Data-sharing policies promoted by the National Institutes of Health (NIH) aim to maximize public benefit derived from genetic studies by increasing research efficiency and the use of a pooled data resource for future studies. Although broad access to data may lead to benefits for populations underrepresented in genetic studies, such as indigenous groups, tribes have ownership interest in their data. The Northwest-Alaska Pharmacogenetic Research Network (NWA-PGRN), a partnership involving tribal organizations and universities conducting basic and translational pharmacogenetic research, convened a meeting in Feb 2012 to discuss the collection, management, and secondary use of research data, and the processes surrounding access to data stored in federal repositories. Meeting attendees included representatives of the three NWA-PGRN tribal partners, other Northwest tribal organizations, university-based researchers, scholars whose work addresses questions related to tribal human subjects and other research processes, and NIH representatives. The goal of the meeting was to exchange information and perspectives about data sharing in research involving tribal-university partnerships, and to identify knowledge that would be helpful to tribal authorities, researchers and NIH officials in preparing for discussions about data sharing.
Outcomes of these discussions showed that data sharing may result in benefits for tribal communities, but the risks must be acknowledged and addressed as part of the research partnership agreement. Tribes have ownership interest in their data and traditions, and past experiences with genetic research have made tribes cautious of broad data-sharing agreements. There is strong support for efficient research processes that expedite the time required to generate benefits from collaborative research despite serious concerns about the potential for harm, but moving forward is dependent on efforts by the scientific community to build and maintain trust. Developing data sharing strategies and protocol may be an appropriate step towards this objective, yet procedures to do so must take into account tribal sovereignty and need for accountability. Tribes may use different mechanisms to ensure appropriate oversight of research – e.g., research review committees, tribally based IRBs, review of draft manuscripts, etc. The key elements are transparency of the data-sharing obligations and options, and the opportunity for tribal authorities to review and approve research involving tribal samples or data.
There are several specific ways in which accountability could be encouraged by NIH as part of the research process. The NIH could develop mechanisms focused on consultation between researchers, research institutes, and the tribal leadership and community to negotiate data-sharing plans in the context of the study period, or through stand-alone planning grants. The meeting group suggested encouraging NIH and other government funders to include dollars designated for consultation with tribes prior to, and throughout the research period. Grant proposals could also require a dissemination plan that specifies how researchers will provide information back to the community during the project period and after completion of the research, which could take the form of resources for community meetings and travel to public venues for tribal representatives and researchers. The group noted that this step of returning to communities could be combined with a research partnership evaluation component that would benefit the NIH in identifying the elements of collaboration that strengthen trust and facilitate respectful negotiation. The group also felt that tribes should have an opportunity to give input related to, and be involved in, the review process for secondary research uses of tribal data.
In the contemporary era, federal policies favoring scientific discovery and innovations in biotechnology must be moderated by respect for tribal sovereignty. In any tribal-university partnership, it will be necessary to establish a relationship of trust in which tribal laws and cultural interests are given deference, and in which an ethic of respectful negotiation is used to secure the rights of the tribe and the interests of the research community in promoting forms of knowledge that are truly of benefit to all.
Link to article: http://www.ncbi.nlm.nih.gov/pubmed/24830328
James RD, Tsosie R, Sahota P, Parker M, Sylvester I, Lewis J, Klejka J, Muzquiz L, Olsen P, Whitener R, Burke W. Exploring Pathways to Trust: A Tribal Perspective on Data Sharing. Genetics in Medicine. PMID 24830328.