School of Biological and Population Health Sciences, College of Public Health and Human Sciences, Oregon State University, Corvallis, OR 97331, USA.
Environ Health Perspect. 2012 Jan;120(1):6-10. doi: 10.1289/ehp.1103904. Epub 2011 Sep 2.
When conducting research with American Indian tribes, informed consent beyond conventional institutional review board (IRB) review is needed because of the potential for adverse consequences at a community or governmental level that are unrecognized by academic researchers.
In this article, we review sovereignty, research ethics, and data-sharing considerations when doing community-based participatory health-related or natural-resource-related research with American Indian nations and present a model material and data-sharing agreement that meets tribal and university requirements.
Only tribal nations themselves can identify potential adverse outcomes, and they can do this only if they understand the assumptions and methods of the proposed research. Tribes must be truly equal partners in study design, data collection, interpretation, and publication. Advances in protection of intellectual property rights (IPR) are also applicable to IRB reviews, as are principles of sovereignty and indigenous rights, all of which affect data ownership and control.
Academic researchers engaged in tribal projects should become familiar with all three areas: sovereignty, ethics and informed consent, and IPR. We recommend developing an agreement with tribal partners that reflects both health-related IRB and natural-resource-related IPR considerations.
在与美洲印第安部落进行研究时，需要超越传统的机构审查委员会 (IRB) 审查的知情同意，因为学术研究人员无法识别可能对社区或政府层面造成的不利后果。
本文回顾了在与美洲印第安民族进行基于社区的参与式健康相关或自然资源相关研究时涉及的主权、研究伦理和数据共享问题，并提出了一个符合部落和大学要求的模型材料和数据共享协议。
只有部落国家本身才能确定潜在的不良后果，而且只有在它们理解拟议研究的假设和方法的情况下才能做到这一点。部落必须在研究设计、数据收集、解释和出版方面真正成为平等的合作伙伴。知识产权 (IPR) 保护的进步也适用于 IRB 审查，以及主权和土著权利原则，所有这些都影响数据的所有权和控制权。
参与部落项目的学术研究人员应该熟悉这三个领域：主权、伦理和知情同意以及知识产权。我们建议与部落合作伙伴制定一项协议，既要反映健康相关的 IRB，也要反映自然资源相关的 IPR 考虑因素。
