and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of
Health (NIH) (http://www.nih.gov)
Components of Participating Organizations
National Center for Research
Resources (http://www.ncrr.nih.gov)
Title: Biomedical Informatics Research Network Coordinating
Center (U24)
Announcement Type
New
Request For Applications (RFA) Number: RFA-RR-08-002
Catalog of Federal Domestic Assistance Number(s)
93.389
Key Dates
Release Date: November
30, 2007
Letters of Intent Receipt
Date: March
17, 2008
Application Receipt
Date: April
16, 2008
Peer Review Date: October 2008
Council Review Date: January 2009
Earliest Anticipated
Start Date: May
1, 2009
Expiration Date: April 17, 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 and Review and
Anticipated Start Dates
1. Letter of
Intent
B. Sending an Application to
the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award
Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy
Requirements
A. Cooperative Agreement Terms
and Conditions of Award
1. Principal
Investigator Rights and Responsibilities
2. NIH
Responsibilities
3. Collaborative
Responsibilities
4. Arbitration
Process
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
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism(s) of Support
This funding opportunity
will use the U24 award mechanism.
As an applicant, you
will be solely responsible for planning, directing, and executing the proposed
project.
This
funding opportunity uses the just-in-time budget concepts. It also uses the
non-modular budget format described in the PHS 398 application instructions
(see http://grants.nih.gov/grants/funding/phs398/phs398.html).
A detailed categorical budget for the "Initial Budget Period" and the
"Entire Proposed Period of Support" is to be submitted with the
application.
The NIH U24 is a cooperative agreement
award mechanism. In the cooperative agreement mechanism, the Principal
Investigator retains the primary responsibility and dominant role for planning,
directing, and executing the proposed project, with NIH staff being
substantially involved as a partner with the Principal Investigator, as
described under the Section VI. 2. Administrative
Requirements, "Cooperative Agreement Terms and Conditions of
Award". Plans for funding this cooperative agreement beyond the
current funding announcement are uncertain.
2. Funds Available
The NCRR intends to commit
approximately $4.5 million dollars in FY 2009 to fund one new and/or
competing continuation grant in response to this RFA. An applicant may request
a project period of up to five years and a budget for total costs of $4.5 million
dollars in the first year.
Section
III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit (an)
application(s) if your organization has any of the following characteristics:
1.B.
Eligible Individuals
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 support.
2. Cost Sharing or Matching
Cost sharing is not
required.
The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing
3. Other-Special Eligibility Criteria
N/A
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)
710-0267, Email: GrantsInfo@nih.gov.
Telecommunications for
the hearing impaired: TTY 301-451-5936.
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 on line 2 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: March 17, 2008
Application
Receipt Date: April 16, 2008
Peer Review Date: October 2008
Council Review
Date: January 2009
Earliest
Anticipated Start Date: May 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 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.
Gregory Farber
Division of Biomedical
Technology
National Center for Research
Resources
6701 Democracy Boulevard
Room 960, MSC 4874
Bethesda, MD
20892 (use 20817 if sending the letter via an overnight
delivery service)
Telephone: (301) 435-0778
Email: farberg@mail.nih.gov
3.B. Sending an
Application to the NIH
Applications must be
prepared using the research grant applications 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 must be sent to:
Office of
Review
National Center for
Research Resources
National Institutes of
Health
6701 Democracy Boulevard,
Room 1001
Bethesda, MD
20892-4874 (regular mail)
Bethesda, MD 20817
(overnight delivery service)
Telephone: (301) 435-0811
Using the RFA Label: The RFA label available in
the PHS 398 application instructions 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.
3.C. Application
Processing
Applications must be received on or before the
application receipt date(s) described above (Section IV.3.A.).
If an application is received after that date, it will be returned to the
applicant without review. Upon receipt, applications will be evaluated for
completeness by the CSR and responsiveness by the NCRR. Incomplete and non-responsive
applications will not be reviewed.
The NIH will not
accept any application in response to this funding opportunity 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 a funding opportunity, it is to
be prepared as a NEW application. That is, the application for the funding
opportunity 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.
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 http://grants.nih.gov/grants/policy/policy.htm.
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 new or competing continuation award if
such costs: are necessary to conduct the project, and 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 new or competing continuation 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
Applicants should use the PHS 398 form, but should not follow the page limits or suggested format for sections A through D of the Research Plan in those instructions. All other instructions in the PHS 398 form should be followed. Sections A through D of the Research Plan for this RFA are described below can be no longer than 100 pages. The maximum length of sections A through D are: Section A must be no longer than 10 pages, Section B must be no longer than 50 pages, Section C must be no longer than 30 pages, and Section D must be no longer than 10 pages.
Section A of the Research Plan is the Overview. The overview should include the specific aims as well as the background and significance of the problem.
Section A of the Research Plan must be no longer than 10 pages.
Section B of the Research Plan is Maintenance of Current BIRN Infrastructure, and should focus on plans to maintain the current BIRN infrastructure or to migrate to an equivalent infrastructure. The original BIRN infrastructure was driven by specific problems in the neurosciences. Neuroscience research was chosen as the first focus area since there was both a community of investigators well versed in digital approaches and the data-driven challenges necessary to test a new computational infrastructure. Three testbed awards have been made as part of the original BIRN awards to ensure that the tools developed by the BIRN CC would be useful to neuroscientists. These testbed awards are the Function BIRN (U24RR21992, end date November 30, 2010) led by Dr. Steven Potkin at the University of California, Irvine, the Morphometry BIRN (U24RR21382, end date May 31, 2009) led by Dr. Bruce Rosen at Massachusetts General Hospital, and the Mouse BIRN (U24RR21760, end date April 30, 2010) led by Dr. Arthur Toga at the University of California, Los Angeles. Each of the testbeds has used the BIRN infrastructure to share data and tools across a limited research community. Some of these data and tools are available across the BIRN testbeds and some are available to the general public at http://www.nbirn.net .
Under this renewal, the BIRN CC must continue to serve the needs of the three testbeds while those awards are active. The BIRN CC must also continue to serve the two early adopters of the BIRN infrastructure: The MRI Study of Normal Brain Development (http://www.brain-child.org/) and the National Database for Autism Research (http://ndar.nih.gov/ ). Among the current services provided by the BIRN CC are: daily support of users; hardware maintenance for the BIRN racks; software maintenance for the key components that allow data sharing such as the Storage Resource Broker; maintenance and support for the BIRN Data Repository; maintenance and support for the BIRN Portal; maintenance of the existing data and tools available in the BIRN Portal; and the maintenance of a user friendly web site.
In this section of the research plan, plans for the maintenance of all of these services and/or the introduction of new services that will take the place of the current infrastructure must be presented. A transition timeline must be included.
A principal role of the testbeds was to ensure that the BIRN CC built an infrastructure that was useful to practicing scientists. As the first testbed awards are retired, the awardees under PAR-07-425 (http://grants.nih.gov/grants/guide/pa-files/PAR-07-425.html ) and PAR-07-426 (http://grants.nih.gov/grants/guide/pa-files/PAR-07-426.html ) will assume this role. The BIRN CC must manage the transition from the originating testbeds to individual awardees. In this section of the research plan, the applicant must describe how that transition will be managed.
The BIRN CC has been responsible for organizing an annual meeting of BIRN users. This meeting allowed users from all of the testbeds to come together to work on BIRN wide problems. A plan for an equivalent meeting or meetings should be described in this part of the application. These meetings must accommodate both original testbed participants as well as those who are interested in or who have awards under PAR-07-425 and/or PAR-07-426. Innovative suggestions for non-face to face meetings or more frequent more focused meetings might be appropriate.
Section B of the Research Plan must be no longer than 50 pages.
Section C of the Research Plan is Future of the BIRN Infrastructure and should focus on the future of the BIRN data and tool sharing infrastructure. The current infrastructure requires both specialized hardware and software. That solution was appropriate when the BIRN infrastructure was first developed, but is not convenient for the majority of biomedical researchers who do not want to purchase or maintain the appropriate hardware. The availability of both computational cycles and large scale storage from commercial vendors raises the possibility of a software only solution to the data sharing problem.
Ideally, using the next generation of the BIRN infrastructure, a biomedical researcher would simply launch appropriate software from his or her desktop computer. The software would ask the researcher where the data sets were located, ask for an appropriate description of the type of data in the data set (including the vocabulary used to describe the data), and ask who should be allowed to access the data set. Once that basic description is available, the data sharing infrastructure would take care of all of the other tasks that are essential for sharing the data with the community. Applicants should describe their plans to achieve this goal. A timeline with specific deliverables must be included. The timeline for completely achieving this goal may be longer than the five year funding period of this award.
As the BIRN data sharing infrastructure moves forward, the data accessible using the infrastructure will become a useful sandbox to allow researchers to explore how to make complex queries on heterogeneous data that has experimental errors. The BIRN CC must ensure that the data housed in the BIRN infrastructure is available for such research initiatives.
A key issue in making high level queries across a heterogeneous data set is the need for controlled vocabularies to describe the experiment and/or the data. PAR-07-425 represents one attempt to solve this problem by providing resources to establish useful vocabularies for communities of researchers. Other vocabularies already exist and are very useful to parts of the research community. In the next funding period, the BIRN CC must develop the necessary infrastructure to allow researchers to query data using both established vocabularies and vocabularies developed under PAR-07-425 as basic components of the infrastructure.
Section C of the Research Plan must be no longer than 30 pages.
Modern software practices must be employed and described in Sections B and C of the application. Examples include alpha and beta testing, production release, interface development, bug reporting, version control, and documentation. The current BIRN Software license is available at http://www.nbirn.net/tools/software_license.shtm . Applicants must agree to use this license for any software developed under this RFA.
In section D of the application, Governance, the applicant must address governance issues. The current governance structure of BIRN involves three levels. The BIRN Executive Committee is composed of two representatives from NIH as well as the PIs of the three testbed awards and the PI of the BIRN CC. The BIRN Operations committee reports to the Executive Committee. The Operations Committee is composed of technical representatives from across the BIRN awardees. The Operations committee is led by a full time executive secretary and has one representative from NIH. This committee discusses challenges facing the BIRN program and formulates options to resolve those problems. The Executive Committee considers those options and makes final decisions. The final governance/management level involves a number of focused Working Groups and Committees that report to the Operations Committee. Examples include the Upload Committee, the IT Work Group, and the Ontology Working Group.
This governance structure will need to be modified as the testbeds are replaced by a broader user community. The applicant must propose a governance structure for the BIRN program. That structure must provide mechanisms that allow the biomedical community to have substantive input on the development of the data sharing infrastructure. The governance structure must also be able to fairly and efficiently resolve problems to the benefit of the broad BIRN community.
Section D of the Research Plan must be no longer than 10 pages
For this RFA, do not follow the PHS 398 instructions for the Appendix. No Appendix is permitted. In addition, no additional or supplementary information will be accepted prior to review. Any supplementary information that is sent to the Office of Review will not be passed to the reviewers.
Plan for Sharing Research
Data
The focus of this RFA is
the maintenance and further development of an infrastructure to share
data. Therefore, applicants must describe fully in the research plan
their plans to share data. This involves the expected schedule for data
sharing from either external or internal sources, the format of the final
dataset, the documentation to be provided, whether or not any analytic tools
also will be provided, whether or not a data-sharing agreement will be required
and, if so, a brief description of such an agreement (including the criteria
for deciding who can receive the data and whether or not any conditions will be
placed on their use). The mode of data sharing must use the proposed
infrastructure.
Software developed
under this RFA will be distributed using the BIRN software license (http://www.nbirn.net/tools/software_license.shtm)
.
Sharing Research Resources
NIH policy expects that
grant recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after
publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section VI.3. Reporting.
Section
V. Application Review Information
1. Criteria
Only the review criteria
described below will be considered in the review process.
The following will be
considered in making funding decisions:
2. Review and Selection Process
Applications that are
complete and responsive to the RFA will be evaluated for scientific and
technical merit by an appropriate peer review group convened by NCRR in accordance with the review
criteria stated below.
As part of the initial
merit review, all applications will:
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 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
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?
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? Is the transition timeline in Section B of the Research Plan detailed and
reasonable? Will the proposed infrastructure accommodate the current
users of the BIRN infrastructure? Will the proposed
infrastructure accommodate the needs of new users of the BIRN
infrastructure? Does section C of the Research Plan contain a detailed
and reasonable plan to move to a software only infrastructure? Will the
governance structure allow BIRN users to have a significant voice in the
direction of the program? Are the proposed software engineering practices
appropriate?
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? Does Section C
of the Research Plan acknowledge and provide plans to adopt cutting edge
technologies to the problem of sharing biomedical research tools and
data? Is the timeline for harnessing these innovative technologies
proposed in Section C reasonable?
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)?
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?
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 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 the Research Plan, Section E on Human Subjects in the PHS Form
398).
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 E on Human Subjects in the
PHS Form 398).
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
Form 398 research grant application instructions 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. Sharing Research Data
Data Sharing Plan: The reasonableness of the
data sharing plan will be assessed by the reviewers. However, reviewers will
not factor the proposed data sharing plan into the determination of scientific
merit or the priority score. The presence of a data sharing plan will be part
of the terms and conditions of the award. The funding organization will be
responsible for monitoring the data sharing policy
2.D. Sharing Research
Resources
NIH
policy expects that grant recipients make unique research resources readily
available for research purposes to qualified individuals within the scientific
community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to
this funding opportunity should include a sharing research resources plan
addressing how unique research resources will be shared or explain why sharing
is not possible.
Program
staff will be responsible for the administrative review of the plan for sharing
research resources.
The adequacy of the
resources sharing plan will be considered by Program staff of the funding
organization when making recommendations about funding applications. Program
staff may negotiate modifications of the data and resource sharing plans with
the awardee before recommending funding of an application. The final version of
the data and resource sharing plans negotiated by both will become a condition
of the award of the grant. The effectiveness of the resource sharing will be
evaluated as part of the administrative review of each non-competing Grant
Progress Report (PHS 2590). See Section VI.3. Reporting.
3. Anticipated Announcement and Award Dates
N/A.
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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
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 NoA 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
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).
The following Terms and
Conditions will be incorporated into the award statement and will be provided
to the Principal Investigator as well as to the appropriate institutional
official, at the time of award.
2.A. Cooperative Agreement
Terms and Conditions of Award
The following special
terms of award are in addition to, and not in lieu of, otherwise applicable OMB
administrative guidelines, HHS grant administration regulations at 45 CFR Parts
74 and 92 (Part 92 is applicable when State and local Governments are eligible
to apply), and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for
this program will be the cooperative agreement (U24), an "assistance" mechanism
(rather than an "acquisition" mechanism), in which substantial NIH
programmatic involvement with the awardees is anticipated during the
performance of the activities. Under the cooperative agreement, the NIH purpose
is to support and stimulate the recipients' activities by involvement in and
otherwise working jointly with the award recipients in a partnership role; it
is not to assume direction, prime responsibility, or a dominant role in the
activities. Consistent with this concept, the dominant role and prime
responsibility resides with the awardees for the project as a whole, although
specific tasks and activities may be shared among the awardees and the NIH as
defined below.
2.A.1. Principal
Investigator Rights and Responsibilities
The U24 Principal
Investigator will have the primary responsibility to: define research
objectives, conduct specific studies, analyze and interpret research data,
manage the team funded under this award, and provide information to the
assigned NIH program officer concerning progress. The Principal
Investigator must abide by the governance structure presented in the
application for consulting with the user community to ensure that the BIRN
infrastructure meets their needs. The Principal Investigator must provide
timely assistance in responding to questions from users and must provide
assistance to those trying to use or modify the existing infrastructure. Awardees will retain custody
of and have primary rights to the data and software developed under these
awards, subject to Government rights of access consistent with current HHS,
PHS, and NIH policies.
2.A.2. NIH
Responsibilities
An NIH Project Scientist
will have substantial programmatic involvement that is above and beyond the
normal stewardship role in awards, as described below.
This
involvement includes membership in the steering committee and making site
visits as needed to receive updates on progress. The Project Scientist
will facilitate interactions between the U24 Principal Investigator (or
designee) and applicants responding to either PAR-07-425 (http://grants.nih.gov/grants/guide/pa-files/PAR-07-425.html ) or PAR-07-426 (http://grants.nih.gov/grants/guide/pa-files/PAR-07-426.html ).
Additionally, an agency
program official or IC program director will be responsible for the normal
scientific and programmatic stewardship of the award and will be named in the
award notice.
2.A.3.
Collaborative Responsibilities
The BIRN Steering Committee
will serve as the governing board for this award. This committee will
serve a similar function to the current BIRN Executive Committee. The
BIRN Steering Committee will have three members: The PI of the award, the
Project Scientist, and a third member representing the BIRN user
community. The third member will be chosen by the PI and the Project
Scientist. The BIRN Steering Committee will meet every six months. Every
other meeting must be face to face, but the alternate meetings can be conducted
using videoconferencing software. The representative of the user
community will be the Chair of the Steering Committee. The Chair will
distribute an agenda for the meeting and will produce concise minutes of the
meetings. Those minutes must be provided to all members of the Steering
Committee no later than 2 weeks after the conclusion of the meeting.
Costs associated with these meetings will be paid for by the BIRN CC and should
be budgeted for.
Each full member will
have one vote. Awardee members of the Steering Committee will be required to
accept and implement policies approved by the Steering Committee.
2.A.4. Arbitration
Process
Any disagreements that
may arise in scientific or programmatic matters (within the scope of the award)
between award recipients and the NIH may be brought to arbitration. An
Arbitration Panel composed of three members will be convened. It will have
three members: a designee of the Steering Committee chosen without NIH staff
voting, one NIH designee, and a third designee with expertise in the relevant
area who is chosen by the other two; in the case of individual disagreement,
the first member may be chosen by the individual awardee. This special
arbitration procedure in no way affects the awardee's right to appeal an
adverse action that is otherwise appealable in accordance with PHS regulations
42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
3. Reporting
Awardees will be
required to submit the PHS Non-Competing Grant Progress Report, Form 2590
annually (http://grants.nih.gov/grants/funding/2590/2590.htm)
and financial statements as required in the NIH Grants Policy Statement.
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.
Gregory Farber
Division of Biomedical Technology
National Center for Research
Resources
6701 Democracy Boulevard
Room 960, MSC 4874
Bethesda, MD 20892
(use 20817 if sending the letter via an overnight delivery service)
Telephone: (301) 435-0778
Email: farberg@mail.nih.gov
2. Peer Review Contacts:
Dr. Bonnie
Dunn
Office of Review
National Center for Research Resources
6701 Democracy Boulevard
Room 1066, MSC 4874
Bethesda, MD 20892
(use 20817 if sending the letter via an overnight delivery service)
Telephone: (301) 435-0824
Email: dunnbo@mail.nih.gov
3. Financial or Grants Management Contacts:
Leslie Le
Office of Grants Management
6701
Democracy Boulevard,
Room 1051, MSC 4874
Bethesda, MD 20892-4874
Telephone: (301)435-0856
FAX: (301)480-3777 (use
20817 if sending the letter via an overnight delivery service)
Email: leleslie@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.
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 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:
NIH-funded investigators
are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central
(PMC) an electronic version of the author's final manuscript upon acceptance
for publication, resulting from research supported in whole or in part with
direct costs from NIH. The author's final manuscript is defined as the final
version accepted for journal publication, and includes all modifications from
the publishing peer review process.
NIH is requesting that
authors submit manuscripts resulting from 1) currently funded NIH research
projects or 2) previously supported NIH research projects if they are accepted
for publication on or after May 2, 2005. The NIH Public Access Policy applies
to all research grant and career development award mechanisms, cooperative
agreements, contracts, Institutional and Individual Ruth L. Kirschstein
National Research Service Awards, as well as NIH intramural research studies.
The Policy applies to peer-reviewed, original research publications that have
been supported in whole or in part with direct costs from NIH, but it does not
apply to book chapters, editorials, reviews, or conference proceedings.
Publications resulting from non-NIH-supported research projects should not be
submitted.
For more information
about the Policy or the submission process please visit the NIH Public Access
Policy Web site at http://publicaccess.nih.gov/ and
view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).
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 RFA 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
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