National Institute of Health (NIH)
09/07/18 - Receipt deadline for Standard Grants (non-AIDS or AIDS-Related); 5:00 PM local time of applicant organization
Grants to USA and territories nonprofits, for-profits, government agencies, and IHEs to support a broad range of health-related research. Applicants are advised that registrations required for the application may take six weeks or more to complete. Applicants requesting larger grant amounts must contact the appropriate program at least six weeks prior to the deadline.
Proposals may be submitted for specified, circumscribed, discrete projects in scientific areas that represent the investigators' specific interests and competencies and that fall within the mission of the participating NIH Institutes and Centers (ICs).
The R01 is the original, and historically the oldest, grant mechanism used by the NIH to support health-related research and development.
All applications submitted to this Parent Funding Opportunity Announcement must propose clinical trial(s).
Research grant applications are assigned to participating ICs based on receipt and referral guidelines and many applications are assigned to multiple participating ICs with related research interests. Applicants are encouraged to identify a participating IC that supports their area of research via the R01 Clinical Trial Required IC-Specific Scientific Interests and Contact website and contact Scientific/Research staff from relevant ICs to inquire about their interest in supporting the proposed research project.
NIH defines a clinical trial as "A research study 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."
NIH not only supports trials of safety and efficacy, it also supports mechanistic exploratory studies that meet the definition of a clinical trial and are designed to explore or understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. These studies may focus on basic and/or translational discovery research in healthy human subjects and in human subjects who are affected by the pathophysiology of diseases and disorders. By addressing basic questions and concepts in biology, behavior, and pathophysiology, these studies may provide insight into understanding human diseases and disorders along with potential treatments or preventive strategies. NIH also supports biomarker studies that meet the definition of a clinical trial and that may provide information about physiological function, target engagement of novel therapeutics, and/or the impact of therapeutics on treatment response. NIH thus supports studies that meet the definition of clinical trials (as noted above) but do not seek to establish safety, clinical efficacy, effectiveness, clinical management, and/or implementation of preventive, therapeutic, and services interventions.
Applicants should note that some ICs only accept applications proposing mechanistic studies that meet NIH's definition of a clinical trial through this funding opportunity announcement. A mechanistic study is designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. If the proposed research project includes clinical trial other than a mechanistic study that would be assigned to one of these ICs, applicants are advised to contact relevant Scientific/Research staff to discuss alternative mechanisms of support of these studies.
Components of Participating Organizations
-National Heart, Lung, and Blood Institute (NHLBI)
-National Institute on Aging (NIA)
-National Institute on Alcohol Abuse and Alcoholism (NIAAA)
-National Institute of Allergy and Infectious Diseases (NIAID)
-National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
-National Institute on Drug Abuse (NIDA)
-National Institute of Environmental Health Sciences (NIEHS)
-National Institute of General Medical Sciences (NIGMS)
-National Human Genome Research Institute (NHGRI)
-National Institute of Mental Health (NIMH)
-National Institute on Minority Health and Health Disparities (NIMHD)
-National Institute of Neurological Disorders and Stroke (NINDS)
-National Institute of Nursing Research (NINR)
-National Center for Complementary and Integrative Health (NCCIH)
Note: Not all NIH Institutes and Centers (ICs) participate in Parent Announcements. Applicants should carefully note which ICs participate in this announcement and view their respective areas of research interest at the R01 Clinical Trial Required IC-Specific Scientific Interests and Contact website. Applicants should also carefully note which ICs accept only mechanistic trials by viewing the Related Notices. ICs that do not participate in this announcement will not consider applications for funding.
GrantWatch ID#: 158058
The scope of the proposed project should determine the project period. The maximum project period is 5 years.
Higher Education Institutions:
-Public/State Controlled Institutions of Higher Education
-Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
-Historically Black Colleges and Universities (HBCUs)
-Tribally Controlled Colleges and Universities (TCCUs)
-Alaska Native and Native Hawaiian Serving Institutions
-Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education:
-Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
-Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
-For-Profit Organizations (Other than Small Businesses)
-City or Township Governments
-Special District Governments
-Indian/Native American Tribal Governments (Federally Recognized)
-Indian/Native American Tribal Governments (Other than Federally Recognized)
-Eligible Agencies of the Federal Government
-U.S. Territory or Possession
-Independent School Districts
-Public Housing Authorities/Indian Housing Authorities
-Native American Tribal Organizations (other than Federally recognized tribal governments)
-Faith-based or Community-based Organizations
-Non-domestic (non-U.S.) Entities (Foreign Institutions)
-Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
-Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
-Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Eligible Individuals (Program Director/Principal Investigator):
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
Standard receipt dates for new grant applications are February 5, June 5, and October 5 and for renewal, resubmission, and revision grant applications are March 5, July 5, and November 5. AIDS and AIDS-related grant application due dates are May 7, September 7, and January 7.
Standard dates apply by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.
Standard AIDS dates apply, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.
The first AIDS Application Due Date for this FOA is May 7, 2018.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
For additional information, the receipt, review and award cycle schedules are posted on:
Standard dates apply by 5:00 PM local time of applicant organization.
When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
This program expires on January 8, 2021.
Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.
It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible.
-Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
-System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
-NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
-eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
-Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.
Program Directors/Principal Investigators (PD(s)/PI(s)):
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
For specific information about the mission of each NIH IC, visit the List of NIH Institutes, Centers, and Offices website:
For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications:
SF424 (R&R) Application Guide:
NIH Guide for Grants and Contracts:
View this opportunity on Grants.gov:
Before starting your grant application, please review the funding source's website listed below for updates/changes/addendums/conferences/LOIs.
Apply Online Using ASSIST:
93.113 -- Environmental Health / 93.172 -- Human Genome Research / 93.213 -- Research and Training in Complementary and Integrative Health / 93.233 -- National Center on Sleep Disorders Research / 93.273 -- Alcohol Research Programs / 93.279 -- Drug Abuse and Addiction Research Programs / 93.307 -- Minority Health and Health Disparities Research / 93.361 -- Nursing Research / 93.837 -- Cardiovascular Diseases Research / 93.838 -- Lung Diseases Research / 93.839 -- Blood Diseases and Resources Research / 93.840 -- Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders / 93.846 -- Arthritis, Musculoskeletal and Skin Diseases Research / 93.855 -- Allergy and Infectious Diseases Research / 93.859 -- Biomedical Research and Research Training / 93.866 -- Aging Research
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