[Ip-health] Buenos Aires Declaration on Ethics and clinical Trials

[Homedes, Nuria PHD]

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Buenos Aires Declaration on Ethics and clinical Trials

"The Buenos Aires Declaration on Ethics and Clinical Trials"  was unanimous=
ly approved at
the First Latin American Workshop on Ethics and Clinical Trials and endorse=
d 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 increa=
sing number of
clinical trials that are taking place in the region and to the questions be=
ing raised as a
result of the many alleged violations of ethics during the approval and imp=
lementation of the trials.

The Workshop was organized by the non-profit organization Salud y F=E1rmaco=
s
(http://www.boletinfarmacos.org),incorporated both in the USA and Argentina=
,which also publishes the free-access electronic bulletin Boletin F=E1rmaco=
s. The Dutch Foundation WEMOS, the Health Science Center of the University =
of Texas and the Pan American Health Organization-Argentine also provided f=
inancial assistance for the Workshop.

Salud y F=E1rmacos and WEMOS perceive serious ethical flaws in the conditio=
ns 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 tria=
ls 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 Rig=
hts" (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 appropri=
ate authority created
for this purpose. The key information of the protocols should be made elect=
ronically 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 reg=
ulatory agencies,
ethics committees, etc.) into the language of the country where the clinica=
l 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 verif=
y that all social and ethnic strata that participate in the trial understan=
d clearly the content of the informed consent form.
        c)  When indigenous populations participate in the trial, the infor=
med consent form should be presented to them in their native language.

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

7. National health authorities should create a national registry of approve=
d ethical committees, of research centers that have proven to have the tech=
nical 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 b=
est available
preventive, diagnostic and therapeutic methods. Placebos can be used only w=
hen 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 communicat=
ed within a reasonable time to those who participated in the trials, and sh=
ould be made available
electronically to the public through the national drug agencies of the coun=
tries where the trials took place.

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

11. In order to obtain authorization for a clinical trial, the pharmaceutic=
al 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 clini=
cal 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 res=
earch should document the financial benefits, obtained from the trials, the=
ir business history, and any complaints raised against them. Regulatory age=
ncies should publish electronically the results of these studies to allow o=
ther countries to know the qualifications of the firms.

13. Following the initiative of the United States and European Union leadin=
g professional
health journals, Latin American medical journals should not publish any res=
ults of clinical
trials unless their protocols have been electronically posted before the in=
itiation of
the trial. Similarly, articles should not be published unless the authors d=
eclare 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 particip=
ant that completes the trial. This information should be shared with trial =
participants as part of the informed consent. Other fringe benefits that th=
e investigator receives from the industry should also be specified.

15. All persons who participate in clinical trials should be insured for po=
tential risks they may suffer during the course of or as a result of the tr=
ial. 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 s=
hould 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 a=
rticle on the results of a clinical trial that in fact was written by someb=
ody else paid by a pharmaceutical industry or that his/her participation wa=
s minimal, the academic center to which the author is affiliated should sta=
rt proceedings leading to an adequate sanction. If the author is a member o=
f a CRO,the firm should be sanctioned and not be allowed to carry out new c=
linical trials in the country.

17. We believe that clinical trials should be carried out by nonprofit orga=
nizations 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 g=
roup and other
vulnerable groups do not participate in clinical trials, unless they direct=
ly 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 a=
vailable therapeutic
arsenal for the benefit of mankind.

Buenos Aires, May 13, 2008


The Declaration of Buenos Aires has been endorsed by the following organiza=
tions:

Acci=F3n Internacional para la Salud-Coordination Center for Latin America =
(AIS-LAC)
Roberto L=F3pez Linares - Coordinator

Acci=F3n Internacional para la Salud-Bolivia (AIS-Bolivia)
Oscar Lanza MD - Coordinator

Acci=F3n Internacional para la Salud-Nicaragua (AIS-Nicaragua)
Leonel Arguello, MD -President

Asociaci=F3n Mexicana para el Uso Racional de los Medicamentos, A.C.
Rogelio Fern=E1ndez MD - President

C=E1tedra de Derechos Humanos de la Facultad de Medicina de la Universidad =
de Buenos Aires
Claudio Capuano MD - Director

C=E1tedra Unesco de Bio=E9tica de la  Universidad Nacional de Brasilia
Prof. Volnei Garrafa -Coordinator

Centro de Informaci=F3n de Medicamentos de la Universidad de Colombia (CIMU=
N)
Jos=E9 Juli=E1n L=F3pez QF - Coordinator General

Centro Universitario de Farmacolog=EDa, Facultad de Ciencias M=E9dicas, Uni=
versidad Nacional de La
Plata (CUFAR) (Argentina) - Centro Colaborador OPS/OMS
Perla Mordujovich de Buschiazzo MD - Director

Comit=E9 de Defensa de los Derechos del Consumidor- Bolivia (CODECO)
Rodrigo Urquieta Arias - Coordinador

Drug Utilization Research Group, Latinoam=E9rica (DURG-LA)
Claudia Vacca QF - President

Fundaci=F3n Instituto para la Investigaci=F3n del Medicamento en los Sistem=
as 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 FOUNDATIO=
N)
Dr. Mario Tristan, Director-General

Red Latinoamericana de =C9tica y Medicamentos RELEM (The Latin American Net=
work of Ethics and Medicines)
N=FAria Homedes MD, DrPH - Coordinator

Red Latinoamericana y del Caribe de Bio=E9tica de UNESCO-Redbio=E9tica
Volnei Garrafa, DDS, PHD - President of Council of Directors

Salud y F=E1rmacos
Antonio Ugalde, PhD - President, USA
Mart=EDn Ca=F1as MD - President, Argentina

Sociedade Brasileira de Vigil=E2ncia de Medicamentos (Sobrevime)
Jose Rub=E9n Alc=E1ntara Bofim MD - President