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NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required) (PA-20-194)

PA-20-194
 
Contacts and Special Interests
Release Date: May 16, 2020
Expiration Date: May 08, 2023


Introduction
The R21 grant mechanism is intended to encourage exploratory/developmental research by providing support for the early and conceptual stages of project development. The NIH has standardized the Exploratory/Developmental Grant (R21) application characteristics, requirements, preparation, and review procedures in order to accommodate investigator-initiated (unsolicited) grant applications. See the NIH Exploratory/Developmental Research Grant Award (R21) page for more information.

R21 Clinical Trial Required Participating Institutes and Centers 
  • NIH Institutes and Centers that accept Investigator-Initiated R21 applications in response to the Parent R21 Clinical Trial Required Announcement  - (PA-19-054): NHGRINIANIAAANIAID, NIDA, NIDCD, NIEHSNIMHDNINR, NICHD
  • NIH Institutes and Centers that only accept Investigator-Initiated R21 applications proposing mechanistic clinical trials in response to the Parent R21 Clinical Trial Required Announcement PA-19-054):  NIAMS ,NIMH
  • NIH Institutes and Centers that DO NOT ACCEPT applications in response to the Parent R21 Clinical Trial Required Announcement but ONLY accept R21 applications proposing clinical trial(s) in response to their specific funding opportunity announcements: NCI, NHLBI, NIBIB, NICHD, NIDCR, NIDDK, NIGMS, NINDS, NLM, FIC, NCCIH, NCATS
NIH
Institute/Center
Scientific/Research Contact
Scientific Research Areas of Interest
Financial of Grants
Management Contact
National Human Genome Research Institute (NHGRI) Bettie J. Graham, Ph.D.
Telephone: 301-496-7531
Email: bettie_graham@nih.gov
 
NHGRI’ specific scientific interest statement:
 
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 Institute on Aging (NIA) Dr. Sanoj Suneja
Telephone: 301-402-7710
Email: SunejaS@mail.nih.gov
 
Ms. Traci Lafferty
Telephone: 301-496-1472
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 
Dale Hereld, M.D., Ph.D.
Telephone: 301-443-0912
Email:  hereldd@mail.nih.gov
Division of Neuroscience and Behavior
Lindsey Grandison, Ph.D.
Telephone 301-443-0606
Email:  lgrandis@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-20-194 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
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 NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required) (PA-19-054). 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
 

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

 
Inquiries:

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 Institute on Drug Abuse (NIDA) Minna Liang, Ph.D.
Telephone: 301-827-5708
Email: liangm@nida.nih.gov
 
Pam Fleming
Telephone: 301-480-1159
Email: pfleming@nida.nih.gov
 
National Institute on Deafness and Other Communication Disorders (NIDCD) Nancy L. Freeman, Ph.D.
Telephone: 301-402-3458
Email: FreemanN@mail.NIH.gov
 
For a list of scientific staff, also see Staff Contacts.
 
The National Institute on Deafness and Other Communication Disorders (NIDCD) uses the Exploratory/Developmental Research Grant Award (R21) to support the development of novel ideas, technologies, or methodologies at an early stage of development which have the potential to break new ground or extend toward new directions or applications.
 
The NIDCD supports basic and clinical biomedical and behavioral research in the communication sciences of hearing, balance, smell, taste, voice, speech and language. The proposed research must be focused on one or more of these scientific mission areas.
 
Christopher Myers
Telephone:  301-435-0713
Email: myersc@mail.nih.gov
National Institute of Environmental Health Sciences (NIEHS) Bonnie Joubert, Ph.D.
Telephone: 984-287-3276
Email: bonnie.joubert@nih.gov
https://www.niehs.nih.gov/funding/grants/announcements/index.cfm
The National Institute of Environmental Health Sciences (NIEHS) will accept investigator-initiated research projects using the R21 mechanism for all areas of environmental health science research; particularly those defined as NIEHS special emphasis areas. Details on these areas can be found at http://www.niehs.nih.gov/research/supported/programs/index.cfm.
To obtain more information about existing NIEHS program areas and their corresponding program administrators, see http://www.niehs.nih.gov/funding/grants/contacts.cfm
 
Aaron Nicholas
Telephone: 984-287- 3297
Email: Aaron.Nicholas@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 exploratory/developmental projects (R21) 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 Nursing Research (NINR) The National Institute of Nursing Research (NINR) will accept investigator-initiated R21 applications for exploratory/developmental projects in areas that are mission-relevant (http://www.ninr.nih.gov/AboutNINR/NINRMissionandStrategicPlan/). This includes potentially high-risk/high payoff projects in the early stages of development and projects having innovative scientific ideas. 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: http://www.ninr.nih.gov/ResearchAndFunding/
DEA/OEP/AreasofscienceFile.htm

 
Brian Albertini
Telephone: 301-594-6869
Email: albertib@mail.nih.gov
National Eye Institute (NEI)
Dr. Cheri Wiggs
Telephone: 301.402.0276
Email: Cheri.Wiggs@nih.gov

NEI accepts clinical trial applications submitted under PA-20-194 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.
 
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
Telephone: 301.435.8178
Email: Karen.Robinson.Smith@nei.nih.gov

 
This page last updated on December 18, 2020
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