An official website of the United States government
Table of IC-Specific Information, Requirements and Staff Contacts
| NIH Institute or Center Contacts | Institute/Center Specific Information |
|---|---|
National Center for Complementary and Integrative Health (NCCIH) Scientific Program Contacts: Grants Management Contact: |
Note: Mechanistic only |
|
Scientific Program Contact:
Grants Management Contact: |
Clinical trials involve studies in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. The NEI accepts applications for minimal risk clinical trials in its mission. Minimal participant risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (45 CFR 46). Please see NOT-EY-23-001 for further information. Basic Experimental Studies involving Humans (BESH) are studies that fall within the NIH definition of a clinical trial and also meet the definition of basic research. The research has the purpose of understanding fundamental aspects of phenomena and uses an experimental manipulation or intervention. Minimal risk research categorized as BESH must reference PA-25-303. For an application that states that the study poses a minimal risk to participants, NEI may request verification from the applicant including the risk determination documentation from the FDA and IRBs prior to award. This will be outlined in the Notice of Award Terms and Conditions when applicable. Applicants are strongly encouraged to consult NEI Program staff at least 10 weeks prior to the application due date to confirm the appropriateness of the proposed project for the funding opportunity. |
National Human Genome Research Institute (NHGRI) Scientific Program Contacts: Grants Management Contact: |
NHGRI supports resources, approaches, and technologies that accelerate genomic research focused on the structure and biology of genomes; the genomics of disease; the implementation and effectiveness of genomic medicine; computational genomics and data science; the impact of genomic technology, advances, and implementation on health disparities and health equity; and ethical, legal, and social issues (ELSI) related to genomic advances. In general, NHGRI supports studies that provide generalizable methods and knowledge. Approaches that are comprehensive across the genome or are generalizable across variants, tissues, diseases, or function may be in scope for NHGRI to the extent they address priority areas described in the NHGRI 2020 Strategic Vision: https://www.genome.gov/2020SV Applications for studies relevant only to a particular disease or organ system should be directed to the appropriate Institute or Center. Applications whose primary scientific objective is to understand a single biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention do not fall under the mission of NHGRI. NHGRI strongly encourages potential applicants to contact program staff in the early stages of developing your application: https://www.genome.gov/research-funding/Funding-Opportunities-Overview/contacts-by-research-area |
National Heart, Lung, and Blood Institute (NHLBI) Scientific Program Contact: Division of Blood Diseases and Resources Center for Translation Research and Implementation Science Division of Lung Diseases Division of Cardiovascular Sciences Grants Management Contact: |
As announced in NOT-HL-19-690, NHLBI will accept applications in response to the NIH Parent (R01 Clinical Trial Required) FOA that propose:
Please refer to NOT-HL-19-690 for additional information/clarification. |
National Institute on Aging (NIA) Scientific Program Contacts: Grants Management Contact: |
|
National Institute on Alcohol Abuse and Alcoholism (NIAAA) Scientific Program Contacts: Division of Medications Development Research Division of Metabolism and Health Effects Division of Neuroscience and Behavior Grants Management Contact: |
|
National Institute of Allergy and Infectious Diseases (NIAID) Scientific Program Contacts: Ellen Goldmuntz, M.D., Ph.D.
DMID IICT Central Contact Mailbox Grants Management Contact: |
Applicants are strongly encouraged to consult the NIAID Scientific/Research Contact listed here prior to submission to confirm the appropriateness of the proposed project for this funding opportunity. |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Scientific Program Contacts: |
Note: Mechanistic only |
National Institute of Biomedical Imaging and Bioengineering (NIBIB) Scientific Program Contacts: Grants Management Contact: |
NIBIB interests include the development and integration of advanced bioengineering, sensing, imaging, and computational technologies for the improvement of human health and medical care. An application is not within the NIBIB mission if its principal focus is the development of a technology with the goal of understanding basic biological function or pathological mechanisms. Additionally, NIBIB only supports projects developing platform technologies that are applicable to a broad spectrum of disorders and diseases. However, applicants may propose research that utilizes only a single tissue, organ, or physiological condition as a model system to facilitate the development of what is expected to be a more broadly applicable enabling technology. For this Notice of Funding Opportunity, NIBIB funding of clinical trials will be in accordance with NOT-EB-21-005 "NIBIB Guidance for Support of Clinical Trial Applications". Briefly, NIBIB will only support mission-focused (see NIBIB's program areas) early stage clinical trial applications, i.e., feasibility, Phase I, first-in-human, safety, or other small clinical trials, that inform early stage technology development. NIBIB will not support applications proposing pivotal, Phase II, III, IV, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern. Also, mechanistic trials are not supported unless the primary focus of the project is on technology development. Applicants are strongly encouraged to contact the NIBIB Scientific Contact listed in this Notice of Funding Opportunity for guidance in advance of submitting an application that includes human subjects research to ensure their proposed project is in compliance with new NIH human subjects research and clinical trials policies and consistent with the types of clinical trial applications that NIBIB supports. |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Scientific Program Contact: Grants Management Contact: |
The NICHD supports research in areas relevant to normal and abnormal human development, including contraception, fertilization, pregnancy, childbirth, prenatal and postnatal development; childhood development through adolescence; intellectual and developmental disabilities; and rehabilitation medicine. https://www.nichd.nih.gov/grants-funding/opportunities-mechanisms/areas-research/Pages/default.aspx. |
National Institute on Drug Abuse (NIDA) Scientific Program Contact: Grants Management Contact: |
|
National Institute on Deafness and Other Communication Disorders (NIDCD) Scientific Program Contact: Grants Management Contact: |
NIDCD accepts low-risk clinical trial applications submitted under PA-20-183 that address communication disorders in the NIDCD’s scientific mission areas of hearing, balance, taste, smell, voice, speech and language, with the goal of producing evidence necessary to advance scientific knowledge and inform the development of intervention(s) for subsequent clinical trials. The NIDCD defines a low-risk clinical trial as a trial meeting ALL the following criteria: Low risk research categorized as Basic Science Experimental Studies involving Humans (BESH), referred to in NOT-OD-18-212, are acceptable under this opportunity. Applications proposing mechanistic studies with human subjects may alternatively be submitted under the Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required) PA-20-184. For an application that states that the study poses a nonsignificant risk to participants, NIDCD may request verification from the applicant including the risk determination documentation from the FDA prior to award. This will be outlined in the Notice of Award Terms and Conditions when applicable. High-risk clinical trials are referred to the companion U01 funding opportunity, PAR-24-050 NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders. Applicants are encouraged to consult NIDCD staff at least 10 weeks prior to the application due date to confirm the appropriateness of the proposed project for the funding opportunity. |
National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK) Scientific Program Contact: Division of Kidney, Urologic and Hematologic Diseases Grants Management Contact: |
NIDDK accepts applications for low risk clinical trials in its mission. Please see NOT-DK-21-004 for further information. |
National Institute of Environmental Health Sciences (NIEHS) Scientific Program Contact: Grants Management Contact: |
https://www.niehs.nih.gov/funding/grants/announcements/index.cfm |
National Institute of General Medical Sciences (NIGMS) NIGMS supports investigator-initiated research in the following clinical research areas: Anesthesiology and Pain Clinical Pharmacology Sepsis Innate Immunity and Inflammation Injury and Critical Illness Wound Healing Additional information is available on the NIGMS website on Clinical Studies and Trials. Alania Foster |
As announced in NOT-GM-22-027, NIGMS will accept applications in response applications to the NIH Parent (R01 Clinical Trial Required) FOA that propose: Studies that meet NIH’s definition of a clinical trial AND are mechanistic in nature. The primary objective of the trial should be to provide mechanistic understanding of the biology underlying one or more of the NIGMS clinical research areas. Studies focusing on mechanism of action of an intervention in these clinical areas are also potentially acceptable, subject to the limitations stated below. NIH provides examples of mechanistic clinical trials in NOT-OD-18-010. A strong evidence base of fundamental biological and clinical information supporting a robust, mechanistic hypothesis for the trial should already exist in peer-reviewed literature. Please refer to NOT-GM-22-027 for additional information. |
National Institute of Mental Health (NIMH)
Scientific Program Contact:
Grants Management Contact: |
As stated in NOT-MH-23-375, NIMH only accepts clinical trial applications proposing mechanistic studies under the Parent R01 Clinical Trial Required (PA-25-305). For consideration by the NIMH, applicants who wish to submit clinical trials that propose to test efficacy, effectiveness or safety should not submit to this NOFO. Instead, clinical trials testing efficacy, effectiveness or safety must be submitted to one of the NOFOs listed on the Support for Clinical Trials at NIMH webpage Applicants are strongly advised to consult with NIMH program staff prior to submitting an application with human subjects to determine the appropriate funding opportunity announcement. NIMH Program Staff contacts Inquiries may be directed to [email protected]. The National Institute of Mental Health (NIMH) |
National Institute on Minority Health and Health Disparities (NIMHD) Grants Management Contact: |
The National Institute on Minority Health and Health Disparities (NIMHD) will accept investigator-initiated research projects (R01) for all program areas supported by the Institute. |
National Institute of Neurological Disorders and Stroke (NINDS) Scientific Program Contact: Grants Management Contact: |
As announced in NOT-NS-18-011, NINDS only accepts clinical trial applications proposing mechanistic studies for the Clinical Trial Required Parent R01 (PA-25-305). Applications that include a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about pharmacologic, behavioral, biologic, surgical, or device interventions should be submitted to an NINDS clinical trial-specific funding announcement (listed on the NINDS website at Clinical Research). Applicants are strongly advised to consult with NINDS program staff prior to submitting an application with human subjects to determine the appropriate funding opportunity. |
National Institute of Nursing Research (NINR)
Scientific Program Contact: Grants Management Contact: |
The National Institute of Nursing Research (NINR) supports research aligned with our mission and strategic priorities, conducted by scientists from any discipline. NINR leads discoveries of innovative systems and models of care, breakthroughs in disease prevention and health promotion, and advances in population and community health. Our research empowers individuals, families, communities, and populations to optimize their health and well-being. Drawing on the strengths of nursing’s holistic, contextualized perspective, core values, and broad reach, NINR funds multilevel and cross-sectoral research that addresses the myriad factors that impact health across the many settings in which nurses practice, including homes, schools, workplaces, clinics, criminal-legal settings, and the community. |
National Library of Medicine (NLM) Grants Management Contact: |
NLM Scientific/Research Contacts, listed by program portfolio, may be found at: PA-25-301 NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) |