Leo Pessini

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ETHICS OF RESEARCH WITH HUMANS Some notes on
the Brazilian experience
Leo Pessini
Prof. Dr. em Teologia Moral / Bioética
Pós-Graduado em Educação Pastoral Clínica e
Bioética nos EUA (Milwaukee, WI) Autor de varias
obras na área da Bioética Superintendente da
União Social Camiliana e Vice-Reitor do Centro
Universitário São Camilo SP.
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I - INTRODUCTION

• The emergence of Brazilian research ethics
  guidelines - 1996.
• - Some updated figures of the process, pointing
  some basic ethical challenges in the field.

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II - THE EMERGENCE OF BRAZILIAN RESEARCH ETHICS
GUIDELINES

• Res. 196/96
• The National Commission of Ethics in Research
  (CONEP) was created in 1996.
• Essentially bioethics in its nature
  multidisciplinary
• - It comprises professionals from several
  backgrounds medicine and health sciences,
  humanities, exact sciences, philosophy, theology,
  and representative vulnerable groups.
• - It is responsible for establishing norms and
  coordinating all types of human research in any
  field.

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II - THE EMERGENCE OF BRAZILIAN RESEARCH ETHICS
GUIDELINES

• - Resolution n.196/96 National Health Council
• Ministry
  of Health
• Resolution 196/96 was also elaborated by a
  bioethics Commission (multidisciplinary) after
  extensive consultation with scientific
  organizations, corporations, governmental organs
  and several segments of society.
• Membership (13) is valid for 4 years, Members are
  nominated by the National Health Council based on
  a list of names indicated by the several
  institutional research ethics committees (CEP).
• Available at www.conselho.saude.gov.br

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II - THE EMERGENCE OF BRAZILIAN RESEARCH ETHICS
Resolution 196/96 Genesis, doctrinaire basis and
operationalization bioethical perspective. The
Resolution is not a deontological code neither
law. It has a doctrinary basis, establishes
rules for bioethics assessment, provides ethical
guidelines for research studies, and implements
an effective system (CONEP-CEP system). This
system is autonomous and independent in all its
actions. It is coordenated by the National
Health Council, which is, by law, an government
organ for social control.
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II - THE EMERGENCE OF BRAZILIAN RESEARCH ETHICS
GUIDELINES
Resolution 196/96 (basic guidelines), New
specific resolutions - New drugs (251/97) -
Foreign cooperation (292/92) - Human
reproduction research (303/00) - Research
involving indigenous peoples (304/00)
- Human genetics research (340/05)
- Multicentric studies (346/00) - Biological
material banks (347/05).
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III -THE EMERGENCE OF BRAZILIAN RESEARCH ETHICS
GUIDELINES
Since 1996, no research study involving human
beings can be started without the previous
approval of an Institutional Ethics Committee
(CEP). A CEP must have CONEPs prior approval
and registration. CEPs are bioethics in its
nature (7 members - multiprofessional), with the
participation of at least one user representative
(vulnerable groups). They are autonomous and
under CONEP coordination. They have 30 days to
issue their review report while CONEP has 60 days.
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III -THE EMERGENCE OF BRAZILIAN RESEARCH ETHICS
GUIDELINES
About 90 of the projects are solely reviewed by
CEPs. About 10 of the research projects
(in accordance with the Resolutions) must also be
approved by CONEP (e.g., new procedures, research
involving indigenous peoples, some genetic
studies and some projects including foreign
cooperation). Resolutions have an ethical
content, they are not a mere deontological code,
they are bioethical tools to be used by CEPs in
the reviewing process.
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III -THE EMERGENCE OF BRAZILIAN RESEARCH ETHICS
GUIDELINES
CONEP is an organ of last resort. CONEP is
responsible for building a Database on human
research ETHICS in any field of RESEARCH
conducted in the country. The CONEP/CEP system
is informatized (SISNEP system), and can be
accessed online. CEPs issue quarterly reports
while investigators are required to send at least
yearly and final reports. Adverse events must
immediately be assessed by the investigator,
reported to the local CEP, and CONEP. The
National Health Surveillance Agency (Anvisa) is
responsible for technical evaluation.
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III -THE EMERGENCE OF BRAZILIAN RESEARCH ETHICS
GUIDELINES
Resolutions have the power of law, but are not
actual laws. Failure to fulfill Resolutions leads
to trial by Professional Councils and the Federal
Prosecutors Office. There is a whole system to
protect research subjects. Informed consent
is aimed to protect the research subject, much
more than exempting the investigator, the sponsor
and the institution from responsibilities. It
is signed in duplicate, one copy to be retained
by the subject.
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III -THE EMERGENCE OF BRAZILIAN RESEARCH ETHICS
GUIDELINES
According to the resolution 196/96 - the
subject has the right to have access to the
medication (in the case of drugs) after the study
is over. - Such medication shall be provided
by the sponsor, or by the Institution and the
investigator, if the sponsor fails to do it.
- The appropriateness of the research method
used in relation to the countrys interests and
priorities, as well as the Researchs
contribution to the community are also assessed.
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IV - SOME IMPORTANT FIGURES
Institutional Ethics Committees - (CEP) 581 -
registered, representing all states of the
federation. This means that about 10,000
people from different backgrounds, have been
getting together at least once a month to review
research projects.
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IV - SOME IMPORTANT FIGURES
- Projects reviewed by CONEP The annual number
is around 1000 projects (1070 in 2006 963 in
2007), approximately 10o of the research
projects reviewed in Brazil. This means that
10,000 projects involving human subjects - in any
field of knowledge - are reviewed in the country
annually.
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IV - SOME IMPORTANT FIGURES
Number of research subjects The average number is
40 subjects, which means that around half a
million people/year are considered protected by
the CEP/CONEP system. D) Approved Pending
Not approved In 2007, 47 of the projects
reviewed by CONEP were approved after the first
review approval was pending in 42 of the cases
(further information was necessary and/or further
requirements should be fulfilled) 11 were not
approved for not meeting basic ethical
requirements.
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IV - SOME IMPORTANT FIGURES
Thematic perspective Around 65 of the projects
reviewed by CONEP include foreign cooperation.
In these cases, the country of origin shall be
notified and approval by a home Committee is
required. The identification of the Brazilian
investigator in charge is always
required. Research projects with foreign
cooperation must be approved by CONEP. These
projects usually include the use of new drugs in
multiple sites (phase II and III).
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V - CONCLUDING REMARKS
One of the permanent challenges in the Brazilian
process is the need of Education in issue ethics
of research with humans. Many people because of
this specific need had the chance to encounter
with bioethics. Its been said that one the
important factors of development of bioethics in
the country is justly the growing network of
social control of the researches made by the
network of ethics research committees Coordenatio
n of this network of ethics committees There
is now an abundant literature in Portuguese on
the subject bioethics several attempts of
introducing Bioethics in undergraduate programs
is being made in many Brazilian universities.
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V - CONCLUDING REMARKS
In the last decade there has been an increasing
interest in ethics in research that keeps
growing. However, there is much to be done in
order to give the society a whole a basic
understanding of medical research and its
requirements, not only regarding the resources
that are invested but also concerning their
participation. We have to recognize that the
Brazilian investigators are now more aware that
scientific investigation needs social and ethics
controls. So, the seed is sown and we hope from
the seed a plant will flourish.
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THANK YOU!
pessini_at_saocamilo-sp.br