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

Table of IC-Specific Information, Requirements and Staff Contacts

NIH Institute or Center Contacts Institute/Center Specific Information

NIH Institute or Center Contacts

Institute/Center Specific Information

National Center for Complementary and Integrative Health (NCCIH)

Scientific Program Contacts:
Hye-Sook Kim, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-827-6910
Email: hye-sook.kim@nih.gov

Grants Management Contact:
Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: debbie.chen@nih.gov

Note: Mechanistic only

National Eye Institute (NEI)

Grants Management Contact:
Karen Robinson Smith
National Eye Institute (NEI)
Telephone: 301-435-8178
Email: kyr@nei.nih.gov

 

National Human Genome Research Institute (NHGRI)

Scientific Program Contacts:
Jennifer Troyer, Ph.D.
Telephone:301-312-3276
Email: troyerj@mail.nih.gov

Grants Management Contact:
Deanna L. Ingersoll
Telephone: 301-435-7858
Email: Deanna.Ingersoll@nih.gov

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)

Grants Management Contact:
Taryn Cobb
Telephone: 301-827-8025
Email: taryn.cobb@nih.gov

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)
  • fundamental or basic experimental studies involving humans (BESH) that do not have specific processes or products in mind
  • “hybrid” applications, i.e., applications that propose non-interventional fundamental science aims along with the mechanistic or BESH clinical trial(s)
  • Studies using surrogate or clinical outcomes for the purpose of providing preliminary proof of an expected effect (these must not be efficacy studies, see next section) of the proposed mechanistic and fundamental or basic experimental study

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

Division of Blood Diseases and Resources
Email: NHLBIDBDRGrantResource@nhlbi.nih.gov
Telephone: 301-435-0080

National Institute on Aging (NIA)

Scientific Program Contacts:
Rene Etcheberrigaray, M.D.
National Institute on Aging (NIA)
Telephone: 301-451-9798
Email: rene.etcheberrigaray@nih.gov

Grants Management Contact:
Traci Lafferty
National Institute on Aging (NIA)
Phone: 301-496-8987
Email:  laffertt@mail.nih.gov

 

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Scientific Program Contacts:
Division of Epidemiology and Prevention Research
Gregory Bloss
Telephone: 301-443-3865
Email: gbloss@mail.nih.gov

Division of Medications Development Research
Joanne B. Fertig, Ph.D.
Telephone: 301-443-0635
Email: jfertig@mail.nih.gov

Division of Metabolism and Health Effects
Svetlana Radaeva, Ph.D.
Telephone: 301-443-1189
Email: sradaeva@mail.nih.gov

Division of Neuroscience and Behavior
John Matochik, Ph.D.
Telephone: 301-451-7319
Email: jmatochi@mail.nih.gov

Grants Management Contact:
Judy Fox
Telephone: 301-443-4704
Email: jfox@mail.nih.gov

 

National Institute of Allergy and Infectious Diseases (NIAID)

Scientific Program Contacts:
Mr. Martin Gutierrez
Division of Acquired Immunodeficiency Syndrome (DAIDS)
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-292-4844   
Email: mgutierrez@niaid.nih.gov

Ellen Goldmuntz, M.D., Ph.D.
Division of Allergy, Immunology and Transplantation (DAIT)
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3502
Email: egoldmuntz@niaid.nih.gov

 

DMID IICT Central Contact Mailbox
Division of Microbiology and Infectious Diseases (DMID)
National Institute of Allergy and Infectious Diseases (NIAID)
NIAID_DMID_IICT@niaid.nih.gov

Grants Management Contact:
Regina Kitsoulis
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2946
Email: regina.kitsoulis@nih.gov

As announced in NOT-AI-21-037, NIAID accepts clinical trial applications submitted under PA-20-183 that are not “high-risk”.  A “high-risk” clinical trial is defined by NIAID as having one or more of the following attributes:

  • provision of a non-routine intervention, that is, an intervention or non-routine use of an intervention that would not otherwise be provided for the condition under study in the local facility where the study is being conducted;
  • administration of an unlicensed product; or
  • administration of a licensed product for an unapproved indication.
  •  

Applicants proposing “high-risk” clinical trials should not submit to this FOA.  Instead applicants proposing “high-risk” clinical trials should refer to NIAID Investigator-Initiated Clinical Trial Resources.  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:
Erik Edgerton
Telephone: 301-594-7760
Email:  edgertont@mail.nih.gov

Note: Mechanistic only

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Scientific Program Contacts:
Moria Bittmann, Ph.D.
301-451-4778
moria.bittmann@nih.gov

Grants Management Contact:
Katie Ellis
Phone: 301-451-4791
Email: kellis@mail.nih.gov

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 (https://grants.nih.gov/policy/clinical-trials.htm) 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:
NICHD Referral Office
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Email: NICHDReferral@mail.nih.gov

Grants Management Contact:
Margaret Young
Grants Management Branch
Telephone: 301-642-4552
Email: margaret.young@nih.gov

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.
Grant applications and project proposals must fall within the missions of the scientific branches of NICHD's Division of Extramural Research or its National Center for Medical Rehabilitation Research. Potential applicants are strongly encouraged to visit these pages for recent scientific advances and emerging public health topics.
If you have questions about projects within a specific research area, you may find an NICHD program officer at https://www.nichd.nih.gov/grants-contracts/research-areas/priorities.

National Institute on Drug Abuse (NIDA)

Scientific Program Contact:
Yuki Lama, PhD
Phone: 301-443-4577
NIDAreferral@mail.nih.gov

Grants Management Contact:
Pam Fleming
Telephone: 301-480-1159
Email: pfleming@nida.nih.gov

 

National Institute on Deafness and Other Communication Disorders (NIDCD)

Scientific Program Contact:
Samah Jafari, MD
National Institute on Deafness and Other Communication Disorders (NIDCD)
Email: Samah.Jafari@nih.gov

Grants Management Contact:
Samantha Tempchin
National Institute on Deafness and Other Communication Disorders (NIDCD)
samantha.tempchin@nih.gov

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:
• 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
• Application budgets are not limited but are generally expected to be less than $500,000 in direct costs in any year. Applicants requesting $500,000 or more must submit a request to NIDCD prior to submitting an application

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 Diabetes, Endocrinology and Metabolic Diseases
Barbara Linder, M.D. Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301 594-0021
Email: linderb@mail.nih.gov

Division of Kidney, Urologic and Hematologic Diseases
Tracy L. Rankin, M.P.H, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301 594-4748
Email: rankint@mail.nih.gov
 
Division of Digestive Diseases and Nutrition
Aynur Unalp-Arida, M.D., Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301 594-8879
Email: aynur.unalp-arida@nih.gov

Grants Management Contact:
Mary K. Rosenberg
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8891
Email: RosenbergM@extra.niddk.nih.gov

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:
Bonnie Joubert, Ph.D.
Telephone: 984-287-3275
Email: bonnie.joubert@nih.gov

Grants Management Contact:
Aaron Nicholas
Telephone: 984-287- 3297
Email: Aaron.Nicholas@nih.gov

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
Zuzana Justinova, M.D., Ph.D.
Email: zuzana.justinova@nih.gov

Clinical Pharmacology
Martha Garcia, Ph.D.
Email: martha.garcia@nih.gov

Sepsis
Xiaoli Zhao, Ph.D.
Email: xiaoli.zhao@nih.gov

Innate Immunity and Inflammation
Xiaoli Zhao, Ph.D. & Shakira Nelson, Ph.D.
Email: xiaoli.zhao@nih.gov
Email: shakira.nelson@nih.gov

Injury and Critical Illness
Chris Chao, Ph.D.
Email: chris.chao@nih.gov

Wound Healing
Martha Garcia, Ph.D.
Email: martha.garcia@nih.gov

Additional information is available on the NIGMS website on Clinical Studies and Trials.
 
Contacts for other research areas at NIGMS are at: Contacts by Research Area.

Lisa Moeller
Email: lm236j@nih.gov

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.
Studies that meet the definition of Basic Experimental Studies Involving Humans (BESH). These clinical trials aim to understand fundamental aspects of phenomena without specific application towards processes or products in mind. Although NIGMS does not participate in R01 PA-20-184, the Institute will accept these applications under the Research Project Grant (Parent R01 Clinical Trial Required), consistent with its basic research mission.
“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)

Jasenka Borzan, PhD
Email: jasenka.borzan@nih.gov

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 here: Clinical Trials FOAs[https://www.nimh.nih.gov/funding/opportunities-announcements/clinical-trials-foas].                                                                               

 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 NIMHReferral@mail.nih.gov.
Also, see Division web pages (below)

The National Institute of Mental Health (NIMH)
Division web pages:

National Institute on Minority Health and Health Disparities (NIMHD)

Grants Management Contact:
Priscilla Grant, JD
Telephone: 301-594-8412
Email:  pg38h@nih.gov

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.

Please click on links below for descriptions of NIMHD’s main research interest areas and contact information for a scientific program contact in each area:
Community Health and Population Sciences
Clinical and Health Services Research
Integrative Biological and Behavioral Sciences

National Institute of Neurological Disorders and Stroke (NINDS)

Scientific Program Contact:
Rebecca Hommer, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Phone: 301-827-2257
Email: Rebecca.hommer@nih.gov

Grants Management Contact:
Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: ChiefGrantsManagementOfficer@ninds.nih.gov

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)

Grants Management Contact:
Brian Albertini
Telephone: 301-594-6869
Email: albertib@mail.nih.gov

The National Institute of Nursing Research (NINR) will accept applications for projects in areas that are mission-relevant (The National Institute of Nursing Research 2022-2026 Strategic Plan). Please contact the NINR Program Director listed in the area of science in which you are interested. NINR Program Staff contacts may be found at: https://www.ninr.nih.gov/researchandfunding/desp/oep/areasofscience

National Library of Medicine (NLM)

Grants Management Contact:
Samantha Tempchin
Telephone: 301-496-4221
Email: tempchins@mail.nih.gov

NLM Scientific/Research Contacts, listed by program portfolio, may be found at: NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trail Not Allowed) (PA-20-195)

 

 


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