Opportunity Information: Apply for PAS 12 167
Apply for PAS 12 167
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Limited Competition Revision Applications to Advance Evidence Based Research Related to Protections for Human Subjects (UL1)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.350 National Center for Advancing Translational Sciences.
- This funding opportunity was created on Apr 20, 2012 and posted on Apr 20, 2012.
- Applicants must submit their applications by May 25, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $5,000,000.00 to eligible and selected applicants.
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
- Other Eligible Applicants include the following Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
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Opportunity Summary:
The funding opportunity titled "Limited Competition Revision Applications to Advance Evidence Based Research Related to Protections for Human Subjects (UL1)" (Funding Opportunity Number PAS-12-167) is a National Institutes of Health (NIH) discretionary grant announcement that uses a cooperative agreement mechanism. It is specifically designed to support revision applications to existing UL1 cooperative agreements, meaning it is not a general open competition for brand-new standalone awards. Instead, it targets already-funded cooperative agreements that support networks or consortia of researchers, with the goal of expanding or refining ongoing work in a focused area: strengthening the evidence base behind human subjects protections and modernizing approaches as research practices and technologies evolve.
At its core, the announcement is about moving human subjects protections toward more data-driven, evidence-based decision-making. The FOA emphasizes research on how well current protections actually work in real-world settings and encourages the development of practical tools and methods that can measure, test, and improve protections over time. The intent is not just to discuss ethics in the abstract, but to generate evidence that can guide policies, oversight practices, and institutional processes in a way that keeps pace with contemporary research, including multi-site studies and large data-driven or specimen-based research.
A major focus area is the question of consent when research involves deidentified human specimens and data. The FOA highlights the need to study the feasibility, costs, benefits, and broader impacts of requiring consent in these contexts, especially using newer or alternative consent models. Examples named in the announcement include notification-based approaches, opt-out models, opt-in models, and broad consent frameworks. In practical terms, this means applicants are expected to examine not only whether a consent approach is ethically appealing, but whether it can be implemented effectively at scale, what it costs institutions and studies to administer, how it affects participation and trust, and what downstream effects it could have on research operations and scientific progress.
The administering agency is NIH, and the associated CFDA number is 93.350, which is linked to the National Center for Advancing Translational Sciences (NCATS). The funding instrument is a cooperative agreement, which generally signals substantial scientific or programmatic involvement by NIH staff during the project compared with a standard grant. In a network or consortium setting, that cooperative structure often matters because it can shape expectations around coordination, harmonization of methods, sharing of findings, and alignment with broader NIH priorities related to human research protections.
The total estimated funding amount listed for the opportunity is $5,000,000, and the program does not require cost sharing or matching. The announcement was posted on April 20, 2012, with an application due date (original and current closing date) of May 25, 2012, and an archive date of June 25, 2012. Those dates indicate it was a time-limited opportunity tied to a particular policy and research moment, likely intended to accelerate targeted work by already-established UL1-supported networks rather than build new infrastructure from scratch.
Eligibility is limited and is described as "Others (see text field entitled Additional Information on Eligibility for clarification)," which typically indicates the applicants must already hold the relevant cooperative agreements that the revisions would attach to. The FOA also clearly excludes foreign participation in several forms: non-U.S. entities (foreign institutions) are not eligible to apply, non-U.S. components of U.S. organizations are not eligible, and foreign components as defined in the NIH Grants Policy Statement are not allowed. In other words, this funding is intended to stay entirely within eligible U.S.-based organizations and activities.
Overall, this FOA can be read as an effort by NIH to strengthen the research foundation for policies and practices that protect people who contribute to research, particularly at a time when large-scale data and specimen use was expanding rapidly. The opportunity pushes applicants to produce actionable evidence about what protections work, what needs improvement, and how different consent models for deidentified specimens and data might perform in the real world, considering operational feasibility and ethical impact together rather than treating them as separate issues. For full details, NIH provided the official announcement link at http://grants.nih.gov/grants/guide/pa-files/PAS-12-167.html, and technical access issues were directed to the NIH Office of Extramural Research (OER) webmaster.
Frequently Asked Questions (FAQs)
What is the title of this funding opportunity?
The funding opportunity is titled "Limited Competition Revision Applications to Advance Evidence Based Research Related to Protections for Human Subjects (UL1)."
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is PAS-12-167.
Which federal agency is administering this opportunity?
This opportunity is administered by the National Institutes of Health (NIH).
What CFDA number is associated with this opportunity?
The associated CFDA number is 93.350, linked to the National Center for Advancing Translational Sciences (NCATS).
What type of funding mechanism is being used?
The announcement uses a cooperative agreement mechanism. That generally means NIH staff are expected to have substantial scientific or programmatic involvement during the project compared with a standard grant.
Is this an open competition for brand-new awards?
No. This is a limited competition focused on revision applications to existing UL1 cooperative agreements. It is not described as a general open competition for new standalone awards.
Who is this opportunity intended for?
It is intended for already-funded UL1 cooperative agreements that support networks or consortia of researchers, with the goal of expanding or refining ongoing work in a specific area related to human subjects protections.
What is the main goal of the FOA?
The main goal is to advance evidence-based research related to protections for human subjects by generating data and practical tools that can measure, test, and improve protections in real-world research settings.
What does "evidence-based" mean in the context of this FOA?
In this context, it emphasizes studying how well current human subjects protections work in practice and producing evidence that can inform policies, oversight practices, and institutional processes, rather than focusing only on ethics in the abstract.
What kinds of research settings or trends is the FOA responding to?
The FOA is framed around modern research practices and technologies, including multi-site studies and large-scale data-driven or specimen-based research, and the need to modernize protections as these approaches evolve.
What is a major topic area highlighted in the FOA?
A major focus area is consent when research involves deidentified human specimens and data, including evaluating whether consent should be required and how different consent approaches perform in practice.
What consent models are specifically mentioned?
The FOA specifically mentions notification-based approaches, opt-out models, opt-in models, and broad consent frameworks as examples of newer or alternative consent models to study.
What does the FOA expect applicants to evaluate about consent models?
Applicants are expected to evaluate feasibility, costs, benefits, and broader impacts. This includes practical implementation at scale, administrative burden and expense, effects on participation and trust, and downstream impacts on research operations and scientific progress.
Does the FOA focus only on ethical debate about consent?
No. The FOA emphasizes producing actionable evidence about what protections work and how to improve them, combining ethical considerations with operational feasibility and measurable outcomes.
What is the estimated total funding amount?
The total estimated funding amount listed is $5,000,000.
Is cost sharing or matching required?
No. The program does not require cost sharing or matching.
When was the opportunity posted?
The announcement was posted on April 20, 2012.
What was the application due date?
The application due date (original and current closing date) was May 25, 2012.
What is the archive date, and what was it for this FOA?
The archive date indicates when the opportunity was archived. For this FOA, the archive date was June 25, 2012.
What does the timing suggest about the nature of the program?
Based on the posted, due, and archive dates, this was a time-limited opportunity intended to accelerate targeted work by already-established UL1-supported networks rather than build new infrastructure from scratch.
How is eligibility described?
Eligibility is limited and is described as "Others (see text field entitled Additional Information on Eligibility for clarification)," which typically indicates applicants must already hold the relevant cooperative agreements that the revisions would attach to.
Are foreign institutions eligible to apply?
No. Non-U.S. entities (foreign institutions) are not eligible to apply under this FOA.
Can a U.S. organization apply if it has a non-U.S. component?
No. Non-U.S. components of U.S. organizations are not eligible under this FOA.
Are foreign components allowed in any form?
No. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
What does the cooperative agreement structure imply for projects in a network or consortium?
In a network or consortium setting, a cooperative agreement can shape expectations around coordination, harmonization of methods, sharing of findings, and alignment with broader NIH priorities related to human research protections.
Where can someone find the official NIH announcement?
The official announcement link provided is http://grants.nih.gov/grants/guide/pa-files/PAS-12-167.html.
Where were technical access issues directed?
Technical access issues were directed to the NIH Office of Extramural Research (OER) webmaster.
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