and Human Services (HHS)
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Department of Health and Human Services
Participating Organizations
National Institutes of
Health (NIH) (http://www.nih.gov)
Components of Participating Organizations
National Institute of
Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov)
Title: RFA: Announcement of a Limited Competition for
the Continuation of the Inflammatory Bowel Disease Genetics Consortium (IBDGC)
(U01)
Announcement Type
This is a limited
competition RFA, which is a modified reissue of RFA-DK-02-011,
which was released July, 24, 2001.
Update: The following updates relating to this announcement have 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
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
This notice is soliciting applications from
investigators currently supported under RFA-DK-02-011,
Inflammatory Bowel Disease Genetics Research Consortium, to continue and expand
their efforts to identify genes predisposing to Inflammatory Bowel Disease
(IBD).
IBD, consisting principally of two subtypes, Crohn’s Disease (CD) and Ulcerative Colitis (UC), is a serious, potentially life-disrupting illness, often requiring treatment by major surgery, with a prevalence of about 3 in 1000 adults in the United States. Although twin and family studies have demonstrated that both genetic and environmental factors are important for the etiology of IBD, its specific etiological factors remain largely unknown. Since the inheritance of IBD is complex, not following an obvious Mendelian pattern, investigators have inferred that multiple genes predispose to IBD, that these genes may differ in different individuals and populations, and that they may interact inter se and with environmental factors in a complex fashion to promote the disease process. Since some families segregate only CD, while others segregate only UC, while still others segregate both CD and UC, investigators have further inferred that some genes predispose specifically to CD, others specifically to UC, and still others nonspecifically to both diseases. Genetic linkage studies have indeed identified several chromosomal regions likely to contain genes predisposing to IBD. However, only one specific gene, CARD15 on chromosome 16, is widely accepted to have been identified as predisposing to IBD.
NIDDK has supported the investigators in the IBD Genetics Consortium (IBDGC) since September, 2002 to identify additional genes predisposing to IBD. The IBDGC has recruited a substantial sample of IBD patients, relatives, and controls, and has done genome-wide high-density genotyping of DNA from many of the individuals in this sample. Analyses of the data from these studies have shown promising evidence for previously unknown genes predisposing to IBD. In order to complete the work of identifying IBD-predisposing genes, and begin to elucidate their complex interactions with each other and with environmental factors, however, the IBDGC will need to enlarge their sample collection, especially of subjects from minority populations (e.g., Ashkenazic Jewish, African American, Puerto Rican). They will also need to recruit a larger sample of patients with early-onset disease, as these may represent a distinct genetic subtype. In addition, they will need to collect more information on environmental exposures (e.g., as inferred from serum antibody titers) than they have previously done.
Identification of genes predisposing to IBD will promote the development of genetically-based diagnostic tests which would permit earlier diagnosis of IBD than is currently possible, thereby facilitating earlier intervention to forestall development of the disease. It will also aid in the elucidation of the pathophysiological mechanisms of the disease, permitting the identification of new targets for preventive and therapeutic intervention. IBD will also serve as a useful testbed for novel genotyping technology and statistical analytic methods, which will be generally applicable to the identification of genes underlying other complex genetic disorders.
NIDDK is soliciting applications for Genetic Research Centers (GRCs) and a Data Coordinating Center (DCC) to continue the efforts of the IBDGC to identify genes predisposing to IBD. The GRCs will recruit subjects into the study, and conduct phenotypic evaluations of these subjects. They will send blood samples from newly recruited subjects to the NIDDK Genetics Repository (supported by an independent contract from NIDDK) for creation and storage of immortalized lymphocyte cell lines, and extraction and storage of DNA from these cell lines. They may carry out some genotyping, resequencing, or other molecular analyses as required by various projects undertaken. They will transmit phenotypic and genotypic data to databases maintained by the DCC.
The DCC will be responsible for the collation, management and support of analysis of both the genetic and clinical data, and coordinating communication and research with the GRCs. In addition to assisting the GRCs in finalizing the study protocols, the DCC will maintain (and modify, as necessary) the data acquisition, transfer, and management system; promulgate procedures for ensuring subject and control confidentiality and safety; oversee procedures for quality control, training, and certification; further elaborate the existing manual of operations; and supervise the orderly collection and transmission of data. It will also coordinate shipment of blood samples from the GRCs to the NIDDK Genetics Repository, and distribution of DNA samples from the NIDDK Genetics Repository to the GRCs, itself, and to third-party providers of genotyping services, as required. It will coordinate large-scale joint genotyping projects, contracting them to third-party providers of genotyping services when this is cost-effective.
The IBDGC will continue recruitment of IBD patients, relatives, and controls to enlarge its existing subject sample to achieve sufficient statistical power to identify IBD-predisposing genes of modest effect size, including replication of findings. It will recruit sufficient numbers of members of minority populations (e.g., Ashkenazic Jews, African Americans, Puerto Ricans) to permit statistically meaningful analyses of these subsets of subjects. It will also recruit sufficient numbers of patients with clinically defined subtypes of IBD, including early onset cases, to permit statistically meaningful analyses of these subsets. It will do detailed clinical and other phenotypic evaluations of newly recruited subjects, including indicators of environmental exposures (e.g., serum antibody titers). It will follow up leads from its ongoing research, and initiate new projects, to identify IBD-predisposing genes. It will genotype the DNA samples from subjects recruited for this study (possibly contracting out large-scale genotyping projects to a third-party provider of these services), and conduct sophisticated statistical analyses of genotypic and phenotypic data as necessary to achieve the goals of gene identification.
This RFA will support the following types of projects:
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Not Applicable
Section
II. Award Information
1. Mechanism(s) of Support
This funding opportunity
will use the U01
Cooperative Agreement 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 U01 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". NIDDK has not yet decided whether to continue these
cooperative agreement projects beyond the prospective 5-year period of support.
2. Funds Available
The
participating IC, NIDDK, intends to commit approximately three million dollars in FY 2007 to fund six Genetic Research Centers (GRCs) and one Data
Coordinating Center (DCC) competing continuation grants in response to this RFA.
An applicant may request a project period of up to five years
and a budget for direct
costs up to 250,000
(GRC) or 650,000 (DCC) dollars per year.
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 IC(s) provide support for this program, awards
pursuant to this funding opportunity are contingent upon the availability of
funds and the receipt of a sufficient number of meritorious applications.
Facilities and
administrative costs requested by consortium participants are not included in
the direct cost limitation, see NOT-OD-05-004.
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:
Institutions eligible to submit an application for a GRC or DCC must be the principle employer of the current Principal Investigator of a GRC or DCC.
1.B. Eligible Individuals
Individuals currently
serving as a Principal Investigator for a GRC or DCC award may apply for
support under this RFA.
2. Cost Sharing or Matching
Not applicable
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
Each eligible applicant may
submit a maximum of one application for a GRC and/or one application for the
DCC.
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.
Foreign Organizations
Several special provisions apply to applications
submitted by foreign organizations:
Proposed
research should provide special opportunities for furthering research programs
through the use of unusual talent, resources, populations, or environmental
conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
3. Submission Dates and Times
Applications must be
received on or before the receipt date described below (Section
IV.3.A). Submission times N/A.
3.A.
Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt
Date(s): November 21, 2006
Application
Receipt Date(s): December 21,
2006
Peer Review Date(s): March-April, 2007
Council Review
Date(s): May 30-31, 2007
Earliest
Anticipated Start Date(s): July 1, 2007
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:
Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney
Diseases
6707 Democracy Boulevard,
Room 752
Bethesda, MD 20892-5452
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: fc15y@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 and all copies of the
appendix material must be sent to:
Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney
Diseases
6707 Democracy Boulevard,
Room 752
Bethesda, MD 20892-5452
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: fc15y@nih.gov
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 NIDDK. 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
The IBDGC will consist of up to six GRCs and one DCC. A GRC is an institution that is actively involved in the recruitment and evaluation of patients, family members and control subjects and the initiation of individual, center-specific genetic studies taking advantage of special patient populations. A GRC should consist of an interdisciplinary team of investigators (e.g., research gastroenterologists, human geneticists) and additional necessary personnel, such as a research coordinator and clerical staff.
GRCs will be required to submit familial, diagnostic, medical therapeutic, other phenotypic, and genetic data to the DCC, and blood samples to the NIDDK Genetics Repository (supported by an independent contract from NIDDK). GRCs must work in concert with the DCC to implement procedures for uniform data collection, handling and transmittal of data, as well as data audits and other data quality control procedures, as established by the study protocol. GRCs will be required to share data and patient specimens with other centers in the IBDGC. It is anticipated that the GRCs will conduct independent analyses (enlisting support from the DCC, as appropriate), in addition to participating in collaborative projects with other centers in the IBDGC. The GRCs and DCC will independently and collectively allocate resources and personnel for the performance of independent, center-specific, as well as collaborative analyses and studies. GRC members will staff the various operational committees of the IBDGC (e.g., Recruitment, Phenotyping, Analytic, etc.), thereby collaborating on the design of joint projects and establishment of uniform procedures and policies.
Applications for GRCs should describe accomplishments related to individual research projects previously undertaken within the IBDGC, as well as participation in previous collaborative projects within the IBDGC (e.g., recruitment of subjects, committee membership or chairmanship, project leadership, etc.). They should provide detailed plans for future subject recruitment related to the research plan described in the DCC application, and indicate the roles which personnel will play in executing this research plan. They should also describe plans for any individual GRC-specific projects to be undertaken.
There should be evidence of strong institutional support for the GRC, including adequate space in which to conduct clinical and research activities and office space for staff. An organizational structure for the GRC should be set forth in the application, delineating lines of authority and responsibility for dealing with problems in all general areas as well as stated willingness to follow commonly agreed upon protocols. The principal investigator should indicate his/her
willingness to participate in a per patient basis for operational costs of patient specimen acquisition and processing. There must be ability to interact with the DCC and transmit and edit data. Applicants should indicate willingness to participate in the Consortium concept outlined in this solicitation, participate in the Steering Committee meetings and abide by its decisions.
The DCC will be responsible for the collection, management and analysis of both the genetic and clinical data, and for coordinating communication and research with the GRCs. The DCC will be expected to provide appropriate molecular biologic, biostatistical, data management, genetic analysis, and coordination expertise to support the special independent studies proposed by the individual GRCs, along with collaborative projects approved by the Steering Committee (see below). Sub-contracting of various aspects of the DCC to other institutions with special expertise may be proposed in the application. The DCC will also be expected to generate appropriately detailed reports to the Steering Committee and to the NIDDK staff (see below). As directed by the Steering Committee, the DCC may appoint an Advisory Committee of experts from outside the IBDGC to provide advice on particular issues which arise in developing and implementing the IBDGC’s research plans. The IBDGC is encouraged to consult experts from a broad range of biological disciplines (e.g., cell biology, immunology, microbiology, etc.), so that the most current developments from research on the pathophysiological mechanisms of IBD will inform these plans. The DCC will also be responsible for the logistics and planning of the meetings of the Steering Committee and the various operational committees of the IBDGC (e.g., Recruitment, Phenotyping, Analytic, etc.). Members of the DCC, along with members of the GRCs, will staff the operational committees.
The application for the DCC should describe the previous research accomplishments of the IBDGC, as well as its overall prospective research plan, including its operational infrastructure (committees, procedures for coordination and communication, etc.). Where appropriate, it should credit the participation of GRC members in the previous work of the IBDGC, and note what roles they are anticipated to play in implementing particular parts of the prospective research plan. The applicant should document his/her willingness to participate on the Steering Committee and appropriate subcommittees, work cooperatively with other members of the Steering Committee, and follow the common protocol established cooperatively by the Steering Committee. It is expected that the PI of the DCC would carry out a significant leadership role in the consortium.
The applicant must also address the following regarding responsibilities and requirements for the DCC:
Participation in the design of the genetic analyses to be undertaken, development of research studies and development of the manual of operation, data collection forms, and questionnaires;
Development and implementation of systems for communication among Steering Committee members, and among study sites;
Data collection, editing, processing, analysis, and reporting;
Monitoring of adherence to the research plan and of data quality;
Establishment of procedures that insure the safety and confidentiality of all records.
The applicant for the DCC must delineate a plan for coordinating submission of blood samples from the GRCs to the NIDDK Genetics Repository, and distribution of DNA samples and samples of immortalized cell lines from the NIDDK Genetics Repository to the GRCs, itself, and third-party providers of genotyping services.
The applicant for the DCC should also address any issues regarding common services, such as genotyping, that could be provided to the various participating GRCs.
Plan for Sharing Research
Data
All applicants must
include a plan for sharing research data in their application. The data sharing
policy is available at http://grants.nih.gov/grants/policy/data_sharing.
All investigators responding to this funding opportunity should include a
description of how final research data will be shared, or explain why data
sharing is not possible.
The reasonableness of
the data sharing plan or the rationale for not sharing research data 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 DCC application should
include an overall sharing plan for data generated during the previous five
years of funding of the IBDGC. GRC applications need not cite this plan
in detail, but applicants should indicate their willingness to participate fully
in it. The plan should indicate specifically what will be shared, with
whom it will be shared (including the NIDDK Data Repository), when it will be
shared, by what means it will be shared, and what conditions will apply to
recipients of shared data. This plan must be approved by NIDDK before
awards will be issued under this RFA. Within two years of the issuance of
awards under this RFA, the IBDGC will be required to develop a plan for sharing
data generated during the second five-year funding period of the IBDGC.
Sharing Research Resources
NIH policy expects that
grant awardee 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.
The DCC application should
include an overall sharing plan for resources (e.g., DNA samples) generated
during the previous five years of funding of the IBDGC. GRC applications
need not cite this plan in detail, but applicants should indicate their
willingness to participate fully in it. The plan should indicate
specifically what will be shared, with whom it will be shared (including the
NIDDK Genetics Repository), when it will be shared, by what means it will be
shared, and what conditions will apply to recipients of shared data. This
plan must be approved by NIDDK before awards will be issued under this
RFA. Within two years of the issuance of awards under this RFA, the IBDGC
will be required to develop a plan for sharing resources generated during the
second five-year funding period of the IBDGC.
Section
V. Application Review Information
1. Criteria
The following will be
considered in making funding decisions:
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 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. NIDDK Program Staff will be responsible for
administrative review of the plan for sharing research data.
2.D. Sharing Research
Resources
NIH policy expects that
grant awardee 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
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 U01, 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.
Under the cooperative agreement, the NIDDK purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity.
Consistent with the above concept, the dominant role and prime responsibility for the activity reside with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NIDDK Project Scientist or designee.
Under the cooperative agreement, a relationship will exist between the recipient of these awards and the NIDDK, in which the performers of the activities are responsible for the requirements and conditions described below, and agree to accept program technical assistance, advice, and/or other coordination above and beyond normal program stewardship from a named NIDDK Project Scientist in achieving the project objectives.
Failure of an awardee to meet the performance requirements, including these special terms and conditions of award, or significant changes in the level of performance, may result in a reduction of budget, withholding of support, suspension and/or termination of the award.
2.A.1. Principal Investigator Rights and Responsibilities
The Awardee is responsible for:
1. Research design and protocol development, including definition of objectives and approaches, planning, implementation, participant recruitment and follow-up, data collection, quality control, interim data and safety monitoring, final data analysis and interpretation, and publication of results.
2. Establishing a Steering Committee to coordinate and manage the project. Awardee(s) will name investigators to serve as members on a Steering Committee and other subcommittees, as appropriate, meeting periodically. Awardees will be required to accept and implement the common protocol(s) and procedures approved by the Steering Committee.
3. Implementing the core data collection method and strategy collectively decided upon by the Steering Committee. For a study involving multiple institutions, it is the responsibility of each awardee/site to ensure that data will be submitted in a timely way to the central Data Coordinating Center. Additionally, individual investigators/sites must demonstrate the ability to implement the strategy specifically designed for their individual study population.
4. Establishing mechanisms for quality control and monitoring. Awardees are responsible for ensuring accurate and timely assessment of the progress of each study, including development of procedures to ensure that data collection and management are: (1) adequate for quality control and analysis; and (2) sufficiently staffed across the participating institutions. For research involving multiple awards, strategies for the analyses of pooled data will be developed by the Steering Committee.
5. Submitting interim progress reports, when requested, to the NIDDK Program Director including as a minimum, summary data on protocol performance. For coordinated multiple awards or a multi-site single award, the Steering Committee may require additional information from individual awardees/sites. Such reports are in addition to the annual awardee noncompeting continuation progress report.
6. Establishing procedures, where applicable, for all participating institutions in coordinated awards to comply with the requirements of 45 CFR Part 46 for the protection of human subjects, and the NIH policy requirements for the inclusion of women, minorities and children.
7. Cooperating in the reporting of the study findings. The awardee(s) will retain custody of and have primary rights to the data developed under these awards, subject to the Government rights of access consistent with current HHS, PHS and NIH policies. The NIDDK will have access to and may periodically review all data generated under an award. Where warranted by appropriate participation, plans for joint publication with NIDDK of pooled data and conclusions, are to be developed by the Principal Investigator or Steering Committee, as applicable. NIH policies governing possible co-authorship of publications with NIDDK staff will apply in all cases. In general, to warrant co-authorship, NIDDK staff must have contributed to the following areas: (a) design of the concepts or experiments being tested; (b) performance of significant portions of the activity; and (c) preparation and authorship of pertinent manuscripts.
8. Support or other involvement of industry or any other third party in the study -- e.g., participation by the third party; involvement of study resources or citing the name of the study or NIDDK support; or special access to study results, data, findings, or resources -- may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification of and concurrence by NIDDK.
9. Study investigators are encouraged to publish and to release publicly and disseminate results and other products of the study, in accordance with study protocols and governances.
10. The NIDDK has established Central Biosample, Genetic, and Data Repositories for the
archival and storage of data and biosamples collected in large, multi-site studies funded by NIDDK. The Data Coordinating Center (DCC) and all Genetic Research Centers (GRCs) will work with the NIDDK Genetic Repository to coordinate procedures for coding, shipping, processing, receipt, and storage of study samples that are to be maintained in the Repository. In addition, the DCC will coordinate with the NIDDK Data Repository to prepare the collected data for eventual archiving and distribution. All samples and data transferred to the Repositories will be under the custodianship of the NIDDK, although the study’s Steering Committee will have proprietary control of and exclusive access to the samples and data for an agreed-upon period of time. Subsequently samples and data will be available to the wider scientific community in accordance with the NIH policy on Data Sharing (http://grants.nih.gov/grants/policy/data_sharing/ and, http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm#goals, and http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm)
through a process that will include prioritized distribution based on review of the scientific merit of the proposed use. Therefore, it is expected that samples and data collected will be available to the broader scientific community, after a proprietary period, at no charge other than the cost of reproduction and distribution.
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.
1. Being the contact point for all facets of the scientific interaction with the awardee (s). As required for the coordination of activities and to expedite progress, NIDDK may designate additional NIDDK staff to provide advice to the awardee on specific scientific and/or analytic issues. Such staff may include another Project Scientist or Analyst, who will provide direct technical assistance to the awardees to optimize the conduct and/or analysis of the study; or who may assist in the coordination of activities across multiple sites.
2. The NIDDK Project Scientist or designee will be a full participant and voting member of the Steering Committee and, if applicable, subcommittees.
3. Serving as a resource with respect to other ongoing NIDDK activities that may be relevant to the protocol to facilitate compatibility and avoid unnecessary duplication of effort.
4. Substantial involvement assisting in the design and coordination of research activities for awardees as elaborated below:
a. Assisting by providing advice in the management and technical performance of the investigations.
b. For multi-institutional protocols, through participation in the Steering Committee and with the agreement of the Principal Investigator(s) of any coordinating center and data management centers, the NDDK Project Scientist or designee may coordinate activities among awardees by assisting in the design, development, and coordination of a common research or clinical protocol and statistical evaluations of data; in the preparation of questionnaires and other data recording forms; and in the publication of results.
c. Reviewing and approving advice regarding the establishment of mechanisms for quality control and study monitoring.
An NIDDK Program Director identified in the Notice of Grant Award will be responsible for the normal stewardship and monitoring of the award. The Program Director may also serve as the Project Scientist.
The NIDDK Program Director responsibilities include:
1. Retaining overall programmatic responsibility for the award, and will clearly specify to the awardee the name(s) and role (s) of any additional individuals with substantial involvement in the project and the lines of reporting authority.
2. Interacting with the principal investigator(s) on a regular basis to monitor study progress. Monitoring may include: regular communications with the principal investigator and staff, periodic site visits for discussions with awardee research teams, observation of field data collection and management techniques, quality control, fiscal review, and other relevant matters; as well as attendance at Steering Committee, data safety and monitoring board, and related meetings. The NIDDK retains, as an option, periodic external review of progress.
3. Reviewing and approving protocols to insure they are within the scope of peer review and for safety considerations, as required by Federal regulations. The NIDDK Program Director will monitor protocol progress, and may request that a protocol study be closed to accrual for reasons including: (a) accrual rate insufficient to complete study in a timely fashion; (b) accrual goals met early; (c) poor protocol performance; (d) patient safety and regulatory concerns; (e) study results that are already conclusive; and (f) emergence of new information that diminishes the scientific importance of the study question. The NIDDK will not permit further expenditures of NIDDK funds for a study after requesting closure (except for patients already on-study).
4. Making recommendations for continued funding based on: a) overall study progress, including sufficient patient and/or data accrual; b) cooperation in carrying out the research (e.g., attendance at Steering Committee meetings, implementation of group decisions, compliance with the terms of award and reporting requirements); and/or c) maintenance of a high quality of research, which will allow pooling of data and comparisons across multiple cooperative agreement awards for common data elements.
2.A.3. Collaborative Responsibilities
In addition to the interactions defined above, NIDDK Staff and Awardees shall share responsibility for the following activities:
Steering Committee
A Steering Committee organized by the Principal Investigator (or P.I. of the Coordinating Center in the case of multiple coordinated awards) will be the main oversight body of the study.
The Steering Committee has primary responsibility to design research activities, establish priorities, develop common protocols and manuals, questionnaires and other data recording forms, establish and maintain quality control among awardees, review progress, monitor patient accrual, coordinate and standardize data management, and cooperate on the publication of results. Major scientific decisions regarding the core data will be determined by the Steering Committee. The Steering Committee will document progress in written reports to the NIDDK Program Director, and will provide periodic supplementary reports upon request.
The Steering Committee will be composed of all Principal Investigator(s), (including those of data coordinating /statistical centers, if any) and co-investigators as deemed necessary, and the NIDDK Project Scientist or designee. Each full member will have one vote. An initial meeting of the Steering Committee will be convened early after award by the NIDDK Project Scientist or designee. The final structure of the Steering Committee will be established at the first meeting. The NIDDK Project Scientist or designee will have voting membership on the Steering Committee, and as appropriate, its subcommittees. Such a committee usually will meet at least twice yearly.
A Chairperson, other than the NIDDK representative, will be selected by a vote of the members. The Chairperson is responsible for coordinating the Committee activities, for preparing meeting agendas, and for scheduling and chairing meetings.
The Steering Committee, possibly acting through its subcommittees, will establish policies and priorities for publication of results and sharing of results and other products of the study with investigators outside the IBDGC. During the period of NIDDK support, unpublished data, unpublished results, data sets not previously released, or other study materials or products are to be made available to any third party only with the approval of the Steering Committee. Within two years after the end of the period of NIDDK support, these materials shall be made available to third parties in a manner consistent with policies previously established 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:
Robert W. Karp, Ph.D.
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney
Diseases
6707 Democracy Boulevard, Room 671
Bethesda, MD 20892-5450
Telephone: (301) 451-8875
FAX: (301) 480-8300
Email: rk56v@nih.gov
2. Peer Review Contacts:
Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney
Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: fc15y@nih.gov
3. Financial or Grants Management
Contacts:
Ms. Florence Danshes
Grants Management Branch
Division of
Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room
734
Bethesda, MD 20892-5456
Telephone: (301) 594-8861
FAX: (301) 480-3504
Email: fd39j@nih.gov
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.
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 PA 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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