Limited Competition Revision Applications to Advance Evidence Based Research Related to Protections for Human Subjects (U10) | Apply Online

Opportunity Summary:

This funding opportunity, PAS-12-168, is a National Institutes of Health (NIH) discretionary grant announcement for a limited competition that supports revision applications to existing cooperative agreements using the U10 mechanism. In practical terms, NIH is not inviting brand-new standalone projects from the general public. Instead, it is asking currently funded NIH-supported research networks or consortia that already operate under cooperative agreements to submit revisions (often called administrative supplements or competitive revisions, depending on the structure) that add new, focused work to their ongoing programs. The overall aim is to strengthen the evidence base behind how human research participants are protected, especially as science and data-sharing practices evolve.

The scientific and policy focus is centered on two closely related themes. First, NIH is looking for research that evaluates how well current human subjects protections actually work in real-world research settings and that develops practical tools and methods to measure, test, and improve those protections over time. This includes work that helps move the field away from relying mainly on tradition, assumption, or compliance checklists, and toward approaches that are demonstrably effective. Projects under this theme could involve developing metrics for participant understanding, assessing the quality of consent processes, evaluating oversight practices, studying how risk is communicated, or creating and validating methods that help institutions and investigators apply protections consistently across diverse studies and populations.

Second, the announcement highlights a specific and timely issue: whether consent should be required for research uses of deidentified human specimens and deidentified data, and what would happen if new consent approaches were adopted. NIH is explicitly interested in the feasibility, costs, benefits, and broader impacts of requiring some form of consent even when traditional identifiers have been removed. The FOA points to novel consent models such as notification-based approaches, opt-out models, opt-in models, and broad consent. This signals interest in evidence that goes beyond theory and captures operational realities, like how these models affect recruitment, participant trust, administrative burden, data availability, equity, and the pace and quality of science. It also implies interest in studying how different communities perceive these models, how well people understand them, and whether they meaningfully improve respect for persons without unintentionally reducing research participation or introducing bias into datasets.

Because this is a cooperative agreement (U10), awardees should expect substantial NIH involvement in the funded activities compared to a typical investigator-initiated grant. Cooperative agreements often include close collaboration with NIH program staff, shared governance structures, and coordination across multiple sites or institutions. That structure fits the types of questions being asked here, since measuring protections and testing consent models often benefits from harmonized methods, shared instruments, common data elements, multi-site implementation, and network-level evaluation.

The opportunity was posted April 20, 2012, with an application due date of May 25, 2012, and an archive date of June 25, 2012. NIH listed an estimated total funding amount of $5,000,000 for this initiative and stated that there is no cost sharing or matching requirement. The activity category is framed broadly under health, income security, and social services, reflecting the cross-cutting nature of human subjects protections and ethics research across many biomedical domains.

Eligibility is limited and excludes foreign participation in several ways. Non-U.S. (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. The announcement’s eligible applicant category is listed as "Others (see text)," which is typical language for limited competitions where only certain current awardees or specific networks/consortia can submit revisions. In other words, the key gatekeeping factor is generally whether an organization already holds an eligible NIH cooperative agreement supporting a relevant network or consortium.

The CFDA program numbers listed span multiple NIH mission areas (for example, cancer, cardiovascular, lung and blood diseases, neurosciences, child health, translational sciences, alcohol research, and sleep disorders), which underscores that NIH views this as a trans-NIH priority rather than something confined to one institute or disease area. That makes sense because questions about consent, privacy, deidentification, and oversight apply across clinical trials, observational studies, biobanking, genomic research, data repositories, and secondary data use in nearly every field.

Overall, PAS-12-168 is best understood as a targeted NIH effort to fund additions to existing research networks so they can generate real evidence on what protects participants most effectively and what the practical consequences would be if consent expectations changed for deidentified biospecimens and datasets. The intended outputs are not just conceptual recommendations, but usable methods, tools, and findings that can inform policy, Institutional Review Board (IRB) practices, research design, and participant-centered approaches to ethical research in an era of large-scale data and specimen sharing.

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