Editorial

A recent draft proposal for revising the Declaration has provoked heated controversy

Some controversial issues raised by the draft Proposed Revision of the Declaration of Helsinki:

Placebo use and risk
Article II. ³ of the current Declaration states that "in any medical study, every patient - including those of a control group, if any - should be assured of the best proven diagnostic and therapeutic method. This does not exclude the use of inert placebo in studies where no proven diagnostic or therapeutic method exists." ⁷

Documentation of informed consent
Article I.9 of the current Declaration states that a physician should "obtain a patient's freely-given informed consent, preferably in writing". ⁷

Article 24 of the Proposed Revision introduces a waiver of written consent "when the research involves only slight risk or when the procedures to be used are customarily used in the practice of medicine without documentation of consent". ⁶

II. Medical research combined with clinical care
(Clinical research)

1. In the treatment of the sick person, the physician must be free to use a new diagnostic and therapeutic measure, if in his or her judgement it offers hope of saving life, reestablishing health or alleviating suffering.

3. In any medical study, every patient -- including those of a control group, if any -- should be assured of the best proven diagnostic and therapeutic method.

6. The physician can combine medical research with professional care, the objective being the acquisition of new medical knowledge, only to the extent that medical research is justified by its potential diagnostic or therapeutic value for the patient.