Department of Health and
Human Services
Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Components of
Participating Organizations
National Library of Medicine (NLM), (http://www.nlm.nih.gov)
Title: Limited
Competition for Continuation of NLM Biomedical Informatics/Bioinformatics
Resource Grant (P41)
Announcement Type
This is a reissue of PAR-04-142
Request For Applications
(RFA) Number: RFA-LM-08-001
Catalog of Federal
Domestic Assistance Number(s)
93.879
Key Dates
Release
Date: June 10,
2008
Letters of Intent Receipt Date(s): July
28, 2008
Application
Receipt Date(s): August
27, 2008
Peer Review Date(s): November 2008
Council
Review Date(s): January
2009
Earliest
Anticipated Start Date: April 1, 2009
Additional Information To Be Available Date (Url
Activation Date): Not applicable
Expiration Date: August 28, 2008
Due Dates for E.O. 12372
Not
Applicable
Additional Overview Content
Executive
Summary
Table of Contents
Part
I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review and
Anticipated Start Dates
1.
Letter of Intent
B. Sending an Application to
the NIH
C. Application Processing
D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Through
its Biomedical Informatics/Bioinformatics Resource Grant program, the National
Library of Medicine provides funding for five (5) centers that provide unique
research resources to large communities of researchers. NLM provides funding to
these centers to support the research, development, maintenance, training and
dissemination activities that assure a resource meets needs of its users. This
FOA has been issued to allow competitive renewal of the existing center, to
provide continuation funds. No applications for new resources will be accepted,
nor will expansion of scope at the existing resource centers be supported.
These grants are not intended to support tools or resources that duplicate
activities of the National Library of Medicine.
NLM’s Biomedical Informatics/Bioinformatics Resource Grants cannot be used to support traditional hypothesis testing or proof of concept research, or to underwrite the initial development of a tool or resource. Investigators who wish to undertake biomedical informatics research, to develop and test novel information technologies, to perform feasibility or proof-of-concept studies, should use one of NLM’s other research grant mechanisms listed at http://www.nlm.nih.gov/ep/Grants.html.
NLM’s Biomedical Informatics Resource grants are not intended to support research that utilizes a tool or database being supported through NLM’s Biomedical Informatics/Bioinformatics Resource Grant program. Such projects should seek funding through customary NIH research grant mechanisms.
To quality for continued support from NLM, biomedical
informatics resources must be of proven value to a large community of users,
and must employ national standards and proven technologies to enable deposit,
exchange, access and dissemination of knowledge. The NLM Biomedical
Informatics/Bioinformatics Resource Grant supports ongoing research and
development for, and maintenance of, the tool or resource, as well as user
training and services, and wide dissemination of the tool or resource.
NLM’s Biomedical Informatics Resource
grants provide funds to support an operations center whose functions include:
(1) maintenance of scalable, appropriate infrastructure to support local and
distant users; (2) support services and collaboration with users and
stakeholders; (3) research and development to improve the longevity, quality,
completeness and utility of the resource; (4) user training; (5) dissemination
of information about the resource, and (6) evaluation of the resource.
Applicants must provide plans for each of these areas.
1. Maintenance of the resource: A unique, widely-used resource requires expertise, equipment and a plan to keep up with the pace of technological change and evolving approaches to information handling. Such maintenance is a principal purpose of NLM’s Biomedical Informatics Resource grant, and evidence of plans to assure continued usefulness and sustainability are a major component of the application for support.
2. Service: Assisting the biomedical investigators and clinicians who use or want to use a tool or database is a fundamental activity of a biomedical informatics resource center. Providing access to the resource's technology should include techniques for helping users obtain, install and use a tool or database; offering consultation and technical assistance; providing users, including other information systems, with a means to upload and download information if appropriate.
3. Technological Research and Development: A biomedical informatics resource requires continuing development of its functionality and technology to sustain value for the user community, and to meet changing needs of health care and biomedical research. Such research and development may involve modification or redesign of database structures, implementation of new software or new communication technologies. Research and development to improve a biomedical informatics resource is meant to assure its quality and robustness.
4. Training: New users may require basic instruction to use the resource effectively, and all users may need re-training as technologies, functionality and interfaces evolve. Training, whether in person or online, should be designed to inform the user community about the features of a tool or database, demonstrating new features as they are developed, and attracting new users to the community. Training may encompass many techniques, including short courses, workshops, and individual training of visiting scientists and students. Applicants should include some training approaches that involve in-person, hands-on training.
5. Dissemination: A biomedical resource center must keep the scientific community informed about the resource, its features and its potential for science by publishing articles or books, conducting conferences, making presentations, distributing software products, or transferring technologies to industry where they will be distributed widely.
6. Evaluation: Regular assessment of the utility, value, quality and completeness of the resource must be undertaken to assure its continued viability. Evaluation should include stakeholder communities including but not limited to users. Evaluation should provide examples of advances in biomedical research or practice that can be traced to the resource.
Applicants for this grant are strongly encouraged to establish an external advisory committee for the resource. Members of this committee should be knowledgeable about the resource, should represent the geographical regions served, and the types of users served. The chair of the external advisory committee should have knowledge of the resource's value, but should not be a member of the resource center’s staff or a major external user of the resource. The external advisory committee should provide guidance to the principal investigator on all aspects of the six areas discussed above, including future directions, growth, marketing, guidelines for the resource's use, and sustainability plans. The external advisory committee should meet at least annually.
See Section VIII, Other Information - Required Federal Citations, for
policies related to this announcement.
Section II. Award Information
1.
Mechanism of Support
This funding
opportunity will use the P41 award mechanism.
The
Project Director/Principal Investigator (PD/PI) will be solely responsible for
planning, directing, and executing the proposed project.
This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
2. Funds Available
The estimated amount of funds available for support is approximately $2,400,000 for 2 or 3 projects. Future year amounts will depend on annual appropriations.
Because the nature
and scope of the proposed research resource 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 IC(s) provide support for this
program, awards pursuant to this funding opportunity are contingent upon the
availability of funds and the receipt of a sufficient number of meritorious
applications.
Facilities and administrative costs requested by
consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
The following organizations/institutions are eligible
to apply:
This FOA is a limited competition for continuation of the NLM Biomedical Informatics/Bioinformatics Resource grant (P41) which was previously reviewed in response to PAR-04-142.. Any institution awarded as part of that announcement is eligible to apply for continuation.
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her 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 support.
2.
Cost Sharing or Matching
This
program does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special
Eligibility Criteria
This FOA supports only renewal applications from organizations that currently receive NLM grant funding for biomedical informatics /bioinformatics resource projects. .
Section IV. Application and Submission Information
1. Address to Request Application Information
The PHS 398
application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301)
435-0714, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY
301-451-0088.
2. Content and Form of
Application Submission
Applications must
be prepared using the most current PHS 398 research grant application
instructions and forms. Applications must have a D&B Data Universal
Numbering System (DUNS) number as the universal identifier when applying for
Federal grants or cooperative agreements. The D&B number can be obtained by
calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number
should be entered on line 11 of the face page of the PHS 398 form.
The title and number of this funding opportunity must
be typed in item (box) 2 only of the face page of the application form and the
YES box must be checked.
3. Submission Dates and Times
Applications must be
received on or before the receipt date described below (Section
IV.3.A). Submission times N/A.
3.A. Receipt, Review and Anticipated Start
Dates
Letter of Intent
Receipt Date(s): July 28, 2008
Application Receipt Date(s): August 27, 2008
Peer Review Date(s): November 2008
Council Review Date(s): January 2009
Earliest
Anticipated Start Date(s): April 1, 2009
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of
intent that includes the following information:
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
plan the review.
The letter of intent is to be sent by the date listed
in Section IV.3.A.
The letter of intent should be sent to:
Dr. Arthur Petrosian
NLM Extramural Programs
6705
Rockledge Drive
Rockledge 1, Suite 301
Bethesda, MD 20892
Telephone: (301) 594-4933
FAX: (301) 402-2952
Email:
petrosia@mail.nih.gov
3.B.
Sending an Application to the NIH
Applications must be prepared using the forms found in
the PHS 398 instructions for preparing a research grant application. 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 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal deliveries
of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At the time of
submission, two additional copies of the
application and all copies of the appendix material must be sent to:
Dr. Arthur Petrosian
NLM Extramural Programs
6705
Rockledge Drive
Rockledge 1, Suite 301
Bethesda, MD 20892
Telephone: (301) 594-4933
FAX: (301) 402-2952
Email:
petrosia@mail.nih.gov
3.C.
Application Processing
Applications
must be received
on or before the application receipt date) described above (Section IV.3.A.). If an application is received after
that date, the application may be delayed in the review process or not
reviewed. Upon receipt, applications will be evaluated for completeness
by the CSR and for responsiveness by the reviewing Institute. Incomplete and/or
non-responsive applications will not be reviewed.
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This initiative is not subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards
are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at NIH Grants
Policy Statement.
Pre-award costs are allowable. A grantee may, at its
own risk and without NIH prior approval, incur obligations and expenditures to
cover costs up to 90 days before the beginning date of the initial budget
period of a renewal award if such costs: 1) are
necessary to conduct the project, and 2) would be allowable under the grant, if
awarded, without NIH prior approval. If specific expenditures would otherwise
require prior approval, the grantee must obtain NIH approval before incurring
the cost. NIH prior approval is required for any costs to be incurred more than
90 days before the beginning date of the initial budget period of a renewal award.
The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project
(see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)
6. Other Submission
Requirements and Information
As indicated in the instructions for PHS 398, applicants seeking renewal funding must include a progress report in the body of the application that summarizes accomplishments since their most recent application. Applicants should include the following data for all years covered by the most recent competitive award: (1) statistics of growth in the user base, and usage by the user community; (2) a report of program income that results from fees, licenses, and other charges to users, if applicable; (3) a list of presentations and training sessions offered to users; (4) a summary of evaluation outcomes.
Applicants should budget for one progress visit each year, to discuss and coordinate plans and activities with NLM Extramural Programs staff.
Funds should be budgeted to support yearly meetings of the external advisory committee. The NLM program officer will serve as a non-voting ex-officio member of the external advisory committee.
Research Plan Page Limitations
The research plan is limited to 25 pages, as described in the instructions for PHS 398.
Appendix Materials
All paper PHS 398 applications must provide appendix material on CD only. Include five identical CDs in the same package with the application. (See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Resource Sharing Plan(s)NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.
If an applicant proposes to charge fees for use or licensing of the NLM-supported resource, the application must include an explanation of the fee plan, and of proposed uses for the fees. NLM reserves the right to redirect user fees to the support of the resource.
Section V. Application Review Information
1. Criteria
Only
the review criteria described below will be considered in the review process.
2. Review and Selection
Process
Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NLM and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.
Peer review for all applications responding to this FOA will be done via a site visit. As part of the scientific peer review, all applications will:
The following will be considered in making funding decisions:
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious 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 scientific knowledge or clinical
practice be advanced? What will be the effect of these studies on the concepts,
methods, technologies, treatments, services, or preventative interventions that
drive this field? Is there convincing evidence that the resource is unique and of
substantial value to biomedical research or practice? Is there evidence of sustained use by a broad,
describable community of users?
Approach: Are the conceptual or clinical framework, design, methods,
and analyses adequately developed, well integrated, well reasoned, and
appropriate to the aims of the project? Does the applicant acknowledge
potential problem areas and consider alternative tactics? Are provisions
made for insightful, timely development, sound maintenance, quality assurance,
and project evaluation? Were goals of the previous funding period met or
exceeded?
Innovation: Is the project original and innovative? For example: Does
the project challenge existing paradigms or clinical practice; address an
innovative hypothesis or critical barrier to progress in the field? Does the
project develop or employ novel concepts, approaches, methodologies, tools, or
technologies for this area? Do the plans for improvement of the resource incorporate
new techniques and technologies?
Investigators: Are the investigators 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? Does the
investigative team bring complementary and integrated expertise to the project
(if applicable)? Is there an
appropriate array of expertise for planning, training, service and evaluation?
Environment: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed studies benefit
from unique features of the scientific environment, or subject populations, or
employ useful collaborative arrangements? Is there evidence of institutional
support? Is
the organization’s technological infrastructure adequate to meet current
and future needs?
2.A. Additional Review Criteria:
In addition to
the above criteria, the following items will continue to be considered in the
determination of scientific merit and the rating:
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 the Research Plan section on Human
Subjects in the PHS 398 instructions).
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 the Research Plan section on Human
Subjects in the PHS 398 instructions).
Care and Use of Vertebrate
Animals in Research: If vertebrate
animals are to be used in the project, the five points described in the
Vertebrate Animals section of the Research Plan will be assessed.
Biohazards: If materials or procedures are proposed that are
potentially hazardous to research personnel and/or the environment, determine
if the proposed protection is adequate.
2.B.
Additional Review Considerations
Budget: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the budget.
2.C. Resource Sharing Plan
When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.
3.
Anticipated Announcement and Award Dates
Not Applicable.
Section VI. Award Administration Information
1. Award Notices
After the peer
review of the application is completed, the PD/PI will be able to access his or
her Summary Statement (written critique) via the eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General.
A
formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization. The NoA signed by the grants management officer
is the authorizing document. Once all administrative and programmatic issues
have been resolved, the NoA will be generated via email notification from the
awarding component to the grantee business official (designated in item 12 on
the Application Face Page). If a grantee is not email enabled, a hard copy of
the Notice of Award will be mailed to the business official.
Selection of an
application for award is not an authorization to begin performance. Any costs
incurred before receipt of the NoA are at the recipient's risk. These costs may
be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.
2.
Administrative and National Policy Requirements
NLM Biomedical Informatics/Bioinformatics Resource Grants
will include special terms and conditions addressing the use of program income,
and for the deposit in PubMed Central of peer-reviewed publications that report
research or resources funded by this grant.
All NIH grant and
cooperative agreement awards include the NIH Grants Policy Statement as part of
the NoA. For these terms of award, see the NIH Grants Policy Statement Part II:
Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
3.
Reporting
Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
Each progress report should include the following information:
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
We
encourage your inquiries concerning this funding opportunity 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:
1. Scientific/Research
Contacts:
Dr.
Valerie Florance
Deputy Director
Extramural Programs Division
National Library of Medicine
Rockledge 1, Suite 301
6705 Rockledge Drive
Bethesda, MD 20892
Telephone: (301) 594-4882
FAX: 301-402-2952
Email: florancev@mail.nih.gov
2. Peer Review Contacts:
Dr.
Arthur Petrosian
Scientific Review Officer
Extramural Programs Division
National Library of Medicine
Rockledge 1, Suite 301
6705 Rockledge Drive
Bethesda, MD 20892
Telephone: (301) 496-4399
FAX: 301-402-2952
Email: petrosia@mail.nih.gov
3. Financial or Grants
Management Contacts:
Dwight
Mowery
Grants Management Officer
Extramural Programs Division
National Library of Medicine
Rockledge 1, Suite 301
6705 Rockledge Drive
Bethesda, MD 20892
Telephone: (301) 496-4221
FAX: 301-402-0421
Email: moweryd@mail.nih.gov
Section VIII. Other Information
Required
Federal Citations
Use of
Animals in Research:
Recipients of PHS support for activities involving
live, vertebrate animals must comply with PHS Policy on Humane Care and Use of
Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
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). Monitoring should be commensurate with risk. The
establishment of data and safety monitoring boards (DSMBs) is required for
multi-site clinical trials involving interventions that entail potential risks
to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, 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 and 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.
Policy
for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/.
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 funding opportunity 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.
Sharing of
Model Organisms:
NIH is committed
to support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH funding
or state why such sharing is restricted or not possible. This will permit other
researchers to benefit from the resources developed with public funding. The
inclusion of a model organism sharing plan is not subject to a cost threshold
in any year and is expected to be included in all applications where the
development of model organisms is anticipated.
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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is 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 Clinical Research:
The NIH
maintains a policy that children (i.e., individuals under the age of 21) must
be included in all clinical 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 (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 applications for research involving human subjects
and individuals designated as key personnel. The policy is available 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 (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.
NIH Public
Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html)
investigators must submit or have submitted for them their final, peer-reviewed
manuscripts that arise from NIH funds and are accepted for publication as of
April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly
available no later than 12 months after publication. As of May 27, 2008,
investigators must include the PubMed Central reference number when citing an
article in NIH applications, proposals, and progress reports that fall under
the policy, and was authored or co-authored by the investigator or arose from
the investigator’s NIH award. For more information, see the Public
Access webpage at http://publicaccess.nih.gov/.
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. For publications listed in the appendix and/or
Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for 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 FOA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described
in the Catalog of Federal Domestic Assistance 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.
Loan Repayment Programs:
NIH encourages applications for educational loan
repayment from qualified health professionals who have made a commitment to
pursue a research career involving clinical, pediatric, contraception,
infertility, and health disparities related areas. The LRP is an important
component of NIH's efforts to recruit and retain the next generation of
researchers by providing the means for developing a research career unfettered
by the burden of student loan debt. Note that an NIH grant is not required for
eligibility and concurrent career award and LRP applications are encouraged.
The periods of career award and LRP award may overlap providing the LRP
recipient with the required commitment of time and effort, as LRP awardees must
commit at least 50% of their time (at least 20 hours per week based on a 40
hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
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