ELSI REGULAR RESEARCH PROGRAM (R01)

RELEASE DATE:  January 15, 2004

PA NUMBER:  PA-04-050 

EXPIRATION DATE:  January 2007, unless reissued.

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
 (http://www.nih.gov)  

COMPONENTS OF PARTICIPATING ORGANIZATION:
National Human Genome Research Institute (NHGRI) 
 (http://www.genome.gov/)
National Institute on Aging (NIA)
 (http://www.nia.nih.gov/)
National Institute of Child Health and Human Development (NICHD)
 (http://www.nichd.nih.gov/)
National Institute on Drug Abuse (NIDA)
 (http://www.nida.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD)
 (http://www.nidcd.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS)
 (http://www.niehs.nih.gov/) 
National Institute of General Medical Sciences (NIGMS)
 (http://www.nigms.nih.gov/)
National Mental Health Institute (NIMH)
 (http://www.nimh.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS)
 (http://www.ninds.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.172, 93.866, 93.865, 
93.279, 93.173, 93.113, 93.115, 93.859, 93.242, 93.853.

THIS PA CONTAINS THE FOLLOWING INFORMATION

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

PURPOSE OF THIS PA  

This PA is designed to solicit research projects that anticipate, analyze and 
address the ethical, legal, and social implications (ELSI) of the discovery 
and use of new information and technologies resulting from human genetic and 
genomic research.  Of particular interest are studies that examine issues 
and, where appropriate, develop policy options in the following areas: 1) 
intellectual property issues surrounding access to and use of genetic 
information; 2) the ethical, legal and social factors that influence the 
translation of genetic information to improved human health; 3) the issues 
surrounding the conduct of genetic and genomic research; 4) the use of 
genetic and genomic information and technologies in non-health care settings; 
5) the impact of genetics and genomics on concepts of race, ethnicity, 
kinship and individual and group identity; 6)the implications, for both 
individuals and society, of uncovering genetic and genomic contributions to 
not only disease, but also ‘normal’ human traits and behaviors; and 7) how 
different individuals, cultures and religious traditions view the ethical 
boundaries for the uses of genetics and genomics.  

This Program Announcement is complemented by PA-04-051, the ELSI Small Grant 
(R03) Program (http://grants.nih.gov/grants/guide/pa-files/PA-04-051.html). 
The R03 program is limited to applications requesting up to $50,000 in direct 
costs per year for no more than two years, 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. 

RESEARCH OBJECTIVES

Background and Significance

The publication of an accurate, comprehensive sequence of the human genome in 
April 2003 marked the completion of the international Human Genome Project 
(HGP).  The attention of the biomedical research community is now turning to 
the interpretation of this fundamental source of knowledge about human 
biology and to the development of new approaches for applying genomic 
technologies and information to improving human health throughout the 
lifespan. Advances in genetics, comparative genomics, high-throughput 
biochemistry and bioinformatics are providing biologists with research tools 
that promise to allow human health and disease to be analyzed and understood 
at an unprecedented level of detail.  Clinical opportunities for gene-based 
pre-symptomatic prediction of illness and adverse drug response are emerging 
at a rapid pace, and the therapeutic promise of genomics has ushered in an 
exciting phase of expansion and exploration in the commercial sector. 

Proactive and sustained efforts will be needed to ensure that the potential 
benefits of these new technologies are maximized and potential harms 
minimized. To achieve this goal, research that anticipates and addresses the 
ethical, legal and social implications (ELSI) of the rapidly increasing 
availability and use of genetic and genomic technologies and information will 
be critical.

Research Scope

With the highly efficient methods of DNA sequencing and genomic analysis that 
have been developed during the course of the HGP, new genetic tests and 
personal genetic sequence information will become more widely available and 
will be used in a variety of settings. In the next few years, people will 
have to continue to seriously consider numerous ethical, legal and social 
questions raised by the availability and use of this information, and then 
formulate and implement policies to address many of them. Without reliable 
data, provided by rigorous research, on which to base such decisions, or to 
develop sound theoretical models to guide the decision-making, there is a 
danger that such policies may be ill-informed and consequently ineffective, 
inappropriate, or even counter-productive. To facilitate the continued 
development of this body of research, the participating institutes will 
support research in the ELSI area, including ‘basic’ investigations directed 
at developing conceptual tools and shared vocabularies, 'applied' projects 
that produce empirical data, and 'translational' projects that use such tools 
and data to identify effective public-policy options.  As with all ELSI 
research, it is important for this research program to consider the 
perspectives of individuals from diverse racial, ethnic and socioeconomic 
backgrounds, as well as children, older adults and people with disabilities.

High priority will be given to those projects that examine issues and, where 
appropriate, develop policy options in the areas identified as “grand 
challenges” during the NHGRI’s two-year long planning process focused on the 
future of genomic research.  These “grand challenges” are described in detail 
in “A Vision for the Future of Genomics Research,” (Nature (2003) 422:835-
847) (http://www.genome.gov/Pages/About/vision.pdf).  They are described 
below, along with some examples of research questions and areas of interest.  
The examples should be understood as illustrative only, and not as limiting.  

1.  Intellectual Property Issues Surrounding Access to and Use of Genetic 
Information (Grand Challenge I-3).  There are a number of important issues in 
this area, including the impact that laws, regulations, and practices in the 
area of intellectual property have on both the development and 
commercialization of genomic technologies and derived products, and the 
access to and use of such technologies and information by both researchers 
and the public.  To maximize the positive impact of genomics on human health, 
it will be necessary to achieve a balance between the commercial incentives 
for development of useful products that are provided by the patent system, 
versus the research benefits of free and open access.  Research to explore 
the way in which these competing priorities can be balanced to achieve 
maximal public benefit is critical.  Because genomic research is global, it 
is also important to examine the impact of international treaties, laws, 
regulations, practices, belief systems and other social and cultural factors 
on these and related questions. 

2.  Ethical, Legal and Social Factors that Influence the Translation of 
Genetic Information to Improved Human Health (Grand Challenges II-5, II-6 and 
III-1) These Grand Challenges address issues of access to and use of new 
genetic information and technologies to improve human health. Research in 
this area is critical given the increasingly rapid introduction of new 
genetic technologies into healthcare, the growing use of multiplex genetic 
testing and the likely availability of new genetic tests for common complex 
diseases. Questions to be addressed include, but are not limited to: How are 
genetic services accessed and used? Are there barriers to equitable access, 
and, if so, how can they be removed?  What effect does the provision of 
genetic risk information have on actual health behaviors?  What are the most 
effective strategies for genetic testing and counseling in large populations?  
What are the most effective methods for providing risk information on genetic 
testing for common complex diseases?  How will the growing mainstream use of 
new genetic technologies affect the health care system as a whole?  How will 
it affect the provider-patient relationship?  What will be the impact on the 
health insurance industry and managed care organizations of the availability 
and increasing use of new genetic technologies? Research also is needed to 
critically evaluate new genetic tests and interventions in terms of utility, 
validity, efficacy, and cost and benefits to individuals and to society.  

3.  Issues Surrounding the Conduct of Genetic Research (Grand Challenge III-
1). As technological capacity for studying human biology expands, new 
questions arise concerning optimal ways to do research that involves human 
participants.  In the past decade, for example, much effort has gone into 
developing guidelines for the use of stored tissue specimens, for community 
consultation when conducting genetic research with identifiable populations, 
and for obtaining the consent of family members whose information may be 
obtained (or unintentionally discovered) when conducting pedigree research. 
Research is now appropriate to examine the impact of such guidelines on the 
safe and effective conduct of genetic and genomic research.  In addition, 
research is needed that will provide data that can serve as the basis for the 
development of guidelines for the safe and effective conduct of other types 
of genetic research in the future. For example, what will be the impact on 
individuals, families and society of the current proliferation of large 
cohort studies that collect DNA samples that are linked to identifiable 
private health and demographic information? How can researchers most 
effectively protect the privacy of participants, their families and their 
communities, without erecting unnecessary roadblocks to the conduct of 
important research that benefits society?  What are the most effective 
procedures for ensuring that participants are fully informed of the potential 
risks and benefits of these studies?  

4.  Issues Surrounding the Use of Genetic Information and Technologies in 
non-Health Care Settings (Grand Challenge III-1 and III-3).  Another 
important area of research is the exploration of the ethical, legal and 
social implications of using genetic information and technologies in non-
health care settings, such as employment, insurance, education, adoption, 
criminal justice, or civil litigation.  Examples of questions that might be 
addressed include, but are not limited to: What are the ethical and social 
implications of the possible use in educational settings of genetic 
information on predisposition to hyperactivity, to learning disabilities or 
to substance abuse?  What would be the legal implications if genetic 
information about behavioral traits, including liability to drug abuse, were 
determined to be admissible in criminal or civil proceedings?  How would this 
information be interpreted and used?  What are the public attitudes and 
values that could influence how this information may be used? How would the 
use of this information interact with individual and societal concepts of 
privacy and responsibility? Are existing legal protections against 
discrimination adequate to ensure against the misuse of genetic information 
in non-health care settings, or is there a role for additional, genetic-
specific legal protections? Genomics also provides greater opportunity to 
investigate hypotheses concerning the geographic ancestry of individuals and 
populations.  Potential research topics stemming from this use of genomic 
data include issues relating to the use of such information to determine the 
likelihood that an individual is a member of a particular group (for example, 
in criminal forensics).

5.  The Impact of Genomics on Concepts of Race, Ethnicity, Kinship and 
Individual and Group Identity (Grand Challenge III-2).  The relevance of 
genomics-derived data to concepts of race, ethnicity, kinship and identity 
has to be considered within complex historical, social and psychological   
contexts.  Potential research questions in this area might include, but are 
not limited to:  How do different individuals and cultures conceive of race, 
ethnicity and kinship, and what role do they believe genetic factors play in 
shaping those identities?  How does genetic information influence individual 
and group identity for individuals from different ethnic or cultural groups 
or for individuals with disabilities? How does the scientific community 
understand and use these concepts in designing and conducting genomics and 
genetics research, analyzing data, and presenting research findings?  How do 
the media interpret and report on these findings?  

6.  The Implications, for Both Individuals and Society, of Uncovering Genomic 
Contributions to ‘Normal’ Human Traits and Behaviors (Grand Challenge III-3). 
Biological research in the future will undoubtedly address the question of 
whether there are genetic contributions to non-disease-related biological 
attributes such as handedness, cognition, diurnal rhythms, aging and various 
behavioral and personality characteristics.  The findings of such research 
may have profound and complex implications for how individuals, families and 
society understand health and illness.  Examples of questions that might be 
addressed in this area include, but are not limited to: How will such 
discoveries interact with current concepts of health and normality?  How are 
these concepts perceived by individuals with disabilities or individuals from 
different cultural or socio-economic backgrounds? How will information on 
these traits or characteristics be understood and used, both by the general 
public and by policy makers? What policies will need to be developed to 
protect against the potential misuse of such information to stigmatize or 
discriminate against individuals and groups?  

7.  How Different Individuals, Cultures and Religious Traditions View the 
Ethical Boundaries for the Uses of Genomics (Grand Challenge III-4). It is 
important for society to define the appropriate and inappropriate uses of 
genomics. Research could explore how different individuals, cultures and 
religious traditions view the ethical boundaries for the uses of genomics.  
For instance, which sets of values determine attitudes towards the 
appropriateness of applying genomics to such areas as reproductive genetic 
testing, 'genetic enhancement' and germline gene transfer.  Among the many 
questions that could be explored are: How are these areas defined and 
understood? How does this conceptualization shape values and attitudes? Are 
there aspects of these concepts and values that are common to all cultures 
and religious traditions? How are these issues viewed by individuals with 
disabilities? How are potential ethical boundaries for the application of 
genomics viewed by the research community?  What might be the impact on 
society and the future of genomic research of the development of public 
policies that define and apply boundaries to the research enterprise?

The research areas and possible research questions described above should be 
seen as a guide to areas of particular interest, but should not be understood 
to be 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.

The research design of all applications should be appropriate to the nature 
of the project(s) proposed and the discipline(s) involved. Interdisciplinary, 
collaborative projects among bioethicists, genome scientists, social 
scientists, clinical researchers, public health researchers, behavioral 
researchers, health economists, legal scholars, historians, theologians 
and/or other scholars in the humanities are particularly encouraged. 

MECHANISM OF SUPPORT 

This PA will use the NIH R01 award mechanism.  As an applicant, you will be 
solely responsible for planning, directing, and executing the proposed 
project.

This PA uses just-in-time concepts.  It also uses the modular budgeting 
format. (see http://grants.nih.gov/grants/funding/modular/modular.htm).   
Specifically, if you are submitting an application with direct costs in each 
year of $250,000 or less, use the modular format.  This program does not 
require cost-sharing as defined in the current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.

ELIGIBLE INSTITUTIONS 

You may submit (an) application(s) if your institution has any of the 
following characteristics:

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign institutions/organizations
o Faith-based or community-based organizations 
   
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.

WHERE TO SEND INQUIRIES

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

o Direct general questions about scientific/research issues to:

Ms. Joy Boyer
ELSI Research Program
National Human Genome Research Institute
Building 31, Room B2B07
Bethesda, MD  20892-2033
Telephone:  (301) 402-4997
FAX:  (301) 402-1950
Email: jb40m@nih.gov

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

Ms. Jean Cahill
Grants Management Branch
National Human Genome Research Institute, NIH
Building 31, Room B2B34 
31 Center Drive
Bethesda, MD 20892-2032 
TEL: (301) 402-0733 
FAX: (301) 402-1951 
Email: jc166o@nih.gov  

Specific programmatic and financial contacts at each of the participating NIH 
Institutes can be found online at: http://www.genome.gov/10001789.

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). Applications must have a Dun and 
Bradstreet (D&B;) Data Universal Numbering System (DUNS) number as the 
Universal Identifier when applying for Federal grants or cooperative 
agreements. The DUNS number can be obtained by calling (866) 705-5711 or 
through the web site at http://www.dunandbradstreet.com/. The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form. The PHS 
398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html 
in an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

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

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

SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS:  Applications 
requesting up to $250,000 per year in direct costs must be submitted in a 
modular budget grant format.  The modular budget 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 http://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 
http://grants.nih.gov/grants/funding/modular/modular.htm

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: 
Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NIH staff member within one of NIH 
institutes or centers who has agreed to accept assignment of the application.   

Applicants requesting more than $500,000 must carry out the following steps:
   
1) Contact the IC program staff at least 6 weeks before submitting the 
application, i.e., as you are developing plans for the study; 

2) Obtain agreement from the IC staff that the IC will accept your         
application for consideration for award; and,
  
3) Identify, in a cover letter sent with the application, the staff member       
and IC who agreed to accept assignment of the application.  

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised 
version of these grant application types. Additional information on this 
policy is available in the NIH Guide for Grants and Contracts, October 19, 
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. 

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 mailed on or before the receipt 
dates described at 
http://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 unfunded version of an application 
already reviewed, but such application must include an Introduction 
addressing the previous critique.  

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.   Appropriate scientific review groups 
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 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 written critique
o 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 evaluate the application in 
order to judge the likelihood that the proposed research will have a 
substantial impact on the pursuit of these goals.  The scientific review 
group will address and consider each of the following criteria in assigning 
the application’s overall score, weighting them as appropriate for each 
application.

o Significance 
o Approach 
o Innovation
o Investigator
o Environment

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.

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

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?

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?

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)?

ENVIRONMENT: Does the research environment in which the work will be done 
contribute to the probability of success? Do the proposed approaches take 
advantage of unique features of the research environment or employ useful 
collaborative arrangements? Is there evidence of institutional support?  

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following 
items will be considered in the determination of scientific merit and the 
priority score:

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 
subjects and protections from research risk relating to their participation 
in the proposed research will be assessed. (See criteria included in the 
section on Federal Citations, below).
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 will be assessed.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the sections on 
Federal Citations, below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to 
be used in the project, the five items described under Section f of the PHS 
398 research grant application instructions (rev. 5/2001) will be assessed.  

ADDITIONAL REVIEW CONSIDERATIONS

Sharing Research Data 

Applicants requesting more than $500,000 in direct costs in any year of the 
proposed research are expected to include a data sharing plan in their 
application. The reasonableness of the data sharing plan or the rationale for 
not sharing research data will be assessed by the reviewers. However, 
reviewers will not factor the proposed data sharing plan into the 
determination of scientific merit or priority score. 
(http://grants.nih.gov/grants/policy/data_sharing)

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

AWARD CRITERIA

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

REQUIRED FEDERAL CITATIONS 

HUMAN SUBJECTS PROTECTION:  Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained. 
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for 
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II), efficacy, 
effectiveness and comparative trials (phase III). The establishment of data 
and safety monitoring boards (DSMBs) is required for multi-site clinical 
trials involving interventions that entail potential risk to the 
participants.(NIH Policy for Data and Safety Monitoring, NIH Guide for Grants 
and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

SHARING RESEARCH DATA:  Starting with the October 1, 2003 receipt date, 
investigators submitting an NIH application seeking $500,000 or more in 
direct costs in any single year are expected to include a plan for data 
sharing or state why this is not possible. 
http://grants.nih.gov/grants/policy/data_sharing .  Investigators should seek 
guidance from their institutions, on issues related to institutional 
policies, local IRB rules, as well as local, state and Federal laws and 
regulations, including the Privacy Rule. Reviewers will consider the data 
sharing plan but will not factor the plan into the determination of the 
scientific merit or the priority score.

Investigators should seek guidance from their institutions, on issues related 
to institutional policies, local IRB rules, as well as local, state and 
Federal laws and regulations, including the Privacy Rule. Reviewers will 
consider the data sharing plan but will not factor the plan into the 
determination of the scientific merit or the priority score.

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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 clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of the 
research. This policy results from the NIH Revitalization Act of 1993 (Section 
492B of Public Law 103-43).

All investigators proposing clinical research should read the "NIH Guidelines 
for Inclusion of Women and Minorities as Subjects in Clinical Research - 
Amended, October, 2001," published in the NIH Guide for Grants and Contracts 
on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. 
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.

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

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm. 

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on 
hESCs can be found at http://stemcells.nih.gov/index.asp and at  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).   
It is the responsibility of the applicant to provide, in the project 
description and elsewhere in the application as appropriate, the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The 
Department of Health and Human Services (DHHS) issued final modification to 
the “Standards for Privacy of Individually Identifiable Health Information”, 
the “Privacy Rule,” on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified 
under the Rule as “covered entities”) must do so by April 14, 2003  (with the 
exception of small health plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on “Am I a covered 
entity?”  Information on the impact of the HIPAA Privacy Rule on NIH 
processes involving the review, funding, and progress monitoring of grants, 
cooperative agreements, and research contracts can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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.healthypeople.gov/.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All 
awards are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm.

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.

Return to Volume Index

Return to NIH Guide Main Index

Department of Health and Human Services

National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892