Slots: 1
Deadlines
Internal Deadline: Friday, June 10th, 2022, 5pm PT
LOI: July 11, 2022
External Deadline: August 11, 2022
Award Information
Award Type: Cooperative Agreement
Estimated Number of Awards: The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Anticipated Award Amount: Maximum of $220,000 per year in direct cost for up to 7 years.
Who May Serve as PI: 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.
Link to Award: https://grants.nih.gov/grants/guide/rfa-files/RFA-HD-23-002.html
Companion Funding Opportunity: https://orif.usc.edu/rfa-hd-23-001/
Process for Limited Submissions
PIs must submit their application as a Limited Submission through the Office of Research Application Portal: https://orif.usc.edu/oor-portal/.
Materials to submit include:
- (1) Single Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 1-page limit will be excluded from review.
- (2) CV – (5 pages maximum)
Note: The portal requires information about the PIs and Co-PIs in addition to department and contact information, including the 10-digit USC ID#, Gender, and Ethnicity. Please have this material prepared before beginning this application.
Purpose
The purpose of the Neonatal Research Network (NRN) is to improve healthcare and outcomes for newborns. This includes finding ways to improve the chances for survival without neurodevelopmental impairment for infants born premature, low-birth weight, or with other serious conditions. NICHD expects the NRN to be its primary and first-line infrastructure involved in implementing multi-site neonatal clinical trials.
As such, the NRN helps address several Congressional and public health goals:
- The Prematurity Research Expansion and Education for Mothers Who Deliver Infants Early (PREEMIE) Act (Public Law 109-450) was passed originally in 2006 and reauthorized in 2018 (Public Law 115-328) to: (1) reduce rates of preterm labor and delivery, (2) work toward an evidence-based standard of care for pregnant peopleat risk of preterm labor or other serious complications, and for infants born preterm, and (3) reduce infant mortality and disabilities caused by premature birth.
- The Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC), established under the 21st Century Cures Act (Public Law No: 114-255), recommended that the Secretary of Health and Human Services “increase the quantity, quality, and timeliness of research on safety and efficacy of therapeutic products used by pregnant women and lactating women.”
- Ongoing and potential future public health crises that impact the health of pregnant people and/or their infants, such as the COVID epidemic, Zika epidemic, and the opioid crisis.
The NRN will also help NICHD address its Strategic Plan 2020, specifically for: Theme 4, Improving Child and Adolescent Health; and Theme 5, Advancing Safe and Effective Therapeutics and Devices for Pregnant and Lactating Women, Children, and People with Disabilities.
The objective of the NRN, therefore, is to conduct definitive, rigorous, and reproducible, multi-site clinical trials and observational studies in newborns and lactating people, providing evidence to guide neonatology, pediatric pharmacology, and lactation clinical practice. This Network of research institutions will work collaboratively to implement common protocols to enroll and follow-up enough patients to achieve statistical power to answer protocol hypotheses more rapidly and definitively than individual centers acting alone.
Study designs may include, but are not limited to: investigational new drug or device, comparative effectiveness, and management trials; biomarker validation studies that are immediately preparatory to trials; and observational studies. Studies may assess both short-term (clinical) and long-term infant and child outcomes (i.e., up to school age). The Network may conduct Phase 3 pharmacologic research to address gaps in knowledge for the use of drugs and therapeutics during pregnancy and lactation – both therapeutics designed to treat lactation complications and therapeutics for other health issues that people may need to use while lactating. Phase 1 and 2 trials will generally be conducted outside of this Network but may be considered on a case-by-case basis (e.g., for trials in rare conditions). When relevant and appropriate, NICHD encourages the inclusion of genomic and proteomic studies, sub-studies, and/or collection of related biospecimens for such research. Examples of studies conducted in the Network can be found at: https://neonatal.rti.org/index.cfm?fuseaction=home.studies.
The Network will also be uniquely poised to collaborate on studies and projects with other networks and initiatives – such as the NICHD Maternal-Fetal Medicine Units (MFMU) Network, the NICHD Maternal and Pediatric Precision in Therapeutics (MPRINT) Initiative, the NIH Helping to End Addiction Long-term (HEAL) Initiative, the NIH Researching COVID to Enhance Recovery (RECOVER) Initiative, the Foundation for the NIH, and other NIH institutes and Federal agencies, such as the Centers for Disease Control and Prevention.
GUIDING PRINCIPLES OF NICHD-SUPPORTED MULTI-SITE CLINICAL RESEARCH
In 2019 the Director of the NICHD, Dr. Diana Bianchi, outlined four guiding principles shaping the 21st century landscape of NICHD-supported multi-site clinical research (see NOT-HD-19-034 Infrastructure for NICHD Multisite Clinical Trials; NOT-HD-19-041 Request for Information on the NICHD Vision for Multisite Clinical Trials Infrastructure; a recorded webinar by Dr. Bianchi outlining NICHD’s vision for multi-site clinical research infrastructure; a concept clearance to the National Advisory Child Health and Human Development Council; and the 2020 NICHD Strategic Plan):
- Enhancing rigor and reproducibility
- Promoting greater availability of multisite clinical trial infrastructure to support trials from a wider range of investigators
- Facilitating data sharing and access to biospecimens
- Facilitating greater involvement of diverse populations in multisite clinical trials.
More information on each guiding principle is available in the Link to Award above.
Clinical Centers (CCs)
The CCs are expected to participate collaboratively on the Steering Committee to achieve the Network’s objectives. The CC’s specific objective is to develop and implement Network protocols, even those approved, but not proposed by non-Network investigators, including recruiting study participants, implementing study interventions, conducting required follow-up examinations, and working together to publish study results. CC’s may also be able to engage in training opportunities.
As such, CCs are responsible for:
- Identifying areas for potential Network research.
- Collaborating with study investigators – both within and outside the Network – in developing Network protocols and budgets for NIH grant submission and/or funding approval.
- Participating in the development and implementation of Network protocols whether the PI is from within the Network or a non-Network PI.
- Implementing funded Network studies, including meeting recruitment goals based on information provided at the time of application, with minimal protocol violations/deviations, and completing any protocol follow-up activities.
- Collecting and transmitting study data to the Data Coordinating Center in an accurate and timely manner.
- Overseeing and monitoring the participation of any satellite sites within the CC. The productivity of the satellite sites will be considered part of the CC’s contribution to the Network.
- Collaborating in data analyses and publication of results.
A typical CC in the Network is generally a regional academic medical center or tertiary care facility, capable of providing research support and supervision for any satellite sites. CCs may choose to partner with additional geographically or organizationally linked satellite sites, particularly to access participant populations not traditionally cared for at the CC. Single, large volume, delivery centers are preferred over multi-site arrangements with smaller centers. CCs are expected to have a minimum of 500 NICU admissions per year, at least 70 percent of which must be inborn infants.
CCs are expected to participate in all approved Network studies (including those proposed by non-Network PIs), unless they do not have the relevant eligible population (e.g., opioid-addicted patients), or have an ongoing local study that conflicts with a Network study that is identified in its application. Centers agree to prioritize Network studies over other studies, including other NIH-funded studies, for subject recruitment.
Each CC will be required to set up appropriate master agreements (memoranda of understanding, subcontracts, data use agreements, etc.) with the DCC and/or adjunct CCs to enable transfer of earned capitation funds and study data for all Network protocols between those entities. CCs are responsible for setting up similar agreements and/or mechanisms with each of their satellite sites, as needed.
Each CC will have the following Network staff:
- Principal Investigator (PI)
- Co-PI/Alternate PI
- Research Coordinator
- Data entry personnel
Visit our Institutionally Limited Submission webpage for more updates and other announcements.