TECHNOLOGIES TO FIND FUNCTIONAL ELEMENTS IN GENOMIC DNA  
 
RELEASE DATE:  January 6, 2004
 
RFA Number:  RFA-HG-04-001 

August 4, 2006 - This RFA has been reissued as RFA-HG-07-029 (R01) 
and RFA-HG-07-028 (R21).

Department of Health and Human Services (DHHS)
 
PARTICIPATING ORGANIZATION: 
National Institutes of Health (NIH)
 (http://www.nih.gov/)

COMPONENT OF PARTICIPATING ORGANIZATION: 
National Human Genome Research Institute (NHGRI) 
 (http://www.genome.gov/) 

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S) 93.172
 
LETTER OF INTENT RECEIPT DATE:  February 20, 2004
APPLICATION RECEIPT DATE:  March 23, 2004  
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA 

The purpose of this RFA is to solicit applications to develop new 
technologies for the efficient, comprehensive, high-throughput 
identification and verification of all types of sequence-based 
functional elements, particularly those other than coding sequences for 
which adequate methods do not currently exist.  This effort is part of 
the Encyclopedia of DNA Elements (ENCODE) Project, the intent of which 
is to identify all functional elements in the human genome sequence 
(http://www.genome.gov/10005107).  This RFA will augment the ongoing 
work of the ENCODE Consortium, which is (a) conducting a pilot project 
to test the ability of current methodologies to identify exhaustively 
the functional elements in a targeted region of the human genome and (b) 
supporting the development of new technology.  Although all aspects of 
technology development will be considered, the emphasis for this RFA is 
on the development of completely novel techniques for identifying 
sequence-based functional elements in the genomes of eukaryotic 
organisms, especially heretofore uncharacterized elements, rather than 
on the incremental improvement of existing methods.
 
RESEARCH OBJECTIVES
 
Background

In April 2003, the sequence of the human genome was essentially 
completed.  For the scientific community to make the best use of that 
fundamental information resource, the identity and precise location of 
all sequence-based functional elements in the genome must be determined.  
While many of the protein-coding sequences are already known, many 
others remain to be identified.  Beyond open reading frames, most other 
sequence-based functional elements, such as non-protein-coding genes, 
transcriptional regulatory elements and determinants of chromosome 
structure and function, remain largely unknown.  A comprehensive 
encyclopedia of all of these features is needed to fully utilize the 
sequence of the human genome to better understand human biology, to 
predict potential disease risks, and to stimulate the development of new 
therapies and other interventions for preventing and treating disease.   

Among the primary reasons for the success of the Human Genome Project 
have been the development and use of high-throughput strategies for data 
generation, and the placement of the data immediately in the public 
domain.  Most of the sequence data, the underlying maps and the sequence 
assemblies were generated through the use of large-scale automated 
processes.  Now, methods such as sequence analysis of whole genomes, DNA 
microarray technology and mass spectrometry have been or are being 
developed as high-throughput approaches for additional types of genomic 
analyses, such as determining the parameters of gene expression and of 
the location of gene products by the thousands at a time instead of 
individually.  High-throughput methods to determine the location of cis-
regulatory elements and, to a lesser extent, other sequence elements, 
are also beginning to be developed.  However, at present, there is no 
single approach or compilation of approaches that can accurately and 
efficiently identify every sequence feature in genomic DNA. 

To address this need, the NHGRI recently initiated the Encyclopedia of 
DNA Elements (ENCODE) Project, the goal of which is to comprehensively 
identify sequence-based functional elements in the human genome 
sequence.  The ENCODE Project currently has two components.  The first 
is a pilot in which existing methods for the exhaustive identification 
and verification of functional sequence elements are being tested and 
compared in a fraction (30 Mb) of human genomic DNA.  This pilot is 
focused on established technologies that can primarily be applied to 
identify coding sequences, transcriptional units, and transcriptional 
control elements. The second component of the ENCODE Project addresses 
the need for new technologies that will be necessary to identify all 
sequence-encoded functional elements on a genome-wide scale.  To this 
end, an initial set of grants was funded, under RFA HG-03-004, to 
develop novel technologies designed to effect systematic and high-
throughput approaches to the comprehensive identification of functional 
sequence elements in the human genome.  The current RFA (HG-04-001) is a 
reissuance of that RFA with an expansion in scope to include the support 
for high risk projects, for testing new ideas for which preliminary data 
have not yet been obtained, and for the development of new approaches to 
identify sequence-based functional elements in the genomes of model 
organisms even if such methods are not directly applicable to 
identifying features in the human genome.  The goal of RFA HG-04-001 is 
to develop a new generation of methods to define functional elements in 
genomes of both human and model organisms.

Research Scope

When fully mature, the ENCODE Project will apply a set of high-
throughput assays to scan the entire human genome for all types of 
sequence-encoded functional elements.  However, many types of functional 
elements cannot currently be studied at such large scale, or even at 
smaller scale, because of the lack of effective, practical high-
throughput methods. The purpose of this RFA is to stimulate the 
development of novel technologies and expand the “tool box” for 
identifying all sequence-based functional elements in eukaryotic genomes 
in a high-throughput manner. The RFA seeks applications for research 
projects to develop efficient technologies (both experimental and 
computational) for, but not limited to, the following areas:  

o   Transcribed sequences; while the emphasis is on non-protein coding 
transcribed sequences, new approaches to identifying protein-coding 
transcribed sequences will be considered.  A description of the entire 
structure of the transcriptional unit, with transcriptional start sites, 
polyadenylation sites, and all alternative transcripts, is an example.
o   Conserved non-coding sequences that represent functional elements.
o   Cis-acting elements that regulate gene expression at either the 
transcriptional or post-transcriptional levels, for example promoters, 
enhancers, insulators, and features that regulate RNA stability and 
translation. 
o   Sequence features that affect or control various aspects of 
chromosome biology, including chromatin structure.   Examples include 
origins of replication and hot spots for recombination. 
o   Epigenetic changes, such as DNA methylation and chromatin 
modifications.

These few examples are illustrative and should not be considered to be 
limiting in any way. Novel and innovative technologies to achieve high-
throughput, large-scale analyses (i.e., applicable to an entire genome) 
of any type of sequence-encoded functional elements are sought. 

The "process" of technology development can be considered to span a 
spectrum of stages. Initially, it involves the development of an 
entirely new methodology (or the significant improvement of an existing 
methodology) to the point of proof of principle. The method must then be 
reduced to practice. For such a new method to have a significant impact 
for genomic studies, it also must be shown that it can be used 
efficiently on a large-scale, or genomic basis, which may require a 
further round of technology development effort. This RFA is intended to 
solicit applications that address any of these phases of technology 
development, with an emphasis on the development of completely novel 
techniques for identifying sequence-based functional elements, 
especially heretofore uncharacterized elements, rather than on the 
incremental improvement of existing methods.

Although the long term goal of the ENCODE project is to develop a 
comprehensive understanding of the human genome sequence, this RFA is 
open to projects employing any other eukaryotic organism.  Technology 
development in other organisms can aid in the identification of 
functional elements in the human genome in two ways:  the technologies 
may be applicable to the human genome, or although uniquely applicable 
to specific genomes because of the characteristics of the organism, 
provide biological insights into functional elements that could not be 
determined from experiments in the human.  The application of the 
proposed technology to organisms other than the one that is the focus of 
the application is not a requirement of this RFA.  However, applicants 
should address the issue of broader application of the technology, if 
appropriate.

An important feature of any newly developed technology will be the ease 
with which it can be exported into other laboratories, or in other ways 
made readily accessible to investigators.  The issue of access, or 
technology transfer, should be specifically discussed in the grant 
application.

The development of computational methods for the study of genomic 
function is encouraged under this solicitation. However, computational 
methods that incrementally improve on current technologies are not being 
sought. Any software developed under this RFA should be freely available 
to other biomedical researchers in the non-profit sector.  

As the technologies to be developed under this RFA are expected to be 
applied eventually to an entire genome, applications proposing to 
analyze a particular gene, gene product or non-coding functional element 
will not be considered to be responsive. 

To encourage the consideration of novel approaches, applicants 
responding to this RFA are not required to have preliminary data. 
However, the research project must be well designed, must be 
scientifically and technically sound, and should propose alternative 
solutions. In the absence of preliminary data, applicants are encouraged 
to present any other information that can be considered as evidence of 
feasibility.

As the work funded under this RFA progresses, the principal 
investigators will be encouraged to interact with the ENCODE pilot 
project consortium and its members.  If work supported under this RFA, 
such as a computational analysis, results in the generation of data 
pertaining to the complete set of target regions of the ENCODE project, 
the principal investigator may be invited to join the consortium (see  
http://www.genome.gov/10005107 for a description of the consortium).  
Among other requirements, this would involve sharing of the data with 
the members of the consortium, as participation involves concurrence 
with a specific data release policy (see RFA HG-03-003 for a detailed 
description of that policy).  Applicants to HG-04-001 may wish to 
address their approach to data release in their proposal.
 
MECHANISM OF SUPPORT
 
This RFA will use the NIH investigator-initiated Research Project Grant 
(R01) and the Exploratory/Development Research Grant (R21) award 
mechanisms.  As an applicant you will be solely responsible for 
planning, directing, and executing the proposed project.  The total 
requested project period for an application submitted in response to 
this RFA may not exceed 3 years for the R01 mechanism, and 2 years for 
the R21 mechanism.  The anticipated award date is September 30, 2004. 
This RFA is a one-time solicitation.  Applications that are not funded 
in the competition described in this RFA may be resubmitted as NEW 
investigator-initiated applications using the standard receipt dates for 
NEW applications described in the instructions to the PHS 398 
application (see 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-019.html).

The R21 mechanism (Exploratory/Developmental grant) is intended to 
encourage new exploratory/ developmental research projects by providing 
support for the early stages of their development.  Awards are made to 
demonstrate feasibility of a subsequent project and to obtain 
preliminary data testing innovative ideas.  Therefore, these grants are 
not renewable.  Continuation of projects developed under this program 
will be through the regular research project grant mechanism (for 
example, R01).  
 
This RFA 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 budget format.  Otherwise 
follow the instructions for non-modular budget research grant 
applications.  This program does not require cost sharing as defined in 
the current NIH Grants Policy Statement at 
http://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm.

FUNDS AVAILABLE 
 
The NHGRI intends to commit approximately $2 million in FY2004 to fund 
6 to 10 new and/or competitive continuation grant applications in 
response to this RFA. An applicant may request a project period of up 
to 3 years and a budget of up to $350,000 direct costs per year for an 
R01 application. For an R21 application, a project period of up to 2 
years and a budget for direct costs of up to $100,000 for up to two 
years may be requested.  Because the nature and scope of the proposed 
research will vary from application to application, it is anticipated 
that the size and duration of each award may vary.  Awards pursuant of 
this RFA are contingent upon the availability of funds and the receipt 
of a sufficient number of meritorious applications. 

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 institutions/organizations

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 inquiries concerning this RFA and welcome the opportunity 
to answer questions from potential applicants.  Inquiries may fall into 
three areas:  scientific/research, peer review, and financial or grants 
management issues:

o Direct your questions about scientific/research issues to:

Elise Feingold, PhD or Peter Good, PhD
Program Directors
Division of Extramural Research
NHGRI
Building 31, Room B2B07
31 Center Drive, MSC 2033
Bethesda, MD  20892-2033
Telephone:  (301) 496-7531
FAX:  (301) 480-2770
Email:  Elise_Feingold@nih.gov or Peter_Good@nih.gov

o Direct your questions about peer review issues to:

Rudy Pozzatti, PhD
Scientific Review Administrator
Review Branch
Division of Extramural Research
NHGRI
Building 31, Room B2B37
31 Center Drive, MSC 2032
Bethesda, MD  20892-2032
Telephone:  (301) 402-8739 
FAX:  (301) 435-1580
Email:  pozzattr@exchange.nih.gov

o Direct your questions about financial or grants management matters to:

Jean Cahill
Chief, Grants Administration Branch
Division of Extramural Research
NHGRI 
Building 31, Room B2B34 
31 Center Drive, MSC 2031
Bethesda, MD  20892-2031
Telephone:  (301) 301-435-7858
FAX: (301) 402-1951
Email:  cahillj@mail.nih.gov
 
LETTER OF INTENT
 
Prospective applicants are asked to submit a letter of intent that 
includes the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this RFA 

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 at the beginning 
of this document.  The letter of intent should be sent to:

Peter Good, PhD
Program Director
Division of Extramural Research
NHGRI
Building 31, Room B2B07
31 Center Drive, MSC 2033
Bethesda, MD  20892-2033
Telephone:  (301) 496-7531
FAX:  (301) 480-2770
Email:  Peter_Good@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001). Applications must 
have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) 
number as the Universal Identifier when applying for Federal grants or 
cooperative agreements. The DUNS number can be obtained by calling 
(866) 705-5711 or through the web site at 
http://www.dunandbradstreet.com/. The DUNS number should be entered on 
line 11 of the face page of the PHS 398 form. 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.
 
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications 
requesting up to $250,000 per year in direct costs must be submitted in 
a 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.

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 
5/2001) 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. The RFA 
label is also available at: 
http://grants.nih.gov/grants/funding/phs398/labels.pdf.
 
SENDING AN APPLICATION TO THE NIH: 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:

Rudy Pozzatti, PhD
Scientific Review Administrator
Review Branch
Division of Extramural Research
NHGRI
Building 31, Room B2B37
31 Center Drive, MSC 2033
Bethesda, MD  20892-2033
Telephone:  (301) 402-8739 
FAX:  (301) 435-1580
Email:  pozzattr@exchange.nih.gov
 
APPLICATION PROCESSING: Applications must be received on or before 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. 

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.
 
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.  However, when a previously unfunded application, 
originally submitted as an investigator-initiated application, is to be 
submitted in response to an RFA, it is to be prepared as a NEW 
application.  That is, the application for the RFA must not include an 
Introduction describing the changes and improvements made, and the text 
must not be marked to indicate the changes from the previous unfunded 
version of the application.  

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the NHGRI. 

Incomplete applications will not be reviewed.   

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 NHGRI in accordance with the review 
criteria stated below.  As part of the initial merit review, all 
applications will:

o 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 and assigned a priority score
o Receive a written critique
o Receive a second level review by the NHGRI National Advisory Council 
for Human Genome Research.
 
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 evaluate the 
application in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals. The 
scientific review group will address and consider each of the following 
criteria in assigning the application’s overall score, weighting them 
as appropriate for each application. 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment

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.

SIGNIFICANCE: Does the application address the problem outlined in this 
RFA? 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?  

APPROACH: Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of 
the project as outlined in this RFA?  Are potential problem areas 
acknowledged and alternative tactics considered?  Does the technical 
approach have the potential to be applied efficiently and cost-
effectively at large scale?  

INNOVATION: Does the project employ novel concepts, approaches, or 
methods for identifying and verifying sequence-based functional 
elements?  Does the project challenge existing paradigms or develop new 
methodologies or technologies rather than providing an incremental 
improvement over existing technologies? Does the project develop new 
methods or technologies to reduce costs or increase quality or 
throughput? 

INVESTIGATOR: Is the principal 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)?

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?  

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the 
following items will be considered in the determination of scientific 
merit and the priority score:

TECHNOLOGY DISSEMINATION:  Does the applicant provide a plan for making 
the technology available to other labs?  Will any software produced be 
freely available to biomedical researchers in the non-profit sector?

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of 
human subjects and protections from research risk relating to their 
participation in the proposed research will be assessed. (See criteria 
included in the section on Federal Citations, below).
 
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 in the 
sections on Federal Citations, below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals 
are to be used in the project, the five items described under Section f 
of the PHS 398 research grant application instructions (rev. 5/2001) 
will be assessed.  

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

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date: February 27, 2004
Application Receipt Date: March 26, 2004
Peer Review Date: June-July 2004
Council Review: September 2004
Earliest Anticipated Start Date:  September 30, 2004

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, including the likelihood that the proposed 
technology could be applied to the ENCODE project in a timely manner and 
the range of technologies that could be developed under this component 
of the ENCODE project. Preference will be given to applications that 
propose the development of completely novel technologies and/or the 
study of novel sequence elements. 

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. 
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 

DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required 
for all types of clinical trials, including physiologic, toxicity, and 
dose-finding studies (phase I); efficacy studies (phase II); efficacy, 
effectiveness and comparative trials (phase III).  The establishment of 
data and safety monitoring boards (DSMBs) is required for multi-site 
clinical trials involving interventions that entail potential risk to 
the participants.  NIH Policy for Data and Safety Monitoring, NIH Guide 
for Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html.  

SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, 
investigators submitting an NIH application seeking $500,000 or more in 
direct costs in any single year are expected to include a plan for data 
sharing or state why this is not possible. 
http://grants.nih.gov/grants/policy/data_sharing.  Investigators should 
seek guidance from their institutions, on issues related to 
institutional policies, local IRB rules, as well as local, state and 
Federal laws and regulations, including the Privacy Rule. Reviewers 
will consider the data-sharing plan but will not factor the plan into 
the determination of the scientific merit or the priority score.

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 "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://stemcells.nih.gov/index.asp 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, in the project description and elsewhere in the application as 
appropriate, 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 RFA is related to one or more of the priority areas. 
Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.healthypeople.gov/.

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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and Human Services (HHS)
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