PA-25-305 NIH Research Project Grant (Parent R01 Clinical Trial Required)

Scope Note

Table of ICO-Specific Contacts and Information

NIH Institute or Center ContactsInstitute/Center Specific Information

National Cancer Institute (NCI)

Scientific Program Contact:
Email: [email protected]

Grants Management Contact:
Office of Grants Administration 
Email: [email protected]

 

National Center for Complementary and Integrative Health (NCCIH)

Scientific Program Contact:
Email: [email protected]

Grants Management Contact:
Email: [email protected] 

Note: Mechanistic only

National Eye Institute (NEI)

Scientific Program Contact:
Email: [email protected]

Grants Management Contact:
Email: [email protected]

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.

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.

National Human Genome Research Institute (NHGRI)

Scientific Program Contact:
Email: [email protected]

Grants Management Contact:
Email: [email protected]

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.

National Heart, Lung, and Blood Institute (NHLBI)

Scientific Program Contacts:

Division of Blood Diseases and Resources
Email: [email protected]
Subject: PA-25-305

Center for Translation Research and Implementation Science 
Email: [email protected] 
Subject: PA-25-305

Division of Lung Diseases 
Email: [email protected] 
Subject: PA-25-305

Division of Cardiovascular Sciences 
Email: [email protected]
Subject: PA-25-305

Grants Management Contact:
Office of Grants Management
Email: [email protected]
Subject: PA-25-305

As announced in NOT-HL-19-690, NHLBI will accept applications in response to the NIH Parent (R01 Clinical Trial Required) FOA that propose: 

  • mechanistic studies that meet NIH’s definition of a clinical trial and that have the primary goal of understanding how an intervention works. Mechanistic studies are designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention (the goal must not be to evaluate safety, pharmacokinetics or pharmacodynamics, efficacy, or clinical trial feasibility)
  • Studies using surrogate or clinical outcomes for the purpose of providing preliminary proof of an expected effect (these must not be efficacy studies) of the proposed mechanistic and fundamental or basic experimental study

Please refer to NOT-HL-19-690 for additional information/clarification.

National Institute on Aging (NIA)

Scientific Program Contact:
NIA Scientific Program Contact
Email: [email protected]

Grants Management Contact:
Email: [email protected]

 

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Scientific Program Contact:
Email: [email protected]

Grants Management Contact:
Email: [email protected]

 

National Institute of Allergy and Infectious Diseases (NIAID)

Scientific Program Contact:
Email:   [email protected] 

Grants Management Contact:
Email: [email protected]  

 

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Scientific Program Contact:
Email:  [email protected]

Grants Management Contact:

Email: [email protected]

Note: Mechanistic only

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Scientific Program Contact:
Email: [email protected]

Grants Management Contact:
Chief Grants Management Officer
Email: [email protected]

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  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.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Scientific Program Contact:
Email: [email protected]

Grants Management Contact:
Email: [email protected]

 

National Institute on Drug Abuse (NIDA)

Scientific Program Contact:
Email: [email protected]  

Grants Management Contact:

Chief Grants Management Officer
Email: [email protected]

 

National Institute on Deafness and Other Communication Disorders (NIDCD)

Scientific Program Contact:
Email:  [email protected] 

Grants Management Contact:
Email: [email protected]

NIDCD accepts low-risk clinical trial applications 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:
• Typically, does not require an Investigational New Drug (IND) or Investigational Device Exemption (IDE) from the FDA. This includes clinical trials involving utilization of a licensed product/device for an approved dose, population, and indication. Or it can be a study that has an IND or IDE but is otherwise determined to be a low-risk trial
• The Potential risk of the intervention to the subjects is low. For example, interventions encountered in routine medical care or procedures, or behavioral interventions
• Intends to gather scientific data/evidence to inform subsequent studies but is not aimed or sufficiently powered to directly change health policy or standard of care, and is not an NIH defined Phase III Clinical Trial 

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.

National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK)

Scientific Program Contacts:
Division of Diabetes, Endocrinology and Metabolic Diseases
Email: [email protected]

Division of Kidney, Urologic and Hematologic Diseases
Email:[email protected]
 
Division of Digestive Diseases and Nutrition
Email: [email protected]

Office of Obesity Research

Email: [email protected]

Grants Management Contact:
Email: [email protected]

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:
Email: [email protected]

Grants Management Contact:
Email: [email protected]

 

National Institute of General Medical Sciences (NIGMS)

Scientific Program Contact:
Email: [email protected]

Grants Management contact:

Email: [email protected]

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.

“Hybrid” applications, i.e., applications that propose non-interventional fundamental science aims along with the clinical trial(s) described above.

Please refer to NOT-GM-22-027 for additional information.

National Institute of Mental Health (NIMH)

Scientific Program Contacts:
Email: [email protected].

Division of Neuroscience and Basic Behavioral Science (DNBBS)  
Email: [email protected] 

Division of Translational Research (DTR)  
Email: [email protected]

Division of AIDS Research (DAR)  
Email: [email protected]

Division of Services and Intervention Research (DSIR)  
Email: [email protected]

Division of Data Science and Technology (DST)  
Email: [email protected]

Center for Global Mental Health Research (CGMHR) 

Email: [email protected]

Grants Management Contact:
Email: [email protected] 

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

National Institute on Minority Health and Health Disparities (NIMHD)

Scientific Program Contacts: 

Division of Clinical and Health Services Research  
Email: [email protected] 

Division of Community Health and Population Science  
Email: [email protected]  

Division of Integrative Biological and Behavioral Sciences Email: [email protected]  

Grants Management Contact:  
Email: [email protected] 

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:
Email: [email protected]

Grants Management Contact:
Chief Grants Management Officer
Email: [email protected]

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).

National Institute of Nursing Research (NINR)

Scientific Program Contact:
Email: [email protected]

Grants Management Contact:
Email: [email protected]

 

National Library of Medicine (NLM)

Scientific Program Contact:  
Email: [email protected]

Grants Management Contact:
Email: [email protected] 

 

This page last updated on: June 3, 2026
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