Virtual Mentor. November 2004, Volume 6, Number 11.
Suggested Reading and Resources
Resources on Research Ethics
- 21 Code of Federal Regulations, part 50 Informed consent. Available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm. Accessed October 28, 2004.
- 21 Code of Federal Regulations, part 56 IRB standards. Available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm. Accessed October 28, 2004.
- 21 Code of Federal Regulations, part 312 Rules on investigational new drugs. Available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm. Accessed October 28, 2004.
- 21 Code of Federal Regulations, parts 812 and 813 Investigational devices. Available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm. Accessed October 28, 2004.
- Accreditation Council for Graduation Medical Education (ACGME) General Competencies. Version 1.3 September 28,1999. ChicagoIL, ACGME, 2000.
- Opinion 2.071 Subject selection for clinical trials. American Medical Association. Code of Medical Ethics 2008-2009 Edition. Chicago, IL: American Medical Association; 2008:35.
- American Medical Association. AMA provides outline for developing national clinical trials registry [press release]. Chicago: AMA; September 9, 2004.
- Andre T, Boni C, Mounedji-Boudiaf L, et al. Oxaliplatin, 5-fluorouracil, and leucovorin as adjuvant treatment for colon cancer. N Engl J Med. 2004;350:2343-51.
- Argiles J, Moore-Carrasco R, Busquets S, et al. Catabolic mediators as targets for cancer cachexia. Drug Disc Today. 2003;8:838-844.
- Ariyoshi Sawako. The Doctor's Wife. Hironaka W, Siller A, trans-ed. Tokyo: Kodansha International; 1981.
- Balducci L. New paradigms for treating elderly patients with cancer: the comprehensive geriatric assessment and guidelines for supportive care. J Support Oncol. 2003;1:30-37.
- Banister E. Learning from the experience of others: ethical issues surrounding use of clinical data for teaching and other professional activities. The Royal College of Physicians and Surgeons of Canada. Available at: http://rcpsc.medical.org/publications/annals/vol35-suppl/learning_e.php. Accessed April 21, 2003
- Bear JC. What's my DNA worth, anyway? Perspect Biol Med. 2004; 47:273-289.
- Bekelman JE, Yan LI, Gross CP. Scope and impact of financial conflicts of interest in biomedical research. JAMA. 2003;289:461.
- Bell I, Caspi O, Schwartz G, et al. Integrative medicine and systemic outcomes research: issues in the emergence of a new model for primary health care. Arch Intern Med. 2002;162:133-40.
- Beresin EV, Baldessarini RJ, Alpert J, et al. Teaching ethics of psychopharmacology research in psychiatric residency training programs. Psychopharmacology. 2003;171:105-111.
- Carpenter D, Moore CD. Robust action in a bureaucratic cohort: FDA scientists and the Investigational New Drug Regulations of 1963. Paper presented at: Yale University Conference on American Political Development; October 2004; New Haven, Conn.
- Chadwick R, Berg K. Solidarity and equity: new ethical frameworks for genetic databases. Nature Rev Genetics. 2001; 2:318-321.
- Chopra SS. Industry funding of clinical trials: benefit or bias? JAMA. 2003;290:113.
- Clift RA, Buckner CD, Thomas ED, et al. Marrow transplantation for chronic myeloid leukemia: a randomized study comparing cyclophosphamide and total body irradiation with busulfan and cyclophosphamide. Blood. 1994;84:2036-2043.
- Constenla M. 5-HT3 Receptor antagonists for prevention of late acute-onset emesis. Ann Pharmacother. 2004;38:1683-1691.
- Cunningham D, Humblet Y, Siena S, et al. A randomized comparison of cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med. 2004;351:337-345.
- Daley GQ, Van Etten RA, Baltimore D. Induction of chronic myelogenous leukemia in mice by the P210bcr/abl gene of the Philadelphia chromosome. Science 1990;247:824-830.
- DeAngelis CD, Drazen JM, Frizelle FA, et al. Clinical trail registration: a statement from the International Committee of Medical Journal Editors. JAMA. 2004:292:1363-1364.
- Dickersin K, Rennie D. Registering clinical trails. JAMA. 2003;290:516-523.
- Dowd MD. Breaching the contract: the ethics of nonpublication of research studies. Arch Pediatr Adolec Med. 2004;158:1014-1015.
- Druker BJ, Sawyers CL, Kantarjian H, et al. Activity of a specific inhibitor of the BCR-ABL tyrosine kinase in the blast crisis of chronic myeloid leukemia and acute lymphoblastic leukemia with the Philadelphia chromosome. N Engl J Med. 2001;344:1038-1042.
- Druker BJ, Talpaz M, Resta DJ, et al. Efficacy and safety of a specific inhibitor of the Bcr-Abl tyrosine kinase in chronic myeloid leukemia. N Engl J Med 2001;344:1031-1037.
- Druker BJ, Tamura S, Buchdunger E, et al. Effects of a selective inhibitor of the Abl tyrosine kinase on growth of Bcr-Abl positive cells. Nat Med. 1996;2:561-566.
- Eiseman E, Bloom G, Brower J, et al. Case Studies of Existing Human Tissue Repositories: "Best Practices" for a Biospecimen Resource for the Genomic and Proteomic Era. Santa Monica, Calif.: Rand; 2003.
- Eisenberg D, Davis R, Ettner S, et al. Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey. JAMA. 1998;280:1569-1575.
- Faderl S, Talpaz M, Estrov Z, et al. The biology of chronic myeloid leukemia. N Engl J Med. 1999;341:164-172.
- FDA Institutional Review Board Inspections, FDA Information Sheets, October 1, 1995; Rockville, Maryland: US Food and Drug Administration; 1995.
- Federman DD, Hanna KE, Rodriguez LL, eds. Responsible Research: A Systems Approach to Protecting Research Partiicpants. Committee on Accessing the System for Protecting Human Research Participants. Institute of Medicine. Washington, DC: The National Academies Press; 2002.
- Ferrario E, Ferrari L, Bidoli P, et al. Treatment of cancer-related anemia with epoetin alfa: a review. Cancer Treat Rev. 2004;30:563-575.
- Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 1987;317:141-145.
- Fried C. Medical Experimentation: Personal Integrity and Social Policy. Amsterdam: North Holland; 1974.
- General Accounting Office (GAO), Protecting Human Research Subjects. GAO/HEHS-96-72); 1996:2, 6.
- Glaspy JA. Hematopoietic management in oncology practice. Oncology. 2003;17:1593-1603.
- Guilhot F, Chastang C, Michallet M, et al, for the French Chronic Myeloid Leukemia Study Group. Interferon alfa-2b combined with cytarabine versus interferon alone in chronic myelogenous leukemia. N Engl J Med. 1997;337:223-229.
- Harris J. Ethical genetic research on human subjects. Jurimetrics. 1999; 40:77-91.
- Hellman S, Hellman DS. Of mice but not men: problems of the randomized clinical trial. N Engl J Med. 1991;324:1585-1589.
- Hensley ML, Peterson B, Silver RT, et al. Risk factors for severe neuropsychiatric toxicity in patients receiving interferon alfa-2b and low-dose cytarabine for chronic myelogenous leukemia: analysis of cancer and leukemia Group B 9013. J Clin Oncol. 2000;18:1301-1308.
- Hurwitz H, Fehrenbacher L, Novotny W, et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med. 2004;350:2335-2342.
- Idler E. Self-assessed health and mortality: a review of studies. Internat R Health Psychol. 1992;1:33-54.
- Jemal A, Tiwari RC, Murray T, et al. Cancer statistics, 2004. CA Cancer J Clin. 2004;54:8-29.
- Johns MEE, Barnes M, Florencio PS. Restoring balance to industry-academia relationships in an era of institutional financial conflicts of interest. JAMA. 2003;289:741.
- Kantarjian HM, Sawyers C, Hochhaus A, et al. Hematologic and cytogenetic responses to imatinib mesylate in chronic myeloid leukemia. N Engl J Med 2002;346:645-652.
- Karlawish JHT, Lantos J. Community equipoise and the architecture of clinical research. Camb Q Health Ethics 1997;6:385-396.
- Kligler B, Maizes V, Schacter S, et al. Core competencies in integrative medicine for medical school curricula: A proposal. Acad Med. 2004;79:521–531.
- Kolata G. A widely used arthritis drug is withdrawn. New York Times. October 1, 2004:A-1.
- Kolb HJ, Schattenberg A, Goldman JM, et al, for the European Group for Blood and Marrow Transplantation Working Party Chronic Leukemia. Graft-versus-leukemia effect of donor lymphocyte transfusions in marrow grafted patients. Blood. 1995;86:2041-2050.
- Lamb GM. Veil of secrecy to lift on drug tests. Christian Sci Mon. September 13, 2004: features 11.
- Maizes V, Koffler K, Fleishman S. Revisiting the health history: an integrative medicine approach. Adv Mind-Body Med. 2002; 18(2):31-4.
- Maizes V, Schneider C, Bell I, Weil A. Integrative medical education: development and implementation of a comprehensive curriculum at the University of Arizona. Acad Med. 2002;77:851-860.
- Matthees BJ, Anantachoti P, Kreitzer MJ, Savik K, Hertz MI, Gross CR. Use of complementary therapies, adherence, and quality of life in lung transplant recipients. Heart & Lung: Journal of Acute & Critical Care. 2001;30:258-268.
- Matulonis UA. End of life issues in older patients. Semin Oncol. 2004;31: 274-281.
- Miller FG, Brody H. What makes placebo-controlled trials unethical? Am J Bioeth. 2002;2:3-9.
- Miller FG, Brody H. A critique of clinical equipoise: therapeutic misconception in the ethics of clinical trials. Hastings Cent Rep. 2003;33: 19-28.
- Miller PB and Weijer C. Rehabilitating equipoise. Kennedy Inst Ethics J. 2003;13:93-118.
- Nathan DG, Weatherall DJ. Academic freedom in clinical research. N Engl Med. 2002;347:1368-1371.
- National Cancer Institute. A Guide to Understanding Informed Consent. Available at www.cancer.gov. Accessed October 28, 2004.
- Nightingale S, Bagley GP. FDA sanctions for practitioners for violations of clinical trial regulations and other misconduct. Bull Fed Scientists. 1994;81:7-13.
- O'Brien SG, Guilhot F, Larson RA, et al. Imatinib compared with interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med. 2003;348:994-1004.
- Parks MR, Disis Ml. Conflicts of interest in translational research.J Translational Med. 2004;2:29. Available at: http://www.translational-medicine.com/content/pdf/1479-5876-2-28.pdf. Accessed October 26, 2004.
- Peggs K, Mackinnon S. Imatinib mesylate—the new gold standard for treatment of chronic myeloid leukemia. N Engl J Med. 2003;348:1048-1050.
- President's Council on Bioethics. Being Human: Readings from the Presidential Council on Bioethics. Washington, DC: Presidential Council of Bioethics; 2003.
- Rennie D. Trial registration: a great idea switches from ignored to irresistible. JAMA. 2004;292:1359-1362.
- Sawyers CL. Chronic myeloid leukemia. N Engl J Med. 1999;340:1330-1340.
- Sawyers CL, Hochhaus A, Feldman E, et al. Imatinib induces hematologic and cytogenetic responses in patients with chronic myelogenous leukemia in myeloid blast crisis: results of a phase II study. Blood. 2002;99:3530-3539.
- Silver RT, Woolf SH, Hehlmann R, et al. An evidence-based analysis of the effect of busulfan, hydroxyurea, interferon, and allogeneic bone marrow transplantation in treating the chronic phase of chronic myeloid leukemia: developed for the American Society of Hematology. Blood. 1999;94:1517-1536.
- Start RD, Brown W, Bryant RJ, et al. Ownership and uses of human tissues; does the Nuffield bioethics report accord with opinion of surgical inpatients? BJM. 1996;313:1366-1368.
- Steinbrook R. Public registration of clinical trials. N Engl J Med. 2004;351:315-317.
- Talpaz M, Silver RT, Druker BJ, et al. Imatinib induces durable hematologic and cytogenetic responses in patients with accelerated phase chronic myeloid leukemia: results of a phase 2 study. Blood. 2002;99:1928-1937.
- US Senate: Fair Access to Clinical Trials Act of 2004 (S 2833). Washington, DC: 108th Congress. 2004.
- University of Arizona Program in Integrative Medicine. Available at www.integrativemedicine.arizona.edu. Accessed August 30, 2004.
- Wang SS, Fridinger F, Sheedy KM, Khoury MJ. Public attitudes regarding the donation and storage of blood for genetic research. Community Genet. 2001;4:18-26.
- Weijer C. The ethics of placebo controlled trials. J Bone Mine Res. 2003;18:1150-1153.
- Wolfe LE, Lo B. Ethical issues in clinical research: An issue for all internists. Am J Med. 2000;109:82-85.
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