PA-25-306 NIH Exploratory/Developmental Research Project Grant (Parent R21 Clinical Trial Required)

Scope Note

Table of IC-Specific Information, Requirements and Staff Contacts

NIH Institute or Center Contacts Institute/Center Specific Information

National Center for Complementary and Integrative Health (NCCIH)

Scientific Program Contacts:
Wen G. Chen, M. MSc, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-451-3989
Email: [email protected]

Grants Management Contact:
Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: [email protected]

 

National Cancer Institute (NCI)

Scientific Program Contacts:
Applications Related to Cancer Treatment/Diagnosis (Preclinical Studies):
Morgan O'Hayre, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7482
Email: [email protected]

Applications Related to Cancer Treatment/Diagnosis (Clinical Studies):
Minkyung Song, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6139
Email: [email protected]

Applications Related to Cancer Prevention/Symptom Management:
Marjorie Perloff, M.D.
National Cancer Institute (NCI)
Telephone: 240-276-7097
Email: [email protected]

Applications Related to Differences in Cancer Incidence and Outcomes:
Tiffany Wallace, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5114
Email: [email protected]

Applications related to Cancer Control:
Mukesh Verma, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6889
Email: [email protected]

Applications Related to the following Cancer Biology research areas:

Technology development or computational approaches:
Eric Johnson Chavarria, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7416
Email: [email protected]

Mechanisms and processes of metastasis and systemic effects of cancer:
Grace Ault, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6201
Email: [email protected]

Genetic and epigenetic mechanisms of tumorigenesis and mechanisms of chemical and physical carcinogenesis:
Keren Witkin, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6230
Email: [email protected]

Mechanisms of precancer states, oncogenic transformation, and tumor growth and behavior:
Stefan Maas, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-413-6230
Email: [email protected]

Mechanisms of early lesion- and primary tumor-microenvironment dynamics:
Elizabeth Woodhouse, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6205
Email: [email protected]

Cancer immunology, hematologic malignancies, or the role of microbial agents in cancer pathogenesis:
Lillian Kuo, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7867
Email: [email protected]

Grants Management Contact:
Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]

 

National Eye Institute (NEI)

Scientific Program Contact:
Cheri Wiggs, Ph.D.
National Eye Institute (NEI)
Phone: (301) 402-0276
E-mail: [email protected]

Grants Management Contact:
Roland Jay Colbert
National Eye Institute (NEI)
Telephone: 301-451-4714
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.

Basic Experimental Studies involving Humans (BESH) are studies that fall within the NIH definition of a clinical trial and also meet the definition of basic research. The research has the purpose of understanding fundamental aspects of phenomena and uses an experimental manipulation or intervention. Minimal risk research categorized as BESH must reference PA-25-303.

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.

Applicants are strongly encouraged to consult NEI Program staff at least 10 weeks prior to the application due date to confirm the appropriateness of the proposed project for the funding opportunity.

National Human Genome Research Institute (NHGRI)

Scientific Program Contacts:
Jennifer Troyer, Ph.D.
Telephone:301-312-3276
Email: [email protected]

Grants Management Contact:
Deanna L. Ingersoll
Telephone: 301-435-7858
Email: [email protected]

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 Institute on Aging (NIA)

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

Grants Management Contact:
Philip Smith
National Institute on Aging (NIA)
Telephone: 301-402-3465
Email: [email protected]

 

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Scientific Program Contacts:
Division of Epidemiology and Prevention Research
Gregory Bloss
Telephone: 301-443-3865
Email: [email protected]

Division of Medications Development Research
Joanne B. Fertig, Ph.D.
Telephone: 301-443-0635
Email: [email protected]

Division of Metabolism and Health Effects
Svetlana Radaeva, Ph.D.
Telephone: 301-443-1189
Email: [email protected]

Division of Neuroscience and Behavior
John Matochik, Ph.D.
Telephone: 301-451-7319
Email: [email protected]

Grants Management Contact:
Judy Fox
Telephone: 301-443-4704
Email: [email protected]

 

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: [email protected]

Patricia C. Fulkerson, M.D., M.P.H.
Division of Allergy, Immunology and Transplantation (DAIT)
Telephone: 202-641-4535
Email: [email protected]

 

DMID IICT Central Contact Mailbox
Division of Microbiology and Infectious Diseases (DMID)
National Institute of Allergy and Infectious Diseases (NIAID)
[email protected]

Grants Management Contact:
Lily Campbell, Ph.D.
Telephone: 301-761-6942
Email: [email protected]

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:
Jana Eisenstein, MS
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Email: [email protected]

Grants Management Contact:
Sahar Rais-Danai
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Email: [email protected]

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Scientific Program Contacts:
Randy King, Ph.D.
301-451-0707
[email protected]

Grants Management Contact:
Tseday Lacy
301-827-7650
[email protected]

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 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: [email protected]

Grants Management Contact:
Margaret Young
Grants Management Branch
Telephone: 301-642-4552
Email: [email protected]

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
[email protected]

Grants Management Contact:
Pam Fleming
Telephone: 301-480-1159
Email: [email protected]

 

National Institute on Deafness and Other Communication Disorders (NIDCD)

Scientific Program Contact:
Nancy Freeman, Ph.D.
Telephone: 301-402-3458
Email: [email protected]

Grants Management Contact:
Samantha Tempchin
Telephone: 301-435-1404
Email: [email protected]

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. 

National Institute of Environmental Health Sciences (NIEHS)

Scientific Program Contact:
Bonnie Joubert, Ph.D.
Telephone: 984-287-3275
Email: [email protected]

Grants Management Contact:
Aaron Nicholas
Telephone: 984-287- 3297
Email: [email protected]

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

National Institute of Mental Health (NIMH)

Scientific Program Contact:
Shuang-Bao Hu, PhD
National Institute of Mental Health (NIMH)
Phone: 301-825-2438
Email: [email protected]

Grants Management Contact:
Heather Weiss
National Institute of Mental Health (NIMH)
Telephone: 301-443-4415
Email: [email protected]

As stated in NOT-MH-23-375, NIMH only accepts clinical trial applications proposing mechanistic studies under the Parent R21 Clinical Trial Required (PA-25-306).

NIMH Program Staff contacts Inquiries may be directed to [email protected].
Also, see Division web pages (below)

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

National Institute of Nursing Research (NINR)

Scientific Program Contact:
[email protected]

Grants Management Contact:
Jennifer N. Tucker
Email: [email protected]

The National Institute of Nursing Research (NINR) supports research aligned with our mission and strategic priorities, conducted by scientists from any discipline. NINR leads discoveries of innovative systems and models of care, breakthroughs in disease prevention and health promotion, and advances in population and community health. Our research empowers individuals, families, communities, and populations to optimize their health and well-being. Drawing on the strengths of nursing’s holistic, contextualized perspective, core values, and broad reach, NINR funds multilevel and cross-sectoral research that addresses the myriad factors that impact health across the many settings in which nurses practice, including homes, schools, workplaces, clinics, criminal-legal settings, and the community.

National Library of Medicine (NLM)

Scientific Program Contacts:
Catherine Farrell, PhD
Scientific contact for Data Science (Computation/Curation, Information Management, Omics) and Bioinformatics
Telephone: 301-402-7081
Email: [email protected]

Sung Sug (Sarah) Yoon, PhD
Scientific contact for Clinical Informatics (Electronic Health Records, Statistical Modeling, Social Determinants of Health) and Personal Health Informatics
Telephone: 301-496-7101
Email: [email protected]

Goutham Reddy, MD, MS
Scientific contact for Clinical Informatics (Health Care Delivery, Imaging, Knowledge Representation)
Phone: 301- 827-6728
Email: [email protected]

Clayton Bingham, PhD
Scientific contact for Data Science (Imaging, Visualization, Statistical Models)
Telephone: 301-594-5929
Email: [email protected]

Yanli Wang, PhD
Scientific contact for Data Science (Data Management, Data Analytics), Translational Informatics, Personal Health Informatics, and Digital Health
Telephone: 301-435-4372
Email: [email protected]


Grants Management Contact:
Andrea Culhane, MA
Chief Grants Management Officer
Phone: 301-402-0069
Email: [email protected]

The National Library of Medicine (NLM) supports innovative research and development in biomedical informatics and data science. This funding opportunity focuses on biomedical discovery and data-powered health, integrating streams of complex and interconnected research outputs that can be translated into scientific insights, clinical care, public health practices, and personal wellness. The scope of NLM's interest in these research domains is broad, with emphasis on new and innovative methods and approaches to foster data driven discovery in the biomedical and clinical health sciences as well as domain-independent, scalable, and reusable/reproducible approaches to discovery, curation, analysis, organization, and management of health-related digital objects.


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