title: Conducting research with tribal communities: sovereignty, ethics, and data-sharing issues.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
  
  
  CONCLUSIONS
  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.
authors: School of Biological and Population Health Sciences, College of Public Health and Human Sciences, Oregon State University, Corvallis, OR 97331, USA. anna.harding@oregonstate.edu
authors: Anna
authors: A
authors: Harding
authors: Barbara
authors: B
authors: Harper
authors: Dave
authors: D
authors: Stone
authors: Catherine
authors: C
authors: O'Neill
authors: Patricia
authors: P
authors: Berger
authors: Stuart
authors: S
authors: Harris
authors: Jamie
authors: J
authors: Donatuto
mesh_terms: D028744:Ethics Committees, Research; D032984:Ethics, Research; D006806:Human Rights; D006801:Humans; D007198:Indians, North American; D033181:Information Dissemination / Q000941:ethics*; D018973:Intellectual Property; D012107:Research Design