{"id":3779,"date":"2017-01-20T12:25:16","date_gmt":"2017-01-20T12:25:16","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/Ciudaddelcabodefinitiva-_Mautone.pdf"},"modified":"2017-01-20T12:25:16","modified_gmt":"2017-01-20T12:25:16","slug":"ciudaddelcabodefinitiva-_mautone-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/es\/ciudaddelcabodefinitiva-_mautone-2\/","title":{"rendered":"Ciudaddelcabodefinitiva-_Mautone"},"author":2,"comment_status":"open","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

Ciudaddelcabodefinitiva-_Mautone<\/a><\/p>\n

ETHICS COMMITTEES
\nMariela Mautone
\nSindicato M\u00e9dico del Uruguay
\nPresenter\u2019s Details
\n\uf0a8 I am a Nephrologist and Professor in Bioethics
\nworking in the Facultad de Medicina de la
\nUniversidad de la Rep\u00fablica (UDELAR)
\n\uf0a8 I represent the Uruguayan Medical Association
\nthe \u201cSindicato M\u00e9dico del Uruguay (SMU)\u201d
\nThe region I represent.
\n\uf0a8 I am representing Uruguay, a
\ndeveloping world country
\nsitutated in South America.
\n\uf0a8 Latin America has the highest
\ndegree of inequality in the world.
\n\uf0a8 I am independent of all
\npharmaceutical and institutional
\ninterests.
\n\uf0a8 I have five years experience
\nworking in two ethics committees
\ninvolving human research in
\nUruguay.
\nPresentation Objective
\n\uf0a8 My objective today, is to talk about the main
\nfunctions that I consider an ethics committee
\nmust have.
\nFunctions of ethics committees
\n\uf0a8 The principle function
\nis to protect human
\nbeings from
\nbiological, physical,
\nemotional, mental,
\nand social harm or
\ndamage from medical
\nresearch that may
\ninfringe on their basic
\nhuman rights.
\nAntonio Berni
\nWhat are the most important skills and
\natributes required for ethics committee
\nmembers?
\n\uf0a8 It is the member\u2019s RESPONSABILITY to be
\ncompletely independent of all institutional,
\ngovernmental, pharmaceutical, and vested financial
\ninterests.
\n\uf0a8 It is the member\u2019s RESPONSABILITY to develop the
\nnecessary skills for studying scientific issues: they
\nmust understand completely the human research that
\nis being proposed (or they must consult with a
\nspecialist in these issues).
\n\uf0a8 They must be able to assess the social value of the
\nresearch, identifying any possible harm that may
\noccur to vulnerable research participants.
\nMember skills and atributes
\ncontinued…
\n\uf0a8 Committee members must check and ensure
\nthat all of the information given to the research
\nparticipants is clear to read, and easy for them
\nto understand. The information must not be
\ndeceptive, mis-leading or have a negative
\neffect on the research participants individual
\nautonomy.
\nWhat are the key personal qualities needed for
\nethics committee members?
\n\uf0a8 They must possess a high level of honesty
\nand personal integrity.
\n\uf0a8 They must be STRONG defenders of their
\nfindings and recommendations
\nProcedures for assessing research
\nprotocols
\n\uf0a8 Assess how HUMAN DIGNITY is affected by
\nthe research project.
\n\uf0a8 Assess how the intrinsic value of all human
\nbeings will be affected.
\n\uf0a8 Assess possible research consequences and
\neffects on the individual and on the society.
\nReviewing both the positive and negative
\npossibilities of all aspects.
\nProcedures for assessing research
\nprotocols continued\u2026
\n\uf0a8 Assess the impact the research will have on the
\nindividuals autonomy.
\n\uf0a8 Assess if individuals have rights to legally redress
\nany negative effects they may experience from
\nthe research.
\n\uf0a8 Only after reviewing the research project details
\nand finding them acceptable, do you go ahead
\nand review the Informed Consent document.
\nProcedures for assessing research
\nprotocols continued\u2026
\n\uf0a8 Assess the research information from the
\nindividual committee member\u2019s perspective.
\n\uf0a8 Assess the research information based on the
\nDeclaration of Helsinki 2002.
\n\uf0a8 (subsequest Declaration of Helsinki reviews have
\nweakened the protections of human beings).
\n\uf0a8 Assess the research information based on the
\nUniversal Declaration on Bioethics and Human
\nRights (2005)
\n\uf0a8 Assess the research information based on the
\nUniversal Declaration of Human Rights signed
\n1948 .
\nFramework and Levels of Accountability needed for
\nimplementing effective protection of Human Beings
\ninvolved in medical research
\n\uf0a8 National governments must have a interest in
\nprotecting the basic social needs of their
\ncitizens.
\n\uf0a8 National political systems must become more
\nactive in protecting the welfare of their
\npopulations.
\n\uf0a8 National Health departments must be active in
\ncoordinating all national research projects and
\nmonitoring their outcomes
\n\uf0a8 National legal systems must become active in
\ncreating laws for the protection of their citizens
\nfrom harmful research projects and practices.
\nFramework and levels of accountibility
\ncontinued\u2026
\n\uf0a8 Establishment of National Ethics Committees.
\n\uf0a8 Establishment of local institutional Ethics
\nCommittees in hospitals and medical
\ninstitutions.
\n\uf0a8 Teaching of ethics committee courses in
\nmedical universities.
\nIn Conclusion:
\n\uf0a8 Ethics committees without a national support
\nstructure will not be able to protect humans beings
\nand their rights in medical research projects.
\n\uf0a8 Blindly following of procedural rules or check lists
\nis not the solution to protecting human from
\nunethical research. More is needed!
\n\uf0a8 Signing a research project\u2019s Informed consent
\ndocument without close consideration may not
\nprotect the human rights of participating
\nindividuals.<\/p>\n"},"caption":{"rendered":"

Ciudaddelcabodefinitiva-_Mautone ETHICS COMMITTEES Mariela Mautone Sindicato M\u00e9dico del Uruguay Presenter\u2019s Details \uf0a8 I am a Nephrologist and Professor in Bioethics working in the Facultad de Medicina de la Universidad de la Rep\u00fablica (UDELAR) \uf0a8 I represent the Uruguayan Medical Association the \u201cSindicato M\u00e9dico del Uruguay (SMU)\u201d The region I represent. \uf0a8 I am representing Uruguay, […]<\/p>\n"},"alt_text":"","media_type":"file","mime_type":"application\/pdf","media_details":{},"post":null,"source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/Ciudaddelcabodefinitiva-_Mautone.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media\/3779"}],"collection":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media"}],"about":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/types\/attachment"}],"author":[{"embeddable":true,"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/comments?post=3779"}]}}