Research Using Biosamples From Selected Type 1 Diabetes Clinical Studies (DP3) | Apply Online

Opportunity Summary:

The funding opportunity titled "Research Using Biosamples From Selected Type 1 Diabetes Clinical Studies (DP3)" (Funding Opportunity Number PAR-11-350) is a National Institutes of Health (NIH) discretionary grant program designed to support ancillary research projects that make use of archived biospecimens collected during selected clinical trials and studies focused on type 1 diabetes. The central idea is to maximize the scientific value of existing, well-characterized samples by enabling new analyses that were not part of the original trial aims. Rather than funding new clinical trials or new sample collection efforts, this program focuses on carefully justified secondary studies that can extract additional mechanistic and translational insights from already-collected materials.

The scientific purpose of the program is to accelerate discoveries about type 1 diabetes by leveraging biosamples that are typically linked to rich clinical, laboratory, and longitudinal outcome data. The FOA emphasizes ancillary studies expected to produce meaningful advances in understanding disease mechanisms and pathogenic processes, as well as identifying or validating biomarkers. These biomarkers may relate to disease progression, risk of progression, response to therapy, or other clinically relevant outcomes. In practical terms, projects might aim to clarify immune pathways involved in beta cell destruction, explore molecular signatures that track with disease activity, or identify markers that predict which patients respond better to a particular intervention studied in the parent clinical trial. Because the samples come from rigorously conducted clinical studies, applicants are expected to propose analyses that take advantage of that context, including well-defined participant populations, standardized collection procedures, and documented clinical endpoints.

The program uses the NIH grant funding instrument and is categorized under the health area, with the CFDA number 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research). The total estimated funding listed for the opportunity is $3,000,000, and the award ceiling is $200,000. The FOA indicates there is no cost sharing or matching requirement, meaning applicants are not required to contribute non-federal funds as a condition of the award. The announcement was posted on September 28, 2011, with an original and current closing date of June 7, 2012, and it was archived on July 8, 2012. These dates indicate the opportunity was time-limited and is no longer accepting applications, but the description still provides a clear model of how NIH structures ancillary-study opportunities around existing clinical-trial biospecimen resources.

Eligibility is broad and includes many types of domestic U.S. organizations as well as foreign entities, reflecting NIH's interest in attracting strong scientific proposals regardless of institutional type, as long as they can meet program requirements and responsibly manage human biospecimens and associated data. Eligible applicants include state, county, city or township governments, special district governments, independent school districts, and public housing authorities/Indian housing authorities. Academic eligibility includes both public and state-controlled institutions of higher education and private institutions of higher education. The FOA also allows nonprofit organizations, including those with 501(c)(3) status and those without 501(c)(3) status (other than institutions of higher education), and for-profit organizations (including small businesses and other for-profit entities that are not small businesses). Tribal eligibility includes federally recognized Native American tribal governments and Native American tribal organizations other than federally recognized governments. The additional eligibility information explicitly includes Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. Importantly, non-domestic (non-U.S.) entities are eligible to apply, non-U.S. components of U.S. organizations are eligible, and foreign components (as defined by the NIH Grants Policy Statement) are allowed, which broadens participation for specialized laboratory capabilities or unique analytic expertise.

From a program design standpoint, the DP3 activity code signals support for a specific type of NIH project mechanism aimed at discrete projects that often involve access to shared resources. For applicants, the practical implication is that proposals need to be tightly aligned with the available archived biosamples and the parent study context, with a clear plan for how the requested samples will be used, what assays or analyses will be performed, and what scientific or clinical value the results would add. Ancillary studies typically must demonstrate that the proposed work is feasible with the quantity and quality of archived specimens, that the analyses are scientifically compelling and methodologically rigorous, and that they are not duplicative of existing or ongoing work. Because these are human-derived biospecimens, applicants would also be expected to address ethics and compliance issues such as informed consent limitations, privacy protections, data security, and any necessary approvals for use of de-identified or coded samples, consistent with NIH policy and human subjects protections.

The agency associated with the opportunity is the National Institutes of Health, and the full announcement was made available through the NIH Grants Guide (the opportunity link is listed as http://grants.nih.gov/grants/guide/pa-files/PAR-11-350.html). For access issues or linking problems, the contact point provided is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.

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