and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK) |
|
Funding Opportunity Title |
Lifestyle Interventions in Overweight and Obese Pregnant Women Consortium (U01) |
Activity Code |
U01 Research Project Cooperative Agreements |
Announcement Type |
New |
Related Notices |
None |
Funding Opportunity Announcement (FOA) Number |
RFA-DK-10-014 |
Companion FOA |
RFA-DK-10-015: Lifestyle Interventions in Overweight and Obese Pregnant Women Consortium Research Coordinating Unit (RCU) (U01) |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.847, 93. 837, 93.865, 93.213 |
FOA Purpose |
This FOA issued by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Heart, Lung, and Blood Institute (NHLBI); Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); and National Center for Complementary and Alternative Medicine (NCCAM), National Institutes of Health, invites grant applications from institutions/ organizations that propose to conduct studies testing behavioral/lifestyle interventions in overweight and obese pregnant women designed to improve weight and metabolic outcomes in both the pregnant women and their offspring. Trials must be designed to test lifestyle interventions to control gestational weight gain and/or influence maternal metabolic profiles. Studies are expected to continue follow-up of mothers and their offspring for a minimum of 12 months post-partum. Weight and/or metabolic outcomes must be assessed in both mothers and offspring. Investigators funded through this FOA must be willing to collaborate to develop a minimal set of common outcomes and to share data. Studies in minority and socio-economically disadvantaged populations are particularly encouraged. |
Posted Date |
January 4, 2011 |
Letter of Intent Due Date |
February 24, 2011 |
Application Due Date(s) |
March 24, 2011 |
AIDS Application Due Date(s) |
Not Applicable. |
Scientific Merit Review |
|
Advisory Council Review |
|
Earliest Start Date(s) |
December, 2011 |
Expiration Date |
March 25, 2011 |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
Nearly half of U.S. women of childbearing age are now
considered overweight or obese, with prevalence rates being higher among some
racial/ethnic minority populations and those of low socioeconomic status. In
addition, amounts of gestational weight gain (GWG) and post-partum weight retention
have been increasing over time, resulting in higher pre-pregnancy BMIs during
subsequent pregnancies. Numerous observational studies have linked
overweight/obesity, and/or excessive GWG during pregnancy to adverse health
consequences in both mothers and offspring. Short-term adverse outcomes include
maternal and fetal mortality, pregnancy-induced hypertensive disorders,
gestational diabetes mellitus, caesarean delivery, pre-term delivery, fetal
macrosomia, and congenital abnormalities. Longer-term adverse outcomes include
obesity and metabolic abnormalities, including type 2 diabetes, in both the
mother and offspring. This vicious cycle of obesity and metabolic disorders in
the offspring of obese women and women is of great public health concern. In
recognition of the importance of overweight/obesity during pregnancy and
appropriate GWG, the IOM recently released revised GWG guidelines, as described
in the 2009 Weight Gain During Pregnancy: Reexamining the Guidelines report.
[IOM (Institute of Medicine). 2009. Weight Gain During Pregnancy: Reexamining
the Guidelines. Washington, DC: National Academies Press.
Pregnancy provides a unique opportunity to implement short-term lifestyle
interventions that could have long-lasting beneficial effects on the health of
both the mother and her offspring. Results of numerous studies of
lifestyle interventions in non-pregnant populations have demonstrated that it
is possible to deliver effective lifestyle interventions for weight management
for 6 months to 1 year. Coupled with the additional motivation of an expectant
mother to maximize the health of her unborn child, these data suggest that it
may be possible to develop effective lifestyle interventions for
overweight/obese women during pregnancy. The long-term goal of these
interventions would be to ameliorate inappropriate gestational weight gain
and/or influence metabolic status of the mother, in order to reduce 1)
post-partum weight retention, 2) the incidence of gestational diabetes and
subsequent development of type 2 diabetes in the mother, and 3) the risk for
obesity, metabolic disturbances and adverse cardiovascular outcomes in the mother
and offspring.
In recent years, small studies have evaluated the effect of behavioral/lifestyle interventions on weight gain/composition, healthy lifestyle patterns and glycemic status in pregnant women. Some of these studies have shown promising results; however, much more research remains to be done to identify effective interventions that will improve weight, glucose and other-pregnancy-related outcomes in the mothers, and determine whether these interventions interrupt the vicious cycle of obesity and metabolic abnormalities in the offspring. In addition, few of these studies have enrolled sufficient women of low socioeconomic status and/or minority populations to rigorously evaluate the efficacy/feasibility of these interventions in such populations. Furthermore, more research is needed to evaluate 1) the feasibility of and barriers to recruitment, 2) acceptability of and adherence to lifestyle intervention, 3) retention, 4) safety to mother and offspring, including inadequate weight gain, 5) ability to measure relevant biological and behavioral outcomes, and 6) ability to track longer-term outcomes in mothers and their offspring. Interventions that have potential for translation to larger, diverse populations and in community-based and/or clinical settings are particularly important.
Objectives and Scope
This funding announcement will support studies of behavioral/lifestyle interventions in overweight and obese pregnant women that are designed to encourage appropriate gestational weight gain and/or influence maternal glycemia. Recruitment and enrollment is encouraged as early as possible in the pregnancy in order to most effectively influence both maternal and fetal/infant outcomes. Interventions in women from racial/ethnic minority populations and diverse socioeconomic backgrounds are particularly encouraged. All studies must include a control group. Study duration and size will vary depending on the primary outcome and calculated sample size.
The primary outcome in these studies must be a measure of health outcome(s) such as weight or glycemia in either the mother or offspring. Secondary outcomes may include behavioral and metabolic indices, CVD risk factors, and obstetrical/fetal outcomes, as appropriate to the study design. Studies that evaluate effects of interventions on sleep disorders are also encouraged. All studies must assess infant outcomes including body weight and length and measures of body fatness at birth and one year, although more frequent measurement is strongly encouraged. Metabolic assessments in the offspring at birth and later are also encouraged. Studies are expected to collect relevant biological samples. This FOA is NOT intended to study women who have type 1 or type 2 diabetes. Studies may enroll and/or plan to intervene in women with a history of GDM. Since a proportion of enrolled participants will develop GDM regardless of history, all applications must include a statistical analysis plan that addresses the potential for confounding associated with variable development of GDM.
Example interventional approaches may comprise, but are not limited to:
Studies should also evaluate the feasibility of recruitment, acceptability of and adherence to lifestyle interventions, retention, safety, and ability to measure relevant biological and behavioral outcomes. All studies must involve a team of professionals with relevant expertise that may include (as appropriate), but is not limited to: obstetrician/gynecologists, pediatricians or family physicians, physiologists, specialists in behavioral interventions, as well as experts in study design, implementation, and bio-statistical analyses.
Studies must be appropriately powered. Applicants are not required to have pilot data for the proposed intervention, if there is adequate data in the literature from related studies that could be used to calculate sample size. Applicants must provide evidence of their ability to recruit and retain subjects, conduct clinical trials, obtain relevant clinical data during pregnancy, and track outcomes in both the pregnant woman and her child for up to one year post-partum. Applicants must also provide a plan for how they would maintain contact with mothers and their offspring in the event that follow-up funds became available. Studies should also budget for the collection and processing of biological samples, as appropriate.
Studies in laboratory animals and/or pharmacologic-related
interventions are not appropriate for this announcement.
Program Organization and Coordination
The interventional trials to be conducted under this FOA will not use a common study protocol.
However, after awards are made, investigators will be required to share knowledge, collaborate on developing and reporting standardized measures of key common variables, link datasets, or work on other collaborative activities. For example, investigators may collaborate on development of assessment measures, methodological techniques, or protocols. When appropriate, the use of common study variables, criteria, and comparison of outcomes is highly encouraged to facilitate future analyses of the studies when possible. These collaborations will be facilitated by the Research Coordinating Unit (RCU) and the NIH Project Scientist(s). It is anticipated that the collaborative planning phase, DSMB review, and IRB approval process may take up to one year. The time required for this collaborative work should be factored into the timeline and design of the proposed intervention.
The NIH will be substantially involved with the clinical centers and RCU awardees in a partnership role. NIH Project Scientists will collaborate on project development, monitor study progress, ensure disclosure of conflicts of interest, appoint a chairperson of the Steering Committee, collaborate/provide input on manuscripts, and assure adherence to NIH policies. NIDDK will appoint the Data and Safety Monitoring Board (DSMB).
A Steering Committee will be the governing body for this project. The Steering Committee will be composed of the Principal Investigators of each clinical center and the RCU and the NIH Program Scientists. Each clinical center PI, the RCU PI, and the NIH will have one vote. It is anticipated that the Steering Committee will meet in-person three times in the first year and twice each year thereafter throughout the course of the project. The Committee will meet regularly by teleconference. It is anticipated that working groups will need to meet by conference calls to finalize common measures and other methodologies.
A DSMB will be established by NIDDK to monitor data and oversee participant safety in all of the studies supported by this initiative. The DSMB will be responsible for monitoring the funded projects and will report to the NIDDK. Therefore, applicants should not identify DSMB members in their applications, or even inquire about the interest of possible DSMB members, because anyone so contacted would not be eligible to serve as a member of the peer review committee that will evaluate the applications for scientific merit.
The DSMB will review the clinical center awardees protocols before the start of each project. Subsequently, the DSMB will monitor and review recruitment, adverse events, quality control, data analysis and publications, and overall awardee performance and scientific directions. The Board will be asked to evaluate study progress, review interim and final data, and to make recommendations regarding appropriate protocol and operational changes which may have substantial effects upon the ultimate interpretation of the study or affect the study’s funding. The DSMB will meet at least twice each year and more frequently if needed. At least one of the meetings each year will be in person. Although each clinical center’s progress will be monitored by the DSMB, applicants are required to include a data and safety monitoring plan in their application.
Awardees will be required to attend Steering Committee meetings and subcommittee meetings, as appropriate, in which study plans, findings, and issues of common interests and concerns will be shared and discussed. Each applicant must include in his/her budgets funds for attending these meetings. The Steering Committee will convene three times during the first funding year and semi-annually for each funding year thereafter. Steering Committee meetings will be for two days and will be held in the Washington, D.C. metro area. Applicants should budget for the attendance of the Principal Investigator and one additional staff member. For budgeting purposes, applicants should assume DSMB meetings for one day, once per year held in the Washington, D.C. metro area and conference calls as needed.
Research Coordinating Unit (RCU)
An RCU will facilitate collaboration and coordination of research activities, communication between and among Centers and the NIH, and data sharing and collaborative manuscripts. Please refer to FOA RFA-DK-10-015 for RCU functions and information on applying as a RCU. Applicants can propose to perform the research coordination functions alone or conduct the clinical trial alone. The PI/PD for the clinical trial can come from the same institution as the PI/PD for the RCU; however, the PI/PD for the clinical trial must not be the same PI/PD for the RCU.
Funding Instrument |
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities. |
Application Types Allowed |
New |
Funds Available and Anticipated Number of Awards |
The following NIH components intend to commit the
following amounts: |
Award Budget |
Direct costs are limited to <$500,000 per year for a five-year period . |
Award Project Period |
The total project period for an application submitted in response to this funding opportunity may not exceed five years. |
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions:
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For profit Organizations
Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are not allowed.
Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization 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.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.
The PD/PI must have the necessary expertise to lead this effort. He or she must be an experienced investigator in pregnancy research, be able to lead a collaborative effort and must establish and/or nurture existing and ongoing partnerships.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.
Awards for a Clinical Center and a Research Coordinating Unit (RCU) will not be made to the same Principal Investigator to ensure that pooled data analyses and data acquisition are performed independently. An institution may submit an application for an RCU, a Clinical Center, or both, but each must have a different PI/PD.
Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.
It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
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.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity
The letter of intent should be sent to:
Francisco O. Calvo, Ph.D.
National Institute of Diabetes and Digestive and
Kidney Diseases
Chief, Review Branch
6707 Democracy Boulevard, Room 752, MSC 5452
Bethesda, MD 20892-5452
(Courier use 20817)
Telephone: 301-594-8897
Email: [email protected]
Applications must be prepared using the PHS 398 research
grant application forms and 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)
At the time of submission, two additional paper copies of
the application and all copies of the appendix files must be sent to:
Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
6707 Democracy Boulevard, Room 752, MSC 5452
Bethesda, MD 20892-5452
(Courier use 20817)
Telephone: 301-594-8897
Email: [email protected]
All instructions in the PHS398 Application Guide must be followed.
Resource Sharing Plan
Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the PHS398 Application Guide, with the following modifications:
Appendix
Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.
Part I. Overview Information contains information about Key Dates.
Information on the process of receipt and determining if
your application is considered on-time is described in detail in the PHS398
Application Guide.
Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants Policy
Statement.
Pre-award costs are allowable only as described in the NIH Grants
Policy Statement.
Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be
reviewed.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.
Applicants must be able to enroll and retain subjects throughout the study and must indicate this capability in their research plan.
Applicants must indicate their willingness to participate in Steering Committee and sub-committee meetings, calls, and other activities, as described in Section VI, Part 2. Applicants should include their time for this effort in their budget. The total time commitment for this FOA for the PI(s) must be appropriate to assure adequate implementation and oversight of the proposed project.
The Steering Committee will meet three times in person during the first year of the award and conference calls as necessary. In subsequent years, semi-annual Steering Committee meetings of investigators from all funded studies will be held to enable sharing and collaborative problem solving. Applicants should budget for key investigators to attend two-day face-to-face Steering Committee meetings in the Bethesda/Washington, D.C. Metro area.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s)
Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the PD/PI(s) and investigative team bring complementary and integrated expertise to the project? Does the PD/PI devote enough time for the research? Are the infrastructure requirements adequately developed? Is there evidence of a multidisciplinary and diverse team of investigators? Is there evidence that the PD/PI and investigative team are willing to collaborate with other investigators in this consortium to develop common measures and disseminate research results?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented?
If the project is in the early stages of development, will the strategy
establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?
Does the applicant acknowledge the successes and failures of past research in the literature and use such knowledge to design and implement the study? Is the study likely to have high participation and/or adherence rates? Are the proposed recruitment and retention strategies adequate? Is the sample size adequate and is the study adequately powered to detect intervention effects? Are there sufficient evidence and justification that the effect size can be achieved through the proposed intervention in the allotted time in the proposed study population? Are the statistical analyses appropriate for the design and unit of randomization selected? Are the informed consent procedures, data collection, quality control, and data management appropriate?
For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.
Collaboration: Have the investigators stated their willingness to collaborate with NIDDK and NIH scientists and staff and with Investigators and staff from other clinical centers and the RCU supported by this program?
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Not Applicable
Renewals
Not Applicable
Revisions
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.
Applications from Foreign Organizations
Not Applicable
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by the National Diabetes and Digestive and Kidney Diseases (NIDDK) (assignments will be shown
in the eRA Commons), in accordance with NIH peer
review policy and procedures, using the stated review
criteria.
As part of the scientific peer review, all applications:
Applications will compete for available funds with all other recommended applications submitted in response to this FOA . Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board . The following will be considered in making funding decisions:
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.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.
Any application awarded in response to this FOA will be subject to the DUNS,
CCR Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
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 and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. . More information is provided at Award Conditions and Information for NIH Grants.
The following special terms of award are in addition to, and
not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB)
administrative guidelines, U.S. Department of Health and Human Services (DHHS)
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, 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.
The PD(s)/PI(s) will have the primary responsibility for:
Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
NIH staff have substantial programmatic involvement that is above and beyond
the normal stewardship role in awards, as described below:
The applicable NIH Project Scientist(s) will:
a. The NIH Project Scientist(s) or designee may provide advice in the management and technical performance of the investigations, coordinating required regulatory clearances for investigational agents used in the study, which are held by NIH. The NIH reserves the right to cross file or independently file an Investigational New Drug Application or an Investigational Device Exemption form with the FDA.
b. The NIH 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. Review procedures for assessing data quality and study performance monitoring.
d. NIH Project Scientist(s) or designee(s) may be co-authors on study publications. In general, to warrant co-authorship, NIH 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; (c) participate in analysis and interpretation of study results and (d) preparation and authorship of pertinent manuscripts.
In addition, a separate NIH Program Official identified in the Notice of Grant Award will be responsible for the normal stewardship and monitoring of the award including review and approval of all progress reports and all budgetary decisions. Additional responsibilities include:
The NIH Program Official 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 NIH will not permit further expenditures of NIH funds for a study after requesting closure except as specifically approved by the NIH.
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.
The NIDDK will appoint members to the Data and Safety Monitoring Board (DSMB) as appropriate; the NIDDK Program Official or their designee will serve as the Executive Secretary and/or NIDDK program representative on the DSMB.
An agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
Areas of Joint Responsibility include:
1. Steering Committee.
A Steering Committee organized by the study investigator(s) will be the main governing 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 NIH and will provide periodic supplementary reports upon request.
The Steering Committee will be composed of all Principal Investigator(s) of the clinical centers, the RCU Principal Investigator, and the NIH. Each clinical center, the RCU, and the NIH will have one vote on the Steering Committee. The final structure of the Steering Committee and voting procedures will be established at the first meeting. The NIH will have voting membership on both the Steering Committee and applicable subcommittees. The frequency of Steering Committee meetings will be dictated by a vote of the members of the Steering Committee.
A Chairperson of the Steering Committee, other than the NIH Project Scientist(s), will be selected by the NIH. The Chairperson provides leadership to the Committee by conducting the Steering Committee meetings, representing the study group to the External Oversight Committee established by the NIH and by interacting closely with the awardees during protocol development and implementation.
2. External Study Oversight.
An independent Data and Safety Monitoring Board will be established by the NIDDK. The Data and Safety Monitoring Board will review interim results periodically and provide recommendations to the NIDDK.
Dispute Resolution:
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 Dispute Resolution. A Dispute Resolution 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 dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]
eRA Commons Help Desk(Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]
Mary E. Evans, Ph.D.
Director, Special Projects in Nutrition, Obesity, and
Digestive Diseases
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK)
National Institutes of Health
6707 Democracy Boulevard
Room 681, MSC 5450
Bethesda, Maryland 20892-5450
(For UPS, FedEx: use 20817)
Telephone: 301-594-4578
Email:[email protected]
S. Sonia Arteaga, Ph.D.
Program Director
Clinical Applications and Prevention Branch
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health
6701 Rockledge Drive, Suite 10018
Bethesda, MD 20892 (for express delivery use 20817)
Phone: 301-435-6677
Fax: 301-480-5158
Email: [email protected]
Caroline Signore, MD, MPH
Program Officer/Project Scientist
Pregnancy and Perinatology Branch
Eunice Kennedy Shriver National Institute of Child Health
and Human Development (NICHD)
6100 Executive Blvd., Room 4B03, MSC 7510
Bethesda, MD 20892
(For FedEx use Rockville, MD 20852)
Telephone: 301-496-5577
Email: [email protected]
Julia T. Arnold, PhD
Project Officer
Program Office - Division of Extramural Research
National Center for Complementary & Alternative Medicine
(NCCAM)
National Institutes of Health
6707 Democracy Boulevard, Suite 401
Bethesda, MD 20892-5475 (for express delivery use 20817)
Telephone: 301.451-6711
Email: [email protected]
Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
6707 Democracy Boulevard, Room 752, MSC 5452
Bethesda, MD 20892-5452
(Courier use 20817)
Telephone: 301-594-8897
Email: [email protected]
Sharon T. Bourque
Senior Grants Management Specialist
National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK)
National Institutes of Health
6707 Democracy Boulevard, Room 707
Bethesda, MD 20892 MSC 5456
(use zip code 20817 for overnight delivery)
Telephone: 301-594-8846
Email: [email protected]
Kim Stanton
Grants Management Specialist
National Heart, Lung, and Blood Institute (NHLBI)
6701 Rockledge Drive, Room 7167
Bethesda, Maryland 20892-7926 (for express delivery use
20817)
Telephone: 301-435-0159
Email: [email protected]
Bryan S. Clark, M.B.A.
Grants Management Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development
(NICHD)
6100 Executive Boulevard, Room 8A01A, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: 301-435-6975
Email: [email protected]
George Tucker
Grants Management Officer
Office of Grants Management
National Center for Complementary and Alternative Medicine
(NCCAM)
6707 Democracy Boulevard, Suite 401
Bethesda, MD 20892
(use zip code 20817 for express/courier delivery)
Telephone: 301-594-9102
Email:[email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
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 Part 52 and 45 CFR Parts 74 and 92.
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