Opportunity Information: Apply for PAS 12 169
Apply for PAS 12 169
- The National Institutes of Health in the education food and nutrition health income security and social services sector is offering a public funding opportunity titled "Limited Competition Revision Applications to Advance Evidence Based Research Related to Protections for Human Subjects (U54)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121 Oral Diseases and Disorders Research 93.233 National Center on Sleep Disorders Research 93.273 Alcohol Research Programs 93.286 Discovery and Applied Research for Technological Innovations to Improve Human Health 93.350 National Center for Advancing Translational Sciences 93.393 Cancer Cause and Prevention Research 93.394 Cancer Detection and Diagnosis Research 93.395 Cancer Treatment Research 93.399 Cancer Control 93.837 Cardiovascular Diseases Research 93.838 Lung Diseases Research 93.839 Blood Diseases and Resources Research 93.846 Arthritis, Musculoskeletal and Skin Diseases Research 93.847 Diabetes, Digestive, and Kidney Diseases Extramural Research 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders 93.865 Child Health and Human Development Extramural Research 93.879 Medical Library Assistance.
- This funding opportunity was created on May 9, 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 PAS-12-169, titled "Limited Competition Revision Applications to Advance Evidence Based Research Related to Protections for Human Subjects (U54)," is a National Institutes of Health (NIH) discretionary grant announcement that uses the cooperative agreement mechanism (U54). It is designed specifically as a limited-competition revision opportunity, meaning it is not a general open call for brand-new standalone projects. Instead, it targets existing NIH-funded cooperative agreements that already support research networks or consortia, and it invites those established groups to submit revision applications that expand or enhance their current scope of work in a focused area: strengthening the evidence base behind human subjects protections.
At its core, the announcement is trying to push the field beyond relying mainly on tradition, policy precedent, or assumptions about what protects research participants. NIH is signaling interest in practical, data-driven research that evaluates how well current human subjects protections actually work in real-world settings and how they might be improved as research methods, data use, and biomedical technologies continue to evolve. A key part of the purpose is the development of tools and methods that can help investigators, institutions, and oversight bodies study and measure protections more systematically. That can include research methods to assess participant understanding, the performance of consent processes, the effectiveness of privacy and confidentiality safeguards, the functioning of IRBs and oversight systems, and other mechanisms intended to reduce risk and respect participant autonomy.
A major emphasis area highlighted in the description is consent for research involving deidentified human specimens and data. Specifically, the FOA calls for research on the feasibility, costs, benefits, and broader impacts of requiring consent even when specimens or datasets are deidentified. This reflects long-running debate in research ethics and regulation: deidentification lowers privacy risk, but it does not necessarily address concerns about autonomy, trust, group harms, or participants preferences about how their materials or data are used. NIH is explicitly interested in studying novel consent models in this space, including approaches such as notification-based frameworks, opt-out systems, opt-in systems, and broad consent. The focus is not just philosophical; it is operational and empirical, asking applicants to examine what these models would mean in practice for participants, researchers, health systems, biobanks, and research timelines, including the administrative and financial burden and any effects on participation, representativeness, and scientific value.
The instrument type is a cooperative agreement, which typically means NIH expects substantial scientific or programmatic involvement from the agency compared to a standard research project grant. In practice, that often aligns well with network or consortium settings where common measures, shared infrastructure, coordinated protocols, and cross-site governance are necessary. Because the FOA is for revision applications, the expectation is that applicants will build on an existing funded foundation and propose well-justified additions that fit the goals of advancing evidence-based human subjects protections research.
The total estimated funding listed for this opportunity is $5,000,000. The FOA was posted on April 20, 2012, with a closing date of May 25, 2012, and it was archived on June 25, 2012. While the activity category listing spans many health-related program areas (multiple CFDA numbers across cancer, cardiovascular, neurological disorders, child health, translational science, and more), the thematic focus of this announcement is clearly anchored in research ethics and oversight science rather than a single disease area. The broad range of CFDA numbers signals that the topic is cross-cutting and relevant across NIH-supported biomedical and behavioral research domains.
Eligibility is constrained. Foreign institutions are not eligible to apply, non-U.S. components of U.S. organizations are not eligible, and foreign components (as NIH defines them in the NIH Grants Policy Statement) are not allowed. The FOA also states there is no cost sharing or matching requirement. The eligible applicant category is listed as "Others (see text)," which typically indicates that eligibility is limited to a specific subset of currently funded U54 cooperative agreements supporting networks/consortia, consistent with the "limited competition" framing.
Operationally, the announcement directs readers to the full posting on the NIH grants site (link provided in the source). For access or technical issues, the contact is the NIH Office of Extramural Research (OER) webmaster email address. Overall, PAS-12-169 is best understood as a targeted effort to generate stronger real-world evidence about which human subjects protections work, under what conditions they work, what they cost, and how emerging consent models for deidentified biospecimens and data might affect participants, institutions, and the research enterprise.
Frequently Asked Questions (FAQs): PAS-12-169 (U54) Limited Competition Revisions on Human Subjects Protections
What is PAS-12-169?
PAS-12-169 is an NIH funding opportunity titled "Limited Competition Revision Applications to Advance Evidence Based Research Related to Protections for Human Subjects (U54)." It supports revision applications that expand or enhance an already-funded NIH cooperative agreement (U54), with a specific focus on building evidence about what human subjects protections work, how well they work in practice, and how they can be improved.
Is this a funding opportunity for brand-new, standalone projects?
No. This is a limited-competition revision opportunity, not an open solicitation for new standalone awards. It is intended for existing NIH-funded cooperative agreements that already support research networks or consortia, and it funds additions or expansions to that current scope of work.
What type of award mechanism does this opportunity use?
This opportunity uses the cooperative agreement mechanism (U54). A cooperative agreement typically involves substantial scientific or programmatic involvement from NIH compared with a standard research project grant, which often fits network or consortium-based work that needs coordination across sites.
Who is the intended applicant for PAS-12-169?
The FOA targets established NIH-funded cooperative agreements (U54) that already support research networks or consortia. The eligible applicant category is listed as "Others (see text)," which aligns with the limited competition framing and indicates eligibility is restricted to a specific subset of currently funded U54 network/consortium awards.
Are foreign institutions eligible to apply?
No. Foreign institutions are not eligible to apply under this FOA.
Can a U.S. organization include non-U.S. components in the application?
No. Non-U.S. components of U.S. organizations are not eligible under this FOA.
Are foreign components allowed (as defined by NIH policy)?
No. Foreign components (as defined in the NIH Grants Policy Statement) are not allowed for this opportunity.
Is there a cost sharing or matching requirement?
No. The FOA explicitly states there is no cost sharing or matching requirement.
What is the main purpose of this funding opportunity?
The purpose is to strengthen the evidence base behind human subjects protections by supporting practical, data-driven research that evaluates how current protections perform in real-world settings and how they might be improved as research practices, data use, and biomedical technologies evolve.
What kinds of research topics are encouraged?
The FOA emphasizes research that measures and evaluates human subjects protections more systematically. Examples described include studying participant understanding, the performance of consent processes, the effectiveness of privacy and confidentiality safeguards, and the functioning of IRBs and oversight systems, as well as developing tools and methods to support this type of evaluation.
What does the FOA mean by "evidence-based" human subjects protections?
In this context, "evidence-based" means moving beyond relying primarily on tradition, policy precedent, or assumptions about protections. NIH is highlighting the need for empirical research that tests how well protections work, under what conditions they work, and what it takes (including resources and operational effort) to implement them.
Is informed consent a major focus area in PAS-12-169?
Yes. A major emphasis is consent for research involving deidentified human specimens and data, including studying the feasibility, costs, benefits, and broader impacts of requiring consent even when specimens or datasets are deidentified.
What specific consent models does the FOA highlight for deidentified specimens and data?
The FOA explicitly points to studying novel consent models such as notification-based frameworks, opt-out systems, opt-in systems, and broad consent, with an emphasis on evaluating what these models mean operationally and empirically.
Why would consent be studied for deidentified specimens or data?
The FOA frames this as an important question because deidentification can lower privacy risk but may not fully address concerns related to autonomy, trust, group harms, or participants preferences about how their materials or data are used. The FOA seeks research on what requiring consent would mean in practice and what impacts it might have.
What kinds of impacts related to consent models does NIH want studied?
The FOA calls for research into feasibility, costs, benefits, and broader impacts. It specifically points to studying administrative and financial burden, effects on participation, representativeness, scientific value, and impacts on researchers, health systems, biobanks, and research timelines.
Is this opportunity focused on a single disease area?
No. Although the activity category listing spans many health-related program areas (reflected in multiple CFDA numbers), the thematic focus is cross-cutting and anchored in research ethics and oversight science rather than a single disease area.
What is the total estimated funding amount for this opportunity?
The FOA lists total estimated funding of $5,000,000.
When was PAS-12-169 posted and when did it close?
The FOA was posted on April 20, 2012, and the closing date was May 25, 2012.
What does it mean that the FOA is archived?
The FOA was archived on June 25, 2012, indicating it is no longer an active, open opportunity as posted.
Where should applicants or readers go for the official full announcement?
The announcement directs readers to the full posting on the NIH grants site via the link provided in the source posting.
Who should be contacted for access or technical issues with the posting?
For access or technical issues, the FOA lists the NIH Office of Extramural Research (OER) webmaster email address as the contact.
What is the overall takeaway of PAS-12-169?
PAS-12-169 is a targeted NIH effort to support established U54 networks/consortia in generating stronger real-world evidence about which human subjects protections work, under what conditions they work, what they cost, and how emerging consent approaches for deidentified specimens and data might affect participants, institutions, and the broader research enterprise.
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| Limited Competition Revision Applications to Advance Evidence Based Research Related to Protections for Human Subjects (U01) Apply for PAS 12 166 Funding Number: PAS 12 166 Agency: National Institutes of Health Category: Education Food and Nutrition Health Income Security and Social Services Funding Amount: Case Dependent |
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| Improving Diet and Physical Activity Assessment (R01) Apply for PAR 12 198 Funding Number: PAR 12 198 Agency: National Institutes of Health Category: Education Food and Nutrition Health Income Security and Social Services Funding Amount: Case Dependent |
| Time Sensitive Obesity Policy and Program Evaluation (R01) Apply for PAR 12 257 Funding Number: PAR 12 257 Agency: National Institutes of Health Category: Education Food and Nutrition Health Income Security and Social Services Funding Amount: Case Dependent |
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| Development of Assays for High Throughput Screening for Use in Probe and Pre therapeutic Discovery (R01) Apply for PAR 13 364 Funding Number: PAR 13 364 Agency: National Institutes of Health Category: Education Food and Nutrition Health Income Security and Social Services Funding Amount: Case Dependent |
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| Empirical Research on Ethical Issues Related to Central IRBs and Consent for Research Using Clinical Records and Data (R01) Apply for RFA OD 14 002 Funding Number: RFA OD 14 002 Agency: National Institutes of Health Category: Education Food and Nutrition Health Income Security and Social Services Funding Amount: Case Dependent |
| Research on Chronic Overlapping Pain Conditions (R01) Apply for PA 14 244 Funding Number: PA 14 244 Agency: National Institutes of Health Category: Education Food and Nutrition Health Income Security and Social Services Funding Amount: Case Dependent |
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| NIH Big Data to Knowledge (BD2K) Enhancing Diversity in Biomedical Data Science (R25) Apply for RFA MD 15 005 Funding Number: RFA MD 15 005 Agency: National Institutes of Health Category: Education Food and Nutrition Health Income Security and Social Services Funding Amount: $200,000 |
| Advancing Mechanistic Probiotic/Prebiotic and Human Microbiome Research (R01) Apply for PA 15 135 Funding Number: PA 15 135 Agency: National Institutes of Health Category: Education Food and Nutrition Health Income Security and Social Services Funding Amount: Case Dependent |
| Exploratory/Developmental Clinical Research Grants in Obesity (R21) Apply for PA 15 163 Funding Number: PA 15 163 Agency: National Institutes of Health Category: Education Food and Nutrition Health Income Security and Social Services Funding Amount: $200,000 |
| Diet and Physical Activity Assessment Methodology (R01) Apply for PAR 15 170 Funding Number: PAR 15 170 Agency: National Institutes of Health Category: Education Food and Nutrition Health Income Security and Social Services Funding Amount: Case Dependent |
| Diet and Physical Activity Assessment Methodology (R21) Apply for PAR 15 171 Funding Number: PAR 15 171 Agency: National Institutes of Health Category: Education Food and Nutrition Health Income Security and Social Services Funding Amount: $200,000 |
| Opportunities for Collaborative Research at the NIH Clinical Center (U01) Apply for PAR 15 287 Funding Number: PAR 15 287 Agency: National Institutes of Health Category: Education Food and Nutrition Health Income Security and Social Services Funding Amount: $500,000 |
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