Understand some relevant considerations and best practices for developing partnerships with American Indian/Alaska Natives through the development and implementation of research studies.
Best Practices for Responsible Management and Sharing of AI/AN Participant Data
American Indian/Alaska Native (AI/AN) communities bear a significant burden of health disparities, yet there remains a lack of meaningful research to alleviate this burden. Inclusivity of AI/AN communities in biomedical research is essential for benefitting from research outcomes, developing prevention and treatment strategies responsive to AI/AN community members’ health needs, and learning from these communities’ strengths and resiliencies. NIH is committed to supporting trustworthy and responsible biomedical research practices, prioritizing research participants as partners in the research enterprise, and supporting respectful, sustained relationships with AI/AN Tribes.
As outlined in NIH Guide Notice Supplemental Information: Responsible Management and Sharing of American Indian/Alaska Native Participant Data, NIH aims to build flexibility into its policies to allow for harmonization with Tribal policies and preferences to support trustworthy and responsible biomedical research practices.
Below are some best practices to consider when developing research studies with AI/AN participants.
Understand Tribal sovereignty and laws, regulations, policies, and preferences. If working with multiple Tribes, researchers should engage with each Tribe to understand their expectations before conducting research.
Engage early with Tribes when developing a data management and sharing plan, before research begins, and continue throughout research. This is an important step toward building trust, facilitating mutually beneficial and equitable partnerships, and developing a culturally appropriate Data Management and Sharing (DMS) Plan.
Establish mutually beneficial partnerships. While the goals of a research project may be well documented, it is also important for researchers to understand the motivations and expectations of research participants/communities.
Agree on who will manage data (e.g., Tribe, researcher, trusted 3rd party). Research agreements should describe planned data management and sharing practices, including when data sharing limitations are appropriate, to ensure mutual agreement about data management and sharing that aligns with AI/AN Tribes’ preferences.
Consider additional protections, as necessary. The DMS Policy recognizes that other factors (e.g., ethical, legal, and technical) may shape permissibility of data sharing, and these factors should be described in the Plans. In addition, to mitigate the potential for group harm to AI/AN Tribes, both individual and community data protections (e.g., deidentification of Tribal affiliation or other group identifiers and controlled access review) should be considered.