An essential ethical condition for a randomized clinical trialcomparing two treatments for a disease is that there be no goodreason for thinking one is better than the other.1,2 Usually,investigators hope and even expect that the new treatment willbe better, but there should not be solid evidence one way orthe other. If there is, not only would the trial be scientificallyredundant, but the investigators would be guilty of knowinglygiving inferior treatment to some participants in the trial.The necessity for investigators to be in this state of equipoise2applies to placebo-controlled trials, as well. . . . [Full Text of this Article]
Van Howe, R. S., Svoboda, J. S.
(2008). Neonatal Pain Relief and the Helsinki Declaration. J Law Med Ethics
36: 803-823
Buchanan, D., Sifunda, S., Naidoo, N., James, S., Reddy, P.
(2008). Assuring Adequate Protections in International Health Research: A Principled Justification and Practical Recommendations for the Role of Community Oversight. Public Health Ethics
1: 246-257
[Abstract][Full Text]
Epstein, S.
(2008). The Rise of `Recruitmentology': Clinical Research, Racial Knowledge, and the Politics of Inclusion and Difference. Social Studies of Science
38: 801-832
[Abstract]
Shah, S, Wu, T
(2008). The medical student global health experience: professionalism and ethical implications. J. Med. Ethics
34: 375-378
[Abstract][Full Text]
Tausig, M., Subedi, S., Subedi, J.
(2007). The bioethics of medical research in very poor countries. Health (London)
11: 145-161
[Abstract]
Buchanan, D R, Miller, F G
(2006). A public health perspective on research ethics. J. Med. Ethics
32: 729-733
[Abstract][Full Text]
Kennedy, S B, Harris, A O, Oudemans, E, Young, L, Kollie, J, Nelson, E S, Nisbett, R A, Morris, C, Bartee, N, George-Williams, E, Jones, J
(2006). Developing capacity to protect human research subjects in a post-conflict, resource-constrained setting: procedures and prospects.. J. Med. Ethics
32: 592-595
[Abstract][Full Text]
Buchanan, D. R., Miller, F. G.
(2006). Justice and Fairness in the Kennedy Krieger Institute Lead Paint Study: the Ethics of Public Health Research on Less Expensive, Less Effective Interventions. Am. J. Public Health
96: 781-787
[Abstract][Full Text]
Shaffer, D N, Yebei, V N, Ballidawa, J B, Sidle, J E, Greene, J Y, Meslin, E M, Kimaiyo, S J N, Tierney, W M
(2006). Equitable treatment for HIV/AIDS clinical trial participants: a focus group study of patients, clinician researchers, and administrators in western Kenya. J. Med. Ethics
32: 55-60
[Abstract][Full Text]
Fischer, B. A IV
(2006). A Summary of Important Documents in the Field of Research Ethics. Schizophr Bull
32: 69-80
[Abstract][Full Text]
Riessman, C. K.
(2005). Exporting ethics: a narrative about narrative research in South India. Health (London)
9: 473-490
[Abstract]
Stern, A. M., Markel, H.
(2005). The History Of Vaccines And Immunization: Familiar Patterns, New Challenges. Health Aff (Millwood)
24: 611-621
[Abstract][Full Text]
Milstien, J., Cash, R. A., Wecker, J., Wikler, D.
(2005). Development Of Priority Vaccines For Disease-Endemic Countries: Risk And Benefit. Health Aff (Millwood)
24: 718-728
[Abstract][Full Text]
Harris, J.
(2005). Scientific research is a moral duty. J. Med. Ethics
31: 242-248
[Full Text]
Bhutta, Z.
(2004). Standards of care in research. BMJ
329: 1114-1115
[Full Text]
Kent, D. M., Mwamburi, D. M., Bennish, M. L., Kupelnick, B., Ioannidis, J. P. A.
(2004). Clinical Trials in Sub-Saharan Africa and Established Standards of Care: A Systematic Review of HIV, Tuberculosis, and Malaria Trials. JAMA
292: 237-242
[Abstract][Full Text]
Wendler, D., Emanuel, E. J., Lie, R. K.
(2004). The Standard of Care Debate: Can Research in Developing Countries Be Both Ethical and Responsive to Those Countries' Health Needs?. Am. J. Public Health
94: 923-928
[Abstract][Full Text]
Farmer, P., Campos, N. G.
(2004). New Malaise: Bioethics and Human Rights in the Global Era. J Law Med Ethics
32: 243-251
Kent, D. M., Fendrick, A. M., Langa, K. M.
(2004). New and Dis-Improved: On the Evaluation and Use of Less Effective, Less Expensive Medical Interventions. Med Decis Making
24: 281-286
[Abstract]
Lie, R K, Emanuel, E, Grady, C, Wendler, D
(2004). The standard of care debate: the Declaration of Helsinki versus the international consensus opinion. J. Med. Ethics
30: 190-193
[Abstract][Full Text]
McMillan, J R, Conlon, C
(2004). The ethics of research related to health care in developing countries. J. Med. Ethics
30: 204-206
[Abstract][Full Text]
Miller, F. G., Silverman, H. J.
(2004). The Ethical Relevance of the Standard of Care in the Design of Clinical Trials. Am. J. Respir. Crit. Care Med.
169: 562-564
[Full Text]
Levine, C., Faden, R., Grady, C., Hammerschmidt, D., Eckenwiler, L., Sugarman, J., on behalf of the Consortium to Examine Clinical Re,
(2004). "Special Scrutiny": A Targeted Form of Research Protocol Review. ANN INTERN MED
140: 220-223
[Abstract][Full Text]
Hyder, A A, Wali, S A, Khan, A N, Teoh, N B, Kass, N E, Dawson, L
(2004). Ethical review of health research: a perspective from developing country researchers. J. Med. Ethics
30: 68-72
[Abstract][Full Text]
Burris, S., Buehler, J., Lazzarini, Z.
(2003). Applying the Common Rule to Public Health Agencies: Questions and Tentative Answers About a Separate Regulatory Regime. J Law Med Ethics
31: 638-653
Wong, T Y, Tan, D T
(2003). The SERI-ARVO Meeting and future challenges of ophthalmic research in Asia. Br. J. Ophthalmol.
87: 379-380
[Full Text]
Carpenter, W. T. Jr., Appelbaum, P. S., Levine, R. J.
(2003). The Declaration of Helsinki and Clinical Trials: A Focus on Placebo-Controlled Trials in Schizophrenia. Am. J. Psychiatry
160: 356-362
[Abstract][Full Text]
Caballero, B.
(2002). Ethical issues for collaborative research in developing countries. Am. J. Clin. Nutr.
76: 717-720
[Full Text]
Palmer, C R
(2002). Ethics, data-dependent designs, and the strategy of clinical trials: time to start learning-as-we-go?. Stat Methods Med Res
11: 381-402
[Abstract]
Zlotkin, S., Arthur, P.
(2002). Reply to NW Solomons and K Schumann. Am. J. Clin. Nutr.
76: 693-694
[Full Text]
Orentlicher, D.
(2002). Universality and its Limits: When Research Ethics Can Reflect Local Circumstances. J Law Med Ethics
30: 403-410
London, L.
(2002). Ethical Oversight of Public Health Research: Can Rules and IRBs Make a Difference in Developing Countries?. Am. J. Public Health
92: 1079-1084
[Abstract][Full Text]
Mill, J. E., Ogilvie, L. D.
(2002). Ethical Decision Making in International Nursing Research. Qual Health Res
12: 807-815
[Abstract]
Fleischer, T.
(2002). Principles of Biomedical Ethics. JAMA
287: 1582-1583
[Full Text]
Zumla, A., Costello, A.
(2002). Ethics of healthcare research in developing countries. JRSM
95: 275-276
[Full Text]
CAPLAN, L R
(2001). Evidence based medicine: concerns of a clinical neurologist. J. Neurol. Neurosurg. Psychiatry
71: 569-574
[Full Text]
Shapiro, H. T., Meslin, E. M.
(2001). Ethical Issues in the Design and Conduct of Clinical Trials in Developing Countries. NEJM
345: 139-142
[Full Text]
Roth, D. E.
(2001). Humanitarian aid and medical research: an illusion of dichotomy in international health. CMAJ
164: 1862-1864
[Full Text]
Benatar, S. R, Singer, P. A
(2000). A new look at international research ethics. BMJ
321: 824-826
[Full Text]
Costello, A., Zumla, A.
(2000). Moving to research partnerships in developing countries. BMJ
321: 827-829
[Full Text]
Temple, R., Ellenberg, S. S.
(2000). Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments. Part 1: Ethical and Scientific Issues. ANN INTERN MED
133: 455-463
[Abstract][Full Text]
Ellenberg, S. S., Temple, R.
(2000). Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments. Part 2: Practical Issues and Specific Cases. ANN INTERN MED
133: 464-470
[Abstract][Full Text]
Weijer, C.
(2000). The future of research into rotavirus vaccine. BMJ
321: 525-526
[Full Text]
Rothman, K. J, Michels, K. B, Baum, M.
(2000). For and against: Declaration of Helsinki should be strengthened FOR AGAINST Rothman and Michels' riposte. BMJ
321: 442-445
[Full Text]
Loue, S., Okello, D.
(2000). Research Bioethics in the Ugandan Context II: Procedural and Substantive Reform. J Law Med Ethics
28: 165-173
Hutton, J L
(2000). Ethics of medical research in developing countries: the role of international codes of conduct. Stat Methods Med Res
9: 185-206
[Abstract]
Emanuel, E. J., Wendler, D., Grady, C.
(2000). What Makes Clinical Research Ethical?. JAMA
283: 2701-2711
[Abstract][Full Text]
Preston, R. A., Materson, B. J., Reda, D. J., Williams, D. W.
(2000). Placebo-Associated Blood Pressure Response and Adverse Effects in the Treatment of Hypertension: Observations From a Department of Veterans Affairs Cooperative Study. Arch Intern Med
160: 1449-1454
[Abstract][Full Text]
Angell, M.
(2000). Investigators' Responsibilities for Human Subjects in Developing Countries. NEJM
342: 967-969
[Full Text]
White, R. M.
(2000). Unraveling the Tuskegee Study of Untreated Syphilis. Arch Intern Med
160: 585-598
[Full Text]
Macklin, R.
(1999). The Ethical Problems with Sham Surgery in Clinical Research. NEJM
341: 992-996
[Full Text]
Edejer, T. T.-T.
(1999). North-South research partnerships: the ethics of carrying out research in developing countries. BMJ
319: 438-441
[Full Text]
Brennan, T. A.
(1999). Proposed Revisions to the Declaration of Helsinki -- Will They Weaken the Ethical Principles Underlying Human Research?. NEJM
341: 527-531
[Full Text]
Levine, R. J.
(1999). The Need to Revise the Declaration of Helsinki. NEJM
341: 531-534
[Full Text]
Muntaner, C.
(1999). Teaching social inequalities in health: barriers and opportunities. Scand J Public Health
27: 161-165
[Abstract]
Kassirer, J. P.
(1999). Should Medical Journals Try to Influence Political Debates?. NEJM
340: 466-467
[Full Text]
Misbin, R. I.
(1999). Comment on the Ethics of Placebo-Controlled Trials in Patients with Type 2 Diabetes Mellitus. J. Clin. Endocrinol. Metab.
84: 823-823
[Full Text]
McIntosh, K.
(1998). Short (And Shorter) Courses of Zidovudine. NEJM
339: 1467-1468
[Full Text]
GOMOLLON, F
(1998). Guidance for trials in Helicobacter pylori infection. Gut
43: 728d-728
[Full Text]
Karlawish, J. H. T., Whitehouse, P. J.
(1998). Is the Placebo Control Obsolete in a World After Donepezil and Vitamin E?. Arch Neurol
55: 1420-1424
[Abstract][Full Text]
Desvarieux, M., Turner, M. T., Whalen, C. C., Johnson, J. L., Mugerwa, R. D., Ellner, J. J., Msamanga, G., Angell, M.
(1998). Questions about a Placebo-Controlled Trial of Preventive Therapy for Tuberculosis in HIV-Infected Ugandans. NEJM
338: 841-843
[Full Text]
Edi-Osagie, E C O, Edi-Osagie, N E, Lurie, P., Wolfe, S. M, Burdon, J., Baraza, R., Landray, M. J, Halsey, N. A, Sommer, A., Black, R. E, Godfrey-Faussett, P., Mwinga, A., Hosp, M., Baggaley, R., Quigley, M., Porter, J.
(1998). Ethics and international research. BMJ
316: 625a-625
[Full Text]
(1997). Tuberculosis Prophylaxis in Africa and Clinical Trials in Developing Countries. AIDS Clin Care
1997: 5-5
[Full Text]
Halsey, N. A, Sommer, A., Henderson, D. A, Black, R. E
(1997). Ethics and international research. BMJ
315: 965-966
[Full Text]
Varmus, H., Satcher, D.
(1997). Ethical Complexities of Conducting Research in Developing Countries. NEJM
337: 1003-1005
[Full Text]
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