The Declaration of Helsinki requires revision because it isdefective in two important respects. First, it relies on a distinctionbetween therapeutic and nontherapeutic research; all documentsthat rely on this spurious distinction contain errors not intendedby their authors.1 Second, it includes several provisions thatare seriously out of touch with contemporary ethical thinking.As a consequence, many researchers routinely violate its requirements.Such routine violations and their associated attitudes rob thedeclaration of its credibility.
Therapeutic and Nontherapeutic Research
The nature of the errors that arise from a reliance on the distinctionbetween therapeutic and nontherapeutic research is made clearby placing . . . [Full Text of this Article]
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]
Salanti, G., Kavvoura, F. K., Ioannidis, J. P.A.
(2008). Exploring the Geometry of Treatment Networks. ANN INTERN MED
148: 544-553
[Abstract][Full Text]
Noble, J. H. Jr, Sharav, V. H.
(2008). Protecting People With Decisional Impairments and Legal Incapacity Against Biomedical Research Abuse. Journal of Disability Policy Studies
18: 230-244
[Abstract]
McMahon, R. P., Kelly, D. L., Boggs, D. L., Li, L., Hu, Q., Davis, J. M., Carpenter, W. T. Jr.
(2008). Feasibility of Reducing the Duration of Placebo-Controlled Trials in Schizophrenia Research. Schizophr Bull
34: 292-301
[Abstract][Full Text]
Dowdy, D W
(2006). Partnership as an ethical model for medical research in developing countries: the example of the "implementation trial". J. Med. Ethics
32: 357-360
[Abstract][Full Text]
Gatchel, R. J., Stowell, A. W., Wildenstein, L., Riggs, R., Ellis, E. III
(2006). Efficacy of an early intervention for patients with acute temporomandibular disorder-related pain: A one-year outcome study. Journal of the American Dental Association
137: 339-347
[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]
Dunn, L. B, Palmer, B. W, Keehan, M.
(2006). Understanding of Placebo Controls Among Older People With Schizophrenia. Schizophr Bull
32: 137-146
[Abstract][Full Text]
Woods, S. W., Gueorguieva, R. V., Baker, C. B., Makuch, R. W.
(2005). Control Group Bias in Randomized Atypical Antipsychotic Medication Trials for Schizophrenia. Arch Gen Psychiatry
62: 961-970
[Abstract][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]
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]
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]
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]
Senn, S
(2002). Ethical considerations concerning treatment allocation in drug development trials. Stat Methods Med Res
11: 403-411
[Abstract]
Foëx, B A
(2001). The problem of informed consent in emergency medicine research. Emerg. Med. J.
18: 198-204
[Abstract][Full Text]
King, N. M. P.
(2000). Defining and Describing Benefit Appropriately in Clinical Trials. J Law Med Ethics
28: 332-343
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]
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]
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]
Angell, M.
(2000). Investigators' Responsibilities for Human Subjects in Developing Countries. NEJM
342: 967-969
[Full Text]
Bevan, D. R.
(2000). Research ethics - an evolving discipline/L'ethique de la recherche, une discipline qui evolue. Canadian J. Anesthesia
47: 5-9
[Full Text]
Morens, D. M., Kopp, V. J., Senn, S., Macpherson, C. C., O'Ryan, M., Misbin, R. I., Levine, R. J.
(1999). Should the Declaration of Helsinki Be Revised?. NEJM
341: 1851-1853
[Full Text]