Minutes of the Interagency Autism Coordinating Committee (IACC) Subcommittee for Planning the Annual Strategic Plan Updating Process on March 17, 2009
The Interagency Autism Coordinating Committee Subcommittee for Planning the Annual Strategic Plan Updating Process convened a meeting on March 17, 2009 in Conference Room A of the Neuroscience Center Building at the National Institutes of Health in Rockville, Maryland, from 12 p.m. to 2:30 p.m. EDT.
In accordance with Public Law 92-463, the meeting was open to the public. Thomas R. Insel, M.D., Director, National Institute of Mental Health, chaired the meeting.
Subcommittee Member Participants: Thomas R. Insel, M.D., IACC Chair, National Institute of Mental Health (NIMH); Della Hann, Ph.D., Executive Secretary, Office of Autism Research Coordination (OARC), NIMH; Ellen W. Blackwell, M.S.W., Centers for Medicare & Medicaid Services (CMS); Story C. Landis, Ph.D., National Institute of Neurological Disorders and Stroke (NINDS); Lyn Redwood, R.N., M.S.N., C.R.N.P., Coalition for SafeMinds; Alison Tepper-Singer, M.B.A.; and Edwin Trevathan, M.D., M.P.H., Centers for Disease Control and Prevention (CDC).
Welcome and Introductions
Subcommittee Chairman Dr. Thomas Insel welcomed the participants to the first meeting of the subcommittee tasked with developing a process for monitoring and updating the Strategic Plan for Autism Spectrum Disorder Research. The Interagency Autism Coordinating Committee (IACC) completed the first strategic plan on January 26, 2009.1 Dr. Insel reviewed the section of the Combating Autism Act which mandates that the IACC annually update the plan.
Discussion of Subcommittees Charge and Parameters
Dr. Della Hann asked the subcommittee members about their expectations for the updating process. She suggested that the strategic plan should be given time for implementation and that the updating process may be more extensive in future years. Ms. Lyn Redwood said that she would like to see a detailed portfolio analysis of private and public funding for recent autism research. The portfolio analysis would help identify research gaps to address in the next version of the strategic plan. Ms. Redwood also stated that she wished to see greater inclusion of objectives relating to treatment and environmental factors in the strategic plan. Ms. Blackwell suggested that the subcommittee solicit feedback from the Secretary of Health and Human Services once he or she is appointed for guidance on the next version of the Strategic Plan for ASD Research.
Ms. Alison Singer said that the stimulus funding from the American Recovery and Reinvestment Act (ARRA) of 2009 would maximize opportunities to support ASD research. Ms. Redwood said that she would also like to examine a cost of disease analysis, like that completed by Dr. Michael L. Ganz,2 to determine the research budget recommendations for the next version of the strategic plan. She also suggested returning to research proposals that received good scores in peer review but were not funded by the National Institutes of Health (NIH) in the past because of insufficient resources.
Dr. Insel remarked that the more than $7.4 billion made available for research through the ARRA created a very different financial landscape from that of six weeks ago. NIH Institutes are currently in the process of seeking Challenge grant applications and all stimulus money must be awarded by September 2010. Dr. Edwin Trevathan recommended that the next version of the strategic plan address the targeted health promotion and intervention needs of adolescents with ASD transitioning into adulthood.
Methods to update the Strategic Plan for ASD Research
Dr. Hann asked the subcommittee to consider what types of information would be needed to update the plan and what methods and sources should be used. Ms. Redwood stated that she would like a presentation to the IACC on the Autism Centers of Excellence (ACE) program and ongoing intramural research on autism. Dr. Insel said that the ACE program is a small but visible piece of NIH autism research, representing less than 20 percent of the overall investment. Dr. Landis talked about the capabilities of the Research Portfolio Online Reporting Tool (RePORT) as well as NIHs new computer-based accounting system, Research, Condition, and Disease Categories (RCDC). RePORT gives funding information by condition and includes information on individual grants. The tool allows public access to detailed information on autism research funding.
Dr. Insel said that 2008 RCDC data would provide a baseline for autism research funding prior to the implementation of the IACC Strategic Plan for Autism Spectrum Disorder Research, however the data will need to be categorized according to the objectives recommended in the plan. Private organizations and public agencies outside NIH, such as the Department of Defense, will need to provide their own autism research portfolio analysis. Dr. Insel stated that the second strategic planning workgroup convened on April 21, 2008 had conducted an initial NIH portfolio analysis of ASD research based on the four themes that had been developed for the scientific workshops (biology, treatment, diagnosis, and risk factors).
Ms. Singer asked if the IACC would solicit portfolio information from private funders and Dr. Hann said that private funders had been cooperative during the first analysis, although some organizations had been reticent to share specific project details. Ms. Singer commented that most private funders for autism research make their grants public on their Web sites, with the exception of the Simons Foundation. Ms. Singer said that during the initial portfolio analysis, several private organizations shared grant information but did not want it to be recorded publically. Dr. Hann said that based on the rules of the Federal Advisory Committee Act (FACA), which govern the conduct of federal advisory meetings, anything shared with the committee must become public record. Ms. Singer recommended that the subcommittee extend a request to private funders for their ASD portfolio analyses with instructions for aligning the information with the Strategic Plan for ASD research.
Dr. Trevathan said that a portfolio analysis of ASD research funded by the Centers for Disease Control and Prevention (CDC) would not be difficult but that he was concerned with developing a working definition of autism research that would be uniformly applied by all funders. He questioned how organizations would weigh research areas that could include autism (such as fetal alcohol syndrome) without overstating their commitment. Ms. Ellen Blackwell expressed similar concerns about accounting for Medicaid and Medicare programs that serve people with ASD but are not specifically directed toward them. Ms. Singer suggested that the CDC report funding that resulted from the Combating Autism Act, but Dr. Trevathan said that the funding from the Act was limited and would exclude important areas of applicable research.
The subcommittee members then examined a proposed list of public and private organizations to provide ASD funding information to the IACC. Ms. Blackwell suggested adding the Department of Housing and Urban Development (HUD) and potentially the Social Security Administration. Dr. Insel questioned whether the Social Security Administration had a research budget. Ms. Blackwell also recommended adding the Administration on Aging, although she added that they might emphasize services over discovery-based evidence. The subcommittee also discussed whether the Administration on Children and Families (ACF) included a research arm. Ms. Redwood suggested adding the Autism Research Consortium (ARC) and the National Center for Complementary and Alternative Medicine (NCCAM). She was reminded that NCCAM would be included in the NIH portfolio analysis. Ms. Redwood recommended adding the Center for Autism and Related Disabilities (CARD). The subcommittee asked the Office of Autism Research (OARC) to solicit funding information from organizations on behalf of the IACC, after developing a template for the needed information.
Ms. Redwood asked if the National Institute of Mental Health (NIMH) included an office that measures the outcome of grant money. Dr. Hann stated that in the spring, RePORTer will include a feature designed to facilitate this sort of analysis by linking grants to the resulting publications in the PubMed database. Dr. Insel said that NIH had an office serving all the Institutes which evaluates research impact by examining the resulting initiatives, tools, and assessments. Ms. Singer urged the subcommittee to move from simply counting the number of publications to finding a qualitative way to measure health outcomes and quality of life. Dr. Hann asked whether the questions formulated for the Strategic Plan for ASD Research could be used as the scaffolding to measure outcome (i.e., How might genetics and/or the environment influence the occurrence of ASD?). Dr. Insel described how outputs such as papers and awards differed from outcome such as identifying a greater number of children at a younger age. Publications are easy to quantify but it is possible to publish without impact, he said.
Ms. Redwood asked if funding mechanisms required that the investigator publish and Dr. Insel said that NIH grantees were only required to write an annual progress report followed by a final progress report at the conclusion of the funding. Dr. Hann said that NIH grant final reports are not publically available but can be obtained under the Freedom of Information Act (FOIA). Any manuscript published with federal funds is made available through PubMed Central. Dr. Landis explained how difficult it was to try to quantify impact. For example, an intervention studys success is measured by whether the intervention is put into practice but other factors, such as the length of time for adoption, must also be considered.
Dr. Insel asked the subcommittee how they should best capture research not specific to autism that could nonetheless have an enormous impact on the field, such as the potential of induced pluripotent stem cells. Ms. Singer again urged the committee to embrace qualitative data and cited research of the optic nerve that revolutionized the treatment for Fragile X. She proposed using the Summary of Advances to identify emerging research areas. Dr. Landis cautioned that advances must be replicated before accepting the study findings, citing a rat study of spinal cord injury funded by the National Institute of Neurological Disorders and Stroke (NINDS) that seemed to offer enormous potential but was never able to be replicated during controlled trials.
Dr. Insel questioned how the subcommittee could best include unexpected findings and evidence from emerging fields such as epigenomics while updating the Strategic Plan for ASD Research. Dr. Trevathan suggested using the targeted expertise of scientific workgroups, as the IACC did during the initial development of the plan. He said that the IACC lacked the scientific research expertise so a process should be put in place to put questions before expert workgroups. Dr. Hann said that the four workgroups that were convened on January 15-18, 2008, to develop the strategic plan were a one-time event and no process to reconvene expert workgroups is currently in place. However, the subcommittee could pose the recommendation to convene scientific workshops to the full IACC.
Dr. Insel asked the subcommittee whether they would recommend using the International Meeting for Autism Research (IMFAR), the annual meeting sponsored by the International Society for Autism Reseach (INSAR), to showcase exciting ASD research advances. Ms. Singer said that many researchers hold their findings until the conference. She suggested that a representative from the IACC present the strategic plan and solicit feedback at IMFAR.
The subcommittee was told that they did not have the authority to convene a standing workgroup, but could convene a conference or workshop. Ms. Redwood requested that the IACC be more involved in appointing the workshop chairs than they were during the 2008 scientific workshops. She also asked whether the IACC could create a group mailing list through which members could send out journal articles. Dr. Hann said that papers from PubMed could easily be sent through such a mechanism but IACC members might encounter copyright issues for other publications. She suggested making the recommendation to the full IACC committee for their review. Dr. Landis cautioned that articles published in peer-reviewed journals vary in quality and that the findings cannot be guaranteed. She was concerned that articles sent out through a committee mailing list could be viewed as receiving the IACCs imprimatur stamp of approval.
Ms. Singer said that before the IACC was reconstituted in 2006 under the Combating Autism Act, the former committee would often hear science updates at the meetings during the afternoon. Dr. Insel suggested recommending to the IACC that the committee invite scientists with instructive work to present. Ms. Blackwell asked that service providers also be invited to speak. The subcommittee agreed that the presentation on State Medicaid given by Ms. Blackwell and Ms. Ann Kohler at the February 4, 2009 IACC meeting was a good model for a useful presentation with broad perspective. Dr. Insel also suggested surveying the media when an interesting finding is released. Ms. Blackwell said that the IACC should branch out to capture a variety of experts while being mindful of resources and suggested using teleconferences and other electronic means to do so. Ms. Singer suggested coordinating with another large meeting such as IMFAR at least once a year. The subcommittee discussed which national meeting would best fit with the timeline for updating the strategic plan by January 2010. They discussed the Society for Neuroscience conference being held October 17 21, 2009 in Chicago, IL, but Dr. Hann said that the conference may occur too late to produce an update of the plan for this years schedule.
Discussion on Timeline for Updating the Strategic Plan for ASD Research
The subcommittee discussed the timeline for updating the plan. They agreed that conferences or workshops must be held before October to identify gaps in the strategic plan. The IACC would have to receive a draft to vote on in January and Dr. Insel questioned whether, based on the relative newness of the plan, the subcommittee wanted to wait a year for any major revisions. Ms. Redwood objected to the idea, saying that it was important to address issues from the first version of the plan that had been put off for the next version.
Ms. Singer recommended holding the IACC workshops in September and then attending IMFAR for feedback on the revised document. Dr. Landis suggested looking to the responses from stimulus funding opportunities for a broad scan of leading edge research on ASD. The NIH specifically requested applications for research on ASD aligned with the Strategic Plan for ASD Research. She also suggested that public input on the plan be captured through a Request for Information, as was done for the initial draft. Ms. Redwood suggested a series of town hall meetings in addition to the RFI. Ms. Blackwell informed the subcommittee that Lee Grossman had offered to let the IACC use the town hall meetings organized by the Autism Society of America (ASA) on July 22-25, 2009, in Chicago as a forum for public input on the strategic plan. Ms. Singer commented that ASA town hall meetings tended to have a heavy emphasis on supports and services. Dr. Insel said that the ASA meetings were within the right timeframe to be useful in updating the plan.
The subcommittee then discussed the timeline for the NIH portfolio analysis, with Dr. Insel commenting that the initial analysis will serve as a baseline. Grants funded by the stimulus package would be known by the end of September.
Dr. Insel reviewed the subcommittees final recommendations: Conduct a portfolio analysis of public and private funders for 2008 and identify ways to measure impact of funding; potentially convene workshops to identify new science or science not currently represented in the strategic plan (could be convened as a satellite of a larger national meeting such as IMFAR); and solicit public input on the strategic plan through an RFI, town hall meeting, and/or webinar presentation of the plan.
Ms. Blackwell suggested that the Food and Drug Administration (FDA) be added to the list of public funders from which the IACC requests a portfolio analysis. Ms. Redwood recommended that the committee hold a webinar for the public to review the present version of the Strategic Plan for ASD Research. Ms. Blackwell said that a webinar was unnecessary and that it was more important to focus on capturing relevant information through the RFI and determining how long the RFI would be open for comment. Ms. Singer asked if the IACC had been invited to present the plan at IMFAR this May and Dr. Insel said that they had not. Ms. Singer said she would look into whether an IACC presentation could be scheduled on the IMFAR agenda.
Dr. Hann asked for clarification from the subcommittee on the timing of the RFI, questioning whether the members felt that comments should be solicited after a revised draft was created. If so, an RFI could not be released on a revised draft until after issues and gaps in the strategic plan were identified in July. Ms. Redwood said that an RFI on the existing version should be put out, but other subcommittee members objected, saying that the comments would be very similar to those received from the August 2008 RFI. Dr. Landis stated that the initial portfolio analysis would be work intensive because grants from the past five years must be categorized by the six-question framework of the strategic plan.
Ms. Singer said that the RFI could focus on generating data for participants at the scientific workshops in September. She said she disliked soliciting public comment without tying the responses to a working document. The subcommittee discussed how to best communicate to the public that their RFI comments were analyzed and considered. Ms. Singer asked whether people who commented on the plan could be sent the finalized version.
Ms. Redwood suggested outsourcing some of the work collecting public response to a private contractor such as the Keystone Center, which is used by the National Vaccine Advisory Committee (NVAC). Dr. Trevathan strongly endorsed holding town hall meetings, saying that nothing could take the place of face-to-face interaction. Dr. Landis stated that different constituencies and communities have very different views and that effective town hall meetings could not be monopolized by any single group.
The subcommittee agreed to have the Office of Autism Research (OARC) contact the IACC members to recommend a portfolio analysis and approve the list of public and private funders from which they would request information. The NIH portfolio analysis could be started immediately and analyses from all other organizations should be completed by June 2009. The subcommittee asked OARC to collect information on costs for the Keystone Centers services. The members discussed the subcommittees function and Dr. Insel said that he felt the full committee assumed that the subcommittee would also implement their suggestions for updating the strategic plan.
Ms. Redwood suggested that the subcommittee meet again before the next full IACC meeting on July 29, 2008, after the portfolio analysis was completed. She recommended that the IACC establish an autism advisory board of researchers and advocates to help with the strategic plan updating. Dr. Insel reminded the subcommittee members that the director of NIH is supposed to attend the IACC meetings and perhaps will after the position is appointed. Dr. Insel recommended that scientific presenters be scheduled to speak at the IACC meetings as soon as the next meeting on May 4, 2009. He said that Dr. David Mandell, whose research focuses on the epidemiology of autism, may be able to present in May. Ms. Redwood again asked that the committee hear presentations on the ACE program and NIH intramural research on ASD at the May meeting.
Dr. Insel stated that the subcommittee would convene again before the July 29, 2009 meeting of the IACC. At that time, OARC would present the subcommittee with cost information on conferences facilitated by the Keystone Center and the subcommittee could further plan potential scientific workshops to be held in September. After holding the workshops, the subcommittee would meet to review information and make recommendations to the IACC in October 2009 on potential updates to the strategic plan.
Ms. Redwood asked if the IACC could hear a presentation on cost of disease analysis at a future meeting and suggested Dr. Ganz. Ms. Blackwell said that estimating the cost of disease is a large and still developing research question. The meeting was then adjourned at 2:30 p.m.
These minutes of the IACC Subcommittee for Planning the Annual Strategic Plan Updating Process were approved by the IACC Subcommittee for Planning the Annual Strategic Plan Updating Process on June 16, 2009.
I hereby certify that this meeting summary is accurate and complete.
Thomas Insel, M.D.
Chair, Interagency Autism Coordinating Committee
2Ganz, M.L. (2007). The lifetime distribution of incremental societal costs of autism. Arch Pediatr Adolesc Med 161(4): 343-9.