Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Funding Opportunity Title
Limited Competition: Clinical Centers for Completion of Ongoing MFMU Network Protocols (UG1 Clinical Trial Optional)
Activity Code

UG1 Clinical Research Cooperative Agreements - Single Project

Announcement Type

Renewal

Related Notices
None
Funding Opportunity Announcement (FOA) Number
RFA-HD-21-029
Companion Funding Opportunity

RFA-HD-21-028 - Limited Competition: Data Coordinating Center (DCC) for Completion of Ongoing MFMU Network Protocols (U24) Clinical Trial Optional)

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.865

Funding Opportunity Purpose

This limited competition funding opportunity announcement (FOA) issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development invites applications from the current Maternal Fetal Medicine Units (MFMU) Network Clinical Center awardees for the completion of ongoing trials and studies.

Key Dates

Posted Date
July 30, 2020
Open Date (Earliest Submission Date)
August 04, 2020
Letter of Intent Due Date(s)

30 days prior to application receipt date

Application Due Date(s)

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.

AIDS Application Due Date(s)

Not Applicable

 

 

Scientific Merit Review

November 2020

Advisory Council Review

January 2021

Earliest Start Date

April 2021

Expiration Date
September 05, 2020
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) invites applications from institutions currently participating as UG1 Clinical Center grantees in the NICHD Maternal-Fetal Medicine Units (MFMU) Network to participate with the NICHD to complete the Network's ongoing clinical trials and observational studies.

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 network were re-competed in 2016, and 12 clinical centers were awarded for the 2016-2021 cycle for membership.

The MFMU 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 MFMU Steering Committee is composed of clinical site PD/PIs, the DCC PD/PI, and the NICHD Project Scientist/Project Coordinator. The Network is currently conducting the following protocols:

  • ALPS Follow Up: This is an observational follow up study of a cohort who participated in a randomized placebo-controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions, and improving short-term outcomes, in the late preterm infant. The offspring are evaluated at age 6-7 years for pulmonary and neurodevelopmental outcomes.
  • Pessary and Progesterone for Preterm Prevention in Twin Gestation with a Short Cervix (PROSPECT) (NCT02518594). A randomized controlled trial of 630 women with a twin gestation and ultrasound evidence of short cervical length, randomized to one of three arms: (1) 200 mg micronized progesterone daily; (2) placebo; or (3) Arabin cervical pessary.
  • Pessary in Singleton Pregnancies with a Short Cervix (TOPS) (NCT02901626). An unblinded, randomized controlled trial of 850 women with a singleton gestation and ultrasound evidence of short cervical length, randomized to either Arabin cervical pessary or usual care.
  • Activity in Women At Risk for Early delivery (AWARE). A secondary protocol to the TOPS trial evaluating if activity level is associated with prolonging of gestational duration.
  • Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean (TXA) (NCT03364491). A randomized placebo-controlled trial of 11,000 women undergoing cesarean delivery. Participants are randomized to receive either: TXA immediately following umbilical cord clamping or a saline placebo, to determine if TXA can help prevent or stop excessive post-partum hemorrhages.
  • Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy (SLEEP) (NCT03487185). A randomized controlled trial of 2,700 women to assess whether treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) in pregnancy will result in a reduction in the rate of hypertensive disorders of pregnancy.
  • Prescription After Cesarean Trial (PACT) (NCT04296396). This is a non-inferiority, randomized trial of 5,500 women with a cesarean delivery randomized prior to discharge to either: an individualized opioid prescription protocol (IOPP) that includes shared decision making, or to a fixed opioid prescription of 20 tablets of oxycodone 5mg.
  • Prematurity Registry (tentative). A retrospective cohort study of all pregnancies with a gestational age between 16 - 34 weeks to examine obstetrical determinants for neonatal morbidity among women with an early preterm delivery.
  • COVID-19/Maternal Morbidity and Mortality Registry (tentative). This is an observational study using rigorous medical record review to investigate the effects of novel coronavirus COVID-19 on pregnancy outcomes, severe maternal morbidity and mortality, and newborn outcomes.

It is possible that with additional funding and scientific need, 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.

A responsive application must provide strong evidence of the applicant’s ability to cooperate with multiple sites involved in clinical trials in design, execution, data collection, and data analysis resulting in publication of multicenter randomized clinical trials and observational studies, particularly in the area of obstetric-perinatal medicine.

The NICHD Program Staff will assist Program Directors/Principal Investigators (PD(s)/PI(s)) of the Maternal-Fetal Medicine Units (MFMU) Network and the Scientific Consult Board in implementing ongoing protocols and taking them to their completion. It is anticipated that up to 12 clinical centers will be involved in the program.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

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.

Application Types Allowed
Renewal

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.

Clinical Trial?
Optional: Accepting applications that either propose or do not propose clinical trial(s)

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NICHD intends to commit $3,400,000 to fund up to 12 awards.

Award Budget
Application budgets are limited to $200,000 in direct costs and need to reflect the actual needs of the projects above as they progress toward completion over time.
Award Project Period

The maximum project period is 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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Only the current Maternal Fetal Medicine Units (MFMU) Network Clinical Center awardees (UG1), funded under RFA-HD-16-019, can apply.

Foreign Institutions

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. 

Required Registrations

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.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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.

Eligible Individuals (Program Director/Principal Investigator)

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.

PD(s)/PI(s) for the Clinical Centers should either be maternal-fetal medicine physicians certified by the American([1] Board of Obstetrics and Gynecology, Maternal Fetal Medicine subspecialty; or should provide evidence of previous certification(s) by the American Board of Obstetrics and Gynecology, Maternal Fetal Medicine subspecialty; or in maternal-fetal medicine by similar non-United States certifying entities as may be applicable; or provide descriptions of training, experience, research and publication history, and leadership so as to be widely recognized as academic maternal fetal medicine physicians. The person designated as the Alternate PD/PI should meet the same criteria as the PD/PI as described in the preceding sentence. The Alternate PD/PI may be one of the named PD(s)/PI(s) on a multiple PD/PI application. Qualifications should be listed in the corresponding investigator(s) biosketch

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

 

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:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) 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.

Letter of Intent

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 activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Dr. Caroline Signore

Telephone: 301-496-5577

Email: signorec@mail.nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

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.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

   Facilities and Other Resources:

Population Available for Clinical Trials

Applicant clinical centers must have academically-oriented divisions of perinatal medicine and a minimum of 3,000 deliveries per year with a minimum of 30 percent documented to be high-risk pregnancies. A large majority of patients with obstetric complications who deliver in the MFMU Network must also receive prenatal care at the institution.

To provide peer reviewers with the specific pregnant and perinatal populations available for study at the clinical center(s), please include information regarding admissions for each year over the designated two-year period (2017-2018) in tabular format; a suggested format is provided below. For centers with more than one clinical site, please include each center's information in separate columns or tables:

 

Site A

2018

Site A

2019

Obstetric outpatient visits, N

   

High-risk obstetric patient clinic visits, N

   

Ultrasounds performed, N

   

1st trimester screens/nuchal translucency exams performed, N

   

2nd trimester fetal anatomic surveys (Level II sonograms) performed, N

   

Obstetrical patients who receive prenatal care, N and %

   

Obstetrical patients who receive prenatal care at the institution who initiate care in the first trimester, N and %

   

Obstetrical patients who receive prenatal care at the institution who initiate care in the second trimester, N and %

   

Obstetrical patients who receive prenatal care at the institution who initiate care in the third trimester, N and %

   

High-risk obstetric patients who receive prenatal care at the institution , N and %

   

Antepartum admissions, N

   

Obstetrical admissions, N

   

Maternal transports, N

   

Cesarean deliveries, N

   

Primary Cesarean deliveries, N

   

VBAC deliveries, N

   

Multiple gestations, N

   

Cardiac disease in pregnancy, N

   

Hypertensive disease in pregnancy, N

   

Pregnant diabetics (admitted/discharged) Type I, N

   

Pregnant diabetics (admitted/discharged) Type II, N

   

Pregnant diabetics (admitted/discharged), gestational, N

   

Preeclampsia and chronic hypertensive patients (admitted/discharged), N

   

Placenta previa, N

   

Preterm premature rupture of membranes, N

   

Chorioamnionitis, N

   

Major fetal malformation or genetic disease, N

   

Infants < 1,500 grams, N

   

Infants 1,501-2,499 grams, N

   

Perinatal mortality rate (per 1,000 births), N

   

Stillbirths (fetal death > 20 weeks) per 1,000 births, N

   

Neonatal deaths per 1,000 births, N

   

NICU admissions, N

   

NICU inborn admissions < 34 weeks, N

   

NICU inborn admissions < 29 weeks, N

   

NICU inborn admissions < 1,500 grams birth weight, N

   

NICU inborn admissions < 1,000 grams birth weight NICU transport admissions, N

   

Average daily census for the NICU, N

   

Average daily census for intermediate care/special care nursery

   

Average NICU length of stay

   

If there is an anticipated increase or decrease in the birth rate for the upcoming cycle (2021-2025), this should be indicated at the time of application.

Single large volume delivery perinatal centers are ideal and may be given preference over multi-site arrangements. If a multi-site center has a long-standing, well-documented collaboration and interaction among institutions, this should be clearly stated in the application, including the investigator responsible at the collaborating site. Centers with more than one clinical site must provide evidence of collaboration among MFM subspecialists on recent trials. Management plans, including supervision, training, in-service, certification, data handling, quality assurance, cost-effective management, and communication, are required for centers with more than one clinical site.

Eligibility and enrollment in previous clinical trials should be included in the application. Ability to follow up infants in clinical trials and observational studies is critical to being an effective member of the MFMU Network. Applications should describe their eligible populations and actual enrolled study subjects. Large eligible populations with low trial enrollment numbers are considered less favorably than smaller populations with higher enrollment rates.

In addition, the patient population served by the MFMU Network must be characterized by demographics, obstetric parameters, and payment status. Proportions of various subgroups, including minorities, that have been eligible and randomized in previous or current clinical trials must be provided. Additionally, centers with ongoing clinical trials should report those patients eligible for MFMU Network studies and not competing with institutional research. If awarded, it is expected that MFMU Network research will be prioritized.

Neonatal Intensive Care Unit

The clinical center should be located in an institution with a neonatal intensive care unit for the delivery of high-risk pregnancies.

Clinical Capabilities

The applicant clinical center is expected to have a full range of perinatal subspecialists, clinical capabilities and support staff, including an active research coordinator. A detailed description of the clinical attributes of the perinatal program must be provided. This should include antenatal fetal testing, intrapartum diagnosis, laboratory testing, availability of subspecialists, and perinatal pathology. Other institutional components related to the MFMU Network must also be described. In particular, the ambulatory facilities for prenatal and postpartum care and neonatal follow-up must be presented, including the established policies and procedures for conducting clinical research in these facilities, in both low-risk and complicated pregnancies. The availability of an institutional pharmacy capable of supporting clinical research, including FDA investigational new drug trials, must be also documented. A description of whether, and how, policies and procedures have been modified to support perinatal clinical research in the past must be provided.

Capabilities for patient recruitment on nights and weekends must be described in the application. The application should describe the site's staffing and experience in clinical care and research.

The application should describe the ultrasound/fetal assessment units, including the number, model, and location of ultrasound machines, and the number of faculty and sonographers (obstetrics, radiology and other) who perform fetal imaging and their level of training.

The neonatal follow-up program should be described in detail. Many MFMU Network studies require follow-up through 18-24 months, and the Network strives for a 90 percent follow-up rate. Information regarding longer term follow-up of infants enrolled in clinical trials should be provided in the application. The number of neonatal follow-up clinic visits in 2018 and 2019 needs to be included in the application, as well as criteria for follow-up (e.g., LBW, ELBW, neurological issue, ECMO, etc.) and the age at which the children are seen in clinic visits. A designated facility for follow-up must be in place at the clinical center.

Applicants should describe in detail mechanisms in place to insure compliance and assistance with neonatal follow-up including procedures for maintaining contact with families, scheduling appointments, actions taken for missed appointments, home visit appointments including staff participating in home visits, and creative measures instituted at the center to insure excellence in follow-up rates and compliance with clinical research study protocols. The follow-up portion of the clinical capabilities must include expertise in performing Bayley Developmental assessments, neurological examinations, and hearing and vision assessments. The current system of follow-up assessment including data collection, population demographics, compliance rates, schedule of follow-up visits, funding sources, policies and procedures for conducting research in the follow-up setting and appropriate specialist involvement in the follow-up program should be delineated in the application.

Perinatal Data System

An established electronic perinatal data system must be in place to collect and analyze patient information. A detailed description of variables collected, quality control, and management of the data system must be provided. An illustration of the use of the system for a recent clinical research application should be included in the application. All successful applications must provide complete, accurate and timely transmission of data to the MFMU Network Data Coordinating Center. Applicants should describe their processes for responses to data entry edits and audits.

Other Support

Applications should include a list of funded clinical research that has augmented MFMU Network as well as non-MFMU clinical research. This includes but is not limited to financial support from NIH, granting agencies, and institutional support. Given the fiscal limitations and costs of clinical research, applicants with a record of obtaining extramural funding for MFMU, as well as non- MFMU maternal-fetal clinical studies or projects will be given high consideration.

Special Strengths

Applicants are encouraged to describe special or unique strengths that may be relevant to MFMU Network research. This can include state-of-the art scientific capabilities such as modern imaging and assessment techniques, proteomics, genomics, micro analysis, placental function assessment, or clinical pharmacology as examples which may be shared or may be available to develop and expand the scientific productivity of the MFMU.

Special administrative strengths or experience and participation in administrative aspects of clinical research (e.g., institutional review boards, data and safety monitoring boards, advisory board for clinical research, clinical research committees) should be highlighted. Level and support of clinical trials should be described.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

PD/PI must be a practicing board certified maternal-fetal medicine physician and should describe his/her clinical, research, administrative and academic commitments in the Biosketch. Due to the demands and nature of the MFMU Network, the identified PD/PI should not have extensive departmental duties (e.g., as Department Chair); rather, he/she should be able to devote the required time to the development, implementation, and management of the Network center.

One maternal-fetal medicine physician must be designated as an Alternate PD/PI who is able to serve in the absence of the PD/PI. A Biosketch should be submitted with the application for the Alternate PD/PI.

At least two additional maternal-fetal medicine physicians should be included as Senior/Key persons. Biosketches must be provided for those individuals.

A full-time clinical research Nurse Coordinator must be designated, with a biographical sketch included as part of the application.

The clinical center(s) should be located in an institution with a Neonatal Intensive Care Unit for care of high-risk neonates. The application should include a biographical sketch of at least one neonatology collaborator

 

All instructions in the SF424 (R&R) Application Guide must be followed.

Each applicant should submit base budget estimates for all years. The budget at the time of application will be limited to a BASE BUDGET with maximum allowances as follows:

  • PD/PI: 1.2 person-months (10 percent) effort

  • Alternate PD/PI, additional investigator or additional PD/PI support: up to 1.2 person-months (10 percent) effort each

  • Nurse Coordinator: 12 person-months (100 percent) effort

  • Data Entry Clerk: 6 person-months (50 percent) effort

  • Supplies and small equipment (itemized and justified): Not to exceed $5,000

  • Travel: A total of 4 trips to DC metro area per Network team, as appropriate. Steering Committee meetings will be held in the Washington, DC metro area two times per year. The PD/PI or designee and Nurse Coordinator are required to attend the meetings in their entirety.

  • Other costs (itemized and individually justified): Not to exceed $3,000

Total funding for clinical centers depends on the base awards and reimbursements for approved protocol-related expenses from the Data Coordinating Center (DCC).

Budgets are limited to $200,000 in direct costs and should reflect the actual needs of the Network protocols as they are completed over the project period. The overall provision of money for the MFMU Network is subject to the availability of NICHD funding.

The DCC will be responsible for issuing payments for the MFMU Network-approved protocol expenses including a per patient capitation. These funds can be used to fund staff positions listed above and other research staff and expenses. To receive reimbursements, a funded clinical center must set up an agreement with the DCC.

  • Participating sites will be required to accept protocol budgets for those studies underway in the Network. Clinical site researchers are encouraged to assist in the development of protocol budgets. The protocol budgets will consist of specific protocol-related allowances, capitated per subject enrolled in each study. Capitation funds can be utilized to fund key personnel.
  • The clinical center PD/PI or designee will be required to help the DCC manage protocol costs. The PD/PI or designee should propose estimates of recruitment efforts for each protocol to the DCC and update these at least annually.
  • The DCC may establish a recruitment limit. If a clinical center investigator believes that their site(s) is able to exceed the limit then permission to do so must be obtained from the DCC.
  • The clinical centers' F&A rates on the initial competitive awards will not be adjusted in future years due to changes in their negotiated rate agreements.
R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims:

  • Describe specific aims for the center.

Research Strategy:

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Clinical Center Activities:

  • The application should indicate that the clinical center will continue its current participation in the trials and studies listed above.
  • The application should NOT propose a new clinical trial or study.

MFMU Research Staffing:

  • The application should describe the respective roles of staff and a management plan for how staff interact with the MFMU subspecialists and other individuals listed under Senior/Key Persons.
  • As many protocols require patient recruitment at night and on weekends, plans for availability for staff must be included in the application. If an institution includes multiple, non-contiguous clinics, then applicants should include appropriate staffing levels to cover all sub-sites, and include a detailed plan for how to manage recruitment, study implementation, data collection, data entry, and data editing among the sub-sites.

Patient Population:

  • Applications should describe the eligible subject populations and actual enrolled study subjects. Eligibility and enrollment in previous clinical trials should also be described. Ability to follow up infants in clinical trials and observational studies is critical to being an effective member of the MFMU Network. Large eligible populations with low trial enrollment numbers are considered less favorably than smaller populations with higher enrollment rates.
  • Centers with ongoing clinical trials should report those patients actually eligible for MFMU Network studies (not competing with institutional research). If awarded, it is anticipated that MFMU research studies will be given high priority.
  • If there are ongoing or pending studies/trials that will limit availability of patients for MFMU Network trials, these must be described in the application. If there is to be a projected increase or decrease in subjects eligible for study, this should be described in the application.

Academic Productivity:

  • Provide evidence of research productivity by the clinical center in previous or ongoing clinical studies and trials, especially those of a cooperative or multicenter design.. Contributions in key areas of research development and design, patient recruitment, retention and study completion, data collection and analysis, and track record of publications should be included in the application.
  • Progress Report for Renewal Applications -- Current MFMU Network members should describe their participation and contribution to the network in detail including patient enrollment in studies, involvement in trials and their particular contribution to the trials (principal investigator at center, trial subcommittee), standing subcommittee activities including chairmanship, and publications.

Integration of research programs:

If the applicant institution is also an NICHD Neonatal Research Network clinical center, the applicant must describe how the two research programs will be integrated.

Progress Report Publication List:

  • Renewal applications should include any publications supported in the prior project periods.

Letters of Support:

  • The departmental and institutional commitments to participate in MFMU Network research should be clearly documented with letters of support from appropriate individuals. Evidence of past support can also be cited. Support in areas of grants management, personnel provision and management, space allocation, procurement, equipment as well as general support of the research should be described as well as evidence of past research support.
  • A letter of assurance of cooperation with the policy for capitation of research costs as outlined below should be provided from the departmental and institutional offices of sponsored research programs.
  • Applications from institutions that have a Clinical and Translational Science Award (CTSA) funded by NIH or other funded maternal-fetal medicine research centers as resources for conducting the proposed research should provide a letter of agreement that identifies the level and type of support from the PD/PI or the CTSA program director
  • There must be a clearly expressed intent to participate in a cooperative manner with other MFMU clinical centers, the NICHD, and the data coordinating center in all aspects of research as outlined in this FOA. Centers are expected to participate in all trials, unless they describe trials that currently conflict with ongoing network trials as part of their application for this FOA. MFMU projects are given priority at awarded clinical sites; a statement that MFMU protocols will be given priority must be included in the application.
  • The clinical center(s) should be located in an institution with a neonatal intensive care unit for the delivery of high-risk pregnancies. The application should include a letter of collaboration from at least one neonatologist collaborator(s) who should also be included among the Senior/Key Persons.

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).

Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

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.

Delayed Onset Study

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.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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.

7. Other Submission Requirements and Information

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 components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

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.

Section V. Application Review Information

1. Criteria

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:

The clinical site will participate in ongoing clinical trials and studies conducted by the MFMU network. Specific new studies are not proposed as part of this UG1 application; hence reviewers will not be evaluating clinical study protocols per se. Rather, the review of the UG1 application will emphasize the overall research environment, capabilities, and experience of the center and center personnel. In addition to the review criteria below, the merit of the application will include how well the center can carry out research projects with particular emphasis on recruitment, retention, and follow up in clinical trials as well as collaboration with other centers in the MFMU Network.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Overall Impact

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).

Scored Review Criteria

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?

Is there a significant track record of productivity in clinical research by the investigators and the clinical team in the recent past? Do the investigators have the scientific, administrative, clinical and academic qualifications to conduct successful clinical research? Does the research team at the center have the institutional support and capabilities including the patient population to participate fully in the Maternal-Fetal Medicine Network? Do the key personnel have the knowledge and experience in areas relevant to the conduct of collaborative clinical research, especially randomized clinical trials, including experience in research design, in maternal-fetal medicine? Is there commitment of staff time for the satisfactory conduct of the studies? Do the investigators have experience as well as qualified team members who would be responsible for data quality and management activities?

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 proposed clinical trial 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?

Are appropriate populations available for enrollment into MFMU studies?

Does the applicant express a strong commitment to prioritizing MFMU studies? Does the application demonstrate willingness to work and cooperate with other MFMU centers and the NICHD in a manner summarized in this FOA? What has been the quality of the unit's participation in randomized clinical trials? Does the applicant have the ability to recruit, retain and follow up infants in clinical trials and observational studies? 

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

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?

 

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 a culture of clinical research evident in the application as demonstrated by staff and institutional commitment to recruit, retain and follow up women and infants enrolled in clinical trials and studies? Do the institutional assurances and commitments express sufficient support to the study in such areas as fiscal administration, personnel management, space allocation, procurement, planning, and budgeting? Are there appropriate administrative, clinical, and data organizational management facilities as described in the requirements?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial 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?

Additional Review Criteria

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.

Specific to applications involving clinical trials

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

Additional Review Considerations

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by 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 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 score.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned on the basis of established PHS referral guidelines 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 appropriate national Advisory Council or Board. 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.
  • Compliance with data and resource/biospecimen sharing policies

3. Anticipated Announcement and Award Dates

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

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’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 onitoring 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).

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General 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.

Cooperative Agreement Terms and Conditions of Award

Cooperative Agreement Terms and Conditions of Award

The NICHD MFMU consists of the Data Coordinating Center and 12 Clinical Centers, with collaborating clinical sites (these awards). The Data Coordinating Center is funded through a separate limited competition solicitation as a cooperative agreement (U24).

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 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:

  • Assistance with identification of priority areas for research
  • Developing and implementing the network protocols including meeting recruitment goals based on information provided at the time of application
  • Collection and transmission of the data to the DCC
  • Local data Management and quality control monitoring
  • Analysis of data and publication of results of the MFMU trials
  • Agreeing to accept the coordinating role of the group and the participatory and cooperative nature of the group process
  • The individual MFMU members will be required to project participant enrollment for a specific prootocol during a specified time frame;

The PD/PI will be a voting member of the Steering Committee; all parties will agree to accept the coordinating role of the group and the participatory and cooperative nature of the group process, and the decisions of the steering committee.

MFMU clinical site awardees will retain custody of and have primary rights to the data and software developed under their awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

NICHD Project Scientist or Project Coordinator

The NICHD Project Scientist or Project Coordinator will provide technical assistance and participate as one voting member of the Steering Committee. Specifically, the NICHD Project Scientist will:

  • Assist with the identification of important areas of study
  • Assist in the development of study protocols
  • Assist in the development and review of capitation-based budgets, including the identification of study costs and special institutional needs
  • Assist in the review and evaluation of each stage of the program before subsequent stages are started, in conjunction with the Steering Committee and the Advisory Board.
  • Assist in publications and reporting results to the community of investigators and health care recipients.
  • Assist in the conduct of the trials, including ongoing review of progress; possible redirection of activities to improve performance and cooperation; and frequent communication with other members of the Steering Committee
  • Participate on the Steering Committee and all active subcommittees

The NICHD will appoint a Program Official, apart from the Project Scientist or Project Coordinator, who will:

  • Carry out continuous review of all activities to ensure that the objectives are being met and that all regulatory, fiscal, and administrative matters are handled according to NIH guidelines.
  • Perform other duties required for normal program stewardship of grants.
  • Assure the scientific merit of the trials, including the option to withhold support of a participating center if technical performance requirements such as protocol compliance, enrollment targets, or randomization of subjects are not met.
  • Initiate a decision to modify or terminate a study based on the input of the data center, Data and Safety Monitoring Board (DSMB), and/or Scientific Consult Board.

Areas of Joint Responsibility include:

The management of the Maternal-Fetal Medicine Units Network includes committees with the following functions:

Steering Committee

  • The Steering Committee will be responsible for protocol implementation. The Steering Committee will have primary responsibility for the conduct of protocols and the preparation of publications. The Steering Committee will be composed of all PD(s)/PI(s), one representative from the data coordinating center, and one NICHD staff.
  • Participating NICHD staff will include the Pregnancy and Perinatology Branch MFMU Network Project Scientist or Project Coordinator. The MFMU Project Scientist 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 independent outside chairperson, who is not participating as a PD/PI, will be selected by the NICHD Director.
  • 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 assists the Steering Committee in the identification and prioritization of topics for perinatal research. The board is selected by the NICHD Director and consists of individuals with expertise in clinical trials, biostatistics, epidemiology, maternal-fetal medicine, and neonatology, along with the Chairperson of the Steering Committee and the MFMU Project Scientist. Additional members will participate based on the need for specific expertise.

Data and Safety Monitoring Board:

  • A Data and Safety Monitoring Board (DSMB) conducts oversight and monitoring of the conduct of clinical trials to ensure the safety of participants and the validity and integrity of the data for all MFMU clinical trials. The DSMB is established by the NICHD and reports to the Director of NICHD. The DSMB is composed of individuals with expertise in clinical trial design and conduct, maternal-fetal medicine, neonatology, basic science, and ethics.

In addition, the NICHD Maternal-Fetal Medicine Units Network 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 arbitration. 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 regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

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

Scientific/Research Contact(s)

Andrew A Bremer, MD, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-7886
Email: andrew.bremer@nih.gov

Peer Review Contact(s)

Sherry Dupere, PhD

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Telephone: 301-451-3415

Email: duperes@mail.nih.gov

Financial/Grants Management Contact(s)

Ryan Talesnik

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6976
Email: talesnikr@mail.nih.gov

Section VIII. Other Information

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.

Authority and Regulations

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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