Tribal Advisory Committee Meeting Summary - December 13, 2023

Wednesday, December 13, 2023

2:00–3:30 p.m. ET

TAC Participants

NIH

Tara A. Schwetz, Ph.D., Director, Division of Program Coordination, Planning and Strategic Initiatives (DPCPSI)
Robin Kawazoe, Deputy Director, DPCPSI
Karina L. Walters, Ph.D., M.S.W., Director, Tribal Health Research Office (THRO)
Sheila A. Caldwell, Ph.D., Senior Science and Policy Advisor and Acting Deputy Director, THRO 
Selina Keryte, Health Science Policy Analyst, THRO
Michael Hahn, Tribal Engagement Team Lead, All of Us Research Program

Guests

Rachael L. Tracy, M.P.H., Research Director and National Institutional Review Board Chair,
Division of Planning, Evaluation, and Research, Office of Public Health Support, Indian Health Service

Contractor Support

Kendra King Bowes, Miami Environmental and Energy Solutions 
Stacy Kish, Notetaker, Audio Associates

QUORUM: Met

Meeting Status

Kendra King Bowes called the virtual meeting to order with the roll call at 2:01 p.m.

Welcome and Introductions

Herminia Frias, M.P.H., TAC Chairperson, welcomed the participants and provided a brief update regarding her meeting with Sheila A. Caldwell, Ph.D., THRO Senior Science and Policy Advisor and Acting Deputy Director, to develop an agenda based on content from the recent caucus. Agenda items include future discussions with Spero Manson, Ph.D., Distinguished Professor Department of Community & Behavioral Health at the University of Colorado Denver, as well as research and Institutional Review Board (IRB) development.

Karina L. Walters, Ph.D., M.S.W., THRO Director, welcomed the attendees. She introduced the new Director of the Division of Program Coordination, Planning and Strategic Initiatives, Dr. Tara A. Schwetz. Dr. Walters thanked Dr. Eisinger, who previously served as acting director. Dr. Walters gave an overview of Dr. Schwetz’s background and credentials.

Tara A. Schwetz, Ph.D., Director of the Division of Program Coordination, Planning and Strategic Initiatives (DPCPSI), looks forward to meeting and working with the members of the TAC. She understands disparities exist across various systems and appreciates the importance of having access to training, resources, and experience to build a science program. She gave a quick update regarding concerns of studies conducted under the NIH National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). She stated that NIH is committed to the highest standard of protection for study participants and honoring Tribal sovereignty, including and especially Tribal data sovereignty. NIH has begun to conduct in-person meetings with Tribes involved in the NIDDK studies. Dr. Walters has led meetings alongside Greg Germino, M.D., Deputy Director of NIDDK with Tribal leaders, and Tribal IRB leaders for two of the Tribes involved in the studies. She will continue to arrange meetings with the additional Tribes involved in the studies.

Chairperson Frias opened the floor for the TAC members to introduce themselves to Dr. Schwetz.

Dr. Walters noted that Monica Bertagnolli, M.D., is the new NIH Director. She presented at the HHS Secretary’s Tribal Advisory Committee meeting and introduced herself to Tribal leaders. Dr. Bertagnolli has a background in rural health.

Indian Health Service National Institutional Review Board

Dr. Walters introduced Rachael L. Tracy, M.P.H., Research Director and National Institutional Review Board Chair, Indian Health Service (IHS). (A copy of the presentation is available at https://nih.account.box.com/login )

Ms. Tracy began with an overview of the IHS mission. IRBs are in place to ensure that research observes three principles of ethics: 1) respect for persons, 2) beneficence, and 3) justice. There are many types of IRBs: federal, medical/clinical, academic, and Tribal.

The Common Rule is a regulation that guides research protections with human subjects funded by certain agencies. Each Tribe may have their own definition of research and its own set of research protections and laws that may extend beyond the Common Rule. Researchers must receive appropriate approvals from the Tribe throughout the process.

Human subject research protections must be approved by an IHS IRB when conducted at a facility under IHS oversight. Federalwide Assurance is the IHS director’s assurance to the HHS Office for Human Research Protections that research will be conducted under Title 45 of CFR part 46 and the Belmont Report.

Tribal IRBs do not have the authority to approve research conducted at IHS facilities and will require a dual review for the research. IRBs aim to ensure risks to the subject are less than minimal in relation to the anticipated benefits, participation is equitable, informed consent is sought and properly documented, data collection, process, and disposition are clearly defined, and Tribal communities are part of that dialog, and their wishes are respected. In addition, IRBs ensure privacy is protected and no coercion was used to gain participants.

IRBs also ensure Tribal authorities involved in the research have full awareness. Researchers must receive consent from Tribal communities involved and have received a Tribal resolution or letter of support. Each area has its own IRB approval process. The IRB ensures that there is meaningful review and ownership of data prior to publication and that data from one study is not used in other studies without prior IRB approval.

Representative IRBs (such as IHS and Tribal) have the best knowledge of the local community and can minimize local harm and misunderstandings. Tribal members and communities may not trust researchers, and community education about IRBs provides a level of understanding when engaging in research.

Common issues that emerge include lack of Tribal approvals especially from appropriate Tribal authorities, gaps in protocol and procedures, and issues with consent forms.

Ms. Tracy provided a map of the eight IHS Area IRBs. Areas without an IHS IRB will be reviewed by the National IRB. (Information on IHS IRBs is located at: https://www.ihs.gov/dper/research/hsrp/instreviewboards/ )

Co-Chair Alicia C. Mousseau, Ph.D., Great Plains Area: Can you provide more specifics on the area IRBs and the timing to move content through those areas?

Ms. Tracy: Each area IHS IRB operates independently. The IHS IRBs typically meet once a month. Timing for approval varies with each area IHS IRB and may depend on how many protocols are on the docket that month. Administratively, IHS IRBs are located at an area office. I will follow up with a list of IHS IRB locations and the dates of the monthly meetings.

Co-Chair Mousseau: Can you provide a list of contacts and date for submittals?

Ms. Tracy noted that the list is available on the IHS National IRB website, but the website is currently being updated. Some IHS IRBs have their own website while others have contacts on the National IHS IRB website. There are also instructions on the website for how to assemble a protocol. All Tribal IRBs maintain these standards but some area IHS IRBs have additional requirements. She will share this information with the TAC. If an area IHS IRB does not have expertise for a given area, they will identify someone for ad hoc review.

IHS IRB considerations include: 1) privacy and confidentiality including Health Insurance Portability and Accountability Act, Privacy Act, 42 CFR Part 2, 164.514, Privacy Act, and 21st Century Cures Act); 2) agreements/MOUs that manage sharing and transfer of data from electronic health records; 3) IT security review; 4) Office of General Counsel legal perspective; and 5) statistical and privacy review. These reviews can take time.

Some Tribal organizations have their own IRB research oversight entities to provide an additional level of oversight and reviews.

Chairperson Frias opened the floor to questions.

Co-Chair Mousseau: Why does it take so long for the IRB process? Can the TAC help facilitate this?

Ms. Tracy: Because IHS is not centralized, the research is handled by each region. The question is whether All of Us can set up shop. This requires approval from the Tribe and moving over to the IHS IRB system. IHS follows the Tribes lead. There are still questions about data, how data will be used, types of research, privacy of American Indian/Alaska Native (AI/AN) data, and Tribal approval of protocols for the use of AI/AN data. IRB, IHS, and Tribes are not clear on these issues.

Dr. Walters noted that THRO is working closely with All of Us and with Dr. Mousseau on many of these issues. The policy is to go with the Tribal approval and Tribal consenting process and follow their research ordinance and laws. THRO supports All of Us. Any recruitment through IHS needs to be coordinated with their IRB process as well.

Ms. Tracy noted that researchers might not have the level of knowledge needed when working with Tribal communities. There is still concern that some in AI/AN communities may not understand what they are getting into when they join All of Us, and what is going to happen to their data.

Co-Chair Mousseau: IHS can be slow. We wanted to open the conversation between IHS and All of Us. Is All of Us being administered in Tribal communities yet?

Michael Hahn, Tribal Engagement Team Lead, NIH All of Us Research Program: These are conversations we want to start. All of Us is not doing recruitment on Tribal land or working with any specific Tribes yet. There are no urban Indian recruitment efforts going on, but individual AI/ANs can sign up.

Ms. Tracy: All of Us has a number of AI/ANs in their database who signed up on their own. Has All of Us released that data to researchers yet?

Mr. Hahn: No.

Mr. Saunkeah, Oklahoma Area: The All of Us discussion has been going on and involves one of several big data projects. There is some misunderstanding when we talk about All of Us and participating in the program. We are not talking about entering into research with All of Us but recruiting participants to put their data into the system that researchers can access. That research with the data is not going to undergo an IRB review because it is de-identified, nor will those projects focus on Tribal communities. Big database projects are very complicated when you are talking about data, biospecimens, and children’s information in the database. There are many issues to discuss in this complex discussion.

Ms. Tracy: There is still misunderstanding about All of Us. It is sharing of electronic data and biospecimens, but there is no specific research being done. There is no direct link between research and medical solutions returning to the participating Tribes. We need more education in AI/AN communities on what this program is.

Mr. Kutz, Portland Area: IHS has a unique responsibility here. When the All of Us process started, a number of years ago, it was not going to have a proper representative sample of AI/ANs across the United States. Without a representative sample, we are not going to get a good understanding of outcomes in Indian Country. I look to IHS to ensure that happens. It is a heavy lift, but you need to hold NIH’s feet to the fire to ensure that there is a representative sample of AI/AN data in the program.

Mr. Saunkeah: Can you address the issue of IRB, recruitment, and interventions when it gets to the research phase to explain what that looks like?

Mr. Hahn: By working through Tribal partnerships and legal agreements with Tribes that will allow recruitment and enrollment with the support of Tribal leadership, All of Us would work with Tribal IRB or designates and honor protections around data and access. When it comes to interventions, we want to make sure we reflect Tribal and urban research priorities that would be reflected through Tribal partnerships and work to ensure the outcomes from the database serve the communities we are reaching out to.

Mr. Saunkeah: Are the research projects already taking place being reviewed by the All of Us IRB?

Mr. Hahn: All of Us has a data passport model. Researchers sign up, become verified, and are trained. Following these steps, they can pursue research projects without review of each individual project, but every project is required to be listed on the program website and can undergo additional review. We ensure that there are ad hoc subject matter experts to give more specific review of AI/AN projects that have been flagged.

Chairperson Frias noted that there are more questions to address. She noted that this is tied to research and trust in the community to understand what is happening with the data. They have a responsibility to understand and ask these questions to gather the information and share it with communities (elders to young people) so everyone understands what is happening in our communities. This will be an on-going conversation.

THRO Updates

Dr. Walters gave an update on recent activities. All of Us held a Tribal consultation on September 28, 2023. Program leadership is reviewing access to All of Us data and how Indigenous voices are incorporated into the data process. Leadership is also exploring how to expand access to international, not-for-profit, and industry researchers, zip codes that overlap with Tribal lands, children’s data, and blessings for bio-samples of individuals who withdraw from the program. There were no Tribal leaders in attendance at the consultation. An outstanding question is how to streamline consultation to better get Tribal leader presence.

The program did receive two letters for written testimony—one from a Tribe and one from an inter-Tribal organization. A report on the consultation is being prepared and should be posted by January 26, 2024. Data from self-identified, Native participants is not available to researchers using the research work bench but will be part of the data set update planned for the fourth quarter of 2024. Multiple Tribal consultations and listening sessions have led to changes in the program to include Tribal engagement.

The Native Collective Research Effort to Enhance Wellness (NCREW) was launched to respond to the opioid crisis. It prioritizes research to address overdose and pain. Program applications were received on November 1 and funding awards are anticipated as early as summer 2024. Money will go directly to Tribal communities to address these issues from a community perspective.

The THRO strategic plan is on track and addressing research within Tribal communities, workforce development and capacity building, streamlined consultation process, and Native-focused initiatives that cut across NIH. After meeting with TAC and Tribal consultation, THRO will have an internal workgroup focus on the strategic plan and other strategic areas. The THRO restarted the Tribal Health Research Coordinating Committee at NIH to ensure greater coordination. Also, THRO created workgroups to focus on 1) Indigenous Knowledge Guidance, 2) Indigenous Data Sovereignty Policy; 3) trans-HHS Boarding School Healing Initiative; and 4) the Strategic Plan. Tribal consultation will be part of all of these workgroup items.

Dr. Walters asked TAC leaders to submit nominations. Mr. Saunkeah expressed interest in the strategic plan, data sovereignty, and indigenous knowledge and boarding school healing initiative workgroups.

Dr. Walters gave an NIDDK update concerning research conducted with Tribal communities in the Phoenix Area. In 2018, concerns were raised regarding five clinical trials, three open studies, one closed study, and one study that had not yet begun at the Phoenix Epidemiology & Clinical Research Branch on Phoenix Indian Medical Center campus. Concerns focused on non-compliance issues and acquisition/usage of samples in the studies.

A special committee was formed with NIH to review the allegations in the closed study and the NIH IRB and the IHS Phoenix Area IRB reviewed the allegations for the three open studies. NIH identified two areas of non-compliance in research for two studies. The IHS Phoenix Area IRB found the same two non-compliance issues, but identified additional non-compliance issues (i.e., researchers’ failure to follow study protocols and record-keeping requirements).

The NIH is committed to the highest standards of ethical conduct, protection of study participants, and Tribal data sovereignty. When Dr. Walters took this role, she stated “our values will be honesty and transparency in the work that we do.” THRO has moved forward to connect with Tribes on this issue. Dr. Germino along with Dr. Walters met with Tribal leaders, Tribal IRB leaders, and research review boards from two of the Tribal communities identified in this review. The discussions focused on the best course of action for the Tribal communities, the next step for the studies and biospecimens, and ensuring that NIDDK protocols align with Tribal research codes, ordinances, and law.

NIDDK and THRO will continue to meet with representatives from the two Tribal communities and arrange meetings with six additional Tribes involved in these studies to discuss the best course of action. NIDDK has put a moratorium on all studies involving DNA with the eight Tribes involved. As biospecimens are identified, NIH will work closely with Tribal leaders and Tribal IRBs to decide the next steps for biospecimen stewardship and transport to a Tribally-approved facility.

Dr. Schwetz stated that NIH is taking this matter seriously. First, NIH is committed to Tribal sovereignty. Second, NIH is ensuring intramural research is conducted with highest integrity and respect of Tribal research and communities. Third, there is a need to develop a NIH-wide Tribal data sovereignty policy. NIH has begun corrective action and looks forward to working with Tribal communities to ensure that we follow Tribal codes and ordinances.

Mr. Saunkeah: How was this issue discovered?

Dr. Walters: It was brought forward in 2018 and came to the attention of NIH and IHS.

Mr. Kutz: Tribal data sovereignty goes beyond NIH. This is one of the things we have been having a conversation about as a TAC.

Dr. Walters: We anticipate having Dr. Germino meet with the TAC to provide an update in February 2024. We are working to rebuild trust where trust has been broken.

TAC Chair Updates

Chairperson Frias stated the capacity building for Tribes that was on the agenda was to be centered around the conversations with Dr. Manson’s discussion on Tribal Epidemiology Centers (TECs). Mr. Saunkeah noted that this came up during the TAC Caucus and he was interested in having a discussion on how to get resources to Tribes like TECs.

The U.S. Indigenous Data Sovereignty & Governance Summit will be held April 11–12, 2024. 

Chairperson Frias asked that members share information for the TAC caucus. She also requested a Box folder to share minutes of caucus meetings.

Request for Next Steps and Action Items - TAC Co-Chairs

Mr. Kutz asked that information about the NARCH Planning Grants (PAR-24-041) be shared in an email.

Note: The agenda item ‘Discussion on Capacity Building for Tribes to Successfully Receive Research Grants’ was not fully addressed during the meeting due to time constraints.

Chairperson Frias thanked all the attendees for their discussion. She wished everyone a happy holiday and new year. The meeting concluded at 3:37 p.m.