Department of Health
and Human Services (HHS)
and Human Services (HHS)
January 25, 2022
NOT-OD-22-214 - Supplemental Information to the NIH Policy for Data Management and Sharing: Responsible Management and Sharing of American Indian/Alaska Native Participant Data.
NOT-OD-22-104 Notice of Extension of the Public Comment Period for NOT-OD-22-064 DRAFT Supplemental Information to the NIH Policy for Data Management and Sharing: Responsible Management and Sharing of American Indian/ Alaska Native Participant Data
NOT-OD-21-013 Final NIH Policy for Data Management and Sharing
NOT-OD-21-014 Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan
NOT-OD-21-015 Supplemental Information to the NIH Policy for Data Management and Sharing: Allowable Costs for Data Management and Sharing
NOT-OD-21-016 Supplemental Information to the NIH Policy for Data Management and Sharing: Selecting a Repository for Data Resulting from NIH-Supported Research
Office of The Director, National Institutes of Health (OD)
NIH is committed to building partnerships with American Indian/Alaska Native communities and strives to partner with Tribal Nations and to inform responsible research practices. Accordingly, and in response to Tribal Consultation, NIH is seeking input on draft Supplemental Information to the NIH Policy for Data Management and Sharing (DMS Policy) to promote responsible management and sharing of American Indian/ Alaska Native participant data under the NIH DMS Policy.
Background
As a steward of the Nation’s biomedical research data, NIH champions policies that support responsible, transparent, and robust data management and sharing practices for NIH-supported research. In 2020, NIH further advanced this commitment through the issuance of a final NIH Policy for Data Management and Sharing (DMS Policy). The DMS Policy promotes the management and sharing of scientific data generated from NIH-funded or conducted research by requiring the submission of Data Management and Sharing Plans (hereinafter Plans) and compliance with NIH Institute, Center, or Office (ICO)-approved Plans. It also emphasizes the importance of good data management practices and establishes the expectation for maximizing the appropriate sharing of scientific data generated from NIH-funded or conducted research, with justified limitations or exceptions.
NIH initiated a multi-year, stepwise process for seeking feedback from the community in developing a robust data sharing policy capable of reflecting the diversity of its community’s data sharing needs. As part of this engagement, in 2019 NIH initiated a formal Tribal Consultation on the draft DMS Policy in accordance with the HHS Tribal Consultation Policy[1] and the NIH Guidance on the Implementation of the HHS Tribal Consultation Policy [2]. The details of the Tribal Consultation process, findings, and recommendations, as well as NIH’s response are provided in the NIH Tribal Consultation Report NIH Draft Policy for Data Management and Sharing [3]. NIH considered these recommendations in the development of the final DMS Policy.
NIH is committed to promoting sustained, equitable, and trustworthy partnerships with Tribal Nations and has developed this Supplemental Information for researchers to promote responsible management and sharing of American Indian/ Alaska Native participant data. Some AI/AN Tribes may promote the use of other frameworks for the ethical governance of research and data, such as the CARE (Collective Benefit, Authority to Control, Reproducibility, Ethics) data sharing principles [4]. The purpose of this Supplemental Information is to:
In 2021, NIH solicited feedback on this Supplemental Information from its Tribal Advisory Committee and further solicited input from Tribal leaders. NIH is seeking public input to further incorporate researcher perspectives, particularly those focused on partnering with AI/AN communities and Tribal Nations, as well as additional public input.
NIH Requests Input on DRAFT Supplemental Information to the NIH Policy for Data Management and Sharing: Responsible Management and Sharing of American Indian/ Alaska Native Participant Data
AI/AN Tribes historically have been underrepresented in biomedical research, which has limited the extent to which they have been able to benefit from the outcomes of that research. Inclusivity of AI/AN participants in biomedical research is essential for developing prevention and treatment strategies responsive to these communities needs. NIH is committed to supporting trustworthy and responsible biomedical research practices, prioritizing research participants as partners in the research enterprise, and cultivating respectful, sustained relationships with AI/AN Tribes. Accordingly, 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.
With the release of the NIH Policy for Data Management and Sharing (DMS Policy), NIH has been working with research participants, the biomedical research community, and Tribal Nations to establish expectations regarding the contours of responsible data sharing as a fundamental component of the research process. NIH recognizes that conducting biomedical research with AI/AN communities, including data management and sharing, must be predicated on respect for Tribal sovereignty, with an acute recognition that our historical failures to honor that sovereignty have caused stigmatization and other harms to AI/AN populations. In response to these concerns, NIH developed this guidance document to help facilitate partnerships between AI/AN communities and researchers to align data management and sharing goals. This guidance also responds to calls NIH heard through the Tribal Consultation for Data Management and Sharing Policy emphasizing respect for sovereignty and restoring trust between researchers and AI/AN communities in data management and sharing practices.
Considerations for Researchers Working with AI/AN Communities
Tribal sovereignty. Researchers should recognize the requirements of Tribal sovereignty when developing partnerships with AI/AN communities and throughout the research process. Tribal sovereignty affords Tribal nations unique rights to control how biomedical research can be performed within Tribal jurisdiction, including how their data can be used, managed, and shared.
Tribal research laws, policies, and processes. Understanding of Tribal laws, regulations, and policies is critical for researchers planning to conduct research with AI/AN communities. Tribal Nations often employ a variety of strategies to protect their communities, including Tribal reviews of prospective research plans in an effort to promote beneficial use and prevent misuse of AI/AN data. For instance, Tribal Nations may have Tribal laws requiring use of their own Institutional Review Boards (IRBs) to assess the benefits and risks of research within Tribal jurisdiction. Sometimes Tribal Nations rely on national or regional Indian Health Services (IHS) IRBs or other research review processes, including Tribal research review committees and presentation and publication committees [6]. Unofficial listings of laws, regulations, and policies applicable to Tribes are available for reference. Tribal websites may also include additional resources on individual Tribal laws, regulations, and policies.
Cultural sensitivities. Awareness of past research misconduct involving AI/AN communities and their data is important for understanding AI/AN communities perception of research and respecting their research related concerns. Historical exploitation through research has often resulted in undermining trust between AI/AN communities, Federally-funded researchers, and the research enterprise. The sharing of biospecimens is not applicable to the DMS Policy but is often a concern of AI/AN communities and should be proactively discussed at the earliest stages of research in parallel to data management plans if collected. NIH emphasizes that proactive, transparent conversations around how data will be managed and shared are of paramount importance to restoring trust and cultivating productive relationships between Tribal Nations, NIH awardees, and the NIH.
Health disparities. AI/AN populations bear a significant burden of health disparities, yet there remains a lack of meaningful research studies to alleviate this burden. Sufficient inclusivity of AI/AN participants in responsive biomedical research studies remains a pervasive challenge, along with limited datasets with insufficient quality and reliability to draw meaningful conclusions. In other instances, the benefits of research either do not meet the needs of AI/AN communities or are not accessible to them, further perpetuating health disparities. As such, the National Congress of American Indians (NCAI) and other groups have advocated for data disaggregation where possible and the separate analysis of AI/AN data, while respecting Tribal sovereignty, to facilitate understanding of health disparities, protective health factors, and health outcomes of AI/AN communities. [7,8]
Facilitating Respectful Partnerships under the NIH DMS Policy
NIH established the NIH DMS Policy to shift the culture of research to make data sharing the norm. In developing this Policy, NIH engaged researchers, institutions, data providers and users, research participants, infrastructure developers, Tribal Nations, and others to support the evolution of a robust data sharing ecosystem which prioritizes responsible data sharing and management practices to allow more equitable access to biomedical data. Through this engagement, NIH worked directly with Tribal Leaders through Tribal Consultation to inform the final policy. NIH supports the recommendations received and developed this guidance in response. In this guidance, NIH is clarifying that researchers are expected to maximize appropriate data management and sharing in a manner that is consistent with applicable laws, regulations, and policies, including those set forth by Tribes. NIH also developed this guidance to promote effective partnerships between researchers and AI/AN communities in hopes of establishing the trustworthiness of the biomedical research enterprise. Clarifying best practices for researchers will facilitate the participation of AI/AN communities in research by mitigating related risks and increasing research transparency for AI/AN communities. Greater AI/AN participation in biomedical research will result in more reliable data that could have a greater impact on reducing health disparities in Tribal Nations.
Proactively engage AI/AN communities in planning for data management and sharing. Researchers are expected to discuss plans for data management and sharing with AI/AN community partners both prior to initiating research and frequently throughout the research process. Engaging in conversation prior to the initiation of a research study equips researchers with a greater understanding of any Tribal laws, regulations, and policies prior to developing a Plan under the NIH DMS Policy.
Establish mutual understandings of goals for data management and sharing. Researchers and AI/AN communities are encouraged to form equitable partnerships with a shared understanding of goals for data management and sharing. While the goals of a research study may be well documented, it is important for researchers to understand the motivations and expectations of research participants who engage in research. For instance, communities may have expectations regarding how their data will be used and shared. Agreeing to present research findings to communities can be one strategy for researchers to sustain relationships and increase trust. It is also helpful to proactively discuss any Tribal preapproval processes that will be used to review manuscripts or the dissemination of research findings. Researchers should convey agreements for data managing and sharing in the Plan (i.e., who made the agreement; applicable Tribal laws, regulations, and policies, etc.) and consider obtaining Tribal letters of support, Tribal resolutions, and/or other forms of written documentation when possible/required.
Incorporate AI/AN data management and sharing practices and preferences in study design. The NIH DMS Policy strongly encourages the use of an established data repository to the extent possible but does not specify use of a particular data repository or which entity manages the data repository selected. NIH is committed to supporting Tribal data science resources, including data repositories, through efforts such as NIH-supported data centers, the Centers of Biomedical Research Excellence research infrastructure, and the NIH Office of Data Science Strategy’s data science training. Prior to submitting a Plan to NIH, researchers and AI/AN partners should consider whether data generated will be managed by researchers, Tribal nations, AI/AN communities, or a trusted third party. Note that as a study evolves, Plans may be updated with NIH approval. Researchers should continue to work with communities to accurately reflect how data generated will be managed and shared.
Consider additional protections and appropriate limitations to future data sharing. Researchers and AI/AN partners are encouraged to jointly consider data sharing expectations, and any appropriate limitations on data sharing for secondary research. The NIH DMS Policy allows for certain factors (e.g., ethical, legal, and technical) to shape permissibility of data sharing and these factors should be described in Plans. Examples of factors that may be considered in determining the scope of data sharing include applicable Tribal laws, regulations, and policies governing participant research and resulting data; and distinct, culturally-embedded values that inform AI/AN community preferences regarding the extent to which data are shared. Tribal laws, regulations, and policies, for example, may apply to de-identified data not protected under Federal regulations. Data sharing may also be limited in instances in which AI/AN communities wish to manage and share their own data, and no appropriate repository exists or is accessible. AI/AN communities have legal rights to determine the conditions by which their data are shared when data are collected within Tribal jurisdiction, including requiring Tribal approvals or participating in research review requests.
Incorporate data management and sharing plans in the informed consent process. The NIH DMS Policy strongly encourages researchers to communicate data sharing and future use conditions to research participants in the informed consent process. This includes descriptions of any oversight safeguards on secondary research (e.g., whether all secondary research or secondary research beyond a prespecified scope will be reviewed by an oversight body), plans related to return of secondary research results (e.g., whether results of secondary analyses will be returned to Tribes), and/or stipulations of the data repository used (e.g., whether certain secondary research domains or questions are acceptable and how long data can be made available for secondary analyses). Individual Tribes may have IRB policies that specifically prohibit broad consent practices. The NIH DMS Policy does not expect informed consent to be obtained in any particular way, such as through broad consent, and emphasizes honoring appropriate sharing limitations in the informed consent process.
Safeguarding against future risk. The NIH DMS Policy indicates that, in developing Plans, researchers should describe how participants privacy, rights, and confidentiality will be protected. Small populations, like AI/AN communities, are at greater risk of privacy vulnerabilities or stigmatization if participant protections are not appropriately planned for and implemented (e.g., it may be easier for data re-identification to occur or possibly stigmatizing data may result from sharing). [9] To mitigate the potential for group harm within AI/AN populations, both individual and community data protections (e.g., deidentification of Tribal affiliation or other group identifiers and Data Access Committee review) may be necessary. In explaining the protections planned for participant data in Plans, researchers working with AI/AN communities are strongly encouraged to include considerations of Tribal sovereignty and the data sharing concerns of AI/AN communities. Consulting Tribal IRBs and/or other AI/AN research oversight entities is helpful for understanding the data sharing preferences of Tribes.
Comment Period
Comments on this Notice must be received no later than March 28, 2022.
Information Requested
NIH is specifically requesting public comment on the draft Supplemental Information. Response to this Notice is voluntary. NIH encourages feedback on the utility of this draft supplemental information for researchers conducting AI/AN-focused research. Respondents are free to address any or all of the content in the document. Respondents should not feel compelled to address all content.
How to Submit a Response
Comments must be submitted at https://osp.od.nih.gov/rfi-data-sharing-management-policy-of-native-participant-data/. Responses will be accepted through March 28, 2022.
Responses to this RFI are voluntary and may be submitted anonymously. You may also voluntarily include your name and contact information with your response. Other than your name and contact information, please do not include in the response any personally identifiable information or any information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in your response. After the Office of Science Policy (OSP) has finished reviewing the responses, the unredacted responses may be posted to the OSP website
NIH Office of Science Policy
[email protected]
References
[1] HHS Tribal Consultation Policy (December 2010) https://www.hhs.gov/sites/default/files/iea/tribal/tribalconsultation/hhs-consultation-policy.pdf.
[2] National Institutes of Health Guidance on the Implementation of the HHS Tribal Consultation Policy (April 2019) https://dpcpsi.nih.gov/thro/policy.
[3] NIH Tribal Consultation Report NIH Draft Policy for Data Management and Sharing (September 2020) https://osp.od.nih.gov/wp-content/uploads/Tribal_Report_Final_508.pdf.
[4] Carroll, S.R., Garba, I., Figueroa-Rodr guez, O.L., Holbrook, J., Lovett, R., Materechera, S., Parsons, M., Raseroka, K., Rodriguez-Lonebear, D., Rowe, R., Sara, R., Walker, J.D., Anderson, J. and Hudson, M., 2020. The CARE Principles for Indigenous Data Governance.Data Science Journal, 19(1), p.43. DOI:http://doi.org/10.5334/dsj-2020-043.
[5] Hodge, F.S. 2012, No Meaningful Apology for American Indian
Unethical Research Abuses. Ethics & Behavior, 22:6, 431-444. http://dx.doi.org/10.1080/10508422.2012.730788.
[6] Hull S.C., and Wilson, D.R. (2017) Beyond Belmont: Ensuring Respect for AI/AN Communities through Tribal IRBs, Laws, and Policies https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6097707/.
[7] Disaggregating American Indian & Alaska Native Data: A Review of Literature (July 2016) https://www.ncai.org/DataDisaggregationAIAN-report_5_2018.pdf.
[8] Van Dyke, E., Blacksher, E. et al., Health Disparities Research Among Small Tribal Populations: Describing Appropriate Criteria for Aggregating Tribal Health Data (July 2016) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4929243/.
[9] Friesen P., Kearns L. et al., Rethinking the Belmont Report? (2017) https://pubmed.ncbi.nlm.nih.gov/28661753/.