Skin Reactions — District of Columbia Area, January-February 2005. MMWR Weekly November 11, 2005 / 54(44);1127-1130. Accessed on 2006-10-08 at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5444a4.htm

Charnely G, Patterson J. Review of Procedures for Protecting Human Subjects in Recent Clinical Studies of Pesticides. 200306-30. Accessed on 2010-10-11 at: http://www.tera.org/publications/humanstudiesmanuscript%20accepted.pdf

Charo RA. Body of Research – Ownership and Use of Human Tissue. N Engl J Med 2006;355:1517-1519. Accessed on 2006-10-13 at: http://content.nejm.org/cgi/content/full/355/15/1517. (Requires free registration.)

Chen EX, Tannock IF. Risks and Benefits of Phase 1 Clinical Trials Evaluating New Anticancer Agents. JAMA. 2004;292:2150-2151. Accessed on 2006-02-14 at: http://jama.ama-assn.org/cgi/content/full/292/17/2150 (Requires free registration.)

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

Chen XP, Xiao B, Xu H, Shi W, Gao K, Rao J. Procedure and clinical assessments of malariotherapy: recent experience in 20 HIV patients. Chin Med J (Engl). 2003;116(7):1016-21. Accessed on v at: http://www.cmj.org/Periodical/PDF/2003/200371016.pdf

Chen XP, Heimlich, HJ, Xiao, B, Liu, S, Lu, Y, Yao, J, Spletzer, EG. Phase-1 Studies of Malariotherapy for HIV Infection. Chin Med Sci J. 1999;14(4):224-8. Accessed on 2006-06-09 at: http://www.bioethicswatch.org/foia/imt_cjms1999.pdf

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

Collier R. Legumes, lemons and streptomycin: A short history of the clinical trial. CMAJ 2009;180(1). Accessed on 2009-03-17 at: http://dx.doi.org/10.1503/cmaj.081879

Collier R. Drug development cost estimates hard to swallow. CMAJ 2009;180(3). Accessed on 2009-03-17 at: http://dx.doi.org/10.1503/cmaj.082040

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

Corrigan OP. Pharmacogenetics, ethical issues: review of the Nuffield Council on Bioethics Report. J Med. Ethics. 2005;31:144-148. Accessed on 2006-05-10 at: http://jme.bmjjournals.com/cgi/content/full/31/3/144


DeCosta A, D'Souza N, Krishnan N, Chhabra MS, Shihaam I, Goswami K. Community based trials and informed consent in rural north India. J Med Ethics. 2004;30:318-323. Accessed on 2006-02-14 at: http://jme.bmjjournals.com/cgi/content/full/30/3/318

Decullier E, Chan AW, Chapuis F. Inadequate Dissemination of Phase I Trials: A Retrospective Cohort Study. PLoS Medicine 2009;6(2): e34. Accessed on 2009-02-18 at: http://dx.doi.org/10.1371/journal.pmed.1000034

Dickert N, Emanuel E, Grady C. Paying research subjects: an analysis of current policies. Ann Intern Med. 2002;136:368-373. Accessed on 2006-04-30 at: http://www.annals.org/cgi/content/full/136/5/368

Dunn LB, Gordon NE. Improving informed consent and enhancing recruitment for research by understanding economic behavior. JAMA. 2005 Feb 2;293(5):609-12. Accessed on 2006-02-14 at: http://jama.ama-assn.org/cgi/content/full/293/5/609 (Requires free registration.)

DuVal G. Institutional ethics reviews of clinical study agreements. J Med. Ethics 2004;30:30-34. Accessed on 2008-03-26 at: http://dx.doi.org/10.1136/jme.2003.005199 (Requires free registration.)

Dworkin RW. Science, Faith, and Alternative Medicine. Policy Review. 2001;108. Accessed on 2006-03-02 at: http://www.policyreview.org/AUG01/dworkin_print.html

Ellenberg SS, Temple R. Placebo-controlled trials and active control trials in the evaluation of new treatments. Part 2: Practical issues and specific cases. Ann Intern Med. 2000;133:464-70. Accessed on 2006-04-30 at: http://www.annals.org/cgi/content/full/133/6/464

Elliot C. Guinea–Pigging. The New Yorker. 2008-01-07. Accessed on 2008-03-26 at: http://www.newyorker.com/reporting/2008/01/07/080107fa_fact_elliott?currentPage=all

Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA. 2000;283(20):2701-11. Accessed on 2006-03-02 at: http://jama.ama-assn.org/cgi/content/full/283/20/2701

Emanuel EJ, Wendler D, Killen J, Grady C. What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research. J Infect Dis. 2004;189:930-937. Accessed on 2006-03-02 at: http://www.journals.uchicago.edu/JID/journal/issues/v189n5/31380/31380.html

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

Emanuel EJ, Currie XE, Herman A; Project Phidisa. Undue inducement in clinical research in developing countries: is it a worry? Lancet. 2005;366(9482):336-40. Accessed on 2006-03-02 at: http://www.thelancet.com/journals/lancet/article/PIIS0140673605669929/fulltext (Free registration required.)

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

Fried TR, Bradley EH, Towle VR, Allore H. Understanding the treatment preferences of seriously ill patients. N Engl J Med 2002;346:1061-6. Accessed on 2006-09-19 at: http://content.nejm.org/cgi/content/full/346/14/1061

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

Frumkin H, Manning CC, Williams PL, Sanders A, Taylor BB, Pierce M, Elon L, Hertzberg VS. Diagnostic chelation challenge with DMSA: a biomarker of long-term mercury exposure? Environ Health Perspect. 2001;109(2):167-71. Accessed on 2006-06-30 at: http://www.pubmedcentral.gov/articlerender.fcgi?tool=pubmed&pubmedid=11266328

Fugh-Berman AJ, 2010 The Haunting of Medical Journals: How Ghostwriting Sold HRT. PLoS Med 7(9): e1000335. Accessed on 2010-09-08 at: http://dx.doi.org/10.1371/journal.pmed.1000335


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

Goodyear M. Learning from the TGN1412 trial. BMJ 2006;332:677-678. Accessed on 2006-03-21 at: http://dx.doi.org/10.1136/bmj.38797.635012.47

Grady C. Quality Improvement and Ethical Oversight. Ann Intern Med 2007;146(9):680-681. Accessed on 2007-05-03 at: http://www.annals.org/cgi/content/short/146/9/680

Greely HT. Moving Human Embryonic Stem Cells from Legislature to Lab: Remaining Legal and Ethical Questions. PLoS Med. 2006;3(5):e143. Accessed on 2006-05-09 at: http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1382005

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

Harris J. Scientific research is a moral duty. J Med Ethics. 2005;31:242-248. Accessed on 2008-03-05 at: http://jme.bmj.com/cgi/content/full/31/4/242

Heath E. The History, Function, and Future of Independent Institutional Review Boards. in: Ethical and Policy Issues in Research Involving Human Participants Volume II Commissioned Papers and Staff Analysis. National Bioethics Advisory Commission, Bethesda, Maryland (August 2001) ISBN 1-931022-17-8. Accessed on 2006-03-02 at: http://www.georgetown.edu/research/nrcbl/nbac/human/overvol2.html

Heimlich HJ, Chen XP, Xiao BQ, Liu SG, Lu YH, Spletzer EG, Yao JL. Malariotherapy For HIV Patients. Presented by Dr. Henry Heimlich at the First International Conference on Immunology and Aging, National Institutes of Health, Bethesda, June 18, 1996. Accessed on 2006-09-19 at: http://web.archive.org/web/20021022101930/http://www.heimlichinstitute.org/malariohiv.html (Page last modified 2002-10-22.)

Ed. this paper was subsequently published as: Heimlich HJ, Chen XP, Xiao BQ, Liu SG., Lu YH, Spletzer EG, Yao JL. Malariotherapy for HIV patients. Mech Ageing Dev. 1997;93(1-3):79-85. Accessed on 2006-09-19 at: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=9089572

Henderson GE, Churchill LR, Davis AM, Easter MM, Grady C, et al. Clinical Trials and Medical Care: Defining the Therapeutic Misconception. PLoS Med 2007;4(11): e324. Accessed on 2007-12-25 at: http://dx.doi.org/10.1371/journal.pmed.0040324

Hey E. The 1996 Continuous Negative Extrathoracic Pressure (CNEP) trial: were parents' allegations of research fraud fraudulent? Pediatrics 2006: 117(6); 2244-6. Accessed on 2007-12-07 at: http://pediatrics.aappublications.org/cgi/content/full/117/6/2244

Herxheimer A. Communicating with Patients about Harms and Risks. PLoS Med. 2005;2(2):e42. Accessed on 2006-03-02 at: http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0020042

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

Hope T, McMillan J. Challenge studies of human volunteers: ethical issues. J Med. Ethics 2004;30:110-116. Accessed on 2008-03-26 at: http://dx.doi.org/10.1136/jme.2003.004440 (Free registration required.)

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


Ioannidis JPA. Evolution and translation of research findings: From bench to where? PLoS Clin Trials. 2006;1(7): e36. Accessed on 2006-12-01 at: http://clinicaltrials.plosjournals.org/archive/1555-5887/1/7/pdf/10.1371_journal.pctr.0010036-L.pdf

Joffe S, Harrington DP, George SL, Emmanuel EJ, Budzinski LA, Weeks JC. Satisfaction of the uncertainty principle in cancer clinical trials: retrospective cohort analysis. BMJ. 2004;328:1463. Accessed on 2006-03-02 at: http://bmj.bmjjournals.com/cgi/reprint/328/7454/1463

Kerridge I, Lowe M, Mitchell K. Competent patients, incompetent decisions. Ann Intern Med 1995;123:878-81. Accessed on 2006-09-19 at: http://www.annals.org/cgi/content/full/123/11/878

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

King M, Nazareth I, Lampe F, Bower P, Chandler M, Morou M, Sibbald B, Lai R. Conceptual framework and systematic review of the effects of participants' and professionals' preferences in randomised controlled trials. Health Technol Assess. 2005;9(35). Accessed on 2006-04-27 at: http://www.hta.ac.uk/fullmono/mon935.pdf

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.)

van Kleffens T, van Leeuwen E. Physicians' evaluations of patients' decisions to refuse oncological treatment. J Med Ethics 2005 Mar;31(3):131-6. Accessed on 2006-09-19 at: http://jme.bmjjournals.com/cgi/content/full/31/3/131

Kiatpongsan S, Sipp D. Offshore stem cell treatments. Nature Stem Cell Reports. 2008-12-03. Accessed on 2009-12-04 at: http://www.nature.com/stemcells/2008/0812/081203/full/stemcells.2008.151.html

Kopelman LM. Children as Research Subjects: Moral Disputes, Regulatory Guidance, and Recent Court Decisions. Mount Sinai Journal of Medicine. 2006;73(3):596-604. Accessed on 2006-05-31: http://www.mssm.edu/msjournal/73/73_3_pages_596_604.pdf

Kramer BS, Wilentz J, Alexander D, Burklow J, Friedman LM, et al. Getting it right: Being smarter about clinical trials. PLoS Med. 2006;3(6):e144. Accessed on 2006-05-09 at: http://www.pubmedcentral.nih.gov/picrender.fcgi?artid=1435786&blobtype=pdf

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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