Comité Nacional de Ética en la Ciencia y la Tecnología. República Argentina.

Comité Nacional de Éticaen la Ciencia y la Tecnología.República Argentina

• Large research and medical databases in clinical and research multi-centers trials.

• Argentina

– Aída Kemelmajer de Carlucci, June 2012.– [email protected]

Basic rules

•  (1). Law 25.326. Personal Data Protection Law, (October 2000).

• SECTION 2. For purposes of this Act, the terms hereinafter mentioned shall have the following meanings: Sensitive data: Personal data revealing racial and ethnic origin, political opinions, religious, philosophical or moral beliefs, labor union membership, and information concerning health conditions or sexual life.

• SECTION 8.- Public or private health institutions, as well as medical science professionals are entitled to collect and treat personal data related to the physical or mental health of patients who make use of their services or who are or may have been under their care, in pursuance of the principles of professional secret.

• SECTION 12.-

• 1.- The transfer of any type of personal information to countries or international or supranational entities which do not provide adequate levels of protection, is prohibited.

• 2.- The prohibition shall not apply in the following circumstances:

• a) international judicial cooperation;• b) exchange of medical information, when so

required for the treatment of the party affected, or in case of an epidemiological survey, provided that it is conducted in pursuance of the terms of Paragraph e) of the foregoing Section;

(2) Law 3301 of the City of Buenos Aires about

Protection of Human Subjects in Health Research, 2010.

• Section 5. 15) Protection of the individual privacy.

• The privacy and data protection must be safeguard according to Law 25.326.

• The privacy of the individuals and the confidentiality of information will be respected, ensuring non-use of information obtained to the detriment of individuals and / or communities. The researcher is obliged to implement methods for the anonymity of the subjects and that enable to dissociate personal data from the functional scientific data for research. Any collection, use and transfer of any data not specifically set forth in the instruments of free and informed consent and in the research protocol are prohibited.

• Section 5. 23) Information of public access.• Activities and broadcast programs on clinical research

should be promoted and a database of public access to information on the researches undertaken in the city will be developed.

• The database will be published online and will provide relevant data of the protocol such as: objective, phase, responsible, place, drugs used or its code, in case of need to preserve confidentiality.

• The enforcement authority will seek to coordinate and / or unify this database with existing databases at the national, provincial and international levels.

• (3) A National project.

• The Chamber of Deputies passed a new bill last month (23 May 2012) stating that all national scientific institutions must provide open access (OA) archives of their research, allowing the public full access to journal articles, dissertation theses and technical reports, as well as data obtained by publicly funded projects, but excluding confidential data.

• The law will give citizens access to research funded through their taxes, and increase the visibility of Argentinean research.

• Not only scientists and professionals, but also the general public, will be able to access public-funded research

(4) Guidelines for Research on Human beings approved by Resolution 1480/2011 of

the Ministry of Health of Argentina on September 13,

2011

• A8. DATA MANAGEMENT AND RESULTS• P15. The information obtained from a human health

research should be recorded and filed so as to allow adequate interpretation and verification.

• P16. When the result of an investigation is published, it should:

• (a) Maintain the accuracy of the data and of their interpretation.

• (b) Declare the sources of finance, labor relations and other potential conflicts of interest.

• Articles that do not meet the ethical standards should not be accepted for publication.

• Publication of the study results. Researchers are obliged to disclose information that is of public interest by any appropriate means available and provided that the confidentiality of participants is respected and that the interpretations or inferences are not presented as if they were proven true or in a way that promote or appear to promote special interests, for example, that it has been proven that a product is effective.

• The publication of the research results, both positive and negative, is strongly recommended to facilitate transparency and to avoid the repetition of studies already completed and the submission of new participants to unnecessary risk.

(5) Research with children; special problems.

GENERAL COMMENT NO. 12 (2009) of the Committee on the Rights of the Child. The

right of the child to be heard. CRC/C/GC/12 - 1/7/2009

• 100. Children, including young children, should be included in decision-making processes, in a manner consistent with their evolving capacities. They should be provided with information about proposed treatments and their effects and outcomes, including in formats appropriate and accessible to children with disabilities.

• II. A jurisprudential case that shows non-compliance with rules.

• The National Administration of Drugs, Foods and Medical Devices (ANMAT) authorized the firm GlaxoSmithKline to conduct a "Clinical Otitis and PneumoniA Study (COMPAS), phase III, randomized, controlled and multicenter study to demonstrate the effectiveness of pneumococcal vaccine for the prevention of acquired pneumonia and acute otitis media.

• The Anmat conducted several inspections at the research authorized center. In Mendoza some irregularities emerged, most linked to the lack of information of mothers and children, who were all vulnerable people.

•

• The Anmat fined 400,000 Argentinean pesos (about 70.000 eu) that the laboratory did not consent. It went to courts but the judge upheld the decision.

• Subsequently, on January 3th, 2012, the Anmat reported that:

• a) the sanctions were linked to irregularities in the provision of informed consent,

• b) none of the deaths (12 children) that occurred during the study were linked to the vaccine administration,

• c) the vaccine is authorized in over 80 countries

• PROTECTING THE PUBLIC DOMAIN: ACCESS TO AND USE OF SCIENTIFIC DATA AND INFORMATION

• Comité Nacional de Ética en la Ciencia y la Tecnología, 2006

• There is an urgent need to rethink the meaning and role of the public domain in general, and of scientific data and information, in particular. The public domain should not only be a matter of concern for the scientific community, as the limitations to the access to knowledge and products derived from there affect the society at large. The fundamental challenge is to prevent the further erosion of the public domain and to ensure that the use of scientific information is not artificially limited by new protectionist measures.

PROVISIONAL CONCLUSIONS

• Clinical trials have made possible the commercialization of drugs that have benefited all humanity; however, a number of clinical trials have not scientific but economic purposes.

• There is no opposition to conduct multicenter clinical trials of transnational companies, provided that the local authority have the ability to distinguish between those that truly seek to develop innovative medicines, from those that aim to produce mass-market medicines that only favor the company.

• On the other hand, the public domain should not only be a matter of concern for the scientific community, as the limitations to the access to knowledge and products derived from there affect the society at large.

• Samuel Finkielman, MD, Former Director of the Institute for Clinical Investigation, University of Buenos Aires (UBA). He works on Clinical Research.

• Stella González Cappa, PhD in Medicine, Full Professor, works on Immunoparasitology and Microbiology research at the School of Medicine (UBA).

• Alberto Kornblihtt, PhD in Chemistry, Full Professor and a Howard Hughes Medical Institute International Research Scholar, works on Molecular Biology at the School of Sciences, UBA. His project studies mechanisms of coupling between transcription and alternative mRNA splicing in human cells.

• Karen Hallberg, PhD in Physics, researcher at the Atomic Centre Bariloche and Balseiro Institute, Member of the Pugwash Conferences for Sciences.

• Ivan Izquierdo, PhD in Medicine, Director of the Memory Research Centre, Pontifícia Universidade Católica do Rio Grande do Sul, Brazil, Member of the National Academies of Sciences of Argentina, Brazil, the United States and the UE. He works on the molecular mechanisms of formation, evocation, persistence and extinction of memory.

Current Members

• Noé Jitrik, Professor of Literature and critics, at the UBA; UNAM and Colegio de Mexico (Mexico), at United States and UE universities, writer, Director of the Institute of Latin American Literature, UBA.

• Aída Kemelmajer, PhD in Law, State Supreme Court Justice, Full Professor University of Cuyo, Mendoza, and several universities of Argentina and the UE; member of the National Academy of Law and Social Sciences.

• Ernesto Maqueda, PhD in Physics; researcher on theoretical physics at Tandar Laboratory. National Commission on Nuclear Energy.

• Armando Parodi, PhD in Biochemistry, Director of the Leloir Foundation, Member of the National Academy of Science of Argentina, USA and other academies in Latin America and Europe, Howard Hughes Medical Institute International Research Scholar. He studies the mechanisms by which proteins that follow the secretory pathway acquire their three-dimensional structures in the endoplasmic reticulum.

• Víctor Ramos, PH.D in Geology, UBA• Carolina Vera, PhD in Meteorology; Professor and Vice Dean of the School of

Sciences, UBA. Chairperson of the American Meteorological Society/STAC Committee on Southern Hemisphere Meteorology and Oceanography. She works on climate change at the Research Centre on Oceanography and Atmosphere, School of Sciences, UBA.

• Otilia Vainstok, Director

Current Members

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[email protected]://www.cecte.gov.ar

Comité Nacional de Éticaen la Ciencia y la Tecnología