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PAR-21-337: Limited Competition: Ruth L. Kirschstein National Research Service Award (NRSA) Predoctoral Research Training Grant for the Clinical and Translational Science Awards (CTSA) Program (T32 Clinical Trial Not Allowed)

Slots: 1. Applicants interested in providing short-term research experiences to health professional participants must apply to the companion NCATS Clinical and Translational Science Award (CTSA) Program Research Education Grants Programs (R25) (PAR-21-339). A short-term research experience is one where the participant is full-time (40 hours per week) for a period of 10 to 15 weeks, or as specified by the sponsoring institution in accordance with its own policies.

Deadlines

Internal Deadline: Contact ORIF.

LOI: N/A

External Deadline: September 16, 2022

Recurring Deadlines: ; January 13, 2023; May 12, 2023; September 15, 2023; January 12, 2024; May 17, 2024; September 13, 2024          

Award Information

Award Type: Grant

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: Application budgets are to reflect no more than 4 trainee slots Hub Tier G; 6 trainee slots for Hub Tier T; 8 trainee slots for Hub Tier C; and 10 trainee slots for Hub Tier A per budget period. NCATS will not award more than these noted slots to a NRSA T32 program. Hub tiers must be ascertained in order to determine the maximum budget that can be requested for the UM1 companion application. Please see PAR-21-293: Clinical and Translational Science Award.                    

Who May Serve as PI: The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be responsible for the selection and appointment of trainees to the approved research training program, and for the overall direction, management, administration, and evaluation of the program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. The PD/PI has responsibility for the day to day administration of the program and is responsible for appointing members of the Advisory Committee (when applicable), using their recommendations to determine the appropriate allotment of funds.

In order to ensure that the PD/PI has adequate time to devote to the training program, a UM1 PD(s)/PI(s) may not be a PD(s)/PI(s) on the T32 predoctoral award.

Link to Award: https://grants.nih.gov/grants/guide/pa-files/PAR-21-337.html

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 objective of the Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Predoctoral Research Training Grant for the Clinical and Translational Science Awards (CTSA) Program is to equip trainees with the knowledge, skills and abilities (KSAs) to advance diagnostics, therapeutics, clinical interventions, and behavioral modifications that improve health.

The NCATS Clinical and Translational Science Awards (CTSA) Program is designed to develop innovative solutions that will improve the efficiency, quality and impact of the process for turning observations in the laboratory, clinic and community into interventions that improve the health of individuals and the public. Sustaining a vibrant clinical and translational research enterprise requires a 21st century workforce that can advance clinical and translational science (CTS) that will, in turn, increase the efficiency and efficacy of translation, with the ultimate goal of getting more treatments to more patients more quickly.

Clinical and translational scientists will possess both deep scientific domain expertise and systems understanding, and their research is expected to be designed to produce discoveries that are simultaneously important for their discipline(s) and contribute to other disciplines, thus intentionally advancing the translational process as a whole. These characteristics will be required to successfully prepare trainees to transition into the many and varied productive career paths available to clinical and translational scientists within the translational science spectrum. Proposed training programs are expected to help trainees develop the following characteristics independent of their particular area(s) of expertise (Reference: Gilliland CT, et al. The Fundamental Characteristics of a Translational Scientist. ACS Pharmacol Transl Sci. 2019;2(3):213-216. doi:10.1021/acsptsci.9b00022):

  • Domain Expert: Possesses deep disciplinary knowledge and expertise within one or more of the domains of the translational science spectrum ranging from basic to clinical to public health research and domains in between.
  • Boundary Crosser: Breaks down disciplinary silos and collaborates with others across research areas and professions to collectively advance the development of a medical intervention.
  • Team Player: Practices a team science approach by leveraging the strengths and expertise and valuing the contributions of all players on the translational science team.
  • Process Innovator: Seeks to better understand the scientific and operational principles underlying the translational process and innovates to overcome bottlenecks and accelerate that process.
  • Skilled Communicator: Communicates clearly with all stakeholders in the translational process across diverse social, cultural, economic, and scientific backgrounds, including patients and community members.
  • Systems Thinker: Evaluates the complex external forces, interactions, and relationships impacting the development of medical interventions, including patient needs and preferences, regulatory requirements, current standards of care, and market and business demands.
  • Rigorous Researcher: Conducts research at the highest levels of rigor and transparency within their field of expertise, possesses strong statistical analysis skills, and designs research projects to maximize reproducibility.

Visit our Institutionally Limited Submission webpage for more updates and other announcements.

PAR-21-339: Limited Competition: NCATS Clinical and Translational Science Award (CTSA) Program Research Education Grants Programs (R25 – Clinical Trial Not Allowed)

Slots: 1. NCATS solicits the submission of one set of companion applications. With this solicitation for the R25 application, a separate, companion FOA solicits applications for a required UM1 (PAR-21-293: Clinical and Translational Science Award). The UM1 and initial R25 applications must be submitted concurrently; an R25 application without the required companion UM1 application will not be reviewed. The R25 application will only be awarded if the UM1 application is awarded. Resubmission of an R25 without the required UM1 will be allowed only if the UM1 application is awarded. The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program

Deadlines

Internal Deadline: Contact ORIF.

LOI: 30 days prior

External Deadline: September 16, 2022

Recurring Future Deadlines: January 13, 2023; May 12, 2023; September 15, 2023; January 12, 2024; May 17, 2024; September 13, 2024

Award Information

Award Type: Grant

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: The maximum budget is $100,000 direct costs/year. The budget request for a given application needs to be adequately justified and reflect the actual needs of the proposed project. Yearly fluctuations in the project workload should be reflected in the requested budget.

Who May Serve as PI: The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.

The UM1 PD(s)/PI(s) may not be a PD(s)/PI(s) on the R25 award.

Link to Award: https://grants.nih.gov/grants/guide/pa-files/PAR-21-339.html

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 overarching goal of this R25 program is to provide support to recipients of Clinical and Translational Science Awards (CTSA) for research experiencess that complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs. To accomplish this over-arching goal, this FOA will support creative educational activities with a primary focus on:

  • Research Experiences:
    • Research experiences are expected to be relevant to NCATS’ mission of studying translation on a system-wide level, agnostic to a specific disease, to better understand the scientific and operational principles underlying each step of the translational process. The goal is not to focus on specific diseases, but on what is common among them and the translational science process. Examples of research experiences appropriate for career levels include, but are not limited to:
      • Undergraduates: to provide hands-on exposure to research that reinforces their interest in clinical and translational science and/or prepares them for graduate school matriculation and/or careers in clinical and translational science for graduate and medical, dental, nursing and other health professional students.
      • Postdoctoral Fellows and Medical Residents: to extend their skills, experiences, and knowledge base in order to engage in clinical and translational science research activities.
      • Junior Faculty: to enhance their research skills, experiences, and knowledge base relative to clinical and translational science by working with faculty members at a partnering institution.
  • Proposed research experiences should involve an innovative approach to provide hands-on exposure to clinical and translational science research in a laboratory or a field setting for a full-time (40 hours per week) period of 10 to 15 weeks in order to stimulate the interest and advance the knowledge base of participants to consider further education and training for future careers as clinical and translational science researchers. The proposed programs should provide research experiences that are not available through formal NIH training mechanisms.R25 programs that propose at least 10 weeks, but fewer than 15 weeks, of full-time research experiences are allowed to request continued part-time support for the participants to work on their research projects, up to the equivalent of 15 weeks of full-time participation, as long as the entire research experience is completed within a 12-month period. Successful participants may be appointed for additional periods of short-term research experiences.

Research education programs may complement ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those training and education programs currently receiving Federal support. R25 programs may augment institutional research training programs (e.g., T32, T90) but cannot be used to replace or circumvent Ruth L. Kirschstein National Research Service Award (NRSA) programs.

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

Visit our Institutionally Limited Submission webpage for more updates and other announcements.

RFA-HD-23-001: NICHD Neonatal Research Network (NRN): Data Coordinating Center (U24 Clinical Trial Optional)

Slots: 1

Deadlines

Internal Deadline: Contact ORIF.

LOI: July 11, 2022

External Deadline: August 11, 2022

Award Information

Award Type: Cooperative Agreement

Estimated Number of Awards: 1

Anticipated Award Amount: An estimated total of $3,100,000.

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. See Section I for more about DCC PI responsibilities.

Link to Award: https://grants.nih.gov/grants/guide/rfa-files/RFA-HD-23-001.html

Companion Funding Opportunity: https://orif.usc.edu/rfa-hd-23-002/

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):

  1. Enhancing rigor and reproducibility
  2. Promoting greater availability of multisite clinical trial infrastructure to support trials from a wider range of investigators
  3. Facilitating data sharing and access to biospecimens
  4. Facilitating greater involvement of diverse populations in multisite clinical trials.

More information on each guiding principle is available in the Link to Award above.

Data Coordinating Center (DCC)

The DCC is expected to participate collaboratively on the Steering Committee to achieve the Network’s objectives. As such, the DCC’s specific objective is to develop, implement, and analyze results for Network protocols, especially providing biostatistical expertise, computer programming, and project management to design protocols, develop statistical analysis plans, develop data management systems, manage Network study funds, monitor data integrity and study safety, and work with study investigators to analyze, and publish study results. The DCC is responsible for:

  • Collaborating with study investigators – both within and outside the Network – in developing Network protocols and budgets for NIH grant submission and/or funding approval.
  • Supporting Network protocol design, training, implementation, and study monitoring. The DCC works with study investigators to design protocols, including developing statistical analysis plans, power analyses, and study budgets. As part of this, the DCC and the study team will review available NIH Common Data Elements (CDEs) and include them in Network studies, as appropriate, to ensure data harmonization with uniform collection of demographic, clinical, imaging, and biological data to the extent feasible. If relevant CDEs have not been developed, the DCC and study investigators may collaborate with NIH staff to develop them. In addition, the DCC may coordinate external services, including procuring study drugs, equipment, and other supplies, implementing masking and randomization methods, and executing subcontracts, such as for additional recruiting sites, vendor services for diagnostic tests, specimen analyses, etc., and consultancy agreements with outside experts.
  • Coordinating closely with and/or managing the Network sIRB(s) to obtain and maintain IRB approvals and continuing renewals for all studies and ensure all recruiting sites have appropriate reliance agreements in place.
  • Providing data management, including developing protocol manuals and forms, programming data management systems, and preparing reports for the DSMB, the FDA, the SC, Network subcommittees, CCs, and NICHD.
  • Conducting statistical analyses of study data for interim monitoring, final results, and secondary data analyses, and collaborating with study investigators to publish results of Network trials and studies in a timely and accurate manner.
  • Sponsoring (or sharing sponsorship obligations with NICHD and/or other institutions) for FDA Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications on behalf of the Network, as needed, such as submitting and/or providing support for FDA-required reports.
  • Managing study (“capitation”) funds, disbursing payments to CCs and non-Network recruiting sites based on enrolled patients and other study-specific milestone triggers specified in the study protocols and budgets. Working with NICHD Program Staff to develop a detailed financial reporting system, reporting at least quarterly and/or as needed on capitation budget expenditures and projections through the anticipated protocol end dates.
  • Managing Network-wide reporting and data and specimen sharing requirements, including, but not limited to: submitting annual data to the NIH Human Subject System; creating and updating ClinicalTrials.gov records for all Network studies, including reporting study results within required timelines; fulfilling Network Data Sharing requirements by preparing and submitting study data and documentation to NIH-approved data repositories; and submitting, or managing the submission of, remaining biospecimens to a NIH-approved specimen repository.
  • Providing the logistical support necessary to run an efficient and productive network, including video/teleconference support, meeting facilitation, and taking meeting minutes. The DCC also creates and maintains a Network website that includes both public-facing pages about the Network and its studies, and private/investigator-only pages to facilitate Network communication (i.e., to distribute study documents to the Network).

As with the CCs, the DCC will be required to set up appropriate master agreements (memoranda of understanding, subcontracts, data use agreements, etc.) with each CC, adjunct CC, and single-trial sites to enable transfer of earned capitation funds and study data for all Network protocols between the DCC and each site.

The DCC will have the following categories of personnel:

  • Principal Investigator
  • Co-PI/Alternate PI
  • Statisticians
  • Research Coordinators and/or Project Assistants
  • Programming staff
  • Logistics and support staff

The DCC should have some degree of flexibility in staffing to be able to respond to changing work effort needs (i.e., changing number and complexity of protocols in various stages of development and implementation, submission deadlines for major conferences, etc.).

Visit our Institutionally Limited Submission webpage for more updates and other announcements.

RFA-HD-23-002: NICHD Neonatal Research Network (NRN): Clinical Centers (UG1 Clinical Trial Optional)

Slots: 1

Deadlines

Internal Deadline: Contact ORIF.

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):

  1. Enhancing rigor and reproducibility
  2. Promoting greater availability of multisite clinical trial infrastructure to support trials from a wider range of investigators
  3. Facilitating data sharing and access to biospecimens
  4. 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.

PAR-21-277: Maximizing Opportunities for Scientific and Academic Independent Careers (MOSAIC) Institutionally-Focused Research Education Award to Promote Diversity (UE5 – Clinical Trial Not Allowed)

Slots: 1

Deadlines

Internal Deadline: August 19, 2022

External Deadline: November 15, 2022

Recurring Deadlines: November 15, 2023

Award Information

Award Type: Cooperative Agreement

Funds Available and Anticipated Number of Awards: The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications responsive to programmatic needs.

Award Budget:

Although the size of award may vary with the scope of the research education program proposed and there are no specific budget limitations, average award size is expected to be $250,000 in direct costs per year. The requested direct costs must be reasonable, well documented, fully justified and commensurate with the scope of the proposed program.

Award budgets should reflect the fact that the number of MOSAIC scholars is expected to grow through time. Each UE5 recipient will be assigned a cohort of approximately five MOSAIC scholars each year. The scholars are expected to participate in the UE5 activities for the entirety of their K99 and R00 awards. Thus, it is expected that each UE5 will grow to support 25 scholars by the fifth year of the award.

Link to Award: https://grants.nih.gov/grants/guide/pa-files/PAR-21-277.html

Who May Serve as PI: PD(s)/PI(s) are expected to be full-time employees of the applicant organization. The PD(s)/PI(s) should have appropriate professional experience in the scientific area in which the application is targeted and be capable of providing both administrative and training leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.

NIH encourages multiple PDs/PIs, particularly when each brings a unique perspective and skill set that will enhance the research education program. The PD/PI team should consider including individuals with experience in areas such as biomedical research, program evaluation, mentoring, and career development and advancement for early-career scientists.

While a faculty member who is a full-time employee of an academic institution cannot serve as a PD/PI, this individual can serve as a member of key personnel (e.g., co-investigator or collaborator).

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 overarching goal of the MOSAIC UE5 program is to support educational activities that encourage individuals from diverse backgrounds, for example those from groups underrepresented in the biomedical sciences, to pursue independent, tenure-track or equivalent, research-intensive faculty positions.

To accomplish the stated overarching goal, this FOA will support creative educational activities with a primary focus on Courses for Skills Development and Mentoring Activities (as described below). The program provides support for well-designed courses for skills development and mentoring activities to prepare cohorts of postdoctoral and early-career faculty scholars supported by MOSAIC K99/R00 awards to transition into, succeed, and advance in independent, tenure-track or equivalent, research-intensive faculty careers.

  • Courses for Skills Development: For example, courses focused on skills related to the career advancement of cohorts of MOSAIC K99/R00 scholars. Support for short courses designed to enhance skills appropriate to transition into and advance within independent academic research careers, e.g., academic job search strategies, communication skills, grant proposal preparation, scientific publishing, laboratory management, budgeting, hiring, mentoring, managing career challenges and expectations, academic advancement, and balancing teaching, research, and service, and life-work balance. These courses could be in-person or provided electronically.
  • Mentoring Activities: For example, formation of cohesive and mutually supportive cohorts of MOSAIC K99/R00 scholars that span the K99 to R00 award phases. One-on-one and group mentoring in scientific, professional and career development skills and strategies for the cohorts of MOSAIC K99/R00 scholars. Activities to enhance the mentoring networks of MOSAIC scholars and prepare participants with a working knowledge of the challenges and opportunities associated with an independent, tenure-track research-intensive faculty career and to improve their skills to meet these challenges and opportunities (e.g. navigating an academic research career as a scientist from an underrepresented background). Additionally, this FOA encourages activities to enhance the caliber of mentoring and institutional support of MOSAIC K99/R00 scholars, including convening regular meetings with appropriate leaders at the institutions where MOSAIC scholars conduct research (e.g., postdoctoral research advisors or postdoctoral affairs deans during the mentored phase; department chairs, deans, or provosts during the independent phase) to exchange ideas, and employ evidence-informed approaches to improve mentoring relationships, promote inclusion and equity in the biomedical research enterprise (e.g., addressing structural racism and discrimination, and sexual harassment), and enhance diversity. It is expected that enhancements made in the mentoring of and support for the MOSAIC K99/R00 scholars will be disseminated throughout the participating institutions and will benefit their trainees and faculty.

Visit our Institutionally Limited Submission webpage for more updates and other announcements.

RFA-AR-23-002: NIAMS Rheumatic Diseases Research Resource-based Centers (P30 – Clinical Trial Not Allowed)

Slots: 1

Deadlines

Internal Deadline: Contact ORIF.

LOI: August 13, 2022

External Deadline: September 13, 2022

Award Information

Award Type: Grant

Estimated Number of Awards: 3

Anticipated Award Amount: $500,000 direct costs per year for up to 5 years.

Who May Serve as PI: Standard NIH language.

Link to Award: https://grants.nih.gov/grants/guide/rfa-files/RFA-AR-23-002.html

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 emphasis of the NIAMS Resource-based Centers Program is to improve access to critical research infrastructure, shared facilities, services, and resources.  Each Center will contain one or more Resource Core(s) that serve a strong research community. For the purposes of this particular announcement, the research community is defined as those investigators (and their funded projects) who will use Center resources for research within the focus of the Center which should be within the NIAMS mission. Successful Resource-based Centers are expected to expand the chosen field(s), provide new research opportunities, and increase the efficiency and impact of research due to resource access.

The focus of the Center is determined by the Program Director/Principal Investigator (PD/PI) and may encompass basic, translational, and/or clinical research in rheumatic diseases. The focus of the Center may be very broad, e.g., mechanisms of autoimmunity underlying rheumatic disease, and serve a diverse group of investigators that share the need for critical shared core services. Alternatively, a Center may have a narrow disease or biology focus or theme. In some cases, the relevant research community may share a highly specialized resource such as a well-defined patient cohort with associated patient data and biospecimens and/or may share a need for highly specialized technologies and services (e.g., single cell analysis or computational biology and machine learning). Potential PDs/PIs are strongly encouraged to contact the Scientific/Research Contact listed in Section VII. Agency Contacts early in the application planning process to discuss the NIAMS mission relevance and FOA responsiveness.

It has become increasingly common and feasible for investigators at different institutions to collaborate to achieve common goals. Therefore, to facilitate collaborative and interdisciplinary research, resources and investigators may be distributed at different institutions and different geographic regions, particularly for resources that do not need to be duplicated at every research site. Similarly, the research community may be defined at the national or regional level, and may include foreign collaborators. Centers designed to serve a research community primarily at a single institution should include outreach plans to expand access to researchers from other institutions to maximize the value of the Center resources.

The NIAMS Resource-based Centers will provide support for:

  • One or more Resource Cores
  • An Administrative Core, that includes a Center Enrichment Program

Resource Cores

Each Center must include one or more Resource Core(s). A Resource Core is a facility and/or resource shared by or providing services to multiple research community investigators, enabling them to conduct their independently-funded individual and/or collaborative research projects more efficiently and/or more effectively. The selection of Resource Cores is left up to the PD/PI, but should be justified by the needs of the research community and should be appropriate for the focus of the Center which should be within the NIAMS mission. Resource Cores may be located at multiple institutions separated geographically as long as the PI can justify the feasibility.

For the purpose of this FOA, examples of Resource Cores include, but are not limited to, Cores providing the following:

  • A technology that lends itself to standardized procedures, automation or preparation in large batches (e.g., histology, tissue culture, immune profiling, biobanking, high-throughput sequencing, genotyping, and other genomic, epigenomic, proteomic and microbiomic assays) or that requires complex instrumentation (e.g., electron microscopy, mass cytometry by time of flight, confocal microscopy, intravital microscopy, and whole animal imaging).
  • Animal preparation (including transgenic, knockout, and other forms of genetic engineering/gene editing) and care.
  • Highly specialized technologies, tools, and expertise such as epidemiology, outcomes, genetics, medical informatics, bioinformatics, biostatistics, systems biology, computational biology and machine learning, pharmacogenomics, etc.
  • Critical infrastructure to support broad sharing of accessible pre-existing patient cohorts and registries, including appropriately-consented patient samples and associated clinical data.

A single Center may propose multiple Resource Cores offering different types of technologies, services, and/or critical resources. However, applications solely focused on clinical methodology core(s) supporting outcomes, epidemiology, clinical trials, and/or health services research exclusively are not responsive to the goals of this FOA and will not be reviewed. Prior consultation with the NIAMS Scientific/Research contact is strongly recommended.

Although the Cores themselves are not required to be innovative, they should be “state-of-the-art” and drive innovation within the research community. In addition, Cores are encouraged to support limited research focused on technology development and/or adaptation of technologies to meet the needs of the research community through new and/or unique state-of-the-art core services. Resource Core support may include personnel, equipment, supplies, services, and facilities. It is expected that the Resource Cores will receive some reimbursement for the cost of providing services or other resources through user fees making the prospect of sustainability at the conclusion of NIAMS support feasible.

Cores are encouraged to leverage existing resources, such as existing registries, tissue banks, and cohorts, and to coordinate with other Cores at the same and/or nearby institutions, particularly if they provide similar or overlapping technologies and services.  Cores may support existing service cores, but should add value beyond the normal use of a resource by fee-for-service or simple access. Whenever possible, generic services (e.g., histology, flow cytometry, genetically engineered animals, etc.), whether offered by new or existing cores, should be customized to meet the needs of the research community. Examples of such customization include the provision of relevant reliable monoclonal antibodies (e.g., for immunostaining of cells and tissue, for flow cytometry, or for ChIP-seq) and tissue or cell type-specific promoters and cre-drivers for genetically engineered animal studies. All Cores are strongly encouraged to enhance the value of the resources they offer through education and training on technologies and other resources offered by the Core, as well as consultation on experimental design and data analysis and interpretation.  Applicants from institutions that have a Clinical Translational Science Award (CTSA) funded by the NIH may wish to identify the CTSA as a resource for conducting the proposed research.

Administrative Core

The Administrative Core has oversight responsibility for the entire Resource-based Center (P30) and also plans and carries out activities that promote the goals of the Center. These goals and activities are selected by the PD/PI of the application, but at the very least need to include outreach activities that promote use of the resources offered by the Center as well as enrichment activities that expand the research community and/or promote innovative research on the topic of focus of the Center and within the NIAMS mission. Outreach for Centers that have a research community at a single institution should extend beyond the borders of that institution in order to make Center resources more available wherever possible. The Administrative Core should have a Director, an Associate Director, and an Advisory Committee to coordinate the Center activities and to evaluate and improve the Center. The Director of the Administrative Core is also the Director of the overall Center. The Advisory Committee should include users of the scientific cores and experts outside the Center with expertise in the management of scientific core facilities.  This Committee should help the Director and Associate Director to regularly evaluate and optimize strategies to meet the scientific needs of the research community over the course of the grant award.

The following are examples of additional goals that would be appropriate for a Resource-based Center. This list is neither mandatory nor inclusive. PDs/PIs are encouraged to propose other innovative goals.

  • Provides leadership for research on the topic of focus by the Center
  • Expands the research community by attracting new investigators and established investigators from other fields
  • Enhances the research environment and promotes synergistic collaborations and/or interdisciplinary research

The Administrative Core must include an Enrichment Program that is designed to expand the research community and/or promote innovative research on the topic of focus of the Center. The Enrichment Program should include outreach activities for the Resource Core(s). Each Center may choose the activities that best suit the needs of the research community, but all activities should occur within the context of and/or with the involvement of the Resource Core(s). Through this Enrichment Program, the Administrative Core can utilize the Resource Cores to foster the development of new investigators, attract investigators from other research fields, enhance the diversity of the research community (see, e.g., Notice of NIH’s Interest in Diversity, NOT-OD-20-031), develop new technologies, and/or foster new collaborations with investigators who have not previously engaged in research within the focus of the Center. The Enrichment Program may include a Pilot and Feasibility (P&F) grant program, but this is optional. Innovative approaches to the Enrichment Program are encouraged.

Visit our Institutionally Limited Submission webpage for more updates and other announcements.