Opportunity Information: Apply for PAR 18 643
The NHLBI Clinical Ancillary Studies (R01 - Clinical Trial Optional) funding opportunity (PAR-18-643) is a National Institutes of Health discretionary grant designed to speed up and broaden research on the clinical course, prevention, and treatment of conditions that fall within the National Heart, Lung, and Blood Institute (NHLBI) mission. The central idea is to get more scientific value out of studies that are already underway by supporting ancillary studies, meaning add-on projects that build on an existing "parent" clinical research study rather than starting a brand-new cohort or trial from scratch.
This FOA invites R01 research project grant applications proposing ancillary studies that attach to ongoing clinical research efforts such as clinical trials, prospective observational studies, and registries. To fit the announcement, the proposed ancillary work must collect new information and/or new biological samples from people who are already participants in the parent study. Just as importantly, the ancillary study must ask and answer new research questions that go beyond what is already laid out in the parent study's approved protocol. In other words, applicants are expected to leverage the existing infrastructure, participant group, and follow-up already in place, but the science itself must be clearly distinct, additive, and within NHLBI's scientific scope.
The announcement also draws clear boundaries around what the funds can and cannot be used for. These awards are not meant to extend the duration of the parent study, and they cannot be used simply to pay for parent study enrollment, capitation payments, or routine study performance costs. The expectation is that the parent study is already funded and moving forward, and the ancillary award covers the incremental work needed to answer the new questions, such as additional measurements, specimen collection, specialized assays, extra data elements, or other new data capture that was not included in the original study plan.
Eligible applicants span a wide range of organizations typically allowed under NIH research grant policies. This includes state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The FOA explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, and faith-based or community-based organizations, as well as regional organizations and U.S. territories or possessions.
On the foreign eligibility side, the FOA makes a distinction between foreign institutions and foreign involvement. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply as the applicant organization. However, non-domestic components of U.S. organizations may participate, and foreign components (as NIH defines them in the NIH Grants Policy Statement) are allowed, meaning the research can include certain types of international collaboration or work conducted abroad as part of a U.S.-led application, as long as it follows NIH policy and the FOA's terms.
The opportunity is administered by NIH and falls under multiple CFDA listings, including 93.233 and 93.837 through 93.840, reflecting its alignment with NIH/NHLBI research funding authorities. The listing includes an award ceiling of $250,000, indicating an upper cap referenced in the opportunity information. The original closing date shown in the source data is January 23, 2020, and the FOA creation date is February 8, 2018, which situates the announcement historically as a published NIH program announcement for ancillary studies rather than a one-time standalone competition.Apply for PAR 18 643
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NHLBI Clinical Ancillary Studies (R01 - Clinical Trial Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233, 93.837, 93.838, 93.839, 93.840.
- This funding opportunity was created on 2018-02-08.
- Applicants must submit their applications by 2020-01-23. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $250,000.00 in funding.
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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FAQs: NHLBI Clinical Ancillary Studies (R01 - Clinical Trial Optional) - PAR-18-643
What is the NHLBI Clinical Ancillary Studies funding opportunity (PAR-18-643)?
PAR-18-643 is a National Institutes of Health (NIH) discretionary grant opportunity from the National Heart, Lung, and Blood Institute (NHLBI). It supports R01 research project grant applications proposing clinical ancillary studies that expand the scientific value of an existing, ongoing clinical research "parent" study.
What is the main purpose of this FOA?
The main purpose is to speed up and broaden research on the clinical course, prevention, and treatment of conditions within the NHLBI mission by funding add-on research that leverages an already underway parent study, rather than starting a new cohort or trial from scratch.
What does "ancillary study" mean in this announcement?
An ancillary study is an add-on project that attaches to an existing parent clinical research study. Under this FOA, the ancillary work is expected to use the parent study's existing infrastructure, participants, and follow-up, while collecting new information and/or new biological samples to answer new questions beyond the parent study's approved protocol.
What kinds of parent studies can an ancillary study attach to?
This FOA invites ancillary studies that attach to ongoing clinical research efforts such as clinical trials, prospective observational studies, and registries.
Do participants in the ancillary study have to be participants in the parent study?
Yes. The ancillary study must collect new information and/or new biological samples from people who are already participants in the parent study.
Does the ancillary study have to address new research questions?
Yes. The ancillary study must ask and answer new research questions that go beyond what is already laid out in the parent study's approved protocol. The science must be clearly distinct and additive, not a restatement of what the parent study already planned to do.
What types of activities might the ancillary award support?
Based on the description, the ancillary award is intended to cover incremental work needed to answer the new questions, such as additional measurements, specimen collection, specialized assays, extra data elements, or other new data capture not included in the original parent study plan.
Can the funds be used to extend the parent study?
No. These awards are not meant to extend the duration of the parent study.
Can the funds be used to pay for parent study enrollment or routine costs?
No. The announcement states the funds cannot be used simply to pay for parent study enrollment, capitation payments, or routine study performance costs. The expectation is that the parent study is already funded and moving forward, and the ancillary award supports the incremental add-on work.
What grant mechanism is used for this opportunity?
The FOA uses the NIH R01 research project grant mechanism, and the FOA is described as "Clinical Trial Optional."
What does "Clinical Trial Optional" mean here?
The opportunity title indicates "Clinical Trial Optional," meaning the FOA allows applications that may or may not include a clinical trial component as part of the proposed ancillary study. (The detailed requirements for clinical trial involvement are not provided in the summary text.)
What scientific areas are considered within scope?
The ancillary study must be within NHLBI's scientific scope and is intended to advance research on the clinical course, prevention, and treatment of conditions that fall within the NHLBI mission.
Who is eligible to apply?
Eligible applicants include a broad range of organization types typically allowed under NIH research grant policies. The list in the opportunity information includes:
- State, county, and local governments
- Special district governments
- Independent school districts
- Public and state-controlled institutions of higher education
- Private institutions of higher education
- Federally recognized Native American tribal governments
- Other Native American tribal organizations
- Public housing authorities / Indian housing authorities
- Nonprofits with 501(c)(3) status
- Nonprofits without 501(c)(3) status
- For-profit organizations (other than small businesses)
- Small businesses
Are minority-serving and community-based organizations eligible?
Yes. The FOA explicitly highlights eligibility for categories including Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), and also includes faith-based or community-based organizations.
Are U.S. territories or regional organizations eligible?
Yes. The eligibility description includes regional organizations and U.S. territories or possessions.
Can a non-U.S. (foreign) institution apply as the main applicant?
No. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply as the applicant organization under this FOA.
Is any foreign involvement allowed?
Yes. The FOA distinguishes between foreign institutions and foreign involvement. Non-domestic components of U.S. organizations may participate, and foreign components (as NIH defines them in the NIH Grants Policy Statement) are allowed, meaning certain international collaboration or work conducted abroad can be part of a U.S.-led application, consistent with NIH policy and the FOA's terms.
Is the parent study expected to already be funded and underway?
Yes. The FOA describes the expectation that the parent study is already funded and moving forward, and the ancillary award supports the additional work needed to answer new questions.
What is the award ceiling mentioned for this opportunity?
The opportunity information includes an award ceiling of $250,000, indicating an upper cap referenced in the listing.
Which agency administers this opportunity?
The opportunity is administered by NIH and is associated with NHLBI.
Which CFDA listings are associated with this FOA?
The opportunity falls under multiple CFDA listings, including 93.233 and 93.837 through 93.840, reflecting its alignment with NIH/NHLBI research funding authorities.
What are the key dates provided in the opportunity summary?
The FOA creation date shown is February 8, 2018. The original closing date shown in the source data is January 23, 2020, placing the announcement historically as a published NIH program announcement rather than a one-time standalone competition.
Is this opportunity meant to start a brand-new cohort or trial?
No. The core concept is to get more scientific value out of studies already underway by funding ancillary (add-on) projects, rather than starting a brand-new cohort or trial from scratch.
What is the simplest way to tell if a proposed project fits this FOA?
Based on the description provided, a good fit would: (1) attach to an ongoing parent clinical study (trial, observational study, or registry), (2) involve participants already enrolled in that parent study, (3) collect new information and/or new biosamples, (4) answer new research questions beyond the parent protocol, and (5) stay within NHLBI's scientific mission.
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