GENE DISCOVERY FOR NEUROLOGICAL AND NEUROBEHAVIORAL DISORDERS

Release Date:  March 26, 2001

RFA:  RFA-NS-02-002

National Institute of Neurological Disorders and Stroke
National Institute on Aging
National Institute of Mental Health

Letter of Intent Receipt Date:  June 7, 2001
Application Receipt Date:       July 10, 2001

THIS RFA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  IT INCLUDES 
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED 
WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA.

PURPOSE
The goal of this Request for Applications (RFA) is to promote the 
identification of genes that cause or contribute to human neurological and 
neurobehavioral diseases.  It is intended to encourage applications for 
genetics research projects with one or more of the following objectives: (1) 
to identify the gene or genes that produce disease susceptibility (2) to 
identify “modifier” genes that affect disease susceptibility or outcome and 
(3) to investigate the relationship between genotype and disease phenotype. 
Because of the interdisciplinary nature of such projects, collaborative 
studies are encouraged.  Studies using invertebrate or vertebrate animal 
models are appropriate if they directly promote the identification of human 
disease susceptibility genes.

RESEARCH OBJECTIVES

Background

Genetic factors contribute to a broad spectrum of neurological and 
neurobehavioral diseases.  During the last decade, genes that cause many 
single-gene neurological disorders have been identified (e.g. Huntington’s 
disease, neurofibromatosis, and Rett Syndrome). For these disorders, familial 
inheritance patterns follow the rules of Mendelian segregation. For common 
disorders (e.g. Parkinson’s disease, epilepsy, Alzheimer’s disease, 
frontotemporal dementia and autism), progress in identifying genes that 
affect susceptibility and outcome has been slow. Such disorders may be caused 
by multiple genes or by a combination of environmental and genetic factors.  
The role of genetics in the response to environmental trauma (e.g. brain or 
spinal cord injury) or to age-related metabolic dysfunction in the brain 
(e.g. oxidative stress) is also poorly understood.

The wealth of genomic information becoming available through the Human Genome 
Project will provide an increasingly powerful tool for gene discovery.  Once 
disease susceptibility genes are identified, it will be possible to study 
gene function, investigate disease pathophysiology, and explore strategies 
for therapeutic intervention.  Gene identification will also provide a basis 
for genetic counseling and improved diagnostic classification.

Scope
Applications submitted in response to this announcement should focus on gene 
discovery or genotype-phenotype analysis.  For gene discovery studies, 
proposals can focus on either single-gene or multigenic disorders. Proposed 
studies can involve the initial collection of biomaterials and clinical 
information from a patient population and/or the application of molecular 
genetic strategies for disease gene identification.  Possible methodologies 
include, but are not limited to, traditional linkage analysis, sib-pair and 
affected-pedigree-member methods, case-control or family-based association 
studies, linkage disequilibrium mapping in genetically isolated populations, 
candidate gene analysis, cytogenetic studies to identify chromosomal 
abnormalities associated with a disorder, and positional cloning techniques.  
The use of invertebrate or vertebrate animal models is also appropriate, if 
this will facilitate the identification of genes that contribute to a 
specific human disorder.  Such models may, for example, permit the 
identification of modifier genes where a primary disease gene has already 
been identified (e.g. for neurofibromatosis, triplet repeat disorders, etc.).

In the area of genotype-phenotype analysis, studies should be designed to 
correlate the mutations present in individual patients (in primary disease 
genes or modifier genes) with clinical outcome.  Projects in which a strong 
case can be made that such correlations will be useful for diagnosis or 
genetic counseling are particularly encouraged.

Since gene discovery requires collaborations among epidemiologists, 
geneticists, clinicians, molecular biologists, and other researchers, 
multidisciplinary projects are encouraged. Because progress in gene 
identification is driven by technological advances in these fields, it is 
important that proposals use state of the art methodologies.

Applications should focus on disorders relevant to the research missions of 
NINDS, NIA, or NIMH.  A partial list of diseases of interest to NINDS is 
given in Appendix A of the planning document Neuroscience at the New 
Millennium; http://www.ninds.nih.gov/about_ninds/plans/strategic_plan.htm).  These 
include common disorders (Parkinson’s disease, Alzheimer’s disease, epilepsy, 
etc.) and a broad range of rarer disorders of the nervous system.  Disorders 
of interest to NIA for this RFA include Alzheimer’s disease and other age-
associated neurodegenerative, cognitive, and motor system disorders (see 
http://www.nia.nih.gov/ResearchInformation/ExtramuralPrograms/NeuroscienceOfAging/Research+Areas.htm and 
http://www.nia.nih.gov/AboutNIA/StrategicPlan/). Disorders of interest to NIMH 
for this RFA include autism and autism spectrum disorders, attention deficit 
hyperactivity disorder, late-onset Alzheimer’s disease, Fragile X Syndrome, 
and Tourette Syndrome.  Disorders not included under this solicitation are 
bipolar disorder or related mood disorders, recurrent early-onset depression, 
eating disorders, obsessive-compulsive disorder or other anxiety disorders, 
panic disorder, schizophrenia or other psychotic disorders, and personality 
disorders.

An important resource available to applicants is the Center for Inherited 
Disease Research (CIDR), a centralized facility established to provide high-
throughput genotyping and statistical genetics services.  CIDR was 
established in 1996 as a joint effort of eight NIH Institutes, and is 
supported through a contract to Johns Hopkins University.  CIDR is available 
to all investigators through competitive peer review by a chartered CIDR 
Access Committee (CAC).  Projects are evaluated based on the need for high 
throughput genotyping and the likelihood that genotyping will lead to 
successful mapping of genes contributing to that disease.  Since NINDS, NIA, 
and NIMH are supporting NIH Institutes, research projects funded under this 
RFA are eligible for no-cost genotyping at CIDR.  Further information about 
CIDR may be found at http://www.cidr.jhmi.edu.  Submission deadlines for 
applications requesting CIDR access are November 1, March 1 and July 1.
An approval letter from the CAC may then be included in the application.

SPECIAL REQUIREMENTS

Plan for Dissemination of Data and Biomaterials

Sharing of biomaterials, data, and software in a timely manner has been an 
essential element in the rapid progress that has been made in the genetic 
analysis of human diseases.  PHS policy requires that investigators make 
unique research resources readily available for research purposes to 
qualified individuals within the scientific community when they have been 
published (see the NIH Grants Policy Statement at 
http://grants.nih.gov/grants/guide/notice-files/not96-184.html) 

To promote dissemination of research results, applicants who respond to this 
RFA must propose detailed plans for sharing data and biomaterials generated 
through the grant.  It is expected that the information to be shared will 
include all clinical, diagnostic, and pedigree structure information. The 
proposed plan may, at the applicant’s discretion, include biomaterials (e.g. 
DNA and cell lines). When possible, it is preferable that data generated 
through grants funded through this RFA be placed, stripped of personal 
identifiers, in common, public access databases that are widely accessible to 
investigators throughout the scientific community.  When applicants propose 
to share biomaterials, it is preferable that these biomaterials be placed in 
a public access repository, if such a repository exists. NIH maintains 
several repositories as resources for the scientific community (see, for 
example, http://zork.wustl.edu/nimh/NIMH_initiative/NIMH%20Human
%20Genetics%20Initiative%20Access%20Information.htm).  Rapid sharing of
data and biomaterials is strongly encouraged.

The Initial Review Group will evaluate the proposed sharing plan and comment 
on its adequacy in an administrative note in the summary statement. The 
adequacy of the plan will be considered by NIH staff in determining whether 
the grant shall be awarded.  The sharing plan as approved, after negotiation 
with the applicant when necessary, will be a condition of the award. 
Evaluation of renewal applications will include assessment of the 
effectiveness of data and biomaterial release.

Informed Consent Procedures

NIH, in consultation with the NIH Office of the General Counsel (OGC) and the 
Office for Human Research Protection (OHRP; formerly the Office for 
Protection From Research Risks (OPRR)), has developed a model consent form 
for human genetic research.  This form will be provided to applicants for use 
in projects funded under this RFA.  This may then serve as a template that is 
subject to modification and/or approval by local institutional review boards.  
It is expected that the applicant’s approved consent form address the 
following: (1) disclosure that clinical data (and biomaterials, if 
applicable) will be stored as part of a national resource of data and 
materials for the genetic analysis of the disease under investigation; (2) 
assurance that such data will be provided to researchers without personal 
identifiers; (3) disclosure that analyses of these data wil be conducted by 
other scientists currently not included within the current research team; and 
(4) disclosure that there is no plan to provide subjects with any financial 
benefits from commerical products derived from the data.  NIH will review 
consent forms and IRB approvals for all projects prior to funding under this 
RFA.

Phenotyping Issues

Phenotyping subjects for complex diseases presents numerous challenges. 
Several methodological problems could significantly reduce the ability to 
detect linkage or linkage disequilibrium, and thereby thwart efforts to 
identify disease susceptibility loci.  For example, efforts to replicate 
results and combine data across different samples may be hampered if 
diagnostic criteria are widely variable across multiple research projects.

Minimizing phenotypic error and imprecision, especially that which 
contributes to false-positive diagnoses of affected status, requires the 
careful application of state-of-the-art diagnostic techniques. For many rare 
disorders, diagnostic criteria remain poorly defined or relatively imprecise.  
It is expected that applicants will use the most sophisticated methodologies 
currently available for a particular disorder.  When possible, applicants are 
encouraged to include the following methodological features in their 
proposals:

o Use of a structured or semi-structured diagnostic interview with patients 
or other informants. It is expected that such procedures will greatly 
facilitate the establishment of a reliable diagnosis, and thus will increase 
the statistical power and utility of the data set for genetic analysis. 

o  Comprehensive synthesis of information systematically collected from 
laboratory procedures, structured or semi-structured clinical interviews of 
high reliability, medical records, and multiple informants.  

o Application of structured operational diagnostic criteria, based on the 
comprehensive synthesis of information for history, laboratory results, 
signs, and symptoms, to establish a final best estimate lifetime diagnosis. 
For example, operational criteria for the clinical diagnosis of Alzheimer’s 
disease have been developed to follow NINCDS-ADRDA Work Group guidelines. It 
is expected that applicants fully document their procedures for establishing 
such a final best estimate lifetime diagnosis. Subjects may be diagnosed in 
any one of multiple systems, but an ICD-10 diagnosis always should be 
established to permit pooling of these data with other pre-existing 
resources.

o  Entry of comprehensive phenotypic data described above into a computerized 
database that may be easily shared amongst other researchers.

MECHANISM OF SUPPORT

This RFA will use the research project grant (R01) and exploratory grant 
(R21) mechanisms.  R01 applications should be submitted in the modular 
format, and  their budgets limited to $250,000/year (direct costs), as 
specified under that format (see URL listed below for further description of 
modular applications).  For this RFA, participating NIH Institutes will use 
the NINDS guidelines for the R21 mechanism, which can be found at 
http://www.ninds.nih.gov/funding/r21guidelines.htm. As described in these 
guidelines, R21 proposals should have the potential for truly groundbreaking 
impact, be restricted to a maximum of $125,000/year (direct costs), and 
limited in duration to a maximum of two years. Applicants are encouraged to 
contact program staff for advice about choosing the appropriate grant 
mechanism. Responsibility for the planning, direction, and execution of the 
proposed project will be solely that of the applicant. This RFA is a one-time 
solicitation.  Future unsolicited competing continuation applications will 
compete with all investigator-initiated applications and be reviewed 
according to the customary peer review procedures.  The earliest anticipated 
award date is April 1, 2002.

Specific application instructions have been modified to reflect "MODULAR 
GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. 
Complete and detailed instructions and information on Modular Grant 
applications can be found at 
http://grants.nih.gov/grants/funding/modular/modular.htm

For administrative reasons all applications received in response to this 
solicitation will be assigned initially to NINDS.  After discussions among 
the participating Institutes following review, applications will be 
reassigned to the Institute(s) that are programmatically most appropriate.  
Because the scope of the research proposed in response to this RFA 
encompasses the interests of several NIH Institutes, applications may receive 
dual assignments based on the established PHS guidelines.  Awards will be 
made and managed by one of the participating NIH institutes.

FUNDS AVAILABLE

The participating Institutes intend to commit a total of approximately 
$4,000,000 in FY2002 to fund approximately 10 to 14 new grants submitted in 
response to this RFA. The total project period for an application submitted 
in response to this RFA may not exceed 5 years. Because the nature and scope 
of the research proposed may vary, it is anticipated that the size of each 
award will also vary. Although the financial plans of the Institute provide 
support for this program, awards pursuant to this RFA are contingent upon the 
availability of funds and the receipt of a sufficient number of meritorious 
applications. At this time, it is not known if this RFA will be reissued.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, for-profit and non-
profit organizations, public and private, such as universities, colleges, 
hospitals, laboratories, units of State and local governments, and eligible 
agencies of the Federal government. Investigators from foreign institutions 
are strongly encouraged to contact program staff before preparing 
applications.  Racial/ethnic minority individuals, women, and persons with 
disabilities are encouraged to apply as Principal Investigators.

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to clarify any 
issues or answer questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Dr. Robert Finkelstein
NINDS
Neuroscience Center, Rm 2143
6001 Executive Blvd.
Bethesda, MD  20892-9527
Telephone:  (301) 496-5745
FAX:  (301) 401-1501
Email:  finkelsr@ninds.nih.gov

Dr. Bradley C. Wise
Neuroscience and Neuropsychology of Aging Program
National Institute of Aging
Gateway Building, Suite 3C307
7201 Wisconsin Avenue MSC 9205
Bethesda, MD 20892-9205
Telephone: (301) 496-9350
FAX: (301) 496-1494
Email: WiseB@nia.nih.gov

Dr. Steven O. Moldin
Division of Neuroscience and Basic Behavioral Science
NIMH
6001 Executive Boulevard, Room 7189, MSC 9643
Bethesda, MD 20892-9643
Telephone: (301) 443-2037
Fax: (301) 443-9890
Email: smoldin@mail.nih.gov

Direct inquiries regarding review issues to:

Dr. Lillian Pubols
Scientific Review Branch
NINDS
Neuroscience Center, Rm 3208
Bethesda, MD 20892
Telephone: (301) 496-9223
FAX: (301) 402-0182
Email: LP28E@nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Tina Carlisle
Grants Management Branch
NINDS
6001 Executive Boulevard, Rm 3290
Bethesda, MD 20892
Telephone: (301) 496-3938
Email: carlislt@ninds.nih.gov

Ms. Linda Whipp
Grants and Contracts Management Office
National Institute of Aging
Gateway Building, Suite 2N212
7201 Wisconsin Avenue MSC 9205
Bethesda, MD 20892-9205
Telephone: (301) 496-1472
FAX: (301) 402-3672
Email: WhippL@nia.nih.gov

Ms. Diana S. Trunnell
Grants Management Branch
NIMH
6001 Executive Blvd., Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2805
Fax: (301) 443-6885
Email:  Diana_Trunnell@nih.gov

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes a 
descriptive title of the proposed research, the name, address, and telephone 
number of the Principal Investigator, the identities of other key personnel 
and participating institutions, and the number and title of the RFA in 
response to which the application may be submitted.  Although a letter of 
intent is not required, is not binding, and does not enter into the review of 
a subsequent application, the information that it contains allows IC staff to 
estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed below.

SCHEDULE SUMMARY

Letter of Intent Receipt Date:    June 7, 2001 
Application Receipt Date:         July 10, 2001
Peer Review Date:                 November, 2001
Council Review:                   February, 2002
Earliest Anticipated Start Date:  April 1, 2002

APPLICATION PROCEDURES

The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets. Only 
limited budgetary information is required under this approach.  The 
just-in-time concept allows applicants to submit certain information only 
when there is a possibility for an award. It is anticipated that these 
changes will reduce the administrative burden for the applicants, reviewers 
and Institute staff.  The research grant application form PHS 398 (rev. 4/98) 
is to be used in applying for these grants, with the modifications noted 
below.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIO

BUDGET INSTRUCTIONS

Modular Grant applications will request direct costs in $25,000 modules, up 
to a total direct cost request of $250,000 per year for R01s or $125,000 per 
year for R21s. The total direct costs must be requested in accordance with 
the program guidelines and the modifications made to the standard PHS 398 
application instructions described below:

PHS 398

o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in 
$25,000 increments up to a maximum of $250,000) and Total Costs [Modular 
Total Direct plus Facilities and Administrative  (F&A) costs] for the initial 
budget period Items 8a and 8b should be completed indicating the Direct and 
Total Costs for the entire proposed period of support.

o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 
of the PHS 398. It is not required and will not be accepted with the 
application.

o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the 
categorical budget table on Form Page 5 of the PHS 398. It is not required 
and will not be accepted with the application.

o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative 
page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for 
sample pages.) At the top of the page, enter the total direct costs requested 
for each year.  This is not a Form page.

o Under Personnel, list all project personnel, including their names, percent 
of effort, and roles on the project. No individual salary information should 
be provided. However, the applicant should use the NIH appropriation language 
salary cap and the NIH policy for graduate student compensation in developing 
the budget request.

For Consortium/Contractual costs, provide an estimate of total costs (direct 
plus facilities and administrative) for each year, each rounded to the 
nearest $1,000. List the individuals/organizations with whom consortium or 
contractual arrangements have been made, the percent effort of all personnel, 
and the role on the project. Indicate whether the collaborating institution 
is foreign or domestic. The total cost for a consortium/contractual 
arrangement is included in the overall requested modular direct cost amount.  
Include the Letter of Intent to establish a consortium.

Provide an additional narrative budget justification for any variation in the 
number of modules requested.

o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by  
reviewers in the assessment of each individual's qualifications for a 
specific role in the proposed project, as well as to evaluate the overall 
qualifications of the research team. A biographical sketch is required for 
all key personnel, following the instructions below. No more than three pages 
may be used for each person. A sample biographical sketch may be 	viewed at:  
http://grants.nih.gov/grants/funding/modular/modular.htm Complete the 
educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on 
research projects ongoing or completed during the last three years.
- List selected peer-reviewed publications, with full citations;

o CHECKLIST - This page should be completed and submitted with the 
application. If the F&A rate agreement has been established, indicate the 
type of agreement and the date. All appropriate exclusions must be applied  
in the calculation of the F&A costs for the initial budget period and all 
future budget years.

o The applicant should provide the name and phone number of the individual to 
contact concerning fiscal and administrative issues if additional information 
is necessary following the initial review. 

The RFA label available in the PHS 398 (rev. 4/98) application form must be 
affixed to the bottom of the face page of the application.  Type the RFA 
number on the label.  Failure to use this label could result in delayed 
processing of the application such that it may not reach the review committee 
in time for review.  In addition, the RFA title and number must be typed on 
line 2 of the face page of the application form and the YES box must be 
marked.

A sample RFA label is available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.  Please note this 
is in pdf format.

Submit a signed, typewritten original of the application, including the 
Checklist, and three signed, photocopies, in one package to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

At the time of submission, two additional copies of the application must be 
sent to:

Dr. Lillian M. Pubols
Scientific Review Branch, NINDS
6001 Executive Blvd.
NSC Rm 3208, MSC 9529
Bethesda, MD 20892-9529
(for courier delivery use: Rockville, MD 20852)

Applications must be received by the application receipt date listed in the 
heading of this RFA.  If an application is received after that date, it will 
be returned to the applicant without review.
  
The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed. This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must 
include an introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by NIH staff.  Incomplete and/or non-responsive applications 
will be returned to the applicant without further consideration.

Applications that are complete and responsive to the RFA will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened by the NINDS Scientific Review Branch in accordance with the review 
criteria stated below.  As part of the initial merit review, all applications 
will receive a written critique and undergo a process in which only those 
applications deemed to have the highest scientific merit, generally the top 
half of the applications under review, will be discussed, assigned a priority 
score, and receive a second level review by the appropriate National Advisory 
Council or Board.


Review Criteria

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments reviewers will be asked to discuss the following aspects 
of the application in order to judge the likelihood that the proposed 
research will have a substantial impact on the pursuit of these goals.  Each 
of these criteria will be addressed and considered in assigning the overall 
score, weighting them as appropriate for each application.  Note that the 
application does not need to be strong in all categories to be judged likely 
to have major scientific impact and thus deserve a high priority score.  For 
example, an investigator may propose to carry out important work that by its 
nature is not innovative but is essential to move a field forward.

(1) Significance:  Does this study address an important problem? If the aims 
of the application are achieved, how will scientific knowledge be advanced?  
What will be the effect of these studies on the concepts or methods that 
drive this field?

(2) Approach:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?

(3) Innovation:  Does the project employ novel concepts, approaches or 
method? Are the aims original and innovative?  Does the project challenge 
existing paradigms or develop new methodologies or technologies?

(4) Investigator:  Is the investigator appropriately trained and well suited 
to carry out this work?  Is the work proposed appropriate to the experience 
level of the principal investigator and other researchers (if any)?

(5) Environment:  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional 
support?

(6) Sharing plan:  Has the investigator proposed an adequate plan to make all 
data and biological materials collected and produced as a result of the 
proposed research accessible in a timely manner to the biomedical research 
community?

(7) R21 applications only:  Does this project have the potential for 
groundbreaking impact?  If successful, will this project achieve at least one 
of the following goals: 1) generate pilot data to assess the feasibility of a 
novel avenue of investigation? 2) involve high risk experiments that could 
lead to a breakthrough in a particular field? or 3) demonstrate the 
feasibility of new technologies that could have major impact in a specific 
area?

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o  The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will also be 
evaluated.

o  The reasonableness of the proposed budget and duration in relation to the 
proposed research.

o  The adequacy of the proposed protection for humans, animals or the 
environment, to the extent they may be adversely affected by the project  
proposed in the application.

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o  scientific merit (as determined by peer review)
o  availability of funds
o  programmatic priorities
o  adequacy of proposed sharing plan

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and 
their sub-populations must be included in all NIH-supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are provided indicating that inclusion 
is inappropriate with respect to the health of the subjects or the purpose of  
the research.  This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43). 

All investigators proposing research involving human subjects should read the 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); 
a complete copy of the updated Guidelines are available at  
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm:  The 
revisions relate to NIH defined Phase III clinical trials and require: a) all 
applications or proposals and/or protocols to provide a description of plans 
to conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups if applicable; and b) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by 
the NIH, unless there are scientific and ethical reasons not to include them.  
This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the Inclusion of Children as Participants in 
Research Involving Human Subjects that was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html
Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained within 
specified page limitations.  Unless otherwise specified in an NIH 
solicitation, internet addresses (URLs) should not be used to provide 
information necessary to the review because reviewers are under no obligation 
to view the Internet sites.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2010," a PHS-
led national activity for setting priority areas.  This Request for 
Applications (RFA), Gene Discovery for Neurological and Neurobehavioral 
Disorders, is related to one or more of the priority areas.  Potential 
applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople/.

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.853, (NINDS), 93.866 (NIA), and 93.242 (NIMH).  Awards are made under 
authorization of Sections 301 and 405 of the Public Health Service Act as 
amended (42 USC 241 and 284) and administered under NIH grants policies and 
Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  This program is 
not subject to the intergovernmental review requirements of Executive Order 
12372 or Health Systems Agency review.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and promote the non-use of all tobacco products.  In addition, 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care, or early 
childhood development services are provided to children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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