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 Institute of Arthritis
and Musculoskeletal and Skin Diseases (NIAMS) (http://www.niams.nih.gov)
Title: Multidisciplinary Clinical Research Centers (P60)
Announcement Type
This is a reissue of RFA-AR-05-001 which was previously released on July 19, 2004.
Update: The following update relating to this announcement has been issued:
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
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
Purpose
The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) invites new and competing continuation applications for Multidisciplinary Clinical Research Centers (MCRCs) in arthritis and/or musculoskeletal disorders and/or skin diseases. Each MCRC will be organized around a methodology core and will be expected to include a minimum of three highly meritorious projects encompassing clinical research drawing from different disciplines. The methodology core will be the foundation of the center, providing key support for development and implementation of clinical projects. Each project must address a critical issue that directly involves prevention, assessment and/or outcomes for patients with chronic diseases within the mission of the NIAMS.
Research Objectives
The goals of the MCRC program are to prevent disease and to assess and improve outcomes for patients with arthritis and other rheumatic diseases, musculoskeletal disorders, including orthopaedic disorders, bone diseases and muscle diseases, and skin diseases. For a comprehensive listing of the disease areas covered in the NIAMS mission, please see http://www.niams.nih.gov/rtac/funding/faq.htm
The key elements of an MCRC will include:
1. A Center Director, Associate Director and an executive committee with outstanding credentials for promoting clinical research;
2. A research base that encompasses diseases/disorders within the NIAMS mission and provides professional and patient resources for developing clinical projects using more than one clinical research approach;
3. A methodology core that will play a key role in the design and implementation of ALL projects supported through the Center; and
4. A minimum of three highly meritorious clinical research projects that are synergistic and encompass disease areas e.g. arthritis or skin diseases, but not just one disease, e.g. osteoarthritis or psoriasis, within the NIAMS mission; use the methodology core; and encompass two or more clinical approaches.
Optional elements of an MCRC are (a) one exploratory/feasibility project supported by the methodology core and lasting no more than three years and (b) other core(s) supportive of two or more of the proposed projects.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1. Mechanism(s) of Support
This funding opportunity
will use the NIH
P60 award
mechanism(s). An applicant may request a project period of up to 5 years and a
budget for direct costs of up to $800,000 per year (excluding F&A costs of
Subcontract(s). 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.
2. Funds Available
The
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
intends to commit approximately $3.6 million in FY 2008 to fund 3 new and/or competing continuation grants in response to
this RFA. An applicant may request a project period of up to 5 years and a budget for direct costs
up to $800,000 per year exclusive of facilities and administrative
costs of subcontracts with collaborating organizations. The earliest anticipated
start date is April 2008.
Because the nature and
scope of the proposed research will vary from application to application, it is
anticipated that the size and duration of each award will also vary. Although
the financial plans of the NIAMS 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.
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:
Foreign
institutions are not eligible to apply.
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
None.
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: [email protected].
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
Letters of Intent
Receipt Date(s): May 29, 2007
Application
Receipt Date(s): June 29, 2007
Peer Review Date(s): October/November, 2007
Council Review
Date(s): January 2008
Earliest
Anticipated Start Date(s): April, 2008
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:
Madeline
Turkeltaub, CRNP, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Democracy 1
6701 Democracy Boulevard, Suite 800
Bethesda, MD 20892
Telephone: (301) 594-2463
FAX: (301) 480-4543
Email: [email protected]
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 and all copies of the
appendix material must be sent to:
Yan Wang, M.D., Ph.D.
Chief, Review Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Democracy 1
6701 Democracy Boulevard, Suite 800
Bethesda, MD 20892
Telephone: (301) 594-4952
FAX: (301)402-2406
Email: [email protected]
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 NIAMS. 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
Guidelines are available
for the MCRC program at http://www.niams.nih.gov/rtac/funding/grants/centers_programs.htm#P60.
These
guidelines are intended to assist the applicant in assembling an application in
a manner to facilitate an optimal review of the complex topics covered in the
application.
The Director and Associate Director should budget for an annual two-day meeting
with NIAMS staff and other MCRC directors. The carryover of an unobligated
balance into the next budget period requires Grants Management Officer prior
approval.
Support staff requested in the Administrative Core may not exceed 1.0 FTE.
Each project must discuss recruitment and retention of patients, clinical expertise and facilities needed, and a data safety and monitoring plan. It is not anticipated that a Data Safety and Monitoring Board will be required for oversight of an MCRC study because multi-site or complex clinical trials are generally not appropriate for the MCRC mechanism. However, if the patient population is at some significant risk, a Data Safety and Monitoring Board should be proposed. For most studies, an independent Safety Officer, not affiliated with the institution, will be appropriate. The methodology core should detail support for the data safety and monitoring issues for the projects proposed. NIAMS has developed guidelines for data safety and monitoring plans: http://www.niams.nih.gov/rtac/clinical/index.htm. If the application is funded, the investigators will be expected to provide detailed methods of operating procedures, patient consent forms, and updated data and safety monitoring plans.
Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.
Plan for Sharing
Research Data
The precise content of
the data-sharing plan will vary, depending on the data being collected and how
the investigator is planning to share the data. Applicants who are planning to
share data may wish to describe briefly the expected schedule for data sharing,
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), and the mode of data sharing
(e.g., under their own auspices by mailing a disk or posting data on their
institutional or personal website, through a data archive or enclave).
Investigators choosing to share under their own auspices may wish to enter into
a data-sharing agreement. References to data sharing may also be appropriate in
other sections of the application.
Applicants
requesting more than $500,000 in direct costs in any year of the proposed
research must include a plan for sharing research data in their application.
The funding organization will be responsible for monitoring the data sharing
policy (http://grants.nih.gov/grants/policy/data_sharing).
The reasonableness of the data sharing plan or the
rationale for not sharing research data may 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.
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 NIAMS 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.
Review criteria for Individual Projects:
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?
Innovation: Is the project original and
innovative? For example: Des 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?
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?
In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score. Additional detail regarding review criteria is provided in the NIAMS Guidelines for Multidisciplinary Clinical Research Centers:
Each project and core (including the administrative unit) will be individually reviewed for scientific merit and a rating assigned by committee consensus. Merit ratings will also be provided for other center elements, i.e., qualifications of the center leadership, the research base, the institutional environment and resources. If a competitive renewal is being sought, the progress during the previous funding period will also be evaluated. To be funded, there must be a highly meritorious methodology core and at least three highly meritorious projects (not including the exploratory/feasibility project, if any) encompassing two or more disease areas within the NIAMS mission.
Review Criteria for MCRC leadership:
Do the Director and Associate Director have the leadership and research qualifications to lead a Center? Does the leadership team (Director, Associate Director, and executive committee) have the collective expertise to assure focused development and implementation of high quality and meaningful clinical research projects?
Review Criteria for Research Base:
Is there a substantial productive and funded research base? Is the research base sufficiently broad to foster new multidisciplinary research? Is there a definition of who will be a Center investigator and what this designation might mean?
Review Criteria for Institutional Environment and Resources:
Is there evidence of a supportive institutional environment for the proposed MCRC? Will the MCRC add an important multidisciplinary element to the institutional environment? Does the proposed MCRC utilize available resources well? Is there support and commitment from the institutional authorities?
Review Criterion for
Applications Seeking Competitive Renewal:
Does the progress report reflect significant accomplishments? Has any
work been published or are publications likely?
Review Criteria for Administrative Unit:
1. Do the proposed MCRC Director, Associate Director and executive committee have the collective expertise and leadership to identify and focus research projects on clinically relevant issues?
2. Is the management proposed appropriate for scientific administration as well as fiscal administration, procurement, property and personnel management, planning, budgeting, etc.?
3. Is there a plan for establishment and maintenance of internal communication and cooperation among the MCRC investigators, core leaders and executive committee? Are there plans for outside review and input?
4. Is there scientific and administrative leadership, commitment and ability, and adequate time commitment of the MCRC Director and Associate Director for the effective management of the MCRC program?
5. Is there documentation of institutional support for the MCRC by the parent institution?
6. Is a plan for data sharing included?
Review Criteria for Methodology Core:
1. Does the methodology core serve all projects proposed in the Center (mandatory)? Have issues relating to data and safety monitoring been addressed? Is there a plan describing teaching services for the research base?
2. Are the services offered appropriate and of high quality, especially for the projects directly supported? How is cost reimbursement proposed?
3. Will the core likely promote multidisciplinary research? Are unique services offered? Is there a plan for prioritizing services to the research base?
4. Are the qualifications of the professional and support personnel appropriate? Is there a plan for interactive leadership of the methodology core and the proposed projects?
5. Are the facilities and equipment adequate? Is there institutional commitment to the core?
Review Criteria for Other Cores:
1.
Will the core have utility to at least two of the MCRC projects?
2. Are the services of high quality? Are there procedures for
quality control? Is the core cost effective?
3. Do the services offered best fit within a core structure? If
this is an add-on to a preexisting core, what is the benefit to the Center over
direct purchase of services from the existing core? If the core offers
new services that may be used by non-MCRC projects, how will the non-MCRC projects
purchase these services from the core?
4. Are the personnel appropriate?
5. Are the facilities and equipment adequate? Is there
institutional commitment to the core?
Review Criteria for Clinical Research Projects:
Significance: Does this project address an important clinical issue, especially one not well studied? Is it likely that the research may have a clinically important impact? Will these studies influence concepts or methods that drive this field?
Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the investigator acknowledge potential problem areas and consider alternative tactics? Does the project utilize the multidisciplinary resources of the Center, especially the Methodology Core? Is a data safety and monitoring plan included, if appropriate?
Innovation: Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (The quality of the idea or the extent to which the research will advance theory or practice should outweigh an emphasis on technical excellence.)
Investigators: Is the investigator appropriately trained and well
suited to carry out this work? Is the work proposed appropriate to the
experience level of the principal investigator and collaborators?
Environment: Does the scientific
environment of the Center contribute to the probability of success? Do the
proposed experiments take advantage of unique features of the Center and employ
useful collaborative arrangements?
Review Criteria for Development/Feasibility Project (Optional):
Significance: Will the proposed work likely yield meaningful
preliminary data leading to a research proposal?
Approach; Are the experimental
approaches adequate?
Innovation; Is the research topic
one that promotes innovative research related to the core center?
Investigator; Is the investigator
appropriately trained and well suited to carry out this work? Is the work
proposed appropriate to the experience level of the principal investigator?
Environment; Is the project
appropriate to the research base of the core center? Does one or more of
the cores offer needed materials/assistance?
After the review of the individual components of the application, the application will be assigned an overall priority score. This score will reflect not only the individual quality of the projects, cores, and administration, but also how the proposed MCRC will bring together all these elements in a workable unit. The overall score may be higher or lower than the average of the descriptors based on the assessment of whether the whole is greater than the sum of its parts. The overall priority score will reflect:
1. The scientific excellence of the Center's research base as well as the relevance and interrelationship of these separately funded research projects to the goals of the Center and the likelihood for meaningful collaboration among Center investigators. The application must convey how the proposed Center will enhance significantly the established research base of the host institution. (In a competing continuation application, the application should document the impact of the Center. This includes the qualifications, experience, and commitment of the Center investigators and their willingness to interact with each other.)
2. The overall environment for a Center. This includes the institutional commitment to the program, including lines of accountability regarding management of the Center, the institution's partnership with the Center, and the institutional commitment to individuals responsible for conducting essential Center functions. This also includes the academic environment and resources in which the activities will be conducted, e.g., the availability of space, equipment, facilities, and the potential for interaction with scientists from other departments and schools.
3. The overall priority score assigned to the application will also reflect how well the policies regarding (a) the inclusion of women, minorities and children in study populations, (b) the protection of human subjects from research risks, (c) sharing research data have been addressed.
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 or the rationale for not sharing research data may 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 funding organization will be responsible for monitoring the data sharing
policy. http://grants.nih.gov/grants/policy/data_sharing.
All
applications are expected to address data sharing. This discussion is to be
included in the Administrative Core.
Program staff will be responsible for the administrative review of the plan for sharing research data.
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.
The carryover of an
unobligated balance into the next budget period requires Grants Management
Officer prior approval.
The grant is excluded from Streamlined Non-competing Award Procedures
(SNAP).
The rebudgeting of funds into or out of the Administrative Core requires Grants
Management Officer prior approval.
Rebudgeting of funds within or into the Administrative Core to increase the
overall level of support staff above 1.0 FTE requires Grants Management Officer
prior approval.
Rebudgeting of funds into or out of the Exploratory and Feasibility Project
requires Grants Management Officer prior approval.
Rebudgeting of funds into or out of the Methodology Core requires Grants
Management Officer prior approval.
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.
Section
VII. Agency Contacts
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:
Madeline
Turkeltaub, CRNP, Ph.D.
National
Institute of Arthritis and Musculoskeletal and Skin Diseases
Democracy 1
6701 Democracy Boulevard, Suite 800
Bethesda , MD 20892
Telephone: (301) 594-2463
FAX: (301) 480-4543
Email: [email protected]
2. Peer Review Contacts:
Yan Wang, M.D., Ph.D.
Chief, Review Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Democracy 1
6701 Democracy Boulevard, Suite 800
Bethesda, MD 20892
Telephone: (301) 594-4952
FAX: (301)402-2406
Email: [email protected]
3. Financial or Grants Management
Contacts:
Steve Austin
Grants Management Specialist
National Institute of Arthritis and Musculoskeletal and Skin Diseases
6701 Democracy Boulevard, Suite 800
Bethesda, MD 20892
Telephone: (301) 594-3504
FAX: (301) 480-5450
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
Human Subjects
Protection:
Federal regulations
(45CFR46) require that applications and proposals involving human subjects must
be evaluated with reference to the risks to the subjects, the adequacy of
protection against these risks, the potential benefits of the research to the
subjects and others, and the importance of the knowledge gained or to be gained
(http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety
Monitoring Plan:
Data and safety
monitoring is required for all types of clinical trials, including physiologic
toxicity and dose-finding studies (phase I); efficacy studies (Phase II);
efficacy, effectiveness and comparative trials (Phase III). 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.
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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