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

 
Contacts and Special Interests

Release Date: May 05, 2020
Expiration Date: May 8, 2023

R01 Clinical Trial Required Participating Institutes and Centers:

  • NIH Institutes and Centers that accept Investigator-Initiated R01 applications in response to the Parent R01 Clinical Trial Required Announcement  - (PA-20-NNN)NHGRINEI, NIANIAAANIAID, NIDANIDCD, NIEHSNIGMSNIMHDNINRNICHD
  • NIH Institutes and Centers that only accept Investigator-Initiated R01 applications proposing mechanistic clinical trials in response to the Parent R01 Clinical Trial Required Announcement (PA-20-NNN)NCCIH, NHLBI, NIAMSNIMHNINDS 
  • NIH Institutes and Centers that DO NOT ACCEPT applications in response to the Parent R01 Clinical Trial Required Announcement but ONLY accept R01 applications proposing clinical trial(s) in response to their specific funding opportunity announcements: NCI, NIBIB, IDCR, NLM, FIC, NCATS

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
 

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) NICHD Referral Office
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Email: NICHDReferral@mail.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
Margaret Young
Grants Management Branch
Telephone: 301-642-4552
Email: margaret.young@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)

Bettie J. Graham, Ph.D.
Telephone: 301-496-7531
Email: bettie_graham@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)



























 

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.

W. Keith Hoots, MD
Director Division of Blood Diseases and Resources
Email: hootswk@nhlbi.nih.gov 
Telephone: 301-435-0080 

Denis Buxton, PhD 
Division of Cardiovascular Sciences 
Email: denis.buxton@nih.gov 
Telephone: 301-435-0515 

James P. Kiley, Ph.D. 
Director Division of Lung Diseases 
Email: kileyj@nhlbi.nih.gov 
Telephone: 301-435-0202

George A. Mensah, MD, FACC, 
Director Center for Translation Research and Implementation Science (CTRIS) 
Email: george.mensah@nih.gov 
Telephone: 301-435-0422

 

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)

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.

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
 
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
 
Greg Deye, M.D.
Division of Microbiology and Infectious Diseases (DMID) 
National Institute of Allergy and Infectious Diseases (NIAID) 
Telephone: 240-627-3371
Email: gregory.deye@nih.gov

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.

Erik Edgerton
Telephone: 301-594-7760
Email:  edgertont@mail.nih.gov

National Institute on Drug Abuse (NIDA)

Beth Babecki, Ph.D.
Telephone: 301-435-1319
Email: bbabecki@nida.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 Diabetes and Digestive and Kidney Diseases (NIDDK)
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
 
 
 
 
 
NIDDK accepts applications for low risk clinical trials in its mission. Please see NOT-DK-21-004 for further information.
Mary K. Rosenberg
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 
 
Telephone: 301-594-8891
Email: RosenbergM@extra.niddk.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)

NIGMS supports investigator-initiated research in the following clinical research areas:

Anesthesiology
Zuzana Justinova, M.D., Ph.D.
email to zuzana.justinova@nih.gov

Clinical Pharmacology
Martha C. Garcia, Ph.D.
email to martha.garcia@nih.gov

Sepsis
Sarah E. Dunsmore, Ph.D.
email to dunsmores@mail.nih.gov

Innate Immunity and Inflammation
Xiaoli Zhao, Ph.D.
email to xiaoli.zhao@ nih.gov

Injury and Critical Illness
Xiaoli Zhao, Ph.D.
email to xiaoli.zhao@ nih.gov

Wound Healing
Martha C. Garcia, Ph.D.
email to 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: https://www.nigms.nih.gov/About/pages/contactbyarea.aspx

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)

Rebecca Hommer, M.D.
 
 
National Institute of Neurological Disorders and Stroke (NINDS)
 
 
Phone: 301-827-2257
 
 
E-mail: Rebecca.hommer@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-18-345). 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 https://www.ninds.nih.gov/Current-Research/Research-Funded-NINDS/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. 

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

 

 
 
 
 
 
 
 
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