Opportunity Information: Apply for RFA NS 12 011
Apply for RFA NS 12 011
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Studies in Parkinsons Disease Biomarkers Discovery (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders.
- This funding opportunity was created on Mar 16, 2012 and posted on Mar 16, 2012.
- Applicants must submit their applications by May 23, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities County governments Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Small businesses Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments State governments Native American tribal governments (Federally recognized) Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) City or township 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) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession 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.
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Opportunity Summary:
The NIH funding opportunity titled "Studies in Parkinsons Disease Biomarkers Discovery (U01)" (Funding Opportunity Number RFA-NS-12-011) is a cooperative agreement mechanism designed to accelerate progress in Parkinsons disease (PD) biomarker research by focusing on clinically meaningful, trial-relevant biomarker discovery and by building shared research resources for the broader scientific community. Issued through the National Institute of Neurological Disorders and Stroke (NINDS) under the NIH, the program sits within the NINDS Parkinsons Disease Biomarkers Program (PDBP) and emphasizes studies that can directly strengthen the design and performance of Phase II clinical trials in PD. In practical terms, the FOA is looking for biomarker work that is not just exploratory in a vacuum, but grounded in clinical hypotheses and aimed at improving how early- to mid-stage therapeutic trials are run, interpreted, and de-risked.
The announcement supports two main types of project goals, and applicants may propose one or both if there is a clear scientific justification. The first goal is hypothesis-driven clinical research to discover biomarkers that can improve the efficiency and outcomes of Phase II PD trials. This can include biomarkers intended to identify or stratify patient subgroups, track disease progression, predict treatment response, or serve as indicators of target engagement or biological effect, provided the work is designed as a rigorous clinical research effort rather than purely descriptive sample collection. The second goal is to support the collection of clinical data and new biological specimens specifically for future exploratory biomarker efforts under the PDBP umbrella. That means projects can be built around generating high-quality datasets and biospecimen repositories that enable later discovery and validation work, as long as the collection strategy is scientifically justified and aligned with PDBP needs. The FOA allows studies that rely on existing cohorts (leveraging already-enrolled participants and previously collected samples/data) and also allows the creation of new cohorts when needed to answer the scientific question or to fill gaps in available resources.
A recurring requirement throughout the opportunity is rigor in study design and justification for sample size and cohort composition. Applicants are expected to provide a statistical rationale for the number of subjects and/or specimens requested, rather than offering a convenience sample or a loosely argued enrollment target. In addition, applicants must explain the scientific reasoning behind the types of participants and samples they plan to include, such as why particular disease stages, demographic groups, clinical phenotypes, or control populations are necessary, and why specific specimen types (for example, blood-derived biospecimens, cerebrospinal fluid, DNA, RNA, or other biologic materials) are essential for the proposed biomarker aims. This emphasis signals that the program is looking for projects that can generate interpretable, reproducible findings and resources that are broadly useful, not merely large collections without a clear analytic plan.
The FOA also makes data and specimen sharing a central program expectation rather than an optional add-on. Broad distribution of clinical data and biological samples to qualified researchers in academia, industry, and government is described as a critical feature of both the PDBP overall and this specific funding announcement. The intent is to create research assets that accelerate PD research across the field by enabling secondary analyses, replication, method development, and follow-on biomarker discovery efforts. Because of that, all participants in any study proposed under this FOA must be consented in a way that permits appropriate sharing and distribution of their samples and associated data to external researchers, consistent with applicable laws, regulations, and policies. This places a practical responsibility on applicants to plan ahead for consent language, governance, privacy protections, and distribution procedures so that collected materials can actually be used as intended by the wider community.
From an administrative standpoint, this is a discretionary NIH opportunity using the cooperative agreement funding instrument (U01). A cooperative agreement indicates that NIH/NINDS expects to have substantial programmatic involvement during the project, beyond what is typical for a standard research project grant. The activity category is health research, and it is listed under CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). The FOA was posted March 16, 2012, with an original and current closing date of May 23, 2012, and an archive date of June 23, 2012. The announcement explicitly states there is no cost sharing or matching requirement.
Eligibility is intentionally broad and includes a wide mix of domestic and non-domestic organizations. 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), and a range of governmental entities such as state, county, city/township, and special district governments, as well as public housing authorities and independent school districts. The eligibility language also calls out additional categories such as historically Black colleges and universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian serving institutions, federally recognized and other tribal organizations/governments, regional organizations, faith-based or community-based organizations, U.S. territories or possessions, and eligible federal agencies. Importantly, the FOA allows non-U.S. entities (foreign institutions) to apply, allows non-U.S. components of U.S. organizations, and permits foreign components as defined by NIH policy, widening the potential applicant pool for international collaborations and cohorts.
Overall, the opportunity is best understood as a targeted push to produce clinically actionable biomarker knowledge and to expand shared PD biomarker resources through the PDBP. It prioritizes hypothesis-led clinical studies tied to Phase II trial needs, well-justified cohort and sample strategies, and a strong commitment to open, field-enabling sharing of de-identified clinical data and biospecimens through appropriate consent and distribution practices. For applicants, success under this FOA would likely depend on demonstrating a clear link between the proposed biomarker work and practical clinical trial decision-making, a statistically and clinically sound plan for recruitment and sampling, and a credible approach to making the resulting data and specimens broadly available to accelerate PD research beyond the boundaries of a single project team.
Frequently Asked Questions (FAQs)
What is the NIH funding opportunity "Studies in Parkinsons Disease Biomarkers Discovery (U01)"?
This NIH funding opportunity supports research focused on Parkinsons disease (PD) biomarker discovery and the creation of shared PD biomarker research resources. It uses a U01 cooperative agreement mechanism and is designed to accelerate clinically meaningful, trial-relevant biomarker work rather than purely exploratory efforts.
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA-NS-12-011.
Which NIH Institute is issuing this opportunity?
The opportunity is issued through the National Institute of Neurological Disorders and Stroke (NINDS) under the NIH.
What program is this opportunity part of?
It sits within the NINDS Parkinsons Disease Biomarkers Program (PDBP).
What is the main purpose of this funding announcement?
The main purpose is to accelerate progress in PD biomarker research by emphasizing biomarkers that are clinically meaningful and relevant to therapeutic development, especially biomarkers that can strengthen the design and performance of Phase II clinical trials in Parkinsons disease.
How does the FOA define "trial-relevant" biomarker research?
The FOA emphasizes biomarker discovery that is grounded in clinical hypotheses and aimed at improving how early- to mid-stage therapeutic trials are run, interpreted, and de-risked, rather than biomarker work that is only exploratory or based on sample collection without a rigorous clinical research plan.
What are the main project goals supported by this FOA?
The FOA supports two main types of goals: (1) hypothesis-driven clinical research to discover biomarkers that improve the efficiency and outcomes of Phase II PD trials; and (2) collection of clinical data and new biological specimens intended to support future exploratory biomarker efforts under the PDBP umbrella.
Can an application propose both main goals in one project?
Yes. Applicants may propose one or both goals if they provide a clear scientific justification.
What kinds of biomarkers does the FOA highlight as useful for Phase II Parkinsons disease trials?
The FOA highlights biomarkers intended to identify or stratify patient subgroups, track disease progression, predict treatment response, or serve as indicators of target engagement or biological effect, as long as the work is designed as rigorous clinical research.
Does the FOA support projects focused on collecting specimens and data for future research?
Yes. One of the two supported goals is the collection of clinical data and new biological specimens specifically for future exploratory biomarker efforts under the PDBP, provided the collection strategy is scientifically justified and aligned with PDBP needs.
Are studies required to be hypothesis-driven?
The FOA places strong emphasis on hypothesis-driven clinical research for biomarker discovery. It also allows resource-building collections for future work, but even those collections must be scientifically justified and aligned with program needs, rather than being purely descriptive or convenience sampling.
Can applicants use existing cohorts and previously collected samples/data?
Yes. The FOA allows studies that rely on existing cohorts, including already-enrolled participants and previously collected samples and/or clinical data.
Can applicants create new cohorts under this FOA?
Yes. The FOA allows the creation of new cohorts when needed to answer the scientific question or to fill gaps in available resources.
What does the FOA require regarding rigor in study design?
The FOA repeatedly emphasizes rigor in study design, including clear justification for cohort composition and a statistical rationale for the number of subjects and/or specimens requested.
Is a statistical justification for sample size required?
Yes. Applicants are expected to provide a statistical rationale for the number of subjects and/or specimens requested, rather than relying on convenience samples or loosely justified enrollment targets.
Do applicants need to justify who is included in the cohort?
Yes. Applicants must explain the scientific reasoning behind the types of participants included, such as disease stages, demographic groups, clinical phenotypes, and control populations, and why those choices are necessary for the proposed biomarker aims.
Do applicants need to justify which specimen types are collected?
Yes. Applicants must justify why specific specimen types are essential for the proposed biomarker aims. Examples mentioned include blood-derived biospecimens, cerebrospinal fluid, DNA, RNA, and other biological materials.
What stance does the FOA take on data and specimen sharing?
Data and specimen sharing are central expectations. The FOA describes broad distribution of clinical data and biological samples to qualified researchers as a critical feature of the PDBP and this funding opportunity.
Who should be able to access shared data and specimens?
The FOA describes sharing with qualified researchers across academia, industry, and government.
What is required in participant consent related to sharing?
All participants in any proposed study must be consented in a way that permits appropriate sharing and distribution of their samples and associated data to external researchers, consistent with applicable laws, regulations, and policies.
What practical planning issues should applicants consider to support sharing?
The FOA signals that applicants should plan ahead for consent language, governance, privacy protections, and distribution procedures so that collected materials can actually be distributed and used by the broader research community.
What funding mechanism is used for this opportunity?
This opportunity uses the U01 cooperative agreement mechanism.
What does a cooperative agreement (U01) imply about NIH involvement?
A cooperative agreement indicates that NIH/NINDS expects to have substantial programmatic involvement during the project, beyond what is typical for a standard research project grant.
What is the activity category and CFDA listing for this opportunity?
The activity category is health research, and it is listed under CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders).
When was the FOA posted and what are the key dates provided?
The FOA was posted on March 16, 2012. The original and current closing date is May 23, 2012, and the archive date is June 23, 2012.
Is there a cost sharing or matching requirement?
No. The announcement explicitly states there is no cost sharing or matching requirement.
Who is 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), and multiple governmental entities (including state, county, city/township, special district governments, public housing authorities, and independent school districts).
Are specific institution types called out as eligible?
Yes. The eligibility language explicitly includes HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian serving institutions, federally recognized and other tribal organizations/governments, regional organizations, faith-based or community-based organizations, U.S. territories or possessions, and eligible federal agencies.
Are non-U.S. (foreign) organizations eligible to apply?
Yes. The FOA allows non-U.S. entities (foreign institutions) to apply, allows non-U.S. components of U.S. organizations, and permits foreign components as defined by NIH policy.
What kind of outcomes does the FOA appear to prioritize?
It prioritizes interpretable and reproducible biomarker findings and the creation of broadly useful shared resources, with a clear link between biomarker work and practical clinical trial decision-making in Phase II Parkinsons disease trials.
What would make a proposed project aligned with the FOA based on the description provided?
Based on the description, alignment would include a clear clinical hypothesis tied to Phase II trial needs, a statistically and clinically sound plan for recruitment and sampling, well-justified cohort and specimen choices, and a credible approach to broad sharing of de-identified clinical data and biospecimens via appropriate consent and distribution practices.
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