RELEASE DATE:  August 13, 2003
RFA Number:  RFA-HG-03-005 

Update: The following update relating to this announcement has been issued: 

January 8, 2009 - This RFA has been reissued as (RFA-HG-09-003).
(Reissued as RFA-HG-06-025).
(See Clarification NOT-HG-04-001).
National Human Genome Research Institute (NHGRI)




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


The Ethical, Legal, and Social Implications (ELSI) Research Program of 
the National Human Genome Research Institute (NHGRI) invites center 
grant applications (P50 and P20) for the development of Centers of 
Excellence in ELSI Research (CEERs).  These CEERs will bring 
investigators from multiple disciplines together to work in innovative 
ways to address important new, or particularly persistent, ethical, 
legal, and social issues related to advances in genetics and genomics. 

This solicitation is intended to augment NHGRI's ELSI regular research 
grants program by supporting research activities that cannot be 
effectively supported by R01 and other research grant mechanisms 
currently available.  NHGRI remains committed to supporting single 
investigator-initiated projects that use the R01, R03, and other 
appropriate grant mechanisms, and the research consortium strategy for 
encouraging interaction among investigators working in an area.  The 
current list of ELSI funding opportunities can be found online at:


Background and Significance

In April 2003, the last of the original goals of the Human Genome 
Project, the sequencing of the human genome, was finished, marking the 
culmination of this historic biomedical research enterprise.  The 
attention of the biomedical research community is now turning to the 
interpretation of this fundamental source of knowledge about human 
biology and to the development of approaches for applying genomics to 
improving human health and preventing disease.  With this changing 
focus, new ELSI issues will inevitably arise, with regard to both 
accomplishing the necessary research and applying the new knowledge.  
Thus, a vigorous program of ELSI research, the results of which will 
inform policy development deliberations, will continue to be an 
essential component of genomics research.  

To date, the NHGRI ELSI Research Program has funded a large number of 
research grants from investigators in a wide range of disciplines.  
Many of these projects have used interdisciplinary approaches to 
investigate important ELSI questions. While considerable progress has 
been made on ELSI issues, much remains to be done.  In addition, as the 
pace of genomic and genetic research increases, the development of 
research teams that have the expertise and flexibility to respond 
rapidly to the large number of emerging and evolving ELSI issues is 
critical.  All of these factors contribute to a need for new and more 
innovative approaches, including new organizational structures and 
funding mechanisms, to carry out ELSI research.  The creation of 
research centers with the resources and expertise to design and 
implement multi-faceted and multi-disciplinary investigations of 
particularly complex, persistent or rapidly emerging ELSI issues will 
be an important addition to ongoing genetic, genomic and ELSI research 

Scope of Research

The CEER program is designed to support the development of a research 
group that will identify and investigate ELSI research questions that 
can best be approached through intensive and extended collaboration 
among investigators from multiple disciplines, using diverse 
methodologies.  The investigators in a CEER will be encouraged to 
consider new ways to explore these questions, design innovative and 
efficient research projects, propose and disseminate health or social 
policy options based on Center research and, when feasible, facilitate 
policy development pertinent to a specific issue.  Center applicants 
are particularly encouraged to identify cutting edge research topics 
and approaches that have the possibility of leading to high payoff 
solutions to important ELSI problems.  

A CEER must identify a theme around which it will be organized.  The 
research agenda should be focused on a single issue or set of related 
issues. CEER themes could be related to one or more of the Grand 
Challenges identified in the NHGRI vision document, "A Vision for the 
Future of Genomics Research" (Nature (2003) 422: 835-847), also 
available at:  In addition, applicants 
can suggest other significant ELSI challenges that extend beyond those 
identified in the document above. Following are examples of possible 
CEER research topics.  They are only examples.

o   Genetic Privacy and Discrimination in Medical and Non-medical 
settings. (Grand Challenge III-1). Although a substantial amount of 
research and policy development has been done on the potential for 
insurance or employment discrimination based on genetic information, 
this topic remains one of the public's most persistent concerns. A 
Center focused on this issue could develop a multi-disciplinary team 
to:  survey existing research data and relevant policies; examine in 
greater depth the ethical, social, cultural and psychological factors 
underlying the persistence of these concerns; analyze the legal, 
political and economic issues affecting the development and 
implementation of relevant state and Federal legislation; examine the 
impact of this legislation on the attitudes, behavior and decision 
making of individuals and insurance companies or employers; and, based 
on these investigations, develop recommendations for the modification 
of existing policies or the development of new, more effective 

o   Ethical, Legal and Social Factors that Influence the Translation of 
Genetic Information to Improved Human Health (Grand Challenges II-5, 
II-6 and III-1).  Examples of projects in this area would include 
analysis of the issues surrounding access to and use of genetic 
information and technologies to improve human health.  A CEER focused 
on this theme could bring its multi-disciplinary research team together 
to identify the most likely scenarios for the diffusion of genetic 
technologies into health care, including estimation of a timeline; 
conduct research to examine factors that will influence utilization, 
such as costs, access, and barriers to access; and develop guidance for 
the fair use of new genetic technologies in the health care system.  

o   Issues Surrounding the Conduct of Genetic Research (Grand Challenge 
III-1). Much effort has gone into developing guidance for the ethical 
conduct of genetic research, including the use of stored tissue 
specimens, community consultation when conducting genetic research with 
identifiable populations, and obtaining the consent of family members 
whose information may be obtained (or even unintentionally discovered) 
through the course of research.  Studies are needed to examine the 
impact of these existing guidelines and practices.  Do they adequately 
protect research participants?  Do they create unnecessary barriers to 
the conduct of ethically and scientifically sound research?  In 
addition, new challenging ethical issues in genomic and genetics 
research continue to arise, for which little guidance exists.  The 
increasing availability and accessibility of large amounts of genetic 
information in public databases creates new concerns about protecting 
the privacy of individual research participants while at the same time 
ensuring access to the data for research purposes.  The availability of 
this information also raises issues such as how best to ensure that 
this data is not used to draw inaccurate or unwarranted conclusions 
about individuals or populations.  In addition, the continued 
development and use of multiplex genetic testing platforms raises 
questions about the appropriate handling of findings that are difficult 
to interpret or incidental findings that may have unanticipated 
implications for research participants.  A CEER focused on these themes 
could utilize the multi-disciplinary resources of the Center to 
identify where the most pressing ethical issues will come from in the 
future; explore how best to address these issues; conduct primary data 
collection and analysis or secondary analysis of existing data, as 
needed; and develop recommendations and a multi-faceted plan for 
dissemination which may result in the development of new research 
ethics guidance.

o   The Impact of Genomics on Concepts of Race, Ethnicity, Kinship and 
Individual and Group Identity (Grand Challenge III-2). A Center focused 
on this topic could explore how different individuals and cultures 
conceive of race, ethnicity, kinship, group identity and self-identity; 
how those perceptions may influence the direction and framing of 
genetic and genomic research questions; how the findings are 
interpreted and presented to the public; and how the public understands 
these concepts.  The CEER team could then develop guidance for 
researchers, media, educators, or policy makers on how to responsibly 
and appropriately interpret and use these concepts and the data 
generated from this type of research.

Although aspects of each of these issues could be addressed through 
regular (R01) or small (R03) research grants, the CEER program will 
allow researchers to propose truly interdisciplinary, innovative and 
comprehensive approaches to exploring and addressing these issues.  To 
further clarify the unique nature of the CEER program, the following 
list of attributes of a successful CEER application is provided.

A successful CEER will: 

o   promote intensive and sustainable interactions among basic genomic 
and genetic scientists, clinical and social scientists, and researchers 
from law, bioethics and the humanities;  
o   be highly innovative and develop new concepts, methods, analyses, 
or ways to consider ELSI issues that will substantially advance the 
state of the art in ELSI;
o   propose a very substantial advance to addressing a critical issue 
in ELSI research. (Achieving a substantial advance can entail 
addressing potentially controversial issues or identifying and 
exploring issues surrounding emerging technologies that are not yet in 
common use.  It also can involve the use of new or unproven approaches 
or methodologies.  These high risk issues and methodologies should be 
balanced by the potential for very high payoff and will require a 
detailed plan and a very effective management strategy.);
o   encompass, as appropriate, the full spectrum of ELSI research from 
'basic' analytical investigations that develop conceptual tools and 
shared vocabularies to data generating qualitative and quantitative 
studies to more 'applied', 'translational' approaches that use these 
conceptual tools and data to explore and define appropriate public-
policy options or research or health care guidelines (These policy 
options and guidelines must incorporate diverse points of view, 
including, as appropriate, communities that may be particularly 
vulnerable or disproportionately affected by the issues being 
o   propose research that cannot be reasonably addressed by a standard 
R01 Research Grant (As multidisciplinary collaborations on the core 
research continue, additional funding may be sought through the ELSI 
regular research and small research grant programs to support other 
related research.); 
o   add value beyond activities in genomics or in ELSI research that 
might already be ongoing at the applying institution;
o   include a strategy for disseminating the results of the Center's 
o   increase the pool of ELSI researchers, by offering innovative, 
substantive training opportunities across appropriate disciplines. It 
will integrate the training of new investigators and broaden the 
training of established investigators; and 
o   help ameliorate the ELSI community's shortage of investigators from 
underrepresented minority communities (African Americans, Alaskan 
Natives, Hispanic Americans, Native Americans, Pacific Islanders) by 
developing effective opportunities to recruit and encourage members of 
these communities to develop as independent ELSI investigators.

A CEER will NOT:

o   simply continue research already being pursued by the team, or by 
o   serve as the obvious next step in a project or field, which could 
be accomplished by assembling state-of-the-art components and 
innovating at the level of a typical R01;
o   be a program project; or
o   provide infrastructure for an existing program or department.  
This RFA will use the Specialized Center (P50) and Exploratory (P20) 
grant mechanisms.  Responsibility for planning, direction, and 
execution of the proposed project will be solely that of the applicant.  
This RFA is a one-time solicitation with a receipt date of November 24, 
2003.  However, NHGRI plans to release this announcement as a Program 
Announcement in 2004.  The anticipated award date for this RFA is July 

A high priority under this program is the establishment of new academic 
Centers in which state-of-the-art ELSI research can be conducted. At 
some institutions, the nucleus of a well-functioning collaborative 
research group that could conduct the research described in this RFA 
may already exist, and such groups will be able to submit suitable P50 
applications for this program directly. However, some groups of 
investigators may require an opportunity to collect preliminary data, 
enhance their collaborative network by strengthening and establishing 
new multi-investigator or interdisciplinary relationships, demonstrate 
effective collaborations, explore organizational concepts, develop 
courses or curricula, or refine and fully develop the vision of the 
proposed P50 CEER project. The Exploratory Grant (P20) mechanism    
should be used when the applicant wishes to request a period of 
planning and preliminary investigation prior to preparing a P50 Center 

P50 Specialized Center Grants

A P50 Center grant application may request up to five years of support. 
The length of award will be determined through the peer review and 
Council advisory processes. Genomics and genetics research is 
constantly evolving, and it is anticipated that most Center projects 
focusing on related ELSI issues are likely to have a limited lifetime 
during which support as a CEER will be appropriate, either because the 
project goals will have been accomplished or the Center will have 
developed to the point that support from another source will be more 
appropriate. Therefore, except in exceptional circumstances, the total 
length of support for any P50 Center under this program will not exceed 
ten years (the initial grant period of up to five years, plus one 
renewal for up to an additional five years). 

Each CEER will have annual administrative site (or reverse site) 
visits.  After the site visit of the third year, a decision will be 
made about whether a fifth year of funding will be provided to the 
Center.  Further, at that review, the Principal Investigator (P.I.) 
will receive advice about the NHGRI's interest in accepting a competing 
renewal application to extend the initial award. The requested budget 
for a CEER may be up to $750,000 in direct costs for the first year for 
continuing operations (e.g., personnel, standard office equipment, 
supplies, travel and other expenses). Future year budgets may exceed 
$750,000 for inflationary adjustments. Under this cap, it is 
anticipated that the size of the awards will vary because the nature 
and scope of research programs will vary. To accommodate collaborations 
that extend beyond single institutions, Facilities & Administrative 
(F&A) charges on the subcontracts, which are formally direct costs to 
the parent institution, will be excluded in considering the $750,000 
operating costs limit.

P20 Exploratory Grants

The planning grant application must explicitly demonstrate how the 
planning activities will lead to the P50 application, and describe in 
substantial detail a vision of the research to be conducted under the 
subsequent P50 grant. The planning grant budget may request funds for 
partial salary of key investigators, travel, and some supplies and 
equipment. Planning grants will be awarded for up to three years and up 
to $150,000 direct cost per year. A planning grant is not required as a 
precursor to a P50 Center application. Funding of a planning grant does 
not obligate NHGRI to fund a subsequent P50 Center grant.

NHGRI intends to commit approximately $3,000,000 (total costs) in FY 
2004 to fund 2-3 Specialized Centers (P50s) and 2-3 Exploratory Centers 
(P20s) in response to this RFA. An applicant may request a project 
period of up to 5 years for a P50 and up to 3 years for a P20 and a 
budget for direct costs of up to $750,000 per year (excluding F&A costs 
on subcontracts) for a P50 and up to $150,000 per year for a P20.  
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 
the 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.


You may submit (an) application(s) if your institution has any of the 
following characteristics:
o 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
o Faith-based or community-based organizations

Foreign institutions are not eligible to apply. However, subcontracts 
to foreign institutions will be considered.

Investigators from majority institutions are encouraged to consider 
partnering with minority-serving institutions.   

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.   

Consortium participation:  Annual meetings of investigators from funded 
Centers will be held. This will facilitate sharing of information about 
current and planned activities as well as communication of research 
findings and policy deliberations (and about experience in organizing 
and operating a CEER). Such meetings will encourage collaboration among 
Centers, reduce duplication of effort, and promote more rapid 
dissemination of knowledge and information.  The initial meeting will 
take place shortly after the Center grants are funded. Funds for travel 
to these meetings for up to four investigators (the PI and three 
others) per year should be included in the requested budget. 

Multidisciplinary and diverse research teams:  The CEER program is 
intended to facilitate the formation of multidisciplinary teams of 
investigators who will develop new ways to frame and investigate ELSI 
research questions.  These research teams may include basic genomic and 
genetic scientists, clinical and social scientists, and researchers 
from law, bioethics and the humanities. However, it is essential that 
the theme be well anchored in genomic and genetic sciences.  NHGRI 
particularly encourages the involvement of minority serving 
institutions and investigators from minority populations and those with 

Management and organization: A CEER will include a well-integrated 
project plan.  The application should describe the specific 
organizational structure that will be used to support the research, and 
the synergism that will result because of this arrangement.  A well 
thought out and carefully described organization is required.  The 
application should explain how different components of the CEER will 
interact and why they are essential to accomplishing the overall goals 
of the research.  How the combined resources create capabilities that 
are more than the sum of the parts should be described.  The PI will be 
responsible for ensuring that the scientific goals are met and for 
developing and managing a decision-making structure and process that 
will allow resources to be allocated to meet the Center's goals.  
Therefore, the PI will be required to commit at least 30% effort to the 
leadership and implementation of the Center.  A timeline for the 
project should be included in the application that shows how the                
Center's goals can be met within the timeframe of the CEER grant.  This 
timeline will be used to help assess progress toward the Center's 

Training:  In addition to a strong research component, a Center is 
required to have a highly effective training component that will 
leverage the strengths of the multidisciplinary nature of the Center 
and its investigators to train the next generation of ELSI scholars, 
genome/genetics researchers, clinical and social scientists, and 
researchers in law, bioethics and the humanities to be able to develop 
independent research programs that address important ELSI problems.  
The training component of the Center must include a specific plan for 
engaging the talents of individuals from underrepresented minority 
groups as outlined in the NHGRI Action Plan 
(  Specific funds may be requested for 
training activities to include up to two post-doctoral trainees per 
year.  The NHGRI has other program announcements that support student 
training.  Doctoral dissertation research for students from under-
representative minority populations is supported through this program 
Further, it is expected after one year of support on this training 
grant, the post-doctoral fellow will have applied for a National 
Research Service Award (NRSA-F32).  For more information 
regarding this program announcement, see: For other 
ELSI funding opportunities, visit:
While exploratory grants are not required to have a training program, 
the types of training activities, particularly for training of 
investigators from under-represented minority populations that are 
appropriate for the subsequent P50 Center should be explored during the 
course of the P20 funding.

Site visits:  Annual administrative site visits will be scheduled to 
assess progress being made in the Centers.  Most will likely be held at 
the funded institution.  Occasionally it may be necessary to hold 
reverse site visits, in which investigators travel to Bethesda to 
report on progress.


Prior to submitting an application, potential applicants are strongly 
encouraged to discuss their project with NHGRI program staff. Inquiries 
may fall into three areas:  programmatic/scientific/research issues; 
peer review issues; and financial or grants management issues:

o Programmatic/scientific/research issues should be directed to:

Elizabeth J. Thomson
Program Director, Ethical, Legal, and Social Implications Research
National Human Genome Research Institute
Building 31, Room B2B07
Bethesda, MD  20892-2033
Telephone:  (301) 402-4997
FAX:  (301) 402-1950

o Peer review issues should be directed to:

Rudy Pozzatti
Scientific Review Branch
National Human Genome Research Institute, NIH
Building 31, Room B2B37 
31 Center Drive
Bethesda, MD 20892-2032 
TEL: (301) 402-0838 
FAX: (301) 435-1580 

o Financial or grants management matters should be directed to:

Jean Cahill
Chief, Grants Management Branch
National Human Genome Research Institute, NIH
Building 31, Room B2B34 
31 Center Drive
Bethesda, MD 20892-2032 
TEL: (301) 402-0733 
FAX: (301) 402-1951 
Prospective applicants are asked to submit a letter of intent by 
October 27, 2003 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 should be sent to:

Elizabeth J. Thomson
Program Director, Ethical, Legal, and Social Implications Research
National Human Genome Research Institute
Building 31, Room B2B07
Bethesda, MD  20892-2033
Telephone:  (301) 402-4997
FAX:  (301) 402-1950


Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001).  The PHS 398 is 
available at in 
an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 710-0267, Email:
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:
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, 
including all appendices, must be sent to: 

Scientific Review Branch
National Human Genome Research Institute, NIH
Building 31, Room B2B37 
31 Center Drive
Bethesda, MD 20892-2032 
TEL: (301) 402-0838 
FAX: (301) 435-1580 
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.  While the investigator may 
still benefit from the previous review, the RFA application is not to 
state explicitly how.

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

Incomplete and/or non-responsive applications will be returned to the 
applicant without further consideration.

Applications that are complete and responsive to the RFA will be 
evaluated for scientific and technical merit by an appropriate peer 
review group convened by the NHGRI in accordance with the review 
criteria stated below.  As part of the initial merit review, all 
applications will:

o Receive a written critique
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 second level review by the National Advisory Council for 
Human Genome Research.

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  
To ensure that applications for this CEERs program are evaluated 
appropriately, the standard NIH review criteria have been adapted to be 
more appropriate for applications of the scope described in this PA. 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 review group will address and consider each of these 
criteria in assigning the application's overall score, weighting them 
as appropriate for each application.  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.  

SIGNIFICANCE: Does this study address an important emerging or 
particularly persistent ELSI problem related to genomic and genetic 
science? If the aims of the application are achieved, will our 
understanding or ability to address these issues be advanced? Will 
these studies have an effect on the field of ELSI research?  Will they 
be relevant and useful to the larger scientific and public policy 

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 methodologies or 

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 approaches?  For proposed multi-component centers, 
is there a demonstrated scientific gain from the interrelatedness and 
synergy among the components? If any individual component were removed, 
would the ability of the CEER to accomplish its overall aims be 

MANAGEMENT: Is the management plan, including the management structure, 
appropriate and adequate to support the CEER? Is there an effective 
plan for use of fiscal resources, shared facilities and human resources 
to attain the research aims and overall CEER goals?  Is there an 
adequate plan for the organization and coordination of the CEER 
personnel?  Is there a high quality plan for making critical decisions 
or choices about the overall research direction for the CEER? Where 
appropriate, are the approaches used or under development to implement 
the research plan cost effective?

PRINCIPAL INVESTIGATOR: Does the PI have the ability, expertise and 
experience to lead, coordinate, and manage all of the activities of the 
CEER?  Does the PI have sufficient leadership qualities and experience 
to develop and implement the CEER plans for the entire project?  

INVESTIGATORS: Are the additional investigators identified in the 
application appropriately trained, from multiple disciplines, and well 
suited to carry out this work?  To what degree will the individual and 
combined expertise of the key personnel contribute to the 
accomplishment of the overall goals of the proposed research?  Is the 
level of effort for the key personnel adequate? 

MULTIDISCIPLINARITY OF RESEARCH TEAM: Is the training, background, and 
expertise of the multi-disciplinary research team appropriate to 
achieve the specific aims and overall goals of the proposed Center? 
Does the multi-disciplinary team bring novel capabilities to the 
research program?  Is there evidence of effective collaboration among 
key personnel?  Is there evidence that the team has sufficient 
expertise in both ELSI and genomic/genetic science? Are investigators 
from minority populations and/or those with disabilities included? 

TRAINING: What is the quality of the proposed training plan and its 
likely effectiveness in producing well-trained researchers who can 
develop new approaches to ELSI questions and research?  Are there plans 
to develop new training opportunities and to integrate them with other 
on-going or planned training?  Plans to achieve effective training of 
underrepresented minorities receive particular attention.

ENVIRONMENT: Does the scientific environment in which the work will be 
done contribute to the probability of success? Does the proposed 
research plan take advantage of unique features of the scholarly 
environment? Is there evidence of adequate institutional support, 
including improvement of infrastructure and relief from other academic 
duties where necessary? Is the environment adequate for proposed 
training activities?

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).
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).

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.


Letter of Intent Receipt Date: October 27, 2003
Application Receipt Date: November 24, 2003
Peer Review Date: March, 2004
Council Review: May, 2004
Earliest Anticipated Start Date: July, 2004


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.

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.

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 
a complete copy of the updated Guidelines are available at
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 

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

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

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

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.

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 
( 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

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

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance Nos. 93.172 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 

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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NIH Funding Opportunities and Notices

H H S Department of Health
and Human Services

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