How can research ethics committees protect patients better?

doi:10.1136/bmj.326.7400.1199

BMJ 2003;326:1199-1201 (31 May), doi:10.1136/bmj.326.7400.1199

Education and debate

How can research ethics committees protect patients better?

Silvio Garattini, director¹, Vittorio Bertele, head of laboratory of regulatory policies¹, Luca Li Bassi, consultant, laboratory of regulatory policies¹

¹ Mario Negri Institute, Via Eritrea 62, 20157 Milan, Italy

Correspondence to: S Garattini garattini@marionegri.it

The duties of research ethics committees are becoming increasingly difficult—what skills and knowledge do their members needto evaluate protocols that contain elements that are not inthe patient's interests?

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

Drug development and marketing has become a huge industry. Thepotentially enormous profits mean that to comply with theirduty and act in the interest of patients and public health,research ethics committees have to carefully assess clinicalprotocols with the necessary scientific knowledge and evaluate the true objectives of new studies and the methods used.

LIANE PAYNE

We have selected four main problems that such committees shouldexamine critically.

The latest revision of the Declaration of Helsinki has reinforceddoubts about whether placebos are always used correctly.¹Using a placebo instead of a comparator drug is advantageousfor the sponsor because the new drug has more chance of beingsuperior, and this superiority can be shown with fewer patientsand therefore with less expense. The use of a placebo can neverbe justified when a drug of proved efficacy is already availablefor a given therapeutic indication.

Some justify . . . [Full text of this article]

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