Collaborative Human Tissue Network (CHTN) (UM1 Clinical Trials Not Allowed) | RFA CA 18 025

FAQs: Collaborative Human Tissue Network (CHTN) (UM1 Clinical Trials Not Allowed) - RFA-CA-18-025

1) What is the CHTN funding opportunity (RFA-CA-18-025)?

RFA-CA-18-025 is a National Cancer Institute (NCI) cooperative agreement (UM1) to sustain and operate the Collaborative Human Tissue Network (CHTN), a major biospecimen resource. The network supports basic and early translational cancer research and the development of research assays by procuring and distributing human tissues and fluids.

2) What is the main purpose of the CHTN program?

The program is designed to help investigators obtain human specimens that match their specific, up-front research needs. Instead of relying primarily on pre-existing collections, CHTN emphasizes prospective collection and distribution so samples are collected in the right way, at the right time, and with appropriate handling and context for modern research use.

3) What types of research does this resource support?

Based on the description provided, CHTN supports basic and early translational cancer research, as well as biomarker and assay development and other pre-clinical or non-trial activities where specimen quality, handling conditions, and contextual information are critical.

4) Are clinical trials allowed under this funding opportunity?

No. The FOA explicitly states "Clinical Trials Not Allowed," indicating the supported work is focused on biospecimen resource operations and related support activities rather than interventional clinical trials.

5) What is meant by "prospective collection" in CHTN?

Prospective collection means tissues and fluids are collected in response to investigator requests, based on predefined requirements such as tissue type, collection conditions, processing timelines, preservation methods, and requested clinical annotations. The intent is to deliver fit-for-purpose specimens rather than relying mainly on previously banked samples.

6) What specimen types and clinical states are included?

Requested specimens can include pre-cancerous lesions, malignant cancers, benign neoplastic tissues, specimens associated with non-neoplastic diseases, and "uninvolved" tissues (often normal adjacent tissue) for comparison.

7) What does "uninvolved" tissue mean in this context?

"Uninvolved" tissue generally refers to tissue not affected by the primary disease process, often described as normal adjacent tissue. These specimens are important for comparative analyses and interpretation of findings.

8) What are awardees expected to do under this program?

The opportunity describes several core expectations: (1) procure high-quality tissues and fluids prospectively in an investigator-defined manner; (2) provide hands-on consultation and support to investigators to clarify and meet specimen requirements; (3) develop, document, and share high-quality operational practices for biospecimen repositories; and (4) conduct education and outreach to inform research and clinical communities about the value of high-quality human tissue resources.

9) What does it mean that the program is "investigator-driven"?

It means specimen collection and distribution are guided by the requesting researchers' specific requirements. The network is organized to respond to customized requests, rather than distributing only what happens to be available in a pre-existing bank.

10) What does the UM1 cooperative agreement mechanism imply?

A UM1 cooperative agreement indicates NCI anticipates substantial programmatic involvement and coordination with awardees. This reflects that CHTN is a networked national resource requiring active coordination, not a standalone research project.

11) What operational capabilities are implied by "customized requests"?

The description indicates awardees should be able to respond to investigator-defined specifications such as particular tissue types, collection conditions, processing timelines, preservation methods, and associated clinical annotations, while maintaining consistent quality and meeting eligibility constraints.

12) Does the program focus on banking tissue or distribution?

The goal is not simply to bank tissue. The emphasis is on delivering high-quality, well-handled biospecimens that can be used confidently in studies, including those requiring strict handling conditions and detailed contextual information.

13) Are applicants required to choose an adult or pediatric role?

Yes. Applicants must position themselves as either the adult biospecimen division or the pediatric specimen division, depending on their capabilities and institutional profile.

14) Can an adult division also provide pediatric specimens?

Yes. The FOA allows flexibility: an adult division capable of handling pediatric collections may also contribute pediatric samples for networked requests.

15) What geographic scope is suggested for specimen procurement?

The opportunity indicates the ability to support requests across patients in North America and potentially beyond, while still adhering to the FOA's eligibility and foreign involvement restrictions.

16) Who is eligible to apply?

Eligibility is broad and includes many U.S.-based organization types, including: state/county/city or township governments; special district governments; public and state-controlled institutions of higher education; private institutions of higher education; independent school districts; public housing authorities/Indian housing authorities; federally recognized Native American tribal governments; other tribal organizations; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses.

17) Does the FOA encourage applications from specific institution types or communities?

Yes. The FOA highlights interest in applications from a wide range of institution types and community-serving organizations, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, faith-based or community-based organizations, Hispanic-serving institutions, HBCUs, TCCUs, regional organizations, and U.S. territories or possessions.

18) Are foreign organizations eligible to apply?

No. Non-U.S. entities (foreign organizations and foreign institutions) are not eligible to apply.

19) Are non-domestic components of U.S. organizations eligible?

No. The FOA states that non-domestic components of U.S. organizations are not eligible.

20) Are foreign components allowed under NIH policy definitions?

No. The FOA specifies that foreign components (as defined by NIH policy) are not allowed.

21) What is the listed funding ceiling for this opportunity?

The award ceiling provided is $800,000.

22) What is the Funding Opportunity Number?

The Funding Opportunity Number is RFA-CA-18-025.

23) Which agency is sponsoring this opportunity?

The opportunity is sponsored by the National Cancer Institute (NCI).

24) What are the associated CFDA numbers?

The CFDA numbers associated with this FOA are 93.393 and 93.396.

25) When was the FOA created and when did it close?

The FOA was created on 2018-06-22 and the original closing date listed is 2018-08-28.

26) What kinds of non-research activities are expected beyond specimen distribution?

The FOA includes expectations for developing, documenting, and sharing operational best practices for biospecimen repositories, as well as education and outreach to help research and clinical communities understand the importance of high-quality human tissue resources.

27) What does "hands-on support to investigators" involve?

Based on the description, it includes consulting with investigators on feasibility, quantities, processing methods, and realistic turnaround times so that specimen requirements are clear and can be met consistently.

28) Why does the FOA emphasize specimen quality and handling conditions?

The FOA notes that modern research questions often depend heavily on specimen quality, handling conditions, and detailed context. The network is designed to ensure specimens are fit for use in cancer biology studies and early translational work, including assay development.