National Heart, Lung, and Blood Institute
American Indian/Alaska Native Interventions Working Group

Minutes April 25-26, 2001 Albuquerque, NM

Minutes from Follow-up Conference Calls:
August 15, 2001
November 6, 2001

Present:
Sally Davis, James Galloway, Emery Johnson, Melvina McCabe, Susan McCraw Helms, Joyce Naseyowma, Sarah Nelson, Kristin Olson-Garewal, Janine Rourke, Bert Thomas. NHLBI Staff: Richard Fabsitz, Jared Jobe, Cay Loria, Teri Manolio. IHS Staff: William Freeman.

Richard Fabsitz opened the meeting at 1:35 pm. The blessing for the meeting was asked by Janine Rourke. Updated agendas and rosters were distributed. Working Group members and staff introduced themselves. Cay Loria presented the background for this project, including an overview of NHLBI's AI/AN projects and the charge to the Working Group.

The Working Group declined to elect a chair and asked that the NHLBI staff lead this meeting with the understanding that they would elect a chair for the second meeting.

Concern was expressed that the Working Group can't represent the interests of all 557 Federally recognized Tribes. Rich Fabsitz reviewed the procedure NHLBI used to allow each Tribal leader to nominate members of the working group through their IHS Area Director to ensure a wide representation on the working group.

Working group members emphasized the sensitivity of conducting research in Native populations. Research must be designed from the view point of the communities and allowing Tribes to set the research agenda is important. One research model that may be appropriate involves participatory approaches. Disseminating results, sustaining interventions, and building capacity within communities are all critical elements in successful research in AI/AN communities.

Initiative Timeline

There was universal agreement that the proposed timeline is too compressed. More time is needed to build partnerships between both Tribes and NHLBI and Tribes and research organizations. It is not unreasonable to spend a year encouraging Tribes to become interested in research. It works best when sufficient time is allowed to do it right; otherwise the project might be perceived as imposed by the Federal government. We might consider before we approach Tribes whether NHLBI is interested in developing a long-term relationship with Tribes, not simply a project that will end in five years. NHLBI could do this by beginning to build Tribal infrastructure for research, which we'll continue to develop over time. There may be some things that NHLBI can't do now because of legal constraints but NHLBI can begin the first steps in the process. The 4-5 years allotted for grants also may be insufficient. For Tribes that are new to research, planning grants would offer them time to build infrastructure. It was noted that Pathways had a 3-year feasibility study period. The issue of possible funding to sustain interventions was also raised; for example, could monies be used to hire staff directly under the auspices of Public Law 638 that allows Tribal self-determination?

Tribal Consultations

The proposed Listening Sessions may not be effective given recent experiences of other outside groups. Apparently attendance is low and little feedback is received after much effort, possibly due to the increasing number of Listening Sessions. Many Tribes are "consulted out." The health providers' meeting in Rapid City may not be the optimal group to visit because it is attended by direct service Tribes (i.e., those with health care provided by IHS). Alternative approaches to getting input from communities were discussed. We must determine how best to approach the Tribes. The Working Group recommended that NHLBI's Tribal consultation involve multiple approaches. They suggested that NHLBI staff visit many communities, with some communities being selected to host Listening Sessions. Visiting and spending time in communities demonstrates commitment and would allow consultation at all levels (e.g., Tribal Leaders, providers, patients). We should be careful in selecting one group to host a regional Listening Session because of inter-tribal politics. Another suggestion was to send a letter to all the Tribes asking them to write us about their health issues. However, when informed of our experience with the Tribal Leader letter, the members suggested direct phone calls to Tribal Leaders, possibly through their Tribal Leader's administrative assistant, as an alternative. Another option was to use a grass-roots effort to gather input through meetings such as the NIHB Consumer conference or by having every working group member contact colleagues at their level. Care must be exercised with this approach, as it may be perceived as bypassing the Tribal leadership. Because NHLBI is a federal agency, we must go through the Tribal government given the government to government relationships that have been established with the Tribes. Another approach is to contact area health boards whose membership represents Tribal governments. Health boards already may have assessed the needs of their communities and have health data on the Tribes in their area. Not every area has a health board so this approach may not be feasible in every area and thus, approaches may need to be tailored to each area. In the end, the group advised that Tribal consultation is a must and they reiterated that multiple approaches to Tribal consultations might be best. Tribal leaders should be approached first. The Tribal Leaders Diabetes Committee, an IHS working group consisting of 6 Tribal Leaders (contact Kelly Acton, IHS), and the National Congress of American Indians executive committee, might be approached for consultation as well as their advice on how best to get input from many Tribal Leaders. We could ask for formal consultation with the National Indian Health Board (NIHB), an organization with official Tribal representatives. We should contact an organization representing urban Indians, such as the National Council of Urban Indians. We could then contact area health boards or regional consortia, including but not limited to: NW Portland IHB, Albuquerque IHB, Alaska Native HB/Alaska Native Tribal Health Consortium (ANTHC), Intertribal Council of Arizona/Nevada/Utah (ITCA/ ITCN/ ITCU), Great Lakes Intertribal HB, United Southeastern Tribes (Nashville), and in Alaska, the National Community Health Practitioners Association. The NIHB may be able to help us decide which area IHBs to contact. NHLBI should be prepared to visit Tribes or areas if invited. The working group warned that it is critical that we know up front what we can and can't do before we consult with the Tribes. For example, Tribes will ask us to give the money to them instead of to universities. We should establish whether or not this is possible before we meet with Tribes and be prepared to show them written regulations documenting the constraints upon us. We should be prepared to present options when possible and be scrupulously honest with them about what we can and can't do. We must followup, do what we promised, and provide continuous feedback. The feedback mechanism should be discussed with Tribes. We want to be careful to distinguish ourselves from other NIH Institutes and organizations that may have a poor track record in research in AI-AN communities because Tribes won't know the difference. One member suggested that we use the word "project" instead of "research" during the consultation process although another thought that this might be misleading. Native organizations should also consult with Tribes if they propose to be grantees.

Partnerships

The Working Group then discussed the issue of partnerships between Tribes and researchers. Tribes must decide with whom to partner. All the Working Group members agreed that NHLBI should not be involved in setting up the partnerships. Rather, the Tribes should be allowed to decide whether to invite universities or other researchers to the consultation sessions. Otherwise, we may be perceived as having ulterior motives by inviting researchers ourselves. We should not require Tribes to partner with outside researchers if they have the capability themselves to conduct the project. Some Tribes are already conducting their own research; for example, NW Portland IHB conducts research. Tribes who want training should request it themselves, and we shouldn't assume that all Tribes need training. The partnerships must include training and building research capacity, if the Tribes desire it. The RFA must specify clearly what the requirements for a partnership between a research organization and communities. Both the Tribes and the research organizations want to be the grantee so that they control the money. Research organizations traditionally have spent the money on their own staff and have not hired staff from the communities. A full and equal partnership between Tribes and research organizations requires significant funds being spent in the communities and hiring staff from the communities, as well as control of the research agenda, data, and bodily fluids. NHLBI should make site visits before the awards to ensure the quality of the partnerships. The Working Group agreed we should make evidence of the strength and quality of the partnerships one of the review criteria. A co-PI and a percentage of the money should be specified as going to the Tribes. We should nominate peer reviewers who will be sensitive to the nature of partnerships and Tribal interests. It was suggested that pressure will be placed on NHLBI to award to research-intensive institutions. One Working Member noted that when her/his Tribe worked with a university, that the university outlined the negotiable and non-negotiable aspects of the proposed partnership. We should tell the communities our mission, research goals and restraints, be visible in the community, and keep them informed. Research organizations need training on how to work with the Tribes. Some AI/AN organizations who have research capabilities (e.g., AAIP, NIHB) may want to partner with Tribes. Some members thought that some Tribes would view these organizations as competitors, whereas other members thought that Tribes might view this as an opportunity for collaboration. We should discuss this with Tribes during our consultations. The results of the research should be disseminated to the community.

Urban Indians

It was noted that David Baines was the only Working Group member who represented Urban Indian interests, but was not present at this meeting. Rich Fabsitz mentioned that an urban organization was contacted by letter and phone, but did not respond to our request to nominate a person to serve on the Working Group. It was suggested that we consider setting up different solicitations; one for urban Indians and one for reservation-based Tribes, eliminating the feeling of competition in their view. Some Tribes don't want any urban health centers to compete directly with them for funding. It was agreed that the major components of diversity were urban versus reservation and small versus large Tribes. Another view that was expressed was that urban Indians can always return to their Tribes fro health care; some use it as a safety net. An urban Indian should still be considered to be an Indian in spite of the fact that she/he left the reservation to find opportunities in urban areas.

Solicitation

The Working Group made some suggestions for the solicitation process. First, we should provide more than the usual debriefing of unsuccessful applicants from the HSA staff members, focusing on mentoring the Native investigators. They suggested in priority order: first, funding 2-3 year feasibility studies; second, one-year planning grants; and third, two solicitations one year apart.

Interventions

Working Group members discussed addressed what they considered to be important heart, lung, blood, and sleep issues in different regions of the country. In the northeastern region, protecting children and preventing chronic disease were described as being the most important health concerns. Other important health concerns are drugs and alcohol abuse, behavioral issues, and the combination of diabetes and heart disease. Diabetes by itself is an easy issue to sell in her community. In Alaska, obesity is a problem in their children, but not diabetes yet. A problem is that the principals in the community schools won't allow people to come in and teach prevention to children. COPD, smoking, and alcohol are important, but not visible health issues. In Arizona, children's health is the primary concern, especially youthful obesity leading to diabetes. Diabetes and its complications, hypertension, obesity, and substance abuse are primary health issues. Diabetes and its complications are far more aggressive in Native populations. Patients don't attend diabetes classes. Public education and prevention of CVD complications from diabetes are critical. They have lots of delayed presentation of MI, in part because their symptoms are atypical due to the diabetes. They also have an increasing incidence of severe peripheral arterial disease; double amputees are not uncommon. They have had no success with diabetes using exercise and dietary interventions. We shouldn't try to sell CVD as another problem, but sell it as a complication of diabetes. They understand that hypertension and renal failure are sequelae of diabetes. They want prevention of obesity and increasing exercise for children. Physicians don't observe the recommendations for behavioral change, and aren't aggressive enough in pushing behavioral change. Secondary prevention is key. In addition to being cost effective, it would be practical to build on the NIDDK diabetes grants. Asthma is also a significant problem. In some areas, pesticides from aerial spraying on farms is a serious health risk. There has been some success with IV drug abuse and tobacco abuse. We need to recognize family and other issues complicating adherence. We should recognize extant efforts by the Tribes. In New Mexico, funds are scarce. Many communities need clinics, running water, electricity, and medicine. Access is an important issue, as is continuity of care. We should not go to clinics, but have school-based health education as a first priority, with obesity and physical education as the subjects. Community-based educational interventions that concentrate on preserving culture, especially language would work well. Initiatives for the elderly have worked on shoestring budgets. Specifice health concerns include chronic disease, fear of cancer, and CVD, the leading cause of death in Navajo.

Can Intervention Research Sell?

The Working Group then addressed whether intervention research could be conducted in Native communities. Some communities lack the ability to implement programs once the research is completed. For example, some communities lack resources to implement physical activity programs that provide safe places for children to get regular exercise. This is exacerbated in areas with severe seasonal weather. It is important to be aware that the research must be compelling to change behavior in AI-AN communities. Moreover, we must outline the benefits of the research, including how the research will change the community in a positive way and possibly demonstrate the potential of the community. What will be done to improve their health? The Working Group also mentioned important cultural issues about which we should be aware. We should be careful to distinguish between tobacco abuse such as cigarette smoking and the religious use of tobacco and peyote. Also, we should be sensitive about what blood disease means, as they are concerned about giving blood for cultural reasons. Genetic material and bodily fluids are their property, and must be respected. Survival of communities as Indian communities is their first priority and their focus is on children to preserve their culture. They fear that their culture will die out. Returning to a traditional diet is appealing to them. We must strengthen Indian communities as Indian communities. Tribes will want to know what will be done with the results of the research. Data ownership is a contentious issue between the Tribes and universities; the grantee owns the data. Ownership of data is important to Tribes, and they may not want to publish the results in journals. Moreover, editing of written material is important to Tribes, because the media have portrayed Native persons quite negatively on several occasions. In addition to the financial issues, these are reasons why Tribes want to be the grantee.

Control Groups

The Working Group then addressed issues related to how control groups are used in intervention studies. There are always concerns in the communities about who doesn't get treated, but control groups are not always a problem. The idea of having a group with no intervention probably would not be viewed positively, but delayed or unrelated interventions would probably be viewed positively. Communities might prefer that controls get another benefit. We shouldn't make assumptions, but should involve the communities in planning the interventions. We should allow Tribes to conduct healing ceremonies or other spiritual activities as part of the research process. The whole concept of alternative medicine is an important issue and demonstrates sensitivity to Native cultures.

Feedback

The Working Group suggested sending letters to Tribal Leaders describing the Working Group nominees and a one-page bulleted summary of meeting highlights. We should thank them for their responses to NHLBI's earlier letter to nominate members of the Working Group. The Working Group would like to see the minutes before the next meeting. We should inform the Working Group if we make a major change from their recommendations.

Next Meeting

The Working Group elected Bert Thomas to chair the next meeting. They agreed to reserve August 15-16 for the next meeting in the Washington area. Only Melvina McCabe would be unable to attend then. The agenda for the next meeting should include a discussion of the feasibility to work with other groups like HCFA, the feasibility of restricting the awards to Tribes and Native organizations. It was suggested that we include NCI and other NIH Institutes and Centers as part of this project. NIH looks unorganized if multiple institutes come to Indian country separately.

Recommendations

1. The Tribes must set the research agenda. Consult with a wide variety of individual Tribes, Native organizations, and grass roots listening sessions. Build long-term relationships for continued research with Native communities.

2. Slow down or the project will be perceived as being imposed by the Federal government. Allow sufficient time for consultation. Consider 2-3 year feasibility grants, or barring that, 1-year planning grants, or solicitations one year apart.

3. Building research capacity is critical. Consider mandating that Tribes or Native organizations be the grantees, as was the case with the NARCH initiative. Barring that, mandate that a significant percentage of the funds be allocated to the Tribes (more than the 30% in the NARCH initiative). Mandate that community members be hired as interventionists and for positions in the project. Mandate a training component in the projects to develop Native scientists. Mandate quality partnerships between Tribes and research institutes if the Tribes choose to partner.

4. Consider "second round" of applications or allowing for resubmission; part of the capacity-building process is teaching Tribes to deal with the grant application system.

5. Determine whether organizations such as AAIP or NIHB can be grantees, what is required for an organization to be a grantee.

6. At tribal meetings have hand-outs available describing plans, mission of Institute, other brief background as needed.

7. Try to simplify application process, recognize the 25-page summary statement is daunting and provide more than the usual mentorship or other support to applicants to deal with critique.

8. Consider pre-award site visits (particularly to assess the quality of the "partnership") or even post-review site visits to help with providing and interpreting feedback.

9. Consider building on existing diabetes grants rather than initiating entirely new program.

10. After project is over, all community members should receive the successful intervention and arrangements made for it to be provided outside the study participants or communities. This needs to be built into the research plan, and part of the design. The outcome must be to understand what is translatable to communities outside the study and what isn't. A plan for dissemination of findings needs to be included as part of the application.

11. Need to be clear on ownership of data and bodily fluids.

2/28/02


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