Opportunity Information: Apply for RFA CA 20 006

The grant opportunity "Communication and Decision Making for Individuals with Inherited Cancer Syndromes (U01 Clinical Trial Optional)" (RFA-CA-20-006) is a National Institutes of Health cooperative agreement funding announcement under the U.S. Department of Health and Human Services. It sits within the Beau Biden Cancer Moonshot initiative, which is aimed at speeding up progress in cancer research and translating proven approaches into real-world improvements. The core focus here is people and families who carry inherited genetic risk for cancer, and the practical problem the announcement is trying to solve is that even when genetic risk is known, communication about that risk and the decisions that follow can be inconsistent, confusing, inequitable, or difficult to implement across clinical and family settings.

At a high level, the announcement is looking for research projects that create, adapt, test, and evaluate interventions that make risk communication and risk-management decision making work better for patients, providers, and families dealing with inherited cancer susceptibility. That can include developing new tools or programs, refining existing ones, and pairing those interventions with implementation approaches that increase real-world uptake in health systems and communities. The emphasis is not only on whether an intervention works in principle, but also on whether it can be delivered effectively, adopted broadly, and sustained in the settings where people actually receive genetic services, counseling, screening, and follow-up care. Because the mechanism is a U01 cooperative agreement, awardees should expect substantial scientific involvement from NIH staff compared with a standard research project grant, with a more collaborative federal role in guiding or coordinating the work.

This opportunity directly aligns with the Cancer Moonshot Blue Ribbon Panel scientific priority area described in Recommendation G, which calls for initiatives that strengthen early detection, genetic testing, and genetic counseling, while also expanding knowledge and accelerating implementation science so that validated strategies are adopted faster and more widely. A key thread running through the announcement is the expectation that projects will help individuals and families make informed clinical risk-management decisions. In practice, that means improving how risk information is explained and understood, how options like intensified screening or preventive interventions are discussed, how family communication about inherited risk is supported, and how providers and systems help patients follow through over time. It also explicitly ties this work to reducing cancer risk and addressing cancer health disparities, signaling that applications should be attentive to equity, access, and the real barriers that different populations face when navigating genetic information and preventive care.

The funding instrument is a discretionary cooperative agreement, with an award ceiling of $600,000 and an anticipated total of about five awards. The activity category is listed under education and health, which fits the emphasis on communication, counseling-related processes, decision support, and implementation strategies rather than basic laboratory discovery. Clinical trials are optional, meaning applicants can propose projects that include a clinical trial component if it is appropriate for evaluating the intervention, but they are not required to do so if their aims are better served through other study designs (for example, pragmatic implementation studies, hybrid effectiveness-implementation designs, or staged adaptation and evaluation frameworks).

Eligibility is broad and includes many types of organizations that could realistically build and test these kinds of interventions and implementation approaches. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities and Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding higher education institutions where relevant); for-profit organizations other than small businesses; and small businesses, along with other entities as allowed by the additional eligibility language in the full announcement. This wide eligibility is consistent with the announcement's applied and implementation-oriented nature, since successful projects may require partnerships among academic researchers, clinical systems, community organizations, payers, public health agencies, and organizations that serve high-risk families.

The key takeaway is that NIH is funding teams to move beyond simply identifying inherited cancer risk and toward making genetic risk information actionable in everyday clinical and family life. Competitive applications for a program like this would typically be expected to show a clear understanding of the communication and decision-making challenges faced by individuals with inherited cancer syndromes, propose an intervention and delivery strategy that can realistically be used in real settings, include a strong plan to evaluate both outcomes and implementation, and explicitly consider how the work will improve access, reduce disparities, and support informed risk-management decisions over time.

  • The Department of Health and Human Services, National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Communication and Decision Making for Individuals with Inherited Cancer Syndromes (U01 Clinical Trial Optional)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.353, 93.399.
  • This funding opportunity was created on Oct 30, 2019.
  • Applicants must submit their applications by Jan 21, 2020. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Each selected applicant is eligible to receive up to $600,000.00 in funding.
  • The number of recipients for this funding is limited to 5 candidate(s).
  • Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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Frequently Asked Questions (FAQs)

What is the name of this grant opportunity?

The funding announcement is titled "Communication and Decision Making for Individuals with Inherited Cancer Syndromes (U01 Clinical Trial Optional)". The announcement number is RFA-CA-20-006.

Which federal agency is offering this funding?

This is a National Institutes of Health (NIH) funding opportunity under the U.S. Department of Health and Human Services (HHS).

What type of award mechanism is being used?

The mechanism is a U01 cooperative agreement. This typically means there will be substantial scientific involvement from NIH staff compared with a standard research project grant, and projects are expected to operate in a more collaborative, coordinated way with NIH.

How does a cooperative agreement (U01) differ from a typical grant?

Based on the description provided, awardees should plan for a more active federal role in guiding and/or coordinating the work. The intent is still to support investigator-driven research, but with more ongoing NIH program involvement than is typical for many other grant types.

What is the main problem this funding opportunity is trying to solve?

The opportunity targets a practical gap: even when inherited genetic cancer risk is known, communication about that risk and the risk-management decisions that follow can be inconsistent, confusing, inequitable, or difficult to carry out across clinical and family settings.

Who is the main focus population for the proposed research?

The focus is on individuals and families who carry inherited genetic risk for cancer, including people dealing with inherited cancer susceptibility and the family communication needs that come with it.

What kinds of projects is NIH looking to fund under this announcement?

NIH is seeking research projects that create, adapt, test, and evaluate interventions to improve how inherited cancer risk is communicated and how people make and implement risk-management decisions. This can include new tools/programs, improvements to existing approaches, and pairing interventions with implementation strategies to increase real-world adoption.

What is meant by "interventions" in this context?

In this announcement, "interventions" refers to structured approaches that improve risk communication and decision making for inherited cancer susceptibility. Examples described at a high level include tools or programs that help patients and families understand risk, support discussions with providers, and enable follow-through on risk-management options over time.

Does the funding focus only on whether an intervention works, or also on real-world use?

The emphasis is explicitly not limited to whether an intervention works "in principle." The announcement prioritizes whether an intervention can be delivered effectively, adopted broadly, and sustained in real settings where people receive genetic services, counseling, screening, and follow-up care.

Are clinical trials required?

No. Clinical trials are optional. Applicants may include a clinical trial component if it fits the evaluation needs of the intervention, but projects can also use other designs when more appropriate.

If clinical trials are optional, what other study designs are compatible with this opportunity?

The announcement notes that aims may be served through approaches such as pragmatic implementation studies, hybrid effectiveness-implementation designs, or staged adaptation and evaluation frameworks, among other non-mandatory clinical trial approaches.

What topics or outcomes are emphasized for improving decision making?

The announcement highlights improving how risk information is explained and understood, how options such as intensified screening or preventive interventions are discussed, how family communication about inherited risk is supported, and how providers and systems support long-term follow-through.

How does this opportunity connect to the Cancer Moonshot initiative?

This funding opportunity sits within the Beau Biden Cancer Moonshot, which aims to speed up progress in cancer research and translate proven approaches into real-world improvements.

What specific Cancer Moonshot priority does it align with?

It aligns with the Cancer Moonshot Blue Ribbon Panel priority described as Recommendation G, which calls for initiatives that strengthen early detection, genetic testing, and genetic counseling, and that expand implementation science so validated strategies are adopted faster and more widely.

Is addressing health equity and disparities part of the intent?

Yes. The announcement explicitly ties the work to reducing cancer risk and addressing cancer health disparities. Applications are expected to be attentive to equity, access, and barriers faced by different populations when navigating genetic information and preventive care.

What is the maximum award amount (award ceiling)?

The award ceiling is listed as $600,000.

How many awards are expected?

The opportunity anticipates making about five awards.

What is the activity category for this funding?

The activity category is listed under education and health, consistent with the focus on communication, counseling-related processes, decision support, and implementation strategies.

What types of organizations are eligible to apply?

Eligibility is broad and includes: state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities and Indian housing authorities; nonprofit organizations (with or without 501(c)(3) status, excluding higher education institutions where relevant); for-profit organizations other than small businesses; and small businesses, plus other entities as permitted in the full announcement.

Why is eligibility so broad for this particular program?

The announcement is applied and implementation-oriented, and successful projects may require partnerships across settings such as academic research, clinical systems, community organizations, payers, and public health agencies. Broad eligibility makes it more realistic to build teams that can test interventions in real-world environments.

What kinds of partnerships or settings fit the goals of this funding?

Based on the description, strong fit settings include those where people actually receive genetic services, counseling, screening, and follow-up care, and partnerships may involve academic researchers, health systems, community organizations, public health agencies, payers, and organizations serving high-risk families.

What is the overall "key takeaway" of what NIH wants to fund?

The core goal is to move beyond simply identifying inherited cancer risk and toward making genetic risk information actionable in everyday clinical and family life, through interventions and implementation approaches that support informed decisions and sustained follow-through.

What would a competitive application generally be expected to demonstrate, based on the description provided?

The description suggests competitive projects would typically show: a clear understanding of communication and decision-making challenges for inherited cancer syndromes; a realistic intervention and delivery strategy that works in real settings; a strong plan to evaluate outcomes and implementation; and explicit attention to improving access, reducing disparities, and supporting informed risk-management decisions over time.

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