4TH LATIN AMERICAN CONGRESS OF CLINICAL RESEARCH

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Zilda Cunha Belo
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1 4TH LATIN AMERICAN CONGRESS OF CLINICAL RESEARCH PATIENT PROTECTION AND PHARMACEUTICAL INDUSTRY PERSPECTIVE TO CONDUCT COUNTRY SELECTION FOR CLINICAL TRIALS LOCAL AND CENTRAL IRB S S : IT S S ROLE IN PATIENT PROTECTION Gysélle Saddi Tannous National Commission for Research Ethics

2 THE ORIGIN OF A SYSTEM LOCAL AND CENTRAL IRB S: IT S ROLE IN PATIENT PROTECTION CONEP/CEP SYSTEM

3 Avaliação Ética das Pesquisas Envolvendo Seres Humanos: de onde partimos. 1986: VIII National Health Conference THE SANITARY BATTLE IS AN ISSUE THAT OVERRULES PARTIES; NO PERSON, INSTITUTION, PARTY, GROUP, CATEGORY OR ENTITY CAN HANDLE THIS PROBLEM ALONE (SÉRGIO AROUCA, SANITARIAN DOCTOR)

4 Conquest : Citizen Constituition from 1988 ART Health is a right which belongs to everyone, simultaneously a duty from State, assured through social and economical policies that aim at the reduction of diseases risks and other worse circumstances, as well as at universal and equal access to actions and services addressed to its promotion, protection and recovery.

5 Regulamentation: Health Organic Law of Assistence LEI 8080/90: DISPLAYS ABOUT CONDITIONS FOR REALIZATION, PROTECTION AND RECOVERY OF HEALTH, ORGANIZATION AND FUNCTIONING OF RELATED SERVICES, AND ESTABILISHES OTHER MEASURES. ART. 7 ACTIONS AND PUBLIC SERVICES RELATED TO HEALTH, AS WELL AS HIRED OR ACCORDED PRIVATE SERVICES, WHICH INTEGRATE THE SISTEMA ÚNICO DE SAÚDE (SUS) ARE DEVELOPED ACCORDING TO ART.198 OF THE CONSTITUTION, OBSERVING THE FOLLOWING PRINCIPLES: VIII COMMUNITY S PARTICIPATION (SOCIAL CONTROL)

6 Regulamentation: Lei 8142, de 28 de dezembro de 1990 DISPLAYS ABOUT THE COMMUNITY S PARTICIPATION IN THE CONTROL OF THE SISTEMA ÚNICO DE SAÚDE (SUS) ART. 1 THE SISTEMA ÚNICO DE SAÚDE-SUS, REGULATED BY THE LAW 8080/90 (HEALTH ORGÂNIC LAW), WILL DISPOSE, IN EACH SPHERE OF GOVERNMENT, WITHOUT PREJUDICE OF THE FUNCTIONS CONCERNED TO LEGISLATIVE POWER, OF THE FOLLOWING COLLEGIATE INSTÂNCES : I- THE HEALTH CONFERENCE II- THE HEALTH COUNCIL

7 THE NATIONAL HEALTH COUNCIL PLENARY IN ITS 59th ORDINARY MEETING, CELEBRATED ON 9 AND 10 OCTOBER 1996, IN USE OF ITS REGIMENTAL COMPETENCES AND ATTRIBUITIONS CONFERED BY THE LAW 8080/90 AND THE LAW 8142/90, DECIDES: TO APROVE THE FOLLOWING RULES IN RELATION TO RESEARCHES ENVOLVING HUMAN BEINGS: RESOLUTION CNS 196/96

8 RESOLUTION CNS 196/96 * VIII NATIONAL COMISSION OF ETHICS IN RESEARCH (CONEP/MS) * IT IS A COLLEGIATE INSTITUTION, WHICH DISPOSES OF CONSULTING, DELIBERATIVE, NORMATIVE, EDUCATIVE AND INDEPENDENT NATURE, VINCULATED TO NATIONAL HEALTH COUNCIL. * THE MINISTRY OF HEALTH WILL FIND THE NECESSARY MEASURES IN ORDER TO SUPPORT THE WHOLE WORK OF THE COMISSION AND ITS EXECUTIVE SECRETARY OFFICE

Nordeste Total: 551CEP 01 CONEP 11 11 4 18 4 7 7 17 2 4 6 4 2 3 27 9 CONEP 14

9 Comitês de Ética em Pesquisa Institucionais: forma organizada de controle social sobre as práticas da ciência SISTEMA CEP/CONEP 38 - Norte Nordeste Total: 551CEP 01 CONEP CONEP Centro Oeste Sul Sudeste Fonte: CONEP/CNS/MS AGOSTO/2007

10 Complementary norms to Res. CNS 196/96 : 1997 Res. CNS 251/97 - New pharmaceutical products, vaccines and diagnostic tests 1999 Res. CNS 292/99 - International cooperation 2000 Res. CNS 303/00 - Human reproduction 2000 Res. CNS 304/00 - Indigenous populations Res. CNS 340/04 - Human genetics

11 Complementary norms to Res. CNS 196/96 : 2005 Res. CNS 346/05 - Multicentric protocols 2005 Res. CNS 347/05 - Storage and use of biological materials 2007 Res. CNS 370/ CEPs register

12 The anual evolution: ANO Nº. DE CEPs CREDENCIADOS NO ANO Nº. ACUMULADO DE CEPs CREDENCIADOS Nº. DE CEPs CANCELADOS TOTAL Fonte: CONEP/CNS/MS AGOSTO/2007

13 Composição dos CEPs segundo atuação profissional Medicina 30% Enfermagem 7% Outros 7% Ciências Exatas 3% Cirurgião Dentista 4% Ciências Biológicas 5% Total: 551 CEPs Bioquímica-Farmácia 6% Total Membros: 8107 Ciências Humanas e Sociais (Outras) 14% Direito 6% Bioética 4% Teologia-Filosofia 5% Serviço Social 3% Ciências da Saúde (Outras) 6% Fonte: CONEP/CNS/MS AGOSTO/2007

14 Projetos analisados na CONEP/ano Quantidade de Projetos OBS: Decréscimo do nº. de projetos a partir de 2005 devido à Res. CNS 346/2005 Fonte: CONEP/CNS/MS AGOSTO/2007

15 The Role and Responsabilities : To guarantee and to protect integrity, rights and fundamental liberties of the researches volunteers, in order to protect them from eventual damages, as well as to assure the society the ethic way in which the researches will be developed, so that the interests and the welfare of the human being always prevail over scientific technics.

16 Possible Ethic Implications from researches with human beings: 1. To identify vulnerabilities x Autonomy 2. Free and clarified permission of the possible participants 3. Assured sigil x transparence of the research process (social control) 4. To monitor researches under development (protection of the participants) 5. Research Social feedbak ( relevance)

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