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Issued by

NATIONAL INSTITUTES OF HEALTH (NIH)

Purpose

Summary

The National Institutes of Health (NIH) remains committed to ensuring research fairness and respect for Tribal customs and research practices. NIH is notifying the community of how the agency will ensure that Tribal disposition preferences are respected when de-identified biospecimens are collected from Tribal populations. While these options are developed specifically for those biospecimens held at NIH facilities or at facilities on behalf of NIH (referred to as NIH held), all researchers are encouraged to review and adopt where practical.

Background

NIH has a responsibility to be good stewards of public funds, funding high-quality research and protecting study participants. Core to achieving this responsibility is respect for participant and community preferences regarding their participation in research, ensuring that our work together is meaningful for them and their health. Part of this commitment is respecting Tribal community customs and preferences regarding return or disposition of participants’ biological samples, commonly referred to as biospecimens, that have been collected and used for research.

NIH recognizes that Tribal Nations have passed Tribal research laws and ordinances pertaining to biospecimens and, in keeping with the intent to honor participant choices, conducted Tribal Consultation to identify respectful and supportable options for the disposition of biospecimens collected from American Indian and Alaska Native (AI/AN) Tribal members. Consistent with Tribal input, NIH is adopting the following set of options for disposition of de-identified biospecimens that respect Tribal sovereignty and cultural sensitivities, including when transfer or return has been requested by a Tribe.

Definitions

Tribal populations: Federally recognized American Indian or Alaska Native Tribe, as published by the Department of the Interior's Bureau of Indian Affairs.¹ Also included for purposes of this policy are Native Hawaiian communities as described in the Native Hawaiian Health Care Improvement Act (42 U.S.C. 11701 et seq.) and other recognized Indigenous populations. These entities are all referred to as Tribes for the purposes of this notice.

Human biospecimens: A quantity of tissue, blood, urine, or other human-derived material.  A single biopsy may generate several human biospecimens, including multiple paraffin blocks or frozen sample.  A human biospecimen can comprise subcellular structures, cells, tissue (e.g., bone, muscle, connective tissue, and skin), organs (e.g., liver, bladder, heart, and kidney), blood, gametes (sperm and ova), embryos, fetal tissue, and waste (urine, feces, sweat, hair and nail clippings, shed epithelial cells, and placenta).

De-identified biospecimens: Human biospecimens from which identifiable information has been removed. If there is a secure and controlled way to link back to the identifiable information of origin, the investigator using the biospecimens must not have access to that linkage in order for the biospecimens to be considered de-identified.

Options for Disposition of Biospecimens Collected from Tribal Populations

Tribes are permitted to request transfer or return of de-identified biospecimens collected from their affected Tribe(s) when held by NIH. Subject to appropriations and the ability to designate funds for this purpose, NIH will pursue the options detailed below in discussion with the Tribe(s).

1. Direct return of biospecimens to Tribe(s)

The Tribe(s) will arrange the return. NIH is poised to assist with return as needed or requested. When de-identified biospecimens are NIH held and a NIH decision for disposition has been made, the de-identified biospecimens can be returned directly to Tribe(s) if Tribe(s) is able to receive biospecimens per applicable national, state, and local laws and regulations and per Tribal customary practices and regulations.

       2. Indirect return of biospecimens to a third-party institution or organization identified by Tribe(s)

The Tribe(s) will arrange the return. NIH is poised to assist with return as needed or requested. When de-identified biospecimens are NIH held and a NIH decision for disposition has been made, de-identified biospecimens can be returned to a Tribally designated third-party institution or organization if the third-party institution/organization is able to receive biospecimens per applicable national, state, and local laws and regulations and per Tribal customary practices and regulations. The third-party institution or organization is expected to work directly with Tribe(s) to identify and implement culturally appropriate solutions.

       3. Indirect return of biospecimens to third-party institution or organization identified by NIH in consultation with Tribe(s) and organized by NIH.

NIH will arrange the return. When de-identified biospecimens are NIH held and a NIH decision for disposition has been made, de-identified biospecimens can be returned to a third-party institution or organization identified by NIH in consultation with Tribe(s) that is able to receive biospecimens per applicable national, state, and local laws and regulations. This third-party institution or organization is expected to work directly with Tribe(s) to identify and implement culturally appropriate disposition practices.

       4. After consultation with Tribe(s), Tribe(s) designates NIH as steward for biospecimens.

When de-identified biospecimens are NIH held, a NIH decision for disposition has been made, and Tribe(s) elects to have NIH continue stewardship of the de-identified biospecimens, NIH and Tribe(s) can develop mutually agreed upon terms for continued stewardship and de-identified biospecimen access, in accordance with applicable federal laws, regulations, and policies, and in alignment with Tribal preferences.

       5. After consultation with Tribe(s), Tribe(s) requests NIH dispose of biospecimens in culturally sensitive manner.

When de-identified biospecimens are NIH held and a NIH decision for disposition has been made, but Tribe(s) does not select any of the options above, Tribe(s) can instead request that NIH dispose of de-identified biospecimens. This disposal must be in accordance with applicable federal law, regulations, and policy, and occur in a culturally sensitive manner as identified through Tribal Consultation.

Resources

For further information about these options, please refer to https://dpcpsi.nih.gov/thro/nih-disposition-biospecimens-collected-tribal-populations

References

[1]  A Federal Register notice is published pursuant to section 104 of the Federally Recognized Indian Tribe List Act of November 2, 1994 (Pub. L. 103-454; 108 Stat. 4791, 4792), in accordance with section 83.6(a) of part 83 of title 25 of the Code of Federal Regulations, and in exercise of authority delegated to the Assistant Secretary—Indian Affairs under 25 U.S.C. 2 and 9 and Department of the Interior Manual part 209, chapter 8.

Inquiries

Please direct all inquiries to:

Tribal Health Research Office

[email protected]