National Institutes of Health Guidance on the Implementation of the HHS Tribal Consultation Policy

1. Introduction

The mission of the National Institutes of Health (NIH) is to seek fundamental knowledge about the nature and behavior of living systems and to apply that knowledge to enhance health, lengthen life, and reduce illness and disability. The NIH is the largest supporter of biomedical and behavioral research in the world, providing funds for more than 40,000 competitive research grants and more than 325,000 research personnel at more than 3,000 research institutions, including Tribal colleges and universities and Tribal governments and small businesses across the Nation.

The NIH is made up of 27 Institutes and Centers (ICs), each with its own broadly defined mission and specific research agenda, often focusing on particular diseases or body systems. Through the ICs, the NIH provides leadership and financial support to researchers in every state and throughout the world. Each year, federal funds are obligated by Congress for the pursuit of research objectives. Each institute determines how to allocate its own funds among the different activities of science. NIH leadership plays an active role in shaping the agency’s research planning, activities, and outlook. The Office of the Director (OD) is the central office at the NIH, responsible for setting policy for the NIH and for planning, managing, and coordinating the programs and activities of all NIH components.

Decision-makers at the NIH seek advice from many sources when setting priorities: the scientific community, including both individual researchers and professional societies; patient organizations and voluntary health associations; Institutes’ and Centers’ Advisory Councils; the Congress and the Administration; the Advisory Committee to the NIH Director (ACD); the Council of Councils; the Scientific Management Review Board; and NIH staff. The NIH encourages and depends upon public involvement in federally supported research and activities. The NIH’s wide-ranging public efforts include outreach and education, nationwide events, request for public input on projects, and special programs specifically designed to involve public representatives in clinical research.

In December 2010, the U.S. Department of Health and Human Services (HHS) issued a Tribal Consultation Policy (TCP) (see The TCP states that before any HHS action is taken that will significantly affect Indian Tribes, consultation with Indian Tribes will occur to the extent practicable and permitted by law. The policy calls on the HHS operating staff and divisions to have an accountable process, as defined in Sections 8 and 9 of the TCP, to ensure meaningful and timely input by Indian Tribes in the development of policies that have Tribal implications.

The purpose of the NIH Guidance on the Implementation of the HHS Tribal Consultation Policy is to facilitate the implementation of the TCP by the ICs and OD. For purposes of the NIH Implementation Guidance, the term Indian will be used to reference the Indian Tribes as defined in 25 U.S.C.479a1, and the Tribal leadership that represents them. The Indian Tribes which are eligible for the special programs and services provided by the United States to Indians because of their status as Indians that are published in a list in the Federal Register each year which are eligible for the special programs and services provided by the United States to Indians because of their status as Indians.

2. Tribal Consultation Process, Procedures and responsibilities

A consultation will occur when HHS, NIH, or an Indian Tribe identifies an NIH action with substantial direct effects for one or more Indian Tribe.

  1. Responsibilities

    1. The NIH Office of the Director, through the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) Tribal Health Research Office (THRO), will be responsible for ensuring agency-wide adherence to the HHS TCP and the provisions of this guidance. The THRO will be the central coordinating site for all Tribal activities.

    2. NIH ICs will identify an official point-of-contact (IC POC) who will be responsible for coordinating internal activities related to Indian issues and facilitating and supporting NIH-wide Indian-related activities. The POC information will be maintained on the NIH OD THRO public website. Government-to-Government consultation at NIH will occur as outlined in the procedures below.

  2. Government-to-Government consultation between NIH and Tribal Leadership and/or representatives will occur through:

    1. An annual NIH Tribal consultation session.

    2. NIH participation in the annual regional Tribal consultation sessions hosted by the 10 HHS regional offices.

    3. NIH Participation in the HHS Annual Tribal Budget and Policy Consultation Session (ATBPCS)

    4. Meetings between the NIH Director (or his/her designee) and elected Indian Tribal leaders (or their designees).

    5. Written communications, e.g., letters, emails, and publications between the NIH Director (or his/her designee) and elected Indian Tribal leaders (or their designees).

  3. As referenced in B.1., the NIH OD, through the THRO, will hold at least one annual NIH-wide Tribal consultation session. The results of the consultation will be documented by the THRO and made available to all consultation participants.

    1. Upon completion of a consultation session, THRO will prepare a summary of the proceeding that documents positions and issues raised that would benefit from ongoing consultation with the Indian Tribes. The summary will be provided to all consultation participants.

    2. Any issues requiring follow-up will be tracked by the relevant IC POC and the THRO, and will be reported to the Indian Tribes as soon as feasible or within 90 calendar days of the consultation session.

  4. In addition to the annual Tribal consultation, other consultations may be held for the purposes of discussing such issues as:

    1. Ongoing proposed research of interest to Indians.

    2. Current or proposed NIH policies, programs, and/or research projects.

    3. Current or proposed research priorities and plans.

  5. To initiate an ad hoc consultation, a written request for the consultation must be submitted to the NIH POC or, if the NIH requests the consultation, to the appropriate Indian leadership. A copy of the request should be provided to THRO.

    1. A consultation request should:

      1. Identify the subject or issue of concern and any related concerns.

      2. Identify the applicable program(s), policy, rule, regulation, statute, or authorizing legislation.

      3. Identify the affected and potentially affected Indian Tribe or Tribes.

    2. A consultation request by an Indian Tribal leader or designee should be addressed to the POC of the most appropriate NIH IC. A request for a consultation with the NIH Director should be directed to the NIH OD POC. If the Indian Tribal representative is uncertain about which IC the request should be directed to, it should be directed to the THRO. Following discussion with the THRO, an IC may request a consultation with an Indian Tribe on the identified issue of concern.

    3. The NIH POC will acknowledge receipt of the request from the Indian Tribal representative within 15 calendar days. The acknowledgement will be in writing, e.g., an email.

    4. If the consultation request needs to be re-assigned to another IC POC, the first IC POC receiving the request will notify the requestor within 30 calendar days after receipt of the consultation request. The second IC POC will acknowledge receipt of the request to the first IC POC and to the requestor within 30 calendar days of its receipt by the second POC.

    5. Proper notice of the type and/or level of consultation, as determined by the NIH OD or IC, will be communicated to all participants and to potentially affected parties within 60 calendar days after receipt of the request at the appropriate office. Appropriate forms of notice include a “Dear Indian Tribal Leader” letter, broadcast email, a Federal Register (FR) notice, and announcements in the media or other outlets.

  6. Consultation can occur through in-person meetings or teleconferences, or through written communication.

    1. Meeting(s): One or more meetings with affected and potentially affected Indian Tribal leaders or representatives may be convened when the issues and concerns for consultation are determined to be relevant to a significant number of (or-all) Indian Tribes. Efforts will be made to ensure fair representation of all affected Indian Tribes. Meetings may be held in person or by teleconference call. NIH policy does not dictate a minimum number of participants, meeting duration, location, or frequency, but such details should be decided on a meeting-by-meeting basis and should be appropriate to the issue and number of parties involved. Meeting notice will be issued at least 30 calendar days in advance of the scheduled meeting. The THRO, as the coordinator of all Indian Tribal Consultation activities, should be notified in advance of all scheduled consultation meetings.

    2. Correspondence: Additional consultations may also occur through written communications between the NIH OD or an IC and Indian Tribal Leadership or designated representatives. Such communications offer another route for commenting on research polices, programs or priorities, and for identifying concerns.

  7. Consultation is considered to have occurred when the NIH Director, NIH Deputy Director, IC Director, IC Deputy Director, or their designee meets and/or exchanges written correspondence with an Indian President/Chair/Governor/Chief/Principal Chief and/or elected/appointed Indian Tribal Leader, or their designee.

  8. Once the consultation process is complete, and if action is proposed, notice of this proposed action will be broadly distributed electronically and posted independently on the NIH, IC, and THRO website to the extent practicable and permitted by law. If comments are to be solicited from Indian Tribes, there will be a 30-day period after publication of the notice to allow for comments. The publication will contain information regarding how and to which office comments are to be submitted.

  9. In addition to the government-to-government consultative process described above, the NIH Director will establish an NIH Tribal Advisory Committee (TAC), as a complementary venue for the exchange of information between NIH and Indian representatives. The TAC will meet up to twice a year to exchange information about the NIH research policies, programs, and priorities and to discuss issues that may require government-to-government consultation. The TAC will support, but not supplant, any government-to-government consultation activities that the NIH undertakes. The TAC meeting is not a substitute for Tribal consultation.

  10. In addition to assisting the NIH in the planning and coordination of consultation sessions, the TAC will provide an established, recurring venue wherein Indian Tribal representatives can advise the NIH regarding the government-to-government consultation process and help to ensure that NIH research policies and program priorities that affect their Tribes are brought to the attention of all affected parties. The TAC will help ensure that Indian Tribal representatives have meaningful and timely input in the development of relevant NIH policies, programs, and priorities.

  11. All TAC meetings and all levels of consultation should be documented appropriately, with electronic copies of documents sent to participants including the Indian Tribal representatives and the NIH POC. At a minimum, appropriate documentation includes a list of participants with affiliations and contact information, a summary of proceedings and a statement of meeting outcomes. Documentation should be completed and made available to stakeholders.

    In addition to sending electronic copies of documentation to participants, documentation of TAC meetings and NIH-wide consultation activities will be posted on the THRO website. To the extent practicable and permitted by law, documentation of consultation activities conducted by individual ICs or the NIH OD will be posted on their respective websites, with copies sent to the THRO for posting on the THRO website as well. The THRO will be responsible for archiving all consultation documentation.

  12. One goal of this guidance is to enhance NIH-Indian Tribal collaborations in future research. At the request of an Indian Tribal or an NIH representative, unresolved issues or concerns will be addressed, to the extent practicable, as a high-priority agenda item during the next regularly scheduled meeting of the TAC. If the concern merits more immediate attention, the party or parties involved should submit a written communication to the NIH OD with a copy to the THRO. The NIH OD, in collaboration with the THRO, will decide the best platform for addressing the concern. Consistent with the HHS Tribal Consultation Policy, Indian Tribal representatives should also submit a written communication to the NIH OD POC, with a copy to the THRO, to apply for any waivers from statutory and regulatory requirements that are discretionary and subject to waiver by NIH.

  13. Although the Implementation Guidance’s goal is to encourage and facilitate consultations, the guidance does not create any rights of action against the NIH for failure to comply with this NIH Implementation Guidance.

  14. The consultation process outlined should lead to a meaningful, outcome-oriented exchange of information that is viewed as useful by Indian and NIH participants. All government-to-government consultations will include an evaluation component comprised of a written survey provided to participants at the end of each session. Using these surveys as data collection tools, the NIH will measure the overall level of satisfaction with the consultation process. The level of satisfaction assessment will also include evaluations of NIH responsiveness to Indian Tribal input, Indian Tribal constituent responsiveness to NIH input, the achievement of mutually satisfactory results, and the provision of timely and thorough documentation to participants.

  15. Conflict resolution. In accordance with the HHS Tribal Consultation Policy, the intent of this guidance is to promote partnership with the Indian Tribes that enhance the ability of NIH and HHS to address issues, needs, and problems resolution. NIH shall consult with Indian tribes to establish a clearly defined conflict resolution process under which Indian Tribes bring forward concerns which have substantial direct effect. However, Indian Tribes and NIH may not always agree and inherent in the government-to government relationship, Indian Tribes may elevate an issue of importance to the HHS.

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