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 301/710-0267, 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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