ETHICAL, LEGAL, AND SOCIAL IMPLICATIONS OF HUMAN GENETICS AND GENOMIC RESEARCH 
REGULAR RESEARCH GRANT PROGRAM

Release Date:  September 22, 2000

PA NUMBER:  PA-00-133

National Human Genome Research Institute
National Institute on Aging
National Institute of Child Health and Human Development
National Institute on Drug Abuse
National Institute on Deafness and Other Communication Disorders
National Institute of Environmental Health Sciences
National Institute for General Medical Sciences
National Institute of Mental Health
National Institute of Nursing Research
National Institute of Neurological Disorders and Stroke

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

This Program Announcement replaces the regular research grant (R01) component 
of PA-96-042, The Ethical, Legal and Social Implications of Genetics 
Research, which was published in the NIH Guide for Grants and Contracts, Vol. 
25, No. 13, April 26, 1996. It is supplemented by the ELSI Education (R25) 
and Small Grants (R03) Program Announcements.

PURPOSE

This Program Announcement (PA) is designed to solicit research projects that 
anticipate, analyze, and address the ethical, legal, and social implications 
of the discovery of new genetic technologies and the availability and use of 
genetic information resulting from human genetics and genomic research. Of 
particular interest are studies that: 1) examine the issues surrounding the 
completion of the human DNA sequence and the study of human genetic 
variation; 2) examine the issues raised by the integration of genetic 
technologies and information into health care and public health activities; 
3) examine the issues raised by the integration of knowledge about genomics 
and gene-environment interactions into non-clinical settings; 4) explore the 
ways in which new genetic knowledge may interact with a variety of 
philosophical, theological, and ethical perspectives; and 5) explore how 
socioeconomic factors, gender, and concepts of race, ethnicity and culture 
influence the use and interpretation of genetic information, the utilization 
of genetic services, and the development of policy. 

This PA is supplemented by the ELSI Education Grants (R25) Program 
(http://grants.nih.gov/grants/guide/pa-files/PA-00-134.html), which is aimed 
at developing innovative educational approaches that will increase knowledge 
and understanding of genetics and genomics research and its ethical, legal 
and social implications. 

In addition, a new ELSI Small Grant (R03) Program has been developed and can 
be accessed online at: http://grants.nih.gov/grants/guide/pa-files/PA-00-132.html.
This Small Grant Program, which is limited to applications requesting up to
$50,000 in direct costs per year, makes use of a streamlined application process
and is designed to encourage the development of small, focused research projects
by legal, historical, ethics and social sciences scholars. It is also designed to 
support smaller exploratory studies that may provide preliminary findings for 
larger research proposals in all research areas of interest.   

Applicants who are preparing an Education (R25) or Small Grant (R03) 
application should refer to the announcements referenced above. The ELSI 
Research Program also will accept conference grant (R13) applications.  These 
applications are limited to $50,000 and to conferences that are highly 
focused and result in a specific product, such as the publication of 
conference proceedings or policy recommendations in a journal article or 
book.  For specific application guidelines and instructions for each of the 
participating Institutes and Centers (ICs), applicants should refer to the 
“Guidelines for Support of Scientific Meetings by NIH,” which are available 
online at http://grants.nih.gov/grants/guide/notice-files/not98-151.html. 

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2010," a PHS 
led national activity for setting priority areas.  This PA, “Ethical, Legal, 
and Social Implications of Human Genetics and Genomic Research”, is related 
to one or more of the priority areas identified in that report. Potential 
applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign for-profit and non-
profit organizations–either public or private, such as universities, 
colleges, hospitals, laboratories, units of State and local governments, and 
eligible agencies of the Federal government.  Racial/ethnic minority 
individuals, women, and persons with disabilities are encouraged to apply as 
principal investigators.  Participation in the program by investigators at 
minority institutions is strongly encouraged. Investigators from foreign 
institutions should be aware that, in the area of ethical, legal and social 
issues, the standard NIH criteria for funding foreign applications are 
applied very strictly (see Award Criteria below).  These investigators are 
strongly encouraged to contact program staff before preparing an application.
 
To be eligible for this award, the proposed Principal Investigator must be an 
independent investigator. That is, he or she should be genuinely independent 
of a mentor.  Individuals in the final stages of training may apply, but 
individuals can not be in a training status at the time the award is made. 

MECHANISM OF SUPPORT

This PA will use the National Institutes of Health (NIH) regular research 
project grant (R01) mechanism. Program contacts at the relevant Institutes 
and Centers (IC)s are available for consultation prior to submission of an 
application. Responsibility for the planning, direction, and execution of the 
proposed project will be solely that of the applicant.

RESEARCH OBJECTIVES

Background and Significance

The NIH, along with several other federal and private national and 
international organizations, is currently engaged in a research effort known 
as the Human Genome Project (HGP). This project is designed to characterize 
the human genome and the genomes of selected model organisms.  The HGP 
currently has several interrelated goals: the determination of the complete 
nucleotide sequence of human DNA and the DNA of several model organisms; the 
development of new technologies to make sustained high throughput DNA 
sequencing efficient, accurate and cost effective; the exploration of human 
genome sequence variation; the development of technologies for interpreting 
the function of DNA sequence; the identification and analysis of the ethical, 
legal, and social implications of this research; and research training. 

The knowledge and technologies that will become available as a result of 
accomplishing these goals will: serve as a resource for studies of gene 
structure and function; promote research into the genetic aspects of human 
growth, development, and variability; increase the understanding of genetic 
contributions to human diseases and disorders; and inform clinical and health 
policies related to genetics. This understanding will lead to insights into 
new ways of dealing with health and disease, including new risk 
identification, risk reduction, diagnostic and therapeutic options. It will 
also help to elucidate more clearly the interaction between genes and the 
environment in the development of disease.

As the Human Genome Project draws closer to completion of the final 
“finished” human DNA sequence, researchers are focusing increasing attention 
on the discovery of variations found in the DNA sequences among individuals. 
The identification, classification, quantification and analysis of these 
genetic sequence variations is expected to constitute one of the most 
powerful, and direct, approaches to the study of a wide range of important 
biological questions. It will allow researchers to identify genetic 
contributions to many common diseases and disorders, such as diabetes, heart 
disease, depression and other forms of mental illness, deafness and hearing 
impairment, and some forms of cancer.  It will also provide the basis for 
studying how genetic variation influences gene function in human growth and 
development.

Knowing the entire sequence of the human genome and understanding more about 
genetic variation among individuals and groups will, however, raise a number 
of ethical, legal, and social issues. These include: how to design and 
conduct genetic and genomic research, not only in a scientifically sound, but 
also an ethical manner; how to interpret and use this information; whether 
and how to integrate this information into clinical settings; and what impact 
this information will have in non-clinical and research settings. Many of 
these issues may be of special concern to individuals from diverse 
communities who traditionally have not been involved in genetics and genomics 
research, or who  may have been adversely affected in the past by certain 
types of research. On the one hand, the exclusion of certain groups from 
research studies has contributed to disparities in the diagnostic and 
treatment options available to members of these groups. On the other hand, 
the inclusion of members of these populations in some early genetic studies 
may have led to an increase in stigmatization and to the potential for 
discrimination in employment, health care, insurance, or society more 
broadly.  These issues may become even more pressing if ongoing research 
reveals data on the interactions among genotype, diseases or traits, and 
traditional, socially-constructed concepts of race, ethnicity and culture. 

Research Scope and Objectives

This program announcement emphasizes the ongoing commitment of the NIH to 
support research and educational activities related to these and other  
ethical, legal, and social implications of human genetics and genomic 
research. The ultimate mission of the ELSI Research Program is to support 
research and education activities that: 1)  promote genetic privacy and fair 
use of genetic information; 2) encourage the responsible integration of new 
genetic information and technologies into clinical and non-clinical settings; 
3) ensure that genetic research is conducted in an ethical manner; and 4) 
improve public and professional understanding about genetics, genome 
technology and related ethical, legal and social issues. 

In July 1997, the ELSI Research Planning and Evaluation Group (ERPEG) was 
created to evaluate the portfolio of ELSI research grants and develop goals 
and recommendations to help guide and strengthen the ELSI research program. 
In February 2000, ERPEG released their final report 
(http://www.nhgri.nih.gov:80/About_NHGRI/Der/Elsi/erpeg_report.pdf), 
which included five goals to help guide ELSI research over the next few years 
and a series of programmatic recommendations for enhancing the ELSI 
research program. 

The five research goals, which were originally published in the October 1998 
issue of “Science” as part of the five year plan for the HGP were designed to 
capture some of the emerging topics in genetics research and to help focus 
the ELSI research agenda through the year 2003.  The goals, described below, 
should be seen as a guide to areas of particular interest to the ELSI 
Research Program, but should not be interpreted as an exhaustive listing of 
all possible research topics.  As genetic research evolves and the 
interpretation and use of genetic information continue to emerge, applicants 
are encouraged to identify additional research topics and issues.

To demonstrate the breadth and complexity of these goals, examples of 
possible research questions are provided. These examples are meant only to 
give a flavor of the possible issues to be addressed, and are not, in any 
sense, exhaustive or comprehensive. 

(1) Examine the issues surrounding the completion of the human DNA sequence 
and the study of human genetic variation.
o What strategies should be used to balance the needs for privacy and safety 
of individuals and groups with the scientific goals of creating resources for 
DNA sequencing and human variation research?
o Will the discovery of DNA polymorphisms influence current concepts of race, 
ethnicity, and culture? 
o What new concerns are being raised by the commercialization and patenting 
of DNA sequence information in the public, academic and private sectors?
o How will genetic data accumulated in research projects be protected when 
there is overlap with patient clinical records that might be more freely 
accessible by health care, public health and commercial interests?

(2) Examine the issues raised by the integration of genetic technologies and 
information into health care and public health activities. 
o What are the clinical and societal implications of identifying common 
polymorphisms that predict disease susceptibility or resistance?
o What are the potential risks and benefits of integrating genetic testing 
for complex diseases, behaviors, and other traits into health care?
o What are the most effective strategies for integrating genetic information 
and technologies into clinical settings in ways that help practitioners see 
health and disease in a genetic context and what will be the ethical, legal 
and social consequences of their increasing availability and use? 
o Will the availability of genetic information influence provider practice?
o Will the availability of genetic information influence individual behavior 
with regard to adherence to screening or therapeutic recommendations?
o Will the availability of genetic information reduce morbidity and 
mortality, and/or reduce health care costs?
o What factors influence: who develops and regulates new reproductive genetic 
technologies; which technologies are incorporated into medical practice; and 
which technologies are accepted or rejected by the public?

(3) Examine issues raised by the integration of knowledge about genomics and 
gene-environment interactions into non-clinical settings.  
o What are appropriate and inappropriate uses of genetic testing in the 
employment setting?
o What issues emerge from the collection, storage and use of blood and other 
tissue samples, including collections by the military, civil and criminal 
justice systems, commercial entities, and federal and state public health 
agencies? 
o What are the implications of obtaining genetic information for use in 
adoption proceedings and establishment of child custody and child support? 
o What are the implications of potential commercial applications resulting 
from the availability of genetic information about individuals and groups?
o What are the potential uses and abuses of genetic information in 
educational settings? 

(4) Explore the ways in which new genetic knowledge may interact with a 
variety of philosophical, theological, and ethical perspectives.
o Will continuing research in molecular biology and functional genomics 
affect how individuals and society view the relationship of humans to one 
another and to the rest of the living world? 
o What are the implications of behavioral genetics for traditional notions of 
personal, social and legal responsibility?
o What are the implications of genetic enhancement technologies for 
conceptions of humanity? 

(5) Explore how socioeconomic factors, gender, and concepts of race, 
ethnicity and culture influence the use and interpretation of genetic 
information, the utilization of genetic services, and the development of 
policy. 
o How are individual views about the value of genetic research, the 
importance of access to genetic services, and the meaning and relevance of 
genetic information affected by concepts of race, ethnicity and culture and 
by socioeconomic factors?
o How is the impact of genetic testing in clinical and non-clinical settings 
affected by concepts of race, ethnicity and culture and other social or 
economic factors?
o In what ways are access to, and use of, genetic information and services 
affected by ethnicity, race, culture or socioeconomic status? 
o What are the most effective strategies to ensure that genetic counseling 
and other genetic services are culturally sensitive and relevant? 
o What if any effect will new genetic discoveries have on existing health 
disparities among various populations.

Also of interest are studies that examine conceptual education or literacy 
issues such as what constitutes genetic literacy and how various audiences 
learn genetic information.

The research design should be appropriate to the nature of the project(s) 
proposed and the discipline(s) involved.  Interdisciplinary, collaborative 
projects between genome scientists, ethicists, clinical genetics researchers, 
other clinical researchers, nurse researchers, mental health researchers, 
social scientists, legal scholars, and/or educators are particularly 
encouraged.  Applicants must address the full range of views on each issue 
they select to investigate in a responsible, scholarly, and balanced manner, 
with the goal of advancing scholarship, achieving better understanding, 
and/or developing useful recommendations.  Projects that use the interpretive 
methods traditional to humanities, law, and the social sciences are 
encouraged. 

This program announcement, along with the ELSI Education Grant (R25) and 
Small Grant (R03) program announcements, is designed to be complementary to 
several other National Human Genome Research Institute (NHGRI), National 
Institutes of Health (NIH), and other Interagency Program Announcements, 
including: 
	
1) PA-99-079, “Research on Ethical Issues in Human Studies” which solicits 
applications to conduct research on ethical issues that arise with research 
involving human participants
(http://grants.nih.gov/grants/guide/pa-files/PA-99-079.html);

2)PA-97-028, ”Individual National Research Service Award (NRSA)” which 
solicits applications for post-doctoral, cross-disciplinary training in 
genetics, genomics and ELSI research 
(http://grants.nih.gov/grants/guide/pa-files/PA-99-122.html);
 
3)PA-97-039, “Linking Nursing and Genetic Research-Individual Postdoctoral 
and Senior Fellowships” which solicits applications for fellowships that will 
enable researchers to investigate the clinical implications of human genetics 
research (http://grants.nih.gov/grants/guide/pa-files/PA-97-039.html);

4) PA-99-059, “Courses in Genomic Analysis and Interpretation and ELSI 
Related Research” which solicits short courses to enhance the skills of 
individuals interested in pursuing laboratory or scholarly research relevant 
to ELSI issues and the Human Genome Project 
(http://grants.nih.gov/grants/guide/pa-files/PAR-99-059.html);

5)PA-99-051, “Short Courses in Research Ethics” which solicits applications 
for grants to develop, conduct, and evaluate short-term courses on ethical 
issues in research, particularly those involving human participants. 
(http://grants.nih.gov/grants/guide/pa-files/PA-99-051.html);

6)PA-99-050, “Mentored Scientist Development Award in Research Ethics” which 
support training in research ethics for health professionals working at 
academic and other health-related institutions in biomedical, behavioral, or 
public health research, particularly research involving human participants 
(http://grants.nih.gov/grants/guide/pa-files/PA-99-050.html);

7) Small Business Innovation Research (SBIR) Program” which includes a 
solicitation for education projects related to the Ethical, Legal, and Social 
Implications of human genetics research, technologies, and information 
(http://grants.nih.gov/grants/funding/sbir.htm).

8) PA-97-047, "Opportunities in Genetics and Nursing Research" which solicits 
applications from ongoing funded NIH nurse researchers to submit a 
competitive supplement on various aspects of genetic research to complement 
their ongoing program of research
(http://grants.nih.gov/grants/guide/pa-files/PA-97-047.html).

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

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

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

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

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

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines on the Inclusion of Children as Participants in 
Research Involving Human Subjects" that was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.  

Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES. Program staff may also provide additional relevant 
information concerning the policy.

URLs IN NIH GRANT APPLICATIONS AND APPENDICES

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

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev. 
4/98) and will be accepted at the standard application deadlines as indicated 
in the application kit. Application kits are available at most institutional 
offices of sponsored research, or on the Internet at 
http://grants.nih.gov/grants/funding/phs398/phs398.html and may be obtained 
from the Division of Extramural Outreach and Information Resources, National 
Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-
7910, telephone 301/435-0714, email: GrantsInfo@nih.gov.

The title and number of the program announcement must be typed on line 2 of 
the face page of the application form and the YES box must be marked.

The Center for Scientific Review (CSR) will not accept any application in 
response to this PA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application. The 
CSR will not accept any application that is essentially the same as one 
already reviewed. This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must 
include an introduction addressing the previous critique.

Applicants planning to submit an investigator-initiated new (type 1), 
competing continuation (type 2), competing supplement, or any amended/revised 
version of an application requesting $500,000 or more in direct costs for any 
year are advised that they must contact the Institute or Center (IC) program 
staff before submitting the application, i.e., as plans for the study are 
being developed. Furthermore, the applicant must obtain agreement from the IC 
staff that the IC will accept the application for consideration for award. 
Finally, the applicant must identify, in a cover letter sent with the 
application, the staff member and IC who agreed to accept assignment of the 
application.  This policy requires an applicant to obtain agreement for 
acceptance of both any such application and any such subsequent amendment. 
Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at: 
http://grants.nih.gov/grants/guide/notice-files/not98-030.html
 
Applications requesting more than $250,000 direct costs in any year must use 
the standard application instructions. 

Applications that request $250,000 or less in direct costs in any year must 
use the modular grant application instructions. Complete instructions and 
information on Modular Grant applications can be found at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

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

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS

BUDGET INSTRUCTIONS

Modular Grant applications  will request direct costs in $25,000 modules, up 
to a total direct cost request of $250,000 per year. (Applications that 
request more than $250,000 direct costs in any year must follow the 
traditional PHS 398 application instructions.)  The total direct costs must 
be requested  in accordance with the  program guidelines and  the 
modifications made to the standard  PHS 398 application  instructions 
described below:

PHS 398

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

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

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

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

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

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

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

o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by  
reviewers in the assessment of each individual's qualifications for a 
specific role in the proposed project, as well as to evaluate the overall 
qualifications of the research team. A biographical sketch is required for 
all key personnel, following the instructions below. No more than three pages 
may be used for each person. A sample biographical sketch may be viewed at:  
http://grants.nih.gov/grants/funding/modular/modular.htm

- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on 
research projects ongoing or completed during the last three years.
- List selected peer-reviewed publications, with full citations;

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

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

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

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

REVIEW CONSIDERATIONS

Applications will be assigned to specific ICs on the basis of established PHS 
referral guidelines. Applications will be evaluated for scientific and 
technical merit by an appropriate scientific review group convened in 
accordance with the standard NIH peer review procedures. As part of the 
initial merit review, all applications will receive a written critique and 
undergo a process in which only those applications deemed to have the highest 
scientific merit, generally the top half of applications under review, will 
be discussed, assigned a priority score, and receive a second level review by 
the appropriate national advisory council or board.

Review Criteria

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

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

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

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

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

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

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

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

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

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

AWARD CRITERIA

Applications will compete for available funds with all other recommended 
applications. The following will be considered in making funding decisions: 
scientific merit of the proposed project as determined by peer review, 
availability of funds, and program priority. 

In order for the NIH to fund applications from foreign institutions, the 
application must meet the following three criteria: (1) The proposed project 
must have special relevance to the mission and objectives of the awarding 
organization and have the potential to advance knowledge that will benefit 
the United States; (2) The project must present special opportunities for 
furthering research programs through the use of unusual talent, resources, 
populations, or environmental conditions in other countries which are not 
readily available in the United States or which provide augmentation of 
existing U.S. resources; and (3) The foreign grant application must be in the 
upper half of the research grant priority scores. 

INQUIRIES

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

Direct general inquiries regarding programmatic issues to:

The ELSI Research Program 
National Human Genome Research Institute 
Building 31, Room B2B07
31 Center Drive, MSC 2033
National Institutes of Health 
Bethesda, MD 20892-2033
TEL: (301) 402-4997 
FAX: (301) 402-1950 
E-mail: elsi@nhgri.nih.gov

Specific programmatic contacts at each of the participating NIH Institutes 
can be found at the following website: 
http://www.nhgri.nih.gov/ELSI/R01contacts.html

Direct general inquiries regarding fiscal matters to:

Grants Administration Branch
Division of Extramural Research 
National Human Genome Research Institute 
Building 31, Room B2B34 
31 Center Drive, MSC 2031
Bethesda, MD 20892-2031
TEL: (301) 435-7858
FAX: (301) 402-1951
E-mail: jc166o@nih.gov  

Specific fiscal contacts at each of the participating NIH Institutes can be 
found at the following website: 
http://www.nhgri.nih.gov/ELSI/R01contacts.html

AUTHORITY AND REGULATIONS 

This program is described in the Catalog of Federal Domestic Assistance No. 
93.172, Human Genome Research; No. 93.866, National Institute on Aging; No. 
93.865, National Institute of Child Health and Human Development;  No. 
93.279, National Institute on Drug Abuse; No. 93.173, National Institute on 
Deafness and Other Communication Disorders; No. 93.121, National Institute of 
Dental and Craniofacial Research; Nos. 93.113 and 93.115, National Institute 
of Environmental Health Sciences; Genetics Program 93.862, National Institute 
of General Medical Sciences; No. 93.242, National Institute of Mental Health; 
and No. 93.361, National Institute of Nursing Research. Awards are made under 
authorization of sections 301 and 405 of the Public Health Service Act, Title 
IV, part A (public Law 78-410, as amended by Public Law 99-158, 43 USC 241 
and 285)and administered under NIH grants policies and Federal Regulations 42 
CFR 52 and 45 CFR Parts 74 and 92.  This program is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a 
smoke-free workplace and promote the non-use of all tobacco products. In 
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking 
in certain facilities (or in some cases, and 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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