Genomics of Transplantation Cooperative Research Program (U01, U19) | Apply Online

Frequently Asked Questions (FAQs)

What is the Genomics of Transplantation Cooperative Research Program (RFA-AI-10-019)?

The Genomics of Transplantation Cooperative Research Program (RFA-AI-10-019) is a National Institutes of Health (NIH) funding opportunity administered through the National Institute of Allergy and Infectious Diseases (NIAID). It supports large-scale, broad-scope genomics research focused on clinical transplantation, with the goal of improving the prediction, prevention, and treatment of graft rejection.

Which NIH institute runs this opportunity?

This opportunity is run through NIH's National Institute of Allergy and Infectious Diseases (NIAID).

What is the main scientific idea behind the program?

The program is built on the idea that transplant outcomes are strongly influenced by human genetic variation and gene activity. By studying inherited genetic differences and gene expression across patients and populations at scale, researchers can identify markers and immune patterns that connect to real clinical transplant outcomes and can support more personalized transplant care.

What types of transplantation are included in the scope?

The scope explicitly includes transplantation of solid organs, tissues, and cells.

What kinds of research does the program prioritize?

The opportunity prioritizes large-scale genomics research that is directly linked to real-world transplant endpoints. It emphasizes research that can connect genomic findings to clinically meaningful outcomes in transplantation, rather than genomics that is purely descriptive.

What are the key scientific goals of the program?

The program aims to:

• Identify and validate gene polymorphisms (inherited genetic variants) and gene expression patterns linked to transplant endpoints.
• Find genomic markers that correlate with or predict transplantation outcomes.
• Define immune response patterns linked to the onset and severity of acute and chronic rejection.
• Predict how individual patients will respond to immunosuppressive medications to support more tailored therapy.
• Clarify why graft survival varies across populations or between individuals, including genetic contributors to those differences.

What does "gene polymorphisms" mean in the context of this program?

In this program, gene polymorphisms refer to inherited genetic variants. The research focus is on finding and validating variants that are associated with clinically important transplant outcomes, such as rejection risk and graft survival.

What does "gene expression patterns" mean in the context of this program?

Gene expression patterns describe how strongly particular genes are turned on or off in relevant cells or tissues. The program is interested in expression patterns that link to transplant endpoints, including immune activity associated with rejection.

How does the program connect genomics research to patient outcomes?

The program is explicitly translational. It seeks genomic markers and immune response patterns that correlate with or predict outcomes such as acute and chronic rejection, response to immunosuppressive drugs, and long-term graft survival, with the longer-term goal of improving patient management and quality of life.

What is meant by a "cooperative agreement" in this funding opportunity?

This opportunity uses a cooperative agreement mechanism rather than a standard grant. That means NIH anticipates substantial scientific and/or programmatic involvement during the award period.

What award mechanisms are available under this program?

Applicants may propose either:

• A single-project cooperative agreement (U01), or
• A multi-project cooperative agreement (U19).

What is the difference between U01 and U19 for this opportunity?

Under this opportunity, U01 supports a single-project cooperative agreement, while U19 supports a multi-project cooperative agreement. The design allows participation by a single institution or by a consortium of institutions, depending on the proposed structure.

Is this program intended for collaborative or interdisciplinary teams?

Yes. The program is designed for interdisciplinary teams that can combine clinical transplantation expertise with genomics, immunology, and related analytic capabilities. The overall structure is meant to support coordinated, collaborative work at a scale large enough to detect meaningful genomic signals and connect them to clinically relevant outcomes.

How much funding was projected for this initiative?

Funding was projected at about $4,000,000 in total costs in FY 2011.

How many awards did NIH expect to make?

NIH expected to make two to four awards across U01 and/or U19 mechanisms.

Were new applications and renewals eligible?

Yes. The opportunity anticipated supporting both new and renewal applications.

Does the opportunity require cost sharing or matching funds?

No. The funding opportunity does not require cost sharing or matching.

What are the key dates for this funding opportunity?

The opportunity had the following dates:

• Posting date: July 23, 2010
• Original and current closing date: November 19, 2010
• Archive date: December 20, 2010

What CFDA numbers are associated with this FOA?

This funding opportunity falls under CFDA numbers 93.855 (Allergy, Immunology and Transplantation Research) and 93.856 (Microbiology and Infectious Diseases Research).

What types of organizations are eligible to apply?

Eligibility is broad and includes many domestic organization types, including:

• Public and private institutions of higher education
• Nonprofit organizations (with and without 501(c)(3) status)
• For-profit organizations (including small businesses and other for-profits)
• Independent school districts
• Government entities (city/township, county, state, special district, and certain public housing authorities/Indian housing authorities)
• Tribal governments and tribal organizations
• Regional organizations
• U.S. territories or possessions
• Eligible federal agencies

Are small businesses and for-profit organizations eligible?

Yes. For-profit organizations, including small businesses and other for-profits, are listed as eligible applicants.

Are nonprofit organizations eligible even if they do not have 501(c)(3) status?

Yes. The eligibility description includes nonprofit organizations with and without 501(c)(3) status.

Are tribal governments and tribal organizations eligible?

Yes. Tribal governments and tribal organizations are explicitly included in the eligibility list.

Are institutions such as HBCUs, HSIs, and TCCUs included in the eligibility language?

Yes. The eligibility language highlights categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and other diverse institutional settings.

Are faith-based or community-based organizations allowed to apply?

Yes. Faith-based or community-based organizations are included in the eligibility language.

What is the long-term outcome NIAID emphasizes for this program?

NIAID emphasizes moving transplantation toward a genomics-informed model that supports more rational and evidence-based development of effective treatments, improves long-term graft survival, and ultimately improves quality of life for transplant recipients.

What clinical problems is the program trying to address?

The program is designed to improve the ability to anticipate rejection risk, understand immune biology in individual patients, and select immunosuppressive strategies more precisely, with a focus on both acute and chronic rejection and long-term graft outcomes.