Working Group Meeting Minutes
James Galloway, Leonard Harjo, Carole Anne Heart, Susan McCraw Helms, Rosemary Nelson, Sarah Nelson, J. Kristin Olson-Garewal, Janine Rourke, Bert Thomas
David Baines, Gordon Belcourt, Robin Carufel, Sally Davis, Emery Johnson, Melvina McCabe, Joyce Naseyowma, Yvette Roubideaux
NHLBI Staff Present:Richard Fabsitz, Jared Jobe, Catherine Loria, Teri Manolio
The meeting was called to order at 2:10 to give everyone sufficient time to make contact. Bert Thomas reviewed the minutes of the meeting with particular emphasis on the recommendations. There was discussion and elaboration of some of the issues within the minutes. The working group noted that data ownership and intellectual property rights were issues growing in importance to communities at the current time. This applies even more to studies that include genetic data. The members also noted that approaches to dealing with control groups in trials was also a sensitive issue. It was emphasized that the issues surrounding urban, rural and reservation Indians continues to have strong but differing opinions. The working group thought that urban Indians should be considered in any health issue because of their numbers. Every attempt should be made to ensure that Tribes assume leadership roles in research partnerships. Finally, it was suggested that the issues of building infrastructure in communities and determining which applications to fund did not always appear to reflect health needs and that often the specific health needs of communities are not known due to lack of data. No corrections or additions were made to the minutes and they were accepted as submitted.
Richard Fabsitz provided a summary of the revisions in the plans for the proposed intervention project based on discussions within the NHLBI regarding what was possible and appropriate within the mission of the Institute. He noted there were a number of changes that will provide a more focused approach to the initiative development effort. Consultations and listening sessions will seek to determine a single area of intervention that will address a health problem or class of health problems common to many AI/AN communities. There is a strong desire to identify intervention opportunities that offered high expectations for success in order to return a positive message to the communities. Translation and dissemination will be built into the project to promote the use of successful programs and activities both within the communities participating in the research and to communities outside the study communities. Capacity building activities will concentrate on those that can be implemented as part of the research effort and will focus on exposure to research and training associated with the study protocol. Building research infrastructure independent of the research study will be more appropriate to other programs within the Institute or offered by other agencies. These include the NARCH program, on which NHLBI will be referenced in the second round of the solicitation, and the Strengthening the Heart Program which is currently funded by NHLBI. Other aspects of building infrastructure and capacity building will be addressed by the new efforts in recruitment and training AI/AN, Hispanic-American and African-American scientists, based on the May workshop that will be reported later this year.
There are two implications of this revised plan: 1) the timeline must be revised to increase the amount of time for the entire process leading up to the release of the RFA and awarding of the grant; and 2) communities that have an existing or developing interest in, and experience with, research will have an advantage. The latter communities include those with existing epidemiology centers, those participating in the Strong Heart Study, Pathways, or Strengthening the Heart Beat, or those establishing Native American Research Centers of Health (NARCH) programs. It is less likely that a community without any previous track record with research could provide a successful application and project in the competitive process required for grant awards.
At this point, Richard Fabsitz noted that two new members had joined the working group and were present on the call. He welcomed Leonard Harjo (Oklahoma), representing NIHB, and Rosemary Nelson from Northern California. He noted that, with these two members, the working group was complete and that, although one meeting had been missed, much of the important work of the working group was yet to be done.
Catherine Loria reminded the group that one of their strongest recommendations from the first meeting was that Tribal consultation must be done and that this process should begin with a meeting with the Tribal Leaders Diabetes Committee (TLDC). She reported that she and Richard Fabsitz attended a quarterly meeting of the TLDC in Ketchikan, Alaska on July 19th. They were given about one-half hour to briefly summarize their request that had been sent prior to the meeting and get feedback. The response was supportive but not substantive in specific comments or recommendations, perhaps because they were near the end of the 2-day agenda. Of note, two areas of potential interest were discussed by the TLDC: lupus and sleep disorders. The first is not part of the NHLBI mission. However, recent data from the Sleep Heart Health Study appear to confirm that American Indians along with African Americans suffer from lower sleep quality than the remaining components of the U.S. population. She also pointed out that, in informal discussions following the meeting, committee members were pleased to see the effort by NHLBI and asked to be kept informed as the effort progresses. The suggestion was made by the TLDC that they needed more time to consider our request and, thus, additional input may be forthcoming over the next few months from TLDC members.
As part of the update of the planned consultation process, Catherine Loria noted that NHLBI staff investigated several options for consultation at both the national and regional level. While some of the regional consortia meetings worked well within our consultation time line, we were less successful at making arrangements to do consultation at national meetings. Because the TLDC met in Alaska, we explored possibilities for consultation that would coincide with our visit with the TLDC. After much discussion with the Alaska Native Health Board, they recommended that a letter would be the fairest way for all tribes/villages, regardless of economic situation, to participate in consultation. As a result, NHLBI staff decided what was fair for Alaska Natives would apply equally for American Indians. Thus, the letter was sent on July 13. Only one reply has been received so far, but it was quite informative and confirms the value of such an effort. Carole Anne Heart and Leonard Harjo both expressed an interest in receiving a copy of the letter, so NHLBI staff agreed to immediately send it to all members of the working group.
Jared Jobe reported that consultation and data gathering will continue until the end of October, 2001. During that time four meetings are currently scheduled: September 17-20 in Denver CO with the NIHB Consumer Conference, October 5-7 in Milwaukee, WI with the Health Directors and Tribal Leaders at the Great Lakes InterTribal Council, October 23-25 in Miami, FL with the Health Directors and Tribal Leaders of the United South and Eastern Tribes, and October 23-25 in Coeur d'Alene, ID with the Northwest Portland Area Indian Health Board. Other meetings are possible depending on invitations received from Tribal leaders. All members of the working group were urged to encourage their Tribal Leaders to respond to the letter. Priority will be given to meetings in the window between now and October 31 where multiple tribes are represented. Carole Anne Heart noted there will be a meeting of Indian educators on December 17th in Rapid City, SD at which Senator Daschle will attend. Although it will not contribute to the consultation and data gathering to shape the RFA, it may be useful for generating applications and enthusiasm for the program.
Jared Jobe reviewed the adjustments to the time line following the recommendations from the first meeting. He noted that several goals were accomplished. The time for consultation had been extended and the time for development of an application had been extended. He noted it had been extended to 8 months, the longest time for submission to an RFA he had seen in his career at the Department of Health and Human Services. As a result, the RFA is scheduled to be released in mid January, 2002 with submission of applications scheduled to be due in mid September 2002. Awards are planned for June 2003 following approval by the NHLB Advisory Council.
Technical assistance both before the applications are due and after awards are made will be an important component of this study. Dissemination of results to the control groups, participating tribes, and outside tribes will also be emphasized.
The next meeting was scheduled tentatively for November 6-7 in Bethesda. The meeting will begin about noon on the 6th and end about noon on the 7th. The agenda at that time will include review of results from the Tribal consultation and data gathering effort, setting priorities for intervention to be included in the RFA, and structural components of the solicitation that will enhance benefits to the communities.
The conference call was adjourned at 3:44 pm EDT.
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