Limited Competition Revision Applications to Advance Evidence Based Research Related to Protections for Human Subjects (U24) | Apply Online

Opportunity Summary:

The funding opportunity PAS-12-165, titled "Limited Competition Revision Applications to Advance Evidence Based Research Related to Protections for Human Subjects (U24)," is a National Institutes of Health (NIH) discretionary grant program that uses a cooperative agreement mechanism (U24). In practical terms, this means NIH is not only providing funding but also expects substantial programmatic involvement as the supported work moves forward. The opportunity is specifically aimed at revision applications, not brand-new standalone awards, and it is limited in competition because it is intended for existing NIH-funded cooperative agreements that already support research networks or consortia. Those networks are expected to either be conducting research in the targeted areas now or to be positioned to do so in the near future.

The central goal of the announcement is to strengthen and expand evidence-based research on human subjects protections. Rather than treating research ethics and compliance as purely administrative requirements, this FOA emphasizes studying protections themselves as a topic of empirical research. The first major focus area is evaluating how effective current human subjects protections are in real-world research settings and developing tools and methods to examine and improve those protections as science changes. This includes building or refining approaches that can measure whether oversight systems (for example, IRB review processes, consent practices, monitoring approaches, or participant communication strategies) actually achieve their intended outcomes, such as minimizing risk, supporting informed decision-making, and maintaining public trust. The language about "evolving" approaches signals interest in protections that can adapt to modern research realities like large-scale data sharing, multi-site studies, pragmatic clinical trials, biobanking, and research that blends clinical care with data-driven discovery.

The second major focus area addresses a long-running and increasingly important question: what it would mean to require consent for research uses of deidentified human specimens and data. Traditionally, many regulations and policies have treated properly deidentified biospecimens and datasets as posing lower risk to individuals, often allowing certain types of research to proceed without specific consent. This FOA invites research that tests the feasibility, costs, benefits, and broader impacts of shifting that default, especially through newer consent models. The announcement explicitly mentions notification approaches and opt-out, opt-in, and broad consent models. Taken together, this suggests NIH was seeking rigorous evidence on questions such as: whether these consent models are workable at scale; how they affect participation rates and representativeness; what they cost institutions to implement; how they influence public attitudes and trust; whether they change the scientific value of resulting datasets; and whether they produce measurable improvements in participant understanding or autonomy without unintentionally harming equity or slowing valuable research.

From an administrative and eligibility standpoint, the opportunity is categorized under "Health, Income Security and Social Services" and ties to multiple CFDA programs, reflecting its cross-cutting relevance across NIH institutes and research domains. The estimated total funding amount listed is $5,000,000. There is no cost sharing or matching requirement, which means applicants are not expected to provide non-federal funds as a condition of award. The FOA was posted April 20, 2012, with an original and current closing date of May 25, 2012, and it was archived June 25, 2012, indicating it was a time-limited call.

Eligibility is constrained in two important ways. First, because this is a revision application to an existing cooperative agreement, only certain current awardees leading eligible networks/consortia would be positioned to apply, consistent with the "limited competition" framing. Second, foreign participation is restricted: 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 by the NIH Grants Policy Statement are not allowed. In other words, this funding was intended to support domestic, U.S.-based infrastructure and collaborations for generating evidence on human subjects protections, rather than supporting work that would be formally carried out through foreign institutional components.

Overall, PAS-12-165 is best understood as a targeted NIH effort to upgrade the evidence base behind research ethics and oversight at a moment when biomedical and behavioral research practices were rapidly changing. By funding revisions to established networks and consortia, NIH was leveraging existing collaborative infrastructure to quickly generate empirical findings, practical tools, and tested methods that could inform policy and practice around consent, deidentification, participant rights, and the effectiveness of the systems designed to protect human subjects.

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Next opportunity: Limited Competition Revision Applications to Advance Evidence Based Research Related to Protections for Human Subjects (U54)

Previous opportunity: Clinical Sequencing Exploratory Research (U01)

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