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]