BMJ 2000;321:442-445 ( 12 August )

Education and debate

For and against
    Declaration of Helsinki should be strengthened
    FOR
    AGAINST
    Rothman and Michels' riposte

Declaration of Helsinki should be strengthened

The first 150 words of the full text of this article appear below.

The World Medical Association is now debating the next revision of the Declaration of Helsinki. Kenneth Rothman and Karin Michels argue that critics of the declaration, notably the US Food and Drug Administration, are trying to give scientists greater latitude than the declaration allows. In particular, Rothman and Michels dispute the morality of performing placebo controlled trials when there is an existing accepted treatment, and they offer other suggestions to strengthen the protection of patients who participate in medical experiments. Michael Baum argues against their absolutism on this issue and against what he considers their anti-science stance

---

Kenneth J Rothman, professor, ^a Karin B Michels, assistant professor. ^b

^a Department of Epidemiology and Biostatistics, Boston University School of Public Health, Boston University Medical Center, Boston, MA 02118-2526, USA, ^b Harvard Medical School Obstetrics and Gynecology Epidemiology Center, Brigham and Women's Hospital, Boston, MA 02115, USA

Correspondence to K J Rothman KRothman@bu.edu

Actions that penalise some for the good of others are defended under the utilitarian banner of doing the greatest good for the greatest number. For this reason we justify imposing quarantine to prevent the spread of infectious illness. In the same spirit some scientists and regulators would ask patients who participate in medical . . . [Full text of this article]

CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    StumbleUpon    Technorati    What's this?

Relevant Articles

The Declaration of Helsinki

Michael D E Goodyear, Karmela Krleza-Jeric, and Trudo Lemmens
BMJ 2007 335: 624-625. [Extract] [Full Text] [PDF]

Revised Declaration of Helsinki

Adnan A Hyder, Delon Human, Francis Crawley, Carel IJsselmuiden, Peter A Singer, and Solomon R Benatar
BMJ 2001 323: 283. [Extract] [Full Text]

Declaration of Helsinki should be strengthened

R J Lilford, Benjamin Djulbegovic, Udo Schuklenk, Kenneth J Rothman, and Karin B Michels
BMJ 2001 322: 299. [Extract] [Full Text]

Ethics code should outlaw placebo controlled trials when an accepted treatment exists
BMJ 2000 321: 0. [Full Text]

This article has been cited by other articles:

• 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]  
• Goodyear, M. D E, Krleza-Jeric, K., Lemmens, T. (2007). The Declaration of Helsinki. BMJ 335: 624-625 [Full text]  
• Amiel, P., Moreau, D., Vincent-Genod, C., Alberti, C., Hankard, R., Ravaud, P., Gottot, S., Gaultier, C. (2007). Noninvitation of Eligible Individuals to Participate in Pediatric Studies: A Qualitative Study. Arch Pediatr Adolesc Med 161: 446-450 [Abstract] [Full text]  
• Nagasako, E. M., Kalauokalani, D. A. (2005). Ethical aspects of placebo groups in pain trials: Lessons from psychiatry. Neurology 65: S59-S65 [Abstract] [Full text]  
• Storosum, J. G., Wohlfarth, T., Gispen-de Wied, C. C., Linszen, D. H., Gersons, B. P.R., van Zwieten, B. J., van den Brink, W. (2005). Suicide Risk in Placebo-Controlled Trials of Treatment for Acute Manic Episode and Prevention of Manic-Depressive Episode. Am. J. Psychiatry 162: 799-802 [Abstract] [Full text]  
• Storosum, J. G., van Zwieten, B. J., Wohlfarth, T., de Haan, L., Khan, A., van den Brink, W. (2003). Suicide Risk in Placebo vs Active Treatment in Placebo-Controlled Trials for Schizophrenia. Arch Gen Psychiatry 60: 365-368 [Abstract] [Full text]  
• Orentlicher, D. (2002). Universality and its Limits: When Research Ethics Can Reflect Local Circumstances. J Law Med Ethics 30: 403-410  
• Miller, F. G., Shorr, A. F. (2002). Unnecessary Use of Placebo Controls: The Case of Asthma Clinical Trials. Arch Intern Med 162: 1673-1677 [Full text]  
• Walsh, B. T., Seidman, S. N., Sysko, R., Gould, M. (2002). Placebo Response in Studies of Major Depression: Variable, Substantial, and Growing. JAMA 287: 1840-1847 [Abstract] [Full text]  
• Emanuel, E. J., Miller, F. G. (2001). The Ethics of Placebo-Controlled Trials -- A Middle Ground. NEJM 345: 915-919 [Full text]  
• Hyder, A. A, Human, D., Crawley, F., IJesselmuiden, C., Singer, P. A, Benatar, S. R (2001). Revised Declaration of Helsinki. BMJ 323: 283-283 [Full text]  
• Storosum, J. G., van Zwieten, B. J., van den Brink, W., Gersons, B. P.R., Broekmans, A. W. (2001). Suicide Risk in Placebo-Controlled Studies of Major Depression. Am. J. Psychiatry 158: 1271-1275 [Abstract] [Full text]  
• Sneyd, J.R. (2001). Editorial III: Lessons from Stafford. Br J Anaesth 86: 469-472 [Full text]  
• Djulbegovic, B., Clarke, M. (2001). Scientific and Ethical Issues in Equivalence Trials. JAMA 285: 1206-1208 [Full text]  
• Lilford, R J, Djulbegovic, B., Schuklenk, U., Rothman, K. J, Michels, K. B (2001). Declaration of Helsinki should be strengthened. BMJ 322: 299a-299 [Full text]  
• Bertholf, R. L. (2001). Protecting Human Research Subjects. Annals of Clinical & Laboratory Science 31: 119-127 [Abstract] [Full text]  
• Lansang, M A, Crawley, F P (2000). The ethics of international biomedical research. BMJ 321: 777-778 [Full text]  

Rapid Responses:

Read all Rapid Responses

Myopic view

Eric Colman
bmj.com, 11 Aug 2000 [Full text]

Re: Myopic view

Kenneth J Rothman, et al.
bmj.com, 12 Aug 2000 [Full text]

Placebo confusion

Stephen Senn
bmj.com, 15 Aug 2000 [Full text]

Sometimes it's unethical to prohibit placebo control

Richard Anderson
bmj.com, 15 Aug 2000 [Full text]

Is democratic or dictatorial research the goal of the WHO debate about the

Hazel Thornton
bmj.com, 15 Aug 2000 [Full text]

Re: Placebo confusion

Kenneth J Rothman, et al.
bmj.com, 15 Aug 2000 [Full text]

Re: Sometimes it's unethical to prohibit placebo control

Kenneth J Rothman, et al.
bmj.com, 15 Aug 2000 [Full text]

Declaration of Helsinki MUST be strengthened

Roger M Goss
bmj.com, 20 Aug 2000 [Full text]

Declaration of Helsinki - more honesty please

Udo Schuklenk
bmj.com, 23 Aug 2000 [Full text]

Equipoise as an essential principle of human experimentation

R J Lilford, et al.
bmj.com, 25 Aug 2000 [Full text]

Standard treatment is compatible with use of placebo.

Peter Allmark
bmj.com, 24 Aug 2000 [Full text]

Equipoise: Analogies must have it.

Adan Rios
bmj.com, 9 Jul 2001 [Full text]

Online poll

Find out more >>