January 16, 2024
- July 29, 2019 - NOTICE OF INFORMATION: NIGMS Priorities for Sepsis Research. See NOT-GM-19-054.
National Institute of General Medical Sciences (NIGMS)
The purpose of this Notice is to inform investigators that the National Institute of General Medical Sciences (NIGMS) will support studies utilizing biospecimens or data generated from the ARDS, Pneumonia, and Sepsis Phenotyping (APS) Consortium funded under RFA-HL-23-001 and RFA-HL-23-002, for research that falls within the NIGMS mission.
The APS Consortium is a prospective, longitudinal observational study that is planning to collect common clinical data elements and biospecimens from approximately 1,000 ARDS, 2,000 pneumonia, and 2,000 sepsis hospitalized adult patients. It is expected that a subset of the participants discharged from the hospital will have follow-up at 3, 6, and 12 months. The consortium is co-funded by the National Heart, Lung, and Blood Institute (NHLBI) and NIGMS and includes 6 clinical centers and 1 coordinating center. Patient recruitment is expected to start in 2024 and be completed by 2028.
Throughout the study, data (including imaging data) and biospecimens will be collected and stored at the APS Consortium Coordinating Center (CCC). These data and biospecimens will be made available equally to investigators from inside and outside the APS Consortium through “ancillary” studies conducted in parallel to the APS consortium during its active phase, and through “secondary” studies after its completion. The CCC has created and will maintain a public website to include information about the available data and biospecimens and a process for requesting access when resources are under CCC stewardship. Additionally, annually and at the end of the program, data will be deposited into an NHLBI repository (e.g., BioDataCatalyst). At the end of the program, remaining biospecimens will be deposited into an NHLBI repository (e.g., BioLINCC). There are established processes to request data and samples from BioLINCC and BioDataCatalyst.
Current NIGMS grantees holding awards with relevant aims or flexible research scope (e.g., Maximizing Investigators' Research Awards (MIRA)) may request access to data and biospecimens from the APS consortium and/or NHLBI repositories to conduct their approved research studies, as allowed by the funding mechanism. Requests for data and biospecimen access for ancillary studies will be reviewed by the governing board of the APS Consortium according to the process described below, and requests for data and biospecimen access for secondary studies will be reviewed by the NHLBI BioLINCC or BioDataCatalyst. Investigators utilizing ongoing NIGMS grant support are advised to contact program staff at NIGMS to confirm the proposed studies fall within the scientific scope of their awards.
NIGMS will also accept applications for new funding to support both ancillary studies and secondary studies that require access to data and biospecimens from the APS Consortium and/or NHLBI repositories, when they fit within the NIGMS mission. This includes, but is not limited to, studies designed to reveal new knowledge of the mechanistic basis of sepsis and its resolution in humans, and to test strategies for translating this knowledge into improved diagnostics and therapies for sepsis patients. Program priorities are detailed in NOT-GM-19-054, NOTICE OF INFORMATION: NIGMS Priorities for Sepsis Research.
For any new studies that meet the definition of “ancillary” (see above) to the APS Consortium, investigators should refer to the CCC public website to determine the availability of data and biospecimens, and should follow the established APS procedure to request access. The APS consortium may review the plans for quality, feasibility, and impact on planned consortium studies. Proposed studies should address new research questions that are beyond those described in the funded APS Consortium studies. Ancillary studies may not be used to extend the duration of the consortium or to provide funds for APS parent study enrollment, capitation, or study performance. A letter of support will be provided to the investigator to ensure both biospecimen and data availability and the cooperation of the APS Consortium. Approval may be contingent upon having funding in place or obtaining future research funding sufficient to successfully conduct the studies. Investigators should contact the APS Consortium well in advance of the due date of a new application to initiate the data and biospecimen access request process.
Application and Submission Information
New applications should be submitted using one of the following Notice of Funding Opportunity (NOFO) or any reissuances of these announcements:
- PA-20-185 NIH Research Project Grant (Parent R01 - Clinical Trial Not Allowed)
- PAR-22-180 Maximizing Investigators' Research Award (R35 - Clinical Trial Optional)
- PAR-23-145 Maximizing Investigators’ Research Award (MIRA) for Early Stage Investigators (ESI) (R35 - Clinical Trial Optional)
- PAR-22-126 Technology Development Research for Establishing Feasibility and Proof of Concept (R21 - Clinical Trial Not Allowed)
- PAR-22-127 Focused Technology Research and Development (R01 - Clinical Trial Not Allowed)
- PAR-23-077 Collaborative Program Grant for Multidisciplinary Teams (RM1 - Clinical Trial Optional)
- PAR-23-110 Biomedical Technology Optimization and Dissemination Center (BTOD)(RM1-Clinical Trial Not Allowed)
All instructions for the selected NOFO must be followed. Applications submitted to the NIH Parent Announcement PA-20-185 will be assigned based on mission appropriateness to NIH ICs and assignment to NIGMS is not guaranteed.
Applicants are strongly encouraged to communicate well in advance with the program contact listed below to ensure a fit to the NIGMS mission. Investigators who are currently part of the APS Consortium or those outside of the APS Consortium will have equivalent consideration of their requests to access data and biospecimens for either ancillary or secondary studies.
Applications may be submitted before a data and/or biospecimens request is fully approved by the APS Consortium or NHLBI biorepositories. However, this may affect the peer review of the application, and the complete availability of the required materials and/or data will be confirmed before an award can be made.
Xiaoli Zhao, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: xiaoli.zhao@nih.gov
and Human Services (HHS)
