RELEASE DATE:  January 22, 2002

PA NUMBER:  PA-02-048

EXPIRATION DATE:  January 2, 2005, unless reissued


National Human Genome Research Institute (NHGRI)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Environmental Health Sciences (NIEHS)
National Institute on Aging (NIA)
National Institute on Drug Abuse (NIDA)


o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations


The purpose of this program announcement (PA) is to stimulate and encourage 
underrepresented minority doctoral candidates from a variety of academic 
INVESTIGATORS) to conduct research related to the ethical, legal, and social 
implications (ELSI) of genetics, genomics, and gene-environment interaction 
research.  It is hoped that this program will facilitate the entry of promising 
new minority investigators into the field of ELSI research.

A dissertation represents the most extensive research experience formulated and 
carried out by a doctoral candidate, with the advice and guidance of a mentor.  
Dissertation research involves a major investment of the doctoral student's 
time, energy, and interest and its substance is often the basis for launching a 
research career.  The usual mechanisms used for the support of doctoral 
dissertation research have not attracted significant numbers of underrepresented 
minority students to the field of ELSI research.  The intent of these 
dissertation research grants is to attract larger numbers of underrepresented 
minority students as ELSI investigators and to assist in providing a positive 
and constructive research experience that will stimulate them to pursue research 
careers in this field.


Background and Significance

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, and 
the role of environmental factors in, many common diseases and disorders, such 
as diabetes, heart disease, depression and other forms of mental illness, 
deafness and hearing impairment, Alzheimer's disease and neurodegenerative 
illness, addiction and substance abuse, as well as some forms of cancer.  It 
will also provide the basis for studying how genetic variation influences gene 
function and individual differences in human growth, development, and behavior, 
and will increase our understanding of gene-environment interactions affecting 
these phenotypes.
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, genomic, and gene-environment interaction 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, genomics, and gene-environment interaction research, may have been 
adversely affected in the past by certain types of research, or fear that 
advances in diagnosis or treatment stemming from such research may not be 
equally accessible to all members of society.  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.

To anticipate, analyze and address these issues, input will be needed from a 
wide array of academic disciplines.  In addition, because genetic information 
affects not only individuals and families, but also communities and large 
population groups, it is essential that researchers are well trained in their 
disciplines and are also cognizant of and sensitive to the concerns of members 
of diverse racial, ethnic and socioeconomic groups.  Individuals from 
populations that are currently underrepresented in ELSI research and who have 
received training in disciplines that are relevant to this research will be 
essential to the success of the next phase of the Human Genome Project.

The number of individuals who are identified as members of underrepresented 
minority groups and who are engaged in ELSI research is currently small.  There 
is a clear need to develop new ways to assist and encourage minority researchers 
to become active in the conduct of studies that can advance the rapidly growing 
knowledge base in ELSI research.  This research initiative is aimed at providing 
underrepresented minority students with assistance to complete their 
dissertation research on an ELSI-related topic and thereby increase their 
representation in ELSI research.

Research Scope

Applications may be made for support of research in any area relevant to the 
ethical, legal and social implications of genetic and genomic research.  
Proposed projects can range from large clinical studies of the impact of genetic 
information and technologies in health care settings to smaller analytical 
studies of how this information affects individuals or how communities view 
themselves or are viewed by others.

General areas of programmatic interest are set out on the NHGRI ELSI Research 
website at http://www.nhgri.nih.gov:80/About_NHGRI/Der/Elsi/.  The following 
five specific research goals have been developed for the NHGRI ELSI program 
through the year 2003 (a list of examples of research questions associated with 
each of these goals is available online at:  

1. Examine the issues surrounding the completion of the human DNA sequence and 
the study of human genetic variation.

2. Examine issues raised by the integration of genetic technologies and 
information into health care and public health activities.

3. Examine issues raised by the integration of knowledge about genomics and 
gene-environment interactions into non-clinical settings.

4. Explore ways in which new genetic knowledge may interact with a variety of 
philosophical, theological, and ethical perspectives.

5. Explore how the social environment, including socioeconomic factors, age, 
gender and concepts of race and ethnicity influence the use, understanding, and 
interpretation of genetic information, the utilization of genetic services, and 
the development of policy.

For additional information on the types of research funded by the NHGRI ELSI 
program, a list of all the grants supported by the NHGRI ELSI program since 1990 
may be found at:  http://www.nhgri.nih.gov:80/About_NHGRI/Der/Elsi/elsiabs.html.

Information on other initiatives supported by the NHGRI ELSI Program may be 
found at:  http://www.nhgri.nih.gov/About_NHGRI/Der/Elsi/#PA.

Each of the sponsoring institutes has a particular interest in ELSI research 
relevant to its own mission.  NIEHS is particularly interested in understanding 
the impact of environmental exposures on human health and disease.  The NIEHS 
expanded its research program on genetic susceptibility to environmentally 
associated diseases through the Environmental Genome Project.  Understanding 
genetic susceptibility to environmental agents will allow more precise 
identification of the environmental agents that cause disease and the true risks 
of exposures.  This can lead to more effective disease prevention and improved 
public health.  Further information on the Environmental Genome Project can be 
found at:  http://www.niehs.nih.gov/envgenom/home.htm.

Questions on the relevance of a particular topic to the objectives of this PA 
may be addressed to the program contact listed under INQUIRIES.


This PA will use the NIH small grant (R03) award mechanism.  As an applicant, 
you will be solely responsible for planning, directing, and executing the 
proposed project.

Grants to support dissertation research will provide no more than $25,000 (one 
module) in direct costs.  An application that exceeds this limit will be 
returned to the applicant without review.  Grants are normally awarded for 
twelve months, but may be extended without additional funds for up to a total of 
24 months.

This PA uses just-in-time concepts.  It also uses the modular budgeting format.  
(see https://grants.nih.gov/grants/funding/modular/modular.htm).


You may submit an application if your institution is a public or private 
institution such as a university or college that supports doctoral level 
training.  The performance site may be foreign or domestic.


The applicant must be a full time student in good standing enrolled in an 
accredited doctoral degree program in a relevant social science or humanities 
discipline, such as anthropology, economics, health policy, public health, 
history, philosophy, political science, psychology, religious studies, or 
sociology.  The applicant must be conducting or intending to conduct research in 
one of the areas described in this PA (see RESEARCH OBJECTIVES).  The applicant 
must have obtained approval of the dissertation proposal by the dissertation 
committee by the time of application.  All requirements for the doctoral degree 
other than the dissertation (and clinical internship, if applicable) must also 
be completed by the time of application. The applicant's eligibility must be 
verified in a letter of certification from the mentor (the chair of the 
dissertation committee or other academic advisor) and submitted with the grant 
application (see SPECIAL REQUIREMENTS).

Priority will be given to applicants who belong to ethnic or racial groups that 
are currently underrepresented in ELSI research.  Within this group, persons 
with disabilities are particularly encouraged to apply.  Academic institutions 
are encouraged to facilitate applications from qualified applicants.


Additional Material

In addition to the completed PHS 398 application form (see SUBMITTING AN 
APPLICATION), the applicant must also submit the following materials, attached 
to the application as Appendices:

o A letter from the applicant's mentor which: (1) fully identifies the members 
of the dissertation committee and certifies their approval of the dissertation 
proposal; (b) certifies that all requirements for the doctoral degree, except 
the dissertation (and clinical internship, if applicable), are completed; (c) 
certifies that the mentor has read the application and believes that it reflects 
the work to be completed in the dissertation; and (d) certifies that the 
institution's facilities and general environment are adequate to conduct the 
proposed research.

o A tentative timeline for completion of the research, the dissertation, and the 
dissertation defense.

o An official transcript of the applicant's graduate school record.

o A statement of the applicant's career goals and intended career trajectory.

o A biography of the mentor, limited to two pages (use the Biographical Sketch 
page in application form PHS 398).

Page Length of Application

The narrative portion of the application that describes the Research Plan of the 
dissertation may not exceed ten pages.

Allowable Costs and Concurrent Support

Costs requested may not exceed $25,000 (one module) in direct costs for the 
total (one year) project period.  Allowable costs include: (1) the applicant's 
salary (not to exceed $20,000) and (2) direct research project expenses, such as 
data processing, payments to subjects, statistical consultant services, 
supplies, and dissertation printing costs; and (3) travel to scientific 
meetings, if adequately justified.  No tuition support is allowed.

An applicant who receives a dissertation research grant under this PA may not at 
the same time receive support under a predoctoral training grant or individual 
fellowship grant awarded by any Federal agency, or by any other 
dissertation grant.

Other Special Conditions for Dissertation Research Grants

o The doctoral candidate must be the designated Principal Investigator and must 
be the only individual named in the application for whom salary support 
is requested.

o The responsible Program Official for the institute awarding the grant must be 
informed if there is a change of mentor.  A Biographical Sketch of the new 
mentor must be provided for approval by the responsible Program Official.

o A dissertation research grant may not be transferred to another institution, 
except under unusual and compelling circumstances (such as if the mentor moves 
to a new institution and both the mentor and the student wish to move together).

o Two copies of the dissertation, including abstract, must be submitted to the 
responsible Program Official and will constitute the final report of the grant.  
The dissertation must be officially accepted by the dissertation committee or 
university official responsible for the candidate's dissertation and must be 
signed by the responsible official.

o Any publications directly resulting from the grant should be reported to the 
responsible Program Official.  The grantee also should cite receiving support 
from the appropriate institute(s) both in the dissertation and any publications 
directly resulting from the dissertation grant.

We encourage your inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into three 
areas:  scientific/research, peer review, and financial or grants 
management issues:

o Direct your questions about scientific/research issues to:

Jean E. McEwen, J.D., Ph.D.
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:  jm522n@nih.gov

James A. Lipton, D.D.S., Ph.D.
Division of Population and Health Promotion Sciences
National Institute of Dental and Craniofacial Research
Building 45, Room 4AS-37J
Bethesda, MD  20892-6402
TEL:  (301) 594-2618
FAX:  (301) 480-8318
Email:  James_Lipton@nih.gov

Shobha Srinivasan, Ph.D.
National Institute of Environmental Health Sciences
Chemical Exposures and Molecular Biology Branch
Division of Extramural Research and Training
P.O. Box 12233, MD EC-21
111 T.W. Alexander Drive
RTP, NC  277709
TEL:  (919) 541-2506
FAX:  (919) 316-4606
E-mail:  sriniva2@niehs.nih.gov

Jennifer Harris, Ph.D.
Behavioral and Social Research Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 533, MSC 9205
Bethesda, MD  20892-9205
TEL:  (301) 496-3138
FAX:  (301) 402-0051
Email:  jh475o@nih.gov

Jonathan D. Pollock, Ph.D.
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4284, MSC 9555
Bethesda, MD  20892-9555
TEL:  (301) 443-6300
FAX:  (301) 594-6043
Email:  jp183r@nih.gov

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

Jean Cahill
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

Martin R. Rubinstein
Grants Management Officer
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
Building 45, Room 4AS-55
Bethesda, MD  20892-6402
TEL:  (301) 594-4800
FAX:  (301) 480-8301
Email:  Martin_Rubinstein@nih.gov

Jackie Russell
Grants Management Officer
Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-24
111 T.W. Alexander Drive
Research Triangle Park, NC  27709
TEL:  (919) 541-0751
FAX:  (919) 541-2860
Email:  Russell@niehs.nih.gov

Linda Whipp
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2N212, MSC 9205
Bethesda, MD  20892
TEL:  (301) 496-1472
FAX:  (301) 402-3672
Email:  lw17m@nih.gov

Gary Fleming, J.D., M.A.
Grants Management Branch
Office of Planning and Resource Management
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
TEL:  (301) 443-6710
FAX:  (301) 594-6847
Email:  gf6s@nih.gov


Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format.  
For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email:  

APPLICATION RECEIPT DATES:  Applications submitted in response to this PA will 
be accepted at the standard application deadlines, which are available at 
https://grants.nih.gov/grants/dates.htm.  Application deadlines are also 
indicated in the PHS 398 application kit.

up to $250,000 per year in direct costs must be submitted in a modular grant 
format.  The modular grant format simplifies the preparation of the budget in 
these applications by limiting the level of budgetary detail.  Applicants 
request direct costs in $25,000 modules.  Section C of the research grant 
application instructions for the PHS 398 (rev. 5/2001) at 
https://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular grants 
is available at https://grants.nih.gov/grants/funding/modular/modular.htm.

SENDING AN APPLICATION TO THE NIH: 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)

APPLICATION PROCESSING:  Applications must be received by or mailed before the 
receipt dates described at 
https://grants.nih.gov/grants/funding/submissionschedule.htm.  The 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 a 
substantial revision of an application already reviewed, but such application 
must include an Introduction addressing the previous critique.


Applications submitted for this PA will be assigned on the basis of established 
PHS referral guidelines.  An appropriate scientific review group convened in 
accordance with the standard NIH peer review procedures 
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific 
and technical merit.

As part of the initial merit review, all applications will:

o Receive a written critique
o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the appropriate national advisory council 
or board

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 
your application in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals:

o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these criteria in 
assigning your application's overall score, weighting them as appropriate for 
each application.  Your 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, you 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 your study address an important problem? If the aims of 
your application are achieved, how do they advance scientific knowledge?  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?  Do you acknowledge potential problem areas and consider 
alternative tactics?

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

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

(5) ENVIRONMENT:  Does the scientific environment in which your 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?

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, your application 
will also be reviewed with respect to the following:

PROTECTIONS:  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.

INCLUSION:  The adequacy of plans to include subjects from both genders, all 
racial and ethnic groups (and subgroups), and children as appropriate for the 
scientific goals of the research.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria included in the section 
on Federal Citations, below)

BUDGET:  The reasonableness of the proposed budget and the requested period of 
support in relation to the proposed research.

OTHER REVIEW CRITERIA:  In the context of this PA, the investigator's academic 
record, career goals, and other information in the Additional Materials will 
inform consideration of the above criteria.  Strong emphasis will be placed on 
the reviewers' assessment of the applicant's potential as a future contributor 
to ELSI research.  Emphasis will also be placed on:  (1) whether the proposed 
research is appropriate to the experience level of the applicant; and (2) 
whether the mentor has the qualifications (based on the mentor's research and 
research training experience, particularly, but not exclusively, in ELSI 
research) to provide the necessary guidance to the applicant.


Applications submitted in response to a PA will compete for available funds with 
all other recommended applications.  The following will be considered in making 
funding decisions:

o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities


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

All investigators proposing clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 
a complete copy of the updated Guidelines are available at 
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) all 
applications or proposals and/or protocols must provide a description of plans 
to conduct analyses, as appropriate, to address differences by sex/gender and/or 
racial/ethnic groups, including subgroups if applicable; and b) investigators 
must report annual accrual and progress in conducting analyses, as appropriate, 
by sex/gender and/or racial/ethnic group differences.

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

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 

requires education on the protection of human subject participants for all 
investigators submitting NIH proposals for research involving human subjects.  
You will find this policy announcement in the NIH Guide for Grants and Contracts 
Announcement, dated June 5, 2000, at 

Office of Management and Budget (OMB) Circular A-110 has been revised to provide 
public access to research data through the Freedom of Information Act (FOIA) 
under some circumstances.  Data that are (1) first produced in a project that is 
supported in whole or in part with Federal funds and (2) cited publicly and 
officially by a Federal agency in support of an action that has the force and 
effect of law (i.e., a regulation) may be accessed through FOIA.  It is 
important for applicants to understand the basic scope of this amendment.  NIH 
has provided guidance at 

Applicants may wish to place data collected under this PA in a public archive, 
which can provide protections for the data and manage the distribution for an 
indefinite period of time.  If so, the application should include a description 
of the archiving plan in the study design and include information about this in 
the budget justification section of the application. In addition, applicants 
should think about how to structure informed consent statements and other human 
subjects procedures given the potential for wider use of data collected under 
this award.

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

HEALTHY PEOPLE 2010:  The Public Health Service (PHS) is committed to achieving 
the health promotion and disease prevention objectives of "Healthy People 2010," 
a PHS-led national activity for setting priority areas. This PA is related to 
one or more of the priority areas. Potential applicants may obtain a copy of 
"Healthy People 2010" at http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of Federal 
Domestic Assistance No. 93.172 (NHGRI); No. 93.121 (NIDCR); Nos. 93.113, 93.115 
(NIEHS); No. 93.866 (NIA); and No. 93-279 (NIDA) and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health Systems 
Agency review.  Awards are made under authorization of Sections 301 and 405 of 
the Public Health Service Act as amended (42 USC 241 and 284) and administered 
under NIH grants policies described at 
https://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 
CFR 52 and 45 CFR Parts 74 and 92.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the use of all tobacco products.  In addition, Public 
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain 
facilities (or in some cases, any portion of a facility) in which regular or 
routine education, library, day care, health care, or early childhood 
development services are provided to children.  This is consistent with the PHS 
mission to protect and advance the physical and mental health of the 
American people.

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