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.

American Medical Association. Opinion 2.071 Subject selection for clinical trials. AMA Code of Medical Ethics.Availableathttp://www.ama-assn.org/apps/pf_new/pf_online?f_n=browse&doc=policyfiles/HnE/E-2.071.HTM&&s_t=&st_p=&nth=1&prev_pol=policyfiles/HnE/E-1.02.HTM&nxt_pol=policyfiles/HnE/E-2.01.HTM& Accessed October 21, 2004

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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