CFM RESOLUTION No. 1,885 / 2008
(Published in the D.O.U. of October 22, 2008, Section I, p.90)
The physician is prohibited from participating in research involving
humans using placebo when
effective available treatment already known.
THE FEDERAL COUNCIL OF MEDICINE, using the powers conferred by Law No. 3,268, of 30
September 1957, regulated by Decree nº 44.045, of July 19, 1958, and amended by Law nº
11,000, of December 15, 2004, and
WHEREAS it is incumbent upon the Federal Council of Medicine and the Regional Councils of Medicine
supervise the ethics and practice of medicine and ensure the prestige and good concept of the profession
throughout the Republic;
WHEREAS article 126 of the Medical Code of Ethics prohibits the physician from obtaining advantages
personal interests, have commercial interests or renounce their professional independence from financial
medical research in which he participates;
WHEREAS Article 129 of the Medical Code of Ethics prohibits the execution or participation of the physician
in research where there is a need to suspend or stop using established therapy and, with that,
harm the patient;
CONSIDERING the need of the Federal Council of Medicine to maintain the ethical standards of Medicine
at the highest levels and, mainly, in the defense of the interests of human beings, unique and true
reason for being in Medicine;
WHEREAS the Declaration of Helsinki, promulgated in 1964 by the World Medical Association and
adopted by all of its members is the document on medical research in human beings, with
greater impact, dimension and acceptance worldwide;
CONSIDERING what was decided at the 2008 General Assembly of the World Medical Association, held on
October 15-18, in Seoul - South Korea, which amended Article 29 of the Declaration of Helsinki, allowing the
use of a placebo even if there is a recognized effective treatment, for methodological reasons;
WHEREAS there is no scientific evidence to justify the ethical compliance adopted in the use of
placebo for amending the current Helsinki Declaration;
CONSIDERING the non-approval by the Brazilian medical representation of the changes proposed for the
new wording of article 29 of the Declaration of Helsinki (revision 2004), renumbered to article 32 in
Seoul-South Korea Assembly;
CONSIDERING what was decided in the plenary session of October 23, 2008,
RESOLVES:
Art. 1º It is forbidden to the doctor any link of any nature with medical research involving human beings,
who use placebo in their experiments, when there is effective and effective treatment for the disease
researched.
Art. 2 This resolution comes into force on the date of its publication, revoking the provisions to the contrary.
Brasília-DF, October 23, 2008
EDSON DE OLIVEIRA ANDRADE LÍVIA BARROS GARÃO
President Secretary-General