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

Release Date:  September 22, 2000

PA NUMBER:  PA-00-134

National Human Genome Research Institute
National Institute on Drug Abuse
National Institute of Dental and Craniofacial Research
National Institute for General Medical Sciences
National Institute of Mental Health
National Institute of Neurological Disorders and Stroke

This Program Announcement replaces the Education Grant (R25) 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 complementary to the ELSI Regular Research Grant 
(R01) and Small Grant (R03) Program Announcements. 

PURPOSE   

The Ethical, Legal and Social Implications of Genetic and Genomic Research 
(ELSI) Education Grant (R25) is a flexible program aimed at developing 
innovative educational approaches that will increase knowledge and 
understanding of genetics and genomics research and its ethical, legal and 
social implications. This program invites investigator-initiated R25 Grant 
applications that pursue a wide range of objectives such as: the development 
and pilot testing of short courses, multi-media continuing education tools, 
national forums, seminars, and/or hands-on workshops designed to educate 
scientists, health care professionals and the lay community.  Other 
appropriate objectives include: the design, development and evaluation of new 
curriculum materials for a variety of audiences in a variety of educational 
settings. Given the current urgent need for health care providers who are 
genetically literate and knowledgeable, health professional education 
projects are of particular interest. Applications to this program should be 
focused on developing and evaluating new and innovative interventions that 
are designed to reach a large and diverse audience or that can be 
successfully exported to other institutions or learning environments.

Applications that examine more conceptual issues, such as what constitutes 
genetic literacy or how various audiences optimally learn genetic 
information, and projects that use an experimental design to test the 
effectiveness of a particular education intervention, will be considered 
under the ELSI Regular Research Grant (R01) program announcement which is 
available online at: 
(http://grants.nih.gov/grants/guide/pa-files/PA-00-133.html) 

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. 

Applications to support media (television or radio) programs and 
documentaries will not be accepted under this program announcement, except in 
special cases in which there is unusually compelling evidence that the 
proposed project will have sound and measurable educational value for a broad 
segment of the population.  All applicants are encouraged to speak with ELSI 
Research Program Staff before submitting an application.

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 Program Announcement 
(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).  Such 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) education grants 
(R25) award mechanism. Responsibility for the planning, direction, and 
execution of the proposed project will be solely that of the applicant.

In general, we expect most applicants will require three years or fewer; 
however competitive renewals may be submitted.

Facilities and Administrative (F&A) costs are payable at the rate of 8 
percent of total modified direct costs.  The 8 percent F&A cost rate will 
also apply to all subcontracts on R25 awards.

PROJECT 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. 

Project Scope and Objectives

This program announcement emphasizes the ongoing commitment of the NIH to 
support educational activities related to these and other ethical, legal, and 
social implications of human genetics and genomic research. The ultimate 
mission of the ELSI education program is to support activities that improve 
public and professional understanding about genetics, genome technology and 
the ethical, legal and social implications of this information and 
technology. 

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 its 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 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 and genomics research and to 
help focus the ELSI research and education 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 and education topics.  As genetic 
research and the interpretation and use of genetic information continue to 
evolve, applicants are encouraged to identify additional topics and issues.

A few examples of possible education activities that would fall within each 
goal area are provided. These are meant only to serve as examples of the 
possible types of projects that could be developed, 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 Development of effective strategies for educating health professionals, 
policy makers, the media, students, and the public regarding the 
interpretation and use of information about genetic variation.

(2) Examine the issues raised by the integration of genetic technologies and 
information into health care and public health activities. 
o Development of curriculum materials that can be used to educate health 
professional students about the integration of genetic information and 
technologies in clinical settings and the associated ethical, legal and 
social issues.
o Development of innovative approaches to provide continuing education to 
practicing health care providers on the appropriate integration of genetic 
information and technologies in clinical settings and the associated ethical, 
legal and social issues.
o Development of effective methods for educating patients and the lay public 
about the use and interpretation of genetic information in health care 
settings.

(3) Examine issues raised by the integration of knowledge about genomics and 
gene-environment interactions into non-clinical settings.  
o Development of effective strategies for providing information to the 
general public on the use of genetic technologies in educational and 
workplace settings.
o Development of innovative educational approaches for diverse audiences, 
such as judges, educators and legislators, on the use and interpretation of 
genetic information and technologies in non-clinical settings.

(4) Explore the ways in which new genetic knowledge may interact with a 
variety of philosophical, theological, and ethical perspectives.
o Development of innovative approaches that can be used to help a variety of 
audiences explore the ways in which genetic information and technologies may 
interact with a variety of philosophical, theological, and ethical 
perspectives.

(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 Development of educational interventions that will teach health care 
professionals how to provide genetic services in a culturally sensitive and 
relevant manner.
o Development of culturally appropriate education materials that can be used 
to convey information on the use and interpretation of genetic information 
and technologies to culturally and socio-economically diverse audiences.
                                  
Projects must integrate a strong scientific foundation with consideration of 
relevant ethical, legal and social issues.  Interdisciplinary teams to 
develop education projects are encouraged.  Of particular interest are 
projects that explore new, innovative approaches to education. Projects that 
propose to develop educational interventions should involve the target 
audience in planning, include an effective evaluation component, and propose 
a model that is transferable and transportable.  Because of the current 
urgent need for health care providers who are genetically literate and 
knowledgeable, health professional education is regarded as having a high 
program priority.

This program announcement is designed to be complementary to several other 
National Human Genome Research Institute (NHGRI), National Institutes of 
Health (NIH), and other Interagency Program Announcements.  A complete 
listing of these announcements is available at the end of the “Research 
Objectives” section of the Regular Research ELSI PA (http address).

INCLUSION OF WOMEN AND MINORITIES IN PROJECTS INVOLVING HUMAN SUBJECTS

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

All investigators proposing projects involving human subjects should read the 
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical 
Research," published in the Federal Register of March 28, 1994 (FR 59 14508-
14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 
18, 1994 available on the web at the following URL address: 
http://grants.nih.gov/grants/guide/notice-files/not94-100.html. 

INCLUSION OF CHILDREN AS PARTICIPANTS IN PROJECTS INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all projects involving human subjects, 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 projects 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 policies.

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.

Applicants planning to submit an investigator-initiated new, competing 
continuation, competing supplement, or any amended/revised version of an 
education grant (R25) 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 application 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

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)

SPECIAL REQUIREMENTS   

This program announcement requires a special section titled “Evaluation Plan” 
that clearly denotes how the proposed education program will be evaluated for 
success or failure based on its purpose and objectives.  This plan should 
include strategies for both formative evaluations  (evaluations designed to 
provide feedback to investigators while the project is in progress, enabling 
them to modify their strategies if necessary) and summative evaluations 
(evaluations conducted after the educational intervention has been completed, 
to determine whether the intervention actually improved the genetic 
“literacy” of the targeted audience). In addition, one of the evaluation 
criteria should focus on the degree of portability that the proposed program 
may have to other institutions or to other settings or broader audiences. 

In general, allowable costs must be consistent with NIH policy and 
recommended by peer reviewers.  These costs include but are not limited to 
the following:  supplies, personnel costs, student compensation (when 
appropriate), consultant costs, equipment, travel, subcontractual costs, 
other expenses and other student costs (when appropriate).  Faculty members  
participating in the design and implementation of the education program can 
request,  with proper justification,  the percent of their time devoted to 
curriculum design and specialized organization, coordinating, and 
implementation activities which are essential to achieving the goals of their 
proposed education plan.   

R25 grants may not be used to conduct traditional biomedical research or as 
training grants.   

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

In the written comments reviewers will be asked to discuss the following 
aspects of the application. 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 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 education project address an important ELSI or 
genetics educational need? If the aims of the application are achieved, to 
what extent will the project further the goals of improving education and 
understanding of genetic and genomic research and its ethical, legal and 
social implications?

(2) Approach: Are the conceptual framework, design and methods adequately 
developed, well-integrated, and appropriate to the aims of the project?

Specifically, to what extent does the project:
-  provide a needs assessment and impact statement;
-  involve the target audience in planning, development and implementation;
-  define and demonstrate the receptivity of the target audience;
-  demonstrate awareness of relevant literature and existing professional and 
public education standards and resources;
-  document the transferability/transportability of the model;
-  involve genome scientists, genetics specialists, education specialists, 
bioethicists, and other individuals as necessary from a wide array of 
disciplines and provides criteria for their selection;
-  include plans for publicizing the availability of the program to the 
appropriate community(s);
-  include plans for recruiting potential participants, including women and 
under represented minorities, as appropriate;
-  include plans for dissemination; and for independent support of the 
education project if long term support will be needed?
 
(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) Project Leader (Principal Investigator): Are the project leader and other 
key personnel appropriately trained and well suited to carry out this work? 
Is the work proposed appropriate to their experience level?

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

(6) Evaluation Plan: Will the evaluation plan adequately assess the 
effectiveness of the project in achieving its objectives, and the degree to 
which the proposed project can be used in other educational institutions or 
settings.

In accordance with NIH policy, the 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 goals of the project. Plans 
for the recruitment and retention of subjects will also be evaluated, as 
appropriate.

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

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. 

Grant funds may be used for expenses clearly related and necessary to conduct 
the proposed project, including both direct costs and allowable facilities 
and administration (indirect) costs. 

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/R25contacts.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/R25contacts.html

AUTHORITY AND REGULATIONS 

This program is described in the Catalog of Federal Domestic Assistance No. 
93.172, Human Genome Research; No. 93.279, National Institute on Drug Abuse; 
No. 93.121, National Institute of Dental and Craniofacial Research; Genetics 
Program 93.862, National Institute of General Medical Sciences; No. 93.242, 
National Institute of Mental Health; and No. 93.361. 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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