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E-DRUG: Declaration on Ethics and Clinical Trials
 
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E-DRUG: Declaration on Ethics and Clinical Trials

Buenos Aires Declaration on Ethics and clinical Trials

"The Buenos Aires Declaration on Ethics and Clinical Trials" was
unanimously approved at the First Latin American Workshop on
Ethics and Clinical Trials and endorsed by the Latin American
organizations that are listed at the end of the Declaration.

Both the Workshop and the Declaration were a response to the
rapidly increasing number of clinical trials that are taking place in
the region and to the questions being raised as a result of the
many alleged violations of ethics during the approval and
implementation of the trials.

The Workshop was organized by the non-profit organization Salud
y F rmacos (
http://www.boletinfarmacos.org),incorporated both in
the USA and Argentina,which also publishes the free-access
electronic bulletin Boletin F rmacos. The Dutch Foundation
WEMOS, the Health Science Center of the University of Texas
and the Pan American Health Organization-Argentine also
provided financial assistance for the Workshop.

Salud y F rmacos and WEMOS perceive serious ethical flaws in
the conditions surrounding clinical trials in Latin America and
believe that the international health community should be aware of
the situation.

The Buenos Aires Declaration on the Ethics of Clinical Trials

At the General Assembly of the First Latin-American Workshop on
Ethics and Clinical Trials (Buenos Aires May 12 and 13,
2008)participants unanimously approved the following declaration:

1. Clinical trials can only be carried out if the population where the
trials take place can benefit from their results.

2. Authorities of countries where clinical trials take place should
require from researches to strictly adhere to the "Universal
Declaration of Bioethics and Human Rights" (UNESCO 2005).

3. All clinical trials that take place in Latin America must be
registered with the national drug agency of the country where the
trials take place or with the appropriate authority created for this
purpose. The key information of the protocols should be made
electronically available to the public.

4. In Latin America, protocols originating from outside the region
must be translated by competent expert translators for
presentation to local authorities (the regulatory agencies, ethics
committees, etc.) into the language of the country where the
clinical trial takes place (Spanish, Portuguese, or French).

5. The informed consent should fulfill the following requirements:
a) Informed consent forms originating from outside the region
must be translated by competent expert translators.
b) Persons, totally independent from the clinical trial, must verify
that all social and ethnic strata that participate in the trial
understand clearly the content of the informed consent form.
c) When indigenous populations participate in the trial, the
informed consent form should be presented to them in their native
language.

6. The ethics committees that approve the implementation of a
clinical trial must be active in the supervision and monitoring of all
critical steps followed including recruiting of participants, data
gathering and publication of results. The tasks should be specified
in writing at the time the ethics committee approves the trial.

7. National health authorities should create a national registry of
approved ethical committees, of research centers that have
proven to have the technical competence to carry out clinical trials,
and of researchers of known qualifications and honesty.

8. New drugs to be tested in clinical trials should be tested against
the best available preventive, diagnostic and therapeutic methods.
Placebos can be used only when no other therapeutic procedure
exists, or under exceptional qualified circumstances, when this
method is indispensable.

9. The results and findings of all the clinical trials should be
communicated within a reasonable time to those who participated
in the trials, and should be made available electronically to the
public through the national drug agencies of the countries where
the trials took place.

10. We condemn those clinical trials whose main objectives
include the promotion of the commercialization of the tested drug.

11. In order to obtain authorization for a clinical trial, the
pharmaceutical industry must commit itself to make, if the drug
tested is useful for the treatment of a disease, economically
accessible to those who need it in the country where the clinical
trial took place.

12. It is necessary to initiate as soon as possible multicentric
studies of Contract Research Organizations (CROs) that work in
Latin America. The research should document the financial
benefits, obtained from the trials, their business history, and any
complaints raised against them. Regulatory agencies should
publish electronically the results of these studies to allow other
countries to know the qualifications of the firms.

13. Following the initiative of the United States and European
Union leading professional health journals, Latin American medical
journals should not publish any results of clinical trials unless their
protocols have been electronically posted before the initiation of
the trial. Similarly, articles should not be published unless the
authors declare possible conflicts of interest.

14. All benefits that clinical trials researchers obtain from trials
should be made public. The information must be specific regarding
the amount that researchers receive by each participant they
recruit, and by each participant that completes the trial. This
information should be shared with trial participants as part of the
informed consent. Other fringe benefits that the investigator
receives from the industry should also be specified.

15. All persons who participate in clinical trials should be insured
for potential risks they may suffer during the course of or as a
result of the trial. The insurance policy should be paid by the
pharmaceutical firm, CRO or organization that carries out the trial.
The policies should be issued by reputable national or foreign
insurance companies, and the damage payment should be
equivalent to the amount that a person suffering a similar injury
would receive in the country where the pharmaceutical firm
responsible for the trial is headquartered.

16. As soon as it is discovered that a person appears as the
author of an article on the results of a clinical trial that in fact was
written by somebody else paid by a pharmaceutical industry or that
his/her participation was minimal, the academic center to which
the author is affiliated should start proceedings leading to an
adequate sanction. If the author is a member of a CRO,the firm
should be sanctioned and not be allowed to carry out new clinical
trials in the country.

17. We believe that clinical trials should be carried out by nonprofit
organizations such as universities on their own or in collaboration
with the ministry of health. The participation of nonprofit
organizations should be promoted.

18. Every effort should be made to insure that those in the lowest
income group and other vulnerable groups do not participate in
clinical trials, unless they directly benefit from their findings.

19. The end of a clinical trial is not to create wealth for an
enterprise, organization or individual. Clinical trials can only take
place to improve or augment the available therapeutic arsenal for
the benefit of mankind.

Buenos Aires, May 13, 2008


The Declaration of Buenos Aires has been endorsed by the
following organizations:

Acci¢n Internacional para la Salud-Coordination Center for Latin
America (AIS-LAC)
Roberto L¢pez Linares - Coordinator

Acci¢n Internacional para la Salud-Bolivia (AIS-Bolivia)
Oscar Lanza MD - Coordinator

Acci¢n Internacional para la Salud-Nicaragua (AIS-Nicaragua)
Leonel Arguello, MD -President

Asociaci¢n Mexicana para el Uso Racional de los Medicamentos,
A.C.
Rogelio Fern ndez MD - President

C tedra de Derechos Humanos de la Facultad de Medicina de la
Universidad de Buenos Aires
Claudio Capuano MD - Director

C tedra Unesco de Bio,tica de la Universidad Nacional de Brasilia
Prof. Volnei Garrafa -Coordinator

Centro de Informaci¢n de Medicamentos de la Universidad de
Colombia (CIMUN)
Jos, Juli n L¢pez QF - Coordinator General

Centro Universitario de Farmacolog¡a, Facultad de Ciencias
M,dicas, Universidad Nacional de La
Plata (CUFAR) (Argentina) - Centro Colaborador OPS/OMS
Perla Mordujovich de Buschiazzo MD - Director

Comit, de Defensa de los Derechos del Consumidor- Bolivia
(CODECO)
Rodrigo Urquieta Arias - Coordinador

Drug Utilization Research Group, Latinoam,rica (DURG-LA)
Claudia Vacca QF - President

Fundaci¢n Instituto para la Investigaci¢n del Medicamento en los
Sistemas de Salud, Colombia (IFARMA)
Francisco Rossi MD- Director

Grupo Argentino para el Uso Racional del Medicamento
(GAPURMED)
Luis Castiglioni MD - President

International Health Central American Institute Foundation (IHCAI
FOUNDATION)
Dr. Mario Tristan, Director-General

Red Latinoamericana de �tica y Medicamentos RELEM (The Latin
American Network of Ethics and Medicines)
N£ria Homedes MD, DrPH - Coordinator

Red Latinoamericana y del Caribe de Bio,tica de
UNESCO-Redbio,tica
Volnei Garrafa, DDS, PHD - President of Council of Directors

Salud y F rmacos
Antonio Ugalde, PhD - President, USA
Mart¡n Ca¤as MD - President, Argentina

Sociedade Brasileira de Vigilƒncia de Medicamentos (Sobrevime)
Jose Rub,n Alc ntara Bofim MD - President

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