Cunetti-WMA-UY

Prof.&Adj. Dra Leticia&Cuñetti
MD&MSc
Biobanks and&databases had open&a&new&field in&research
Since WMA)recommendations aim to promote the ethical conduct on research
and)to protect human subjects from it´s associate risk
It’s our duty to recommendan
ethically correct informed consentprocess
which takes into account the willingnessand&trust&of&those
donatingand&sharing part of&themselves,&
but also we must recommend high standardsof&protection
This is why we must reinforce in&thisdraft some aspects
that we already know as&the weaker chains of&this process:
• Type of&consent
• The quality of&the information given
• Accreditation processof&Research Ethical Committees
dealing with Biobanksor Databases
• Type of&consent Broad informed consent
• The quality of&the information given
Transparency:)))))Real)interest behindthe proyect
• Include a&description of&the purpose
• Avoiding simple&referral as&research or investigation
• Include financial source
• Include Institution that supports the investigation
Full&information is the only way to achieve free&consent
The information given should be fully evaluated by the Research Ethical Committee
• Accreditationprocessof&Research Ethical Committees
dealing with Biobanksor Databases
Uruguay:)National Research EthicsCommission Normatization
Regulation
Acreditation
Restrictive Ethical position&towards research
vs&
Ethical position&which encourage research with appropiate protection
• Accreditationprocessof&Research Ethical Committees
dealing with Biobanksor Databases
Research Ethic Committeesare&highly variable&around the world
Many so&called
“Independant Ethic Committee”
which are3independant of3an
institution
but are3financially dependant of3
the promotor
• Accreditationprocessof&Research Ethical Committees
dealing with Biobanksor Databases
In&the draft we rely on REC&as&if they are&all reliable worldwide
This declaration should strongly recommend:
Wide range of&diversity
This declaration should list
which are&the high standardsof&protectionrecommended