GENE DISCOVERY FOR COMPLEX NEUROLOGICAL AND NEUROBEHAVIORAL DISORDERS

RELEASE DATE:  March 31, 2003 (see correction NOT-NS-03-013)

PA NUMBER:  PAS-03-092

March 2, 2006 (NOT-OD-06-046) – Effective with the June 1, 2006 submission date, 
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using 
the electronic SF424 (R&R) application. Accordingly, the R21 portion of this funding opportunity 
expires on the date indicated below. Other mechanisms relating to this announcement will continue to 
be accepted using paper PHS 398 applications until the stated expiration date below, or transition 
to electronic application submission. A replacement R21 (PAS-06-204) funding opportunity announcement 
has been issued for the submission date of June 1, 2006 and submission dates thereafter.

EXPIRATION DATE: for R21 Applications: March 2, 2006
EXPIRATION DATE: for R01 Applications: July 2, 2006

National Institute of Neurological Disorders and Stroke (NINDS)
 (http://www.ninds.nih.gov)
National Institute on Aging (NIA)
 (http://www.nia.nih.gov)  
National Institute of Drug Abuse (NIDA)
 (http://www.nida.nih.gov)   
National Institute of Environmental Health Sciences (NIEHS)
 (http://www.niehs.nih.gov)  

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.853 (NINDS), 93.866 
(NIA), 93.279 (NIDA), 93.113 and 93.115 (NIEHS)

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Special Requirements
o Mechanism(s) of Support
o Funds Available 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA  

The goal of this Program Announcement (PA) is to promote the identification 
of susceptibility genes for complex neurological and neurobehavioral 
disorders.  For this PA, complex disorders are defined as those caused by the 
interaction of multiple genes, or by a combination of genetic and 
environmental risk factors.  Many of these disorders are relatively common 
and clinically heterogeneous.  Projects focusing on any phase of the gene 
discovery process, from initial patient ascertainment to positional cloning, 
are appropriate.  Novel approaches, including the use of intermediate 
phenotypes that potentially underlie complex disorders, are also encouraged.

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 many 
common disorders (e.g. stroke, Parkinson's disease, epilepsy, Alzheimer's 
disease, and attention deficit hyperactivity disorder), inheritance patterns 
are more complex, and progress in identifying genes that affect 
susceptibility and disease outcome has been slow. Such disorders appear to be 
caused by multiple genes or by a combination of genetic and environmental 
factors.

The wealth of genomic information becoming available through the Human Genome 
Project is providing a 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 
improved diagnostic classification, genetic counseling and understanding of 
pharmacogenetic interactions.

Scope

Applications submitted in response to this announcement should focus on the 
identification of susceptibility genes that contribute to genetically complex 
disorders affecting the nervous system, or to the phenotypes that underlie 
these disorders.  Proposed studies can involve the initial collection of 
biomaterials and clinical information from a patient population or the 
subsequent application of genetic or molecular strategies for gene 
localization.  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.  This PA focuses on human studies - 
projects using invertebrate or vertebrate animal models are not appropriate.  
Since gene discovery requires collaborations among epidemiologists, 
geneticists, clinicians, molecular biologists, and other researchers, 
multidisciplinary projects are encouraged.

Since complex disorders are clinically and genetically heterogenous, the 
identification of susceptibility genes by standard genetic methodologies has 
been difficult.  Therefore, the development of novel approaches and the use 
of state-of-the-art technologies are essential.  An example of such an 
emerging strategy is the use of intermediate phenotypes (endophenotypes) to 
facilitate gene discovery.  Endophenotypes are characteristics that may 
represent more proximal readouts of gene function.  Examples include enzyme 
activities, plasma levels of particular neurotransmitters, changes in gene 
expression, structural or functional phenotypes detected by brain imaging, 
and behavioral or cognitive deficits.  Classifying patients based on such 
parameters has, in certain cases, accelerated the process of gene discovery.  
The use of this strategy is appropriate if the applicant: (1) demonstrates 
that the phenotype in question can be reliably and accurately measured (2) 
provides evidence suggesting that the phenotype underlies a particular 
neurological/neurobehavioral disorder or group of disorders and (3) makes a 
strong case that use of this phenotype will facilitate the discovery of 
susceptibility genes.

Applications should focus on complex neurological or neurobehavioral 
disorders relevant to the research missions of NINDS, NIA, NIDA, or NIEHS.  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 
neurological disorders (e.g. stroke, Parkinson's disease, epilepsy, multiple 
sclerosis, and Alzheimer's disease) and neurobehavioral disorders (e.g. 
autism, attention deficit hyperactivity disorder, and Tourette Syndrome).  
Disorders of interest to NIA for this PA 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/strat-plan/2001-2005). Disorders of interest to NIDA 
for this PA include drug abuse and/or drug dependence on stimulants (e.g., 
cocaine and amphetamine), narcotics (e.g., opiates), nicotine, 
benzodiazepines, barbiturates, cannabis, hallucinogens, and/or multiple drugs 
of abuse in human beings. Intermediate phenotypes of interest to NIDA include 
but are not limited to sensation seeking, impulse control, responses to 
rewarding stimuli as measured by neuroimaging, and initial reactivity to drug 
exposure. Disorders of interest to NIEHS for this PA are Parkinson's disease, 
amyotrophic lateral sclerosis (ALS), ADHD, autism and autism spectrum 
disorders and other neurodegenerative disorders when the focus of the gene 
discovery is on those genes that can be influenced by environmental exposures 
contributing to the onset of the 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 NIDA support CIDR, research projects funded by these Institutes under 
this PA are eligible for no-cost genotyping.  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 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).  In 
addition, NIH recently released a statement on the sharing of research data 
that applies to all investigator-initiated applications with direct costs 
greater than $500,000 in any single year 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). 

All applicants who respond to this PA must propose plans for sharing data and 
biomaterials generated through the grant.  Applicants should explain how 
funds for the storage and distribution of data and biomaterials will be 
obtained, and may request such funds in the budget of the application.  It is 
expected that the information to be shared will include clinical, diagnostic, 
and pedigree structure information. Biomaterials to be shared should include 
patient DNAs and cell lines. When possible, data and biomaterials should be 
placed in databases or repositories that will permit their efficient 
distribution to investigators throughout the scientific community.  An 
example of such a facility is the NINDS Human Genetics Resource Center 
(http://locus.umdnj.edu/ninds). 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.  
Reviewers will not factor the proposed data-sharing plan into 
the determination of scientific merit or priority score.  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.

Phenotyping Issues

Phenotyping subjects for the analysis of complex diseases presents numerous 
challenges. 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 Entry of comprehensive phenotypic data described above into a computerized 
database that may be easily shared with other researchers.

MECHANISMS OF SUPPORT 

This PA will use the NIH research project grant (R01) and 
exploratory/developmental grant (R21) award mechanism(s).  As an applicant, 
you will be solely responsible for planning, directing, and executing the 
proposed project. Applicants are encouraged to contact program staff for 
advice about choosing the appropriate grant mechanism.

The R21 mechanism is intended to encourage new exploratory/developmental 
research projects by providing support for the early stages of their 
development.  For example, such projects could assess the feasibility of a 
novel area of investigation or a new experimental system that has the 
potential to enhance health-related research.  These studies may involve 
considerable risk but may lead to a breakthrough in a particular area, or to 
the development of novel techniques, agents, methodologies, models or 
applications that could have major impact on a field of biomedical, 
behavioral, or clinical research.

Applications for R21 awards should describe projects distinct from those 
supported through the traditional R01 mechanism.  For example, long-term 
projects, or projects designed to increase knowledge in a well-established 
area will not be considered for R21 awards.  Applications submitted under 
this mechanism should be exploratory and novel.  These studies should break 
new ground or extend previous discoveries toward new directions or 
applications.

R21 applications may request a project period of up to two years with a 
combined budget for direct costs of up $275,000 for the two year period.  For 
example, you may request $100,000 in the first year and $175,000 in the 
second year.  The request should be tailored to the needs of your project.  
Normally, no more than $200,000 may be requested in any single year.  

This PA uses just-in-time concepts.  It also uses the modular as well as the 
non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, if 
you are submitting an application with direct costs in each year of $250,000 
or less, use the modular format.  Otherwise follow the instructions for non-
modular research grant applications.  This program does not require cost 
sharing as defined in the current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.

Competing continuation applications submitted in response to this PA will 
compete with all investigator-initiated applications and be referred and 
reviewed according to the customary peer review procedures.  Responsibility 
for the planning, direction, and execution of the proposed project will be 
solely that of the applicant. The earliest anticipated award date is April 1, 
2004.

FUNDS AVAILABLE

Applications submitted in response to this PA will compete with all 
investigator-initiated applications for funding. The participating Institutes 
intend to commit a total of approximately $3,000,000 (total costs) per year 
in additional funding to this PA.

The total project period for an application submitted in response to this PA 
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 PA 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 PA will be reissued.

ELIGIBLE INSTITUTIONS 

You may submit (an) application(s) if your institution has any of the 
following characteristics:

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into two 
areas:  scientific/research and financial or grants management issues:

Direct inquiries regarding scientific/research 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. Marilyn Miller
Neuroscience and Neuropsychology of Aging
NIA
7201 Wisconsin Avenue Suite 350
Bethesda, MD 20892 
Telephone (301) 496-9350
Fax: (301) 496-1494
Email:  MillerM@nia.nih.gov

Jonathan D. Pollock, Ph.D.   
Genetics and Molecular Neurobiology Research Branch  
NIDA  
6001 Executive Blvd, Rm 4274  
Bethesda, MD 20892  
Telephone:  (301) 435-1309  
FAX:  (301) 594-6043  
Email:  jp183r@nih.gov

Kimberly A. Gray, Ph.D.
Chemical Exposures and Molecular Biology Branch
NIEHS
PO Box 12233 (MD EC-21)
Research Triangle Park, NC 27709
Telephone:  (919) 541-0293
FAX:  (919) 316-4606
Email:  kg89o@nih.gov

Direct inquiries regarding financial or grants management matters to:

Ms. Kathleen Howe
Grants Management Branch
NINDS
6001 Executive Boulevard, Rm 3266
Bethesda, MD 20892
Telephone:  (301) 496-7392
Email:  howek@ninds.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which 
are available at http://grants.nih.gov/grants/dates.htm.  Application 
deadlines are also indicated in the PHS 398 application kit.

SUPPLEMENTAL INSTRUCTIONS:  All instructions for the PHS 398 (rev. 5/2001) 
must be followed, with these exceptions:

o   Research Plan

For R21 applications only, items a – d of the Research Plan (Specific 
Aims, Background and Significance, Preliminary Studies, and Research 
Design and Methods) may not exceed a total of 15 pages.  No preliminary 
data is required for R21 proposals, but may be included if it is 
available.  Please note that a Progress Report is not needed for R21 
awards; competing continuation applications for an 
exploratory/developmental grant will not be accepted.

Appendix.  Use the instructions for the appendix detailed in the PHS 
398 except that for R21 applications, no more than 5 manuscripts, 
previously accepted for publication, may be included.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS:  Applications 
requesting up to $250,000 per year in direct costs must be submitted in 
the modular grant format.  The modular grant format simplifies the 
preparation of the budget in these applications by limiting the level 
of budgetary detail.  Applicants request direct costs in $25,000 
modules.  Section C of the research grant application instructions for 
the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-
by-step guidance for preparing modular grants.  Additional information 
on modular grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: 
Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NIH staff member within one of NIH 
institutes or centers who has agreed to accept assignment of the application.   

Applicants requesting more than $500,000 must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the 
application, i.e., as you are developing plans for the study; 

2) Obtain agreement from the IC staff that the IC will accept your 
application for consideration for award; and,
  
3) Identify, in a cover letter sent with the application, the staff member 
and IC who agreed to accept assignment of the application.

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised 
version of these grant application types. Additional information on this 
policy is available in the NIH Guide for Grants and Contracts, October 19, 
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.

In addition, beginning with the October 1, 2003 receipt deadline, all 
applications requesting direct costs greater than $500,000 in any single year 
must include a plan for data sharing in accordance with the recent NIH 
Statement on Sharing Research Data 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html).

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, and five 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)

APPLICATION PROCESSING: Applications must be received by or mailed on or 
before the receipt dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.  The CSR will 
not accept any application in response to this PA 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 a substantial revision of an application already reviewed, but 
such application must include an Introduction addressing the previous 
critique.

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
convened in accordance with the standard NIH peer review procedures 
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific 
and technical merit.  

As part of the initial merit review, all applications will:

o Receive a written critique
o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o 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 your application in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of these 
goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment

The scientific review group will address and consider each of these criteria 
in assigning your application's overall score, weighting them as appropriate 
for each application.  Your 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, you 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 your study address an important problem? If the aims 
of your application are achieved, how do they advance scientific knowledge?  
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?  Do you acknowledge potential problem areas and consider alternative 
tactics?

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

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

(5) ENVIRONMENT:  Does the scientific environment in which your 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?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

SHARING PLAN:  The adequacy of the proposed plan to make all data and 
biological materials collected and produced as a result of the proposed 
research accessible to the biomedical research community in a timely manner.  
Reviewers will not factor the proposed data-sharing plan into 
the determination of scientific merit or priority score, but will be asked to 
comment on the plan in an administrative note in the summary statement.

PROTECTIONS:  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.

INCLUSION:  The adequacy of plans to include subjects from both genders, all 
racial and ethnic groups (and subgroups), and children as appropriate for the 
scientific goals of the research.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria included in the 
section on Federal Citations, below)

BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

AWARD CRITERIA

Applications submitted in response to a PA will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities
o Adequacy of proposed sharing plan

REQUIRED FEDERAL CITATIONS 

HUMAN SUBJECTS PROTECTION:  Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained.

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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 clinical research projects unless a 
clear and compelling justification is 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 clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/
notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines 
are available at http://grants.nih.gov/grants/funding/women_min/guidelines
_amended_10_2001.htm. The amended policy incorporates: the use of an NIH 
definition of clinical research; updated racial and ethnic categories in 
compliance with the new OMB standards; clarification of language governing 
NIH-defined Phase III clinical trials consistent with the new PHS Form 398; 
and updated roles and responsibilities of NIH staff and the extramural 
community. The policy continues to require for all NIH-defined Phase III 
clinical trials that: a) all applications or proposals and/or protocols must 
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) investigators must report annual accrual and 
progress in conducting analyses, as appropriate, by sex/gender and/or 
racial/ethnic group differences. 

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy 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 is available at 
http://grants.nih.gov/grants/funding/children/children.htm. 

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS:  NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on 
hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).   
It is the responsibility of the applicant to provide the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modification to 
the "Standards for Privacy of Individually Identifiable Health Information", 
the "Privacy Rule," on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified 
under the Rule as "covered entities") must do so by April 14, 2003  (with the 
exception of small health plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on "Am I a covered 
entity?"  Information on the impact of the HIPAA Privacy Rule on NIH 
processes involving the review, funding, and progress monitoring of grants, 
cooperative agreements, and research contracts can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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.   Furthermore, 
we caution reviewers 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 PA 
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 at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All 
awards are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the 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


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Research (OER)
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and Human Services (HHS)
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