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3.
J Empir Res Hum Res Ethics ; 5(1): 19-31, 2010 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-20235861

RESUMO

The philosophical underpinning of Community-Engaged Research (CEnR) entails a collaborative partnership between academic researchers and the community. The Community-Based Participatory Research (CBPR) model is the partnership model most widely discussed in the CEnR literature and is the primary model we draw upon in this discussion of the collaboration between academic researchers and the community. In CPBR, the goal is for community partners to have equal authority and responsibility with the academic research team, and that the partners engage in respectful negotiation both before the research begins and throughout the research process to ensure that the concerns, interests, and needs of each party are addressed. The negotiation of a fair, successful, and enduring partnership requires transparency and understanding of the different assets, skills and expertise that each party brings to the project. Delineating the expectations of both parties and documenting the terms of agreement in a memorandum of understanding or similar document may be very useful. This document is structured to provide a "points- to-consider" roadmap for academic and community research partners to establish and maintain a research partnership at each stage of the research process.


Assuntos
Pesquisa Participativa Baseada na Comunidade/ética , Pesquisa Participativa Baseada na Comunidade/organização & administração , Relações Comunidade-Instituição , Beneficência , Interpretação Estatística de Dados , Humanos , Disseminação de Informação , Consentimento Livre e Esclarecido , Modelos Teóricos , Negociação , Seleção de Pacientes , Projetos de Pesquisa , Apoio à Pesquisa como Assunto
4.
J Empir Res Hum Res Ethics ; 5(1): 5-17, 2010 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-20235860

RESUMO

In the 30 years since the Belmont Report, the role of the community in research has evolved and has taken on greater moral significance. Today, more and more translational research is being performed with the active engagement of individuals and communities rather than merely upon them. This engagement requires a critical examination of the range of risks that may arise when communities become partners in research. In attempting to provide such an examination, one must distinguish between established communities (groups that have their own organizational structure and leadership and exist regardless of the research) and unstructured groups (groups that may exist because of a shared trait but do not have defined leadership or internal cohesiveness). In order to participate in research as a community, unstructured groups must develop structure either by external means (by partnering with a Community-Based Organization) or by internal means (by empowering the group to organize and establish structure and leadership). When groups participate in research, one must consider risks to well-being due to process and outcomes. These risks may occur to the individual qua individual, but there are also risks that occur to the individual qua member of a group and also risks that occur to the group qua group. There are also risks to agency, both to the individual and the group. A 3-by-3 grid including 3 categories of risks (risks to well-being secondary to process, risks to well-being secondary to outcome and risks to agency) must be evaluated against the 3 distinct agents: individuals as individual participants, individuals as members of a group (both as participants and as nonparticipants) and to communities as a whole. This new framework for exploring the risks in community-engaged research can help academic researchers and community partners ensure the mutual respect that community-engaged research requires.


Assuntos
Pesquisa Participativa Baseada na Comunidade/ética , Relações Comunidade-Instituição , Experimentação Humana/ética , Direitos Humanos , Humanos , Autonomia Pessoal , Medição de Risco , Terminologia como Assunto
5.
J Empir Res Hum Res Ethics ; 5(1): 33-47, 2010 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-20235862

RESUMO

The ethical conduct of Community-Engaged Research (CEnR), of which the Community-Based Participatory Research (CBPR) model is the partnership model most widely discussed in the CEnR literature and is the primary model we draw upon in this discussion, requires an integrated and comprehensive human subjects protection (HSP) program that addresses the additional concerns salient to CEnR where members of a community are both research partners and participants. As delineated in the federal regulations, the backbone of a HSP program is the fulfillment of nine functions: (1) minimize risks; (2) reasonable benefit-risk ratio; (3) fair subject selection; (4) adequate monitoring; (5) informed consent; (6) privacy and confidentiality; (7) conflicts of interest; (8) address vulnerabilities; and (9) HSP training. The federal regulations, however, do not consider the risks and harms that may occur to groups, and these risks have not traditionally been included in the benefit: risk analysis nor have they been incorporated into an HSP framework. We explore additional HSP issues raised by CEnR within these nine ethical functions. Various entities exist that can provide HSP---the investigator, the Institutional Review Board, the Conflict of Interest Committee, the Research Ethics Consultation program, the Research Subject Advocacy program, the Data and Safety Monitoring Plan, and the Community Advisory Board. Protection is best achieved if these entities are coordinated to ensure that no gaps exist, to minimize unnecessary redundancy, and to provide checks and balances between the different entities of HSP and the nine functions that they must realize. The document is structured to provide a "points-to-consider" roadmap for HSP entities to help them adequately address the nine key functions necessary to provide adequate protection of individuals and communities in CEnR.


Assuntos
Pesquisa Participativa Baseada na Comunidade/ética , Pesquisa Participativa Baseada na Comunidade/organização & administração , Relações Comunidade-Instituição , Experimentação Humana/ética , Gestão de Riscos , Confidencialidade , Conflito de Interesses , Humanos , Consentimento Livre e Esclarecido , Seleção de Pacientes , Revisão da Pesquisa por Pares , Pesquisadores/educação , Justiça Social , Populações Vulneráveis
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