MOLECULAR LIBRARIES SCREENING INSTRUMENTATION
RELEASE DATE: July 13, 2004
RFA Number: RFA-RM-04-020 (see NOT-RM-04-015)
EXPIRATION DATE: January 25, 2005
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
This Request for Application (RFA) is developed as an NIH Roadmap
initiative (http://nihroadmap.nih.gov). All NIH institutes and centers
(ICs) participate in Roadmap initiatives. This RFA will be administered
by the National Human Genome Research Institute (NHGRI)
(http://www.genome.gov) on behalf of NIH.
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.172
LETTER OF INTENT RECEIPT DATE: January 4, 2005 (per NOT-RM-04-015)
APPLICATION RECEIPT DATE: January 24, 2005 (per NOT-RM-04-015)
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The National Institutes of Health invites research applications to
develop innovative instrumentation to accelerate the pace and maximize
the efficiency of molecular library high throughput screening. This RFA
is one component of the Molecular Libraries and Imaging Initiative of
the NIH Roadmap. Investigators are encouraged to collaborate, as
appropriate, with investigators working on assay development and on
establishment of screening centers for the Molecular Libraries and
Imaging Initiative.
Applications in response to this RFA should propose design-directed,
discovery-driven, or hypothesis-driven research on high throughput
screening instrumentation. It is expected that research proposals will
include specific aims with quantitative measures of anticipated
achievements, and well-defined milestones that chart key steps toward
the goal of innovative and substantial advances in instrumentation.
The NIH Roadmap initiatives encourage multidisciplinary approaches.
Investigators who may be new to NIH and biomedical research, from
fields such as physics, chemistry, or engineering, are encouraged to
participate in this program.
RESEARCH OBJECTIVES
The NIH Roadmap is a series of new initiatives designed to identify
major opportunities and gaps in biomedical research that no single NIH
institute could tackle alone but which the agency as a whole can pursue
to stimulate the progress of biomedical research and to catalyze
changes that will serve to transform new scientific knowledge into
tangible benefits for public health (http://nihroadmap.nih.gov/).
The Molecular Libraries and Imaging Initiative (MLII)
(http://nihroadmap.nih.gov/molecularlibraries/index.asp) is one of the
components comprising the Roadmap theme of New Pathways to Discovery .
Its goal is to build a better toolbox to advance our understanding of
the interconnected networks of molecules that comprise cells and
tissues, their interactions, regulation, and the combination of
molecular events that lead to disease. One objective of the MLII is to
develop a publicly available database of biological activities for
small organic molecules and to provide access to these molecules to the
scientific community. This initiative is expected to promote the use
of chemical probes to study cellular pathways in greater depth and to
provide new options for investigating the functions of major components
of the cell in health and disease. Crucial to the objectives of the
MLII is also the development of novel assays and instrumentation for
assessing activities of small molecules and probes and for facilitating
their application to studies of biology and pathophysiology. The MLII
will provide unprecedented access for the academic community to such
resources and knowledge, and ultimately will enable and catalyze the
identification of novel targets for therapeutic intervention.
This announcement is focused on development of innovative
instrumentation for high throughput screening of synthetic chemical and
natural product libraries such as the ones that will be registered and
housed in the NIH-sponsored molecular libraries screening centers.
High throughput molecular screening (HTS) is the automated, rapid
testing of thousands of distinct small molecules or probes in cellular
models of biological mechanisms or disease, or in biochemical or
pharmacological assays. Active compounds identified through HTS can
provide powerful research tools to elucidate biological processes
through chemical genetic approaches, or can form the basis of
therapeutics or imaging agent development programs. HTS has
experienced revolutionary changes in technology since the advent of
molecular biology and combinatorial chemistry, and the incorporation of
modern information management systems. Current HTS instrumentation
allows screening of hundreds of thousands of compounds in a single day
at a rate orders of magnitude greater than was possible a decade ago.
However, there are still bottlenecks which currently limit HTS
capacity, such as (a) compound collection maintenance, tracking, and
disbursement, and (b) rapidity, accuracy, and content of assay
instrumentation.
This RFA seeks to develop HTS instrumentation that is not only faster
and more efficient than currently available systems, but also
substantially more sensitive with high levels of specificity,
reproducibility, and accuracy. Other important criteria include greater
screening capacity, flexibility, and multiplexing capabilities.
Examples of potential research areas that are responsive to this RFA
include, but are not limited to:
o novel high throughput screening system integration
o innovative methods for highly parallel ligand/target binding
detection
o innovative microfluidics and lab-on-chip technologies
o improved cell-based high-content assay formats to acquire many
outputs in parallel
o innovative methods for data acquisition and management
All applications are expected to describe clearly advantages in
efficiency and/or scale versus current technologies. A description of
the practical application of instrumentation derived from the proposed
research must also be included.
MECHANISM OF SUPPORT
This RFA will use the NIH R01 award mechanism. As an applicant you
will be solely responsible for planning, directing, and executing the
proposed project. NIH encourages multidisciplinary research. It is
expected that the PI will bring together the necessary physical,
engineering and biological expertise and resources to successfully
achieve the goals of the RFA. This RFA is a one-time solicitation.
Future unsolicited, competing-continuation applications based on this
project will compete with all investigator-initiated applications and
will be reviewed according to the customary peer review procedures. The
earliest expected award date is June, 2005. Applications that are not
funded in the competition described in this RFA may be resubmitted as
NEW investigator-initiated applications using the standard receipt
dates for NEW applications described in the instructions to the PHS 398
application form.
The initial support for an R01 award in response to this RFA may be up
to four years.
This RFA uses just-in-time concepts. It also uses the modular
budgeting as well as the non-modular budgeting formats (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 budget format.
Otherwise follow the instructions for non-modular budget research grant
applications. This program does not require cost sharing as defined in
the current NIH Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm.
FUNDS AVAILABLE
The NIH intends to commit approximately $4M to fund new competitive
grants in response to this RFA. An applicant may request a project
period of up to four years. The number of awards and level of support
will depend on the number of applications of high scientific merit that
are received. Because the nature and scope of the proposed research
will vary from application to application, it is anticipated that the
size and duration of each award will also vary. Although the financial
plans of the NIH provide support for this program, awards pursuant to
this RFA are contingent upon the availability of funds and the receipt
of a sufficient number of meritorious applications.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the
following characteristics:
o Domestic 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
Foreign institutions may not apply; however, participating
collaborators can be located at foreign institutions.
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.
SPECIAL REQUIREMENTS
o Milestones that chart key steps towards the goal of innovative and
substantial advances in high throughput molecular screening
instrumentation
o 25% minimum effort level by the PI
o Investigators are encouraged to collaborate, as appropriate, with
investigators in other components of the Molecular Libraries and
Imaging Initiative, such as those involved in assay development
(RFA RM-04-012) and in establishment of screening centers (RFA RM-04-017).
These collaborations need not be formalized at the time of the grant
application, but funds should be budgeted for this effort. Public and
private partnership is also encouraged.
All applications that list direct costs of $500,000 or more per year
must also have a plan to address intellectual property and
accessibility of research resources, as described below.
Intellectual Property Rights and Accessibility of Research Resources
NIH is interested in ensuring that the research resources developed
through this RFA become readily available to the research community.
Applicants who respond to this RFA must include a plan addressing if,
or how, they will exercise their intellectual property rights, should
any intellectual property be generated, while making such research
resources available to the broader scientific community for research
purposes consistent with the goals of the NIH Molecular Libraries and
Imaging Initiative. A reasonable time frame for release of materials
should be specified in the sharing plan and will be considered during
the review. Furthermore, transfers of research resources must be made
consistent with the NIH Research Tools Policy
(http://www.ott.nih.gov/policy/rt_guide_final.html) and other NIH
sharing policies. In the development of the sharing and intellectual
property plans, applicants should confer with their own institution's
office(s) responsible for handling technology transfer related matters
and/or their sponsored research office. If applicants or their
representatives require additional guidance in preparing these plans,
they are encouraged to make further inquiries to the appropriate
contacts listed below for such matters.
The scientific review group will evaluate the adequacy of the proposed
plan for handling intellectual property rights. Comments on the plan
and any concerns will be presented in an administrative note in the
Summary Statement. These comments will not affect the priority score of
the application. NIH program staff, in determining whether the
application shall be awarded, will consider the adequacy of the
proposed plan. The plan as approved, after negotiation with the
applicant when necessary, will be part of the terms and conditions of
the award. Evaluation of non-competing continuation applications will
include assessment of the awardee's adherence to the proposed plan, and
will be a criterion for continued funding of the award. Applicants also
are reminded that the grantee institution is required to disclose each
subject invention to NIH within two months after the inventor discloses
it in writing to grantee institutional personnel responsible for patent
matters. The awarding Institute reserves the right to monitor awardee
activity in this area to ascertain if patents or patent applications
are adversely affecting the goals of this RFA. Principles and
guidelines for recipients of NIH research awards on obtaining and
disseminating biomedical research resources can be found at
http://www.ott.nih.gov/policy/rt_guide_final.html. This document also
defines terms, parties, responsibilities, prescribes the order of
disposition of rights, prescribes a chronology of reporting
requirements, and delineates the basis for and extent of government
actions to retain rights. Patent rights clauses may be found at 37 CFR
Part 401.14 and are accessible from the Interagency Edison web page,
http://www.iedison.gov.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA 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:
Bradley A. Ozenberger, Ph.D.
Division of Extramural Research
National Human Genome Research Institute
National Institutes of Health, DHHS
Suite 4076 - MSC 9305
5635 Fishers Lane
Bethesda, MD 20892-9305
(express/courier services should be directed to Rockville, MD 20852)
Telephone: (301) 496-7531
FAX: (301) 480-2770
Email: bozenberger@mail.nih.gov
Fei Wang, Ph.D.
Division of Discovery Science & Technology
National Institute of Biomedical Imaging and Bioengineering
National Institutes of Health, DHHS
6707 Democracy Boulevard, Suite 200
Bethesda, MD 20892-5477 (20817 for express/courier services)
Telephone: (301)451-4778
Fax: (301)480-4973
Email: wangf@mail.nih.gov
o Direct your questions about peer review issues to:
David T. George, Ph.D.
Office of Scientific Review
National Institute of Biomedical Imaging and Bioengineering
National Institutes of Health, DHHS
6707 Democracy Boulevard, Suite 920, MSC5469
Bethesda, MD 20892-5469 (20817 for express/courier services)
Telephone: (301) 496-8633
Fax: (301) 480-0675
Email: georged1@mail.nih.gov
o Direct your questions about financial or grants management matters
to:
Cheryl Chick
Grants Administration Branch
National Human Genome Research Institute
National Institutes of Health, DHHS
Suite 4076 - MSC 9306
5635 Fishers Lane
Bethesda, MD 20892-9306
Telephone: (301) 435-7858
FAX: (301) 402-1951
Email: ChickC@mail.nih.gov
LETTER OF INTENT
Prospective applicants are strongly advised to submit a letter of
intent that includes the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does
not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review
workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning
of this document. The letter of intent should be sent to:
Dr. Bradley A. Ozenberger
Division of Extramural Research
National Human Genome Research Institute
National Institutes of Health, DHHS
Suite 4076 - MSC 9305
5635 Fishers Lane
Bethesda, MD 20892-9305
Telephone: (301) 496-7531
FAX: (301) 480-2770
Email: bozenberger@mail.nih.gov
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 document 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.
APPLICATION PREPARATION INSTRUCTIONS: Follow the PHS 398 instructions
for "Preparing Your Application" with the following modifications and
additions:
1. Page limitations for applications in response to this RFA have been
increased to a maximum of 30 pages from the usual 25-page limit for
sections A-D of the "Research Plan". Applicants are encouraged to be
concise and use fewer pages.
2. A program plan should list major tasks with a timeline of
quantitative milestones for the entire project period. This
information should be included in the Research, Design, and Methods
section of the application.
3. Budget Items: The PI is expected to devote a minimum of 25% effort
to the proposed research. Information documenting and justifying the
level of effort on the proposed research activities for all personnel
should be included in the application.
4. Applications must include a plan for making available to the
research community any technologies developed or enhanced by work
conducted as part of this RFA. Investigators using PHS funds are
required to make unique research resources readily available for
research purposes to qualified individuals within the scientific
community when the results have been published. The intent of this
policy is not to discourage, impede, or prohibit the organization that
develops the unique research resources or intellectual property from
commercializing the products.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev.
5/2001) application form must be affixed to the bottom of the face page
of the application. Type the RFA number on the label. Failure to use
this label could result in delayed processing of the application such
that it may not reach the review committee in time for review. In
addition, the RFA title and number must be typed on line 2 of the face
page of the application form and the YES box must be marked. The RFA
label is also available at:
http://grants.nih.gov/grants/funding/phs398/labels.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten
original of the application, including the Checklist, and three 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 (20817 for express/courier services)
At the time of submission, two additional copies of the application and
all copies of the appendix material must be sent to:
David T. George, Ph.D.
Office of Scientific Review
National Institute of Biomedical Imaging and Bioengineering
National Institutes of Health, DHHS
6707 Democracy Boulevard, Suite 920, MSC5469
Bethesda, MD 20892-5469 (20817 for express/courier services)
Telephone: (301) 496-8633
Fax: (301) 480-0675
Email: georged1@mail.nih.gov
APPLICATION PROCESSING: Applications must be received on or before the
application receipt date listed in the heading of this RFA. If an
application is received after that date, it will be returned to the
applicant without review.
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.
The Center for Scientific Review (CSR) will not accept any application
in response to this RFA that is essentially the same as one currently
pending initial review, unless the applicant withdraws the pending
application. However, when a previously unfunded application,
originally submitted as an investigator-initiated application, is to be
submitted in response to an RFA, it is to be prepared as a NEW
application. That is, the application for the RFA must not include an
Introduction describing the changes and improvements made, and the text
must not be marked to indicate the changes from the previous unfunded
version of the application.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by the sponsoring ICs. Incomplete applications
and/or non-responsive applications will be returned to the applicant
without further consideration.
Applications that are complete and responsive to this RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by the NIBIB in accordance with the review
criteria stated below. As part of the initial merit review, all
applications will:
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications
under review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the NHGRI National Advisory Council
or Board.
REVIEW CRITERIA
The goal of this RFA is to develop innovative instrumentation to
accelerate the pace and maximize the efficiency of molecular library
high throughput screening. 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
this goal. 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. 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.
o Significance
o Approach
o Innovation
o Investigators
o Environment
SIGNIFICANCE: If the specific aims of the application are achieved,
will they provide significant advances in Molecular Libraries Screening
Instrumentation? Is the research likely to have a significant impact on
other areas of this field? Will the technological advances have a
significant impact on human health?
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? Is a timetable with adequate research
milestones proposed? Are appropriate specifications and evaluation
procedures provided for assessing technological progress? Is there a
plan for coordination with assay development and implementation
components of the public screening centers? If partnership with
industry or small business is included, does this positively affect the
research goals and technology dissemination?
INNOVATION: Does the project employ new approaches or methods? Are the
aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies?
INVESTIGATORS: Is the PI capable of coordinating and managing the
proposed research? Is there evidence of successful collaboration among
the investigation team? Are the investigators appropriately trained in
their disciplines and capable of conducting and contributing to the
management of the proposed work?
ENVIRONMENT: Does the scientific and technological environment in which
the 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
MILESTONES: The research proposals in response to this RFA must have
specific aims which include quantitative measures of anticipated
achievements and well-defined milestones that chart key steps to
achieving the specific aims as specified in the application. Are the
milestones achievable? Will Molecular Libraries Screening
Instrumentation be significantly advanced by achieving the milestones?
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).
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. 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
TECHNOLOGY SHARING AND DISSEMINATION: Applicants must include a plan in
their proposal for the sharing and dissemination of developed
technology. The reasonableness of the technology sharing and
dissemination plan or the rationale for not sharing research findings
and technologies will be assessed by the reviewers. However, reviewers
will not factor the proposed sharing and dissemination plan into the
determination of scientific merit or priority score.
INTELLECTUAL PROPERTY RIGHTS: Applicants must include a plan
addressing if, or how, they will exercise their intellectual property
rights, should any intellectual property be generated, while making
such research resources available to the broader scientific community
for research purposes consistent with the goals of the NIH Molecular
Libraries and Imaging Initiative. The reasonableness of the
intellectual property rights plan will be assessed by the reviewers.
However, reviewers will not factor the proposed intellectual property
rights plan into the determination of scientific merit or priority
score.
BUDGET: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: September 22, 2004 (see change NOT-RM-04-015)
Application Receipt Date: October 22, 2004 (see change NOT-RM-04-015)
Peer Review Date: February - March, 2005 (see change NOT-RM-04-015)
Council Review: May, 2005 (see change NOT-RM-04-015)
Earliest Anticipated Start Date: June, 2005
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic 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: 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.
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.
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).
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 RFA 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)(cite appropriate authorizations) and
under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92 (cite
relevant regulations). 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.
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NIH Funding Opportunities and Notices
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Department of Health and Human Services (HHS)
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