Anexo D Aprovação do CEP e TCLE

COMITÊ DE ÉTICA EM PESQUISA — CEP/GHC

O Comitê de Ética em Pesquisa do Grupo Hospitalar Conceição (CEP/GHC), que é reconhecido pela Comissão Nacional de Ética em Pesquisa (CONEP)/MS desde 31/10/1997, pelo Office For Human Research Protections (OHRP)/USDHHS, comoInstitutionalReviewBoard(IRB0001105),epeloFWA -FederalwideAssurance(FWA 00000378), em 4 de fevereiro de 2016, reavaliou o seguinte projeto depesquisa:

Projeto:15113 Versão do Projeto: Versão doTCLE:

Pesquisadores: RITA DE CÁSSIA ALVES LIRA

KELIN ROBERTA ZABTOSKI MARINEIDE GONÇALVES DE MELO BRENO RIEGEL SANTOS

Título: TRIPAIIII – “Tecnologias inovadoras para identificação de comportamentos de risco para o HIV e adesão ao tratamento antirretroviral em casais sorodiscordantes para o HIV”

Documentação:

Aprovados Aspectos Metodológicos: Aprovados Aspectos Éticos:

Aprovados

Parecer final: Este projeto, bem como os documentos adicionais incluindo o Termo de Consentimento Livre e Esclarecido (se aplicável), por estar de acordo com as Diretrizes e Normas Internacionais e Nacionais especialmente as Resoluções 466/12 e complementares do Conselho Nacional de Saúde, obteve o parecer de APROVADO, neste CEP.

Considerações Finais: Toda e qualquer alteração do projeto deverá ser comunicada imediatamente ao CEP/GHC, bem como os Eventos Adversos ocorridos. O Pesquisador responsável compromete-se a encaminhar, dentro dos prazos estipulados, o(s) relatório(s) parcial(ais) e/ou final ao Comitê de Ética em Pesquisa do GHC e o Centro de Resultados onde foi desenvolvida apesquisa.

O Comitê de Ética em Pesquisa do Grupo Hospitalar Conceição (CEP/GHC), que é reconhecido pela Comissão Nacional de Ética em Pesquisa (CONEP)/MS desde 31/10/1997, pelo Office For Human Research Protections (OHRP)/USDHHS, como Institutional Review Board (IRB0001105) e pelo FWA - Federalwide Assurance (FWA 00000378), em 17 agosto de 2016, avaliou a emenda ao projeto referente ao seguinte estudo:

Projeto: 13010 Versão do Projeto: Versão doTCLE:

Pesquisadores:

RITA DE CÁSSIA ALVES LIRA KELIN ROBERTA ZABTOSKI EDUARDO SPRINZ MARINEIDE GONÇALVES DE MELO

BRENO RIEGEL SANTOS

Título: TRIPAI III – Estudo de extensão para acompanhamento de casais sorodiscordantes

Documentação: Aprovada Aspectos Metodológicos: Adequados Aspectos Éticos: Adequados

Parecer final: Esta emenda ao projeto de pesquisa, bem como o(s) Termo(s) de Consentimento Livre e Esclarecido (se aplicável), por estar de acordo com as Diretrizes e Normas Internacionais e Nacionais e complementares do Conselho Nacional de Saúde, especialmente a Resolução 466/12, obteve o parecer de APROVADO(S) neste CEP. O Pesquisador responsável deve encaminhar dentro dos prazos estipulados, o(s) relatório(s) parcial(ais) e/ou final ao Comitê de ética em Pesquisa do GHC e o Centro de Resultados onde foi desenvolvida apesquisa.

Porto Alegre, 17 de aqosto de 2016.

ROSA MARIA LEVANDOVSKI

University of California Los Angeles 11000 Kinross Avenue, Suite 211 Los Angeles, CA 90095- 1694 http://ohrpp.research.ucla.edu GC-IRB: (310) 825-7122 M-IRB: (310) 825-5344 APPROVAL NOTICE DATE: 7/1/2015

TO: KARIN NIELSEN

PEDIATRICS-ADMINISTRATION FROM: DANIEL CLEMENS, MD, PhD

Chair, MIRB1

RE: IRB#14-001020-CR-00001 2015 Review for IRB#14-001020

Innovative technology for identification of HIV-risk behaviors and antiretroviral adherence in HIV- serodiscordant couples in Porto Alegre, Brazil.

Version: Version 1.0

The UCLA Institutional Review Board (UCLA IRB) has approved the submission listed below. UCLA's Federalwide Assurance (FWA) with Department of Health and Human Services is FWA00004642.

Submission and Review Information

Type of Submission Continuing Review

Type of Review Expedited Review

Approval Date for this Submission 7/1/2015 Expiration Date of the Study 6/30/2016

Funding Source(s)

1) Other: AIDS Institute and Center for AIDS Research with funding from the U.S.National Institutes of Health. Brazil funding from local Hospital fundingsource.

Grant PI: KARIN NIELSEN

Grant Title: Innovative technology for identification of HIV-risk behaviors and antiretroviral adherence in HIV-serodiscordant couples

Grant Number: AI28697 UCLA AIDS Institute and Center for AIDS Research

Regulatory Determinations

Important Note: Approval by the Institutional Review Board does not, in and of itself,

constitute approval for the implementation of this research. Other UCLA clearances and approvals or other external agency or collaborating institutional approvals may be required before study activities are initiated. Research undertaken in conjunction with outside entities, such as drug or device companies, are typically contractual in nature and require an agreement between the University and the entity.

General Conditions of Approval

As indicated in the PI Assurances as part of the IRB requirements for approval, the PI has ultimate responsibility for the conduct of the study, the ethical performance of the project, the protection of the rights and welfare of human subjects, and strict adherence to any stipulations imposed by the IRB.

The PI and study team will comply with all UCLA policies and procedures, as well as with all applicable Federal, State, and local laws regarding the protection of human subjects in research, including, but not limited to, the following:

• Ensuring that the personnel performing the project are qualified, appropriately

trained, andwill adhere to the provisions of the approvedprotocol,

• Implementing no changes in the approved protocol or consent process or documents

without prior IRB approval (except in an emergency, if necessary to safeguard the well-being of human subjects and then notifying the IRB as soon as possibleafterwards),

• Obtaining the legally effective informed consent from human subjects of their

legallyresponsible representative, and using only the currently approved consent process and stamped consent documents, as appropriate, with humansubjects,

• Reporting serious or unexpected adverse events as well as protocol violations or

otherincidents related to the protocol to the IRB according to the OHRPP reportingrequirements.

• Assuring that adequate resources to protect research participants (i.e., personnel,

funding,time, equipment and space) are in place before implementing the research project, and that the research will stop if adequate resources becomeunavailable.

• Arranging for a co-investigator to assume direct responsibility of the study if the PI

will be unavailabletodirectthisresearchpersonally, for example, when on sabbatical leave or vacation or other absences. Either this person is named as co-investigator in this application, or advising IRB via webIRB in advance of sucharrangements.

-- The UCLA IRB determined that the research meets the requirements for expedited review

per 45 CFR 46.110 category 5.

-- The IRB determined that no separate consent or consent waiver determination is necessary, as the proposed procedures are within the scope of the consent form used with subjects