NINDS Advisory Council Meeting Minutes, September 15-16, 2011

Department of Health and Human Services 
Public Health Service
National Institutes of Health
National Advisory Neurological Disorders and Stroke Council

Summary of Meeting[1]
September 15-16, 2011

The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 182^nd meeting on September 15-16, 2011, at Building 31, Conference Room 10, Bethesda, Maryland. Dr. Story Landis, Director of the National Institute of Neurological Disorders and Stroke (NINDS), served as Chairperson.

In accordance with Public Law 92-463, the meeting was:

Council members present were:

Council member absent was:

Dr. Robert Ruff, Department of Veterans Affairs

Dr. Geoffrey Ling, Department of Defense

Council Roster (Attachment 1)

Ex Officio Members absent:

Dr. Robert Ruff, Department of Veterans Affairs

Dr. Geoffrey Ling, Department of Defense

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

Dr. Andrea Baruchin, Foundation for the National Institutes of Health

Dr. Eric Nelson, Parent Project Muscular Dystrophy

Mr. Ted Shoneck, Tunnell Government Services, Inc.  

Mr. Ronald Bartek, Friedreich's Ataxia Research Alliance

Ms. Maggie Owner, Lewis-Burke Associates LLC

Deborah Outlaw, American Tinnitus Association

NINDS employees present for portions of the meeting included:

Other Federal employees present for portions of the meeting included:

Dr. Gray Handley, NAIID
Dr. Julie Schneider, NCI
Dr. Nora Yang, NGHRI
Dr. Susan Old, NGHRI
Dr. Kevin Walton, CSR
Dr. Stacey FitzSimmons, CSR
Dr. Wei-Qin Zhao, CSR
Dr. Catherine Bennett, CSR
Dr. Dan Gerendasy, CSR
Dr. Pat Manos, CSR
Dr. Kristin Kramer, CSR
Dr. Yuan Luo, CSR
Dr. Christine Melchior, CSR
Dr. Rene Etcheberrigaray, CSR
Dr. Peter Guthrie, CSR
Dr. Laurent Taupenot, CSR
Dr. Suzan Nadi, CSR
Dr. Samuel Edwards, CSR
Dr. Mary Schueler, CSR
Dr. Seetha Bhagavan, CSR

I. Call to Order and Opening Remarks

Dr. Landis, Director, NINDS, welcomed Council members, visitors, and staff to the 182^nd meeting of the National Advisory Neurological Disorders and Stroke Council meeting. 

Dr. Landis introduced four new Council members:  Mr. Paul Gross, Dr. David Ginty, Dr. David Holtzman, and Dr. Kevin McNaught.  She also announced that Dr. Ben Barres was reappointed for a full four-year term having completed the remainder of a member’s term who had resigned..

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

Approval of Council Minutes -- Dr. Finkelstein requested, and the Council voted approval, for the May 26-27, 2011, Council meeting minutes.

The following future Council meeting dates were confirmed:

• February 16-17, 2012 - (Thursday and Friday)
• May 24-25, 2012 - (Thursday and Friday)
• September 20-21, 2012 - (Thursday and Friday)
• January 31-February 1, 2013 - (Thursday and Friday)
• May 23-24, 2013 - (Thursday and Friday)
• September 12-13, 2013 - (Thursday and Friday)

Expedited Review Process - A subset of Council members, prior to the meeting, approve applications with scores within the payline for which there are no unresolved issues.  Dr. Finkelstein thanked Donna Ferriero, Sharon Hesterlee, and Amita Sehgal for handling this responsibility for the three Council rounds in Fiscal Year 2012. 

For this Council round, 158 applications were eligible to be expedited including 4 career or K applications.  One hundred forty of these have already been issued and most of the others will be issued shortly after Council.   Tia Decoster and the Grants Management Branch were thanked for having reissued 1300 awards due to late FY 11 funding guidance.  Revisions were done in conjunction with issuing current and future grant awards. 

DER Announcements -- Dr. Finkelstein introduced new DER staff:  Dr. Vicky Holets Whittemore, Program Director, Channels, Synapse, Circuits Cluster, and Dr. Ernie Lyons, Chief, Scientific Review Branch (SRB).  Dr. Whittemore had recently rotated off Council, and Dr. Lyons was a Scientific Review Officer in SRB. 

Loan Repayment Program -- Dr. Finkelstein reported that NINDS had 117 eligible applications for the two Loan Repayment Programs (LRP) in which it participates.  NINDS was able to pay 62 applications -- 39 for the Clinical Research LRP and 23 for the Pediatric Research LRP.  These are success rates of 56% (39/70) for the clinical LRP and 49% (23/47) for the Pediatric Research LRP.  Of the 62 awardees, there were 46 M.D.s, 8 M.D./Ph.D.s, 6 Ph.D.s, and 2 with various combinations of “other” degrees.”  Areas of Specialty included Neurology (22), Neurosurgery (6), Pediatric Neurology (9), Emergency Medicine/ Neurocritical Care (6), Neuropsychology/Neuropsychiatry (4), Rehabilitation Medicine (11), and 4 “other.”

III. Report of the Director, NINDS

National Center for Advancing Translational Sciences (NCATS)
Dr. Landis reported on recent developments regarding the formation of the National Center for Advancing Translational Sciences (NCATS), and noted that Dr. Collins had discussed his vision for the proposed Center in a recent issue of Science Translational Medicine (Collins, Sci Transl Med 6 July 2011).  The proposed mission for NCATS is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics, therapeutics, and devices across a wide range of human diseases and conditions.  NCATS will be formed by assembling existing NIH programs under one umbrella organization.  Programs proposed to be incorporated into or managed by NCATS include: the Clinical and Translational Science Awards (CTSA) program; components of the Molecular Libraries Program, including the National Chemical Genomics Center (NCGC); Therapeutics for Rare and Neglected Diseases (TRND); Rapid Access to Interventional Development (RAID); the Office of Rare Diseases Research (ORDR); NIH-FDA Regulatory Science Initiative and the Cures Acceleration Network (CAN; if appropriated).  Though original plans called for an October 1, 2011, launch for NCATS, it will not move forward until NIH receives a specific appropriation for the Center.

Financial Conflicts of Interest (FCOI) Regulations – Final Rule
Dr. Landis reported on the revised FCOI regulations that were published in the Federal Register on August 25, 2011, (Vol. 76, No. 165).  The revision to the regulations on Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors should be implemented by institutions no later than 365 days after publication of the final rule in the Federal Register.  Major areas addressed in the revised regulations include: definition of significant financial interest, extent of investigator disclosure, information reported to PHS awarding component, information made accessible to the public, and investigator training.

Advance Notice of Proposed Rulemaking (ANPRM) for Revision to Common Rule
Dr. Landis reported on the ANPRM for Revision to Common Rule that was published in the Federal Register on July 26, 2011, (Vol. 76, No. 143).  The Department of Health and Human Services requests comments on how current regulations for protecting human subjects who participate in research might be modernized and revised to be more effective.  This ANPRM seeks comment on how to better protect human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.  A number of specific issues being discussed include: use of a single Institutional Review Board (IRB) for multi-site trials, simplified consent, expansion of oversight, and consent requirements for all research using biospecimens.  Public comment for the ANPRM closes October 26, 2011.

NIH Budget (FY11 – FY13)
Dr. Landis provided updates on the NIH budget for fiscal years 11 – 13. 

FY11
As part of the President’s Budget, the NIH budget request for FY11 was submitted to Congress on February 1, 2010.  Funds for FY11 were appropriated in 6 continuing resolutions, the final of which was signed by President Obama on April 15, 2011 (P.L. 112-10).  FY11 appropriations for NIH and NINDS were reduced by 1.0% from FY10 funding levels, and as a result, NIH instituted a policy for non-competing grants that mirrored the reduction that NIH received in its budget.  NINDS maintained a payline of the 14^th percentile.

FY12 and FY13
As part of the President’s Budget, the NIH budget request for FY12 was submitted to Congress on February 14, 2011.  This request included a 2.6% increase for NIH over FY11 and a $29 M increase for NINDS.  On May 11, 2011, the Senate Committee on Appropriations held a hearing on the FY12 NIH budget.  Drs. Collins, Varmus, Fauci, Rodgers, and Shurin provided testimony at this hearing.  Current predictions for NIH funding for FY12 range from no change to a 2% reduction.  Although appropriations for FY13 are unclear, OMB has instructed federal agencies to tailor the budget requests to “be at least 5 percent below 2011 enacted discretionary appropriation.”  There are a number of unknown variables that complicate predictions for FY13, including the outcome of the 2012 elections and the ability of the Super-committee to reach a compromise.

Managing in challenging fiscal times
Dr. Landis reported on a number of principles that emerged from the Institute’s strategic planning process that have guided NINDS’s activities as budgets become more constrained, including the need to: balance opportunities and needs across the spectrum of research, monitor programs to determine whether they are meeting their intended goals, and actively manage translational and clinical sciences by setting priorities.  As a result, some programs have been ended (e.g., Clinical Research Consortium, Microarray Consortium), and others are being managed more actively (e.g., Clinical Trials).  NINDS has initiated several programs including: NeuroNEXT (network for early phase clinical trials for neurological disorders), Epilepsy Centers Without Walls, Parkinson’s Disease Biomarkers Project (2012), and the NIH Blueprint Neurotherapeutics Network.  Moving forward, Dr. Landis noted that as NIH may be faced with constrained budgets for five or ten years in the future, NINDS should plan accordingly.  Dr. Landis identified a number of strategies under discussion across NIH that involve more active management of the extramural grant portfolio including: limits to award size, limits to the number of grants or total NIH dollars per investigator, and limits to salary support.  Additionally, NINDS will continue to rigorously assess its major programs and articulate the mission of the Institute to the public.

Diversity in the Biomedical Workforce
Dr. Landis reported on the findings of a recently-published study: Race, Ethnicity, and NIH Research Awards spearheaded by Dr. Raynard Kington during his tenure as Acting Director, NIH (Ginther et al., Science 333, 1015 (2011)).  This study analyzed the probability of securing new NIH R01 funding by race/ethnicity, controlling for observable characteristics such as NIH training, research experience, and institution.  Analysis of over 40,000 applicants suggested that black and Asian applicants were significantly less-likely to receive a Type 1 (new) R01 award.  Other conclusions reported in this study: black and Hispanic applicants are less likely to resubmit a revised application; participation in NIH supported training or career development programs has a positive effect on R01 award rates, however this advantage appears to help white applicants more than black and Asian applicants; award probabilities are correlated with NIH funding rank of applicant’s institution but in each group black applicants have the lowest award probability; and only citations and prior review committee experience reduce disparities for black applicants.

Dr. Landis noted that NIH has initiated a number of new programs to address these issues, including establishing an “Early Career Reviewers” program to increase the exposure of investigators from diverse institutions to the review process and to increase diversity on review panels; encouraging institutions to create pre-application mentoring programs for junior faculty; and funding grants designed to study different interventions to strengthen the pipeline and improve workforce diversity (e.g., Pathfinder awards).  Additionally, two high-level groups have been formed to recommend actions to help NIH increase workforce diversity and foster environments that support diversity.

Lastly, Dr. Landis reported on the recent NINDS workforce diversity planning efforts and the steps that have been taken by the Institute to implement the planning panel’s recommendations.  NINDS has integrated the diversity programs for individuals into the Office of Training to create a new Office of Training, Career Development and Workforce Diversity.  The NINDS has also focused the efforts of the Office of Special Programs on the Specialized Neuroscience Research Programs and potential new programs to increase faculty diversity.  Additionally, the Institute has established an internal working group and a council working group on diversity.

IV. Gender and Javits Awards

Dr. Anna Taylor, Health Program Specialist, NINDS Division of Extramural Research, reported findings of an NINDS analysis looking at potential gender disparity in the NINDS Javits Award.  Javits awards were established by NINDS in 1983, and are prestigious awards made to exceptional researchers in the neurological sciences.  Javits awards are typically made to investigators who have a history of receiving outstanding scores without the need to revise and resubmit and who are considered by their peers to be a leader in their field.  Dr. Taylor reported that since 2005, NINDS has issued 45 Javits awards, including 4 to women; however, after controlling for factors such as application type and score, the disparity was reduced from 10x to 2x.  Other variables considered had no significant effect on the disparity, including: funding history, seniority, publication history, and service record.  Moving forward, NINDS will make modifications to the award nomination process to ensure that all eligible Javits receive equal consideration.

V. Training, Career Development, and Special Programs Subcommittee

Dr. Courtney Ferrell Aklin, Program Director in the Office of Special Programs in Diversity, discussed the recommendations for management of institutional programs by the NINDS Planning Panel on Workforce Diversity and the ways that NINDS is moving to address these recommendations.  As a first step towards enhancing diversity in academic research institutions, NINDS released a Request for Information, soliciting input from the neuroscience research community on innovative strategies and practices that have proven successful in increasing the diversity of research faculty and students.   Specifically, commenters were asked to address: the role of NINDS in assisting institutions in enhancing diversity among their student and faculty populations; present obstacles that make it difficult for individuals from underrepresented groups to advance within the neurosciences; and activities that institutions engage in to promote diversity (NOT-NS-11-021).

Dr. Michelle Jones-London, Program Director in the Office of Training, Career Development and Workforce Diversity, discussed a number of individual awards aimed at increasing the diversity of the biomedical workforce through various early career stages.  Specifically, Dr. Jones-London discussed: Diversity Research Education Grants in Neuroscience (PAR-11-010; R25), Blueprint Program for Enhancing Neuroscience Diversity through Undergraduate Research Education Experiences (RFA-MH-070; R25); Individual Predoctoral Fellowships to Promote Diversity (PA-11-112; F31); Research Supplements to Promote Diversity in Health-Related Research (PA-08-190); and Career Development Award to Promote Diversity in Neuroscience Research (PAR-09-065; K01).  Additionally, Dr. Jones-London described the Neuroscience Scholars Program at the Society for Neuroscience, designed to build a network for diverse researchers and the Biannual Grant Writing Workshop for Diverse Investigators.

VI. Clinical Trials Subcommittee

Dr. Elizabeth McNeil, NINDS Office of Clinical Research, provided an overview of the newly approved Neuro-NEXT Research Network (Network for Excellence in Neuroscience Clinical Trials). The goal(s) of the Research network are: 1) to develop a network at major research institutions to efficiently test the most promising therapies in scientifically valid, biomarker-informed,  phase II clinical trials whether from academic or industry investigators; 2) to establish a network with the flexibility to rapidly develop a cadre of disease-specific investigators to design and execute trials of promising therapies in a variety of disorders affecting both children and adults; 3) to establish a network that can leverage the clinical research infrastructure in their institutions to considerably strengthen the spectrum of NINDS clinical research; 4) to establish a network that will decrease the time/cost between trial design and trial completion.  Dr. McNeil explained the structure of the network will consist of a clinical coordinating center, a data management center, and 25 geographically distributed clinical sites.  The funding plan for the network was discussed during the closed portion of the NANDS council meeting.  A question and answer session among the council members followed the presentation regarding the plans for incorporating new studies and managing budgets across the network and the independently funded projects.

Dr. Scott Janis, NINDS Office of Clinical Research, provided a summary of the recently-published findings in the September 2011 New England Journal of Medicine of the SAMMPRIS (Stenting & Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis) phase III clinical trial. This trial was a prospectively planned phase III trial to enroll 764 patients with 70-99% stenosis of a major intracranial artery who had a recent (within 30 days) non-disabling stroke or trans-ischemic attack (or TIA).  Patients were randomized to receive either aggressive medical management alone (AMM) or AMM and angioplasty and stenting with the FDA approved Wingspan Stent System.  Enrollment in the trial was terminated after 451 subjects were randomized due to an analysis performed by the Data and Safety Monitoring group (DSMB) that found there was no statistical chance of showing benefit from the stenting group due to the superior statistical improvement in the aggressive medical management group and safety concerns in the stented group regarding a high peri-procedural risk with the use of the stenting system in the population studied in the trial.  Dr. Thomas Brott, Chair of the Clinical Trials Subcommittee, further discussed the context of the improvement due to medical therapy and applauded the effort in the trial to aggressively control the major risks factors for this disease.

VII. Concept Clearance for FY13 Proposed Initiative

Dr. Yuan Liu, Chief, Office of International Activities, presented a concept for a U.S. – China Collaborative Biomedical Research Program.  This program was initiated in 2010, with the signing of a Memorandum of Understanding by Dr. Collins and the president of the National Natural Science Foundation, Yiyu Chen.  This MOU signified NIH and NSF-China’s plans to work together to develop new models to support mutually beneficial research projects between U.S. and Chinese scientists in basic biomedical research.  In support of this initiative, Dr. Liu proposes NINDS’s participation in an effort that would support parallel funding for collaborations between U.S. and Chinese investigators.  In this proposal, the NIH would fund the US portion of the collaboration utilizing three year R01s.  NINDS hosted a number of workshops to identify potential areas for collaboration in Stroke and Parkinson’s disease.

Dr. Finkelstein requested, and was granted approval to move forward with this initiative.

VIII. 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, 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 76 research career development and institutional training grant applications; of this total, 60 applications had primary assignment to NINDS, and 39 of them (65.0 percent) were recommended for support in the amount of $4.8 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 $1.6 million.

Research Project and Center Awards

The Council reviewed a total of 1,597 research project and center applications; of this total, 1,256 applications had primary assignment to NINDS, and 693 of them (55.2 percent) were recommended for support in the amount of $200.8 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 $57.9 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, no Javits awards were recommended.

Small Business Innovation Research and Small Technology Transfer Award Programs

The Council reviewed a total of 144 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications; of this total, 118 applications had primary assignment to NINDS and 70 of them (59.3 percent) were recommended for support in the amount of $18.1 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 $3.8 million.

IX. Adjournment

The meeting was adjourned at 11:10 a.m. on Friday, September 16.

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.