Notice Number: NOT-GM-19-057

Key Dates
Release Date: August 22, 2019
Response Date: November 15, 2019

Issued by
National Institute of General Medical Sciences (NIGMS)

Purpose

The National Institute of General Medical Sciences (NIGMS) wants to advance the understanding of sepsis and its resolution, and to accelerate translation of this understanding into prevention, early detection strategies and improved therapies. Through this Request for Information (RFI), NIGMS is seeking input on strategies for acquiring and providing access to biological materials from humans for use in mechanistic studies of sepsis.

Background

Despite decades of intensive study, sepsis remains a poorly understood condition with limited diagnostic tools and few specific treatments. Last year, NIGMS convened a working group of the National Advisory General Medical Sciences Council (NAGMSC) to advise the Institute on how to optimize its research grant support of preclinical and clinical sepsis studies to most effectively acquire fundamental knowledge of human sepsis, and to enable translation of this knowledge into clinically relevant sepsis-specific diagnostic tools and treatments.

Based on the recommendations of the NAGMSC Sepsis Working Group, and consistent with its mission, NIGMS intends to continue its support of fundamental discovery and mechanistic science (basic and clinical) relevant to sepsis; the institute’s priorities are stated in NOT-GM-19-054. The Working Group specifically recommended that NIGMS encourage the utilization of human clinical materials to make more rapid progress towards a mechanistic understanding of sepsis for better identification, staging and endotyping of the disease.

Accordingly, NIGMS wants to obtain feedback, comments, and novel ideas that address the opportunities and challenges in collecting, organizing, maintaining and gaining access to human biospecimens for use in understanding and eventually preventing or controlling sepsis. Where possible, NIGMS intends to collaborate and partner with other NIH Institutes and Centers, Federal agencies and private funding organizations interested in sepsis, to ensure that any biospecimen sets are efficiently created and maximally available to the research community.

Information Requested

NIGMS seeks input from community stakeholders, including clinicians, researchers in academia and industry, and scientific societies and advocacy organizations, as well from interested members of the public, on strategies to provide shareable biological/clinical materials, either from already existing repositories or any to be created.

The intent of this RFI is defining the optimal shared biospecimens for mechanistic studies of human sepsis as well as considerations related to the creation and maintenance of biorepositories directly related to sepsis.

Input sought through this RFI includes, but is not limited to, the following:

• The need for repositories of biospecimens and/or clinical samples for sepsis research and the types of material that should be collected and stored.
• Patient populations that could be useful sources of biospecimens, as well as appropriate control groups, for studies designed to predict and understand sepsis.
• Challenges associated with the collection, maintenance and distribution of shareable clinical samples for sepsis research, including issues related to informed consent, data confidentiality, and infrastructure.
• Emerging technologies or methodologies that have the potential to advance sepsis research, but would require specialized biospecimens, collection procedures, and/or storage protocols.
• Examples of existing biospecimens in repositories already available to the research community, and assessment of whether these are adequate to advance our understanding of sepsis.
• Lessons learned from biological material collections for other diseases that might be applied successfully to sepsis research.
• Any other topics the respondent feels are pertinent to biobanking of samples for sepsis research.

How to Submit a Response

Responses to this RFI will be accepted through November 15, 2019. All comments will be anonymous and must be submitted via a web form at https://www.research.net/r/sepsisRFIbiospecimens

Responses to this RFI are voluntary. The Government is under no obligation to acknowledge receipt of the information provided and respondents will not receive individualized feedback. This RFI is for planning purposes only and should not be construed as a solicitation or as an obligation on the part of the United States Government. NIGMS does not intend to make any type of award based on responses to this RFI or to pay for either the preparation of information submitted or the United States Government's use of such information.

The information submitted will be analyzed and may be shared internally, appear in reports or be reflected in future solicitations, as appropriate and at the Government's discretion. Proprietary, classified, confidential, or sensitive information should not be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s) or other activities. No basis for claims against the U.S. Government shall arise as a result of a response to this request for information or from the Government's use of such information.

Inquiries

Please direct all inquiries to:

National Institute of General Medical Sciences (NIGMS)
Email: NIGMSsepsisRFI@nigms.nih.gov