NINDS Advisory Council Meeting Minutes, May 24-25, 2007

¹ For the record, it is noted that members absent themselves from the meeting when the Council is discussing applications (a) from their respective institutions or (b) in which a real or apparent conflict of interest  might occur.

Members of the public present for portions of the open meeting included:

Dr. John Swann, Baylor University
Dr. Elizabeth Hoffman, American Psychological Association

NINDS employees present for portions of the meeting include:

Dr. Alan Willard Ms. Ruth Linn Dr. Scott Janis Dr. Frances Yee Dr. Merrill Mitler Dr. Claudia Moy Dr. Robin Conwit Dr. Melinda Kelley Dr. Raul Saavedra Dr. Katrina Gwinn Ms. Nena Wells Dr. Story Landis Dr. Brandy Fureman Dr. Linda Porter Dr. Dan Tagle Dr. Tom Jacobs Dr. Yuan Liu Dr. Alfred Gordon Dr. Emmeline Edwards Dr. Ernie Lyons Dr. Eugene Oliver Dr. Diane Murphy Dr. Laura Mamounas Dr. Robert Baughman Dr. Robert Finkelstein Ms. Stephanie Fertig Dr. Ursula Utz Dr. John Porter Dr. Jill Heemskerk Dr. David Owens Dr. Heather Rieff Ms. Rebecca Desrocher Dr. Wendy Galpern Dr. Eugene Golanov Dr. Jane Fountain Ms. Lydia Munger Ms. Lynn Rundhaugen Ms. Maureen Hambrecht Dr. Richard Benson Ms. Carol Rowan Dr. Audrey Kalehua Ms. Stephanie Mitchell Mr. James Washington Dr. Margaret Sutherland Mr. Anthony Jackson Dr. Amelie Gubitz Dr. David Jett Ms. Yvonne Talley Ms. Denise Chatman Ms. Anita Miller Ms. Kathleen Howe Ms. Kimberly Campbell Ms. Brenda Kibler Mr. Christopher Leyes Mr. Brian Campbell Ms. Aricia Ajose

Ms. Margaret Jacobs Dr. JoAnn McConnell Dr. Michael Nunn Dr. Thomas Miller Dr. Naomi Kleitman Dr. Audrey Penn Dr. Yejun He Dr. Daofen Chen Mr. Paul Myers Dr. Randall Stewart Ms. Cikena Reid Dr. Robert Zalutsky Dr. Katie Woodbury-Harris Dr. Debra Hirtz Dr. Shanta Rajaram Ms. Stacey Chambers Mr. Paul Girolami Dr. Shai Silberberg Dr. Ned Talley Dr. Joe Pancrazio Mr. Phil Wiethorn Dr. John Lynch Dr. Michelle Jones-London Dr. Mark Scheideler Dr. Robert Riddle Ms. Daphne Robinson Dr. Ramona Hicks Ms. Donna James Dr. Debra Babcock Ms. Christina Vert Ms. Maxine Davis-Vanlue Mr. Peter Gilbert Dr. Lorenzo Refolo Ms. Sylvia Parsons Ms. Pamela Mayer Dr. Ran Zhang Dr. William Benzing Dr. Manfred Schubert Ms. Natalie Frazin Dr. Walter Koroshetz Ms. Tijuanna Decoster Mr. Aaron Kinchen Mr. Mutema Nyankale Ms. Andrea Romaniuk Mr. Steve Markowski Captain James Stables Dr. Richard Crosland Mr. Anthony Petruccelli Dr. Alan Koretsky Ms. Gloria Ike Ms. April Toney Ms. Nicole Williams Mr. Gavin Wilkom Ms. Robin Latham

Other Federal employees present for portions of the meeting included:

Dr. Pat Manos, CSR
Dr. Deborah Lewis, CSR
Dr. Alan Krensky, OD
Dr. Betsy Wilder, OD
Dr. Jonathan King, CSR
Dr. Peter Guthrie, CSR
Dr. Christine Melchior, CSR
Dr. Rene Etcheberrigaray, CSR
Dr. Suzan Nadi, CSR
Dr. Biao Tian, CSR
Dr. Seetha Bhagavan, CSR
Dr. Jay Joshi, CSR

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OPEN PORTION - May 24, 2007 10:30 a.m.

I. Call to Order and Opening Remarks

Dr. Story Landis, Director, NINDS, welcomed everyone to the 169th meeting of the NINDS Advisory Council. Dr. Landis announced that this was the last Council meeting for Dr. Alicia Conill, Dr. Ray Dingledine, Dr. Bill Mobley, Mr. Robert Waterman, and Dr. Huda Zoghbi. She expressed her deep appreciation for their contributions as members of the Advisory Council. The slate of new Council members has been approved by the NIH Director and is awaiting approval by the Secretary of HHS. Dr. Ralph Dacey will be unable to attend today's meeting, and Dr. Geoffrey Ling may be unable to attend.

NINDS periodically invites, as guests of the Council, the chairpersons of review committees and study sections as part of the Institute's continuing effort to strengthen the liaison between initial review groups and the Council. Dr. Landis introduced Dr. John Swann, who is Chair of the CSR Developmental Brain Disorder Study Section. Dr. Swann is Professor in the Department of Pediatrics, Division of Neuroscience, Baylor College of Medicine and Scientific Director of the Cain Foundation's Laboratories at Texas Children's Hospital.

II. Report of the Associate Director for Extramural Research, NINDS

Dr. Robert Finkelstein, Associate Director for Extramural Research, NINDS, informed the Council that they would be in open session today and in closed session to the public tomorrow when individual grants are discussed.

Approval of Council Minutes-Dr. Finkelstein requested, and the Council voted approval, for the February 15-16, 2007, Council meeting minutes.

Consideration of Minutes of Previous Council Meeting

The minutes of the Council meeting of September 14-15, 2006, were considered and accepted as written.

Confirmation of Dates for Future Council Meetings

September 20-21, 2007 (Thursday and Friday)
February 7-8, 2008 (Thursday and Friday)
May 29-30, 2008 (Thursday and Friday)
September 18-19, 2008 (Thursday and Friday)
February 5-6, 2009 (Thursday and Friday)
May 28-29, 2009 (Thursday and Friday)
September 17-18, 2009 (Thursday and Friday)

Expedited Review Process--A subset of Council members, prior to the meeting, approve applications within the payline for which there are no unresolved issues. Robi Blumenstein, David Van Essen, and Laura Ment are serving in this capacity for FY 2007. This round, 118 applications were eligible to be expedited, and 80 have already been issued. Recognition should be given to the Grants Management Branch for issuing the awards and to Dr. Raul Saavedra, the Scientific Review Administrator, for arranging the review of the K award applications in an expeditious manner.

Introduction of new DER Staff--Dr. Finkelstein first thanked Ms. Maxine Davis-Vanlue for her stellar work filling in as Acting Grants Management Branch Chief during the interim period. The new Grants Management Chief is Tijuanna Decoster. Other new staff are: Tony Jackson, NIH RAID program analyst in the Technology Development Group; Dr. Fong Wong, program analyst in Technology Development; Dr. Ran Zhang and Dr. Amelie Gubitz, program analysts in the Neurogenetics Cluster; Dr. Brandy Fureman, project manager in Clinical Trials; and Dr. Margaret Sutherland, program director in the Neurodegeneration Cluster. Leaving NINDS are Dr. Gabrielle Leblanc, program director in Neurogenetics, and Dr. Michael Nunn, program director in the Neural Environment Cluster, both of whom made an enormous contribution to NINDS and to advancing their respective fields of science.

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III. Report of the Director, NINDS

Congressional Theme Hearings-The Senate Appropriations subcommittee held "theme" hearings, which grouped the Institute/Center (I/Cs) around common issues. NINDS participated, along with NIMH, NIDA, NIAAA, and NIDCD, in the brain behavior and neuroscience group. Each I/C Director had an opportunity to speak to the committee. Dr. Landis spoke about recent scientific advances supported by NINDS and about the Neuroscience Blueprint projects. The I/C Directors emphasized the idea of NIH funding as an investment, not an entitlement.

Roadmap 1.5-The I/C Directors met and discussed the upcoming series of Roadmap proposals. Some will begin in FY07, with others beginning in FY08 and FY09. They include proposals on the human microbiome, epigenetics, phenotyping, protein capture agents, inflammation, and immunity. The proposals that will be moving forward will be posted on the NIH website in the next few days. There are a number of pilot projects and working groups that are ongoing, including one on Health Disparities and another on Workforce, Training, and Career Development.

NIH Reform Act-The NIH Reform Act was passed by Congress at the end of 2006. It mandated a number of changes in how NIH operates. To respond to the requested reforms, NIH formed a number of committees responsible for studying the reforms and recommending ways to implement them in a way that is consistent with NIH's mission. Their work is currently underway.

Peer Review at NIH-In the past year, NIH has been interested in assessing the peer review process for potential improvement. Two working groups were established: 1) an advisory committee to the Director and 2) a steering committee. Over the next year, they will examine every aspect of peer review, including how it is run, what the review criteria should be, application length, etc. A significant effort will be made to engage the academic community for ideas on what works well and what can be improved. Dr. Landis encouraged staff, patient groups, and extramural investigators to share their views on this important topic.

NIH Blueprint-Blueprint activities are on-going. A pay plan has been developed for the neurodegeneration initiatives, which will be presented in the closed session. A workshop took place recently to discuss opportunities for enhancing developmental neuroscience research, the summary of which will be posted on the NINDS website. We expect some initiatives to result from the workshop. A workshop on use of human embryonic stem cells in neuroscience research will be held at the end of June. The third Blueprint scientific theme is neuroplasticity, and a workshop is being organized on this topic. The Blueprint committee is now discussing future directions for their efforts.

NINDS Planning Process-A new planning component introduced at the last Council meeting was the idea of aspirational goals for NINDS. To help with their development, a series of "Blue Sky" meetings have been planned. The first three meetings will focus on clinical research and will begin with a meeting of Institute staff. The next two meetings will be held with representatives of patient groups and with the extramural research community. Blue Sky meetings for basic and translational research are planned for the fall. The groups will discuss where they think neuroscience should be in 15 years. A website has been set up: http://www.ninds.nih.gov/bluesky/ which describes the Blue Sky initiative and invites input from outside stakeholders.

Program Project Grants-At its last meeting, Council recommended a policy change for unsolicited P01s and P50 (program project and center) grants. A notice in the NIH Guide for Grants and Contracts has been published, which states that program project and unsolicited specialized center grants can only be renewed once, for a maximum of ten years of award. After this period, existing groups that want to continue working together will have to develop new proposals or apply through other funding mechanisms (e.g., P30 core grants, multi-PI awards).

Udall Center Evaluation-At the request of the Advisory Council and the Parkinson's Action Network, an independent evaluation of the Congressionally-mandated Udall Centers of Excellence program was undertaken, chaired by Council member Dr. Ralph Dacey. The results will be reported to Council at the September meeting.

Joint Council Meeting-Seven years ago, Drs. Gerry Fischbach and Steve Hyman (then the Directors of NINDS and NIMH respectively) arranged to have a joint Council meeting between the two Institutes. Dr. Landis asked if there was any interest by the current Council in having a similar joint session with the NIMH Council. Council expressed enthusiasm for the idea and suggested discussing issues relating to mental health consequences of neurodegenerative disorders (e.g. depression in Parkinson's disease and epilepsy).

NIH Strategies to Protect Vulnerable Investigators

1. Pathway to Independence Award--The intent of this program is to enable a more seamless transition from postdoctoral research to an independent career. Currently, the average age of an investigator receiving their first R01 is 44. NIH would like to decrease that average age, increase the number of job openings at universities, and improve morale among postdocs. The Pathway to Independence award is divided into two phases: A K99 award, which provides support for one to two years of fellowship training, and a three-year R00 research grant, which requires applicants to secure an independent research position and pass an administrative review of their project. NIH has received 1,000 applications over four Council rounds. The goal is to make 170 awards. Eighty have been awarded to date, with NINDS funding 14 of them.

2. NIH Director's New Innovator Award-This award is designed to encourage highly innovative new investigators. More than 2,000 applications are expected. NIH expects to make at least 14 awards in FY07.

3. New Investigators- In an effort to prevent a decrease in new investigator funding due to a flat budget, NIH has committed to funding as many new investigators in 2007 as were funded on average over the last five years. NINDS will fund new investigators up to the 25th percentile to reach its target of 128. NIH made 576 awards to date towards a goal of 1,525, with 84 percent scoring within the 15th percentile.

4. NIH Director's Bridge Award-In the last continuing resolution, Congress appropriated $91 million for "bridge awards." These awards are intended for investigators attempting to renew their R01s who have limited other support. In the first phase of the bridge awards, NINDS received 14 percent of the available funding.

Council expressed concern about investigators applying for their first competing renewal applications. The Institute will fund a number of these investigators through bridge awards. There is also a budget for "high program priority" applications that score beyond the payline, and many first competing investigators have been nominated for these funds. In addition, there is a possibility that NINDS may have funds remaining at the end of FY07 that can be used for this population. Council will be asked for their recommendations for the use of these funds.

NINDS will analyze how new investigators funded through the extended R01 payline (see #3) fare on their first competing renewals. NINDS will also investigate whether there should be additional programs developed for vulnerable investigators, and whether the Institute should invest more in early-career programs such as F31, F32 and Ks.

During the discussion period, Council members expressed their interest in maximizing communication with new investigators; understanding to what extent funding new investigators is affecting the payline, and determining whether NIH study sections are sufficiently sensitive to the issue of new investigators. Dr. Landis concluded the morning session by noting that funding has not kept pace with the opportunities in science and expressed optimism about a better funding picture in the years ahead.

IV. The New Office of Portfolio Analysis and Strategic Initiatives (OPASI)

Dr. Alan Krensky, OPASI Director Designee, reported that among the key provisions within the NIH Reform Act of 2006 was the call for the creation of a Division of Program, Coordination, Planning, and Strategic Initiatives (DPCPSI). The new office will be guided by a Council of Councils, made up of Council members from the various Institutes. Currently, NIH has an Office of Portfolio Analysis and Strategic Initiatives, which will transition to the DPCPSI structure. OPASI's mission is to provide the I/Cs with the methods, tools, and information necessary to improve management of NIH's large and complex scientific portfolios. It is a service organization that facilitates interactions among I/Cs with common interests. It also identifies emerging scientific opportunities and public health challenges, helps accelerate investment in these areas, and coordinates NIH's evaluation processes. OPASI has three divisions, which are responsible for portfolio analysis, strategic initiatives, and evaluation. The Division of Strategic Coordination includes the NIH Roadmap. Roadmap initiatives are trans-NIH initiatives that have high potential to transform how biomedical research will be conducted, are projects that not one institute alone could sponsor, and have a public health benefit. Roadmap concepts, which originated from scientific meetings, staff, and the public, were reviewed by scientists from academia and industry and a Council of Public Representatives. They were next distilled by NIH staff and were then put on the NIH website for comment from the broad science and patient communities. Following the public comment period, the I/C directors met and distilled the over 300 concepts down to five. Working groups were formed to develop the initiatives and present them to the I/C directors for final review. The five Roadmap topics are: 1) the microbiome, 2) inflammation as a common mechanism of disease, 3) protein capture agents and proteomics, 4) standardization of human disease pheontypes, and 5) epigenetics. The two that will be published in the NIH Guide soon are the microbiome and epigenetics initiatives. There are several other areas of trans-NIH research that impact public health, where there is potential for OPASI to assist in building and coordination. They include obesity, informatics, and health disparities. The success of OPASI will be measured in its ability to fill gaps, alleviate redundancies and add value to strategic planning.

In response to questions, Dr. Krensky explained that OPASI's source of funds for research is the Roadmap. He will assemble a small group of NIH program staff to discuss how best to collect the information on burden of disease and public health priorities. The information will only be one factor in decision-making at NIH. He emphasized that trans-NIH, OPASI projects are to be balanced with the individual I/Cs' specific missions. There was a discussion about the pros and cons of the NIH coding system, use of the information that will be collected, and limits of the information, given the fact that basic science will not be included at first, and clinical data may have multiple disease relevancy.

V. Conference (R13/U13) Grants-Strategy and Council Oversight

New Federal guidelines indicate that R13 and U13 Conference Grants must be reviewed by an independent (external) review group and then reviewed by the Institute's Advisory Council. Dr. Laura Mamounas, Program Director, Neurogenetics Cluster, provided an overview to Council of the importance of conference grants to the NINDS mission and the current NINDS procedures for reviewing and funding R13 and U13 applications. NIH guidelines, updated in 2003, require that applicants obtain advance permission from the relevant I/C prior to submission of R13 or U13 applications to the NIH. The NINDS Referral Officer and program staff evaluate the proposed conference topic for relevance to the interests and mission of the NINDS. The review of R13/U13 conference grants is organized by the NINDS Scientific Review Branch. Previously, applications requesting less than $50,000 direct costs were typically reviewed by NINDS program and OSPP staff with external reviewers recruited as needed. After review, NINDS Clusters presented preliminary funding priorities and recommendations at the Training and Special Programs Committee (TSPC) meeting with the final funding decision made by the Director. Awards are intended to provide partial support for the conference, typically in the range of $10,000 to $35,000 for R13s, and are generally limited to one year of support. Each year, NINDS awards approximately 35 to 40 R13 grants and 2 to 3 U13 grants, and spends a total of about $750,000 to $800,000 annually on conference grants. In discussion, members of the Council supported the use of NINDS funds to support conference grants, and felt that the current R13/U13 budget is appropriate. Council also felt that the amount of individual R13 awards (with the goal of providing partial support for the conference) and the length of the award (one year of support) are appropriate in the current NIH fiscal climate.

In response to questions, staff explained that the intent of R13 grants is to provide partial support, with the grantee institution and other sources paying the balance. Most R13 conferences are on basic science topics, and most of the Institute-sponsored workshops are disease-related or address gaps in research. Both types of workshops require an evaluation at the conclusion of the meeting, and both mechanisms aid the Institute in accomplishing its mission. Council members suggested video archiving the Institute-sponsored workshops and encouraging groups without a history of cooperation to work together on a workshop. Mr. Waterman noted that Restless Leg Syndrome field was moved forward by NINDS conference grants.

VI. NINDS Budget Issues-Closing FY07 and Looking Ahead

Before the budget presentation, Dr. Landis polled the Council for their views on a possible joint Council meeting with NIMH. The Council expressed its support. Dr. Landis invited Council members to send discussion topics to Dr. Finkelstein. They will be collected, circulated to NIMH and an agreement will be reached on which topics to discuss at the first joint Council session.

The NIH budget increased significantly from 1995 to 2007. However, since the budget doubling ended in 2003, when inflation is taken into account, there has actually been a decrease in the budget. An analysis was done of the increase in research project grant application over that period. NIDA had an increase of 70 percent; NINDS, NICHD, and NIA applications increased by 52 percent, and other institutes' applications increased by lesser amounts. NIDCD and NEI have consistently had higher paylines than NINDS. NIA and NICHD have had lower paylines.

In FY07, the NIH budget included an additional $620 million which was targeted to the Office of the NIH Director. Of these funds, $483 million are for the Common Fund, $40 million for 14 New Innovator grants, $91 million to provide bridge funding for experienced investigators, and $69 million for the National Children's Study. This allocation reduces NINDS's financial burden by $18.5 million, which had previously been budgeted for the NIH Roadmap. In total, the NINDS FY07 budget exceeds that of FY06 by $15 million. NIH issued a policy that no inflationary increases would be made on the out-years of grants in FY07, thereby saving NINDS approximately $15 million. NINDS's funding strategy includes a 12.5 percent cut to modular grants and 17.5 percent in non-modular grants. The payline for established investigators is the 9th percentile. Eleven point six (11.6) percent of NINDS's R01s fell within the 9th percentile. Grants paid outside of the payline include those designated as High Program Priority (HPP), grants to new investigators, and grants in response to initiatives with set-aside budgets. Despite the fact that the payline is at the 9th percentile, NINDS actually funds 15 percent of research project grants. NINDS has funded 105 new investigators so far in this fiscal year, but needs to fund 23 more to meet its target of 128. NINDS has made 14 K99/R00 (NIH Pathway to Independence) awards. In looking forward to FY08, we expect to get a budget within the first quarter of the year. The President's NIH budget for FY08 is $28.6 billion; $371 million less than FY07; however, Congress has proposed an increase in the NIH budget. If there are unobligated funds available in FY07, NINDS would like to receive Council feedback about how they should be used. Suggestions included providing priority assistance to first-time renewals and experienced investigators with A2s, awarding FY08 grants in FY07, and if there are enough funds, raising the payline. Council also recommended making the public (including Congress) more aware of NINDS successes.

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VII. Concept Clearance for the FY 2009 Proposed Initiatives

Council voted in favor of concept clearance for the following initiatives:

• FY2008 Continuation of the Senator Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers
• Exceptional, Unconventional Research Enabling Knowledge Acceleration (participation in the NIGMS EUREKA program)
• Nanobiotechnology Approaches to Crossing the Blood-Brain Barrier
• Consortium for Accelerated Research in Lysosomal Storage Disorders
• Immune Cell Trafficking in CNS Disorders

VIII. Council Subcommittee Reports

Training, Career Development, and Special Programs Subcommittee- Dr. Francisco Gonzalez-Scarano, Chair

In this subcommittee meeting, Dr. Korn presented data on the success rate of the various training support mechanisms. The subcommittee discussed four specific issues. The first was the decrease in the number of K08 applications in the last two cycles. It is not clear why the numbers are down. It is possible that MDs and MD/PhDs are turning from laboratory research to clinical research, but if that were the case, the number of K23 applications would have increased, which they have not. The Subcommittee recommended making it better known that 50 percent of all K-type applications are funded in the first submission. The K08 success rate has remained constant over the last several cycles. Dr. Koroshetz will discuss the K08 program at the upcoming NINDS-ANA meeting. The second mechanism discussed was a proposal that the F31 (pre-doctoral training program) awards be limited to three years. The purpose of the program is to fund the thesis portion of a Ph.D., and it was agreed that three years should be adequate for that purpose. The third issue was a proposal to remind F30 applicants that the purpose of the award is to support the graduate portion of the MD/PhD career and the last one and one half to two years of medical school tuition. Because of the possible delay in award, some applicants were only getting support for the MD portion. A notice will be issued to remind applicants that the grant should cover some portion of the Ph.D. program. The last issue discussed was the difficulty in determining eligibility for the K99/R00 Pathway to Independence award based on the title of the applicant. The purpose of the program is to facilitate transition from mentored to independent research. Since the title of "Instructor" may or may not indicate a mentored position, in the future, all applications will be looked at individually to determine eligibility.

Basic and Preclinical Programs Subcommittee-Dr. Raymond Dingledine, Chair

The subcommittee discussed questions relating to improving the dissemination of research findings, promoting data-sharing among investigators, and a novel NIH initiative aimed at encouraging innovation.

The first question was what changes in research publication procedures would be recommended to improve the dissemination of research results? Two suggestions were made: 1) Encourage attendance at a conference sponsored by the Society for Neuroscience in June at Washington University that will address issues such as capturing journal article metadata on experimental methods, linking content from journals, abstracts, and databases, the standardization and sustainability of databases and supplemental materials, and possibilities for leveraging peer review of manuscripts within a consortium of journals. 2) Widely disseminate the results of the conference. The results will be shared at the Blueprint IC Directors meeting in September.

The second question was what can NINDS do to promote sharing and mining of neuroscience research data? There are two efforts underway in which NINDS is participating to encourage data sharing: 1) A satellite symposium to the Society for Neuroscience Annual Conference has been organized by NINDS to discuss issues of data sharing and reanalysis. The speakers will share experiences of sharing and reanalyzing data, and a panel discussion will address issues such as the importance of data sharing, what data should be shared, and when and with whom those data should be shared. Methods of more efficient data sharing will be discussed, as well as potential ways to overcome some of the current technical and sociological obstacles to data sharing. 2) A proposed FY09 initiative entitled, "Collaborations in Sharing, Analyzing, and Reusing of Neuroscience Research Data," was discussed. The goal of this initiative is to promote collaborations between experimental neuroscientists and mathematicians, statisticians, or computational and informatics scientists to facilitate sharing and reanalysis of experimental neuroscience data. The subcommittee was supportive of the concept for this initiative.

The third discussion regarded NINDS participation in the Exceptional, Unconventional Research Enabling Knowledge Acceleration (EUREKA) NIH initiative. The research plan emphasizes vision rather than a detailed experimental plan. Questions arose regarding the effectiveness of programs such as the Pioneer Awards in terms of stimulating innovation. It was noted that these other programs have not been in place long enough to provide sufficient data for a program evaluation. The review for applications under this program will be different from a standard review, in that an ad hoc committee for their review will be formed. Concerns were raised about the ability of peer review to evaluate this type of application. The subcommittee was supportive of the EUREKA concept.

Clinical Trials Subcommittee-Dr. Laura Ment, Chair

The entire subcommittee meeting was in closed session for the discussion and consideration of individual clinical trial applications; therefore, there is no report at this time.

IX. Council Consideration of Pending Applications

This portion of the meeting, involving specific grant review, was closed to the public. The Council gave special attention to applications from foreign institutions and other applications, which needed specific discussion. Prior to the discussion of the grants, Dr. Finkelstein reminded Council regarding conflict of interest and confidentiality as follows:

Conflict of Interest

The regulations concerning conflict of interest were reviewed. Council members were reminded that materials furnished for review purposes and discussion during the closed portions of the meeting are considered privileged information. All Council members present signed a statement certifying that they had not been involved in any conflict of interest situations during the review of grant applications.

Confidentiality

During the closed session, any information that is discussed and the outcome of any recommendation are considered privileged information. They may not be discussed outside of the closed session. If an applicant requests support for his or her application from a Council member, the Council member must respond that he/she is not permitted to discuss the application. Any inquiry should be referred to Dr. Robert Finkelstein as the Council Executive Secretary, who will then refer the questions to the appropriate staff member for response.

Research Training and Career Development Programs

The Council reviewed a total of 145 research career development and institutional training grant applications; of this total, 85 applications had primary assignment to NINDS, and 69 of them (81.2 percent) were recommended for support in the amount of $9.1 million first-year direct costs. It is anticipated that, of the research career development and institutional training grant applications competing at this Council, NINDS will be able to pay first-year direct costs of approximately $2.6 million.

Research Grant Awards

The Council reviewed a total of 2,231 research grant applications; of this total, 1,325 applications had primary assignment to NINDS, and 762 of them (57.5 percent) were recommended for support in the amount of $219.7 million first-year direct costs. It is anticipated that, of the research grants competing at this Council, NINDS will be able to pay first-year direct costs of approximately $54.6 million.

Senator Jacob Javits Neuroscience Investigator Awards

The Senator Jacob Javits Neuroscience Investigator Awards are made to distinguished investigators who have a record of scientific excellence and productivity, who are actively pursuing an area of research of strategic importance, and who can be expected to continue to be highly productive for a seven-year period. Candidates are nominated and selected at each Council meeting. At this meeting, the Council recommended three investigators as Javits awardees.

Small Business Innovation Research and Small Technology Transfer Award Programs

The Council reviewed a total of 178 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications; of this total, 107 applications had primary assignment to NINDS and 55 of them (51.4 percent) were recommended for support in the amount of $16.0 million first-year direct costs. It is anticipated that, of the SBIR and STTR applications competing at this Council, NINDS will be able to pay first-year direct costs of approximately $8.5 million.

X. Adjournment

The meeting was adjourned at 9:50 a.m. on Friday, May 25.

 

We certify that, to the best of our knowledge, the foregoing minutes and attachments are accurate and complete.

Robert Finkelstein, Ph.D.
Executive Secretary
National Advisory Neurological Disorders and Stroke Council

Director, Division of Extramural Research
National Institute of Neurological Disorders and Stroke

Story C. Landis, Ph.D.
Chairperson
National Advisory Neurological Disorders and Stroke Council

Director
National Institute of Neurological Disorders and Stroke

These minutes will be formally considered by the Council at its next meeting.  Corrections or notations will be incorporated in the minutes of that meeting.

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