INTELLECTUAL PROPERTY RIGHTS IN GENETICS AND GENOMICS

RELEASE DATE:  June 2, 2004
 
RFA Number:  RFA-HG-04-004 

EXPIRATION DATE:  November 19, 2004

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.nhgri.nih.gov )

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:  93.172
 
LETTER OF INTENT RECEIPT DATE:  October 21, 2004
APPLICATION RECEIPT DATE:  November 18, 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 Special Requirements 
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
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 encourage the study of the role of laws 
and policies regarding intellectual property rights in genetics and 
genomics research and development, and the effect of such laws and 
policies on progress in these fields and on commercialization, drug 
development, health care delivery, and the public health.  

RESEARCH OBJECTIVES
Since its inception, the Human Genome Project has attempted to follow a 
policy of free and open access to genetic and genomic data (e.g., NHGRI 
Policy Regarding Intellectual Property of Human Genomic Sequence (April 
9, 1996), http://www.genome.gov/10000926; NHGRI Policy on Human Genomic 
Sequence Data (Dec. 21, 2000), http://www.genome.gov/10000910).  NIH 
policy recognizes the appropriateness of intellectual property 
protections for discoveries that are associated with useful products, 
but promotes the free dissemination of research tools whenever 
possible, especially when the prospect of commercial gain is remote 
(Report of the National Institutes of Health (NIH) Working Group on 
Research Tools, http://www.nih.gov/news/researchtools/).

Over the past three decades, however, many patents have been granted on 
gene sequences and other types of basic information derived from 
genetic sequence.  For some, this has generated apprehension that gene 
patents are being granted too broadly or freely, especially for 
foundational tools.  The concern is that the too-liberal issuance of 
such patent rights, especially when coupled with exclusive licensing 
practices, will result in the imposition of reach-through restrictions 
or excessive fees, and inhibit investigators from conducting additional 
research with these tools.  This, it is feared, will ultimately be to 
the detriment of advances in medical research and to public health.  

In January 2001, partly in response to a letter from the NIH urging the 
implementation of stricter criteria for the issuance of biotechnology 
patents, the U.S. Patent and Trademark Office revised its guidelines to 
patent examiners regarding patents on DNA sequence and sequence-derived 
intellectual property, effectively “raising the bar” on utility 
standards in this area (U.S. Patent and Trademark Office, Utility 
Examination Guidelines, Fed. Reg. Vol. 66, No. 4 (January 5, 2001)).  
However, questions remain about whether this revision raised the “bar” 
high enough to serve the public interest.

An example of the potential problem is the recent acquisition and 
aggressive pursuit by Genetic Technologies Limited (GTG), an Australian 
company, of exceptionally broad global patent protection covering the 
use of information to derive risks of disease in all non-coding regions 
of the genome (see Nature, (2003) 423: 105).  While this is perhaps an 
extreme example (and the validity of GTG’s patents has not yet been 
tested in the courts), other controversial cases can also be cited 
(e.g., the Myriad Genetics BRCA1 patent, the University of Miami 
Canavan disease patent, the CCR5 HIV co-receptor gene patent).  Such 
cases are increasingly leading genetics and genomics researchers, 
business entities, health care providers, and consumers to question how 
the balance between providing intellectual property protection and 
fostering biomedical innovation can best be attained.  

Issues regarding the appropriate scope of protection for intellectual 
property rights in genetics and genomics research and development will 
only increase in complexity as progress in these fields continues.  For 
example, large-scale proteomics efforts (such as protein biomarker 
discovery projects, the NIGMS Protein Structure Initiative 
(http://www.nigms.nih.gov/psi/), and initiatives to characterize 
protein-protein interactions) will generate new types of potentially 
patentable information, and with this information, new intellectual 
property challenges.  Such challenges will also arise in several areas 
of research being emphasized under the new NIH Roadmap Initiative 
(http://nihroadmap.nih.gov/).  For example, in the “chemical genomics” 
area, questions will arise about whether patents should be filed on the 
compounds that will be discovered or whether to place such compounds in 
the public domain, and about how pricing should be determined should a 
compound discovered through this process end up as a drug.  In the 
bioinformatics and computational biology area, questions will arise 
about how best to promote the widespread distribution of new software 
to be developed (e.g., using an open source model of licensing or some 
other model).  
  
Anticipating the growing need to confront questions of this type, the 
NHGRI has identified addressing intellectual property issues as one of 
the “Grand Challenges” for the future of genomics. Specifically, the 
Institute’s document “A Vision for the Future of Genomics Research,” 
(Nature (2003) 422: 835-847, also available at: 
http://www.genome.gov/11006873), called for “the development of policy 
options in the area of intellectual property that will facilitate the 
widespread use of genetic and genomic information in both research and 
clinical settings.”  To be maximally informed and effective, however, 
the development of such policy options must be based on a solid and 
broad-based body of theoretic and empiric data.  While a number of 
studies already conducted or now underway provide a good preliminary 
foundation on which to build, there is a clear need for additional 
research and scholarship in this area.  

In 2004, the Board on Science Technology and Economic Policy (STEP 
Board) and the Science, Technology, and Law Program of the National 
Academies of Sciences convened a committee on Intellectual Property in 
Genomic and Protein Research and Innovation (the “NAS Committee”).  The 
NAS Committee’s charge is to review the patenting and licensing of 
human genetic material and proteins and their implications for 
biomedical research, therapeutic and diagnostic products, and medical 
practice.  The NAS Committee is expected to release its report in the 
Summer of 2005, but there will clearly be a need for other, more in 
depth, examinations and analyses of these issues, by investigators from 
a broad range of disciplines.

To assist in addressing this need, the NHGRI proposes a new initiative 
to encourage the study of the role of laws and policies regarding 
intellectual property rights in genetics and genomics research and 
development, and the effect of such laws and policies on progress in 
these fields and on commercialization, drug development, health care 
delivery, and public health.  The initiative is designed to support 
rigorous, carefully focused legal, statistical, economic, political 
science, historical, and other social scientific investigations, both 
theoretical and empirical.  

As used in this RFA, the term “genetics and genomics” includes genomics 
(broadly defined to include both nucleic acid and protein products of 
large-scale analyses of the human and other genomes and methods for 
identifying and analyzing them) and human molecular genetics. The term 
is not, however, meant to include all of biotechnology, although the 
line between genomics and biotechnology is frequently hard to define.  
For example, the term “genetics and genomics subject matter” includes 
the following:

(1)   Both individual elements of data and comprehensive databases or 
other resources regarding genes and gene fragments; gene 
regulatory sequences; ESTs; SNPs; haplotypes; proteins and 
protein structures; protein-protein interactions; cellular 
pathways; computational models of the cell; gene expression 
profiling (microarrays); small molecules; and mouse (or other 
animal) knockouts.

(2)   The relationships between diseases or traits and genes, SNPs, 
haplotypes, or proteins; the relationships among genotype, 
environment, and phenotype (e.g., in large databases); and the 
use of such information in diagnostics.  

(3)   Fundamental tools or methods for the production or analysis of 
data or databases of the types listed above, the bioinformatics 
software to probe the databases, and the algorithms that the 
software elaborates.  

The term “genetics and genomics subject matter” as used in this 
initiative does not, however, include such subject matter as biomedical 
devices, engineered tissues, stem cells, large-scale cell culture, 
whole organism cloning, or individual treatment applications.  
   
Some examples of appropriate topic areas, with examples of specific 
research questions for each area, are listed below.  Investigators are 
welcome to propose research in one or more of these topic areas, or in 
similar areas.  Investigators should not be constrained by the specific 
research questions included on this list.  The focus of the research, 
however, should remain on intellectual property rights to genetics and 
genomics-related subject matter, and should not be so broad as to 
encompass other major areas of biotechnology.

1.   TYPES OF INTELLECTUAL PROPERTY RIGHTS AND RELATED POLICY 
IMPLICATIONS.  What types of intellectual property rights to 
genetics and genomics-related subject matter are being, or should 
be, sought, obtained, or refused?  What types of entities are 
seeking, obtaining, or being refused, intellectual property 
rights in this field?  What are, or should be, the standards for 
novelty, non-obviousness, and utility in this field?  What is, or 
should be, the breadth of the claims in this field?  Do 
intellectual property rights to genetics and genomics-related 
subject matter benefit the public when there is no identifiable 
product?  What has been the effect of intellectual property 
rights in this field on research in the private sector?  What are 
the mechanisms, existing or proposed as well as legal or business 
custom, for protecting information contained in databases 
generally, and what are the policy implications of allowing or 
refusing protection for genomic and genetic databases, whether 
through intellectual property or sui generis protection?  What 
is, or should be, the role of patents, copyrights, trade secrets, 
and sui generis intellectual property rights for various data 
types?  How do the laws governing patents, copyrights, trade 
secrets, and sui generis intellectual property rights act as an 
incentive, a disincentive, or a neutral factor in determining the 
planning, content, and progress of genetics and genomics research 
and development programs?    

2.   OWNERSHIP AND ASSIGNMENT OF INTELLECTUAL PROPERTY RIGHTS AND 
RELATED POLICY IMPLICATIONS.  What are, or should be, the 
mechanisms for exploiting intellectual property rights to 
genetics and genomics-related subject matter?  How frequently 
are, or should, such rights be assigned (e.g., sold, or licensed 
exclusively or non-exclusively to third parties)?  What are, or 
should be, the usual mechanisms of such assignments?  Who are, or 
should be, the usual parties to such assignments?  To what extent 
would genetics and genomics subject matter be treated differently 
if the corresponding intellectual property rights were not 
assigned?  What are, or should be, the practices of biotechnology 
and pharmaceutical companies regarding the sharing of 
commercially valuable data?  What are, or should be, the 
practices of universities regarding the sharing of commercially 
valuable data (government funded and non-government funded)? How 
have universities interpreted the Bayh-Dole Act, and what has 
been the impact of Bayh-Dole on genetics and genomics research?  
Are, or should, assignments in this field under Bayh-Dole 
typically be pursuant to employment contract or policies, or the 
result of arms-length negotiations?  What is the practical impact 
of restrictions or limitations on the ownership of intellectual 
property rights imposed by government funding agencies (such as 
“Declaration of Exceptional Circumstances”)?  How will the 
mechanisms of assignment of intellectual property rights, and 
restrictions on such assignment, likely affect genetics and 
genomics subject matter in the future?  

3.   LICENSING PRACTICES AND RELATED POLICY IMPLICATIONS.  What are 
the categories of genetics and genomics subject matter for which 
intellectual property rights are licensed or may be licensed in 
the future?  What are the relative numbers of intellectual 
property rights involving genetics and genomics subject matter 
that are subject to licensing arrangements?  What are the terms 
of such licenses (including exclusivity versus non-exclusivity, 
royalty rates, fields of use restrictions, etc.), and who are the 
parties to such agreements? What are the structures for such 
licensing arrangements (e.g., cross-licensing, block or blanket 
licenses, compulsory licenses, etc.)? What are the structures and 
operation of patent pools?  How are end user license agreements 
(EULAs) attached to the sale of research tools being used, and 
how broad are their “reach-through” provisions?  To what extent 
might the genetics and genomics subject matter be differently 
treated if the corresponding intellectual property rights were 
not licensed or were not disclosed and treated as a trade secret? 
How are the planning, content, and progress of genetics and 
genomics research and development programs affected by refusals 
to license or offers to license on unacceptable terms?  How does 
the way in which genetics and genomics subject matter is licensed 
affect the prospects for commercialization?  What is the effect 
of being required to obtain multiple licenses to conduct some 
types of research or clinical tests?  Does an open source model 
of licensing genomic software tools increase the usefulness of 
the tools and improve their acceptance in the research community?  
Are intellectual property rights involving genetics and genomics 
subject matter to which licensing arrangements pertain more or 
less likely to be involved in infringement litigation?  What 
would be the policy implications of limiting exclusive licenses 
in the field of genetics and genomics to therapeutics and 
vaccines (i.e., excluding diagnostics)?  

4.   ENFORCEMENT AND RELATED POLICY IMPLICATIONS.  What are the 
categories of genetics and genomics subject matter for which the 
intellectual property rights have been involved in administrative 
or judicial action?  What legal issues have been raised in such 
lawsuits, and who have been the parties to such lawsuits? What 
has been the resolution of such cases (e.g., dismissal, 
settlement, administrative action, trial verdict or judgment, 
appellate judgment, remedies and relief awarded, etc.)?  What are 
the relative numbers of intellectual property rights involving 
genetics and genomics subject matter that have been filed in 
various forums?  What are the numbers of intellectual property 
rights involving genetics and genomics subject matter that have 
been challenged but that do not actually reach litigation?  How 
frequently are cease and desist letters issued, and how do 
universities or companies respond to them?  How have the 
planning, content, and progress of genetics and genomics research 
and development programs been affected by threat, actual or 
perceived, of infringement litigation?  What strategies are 
employed to allocate the risk of, to prepare for, or to defend 
against, infringement litigation?  What impact has Madey v. Duke, 
64 USPQ2d 1737, 307 F.3d 1351 (Fed. Cir. 2002), cert. Denied, 156 
L.3d. 656 (2003), interpreting the experimental use (research) 
exemption to patent infringement in the context, had in the 
context of academic research?  What would be the policy 
implications of formalizing a research exemption in the patent 
law?  

5.   INTERNATIONAL ISSUES AND RELATED POLICY IMPLICATIONS.  What are 
the categories of genetics and genomics subject matter for which 
intellectual property rights have been or may be sought both in 
the United States and abroad?  How does the operation of 
intellectual property rights involving genetics and genomics 
subject matter differ in the United States from other countries 
(e.g., what are the differences in the criteria for patentability 
applied in the U.S. and by other major patent offices, such as in 
Europe and Japan)?  What mechanisms of procurement, ownership, 
licensing, and enforcement (or restrictions on these activities) 
exist only in other countries, and what are the advantages and 
disadvantages of such?  How are international treaty obligations 
likely to affect the laws and customs in the United States 
governing intellectual property rights to genetics and genomics 
related subject matter?  How do territorial and jurisdictional 
limitations on intellectual property rights affect the planning, 
content, and progress of genetics and genomics research and 
development programs?

6.   OVERARCHING ISSUES.  Has the planning, content, and progress of 
genetics and genomics research and development programs been 
enhanced, or conversely chilled, by intellectual property rights?  
Have intellectual property rights positively or negatively 
affected the quantity and quality of the publication of 
scientific advances involving genetics and genomics, or the 
timing of data release and publication?  What are the legal and 
practical implications for unfettered research activities (e.g., 
the significance of a bona fide research use exemption to patent 
infringement, a fair use defense to copyright infringement, a 
reverse engineering exception to trade secret misappropriation, 
etc.)?  Are existing mechanisms of protection of intellectual 
property rights to genetics and genomics related subject matter 
adequate or inadequate to the task of striking the proper balance 
between intellectual property rights and open access to devices, 
methods, products and data involved in genetics and genomics 
research and development?  How have intellectual property rights 
to genetics and genomics-related subject matter positively or 
negatively affected public access to health care (e.g., 
accelerated or delayed the commercial availability of diagnostics 
or treatments, increased or decreased their cost, etc.)?
 
A major goal of this initiative is to help expand the research base 
necessary to inform the future development of policy options regarding 
intellectual property in the contexts of genetics and genomics research 
and development. In this sense, the proposed development of policy 
options by applicants to this initiative is not required, but is 
encouraged when feasible.  

Investigators may propose to examine existing databases related to 
biotechnology and intellectual property rights or to gather new 
empirical data.  However, proposals that are primarily dependent on 
data mining efforts should identify and incorporate innovative 
analytical methodologies to interpret the data.  

Although applications for proposals to examine issues regarding 
intellectual property, genetics, and genomics in the specific context 
of differing cultures and belief systems are beyond the scope of this 
initiative, the NHGRI encourages research on these topics as part of 
its regular research program in the area of Ethical, Legal, and Social 
Implications (ELSI).  Applicants interested in conducting research on 
such topics are strongly encouraged to consider submitting R01 or R03 
applications under one of the appropriate standing NHGRI Program 
Announcement for the ELSI Program.  See 
http://grants.nih.gov/grants/guide/pa-files/PA-04-050.html 
(R01 Program Announcement); 
http://grants.nih.gov/grants/guide/pa-files/PA-04-051.html 
(R03 Program Announcement).  

MECHANISMS OF SUPPORT
 
This RFA will use NIH R01 and R03 award mechanisms.  Applicants are 
solely responsible for planning, directing, and executing the proposed 
project.  This RFA is a one-time solicitation.  Future unsolicited, 
competing-continuation applications based on this project will compete 
with all investigator-initiated applications and will be reviewed 
according to the customary peer review procedures. The earliest 
anticipated award date is July 15, 2005.  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.  

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 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.  

FUNDS AVAILABLE 
 
NHGRI intends to commit approximately $1 million in FY 2005 to fund 
about 6-8 new or competitive continuation grants in response to this 
RFA. An applicant for an R01 award may request a project period of up 
to three years and a budget for direct costs of up to $250,000 per 
year; an applicant for an R03 award may request a project period of up 
to two years and a budget for direct costs of up to $50,000 per year. 
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 will also vary. Although the financial plans of 
NHGRI 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. 
 
ELIGIBLE INSTITUTIONS
 
You may submit an application 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
o Faith-based or community-based 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 his/her 
institution to develop an application for support.  Investigators who 
have not previously applied for or received NIH funding and who are 
unfamiliar with the NIH grants process are welcome to apply.  Such 
investigators are particularly encouraged to contact the individuals 
designated in this announcement (see WHERE TO SEND INQUIRIES) as the 
contact points for questions about scientific/research issues, peer 
review issues, and financial or grants management matters with 
questions about the NIH grants application process.  

Investigators from a variety of disciplines, including those in law, 
economics, statistics, health policy, political science, history, and 
other social science disciplines, are particularly encouraged to apply 
under this initiative.  Investigators are encouraged (but are not 
required) to form multidisciplinary teams to frame the research 
questions more effectively and to develop innovative ways of 
investigating them.  Investigators are encouraged to incorporate into 
their project teams individuals with expertise in genetics, genomics, 
or other relevant clinical or basic sciences where appropriate.  
Collaborations between academic investigators and individuals who are 
actively engaged in the practice of intellectual property law are also 
encouraged.     
 
Investigators from institutions in countries outside the U.S. are 
eligible to apply under this initiative.  However, applications from 
investigators in institutions in countries outside the U.S. that 
propose research that will primarily involve analyses of intellectual 
property rights outside the U.S. must specifically address how the 
proposed research is relevant to the development of future policy 
options in the U.S. 
 
Individuals from underrepresented racial and ethnic groups as well as 
individuals with disabilities are always encouraged to apply for NIH 
programs.   

SPECIAL REQUIREMENTS

Annual meetings of investigators will be held.  This will facilitate 
the sharing of information, encourage collaboration, reduce possible 
duplication of effort, and promote more rapid dissemination of research 
findings.  The initial meeting will take place shortly after the awards 
are made.  Funds for travel to these meetings for up to two 
investigators per year should be included in the requested budget.   

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 Applicants are strongly encouraged to consult with the Program 
Director early in the process of preparing an application.  Direct your 
questions about scientific and research issues to:

Jean E. McEwen, J.D., Ph.D.
National Human Genome Research Institute
Division of Extramural Research
Ethical, Legal, and Social Implications Program
5635 Fishers Lane, Suite 4076, MSC 9305
Bethesda, MD  20892-9305
Telephone:  
   Until June 28, 2004:  (301) 402-4997
   After June 28, 2004:  (301) 496-7531
FAX:  (301) 402-1950
Email: jm522n@nih.gov

o Direct your questions about peer review issues to:

Rudy O. Pozzatti, Ph.D.
National Human Genome Research Institute
Scientific Review Branch
5635 Fishers Lane, Suite 4076, MSC 9306
Bethesda, MD  20892-9306
Telephone:  (301) 402-0838
FAX:  (301) 435-1580
Email: rp7s@nih.gov

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

Cheryl Chick
National Human Genome Research Institute
Grants Administration Branch
5635 Fishers Lane, Suite 4076, MSC 9306
Bethesda, MD  20892-9306
Telephone:  (301) 435-7858 
FAX:  (301) 402-1951
Email: ChickC@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 NHGRI 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:

Jean E. McEwen, J.D., Ph.D.
National Human Genome Research Institute
Division of Extramural Research
Ethical, Legal, and Social Implications Program
5635 Fishers Lane, Suite 4076, MSC 9305
Bethesda, MD  20892-9305
Telephone:  
   Until June 28, 2004:  (301) 402-4997
   After June 28, 2004:  (301) 496-7531
FAX:  (301) 402-1950
Email: jm522n@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 document 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/label-bk.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 O. Pozzatti, Ph.D.
National Human Genome Research Institute
Scientific Review Branch
5635 Fishers Lane, Suite 4076, MSC 9306
Bethesda, MD  20892-9306
Telephone:  (301) 402-0838
FAX:  (301) 435-1580
Email: rp7s@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 NHGRI.  Incomplete or non-responsive 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 National Human Genome Research 
Institute Advisory Council. 
 
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.  The scientific review group will address and 
consider each of these 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 this study address an important problem? Are the 
aims of the application responsive to the goals and objectives of the 
RFA?  If the aims of the application are achieved, how will knowledge 
be advanced? What will be the effect of these studies on the concepts 
or methods that drive this field or on the development of policy?

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?  It is understood that research 
methodologies for investigators in law and in certain other disciplines 
often differ from those used in traditional social science or basic 
science disciplines.  However, an adequate description at least of the 
conceptual framework and of the analyses is still required by all 
investigators, regardless of field.  

INNOVATION: Does the project employ novel concepts, approaches or 
methods? Are the aims original and innovative? Does the project 
challenge existing paradigms or develop new approaches to analyzing 
issues?

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)?

ENVIRONMENT: Does the environment in which the work will be done 
contribute to the probability of success? Does the proposed research 
take advantage of unique features of the 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:

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).

ADDITIONAL CONSIDERATIONS 

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:  October 21, 2004  
Application Receipt Date:  November 18, 2004  
Peer Review Date:  February/March, 2005  
Council Review:  May 2005
Earliest Anticipated Start Date:  July 15, 2005

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 and program balance.

The overall balance of the portfolio will be considered when final 
funding decisions under this initiative are made. 
 
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

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. 

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.

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 RFA 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).  

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.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.

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