Notice Number: NOT-AI-18-021
Release Date: March 13, 2018
Response Date : April 12, 2018
National Institute of Allergy and Infectious Diseases (NIAID)
This Request for Information (RFI) solicits input from the extramural scientific community to inform NIAID about areas of scientific opportunity that will benefit from the unique research resources of the NIH Clinical Center in Bethesda, Maryland. In particular, input is sought to identify areas where the extramural scientists may best take advantage of the NIH Clinical Center resources.
The NIH Clinical Center is the largest biomedical research hospital in the world, and it is a unique local, regional, and national research resource. Although this Clinical Center represents a key resource for NIH intramural scientists to conduct clinical research and clinical trials, extramural scientists funded by NIH grants and contracts also may access this distinctive facility. To ensure the Clinical Center maximizes its potential to support the best possible extramural science, the NIAID seeks input regarding needs and opportunities for inpatient and outpatient clinical research resources.
The NIAID mission is to conduct and fund research to understand, treat, and prevent infectious, immunologic and allergic diseases. Scientific priorities are described in theNIAID Strategic Plan, 2017pdf. Support for clinical research and clinical trials conducted by NIAID and NIAID-funded scientists is available through the NIAID Division of Clinical Research (DCR). DCR provides multi-disciplinary trans-NIAID services to facilitate clinical research, such as assisting in protocol development, study design, statistics and regulatory compliance (see https://www.niaid.nih.gov/about/dcr). In particular:
Biostatistics Research Branch (BRB) is part of DCR and provides methodological research and statistical collaboration to enhance scientific rigor and discovery (see https://www.niaid.nih.gov/about/biostatistics-research-branch).
The DCR Office of Clinical Research Policy and Regulatory Operations (OCRPRO) facilitates the clinical research enterprise by providing protocol development and regulatory, clinical trials management and safety oversight (see https://www.niaid.nih.gov/about/clinical-research-policy-regulatory-operations).
The NIAID plans to enhance clinical research opportunities for extramural researchers by providing better access to both Clinical Center and DCR resources, as well as grant support through future funding opportunity announcements.
Through this RFI, the NIAID invites academic and industrial researchers, members of scientific or professional organizations, and other interested individuals and entities to provide comments on:
Scientific opportunities within NIAID’s priorities that are best poised to utilize the unique resources of the Clinical Center (for a description of resources, see https://clinicalcenter.nih.gov/translational-research-resources/resources.html);
Services that would be needed from NIAID’s DCR to facilitate full utilization of Clinical Center resources
We welcome input that includes, but is not limited to, the following topics:
Interest in the ability to perform infectious disease challenge studies in healthy humans;
Areas of biomedical research that are currently limited by a lack of inpatient research beds;
Extent to which extramural researchers will need assistance in protocol development, study design, statistics and regulatory compliance;
Questions about potential limitations to the use of the Clinical Center and DCR resources, particularly with respect to recruitment of human subjects and the size of cohorts needed to get statistically-meaningful outcome measures.
It is anticipated that the extramural research itself would be largely be conducted at the Clinical Center, with some additional NIAID support for work to be performed in the extramural investigator’s laboratory. While collaborations with intramural investigators is allowed, it is not required. Moreover, projects that take only minimal advantage of Clinical Center resources, such as projects only utilizing banked samples or data, would not be considered for NIAID support.
The NIH will use the input received through this RFI to consider new funding opportunities that provide access to the Clinical Center to extramural scientific communities to address research questions that may be most effectively and efficiently answered by interventions or procedures that require inpatient or outpatient cohorts.
Responses to this RFI are voluntary. Please do not include any personally identifiable or other information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in your response.
This request is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the NIAID, NIH, or United States Government. The NIAID will not make any awards based on responses to this RFI, nor will the NIAID otherwise pay for the preparation of any information submitted or for the Government's use of such information. The NIAID will use the information submitted in response to this RFI at its discretion and will not provide comments to any responder's submission. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
We look forward to your input and hope that you will share this RFI with your colleagues.
Please direct all inquiries to:
Please direct all inquiries to:
H. Clifford Lane, M.D.
National Institute of Allergy and Infectious Diseases