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 : IT’S ROLE IN PATIENT PROTECTION Gysélle Saddi Tannous National Commission for Research Ethics
THE ORIGIN OF A SYSTEM
LOCAL AND CENTRAL IRB´S: IT’S ROLE IN PATIENT PROTECTION
CONEP/CEP SYSTEM
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)
Conquest : Citizen Constituition from 1988 ART. 196 -
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
addressed recovery .
access to
its
to
actions
promotion,
and
services
protection
and
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 CONTROL)
PARTICIPATION
(SOCIAL
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
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
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
Comitês de Ética em Pesquisa Institucionais: forma organizada de controle social sobre as práticas da ciência SISTEMA CEP/CONEP 1
3
90 - Nordeste
38 - Norte 11 2
6
31 – Centro Oeste
Total: 551CEP 01 CONEP
7 4
3
18
4
11
9 CONEP 14 5
27
66
9
292 - Sudeste
161 33
4 7 17 4 2
56
25 42
100 - Sul
Fonte: CONEP/CNS/MS AGOSTO/2007
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 2004 - Res. CNS 340/04 - Human genetics
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 370/2007 - CEPs register
The anual evolution: ANO
Nº. DE CEPs CREDENCIADOS NO ANO
Nº. ACUMULADO DE CEPs CREDENCIADOS
Nº. DE CEPs CANCELADOS
1997
84
84
0
1998
44
128
0
1999
34
162
1
2000
33
195
1
2001
38
233
4
2002
38
271
4
2003
51
322
29
2004
64
386
25
2005
73
459
29
2006
73
532
10
2007
19
551
1
551
104
TOTAL
Fonte: CONEP/CNS/MS AGOSTO/2007
Composição dos CEPs segundo atuação profissional Enfermagem 7%
Medicina 30%
Outros 7% Ciências Exatas 3% Direito 6% Serviço Social 3%
Cirurgião Dentista 4%
Ciências da Saúde (Outras) 6%
Ciências Biológicas 5% Bioquímica-Farmácia 6%
Total: 551 CEPs Total Membros: 8107
Ciências Humanas e Sociais (Outras) 14%
Bioética 4% Teologia-Filosofia 5%
Fonte: CONEP/CNS/MS AGOSTO/2007
Projetos analisados na CONEP/ano 2007
481
2006
1052
2005
1256
2004
1738
2003
1538
2002
1563
2001
1321
2000
964
1999
561
1998
265
1997
169 0
500
1000
1500
2000
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
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.
Possible Ethic Implications from researches with human beings: 1. 2. 3. 4. 5.
To identify vulnerabilities x Autonomy Free and clarified permission of the possible participants Assured sigil x transparence of the research process (social control) To monitor researches under development (protection of the participants) Research Social feedbak ( relevance)
homepage: http://conselho.saude.gov.br/comissao E-mail:
[email protected]