Research Project Grant (Parent R01 Clinical Trial Required) (PA-20-183)

NIH Institute
Or Center
Contacts

Scientific/Research Contact
Institute/Center Specific Information

Financial or Grants
Management Contact

National Center for Complementary and Integrative Health (NCCIH)

Wendy Weber, ND, PhD, MPH
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-402-1272
Email: weberwj@mail.nih.gov
 

Shelley Carow
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3788
Email: carows@mail.nih.gov
 

National Eye Institute (NEI)







































 

Ellen Liberman, PhD
National Eye Institute (NEI)
Telephone: 301- 451-2020      
Email: ellenliberman@nei.nih.gov

NEI accepts clinical trial applications submitted under PA-20-183 that include human subjects prospectively assigned to one or more interventions that are minimal risk as defined by 45 CFR 46. Minimal 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. As part of the review process, the application must include a clear, detailed plan for monitoring safety that is commensurate with the risks to study participants. In addition to the minimal risk designation from the Institutional Review Board, other reporting to the NEI may be required and will be outlined in the Notice of Award Terms and Conditions.

Applications proposing mechanistic studies with human subjects must be submitted under the Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required) PA-20-184: https://grants.nih.gov/grants/guide/pa-files/PA-20-184.html

Applicants who wish to submit complex, large-scale, high resource- or safety-risk clinical trials that propose to test efficacy, effectiveness or safety should not submit to this FOA. Instead, these clinical trials must be submitted to one of the Clinical Research cooperative agreement FOAs listed here: https://www.nei.nih.gov/grants-and-training/funding-opportunities/current-funding-opportunities

Applicants are strongly advised to consult with NEI program staff prior to submitting an application with human subjects to determine the appropriate funding opportunity announcement

Karen Robinson Smith
National Eye Institute (NEI)  
Telephone: 301-451-2020 
Email: Karen.Robinson.Smith@nei.nih.gov





































 

National Human Genome Research Institute (NHGRI)

Jennifer Troyer, Ph.D.
Telephone: 301-312-3276
Email: troyerj@mail.nih.gov
 
NHGRI will support the development of resources, approaches, and technologies that will accelerate GENOMIC research on the structure of genomes, the biology of genomes, and the biology of disease; that will advance the science of genomic medicine; and that will incorporate genomics to improve the effectiveness of healthcare. NHGRI will also support GENOMIC research in several cross-cutting areas, including the ethical, legal and societal implications of genomics and genetics research, bioinformatics, technology development, and research training and career development.
 
 In general, NHGRI supports studies that provide generalizable methods and knowledge.  Applications for studies relevant only to a particular disease or organ system should be directed to the appropriate Institute or Center. NHGRI strongly encourages potential applicants to contact program staff in the early stages of developing your application. The contact information for the three scientific programs are:
Division of Genome Science: https://www.genome.gov/27550609/division-of-genome-sciences-staff/
Division of Genomic Medicine: https://www.genome.gov/27550610/division-of-genomic-medicine-staff/
Division of Genomics and Society: https://www.genome.gov/27550080/division-of-genomics-and-society/
 

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

National Heart, Lung, and Blood Institute (NHLBI)



























 

• 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

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





























 

National Institute on Aging (NIA)

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

Traci Lafferty
National Institute on Aging (NIA)
Telephone: 301-496-8987
Email: laffertt@nia.nih.gov
 

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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
 

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

National Institute of Allergy and Infectious Diseases (NIAID)

• 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.

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

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

As announced in NOT-AR-18-008, NIAMS only accepts clinical trial applications proposing mechanistic studies for the Research Project Grant (Parent R01 Clinical Trial Required) (PA-19-055). Applicants who wish to submit clinical trial applications for consideration by NIAMS should not submit the application to this FOA.  Instead, applicants must submit clinical trial applications to one of the FOAs listed at http://www.niams.nih.gov/Funding/Clinical_Research/clinical_main.asp. Applicants are strongly advised to consult with NIAMS program staff prior to submitting an application with human subjects to determine the appropriate funding opportunity
 
 
For information regarding NIAMS supported scientific areas/programs and contacts, please see: https://www.niams.nih.gov/grants-funding/supported-scientific-areas.

National Institute on Drug Abuse (NIDA)

NIDA Referral Office

NIDAreferral@mail.nih.gov

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

National Institute on Deafness and Other Communication Disorders (NIDCD)

https://www.nidcd.nih.gov/about/staff-organization/division-of-scientific-programs

Christopher Myers
Telephone: 301-402-0909
Email: myersc@mail.nih.gov

National Institute of Environmental Health Sciences (NIEHS) 

Bonnie Joubert, Ph.D.
Telephone: 984-287-3275
Email: bonnie.joubert@nih.gov
 https://www.niehs.nih.gov/funding/grants/announcements/index.cfm

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

National Institute of General Medical Sciences (NIGMS)

• 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.

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

National Institute of Mental Health (NIMH)

As stated in NOT-MH-19-031, NIMH only accepts clinical trial applications proposing mechanistic studies under the Parent R01 Clinical Trial Required (PA-19-055). 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 FOA. Instead, clinical trials testing efficacy, effectiveness or safety must be submitted to one of the FOAs listed here: https://www.nimh.nih.gov/funding/opportunities-announcements/clinical-trials-foas/index.shtml#ctfoa. 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.
 
Aileen Schulte, PhD
Telephone: 301-443-1225
Email: aschulte@mail.nih.gov

Terri Jarosik
National Institute of Mental Health (NIMH)
Telephone: (301) 443-3858
Email: tjarosik@mail.nih.gov

National Institute on Minority Health and Health Disparities (NIMHD)

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
                  

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

National Institute of Neurological Disorders and Stroke (NINDS)

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

National Institute of Nursing Research (NINR)

The National Institute of Nursing Research (NINR) will accept applications for projects in areas that are mission-relevant (http://www.ninr.nih.gov/AboutNINR/NINRMissionandStrategicPlan/). 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

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