Freedom of Information Act Office
IC Directors' Meeting Highlights
July 26, 2006
| To: | IC Directors |
| From: | Director, Executive Secretariat |
| Subject: | IC Directors Meeting Highlights—April 27, 2006 |
Discussion Items
I. Tuition Policy
Drs. Ruiz Bravo and Berg presented to the group on the tuition policy for the Ruth L. Kirschstein National Research Service Awards (NRSA). The funding of tuition is governed by a formula that provides for each T32 trainee, annually, the sum of $3,000 plus 60 percent of the requested tuition in excess of $3,000. This level, once established for a given competing grant, is used for the subsequent non-competing renewal awards during the project period. The current tuition reimbursement policy has been in place for 6 years and applies to institutional training grants and individual predoctoral fellowships. Given the current period of limited budget expansion and trend in tuition growth, the NIH must re-examine aspects of its NRSA policies that may not be sustainable. On November 30, 2005, the NIH held a Town Hall meeting to hear comments and insights concerning possible revisions to certain fiscal policies that govern the NRSA programs, which comprise institutional training grants (T32, T34, and T35) and individual fellowships (F30, F31, F32, and F33).
The NIH considered the feedback from the meeting participants and other stakeholders, evaluated and modeled several options, and drafted a proposed new policy. The NIH will solicit comments on plans to revise its approach to funding tuition, fees, health insurance, training related expenses (institutional NRSA), and institutional allowance (individual NRSA). These proposed changes are described below (note: Notice Number NOT-OD-06-064 was published on May 3, 2006).
Tuition and fees: For institutional (T32, T34, and T35) and individual (F30 and F31) predoctoral NRSA awards, an amount per trainee equal to 60 percent of the level requested by the applicant institution, up to $16,000 per year, will be provided. If the program supports formally combined dual-degree training (e.g., M.D.-Ph.D., D.D.S.-Ph.D.), the amount provided per trainee will be up to $21,000 per year. For institutional (T32, T34, and T35) and individual (F32 and F33) postdoctoral awards, an amount per trainee equal to 60 percent of the level requested by the applicant institution, up to $4,500 per year, will be provided. If the program supports individuals in formal degree-granting training, the amount provided per trainee enrolled in a degree-granting program will be up to $16,000 per year.
Training related expenses: For institutional training grants (T32, T34, and T35), the training-related expenses category will be modified to include health insurance as an allowable expense. An additional $2,000 per predoctoral trainee, per year, and an additional $4,000 per postdoctoral trainee, per year, will be provided in this category. This category will be referred to as "health insurance and training-related expenses."
Predoctoral Institutional Allowance: For individual predoctoral fellowships (F30 and F31), the institutional allowance category will be modified to include health insurance as an allowable expense. The NIH proposes to provide additional funding in this category so that it is comparable to that provided via the new "health insurance and training-related expenses" category of predoctoral institutional training grants. Specifically, an additional $1,450 per predoctoral fellow, per year, will be provided in this category which will be referred to as "health insurance and institutional allowance."
Postdoctoral Institutional Allowance: For individual postdoctoral fellowships (F32 and F33), the current institutional allowance category already includes health insurance as an allowable cost. The NIH proposes to adjust the funding provided under this category so that it is comparable to that provided via the new "health insurance and training-related expenses" category of postdoctoral institutional training grants. Specifically, an additional $850 per postdoctoral fellow, per year, will be provided in this category which will be referred to as "health insurance and institutional allowance."
Dr. Ruiz Bravo thanked Warren Jones, Walter Goldschmidts, the ad hoc training committee, Joe Mosimann, and Jim Onken for their efforts on this project.
II. NIH Policy for Genome-Wide Association Studies (GWAS)
Dr. Nabel, Chair, reported on the Committee on Trans-NIH Data Sharing for GWAS. This Committee, comprising members from 18 ICs and several OD Offices, was charged with developing an NIH policy for GWAS to present to ICs for consideration. The driving principle is that the greatest public benefit will be realized if data from GWAS are made available, under terms and conditions consistent with the informed consent provided by individual participants, in a timely manner to the largest possible number of investigators. The audiences of the policy are study participants, the public, and investigators. The critical policy areas are —
- Expectations for submission of GWAS data,
- Access to GWAS data,
- Publication of results based upon GWAS data, and
- Intellectual property rights derived from GWAS data.
The Committee decided that for optimal accessibility and integration a single database should be maintained, preferably an NIH-supported database. Three working groups have been formed: a database and technical advisory group, a group to set genotyping standards, and a group on data access policy. The short-term plans are to develop a program announcement that will provide guidance on overall NIH policy directions. [Note: NIH Guide Notice NOT-OD-06-071, published on May 15, 2006, informs investigators of the NIH plans to (1) update data-sharing policies for research applications involving GWAS data; (2) initiate a public consultation process to inform policy development activities over the next few months; and (3) track GWAS applications and awards at a central level.] Medium-term plans include refining the draft proposal and engaging in a broad consultative process on the creation of a central database. And the longer-term plans are to develop a strategic plan for revisions in the privacy rule and continued communication with the public and scientific community on issues surrounding the database including privacy protection.
Dr. Nabel pointed out that a Policy Forum article was published in the April 21 Science on the ethical and policy questions regarding how much information about a particular individual’s DNA sequence ought to be publicly accessible (http://www.sciencemag.org/cgi/content/full/312/5772/370), and that this area will require careful attention. The group then engaged in a discussion of the opportunities and challenges of this trans-NIH effort.
Scientific Presentation
III. Amyotrophic Lateral Sclerosis (ALS): Clues to Etiology and Therapeutics from Genetics
Dr. Landis presented the latest findings related to ALS, which appears in three types:
- Sporadic
- Environmental
- Familial
In all types, the disease results in motor neuron death and 90 to 95 percent of those diagnosed die within 5 years.
Three percent of ALS cases result from a specific genetic defect that leads to mutation of the enzyme known as superoxide dismutase 1 (SOD1). Research on this mutation is providing clues about the possible causes of motor neuron death in ALS. Mutant SOD1 transgenic mice have been found extraordinarily useful in studying ALS, but the concern remains as this defect represents only one type of ALS and other unidentified genetic causes exist.
Dr. Landis described a study (“Wild-Type Nonneuronal Cells Extend Survival of SOD1 Mutant Motor Neurons in ALS Mice.” A. M. Clement, M. D. Nguyen, E. A. Roberts, M. L. Garcia, S. Boillée, M. Rule, A. P. McMahon, W. Doucette, D. Siwek, R. J. Ferrante, R. H. Brown, Jr., J.-P. Julien, L. S. B. Goldstein, D. W. Cleveland. Science 3 October 2003: Vol. 302. no. 5642, pp. 113 – 117) that concluded that nonneuronal cells that do not express mutant SOD1 delay degeneration and significantly extend survival of mutant-expressing motor neurons.
She also referred to a cooperative effort to find new targets for effective therapeutics for ALS. The ALS Association, NINDS, and the Robert Packard ALS Center at Johns Hopkins University recently announced funding of a search for genes involved in the sporadic form of the disorder in people who have no family history of the disease. The search will use the newly established DNA banking project-a repository of samples from patients and healthy people for comparison-made possible through NINDS. Investigators Bryan Traynor, M.D., a fellow at NIMH, and John Hardy, Ph.D., of NIA, will lead the joint effort with NINDS and the Robert Packard ALS Center at Johns Hopkins University. The work will be carried out at the NIA Neurogenetics Laboratory, in Bethesda. Traynor and Hardy will take on the challenge of sporadic ALS directly by using the newest technology to search through the entire genome of more than 500 people who will contribute samples.
After discussing current therapeutic treatment of ALS patients, most specifically riluzole, Dr. Landis described the NINDS Neurodegeneration Drug Screening Consortium and potential treatments and therapies including gene therapy delivered by viral vectors; the possibility of stem cells making new motor neurons; and the development of assistant technologies that would simulate neuromotor activities.
Dale Johnson
cc: OD Senior Staff
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