Opportunity Information: Apply for PAR 12 265
Apply for PAR 12 265
- The National Institutes of Health in the food and nutrition health sector is offering a public funding opportunity titled "Ancillary Studies to Major Ongoing Clinical Research Studies to Advance Areas of Scientific Interest within the Mission of the NIDDK (R01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847 Diabetes, Digestive, and Kidney Diseases Extramural Research.
- This funding opportunity was created on Jul 9, 2015 and posted on Aug 16, 2012.
- Applicants must submit their applications by Jan 7, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: For profit organizations other than small businesses County governments Public housing authorities/Indian housing authorities Small businesses Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Private institutions of higher education State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments City or township governments Native American tribal organizations (other than Federally recognized tribal governments).
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:
This grant opportunity, titled "Ancillary Studies to Major Ongoing Clinical Research Studies to Advance Areas of Scientific Interest within the Mission of the NIDDK (R01)" (Funding Opportunity Number PAR-12-265), is an NIH discretionary grant mechanism that supports investigator-initiated Research Project Grant (R01) applications for ancillary studies that build on major clinical research efforts that are already underway. In practical terms, it is designed for researchers who want to add a focused, scientifically valuable "add-on" project to an existing large study, such as an ongoing clinical trial, a large epidemiologic cohort, or a disease registry/database. Rather than funding a brand-new standalone parent trial or cohort, this FOA funds additional targeted research that leverages the infrastructure, participants, data systems, and/or specimens already available through an ongoing parent study.
A central requirement is that the parent study must be ongoing at the time the ancillary work is proposed and conducted. The parent study can be supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), other NIH Institutes and Centers, other government agencies, or even the private sector. The key idea is efficiency and scientific payoff: the ancillary study should generate important new knowledge faster and more cost-effectively than would be possible if the investigator had to recruit a new cohort or launch a new trial from scratch. Because the work is tied to an active parent project, applicants need to demonstrate that the ancillary study is feasible within the parent study's timeline, operations, and participant contact schedule, and that it will not compromise the integrity or primary aims of the parent study.
The scientific scope must align directly with NIDDK's mission and priority areas, meaning the research question has to fall within diseases and topics that NIDDK supports, broadly covering diabetes, endocrinology and metabolic diseases; digestive diseases, nutrition, and obesity-related topics; and kidney, urologic, and hematologic diseases. The FOA stresses that the ancillary study should "advance the scientific research mission of the NIDDK," so the application is expected to make a clear case that the proposed question is not only interesting but also strategically relevant to NIDDK's portfolio. The FOA points applicants to the NIDDK research areas webpage for guidance on what topics are considered within scope.
Another defining feature is that the ancillary study must obtain approval from the appropriate governing body of the parent study. Depending on how the parent study is organized, this may mean obtaining permission from the parent study's steering committee, executive committee, data coordinating center leadership, trial leadership, or other oversight structure that controls access to participants, data, and biospecimens. This requirement matters because ancillary studies typically depend on coordinated participant contact, use of shared resources, and adherence to the parent study's policies around consent, specimen use, data access, publication, and protection of participant confidentiality.
The FOA also makes clear what counts as an "ancillary study" for purposes of eligibility: the project must collect new information from participants who are already enrolled in the parent study and/or perform assays on existing or newly collected biologic samples. In other words, the funded work should create new data, such as new measurements, new questionnaires, new clinical assessments, device-based monitoring, imaging, or laboratory analyses of biospecimens, rather than simply performing secondary analyses of already-existing datasets without any new data or specimen work. The emphasis on collecting new information or conducting new assays underscores NIDDK's interest in encouraging incremental but meaningful scientific expansion of ongoing studies, especially when it involves novel biomarkers, mechanistic substudies, additional endpoints, or hypothesis-driven measurements that were not part of the original parent protocol.
From an administrative perspective, this FOA uses the R01 funding instrument, which generally supports discrete, hypothesis-driven projects led by qualified investigators and institutions. The opportunity is listed under the broad activity category of Food and Nutrition Health and is associated with CFDA 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research). There is no cost sharing or matching requirement, which simplifies budgeting for applicants because they are not required to commit non-federal funds as a condition of award.
Eligibility is intentionally broad and includes many organization types, reflecting NIH's general approach to allowing a wide range of institutions to apply when they have the expertise and access needed to do the work. Eligible applicants include public and private institutions of higher education, nonprofits (including those with and without 501(c)(3) status), for-profit organizations (including small businesses), state and local governments, school districts, special district governments, public housing authorities/Indian housing authorities, Native American tribal governments and tribal organizations, and U.S. territories or possessions. The FOA also explicitly notes additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, tribally controlled colleges and universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and foreign (non-U.S.) entities. This broad eligibility matters because parent studies and their participant populations may be managed across diverse institutional settings, and ancillary work sometimes benefits from specialized assay capacity, analytic expertise, or community partnerships that exist outside traditional academic medical centers.
Key practical takeaways for an applicant are that success hinges on clearly tying the ancillary question to NIDDK priorities, proving that the parent study is active and suitable for the proposed add-on, and documenting governance approval and logistical feasibility. Competitive applications generally need to show why the ancillary study is scientifically important, why the question cannot be answered without leveraging the parent study's existing platform, how new data or specimen assays will be collected or performed, and how participant burden, consent, privacy, and parent-study operations will be handled. The FOA was originally posted August 16, 2012, with later listed closing dates that indicate it has been archived (archive date February 8, 2016), but it remains a useful reference point for how NIDDK frames ancillary-study opportunities and what core elements NIH expects in ancillary R01 proposals.
For additional official details, the announcement link is provided as http://grants.nih.gov/grants/guide/pa-files/PAR-12-265.html, and general technical access issues were directed to the NIH Office of Extramural Research (OER) webmaster contacts listed in the source information.
Frequently Asked Questions (FAQs)
What is the title and funding opportunity number for this grant?
The opportunity is titled "Ancillary Studies to Major Ongoing Clinical Research Studies to Advance Areas of Scientific Interest within the Mission of the NIDDK (R01)" and the Funding Opportunity Number is PAR-12-265.
What type of grant mechanism is used?
This funding opportunity uses the NIH Research Project Grant (R01) mechanism and supports investigator-initiated applications.
What is the purpose of this funding opportunity?
It supports ancillary ("add-on") studies that leverage major clinical research efforts that are already underway, such as ongoing clinical trials, large epidemiologic cohorts, or disease registries/databases. The goal is to generate important new knowledge efficiently by using existing infrastructure, participants, data systems, and/or specimens from a parent study.
What is considered a "parent study" under this opportunity?
A parent study is a major ongoing clinical research study (for example, a clinical trial, cohort study, or registry/database) that is already in progress and provides the platform (participants, operations, data systems, and/or specimens) that the ancillary study will build on.
Does the parent study have to be active while the ancillary study is conducted?
Yes. A central requirement is that the parent study must be ongoing at the time the ancillary work is proposed and conducted.
Who can support the parent study (NIDDK only, or others too)?
The parent study may be supported by NIDDK, other NIH Institutes and Centers, other government agencies, or the private sector. The key requirement is that it is ongoing and can support the proposed ancillary work.
What kinds of research projects fit best as an ancillary study?
Projects that add focused, hypothesis-driven measurements or assays to an active parent study. Examples described in the opportunity include adding new measurements, questionnaires, clinical assessments, device-based monitoring, imaging, or lab analyses of biospecimens using participants and/or specimens tied to the parent study.
Does this funding opportunity support starting a brand-new clinical trial or cohort from scratch?
No. The intent is to fund targeted research that builds on an existing, ongoing parent study rather than launching a brand-new standalone parent trial or cohort.
What are the scientific areas that must be addressed?
The ancillary study must align with NIDDK's mission and priority areas, broadly covering diabetes, endocrinology and metabolic diseases; digestive diseases, nutrition, and obesity-related topics; and kidney, urologic, and hematologic diseases.
How should applicants confirm whether their topic is within NIDDK's mission?
The opportunity points applicants to the NIDDK research areas webpage to determine what topics are considered within scope and to help frame the relevance of the proposed ancillary question.
What is a key scientific rationale expected in the application?
The application should make a clear case that the ancillary question advances NIDDK's scientific mission and that the work will generate important new knowledge faster and more cost-effectively than recruiting a new cohort or starting a new trial.
Does an ancillary study need permission from the parent study leadership?
Yes. The ancillary study must obtain approval from the appropriate governing body of the parent study (for example, a steering committee, executive committee, data coordinating center leadership, trial leadership, or other oversight structure that controls access).
Why is parent-study governance approval required?
Because ancillary studies often rely on coordinated participant contact and shared resources, and must follow the parent study's policies on consent, specimen use, data access, publication, and protection of participant confidentiality.
What qualifies as an "ancillary study" for eligibility purposes?
For this opportunity, an ancillary study is expected to collect new information from participants already enrolled in the parent study and/or conduct assays on existing or newly collected biological samples. The emphasis is on generating new data or new assay results tied to the parent study.
Are simple secondary analyses of existing datasets supported?
The opportunity emphasizes new data collection and/or new specimen assays rather than only secondary analyses of already-existing datasets without any new data or specimen work.
Can the ancillary study use existing specimens, newly collected specimens, or both?
Yes. The described scope includes conducting assays on existing biological samples and/or on newly collected samples, as long as the work is tied to participants in the ongoing parent study.
How important is feasibility within the parent study's timeline and operations?
Very important. Applicants are expected to demonstrate that the ancillary work is feasible within the parent study's timeline, operations, and participant contact schedule, and that it will not compromise the integrity or primary aims of the parent study.
What does the opportunity say about protecting the parent study's integrity?
The ancillary study should be designed so it does not compromise the parent study, including its primary aims and operational conduct.
Is there a cost sharing or matching requirement?
No. The opportunity states there is no cost sharing or matching requirement.
What is the associated CFDA number and program area?
The opportunity is associated with CFDA 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research) and is listed under the broad activity category of Food and Nutrition Health.
Which organizations are eligible to apply?
Eligibility is broad and includes public and private institutions of higher education; nonprofits (with and without 501(c)(3) status); for-profit organizations (including small businesses); state and local governments; school districts; special district governments; public housing authorities/Indian housing authorities; Native American tribal governments and tribal organizations; and U.S. territories or possessions.
Are specific institutional categories explicitly included?
Yes. The opportunity explicitly notes additional eligible applicant categories such as HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, tribally controlled colleges and universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and foreign (non-U.S.) entities.
Can foreign (non-U.S.) entities apply?
Yes. Foreign (non-U.S.) entities are explicitly listed among eligible applicant categories.
What are practical elements a competitive application should address?
Based on the opportunity description, strong applications typically (1) tie the ancillary question clearly to NIDDK priorities, (2) show the parent study is active and suitable, (3) document parent-study governance approval, (4) explain how new data and/or assays will be obtained, and (5) address participant burden, consent, privacy, and operational logistics within the parent study.
When was this funding opportunity posted, and what is its current status?
It was originally posted on August 16, 2012. The closing dates and the listed archive date (February 8, 2016) indicate it has been archived.
Where can applicants find the official announcement?
The announcement link provided is: http://grants.nih.gov/grants/guide/pa-files/PAR-12-265.html
Where were technical access issues directed?
General technical access issues were directed to the NIH Office of Extramural Research (OER) webmaster contacts listed in the source information.
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