Department of Health
and Human Services (HHS)
and Human Services (HHS)
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
U24 Resource-Related Research Projects – Cooperative Agreements
Reissue of RFA-HD-13-013 - Data Coordinating Center for the NICHD Cooperative Multicenter Maternal Fetal Medicine Units Research Network (U10)
None
RFA-HD-21-029, UG1 Clinical Research Cooperative Agreements - Single Project
93.865
|
This limited competition funding opportunity announcement (FOA) issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development invites an application from the current Data Coordinating Center (DCC) awardee of the Maternal-Fetal Medicine Units (MFMU) Network, for the completion of ongoing trials and studies. |
Not Applicable
September 4, 2020
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
November 2020
January 2021
April 2021
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. 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.
Research Objectives
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) invites an application from the current Data Coordinating Center (DCC) for the NICHD Maternal-Fetal Medicine Units (MFMU) Network. The MFMU Network is a multicenter clinical research program designed to perform interventional and observational clinical studies to improve maternal, fetal and neonatal health, with an emphasis on conducting randomized-controlled trials.
The objective of this program is to facilitate the advancement of pregnancy care by establishing a network of academic centers that, by rigorous patient evaluation using common protocols, can study the required numbers of patients and provide answers more rapidly than individual centers acting alone.
The infrastructure is set up for carefully designed, randomized double-blinded placebo-controlled, as well as management trials, and observational studies. The infrastructure also supports the ability to follow participants to assess both short-term (clinical effect) and long-term (neurodevelopmental outcome) measures.
The aims of the Network are to reduce maternal, fetal, and infant morbidity related to preterm birth, fetal growth abnormalities, and maternal complications and to provide the rationale for evidence-based, cost-effective, obstetric practice.
The clinical centers for the MFMU Network were re-competed in 2016, and 12 clinical centers were awarded for the 2016-2021 cycle for membership.
The MFMU Steering Committee is composed of clinical site PD/PIs, the DCC PD/PI, and the NICHD Project Scientist/Project Coordinator. The Steering Committee assures compliance with Network policies and procedures, selects topics for investigation, designs study protocols, implements studies, participates in the analysis and interpretation of data, and reports results in presentations and publications. The Network is currently conducting the following protocols:
It is possible that with additional funding and scientific need as determined by the Institute, the network could design clinical trial(s) of diagnostics, vaccines, and/or therapeutics related to COVID-19 in pregnancy. New studies or trials on any other topic will not be allowed.
The DCC plays a pivotal role in data management and analysis, statistical expertise, and logistical services required for the MFMU. In support of the activities of the MFMU, the DCC will:
A responsive application must provide strong evidence of the applicant’s ability to cooperate with multiple sites involved in clinical trials -- including the design, execution, data collection, and data analysis resulting in publication for multicenter randomized clinical trials and observational studies, particularly in obstetric-perinatal medicine. The DCC must provide logistical support for meetings, teleconferences, and the steering committee. Experience with the U.S. Food and Drug Administration's Investigational New Drug (IND) and Investigational New Device (IDE) application procedures is essential. The DCC must also develop and maintain a MFMU website for both public access and private secure investigator and staff access. The DCC is the primary liaison to the DSMB and is responsible for coordination of DSMB activities. The DCC oversees the capitation disbursement system for ongoing studies and trials.
Scope
The funded DCC will cooperate with the NICHD MFMU clinical site Principal Investigators and the NICHD Program Project Scientist/Project Coordinator in identifying research topics of high priority and designing appropriate protocols. The participating DCC will have primary responsibility for data management and analysis for MFMU research in collaboration with the Steering Committee. All parties in the Network will agree to accept the coordinating role of the group and the participatory and cooperative nature of the group process, including Network Policies and Procedures.
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Need help determining whether you are doing a clinical trial?
NICHD intends to fund one award for a total of $7,412,000 for fiscal year 2021 that includes base costs plus capitation costs. Future year amounts will depend upon annual appropriations.
Application budgets are limited by award amounts and should reflect the actual needs of the Network protocols as they are completed over the project period.
The total project period may not exceed 4 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
N/A
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 SF424 (R&R) Application Guide.
The PD(s)/PI(s) must possess a doctoral degree in a relevant field such as statistics, biostatistics, or epidemiology, and is required to commit 10.2-12.0 person-months (85 to 100 percent) effort to the DCC activities of the NICHD MFMU in the first year of the project period. The PD(s)/PI(s) must have clinical trials, administrative, and statistical expertise. Active participation of the PD(s)/PI(s) is expected during all phases of a clinical research study.
One individual must be designated as an Alternate PD(s)/PI(s), who is able to serve in the absence of the PD(s)/PI(s). The alternate PD(s)/PI(s) must possess a doctoral degree in a relevant field such as statistics, biostatistics, or other relevant area and should commit at least 1.2 person-months (10 percent) effort to the project.
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.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Budget
The first year budget will be limited to a total cost of $7,412,000 for BASE BUDGET plus CAPITATION COSTS. Allowable costs include:
Budget for Entire Proposed Period of Support
Follow instructions in the PHS 398 Application Guide.
Applicants should submit BASE BUDGET estimates for all years, taking into account protocol completion over time. The base budget plus capitation costs is limited to $7,142,000 in total costs for the first year, and is expected to decrease over time, as studies are completed. As appropriate, costs should be broken out for each of the supported studies.
Capitation costs should be broken out for each supported study, and are expected to decrease over time, as study activities are completed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy: Without duplicating information in the biosketches, applications must address the following items:
Evidence of Successful Past Performance
DCC applicants must describe prior experience in the design, conduct, data analysis, and management of major collaborative clinical research projects preferably in perinatal medicine, and provide evidence of successful performance as a DCC for multi-site studies within the past three to five years. Further, applicants need to show evidence of monitoring of trials, including the ability to generate monthly reports of enrollment and follow up for the NICHD MFMU clinical centers and subcommittees, data and safety reports for DSMB, and provision of support of data files.
Academic Productivity
DCC applicants must provide evidence of research productivity in previous or ongoing clinical trials, especially those of a cooperative or multicenter design in the field of obstetric-perinatal medicine. Contributions in key areas of research development and design, data collection and analysis, monitoring of trial progress, and track record of publications that resulted from participation in the studies should be listed.
Staffing Plan and Capabilities
The application should describe plans for staffing DCC functions and provide evidence of multicenter collaboration on recent clinical trials, especially those in obstetric-perinatal medicine, including publications resulting from these studies. The proposed DCC should have some degree of flexibility in staffing to be able to respond to the changing needs and seasonal variation in work effort of the Network. For instance, meeting deadlines, trial startup and completion, and other variables necessitate increases and decreases in staff effort from the DCC over time. Logistical staff for day-to-day functioning of the network, and support staff to manage clinical site capitation, must be described and justified. It is expected that staff effort will decrease over time as studies are completed.
Capacity and Ability to Manage Data and Communications
Applications must describe the ability to assist in protocol development with respect to design of procedure manuals, data collection forms, data management systems, electronic technology, and data entry systems. Prior experience in data quality assurance is required. Applicants should provide evidence of data management and program support capabilities by describing their standard operating procedures to include data collection, management, analysis, and quality control. A system to ensure availability of patient randomization for studies outside of normal business hours (i.e., nights, weekends, and holidays) is required. Applicants must include plans for support of electronic mail and communication. The DCC must develop and maintain a website for both public access and private, secure investigator access. Previous experience in obstetric-perinatal medicine studies and FDA IND and IDE (Food and Drug Administration Investigational New Drug/Device) protocols are preferred. Knowledge of federal patient-privacy and data confidentiality requirements and appropriate experience in ensuring that relevant mechanisms and procedures are in place must be provided in the application.
Evidence of Reporting Capabilities
Applications must provide evidence of experience with generation of monthly reports on subject enrollment for multiple concurrent studies, reports for use by the DSMB and Scientific Consult Board, and reports for Steering Committee meetings is required. Documentation and dissemination of meeting minutes and minutes of conference call meetings are required to be performed in a timely manner. The applicant should delineate previous history of such activities in the application. Further, experience in preparing data presentation and manuscripts for publication is to be described in the Research Plan. The DCC PD/PI will give a report to the Steering Committee quarterly at the Steering Committee meetings as necessary.
Logistical and Other Support Services
Applications must describe experience and capabilities with respect to logistical and support services relevant to the MFMU. The DCC is responsible for supporting the infrastructure for meetings and teleconferences. The DCC provides arrangements and documentation in the form of minutes for Steering Committee meetings (at least two face-to-face meetings per year in the DC metropolitan area and others conducted virtually, as necessary) and conference calls, DSMB meetings (one per year and as needed) and committee conference calls, and other meetings as needed by the Network. On occasion, the DCC handles travel arrangements for selected consultants as needed. The MFMU communicates on an ongoing basis via email and teleconference; these activities are supported by the DCC. Expertise in coordinating sample storage and study drug/equipment assignment is required. The DCC oversees the capitation system for the studies and trials and maintains subcontracts/Memoranda of Understanding with the clinical sites for disbursement.
Onsite and Off-site Monitoring Ability
Applications must provide evidence of experience in organizing and conducting both onsite and remote monitoring for clinical research studies. Generation of data errors and needed edits is required. The DCC needs to ensure that the MFMU centers fully comply with NIH regulatory requirements, including Human Subjects Protections, informed consent, reporting of adverse events and protocol deviations, human and animal safety and welfare provisions, and FDA requirements as indicated by specific studies.
Technology Transfer, Data Management and Protocol Training Capabilities
Applications are expected to describe capabilities in technology transfer, data management, and protocol training. The DCC must be able to assist the clinical centers in data management and communication activities. Training and technical expertise as well as experience and resources must be delineated. Training sessions for scientific protocols, ongoing yearly certifications necessary for the MFMU studies (e.g., developmental tests, standardized physician examinations, follow up), and data entry are arranged through the DCC.
Administrative and Management Capabilities
The PD/PI should delineate his/her skills as a manager or administrator for a DCC. The PD/PI must provide evidence of experience and ability to estimate the appropriateness and reasonableness of resources needed for individual projects and ability to manage those resources efficiently during the course of the research. Flexibility of personnel based on needed effort is required. Prior experience with meeting deadlines (e.g., FDA reporting requirements, national meetings, Steering Committee meetings, DSMB meetings, scientific consult board meetings, and so forth) should be delineated in the application. Experience with capitation for study subject recruitment by clinical centers is mandatory. This includes providing and monitoring funds to the clinical centers for patient recruitment at regular intervals. Experience with subcontracts is required as there is occasional need to supplement resources through arrangements with outside organizations based on individual protocol requirements.
Preparation of Data and Biospecimens for Sharing
The DCC must describe plans for ensuring that all datasets from MFMU studies conducted after 1990 are cleaned, documented, deidentified, and otherwise prepared for submission for submission into the NICHD Data and Specimen Hub (DASH) or other NIH approved repositories consistent with the content of the consent forms collected during the study. This should include the preparation of any linking files necessary to associate clinical data with biospecimens stored in the NICHD biorepository.
Special Strengths of the PD/PI or Institution
Applicants are encouraged to describe special or unique strengths that may be relevant to MFMU research. These can include state-of-the art data management systems, which may be shared or may be available to develop and expand the scientific productivity of the MFMU. In addition, special administrative strengths or experience as well as participation in administrative aspects of clinical research (IRB, DSMB, scientific board for clinical research, clinical research committees and so forth) for the PD/PI and additional staff members should be highlighted. Level of support for clinical trials can be described.
Applications from institutions that have a Clinical and Translational Science Award (CTSA) funded by NIH or other funded perinatal research centers as resources for conducting the proposed research should provide a letter of agreement that identifies the level of support from the PD/PI or the CTSA program director.
Intent to Participate
There must be a clearly expressed intent to participate in a cooperative manner with MFMU clinical centers, NICHD, the DSMB, and the scientific consult board in all aspects of research as outlined in this RFA. MFMU projects must be given priority at awarded clinical centers.
Letters of Support: Provide letters of support specific to the Data Coordinating Center.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
The following modifications also apply:
NICHD Plans for Sharing Human and Non-Human Data and/or Biospecimens
NICHD expects that data, biospecimens, and results of NICHD-funded research will be shared with the wider scientific community to the extent feasible and in a timely manner. NIH Data Sharing Policy expects the timely release and sharing of data to be no later than the acceptance for publication of the main findings from the final dataset. All NICHD applications, regardless of the amount of direct costs requested for any one year, must include a Sharing Plan that addresses sharing of data as well as biospecimens, if applicable. Ideally, this plan would include submitting data or biospecimens to an appropriate repository. These plans will also be considered by program staff as award decisions are being made as appropriate and consistent with achieving the goals of the program.
Specifically, for human data, the NICHD encourages the use of the Data and Specimen Hub (DASH), a centralized resource for researchers to store and access de-identified data from studies funded by NICHD. They can also submit information about the location and availability of biospecimens to DASH, if applicable. Submission of data to the NICHD DASH is one way that grantees may meet the requirements of the NIH Data Sharing Policy and make study data available for secondary analyses. Information about DASH may be obtained at https://dash.nichd.nih.gov/ .
If use of DASH is not feasible, NICHD expects awardees to share data and/or biospecimens through other equivalent broad-sharing data and/or biospecimen repositories. For projects generating large-scale human genetic data, applicants should provide a Provisional or Institutional Certification specifying whether the individual-level data can be shared through an NIH approved repository, such as dbGaP, in line with the NIH Genomic Data Sharing Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html)
All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Not Applicable
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
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 submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NICHD. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
I
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
This award is primarily to support the completion of ongoing clinical trials and studies and thus review criteria will focus on capabilities for the completion of these studies, rather than on the development of new clinical trials.. The designation of "clinical trial optional" is to allow flexibility if the need for a new trial arises during the period of this award.
Reviewers will provide an overall impact 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.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? 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?
In addition, for applications involving clinical trials
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?
In addition, for applications involving clinical trials
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the ongoing clinical trials and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
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?
In addition, for applications involving clinical trials
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:
1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
In addition, for applications involving clinical trials
Note: This award is primarily to support the completion of ongoing clinical trials and studies and thus review criteria focused on capabilities for the development of new clinical trials will not generally be applicable.
Does the application adequately address the following, if applicable:
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
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?
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for conducting clinical trials?
Does the application adequately address the capability and ability to conduct clinical trials at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
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 score, but will not give separate scores for these items.
Study Timeline
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate? Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
For research that involves human subjects but does not involve one of the 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 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 Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
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.
Not Applicable
For Renewals, the committee will consider the progress made in the last funding period.
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 score.
Not applicable
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).
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) Genomic Data Sharing Plan (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
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 Scientific Review Branch, NICHD in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications will be assigned to the appropriate NIH Institute or Center. 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 National Advisory Child Health and Human Development (NACHHD) Council. The following will be considered in making funding decisions:
Information regarding the disposition of applications is available 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’s 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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
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.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
The NICHD MFMU consists of 12 Clinical Centers, collaborating clinical sites, and the DCC (this award). The Clinical Centers are funded through a separate limited competition solicitation as cooperative agreements (UG1).
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 75 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:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
NICHD Project Scientist/Project Coordinator may:
NICHD Program Official
Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. This role is separate from the Project Scientist/Project Coordinator and will include the following:
Areas of Joint Responsibility include:
In addition to the above specified rights, responsibilities and involvement, the DCC has collaborative responsibilities involving interactions with the Steering Committee, the Scientific Consult Board, and the Data Safety and Monitoring Board.
Steering Committee
A Steering Committee will be responsible for protocol development, assisted by the Scientific Consult Board and the DSMB. The Steering Committee will have primary responsibility for the conduct of protocols and the preparation of publications. The Steering Committee will be composed of one PD/PI from each clinical centers, the PD/PI from the DCC, and the NICHD Project Scientist/Coordinator.
Participating NICHD staff will include the Pregnancy and Perinatology Branch MFMU Project Scientist/Project Coordinator. The MFMU Project Scientist/Project Coordinator will be the only voting NICHD staff member of the Steering Committee. A member of the NICHD Grants Management Branch advises the Steering Committee on funding matters. An outside Chairperson, who is not participating as a PD/PI, will be selected by the NICHD.
Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.
Scientific Consult Board
The Scientific Consult Board is an independent group that assists the Steering Committee in the identification of topics for perinatal research. The Scientific Consult Board is selected by the NICHD and consists of individuals with expertise in clinical trials, biostatistics, epidemiology, obstetrics, perinatology, and neonatology, and the Chairperson of the Steering Committee. Additional members will participate based on the need for specific expertise. The Board's primary purpose is to review and comment upon proposals for projects to be conducted by the MFMU. The board provides input to the Steering Committee on the scientific merit and potential impact of proposed studies.
Data Safety and Monitoring Board
A DSMB monitors the safety of ongoing clinical trials. The DSMB is established by the NICHD and reports to the Director of NICHD. The DCC is the liaison with the DSMB. The DSMB is composed of individuals with expertise in clinical trial design and conduct, obstetrics, perinatology, neonatology, basic science, and ethics.
In addition, the NICHD MFMU has established policies and procedures that govern its operations, including publications. These policies and procedures can be amended by the Steering Committee and the NICHD.
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.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
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.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Andrew Bremer, MD, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-7886
Email: andrew.bremer@nih.gov
Sherry Dupere, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-451-3415
Email: duperes@mail.nih.gov
Ryan Talesnik
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6976
Email: talesnikr@mail.nih.gov
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 Part 75.
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