Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Funding Opportunity Title	Lifestyle Interventions in Overweight and Obese Pregnant Women Consortium Research Coordinating Unit (RCU) (U01)
Activity Code	U01 Research Project Cooperative Agreements
Announcement Type	New
Related Notices	None
Funding Opportunity Announcement (FOA) Number	RFA-DK-10-015
Companion FOA	RFA-DK-10-014, Lifestyle Interventions in Overweight and Obese Pregnant Women Consortium (U01)
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestics Assistance (CFDA) Number(s)	93.847
FOA Purpose	This Funding Opportunity Announcement (FOA), issued by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), invites cooperative agreement grant applications from institutions to function as the Research Coordinating Unit (RCU) for the Lifestyle Interventions in Pregnancy Clinical Trials Consortium. This FOA runs parallel with a separate Funding Opportunity Announcement (FOA) that solicits applications for clinical trials (see RFA-DK-10-014). The purpose of the RCU is to promote collaboration, coordination and exchange of scientific information among investigators conducting lifestyle interventions in overweight and obese pregnant women. The ultimate goal of the program is 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. Among other tasks, the RCU will facilitate collaboration and coordination of research activities, communication between and among Centers and the NIDDK, and data sharing and collaborative manuscripts. In addition, the RCU will plan, arrange, and support meetings/conference calls of the Steering Committee and its subcommittees and the DSMB.

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	June, 2011
Advisory Council Review	October 2011
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

Background

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.

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)

The primary goal of the RCU is to facilitate coordination of research activities and communications between and among awardees and the NIH. In consultation with the awardees and NIH, the RCU will be expected to provide leadership in the conduct of a number of tasks, including but not limited to the following:

Common Measures and Data Sharing

• Promote collaboration across the clinical centers, among the investigators, and with NIH.
• Facilitate the development of standardized variable definitions and common measures and methods. This may involve compiling a list of proposed standardized variable definitions and common measures or methods, reviewing relevant literature, assessing the advantages and disadvantages for common measures and standardized definitions, and facilitating testing of study forms if needed.
• Establish and maintain a computer system to receive and store any datasets that are common or linked across studies.
• Facilitate data sharing where appropriate, which may entail transfer and linkage from two or more projects on the same topic for greater statistical power and analyses.
• Provide support for analysis of data for manuscripts that are common across studies or are collaborative.
• Have appropriate data management, programmatic, statistical, and scientific expertise to achieve the above goals.
• Meetings
• Compile individual study protocols and other documents, and provide relevant reports to NIH and the DSMB.
• Plan, arrange, and support meetings of the Steering Committee (SC) and its subcommittees and DSMB. 
• Prepare minutes of SC meetings, distribute to members, and post on the program website. 
• Arrange regular, usually monthly, conference calls for the SC and subcommittees.
• RCU applicants must include funds for RCU staff to attend one face-to-face DSMB meeting each year in the Washington, D.C. metro area as well as the meeting costs (meeting room, refreshments, etc.). Applicants should also budget for one DSMB meeting by teleconference/webinar per year.

Communications

• Develop and maintain a high-availability web site and email system for group communication and for distribution of study documents, forms and information.
• Facilitate development of subcommittees and monthly communication among investigators as necessary.
• Facilitate sharing of data and development of collaborative manuscripts among clinical center awardees.
• Facilitate information exchange among and between the clinical centers and NIH.
• Participate in the scientific discussions and implementation of the studies as needed.
• Facilitate the dissemination of study results, including the preparation of limited access data files for public use.
• Facilitate the submission of manuscripts accepted for publication to PubMed Central according to NIH policy (http://publicaccess.nih.gov).

Applicant institutions may apply for both the clinical centers and RCU components of this program. The PD/PI for the RCU must not be the same PD/PI for the clinical center application, but can be from the same institution. Applicants proposing to perform the research functions of a clinical center should describe how these activities will be performed in a separate application responsive to RFA-DK-10-014.

Please Note: The evaluation of the clinical center applications will be separate from the overall review of the scientific merit of the RCU application (see Section IV. 2.B). The PI/PD for the RCU can come from the same institution as the PI/PD for the clinical trial; however, the PI/PD for the RCU must not be the same PI/PD for the clinical trial. Applicants should include in the budget for the RCU the cost of meeting rooms and equipment for in-person meetings. The budget and budget narrative should include the direct and facility and administrative (F&A) costs for the RCU component not to exceed the funding levels provided in Section II.2. 

See Section VIII, Other Information - Required Federal Citations for policies related to this announcement.

Facilities and Environment

All applicants must provide evidence that the institution or institutions in which the coordination will take place have the infrastructure, resources and institutional support needed to achieve the goals outlined above. Applicants must demonstrate the availability of adequate office and other facilities needed to carry out the objectives of the RCU. To the extent possible, it is desirable for the RCU to have a commitment for sufficient contiguous space so that the RCU has a high degree of cohesion and visibility. Internet access to scientific literature and other information must be readily available. Relevant support services, including for example adequate data management and analytic support, must also be readily accessible and documented in the proposal.

Research Plan

In lieu of a research plan, the following items should be addressed satisfactorily by the applicant:

Evidence of Leadership and Performance Experience:

• The PD/PI should demonstrate leadership and experience in conducting the following coordinating functions for research studies.
• Promoting collaboration across studies and among investigators.
• Promoting collaboration across studies to identify common measures or constructs and instruments and to standardize procedures.
• Providing expert assistance in supporting the linkage of datasets or analysis of collaborative data when appropriate. 

Capacity and Ability to Manage Data and Communications: 

• Applicants must indicate in their application their capability to utilize electronic technology to meet the goal for coordination of clinical trials. 
• Applicants should have experience in developing and maintaining data management systems. 
• Applicants should provide evidence of data management and program support capabilities by describing the processes for potential data linkages, meta-analyses or pooled/linked data analyses, data security, privacy protections, and quality control. 
• Applicants should propose methods to be employed to facilitate communication between RCU staff, clinical center investigators and staff, as well as NIH personnel.

Academic and Management Capabilities: 

• Applicants should demonstrate experience as a PI for an RCU.  
• Evidence of scholarship in lifestyle interventions and/or pregnancy outcomes research within the RCU team.

Staffing Expertise and Capabilities: 

Applicants must propose an operational structure for coordinating functions at the RCU, including lines of responsibility for professional staff at the RCU. The PD/PI must have sufficient effort to assure adequate implementation and oversight of the proposed project.

Evidence of Communication Capabilities: 

The RCU is responsible for supporting infrastructure for meetings and teleconferences.  Applicants should have experience arranging logistical services for multiple studies, such as assuring meetings (e.g., DSMB meetings, SC meetings) are held and minutes are recorded and communicated to investigators and NIH in a timely manner.

Departmental and/or Institutional Commitment: 

Applicants must demonstrate departmental and/or institutional commitment to participate in research and must provide letters of support from appropriate individuals.  Support in areas of secure transfer of data, information technology, equipment, and general support of research, should be described along with evidence of previous research support.

Other Functions

• Applicants must provide support for potential linkage of datasets and subsequent meta-analyses or collaborative analyses across trials and take appropriate leadership in preparation of scientific reports and manuscripts and publication and presentation of findings.
• Applications must include a plan to prepare public-use files for archiving and sharing results and bio-samples consistent with NIH policies.
• Awardees must agree to the Cooperative Agreement Terms and Conditions of Award in Section VI.2.A.

Awardees must agree to the Cooperative Agreement Terms and Conditions of Award in Section VI.2.A.

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 The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NIDDK will contribute up to $500,000 in direct costs for one award in FY 2011.
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:

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American tribal organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• eRA Commons

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 and/or involve other investigator(s) with the appropriate expertise, be able to lead a collaborative effort, and to 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 PI/PD 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.
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]

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 page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed.

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:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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.

For coordination among investigators, RCU applicants are required to participate in three meetings in the first year of the award and conference calls as necessary. In subsequent years, semi-annual meetings of investigators from all funded studies will be held to enable sharing and collaborative problem solving.  Applicants should budget for key investigators and RCU staff to attend two-day face-to-face meetings in the Bethesda/Washington, D.C. Metro area. 

Awardees are required to participate in monthly steering committee conference calls and should include their time for this effort in their budget. The principal investigators from each clinical center team, the RCU principal investigator and the NIH staff will comprise the committee. The committee will establish policies and procedures for the consortium such as approaches to 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.

RCU applicants should budget for at least the RCU Principal Investigator and other relevant investigators/staff members to travel to all meetings. RCU applicants should include in the budget for the RCU the cost of meeting rooms and equipment for in-person Steering Committee and DSMB meetings. Applicants should also include in the budget for the RCU the cost of regular SC and sub-committee teleconferences/webinars and related expenses.

For applicants proposing to become a clinical center, please see RFA-DK-10-014 for application guidance. The total time commitment for this FOA for the RCU PD/PI(s) must be appropriate to assure adequate implementation and oversight of the proposed project.  

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

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? Does the applicant address the importance of performing coordinating functions in order to enhance the value of the research programs as indicated in the FOA under Program Organization and Coordination?

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? Does the applicant have prior experience in performing coordinating functions and/or expertise in outcomes research? Is there adequate demonstration of prior successful efforts as a coordinating unit?

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? Are the proposed approaches appropriate for facilitating coordination among clinical center projects and serving as a resource among Centers?  Are state-of-the-art coordinating and resource strategies proposed? Are the proposed coordination strategies adequate? Does the applicant propose adequate plans to facilitate the development of common measures and/or linkage and analysis of common data across the studies? 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? Is there evidence of institutional support? Is there availability of adequate data management, programmatic, and statistical support if needed?

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 NIH scientists and staff and with investigators and staff from the clinical centers 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 Institute of Diabetes and Digestive and Kidney Diseases (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:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review), will be discussed and assigned an overall impact/priority score.
• Will receive a written critique.

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 NDDK Advisory Council . The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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:

• Developing the research design and study protocol, including definition of objectives and approaches, sample size and power calculations, and establishing procedures for participant recruitment and follow-up, data collection, quality control, interim data and safety monitoring, final data analysis and interpretation, and publication of results.
• Establishing a Steering Committee to implement, coordinate and manage the project(s). 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. The Steering Committee Chair will be appointed by the NIH.
• Implementing collection of data specified by the study protocol or by the Steering Committee, as applicable. Each awardee/site is required to ensure that data will be submitted expeditiously to the Research Coordinating Unit, as determined by the Steering Committee and the NIH. Additionally, individual investigators/sites must demonstrate the ability to implement the strategy specifically designed for their individual study population.
• Establishing procedures for data quality and completeness. 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; (2) as simple as appropriate in order to facilitate cooperation/referral of study participants by physicians to avoid unnecessary expense; and (3) sufficiently staffed across the participating institutions. A plan for analysis of pooled data will be developed by the Steering Committee.
• Submitting interim progress reports, when requested, to the appropriate NIH Program Official including as a minimum, summary data on protocol performance. For coordinated multiple awards or a multi-site single award, the appropriate NIH Program Official may require additional information from individual awardees/sites. Such reports are in addition to the required annual non-competing continuation progress report.
• Establishing procedures, where applicable, for all participating institutions in coordinated awards to comply with FDA regulations for studies involving investigational agents or devices and 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.
• 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 awardee must also be adherent to Study Publication and Presentation Policy. The NIH will have access to and may periodically review all data generated under an award. NIH staff may co-author publications of findings with awardees consistent with NIH and study policies.
• 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 NIH support; or special access to study results, primary data/summary information, or resources -- may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party is permitted only after concurrence by NIH.
• 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 steering committee policies on publications.
• Maintaining confidentiality of information: The awardee(s) will maintain the confidentiality of the information developed by the investigators (i.e., protocols, data analysis, conclusions, etc.) as well as proprietary information of a company collaborating with the study.
• 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. All clinical/RCU PIs or his/her designee will coordinate with the NIDDK Data Repository to prepare the collected data for eventual archiving and distribution. In addition, if applicable, the PI or his/her designee will work with the NIDDK Biosample Repository to coordinate procedures for coding, shipping, processing, receipt, and storage of study samples that are to be maintained in the Repository. 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).
• The Food and Drug Administration Amendments Act of 2007 (FDAAA or US Public Law 110-85) was passed on September 27, 2007. The law requires mandatory registration and results reporting for certain clinical trials of drugs, biologics, and devices. If applicable, the PI or his/her designee will perform the mandatory study registration and reporting of study results to ClinicalTrials.gov. For more information about this law and requirements for sponsors and/or investigators, visit the PRS and U.S. Public Law 110-85 Information Page at http://prsinfo.clinicaltrials.gov/fdaaa.html.

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:

• Serve as 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, NIH may designate additional NIH 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.
• Participate on the Steering Committee that oversees study conduct. NIH Project Scientists or designee(s) will be full participants on the Steering Committee and, if applicable, subcommittees. NIH will have one collective voting member of the Steering Committee.
• Serve as a resource to study investigators with respect to other ongoing NIH activities that may be relevant to the study to facilitate compatibility with the NIH mission(s) and avoid unnecessary duplication of effort.
• Be substantially involved in and/or assisting with the design and coordination of research activities for awardees as elaborated below:

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:

• 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, 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 NIH retains, as an option, periodic review of progress by researchers not involved with the study.
• Reviewing and approving protocols prior to implementation to insure they are within the scope of peer review, for safety considerations, as required by Federal regulations.

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
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]

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]

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.