Ciudaddelcabodefinitiva-_Mautone
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ETHICS COMMITTEES
Mariela Mautone
Sindicato Médico del Uruguay
Presenter’s Details
I am a Nephrologist and Professor in Bioethics
working in the Facultad de Medicina de la
Universidad de la República (UDELAR)
I represent the Uruguayan Medical Association
the “Sindicato Médico del Uruguay (SMU)”
The region I represent.
I am representing Uruguay, a
developing world country
situtated in South America.
Latin America has the highest
degree of inequality in the world.
I am independent of all
pharmaceutical and institutional
interests.
I have five years experience
working in two ethics committees
involving human research in
Uruguay.
Presentation Objective
My objective today, is to talk about the main
functions that I consider an ethics committee
must have.
Functions of ethics committees
The principle function
is to protect human
beings from
biological, physical,
emotional, mental,
and social harm or
damage from medical
research that may
infringe on their basic
human rights.
Antonio Berni
What are the most important skills and
atributes required for ethics committee
members?
It is the member’s RESPONSABILITY to be
completely independent of all institutional,
governmental, pharmaceutical, and vested financial
interests.
It is the member’s RESPONSABILITY to develop the
necessary skills for studying scientific issues: they
must understand completely the human research that
is being proposed (or they must consult with a
specialist in these issues).
They must be able to assess the social value of the
research, identifying any possible harm that may
occur to vulnerable research participants.
Member skills and atributes
continued…
Committee members must check and ensure
that all of the information given to the research
participants is clear to read, and easy for them
to understand. The information must not be
deceptive, mis-leading or have a negative
effect on the research participants individual
autonomy.
What are the key personal qualities needed for
ethics committee members?
They must possess a high level of honesty
and personal integrity.
They must be STRONG defenders of their
findings and recommendations
Procedures for assessing research
protocols
Assess how HUMAN DIGNITY is affected by
the research project.
Assess how the intrinsic value of all human
beings will be affected.
Assess possible research consequences and
effects on the individual and on the society.
Reviewing both the positive and negative
possibilities of all aspects.
Procedures for assessing research
protocols continued…
Assess the impact the research will have on the
individuals autonomy.
Assess if individuals have rights to legally redress
any negative effects they may experience from
the research.
Only after reviewing the research project details
and finding them acceptable, do you go ahead
and review the Informed Consent document.
Procedures for assessing research
protocols continued…
Assess the research information from the
individual committee member’s perspective.
Assess the research information based on the
Declaration of Helsinki 2002.
(subsequest Declaration of Helsinki reviews have
weakened the protections of human beings).
Assess the research information based on the
Universal Declaration on Bioethics and Human
Rights (2005)
Assess the research information based on the
Universal Declaration of Human Rights signed
1948 .
Framework and Levels of Accountability needed for
implementing effective protection of Human Beings
involved in medical research
National governments must have a interest in
protecting the basic social needs of their
citizens.
National political systems must become more
active in protecting the welfare of their
populations.
National Health departments must be active in
coordinating all national research projects and
monitoring their outcomes
National legal systems must become active in
creating laws for the protection of their citizens
from harmful research projects and practices.
Framework and levels of accountibility
continued…
Establishment of National Ethics Committees.
Establishment of local institutional Ethics
Committees in hospitals and medical
institutions.
Teaching of ethics committee courses in
medical universities.
In Conclusion:
Ethics committees without a national support
structure will not be able to protect humans beings
and their rights in medical research projects.
Blindly following of procedural rules or check lists
is not the solution to protecting human from
unethical research. More is needed!
Signing a research project’s Informed consent
document without close consideration may not
protect the human rights of participating
individuals.