ELSI SMALL GRANT RESEARCH PROGRAM (R03)
RELEASE DATE: January 15, 2004
PA NUMBER: PA-04-051 (Reissued as PA-08-013)
(See NOT-HG-06-013 for details on expiration of this Notice.
Also see NOT-HG-05-002)
March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date,
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using
the electronic SF424 (R&R) application. Parent R03 (PA-06-180) and R21 (PA-06-181)
funding opportunity announcements have been issued for the submission date of
June 1, 2006 and submission dates thereafter. Applications relating to R33 and R34
activities must be in response to NIH Institute/Center (IC)-specific announcements.
EXPIRATION DATE: May 17, 2006 unless reissued.
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENTS OF PARTICIPATING ORGANIZATIONS:
National Human Genome Research Institute (NHGRI)
(http://www.genome.gov/)
National Mental Health Institute (NIMH)
(http://www.nimh.nih.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 Deafness and Other Communication Disorders (NIDCD)
(http://www.nidcd.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
(http://www.niddk.nih.gov/)
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS)
(http://www.niehs.nih.gov/)
National Institute of Nursing Research (NINR)
(http://www.ninr.nih.gov/)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.172, 93.866, 93.865,
93.173, 93.847, 93.279, 93.113, 93.115, 93.242, 93.361.
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 Small Grant PA, which 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 whose analytical style of inquiry often has not been
adequately encouraged or supported by the more traditional NIH R01
application process. It is also designed to support smaller exploratory
studies that may provide preliminary findings or pilot data for larger
research proposals in all research areas of interest.
Applications requesting more than $50,000 in direct costs should be submitted
under the ELSI Regular Research Grant (R01) PA, PA-04-050: ELSI Regular
Research Program (http://grants.nih.gov/grants/guide/pa-files/PA-04-050.html).
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.
This Program Announcement is complemented by PA-04-050, the ELSI Regular
Research Grant (R01) Program
(http://grants.nih.gov/grants/guide/pa-files/PA-04-050.html).
The R01 program will accept applications for grants with direct costs
greater than $50,000 per year for more than two years. An R01 grant
application may build upon the preliminary work done through a small
research grant (R03).
The NHGRI ELSI Research Program also will accept conference grant (R13)
applications on these and related topics. For application guidelines and
instructions, please refer to PAR-03-176: NIH Support for Conferences and
Scientific Meetings.
http://grants.nih.gov/grants/guide/pa-files/PAR-03-176.html.
MECHANISM OF SUPPORT
This PA will use the NIH R03 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).
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) 710-0267, Email: GrantsInfo@nih.gov.
For the purposes of this ELSI small grant program announcement, all of the
participating institutes have agreed on the following guidelines and will use
the standard application receipt dates. Institute specific small grant
program guidelines and receipt dates should not be used in responding to this
announcement.
The title and number of the program announcement must be typed on line 2 of
the face page of the application form and the YES box must be marked.
The application should not exceed a total of ten pages for the following
sections: specific aims, background and significance, progress
report/preliminary studies, and experimental design and methods. Tables and
figures are included in the ten page limitation. The ten page limit does not
include Sections 5-9 (Human Subjects, Consortia, Literature cited) or the
appendices.
All small grant (R03) applications must use the modular grant application
instructions.
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
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.
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
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 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
In the review of small grant (R03) applications, additional weight will be
given to the qualifications and track record of the principal investigator
and the significance and timeliness of the issue being addressed. 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.
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 or technologies?
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 CONSIDERATIONS
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).
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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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Department of Health and Human Services (HHS)
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NIH... Turning Discovery Into Health®
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