and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Cancer Institute (NCI) |
|
Funding Opportunity Title |
Collaborative Human Tissue Network (CHTN) (UM1) |
Activity Code |
UM1 Multi-component Research Project Cooperative Agreements |
Announcement Type |
Reissue of RFA-CA-08-503 |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
RFA-CA-13-007 |
Companion Funding Opportunity |
None |
Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed. See Section III. 3. Additional Information on Eligibility. |
|
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.394 |
Funding Opportunity Purpose |
The purpose of this Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), is to support the Collaborative (currently "Cooperative") Human Tissue Network (CHTN). The goal for CHTN is to collect and distribute high quality human tissue specimens to facilitate basic and early translational cancer research. The CHTN is designed as a unique biospecimen resource in that it is based on prospective collection and distribution of samples upon specific investigators requests. Samples to be collected from patients include pre-cancerous, cancerous, and benign neoplastic tissues, as well as specimens corresponding to non-neoplastic diseases and uninvolved tissues. This FOA solicits applications for CHTN awards from institutions/teams capable of contributing to the mission of CHTN by: (1) providing prospective investigator-defined procurement of high-quality malignant, benign, diseased, and uninvolved (normal adjacent) tissues and fluids from patients throughout North America and elsewhere; (2) assisting individual investigators with regard to specific specimen needs of their research; (3) assisting in developing and disseminating knowledge on high quality practices for successfully operating a biospecimen repository; and (4) educating the community about the importance of the availability of high quality human tissue specimens for medical research. Depending on their profile and capabilities, applicants must indicate whether they propose to function as the CHTN adult biospecimen division or the pediatric specimen division. Nonetheless, it will be acceptable for an adult biospecimen division, if capable, to contribute pediatric samples for networked requests. This FOA is open to all qualified applicants irrespective of their previous association with the CHTN. |
Posted Date |
February 21, 2013 |
Letter of Intent Due Date(s) |
April 30, 2013 |
Application Due Date(s) |
May 31, 2013 |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
October-November 2013 |
Advisory Council Review |
January 2014 |
Earliest Start Date |
April 2014 |
Expiration Date |
June 1, 2013 |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the PHS 398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.
Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The Cancer Diagnosis Program of the National Cancer Institute (NCI) invites applications for cooperative agreement awards for the NCI-supported Collaborative (currently "Cooperative") Human Tissue Network (CHTN, http://www.chtn.nci.nih.gov/).
All individual CHTN awardees (referred to as CHTN Divisions ) collectively will form the CHTN as a national resource network.
The purpose of the CHTN resource is to collect and distribute high quality benign, pre-cancerous, and cancerous, as well as normal human tissue specimens, for basic and early translational studies in order to accelerate the advancement of discoveries in cancer diagnosis and treatment. In addition, research on basic biological mechanisms and on other types of human diseases has been supported. The Network was established to facilitate research by providing human tissue specimens to the scientific community. Since its establishment by the NCI in 1987, the CHTN has provided more than 950,000 tissue specimens from a wide variety of human tissues/organs to over three thousand investigators. The objective of this Funding Opportunity Announcement (FOA) is to continue the support for CHTN to ensure that biospecimens critical to progress in cancer research are available to the scientific community.
Presently, the organizational structure of the Network comprises six Divisions (i.e., six individual CHTN awardees), that include five adult biospecimen Divisions and one pediatric biospecimen Division. The continuation of CHTN will maintain these two types of Divisions.
Applicants are expected and encouraged to apply for that type of CHTN Division that matches their capabilities. However, applicants proposing to predominantly procure adult specimens can also contribute pediatric samples for networked requests.
Note: It is expected that some institutions that have already been part of the CHTN program will apply again for CHTN membership. However, prior association with this program is NOT required. All institutions with appropriate capabilities are encouraged to apply for these awards. Irrespective of prior participation in the program, all applications submitted in response to this FOA will be considered "new" applications.
The CHTN was established to address the increasing demand by the scientific community for access to high quality human tissue specimens (biospecimens) for cancer research. Often, researchers are unable to establish the necessary clinical collaborations for access to the biospecimens they need. This network of tissue collection laboratories was established to make high quality human specimens available to the general scientific community for basic and early translational cancer research.
The CHTN currently consists of a network of six institutions, each of which is referred to as a CHTN Division." The Network provides prospective investigator-defined procurement of pre-cancerous, cancerous, benign neoplastic, non-neoplastic samples, as well as uninvolved tissues and fluids to researchers throughout North America and elsewhere. Samples are annotated with patient demographics including gender, age, and race. The pathology report is included. The Divisional PDs/PIs should be actively involved in the practice of anatomic pathology, provide quality control assessments of each sample, and be responsible for proper histopathological characterization.
The CHTN provides tissues for investigators using several methods of specimen preparation including snap frozen, fresh, formalin-fixed paraffin embedded (FFPE) and/or stained and unstained slides. The CHTN also produces tissue microarrays (TMAs) representing multiple tissue types. The CHTN also provides macro-dissection and nucleic acid isolation services. The CHTN does not generally serve as a tissue bank, but it does store limited numbers of specialized tumor types, such as rare pediatric and adult tumors (gliomas, sarcomas, etc.), to ensure their availability in the future.
Currently, five Divisions of the CHTN provide specimens from adults and each is assigned a geographic area of the United States (U.S.) from which researchers' requests are received. A sixth Division, the Pediatric Division, receives requests for pediatric specimens from across the U.S.. In order to serve investigators as rapidly as possible, biospecimen requests that cannot be filled within a few weeks by the assigned division are "networked" to all Divisions.
Systems have been developed to facilitate efficient communication among Divisions and to share investigators' requests and determine biospecimen availability. The CHTN Informatics System (IT) has two components:
Since 1987, the CHTN has become a vital resource for the research community. The CHTN continues to have a significant scientific impact at several levels: more than 40,000 specimens are provided per year. Since its inception, the CHTN has distributed over 950,000 specimens. Currently, the CHTN serves over 400 individual researchers per year, supporting multiple requests and projects for many of them. The majority of CHTN users are government funded grantees, most of whom have R01 grants. About 20% of CHTN users are scientists affiliated with the biomedical industry.
The continuation of the Network is expected to facilitate basic cancer research discovery, early translation, as well as the development and application of new technologies to clinical specimens.
This FOA requests applications for cooperative agreements for the CHTN either for "Adult Biospecimen Division" or "Pediatric Biospecimen Division." Regardless of which type of Division is proposed, all applicants responding to this FOA must have appropriate capabilities to serve the CHTN objectives outlined below.
The major focus of the entire Network is to collect and distribute high quality human biospecimens for basic "discovery" research and early translational research. The prospective collection model fills a unique niche for the research community and covers a wide range of specimens needed for research. Users of CHTN come from all sectors of the research community, including academic and non-academic institutions such as Industry and Government Agencies, as well as NCI-funded initiatives.
The NCI will fund up to six awards (i.e., six CHTN Divisions). CHTN awardees will be part of a network to prospectively collect and distribute high quality tissue specimens to investigators throughout North America and elsewhere. The Network will provide large numbers of tumor specimens from a wide variety of cancers and it will also provide researchers with access to biospecimens of rare tumor types. Pre-cancerous, cancerous, benign neoplastic, non-neoplastic diseases as well as univolved tissues will be collected and prepared to meet researcher requests. Tissues and fluids will be procured. Biopecimens will be excess materials collected during the course of routine medical care or at autopsy.
Even though applicants proposing an Adult Biospecimen Division must be predominantly focused on procuring adult specimens, they may also contribute pediatric samples for networked requests, if they have (or expect having) access to such biospecimens
The Network is not intended generally to function as a tumor bank, but it may store biopecimens pending the completion of shipments and may bank rare tumors that would not otherwise be available (e.g., gliomas, sarcomas, pediatric tumors, etc.). Biospecimens corresponding to pre-malignant lesions, when available, can also be stored for future distribution. The Network is intended to provide biospecimens for basic discovery research and early translational studies. Therefore, data routinely provided with the biospecimens will generally be limited to histopathologic and demographic information, such as that related to diagnosis, sex, age, race, and pathology report.
Main Required Capabilities/Attributes
All applicants must be able to meet specific requirements for the key capabilities and essential attributes of the infrastructure listed below.
All the applicants must have the following capabilities in place (by the time of award start):
Leadership appropriate to ensure meeting the goals of the CHTN, including the availability of suitable biospecimens for patient diagnosis and quality control of research specimens. Therefore, the PD/PI of each proposed Division must be a board-certified surgical or anatomical pathologist, actively involved in the operation of a pathology laboratory that has demonstrated access to human tissues.
Ability to collect matched blood/tumor or other matched normal tissue/tumor specimens.
Ability to procure a wide range of samples, including: a) various tumor types, such as common cancers (lung, breast, ovary, colon, prostate, etc.); b) less frequent tumors (central nervous system, soft tissue sarcomas, head and neck tumors, endocrine tumors, etc.); c) normal, pre-malignant, malignant or matched uninvolved tissue samples; d) matched blood/normal or tumor samples; e) fluids such as plasma, serum, sputum, urine, etc.; f) nucleic acid extractions; g) specific samples that are difficult to procure for research purposes, such as bone marrow (normal, diseased), melanoma, others.
Each Division is expected to collect samples from their local Institution(s); arrangements may include forming consortium with appropriate satellite sites (hospitals) that would contribute to the procurement of a wide range of samples (including the types indicated above).
The ability to fulfill highly customized requests such as: a) fresh tissues prepared in requestor-specified media, including standard and customized media, requestor-defined use (or no use) of antibiotics etc.; b) touch preparations (slides); c) fluids processed at -20 C, -80 C, ambient temperature, ice pack, liquid Nitrogen/Vapor Phase, etc.
Appropriate informatics technology (IT) systems. Each applicant institution has to have an operating IT system that handles and tracks the following local data: availability of biospecimens, donor consent, HIPAA authorization, donor code, site where biospecimen was collected, donor demographics, biospecimen diagnosis (organ, diagnosis, modifiers of diagnosis), other biospecimen information such as amount, processing (e.g. paraffin block, frozen, etc), pathology report information, biospecimen quality control information, collection and processing times, storage sites for each biospecimen.
Reliable Quality Management System for collecting, processing, storing, and shipping tissue and fluid biospecimens. All collection sites/Laboratories should be College of American Pathology (CAP) accredited. CAP accreditation for the biorepository/biobank is not mandatory.
In addition to the required aspects, the following (optional but strongly encouraged) capabilities would be viewed as advantageous:
General Expectations for the Network
Given the diverse and variable needs of basic discovery and early translational research, it is expected that the proportion of highly customized and/or non-standard requests will increase. Therefore, it is necessary to maximize the networking efficiency and capability of the CHTN.
Although separate awards will be made for each CHTN Division, awardees will be required to work collaboratively with other CHTN Divisions. Requests for biospecimens will be networked by Divisions so that they can be fulfilled more rapidly.
Members of the Network (i.e., CHTN Divisions) will be expected to collaboratively establish and implement appropriate procedures to collect, process, and handle biospecimens to assure that they are of high quality and suitable for a wide variety of studies and technologies.
Individual Divisions will be expected to provide some additional services matching their unique capabilities (such as special types of biospecimen processing, which may include DNA/RNA preparations, tissue microarrays, or macrodissections).
Each Institution may have their own Informatics module system for biospecimen collection, but would need to use a common Informatics system for tracking the CHTN applications, requests, and distribution of specimens, as well as reports to NCI.
General operating policies for the Network will be established by a Coordinating Committee. This committee will consist of the PD/PI, a second representative from each participating institution (the coordinator) and a representative from the NCI (i.e., the Program Official serving as Project Scientist). The Coordinating Committee will establish standards for quality control, define equitable policies for distributing specimens, set processing and handling fees, develop biohazard procedures, and establish policies to address the legal, ethical, and human subjects issues related to the use of human specimens for research according to the NCI guidelines (http://biospecimens.cancer.gov/practices/ ) and recommendations by International Society for Biological and Environmental Repositories (ISBER, http://www.isber.org/bp/) .
The Network will be expected to remain responsive to changes in the science. The Coordinating Committee will establish mechanisms to assess the changing specimen needs of the scientific community and make operational changes or modifications of CHTN services as needed to rapidly respond to those needs. The Network must meet the requirements of the Federal Human Subjects Regulations 45CFR46 (i.e., the Common Rule; http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html ). Federal requirements to protect human subjects apply to a much broader range of research than many investigators realize, including research that uses biospecimens (e.g., cells, blood, urine, and saliva), residual diagnostic biospecimens, and medical information. Information on Office for Human Research Protections (OHRP) Policy on Coded Specimens and Data can be found at http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf. The Network will be expected to address the evolving legal, ethical, and human subjects policy issues related to the use of human biospecimens for research purposes. These issues are addressed in the NCI Best Practice Guidelines for Biospecimen Resources (http://biospecimens.cancer.gov/practices/ ) and the OHRP website (http://www.hhs.gov/ohrp/). Samples are generally de-identified, however informed consent beyond that provided in the surgical consent form is desirable for research use of identifiable specimens collected during routine medical care. CHTN awardees will be expected to provide appropriate guidance to users applying to the CHTN for samples regarding tissue collection, processing, and storing.
Funding Instrument |
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH staff will assist, guide, coordinate, or participate in project activities. |
Application Types Allowed |
New The OER Glossary and the PHS 398 Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
NIH intends to fund up to six awards, corresponding to a total of $5.8 million in total costs for fiscal year 2014. Future year amounts will depend on annual appropriations. |
Award Budget |
Application budgets must reflect actual needs of the proposed activities. Budget requests must not exceed $1.2 M in total costs per year. However, it is expected that various applications will have smaller budget requests commensurate with the proposed scope of activities. |
Award Project Period |
All applicants must request a project period of 5 years. |
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
Governments
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in
the NIH Grants Policy Statement, are not allowed.
Applicant organizations must complete the following registrations as described in the PHS 398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
This FOA does not allow for multiple PDs/PIs; only a single PD/PI may be designated on the application. In addition, the PD/PI of each participating group must be a board-certified anatomical and/or surgical pathologist, who is actively involved in the operation of a pathology laboratory that has demonstrated access to human cancer tissues.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.
It is critical that applicants follow the instructions in the PHS 398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Rodrigo Chuaqui, MD
Program Director
Cancer Diagnosis Program
Division of Cancer Treatment and Diagnosis (DCTD)
National Cancer Institute, Shady Grove Campus
9609 Medical Center Drive, Rockville, MD 20850-9730
Room: 4W450
Phone: 240-276-5910
FAX: 240-276-7889
Email: [email protected]
Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:
Referral Officer
Division of Extramural Activities
National Cancer Institute
9609 Medical Center Drive, Room 7W412
Bethesda, Maryland 20892-9750 (for Express mail, use Rockville, MD 20850)
Telephone: 240-276-6390
Fax: 240-276-7682
E-mail: [email protected]
In addition to the items mentioned above, applicants may also include in this submission to the NCI a file (in bookmarked pdf format) of the entire application. The file should be verified by the instutional official that it is a true copy of the application,
All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed with the following exceptions or additional requirements for the Research Strategy subsections listed below:
A. Overview of Biobanking Background and Organizational Structure (12 pages)
B. Leadership Structure and Interactions (6 pages)
C. CHTN Operations and Quality Management System (QMS) (12 pages)
D. Data Management and Informatics (6 pages)
E: Human Biospecimen-related Legal and Ethical Unit (6 pages)
F: CHTN Shared Services (6 pages)
The following sections supplement the instructions found in the PHS 398 Application Guide.
The application should be assembled and paginated as one complete document in the following order:
Face Page
Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells
Detailed Budget for Initial Budget Period
Budget for Entire Proposed Period of Support
Budgets Pertaining to Consortium/Contractual Arrangements
Biographical Sketches
Resources
Research Plan
Specific Aims
Research Strategy with the following sub-sections:
A. Overview of Biobanking Background and Organizational Structure
B. Leadership Structure and Interactions
C. CHTN Operations and Quality Management System (QMS)
D. Data Management and Informatics
E: Human Biospecimen-related Legal and Ethical Unit
F: CHTN Shared Services
Bibliography and References Cited
Protection of Human Subjects
Inclusion of Women and Minorities
Targeted/Planned Enrollment Table
Inclusion of Children
Vertebrate Animals
Select Agent Research
Multiple PD/PI Leadership Plan
Consortium/Contractual Arrangements
Letters of Support (e.g., Consultants)
Resource Sharing Plan
Appendix
All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions for the application parts listed below.
Modify Form Page 3 of the PHS 398 to replace standard sub-sections of "Research Strategy" with the following new sub-sections:
A. Overview of Biobanking Background and Organizational Structure
B. Leadership Structure and Interactions
C. CHTN Operations and Quality Management System (QMS)
D. Data Management and Informatics
E: Human Biospecimen-related Legal and Ethical Unit
F: CHTN Shared Services
Follow the current PHS 398 instructions to provide a detailed budget (direct costs) for the entire application for the first 12-month period (Form page 4) and the entire proposed project period (Form page 5). Use Additional Form Pages 4 and 5 to provide detailed separate budget information (first year and cumulative budgets for the entire project period) for the following individual application components:
Additional Budgetary Requirements
1) Travel Funds. Funds for travel of two people to attend each of the two Coordinating Committee meetings per year should be included as a budget line item. Travel to national meetings to take part in exhibits to publicize the CHTN should also be included. Travel for other purposes may be proposed with appropriate justification. Justified situation includes, but is not limited to, travel for Coordinating Committee subcommittee meetings and/or other appropriate meeting travel.
2) CHTN Shared Services. Budget items may be proposed, with appropriate justification, for expenses to be shared by all network members. These expenses include, but are not limited to, shared costs for administrative activities, database development/maintenance, publication and impact analysis, and maintenance and marketing activities. A detailed budget justification should be provided for each shared budget item requested. The final decision on the structure/details of these shared resources will be made by the CHTN Central Committee after the awards are made.
3) CHTN Data Management and Informatics and Other Budget Items. Budget items in support of the CHTN informatics activities may be proposed with appropriate justification, for expenses by the individual division. Budgets may include, but are not limited to, expenses associated with computer hardware, software, development, Quality Management Systems, and support that are needed at each site.
Budgets for individual ACSR Proposed Regional Biospecimen Repositories must be provided as individual subcontractual budget pages following the PHS 398 instructions.
In addition to standard content of this section, applicants are encouraged to include appropriate detailed summary tables, lists, and other relevant detailed information documenting their capabilities and accomplishments in biospecimen collection. This may include, among others, data relative to number of samples that are collected in the biorepository over a given period, number of patients from whom samples are collected, samples by disease (normal, benign, malignant, normal matched with tumor), by preparation (frozen tissue vs. FFPE), by organ, tumor types the repository has access to, types of samples (tissue, fluids, other), etc. Information documenting informatics capabilities, as well as SOPs in place for tissue acquisition, various processing/preservation methods and storage, as well as Human Subjects documents such as IRB approval and informed consent documents can also be included. These additional materials are expected not to exceed 20 pages.
All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:
Research Strategy: Standard Sections of the PHS 398 Research Strategy are replaced by the following new Sections A-F (specified below).
A. Overview
In this sub-section, applicants must identify the type of CHTN Division proposed (i.e., Adult Biospecimen Division or Pediatric Biospecimen Division). Applicants should summarize their capabilities and experience related to biospecimen procurement in the division type chosen.
All Applicants must include a list of tumor types and other biospecimens that the applying Institution and its collaborators can provide to the network.
All applicants: Describe the organizational structure and network capability of applying institutions including the following elements:
B. Leadership Plan and Personnel Responsibilities and Interactions
Avoiding repetition with the form pages, describe succinctly the qualifications and responsibilities of the PD/PI and other individuals listed as Key Personnel. This description should emphasize:
In this section, the applicants should also state their willingness to collaborate with the other CHTN awardees as outlined in this FOA and to adhere to the Terms and Conditions of the Cooperative Agreements as defined in Section VI.2 of this FOA.
C. Standard Operating Procedures (SOPs) and Quality Management System (QMS)
Describe SOPs for biospecimens procurement and handling in your Institution and the efforts to ensure the adherence to the NCI Best Practices for Biospecimen Resources (http://biospecimens.cancer.gov/bestpractices/2011-NCIBestPractices.pdf). Describe the procedures for collecting, processing, and distributing specimens (provide an overview, not entire SOPs). In particular, address the following aspects:
D. Data Management and Informatics
Each applicant institution has to have an operating IT system that handles the following local data: availability of biospecimens, donor consent / HIPAA authorization, donor code, site where biospecimen was collected, donor demographics, biospecimen diagnosis (organ, diagnosis, modifiers of diagnosis), other biospecimen information such as amount, processing (e.g., FFPE, frozen, etc.), pathology report information, biospecimen quality control information, collection and processing times, storage sites for each biospecimen.
Each applicant institution has to propose an IT system that can handle networked data regarding information about investigators and their requests. The system should be able to track the following information in a given period:
In addition, indicate whether the informatics system can provide updates on the status of fulfillment for active requests, as well as the time to fulfill each request.
Describe how the system can be potentially used as a common informatics system to manage the resource, monitor the progress, and develop the strategies to ensure that the resource remains responsive to researchers needs. Describe a plan to integrate the institutions informatics system into a Network IT system.
The informatics system should follow conventions that would allow it to be integrated with local (e.g. hospital Electronic Medical Records) and national (e.g., National Cancer Database) systems for the purposes of providing electronic annotation.
The Informatics system should also use a minimal set of standard data elements with controlled vocabularies. The approach should be based on and extended from existing biospecimen data models registered in the NCI Data Standards Repository (caDSR).
Adoption of a common IT system and/or changes to a common system is a prerogative of the CHTN Central Committee.
E. Human Biospecimen-related Legal and Ethical Unit
In this section, address the institutional legal, ethical, and human subjects policy issues related to the use of biospecimens for research. These must be in accordance with the policies and procedures that govern the collection and distribution of specimens by the CHTN. These include: Protection of Human Subjects (for specific information, go to http://www.chtn.nci.nih.gov/human-subjects/), IRB Policy (http://www.chtn.nci.nih.gov/irb/), HIPAA Compliance policy (http://www.chtn.nci.nih.gov/hipaa/), and Transferring Biospecimens to a Third Party (http://www.chtn.nci.nih.gov/third-parties/). Specifically, it must include a proposal for obtaining consent for future research use of tissue and a plan to sever the link between the specimens to be provided to the researcher and the identities of the patients. Occasionally, CHTN users request samples with attached clinical information. Even though this is not a major aim of the CHTN, it will be advantageous for the applicants' Institution to have informed consent in place for performing retrospective chart reviews in these cases.
Applications submitted in response to this FOA must include plans to obtain consent for future research use of specimens collected during the proposed project period or to sever any link between the specimen to be distributed to the researcher and the identity of the patient.
In addition, describe the involvement of patient advocates with the applicant CHTN Division. Explain how their activities will contribute to increasing the public’s awareness and understanding of the importance of biospecimens for cancer research as well as of the CHTN itself.
F. CHTN Shared Services
Describe in detail the purpose of each of the following services and the duties of the persons in charge:
Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modification:
In addition, data sharing plans are expected to be consistent with the following provisions:
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide. with the following modifications:
Part I. Overview Information contains information about Key Dates.
Information on the process of receipt and determining if
your application is considered on-time is described in detail in the PHS 398
Application Guide.
Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH
Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH
Grants Policy Statement.
Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by the NCI. Applications that are incomplete and/or nonresponsive will not be reviewed.
The NCI will hold a pre-application teleconference, which is tentatively planned for April 2013. All prospective applicants are encouraged to participate in this teleconference. For a specific date/time and further details, please visit the website of the NCI Cancer Diagnosis Program at http://www.cancerdiagnosis.nci.nih.gov/fundingOpportunities/default.htm.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.
For this particular announcement, note the following:
The emphasis of this FOA is on optimizing prospective collection and distribution of human cancer and other relevant biospecimens in response to specific investigators requests. For the optimal functioning of CHTN as a unique resource, it is essential that its components (i.e., Divisions ) have access to sufficiently large numbers of diverse tumor and normal samples. Also essential is the ability to meet highly individualized and changing requests from cancer researchers. Moreover, the proposed Divisions must have capabilities to ensure rigorous approaches to sample procurement, processing, handling, and documenting.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the proposed CHTN Division to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the resource proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a proposed CHTN Division that by its nature is not innovative may be essential to advance a field.
Significance
Does the proposed CHTN Division address an important problem or a critical barrier to progress in the field? If the aims of the proposed CHTN Division are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Specific for this CHTN FOA:
How will the CHTN Division, as proposed by the applicant, help fulfill the needs of the cancer research community? What is the likelihood for the proposed CHTN Division will significantly facilitate cancer research and/or inspire new projects/directions of high significance for the field? What is the potential of the proposed CHTN Division to contribute significantly to the goals of the CHTN as a national resource in cancer research and bring special capabilities?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the proposed CHTN Division? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the resource?
Specific for this CHTN FOA:
How strong are the credentials and experience of the PD/PI and key personnel of the applicant group regarding sample procurement and preparation of specimens?
Are the qualifications, experience, and proposed responsibilities of the PD/PI and other key personnel well suited to organize and maintain the CHTN Division, maintain quality control and equitable access, and manage record keeping?
How sufficient are the proposed efforts of the PD/PI and key personnel to ensure: (i) proper oversight of all operations and management; (ii) integration with the other participating groups; and (iii) a high quality of biospecimens?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Specific for this CHTN FOA:
To what degree are the proposed biobanking procurement and shipping methods creative and/or improved? Are the proposed approaches more efficient and/or effective than current practices of the CHTN or similar resources regarding collection of high quality specimens, obtaining informed consent from human subjects and maintaining confidentiality, sharing specimen requests, improving informatics systems to support resources or marketing techniques or strategies to utilize the resource?
How innovative are the attempts proposed to involve patient advocates in formulating the goals and specific efforts of the applicant CHTN Division?
Approach
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the proposed CHTN Division? Are potential problems, alternative strategies, and benchmarks for
success presented? If the project is in the early stages of development, will
the strategy establish feasibility and will particularly risky aspects be
managed?
If the proposed CHTN Division involves clinical research, are the plans for 1)
protection of human subjects from research risks, and 2) inclusion of
minorities and members of both sexes/genders, as well as the inclusion of
children, justified in terms of the scientific goals and research strategy
proposed?
Specific for this CHTN FOA:
How meritorious are the proposed plans for the collection and distribution of specimens? Are these plans realistic and properly addressing the overall goals of the Network?
Are there appropriate plans to assure the collection of high quality specimens with associated demographic and histopathologic data?
Are the plans sufficient to assure collection of rare specimens (e.g., gliomas, sarcomas, pediatric tumors, etc.) which might otherwise not be available?
How strong are the capabilities of the proposed CHTN Division in terms of collecting biospecimens of major tumor types, as well as matched blood and tumor specimens? Will the proposed Division have collections of retrospective material, both FFPE and frozen that could supplement/complement requests in the future, especially for more difficult-to-obtain samples?
How good are the plans proposed to improve quality control of specimens and/or services?
Are the proposed procedures for the protection of human subjects and patient confidentiality appropriate?
How reasonable and equitable are the proposed procedures for the evaluation of requests for specimens and other services?
Are the plans for cooperation and coordination with other participating CHTN awardees (i.e., other CHTN Divisions) and the NCI well described and are they likely to be effective?
What are the quality and adequacy of the applicant's informatics system as pertaining to this type of resource? Are the tracking capabilities of the IT system adequate and consistent with the CHTN goals? In addition to investigators and specimens, can other metrics be tracked, such as: grants/projects, cases (patient donors), tumor numbers, tumors by organ, histology type, grade, etc? Is the current and proposed IT plan properly and sufficiently addressing the issue of maximizing consistency and compatibility of this project with other NCI IT activities?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Specific for this CHTN FOA:
How advantageous is the applicants' environment in terms of arrangements (consortia) with satellite sites (hospitals) to facilitate the procurement of a wide range of samples, including tumor, matched uninvolved tissue, and normal samples?
How adequate are the facilities and equipment in the proposed Division for prospective tissue procurement, as well as retrospective collections of FFPE and frozen material and fluids?
How adequate and supportive is the environment to facilitate collegial interactions within the applicant’s Division and collaborations with other Divisions?
As applicable for the CHTN Division proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed resource involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Not Applicable
Renewals
Not Applicable
Revisions
Not Applicable
As applicable for the CHTN Division proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Not Applicable
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NCI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to the DUNS, SAM
Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
The administrative and funding instrument used for this program will be the cooperative agreement (U24), a resource-related agreement to improve biomedical research. In a cooperative mechanism, substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
Throughout these Terms and Conditions of Award, Collaborative Human Tissue Network (CHTN or Network ) refers to all individual CHTN awardees forming together the CHTN resource. The Network and its Divisions (i.e., each individual CHTN awardee) comprise the organizational structure that is composed of the awardee institution(s), principal investigators and other key personnel, all of whom agree to collaborate on research goals of the CHTN resource.
The PD(s)/PI(s) will have the primary responsibility for:
Awardees must agree that each awarded CHTN Division and the entire Network will be subject to continued evaluation by the NCI of the overall performance and adequacy of the financial and scientific aspects of the resource. This evaluation will include (but not be limited to) human subject issues, procurement and distribution, quality assurance and quality control, informatics system(s), and involvement of patient advocates.
Awardees must agree to provide biospecimens to the scientific community without requiring any collaborative arrangements. The costs of processing and handling, shipping and other appropriate costs may be charged to researchers, in accordance with policies established by the Coordinating Committee and consistent with NIH regulations.
PDs/PIs of individual CHTN Divisions will be expected to propose’s to the CHTN Coordinating Committee pilot projects addressing issues relevant to the Network. These can include data and safety monitoring, customer management systems or others. Approval of these projects will be a prerogative of the CHTN Coordinating Committee.
Individual awardees (and the entire CHTN Network) will be expected to use an Informatics systems that maximizes consistency and compatibility with other NCI IT activities and initiatives that follow CBIIT hardware and security requirements (hardware, hosting, IT security, IT compliance and disaster recovery.)
NIH
staff have substantial programmatic involvement that is above and beyond the
normal stewardship role in awards, as described below:
The NCI will have substantial programmatic involvement that is above and beyond
the normal stewardship role in awards, as described below.
The Cancer Diagnosis Program of the NCI’s Division of Cancer Treatment and Diagnosis will designate an NCI Program Director to serve as a Project Scientist. The role of the Project Scientist will be to advise, assist and facilitate, but not to direct the activities of the Network. Specifically, the CHTN Project Scientist will:
The NCI Project Scientist will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications. If such participation is deemed essential, these individuals will seek NCI waiver according to the NCI procedures for management of conflict of interest.
Additionally, an NCI Program Official will be responsible for the normal scientific and programmatic stewardship of the award. The NCI Project Scientist and the NCI Program Official may be the same person. In that case, Program Official/Project Scientist will seek NCI waiver according to the NCI procedures for management of conflict of interest to enable her/him to attend peer review meetings of renewal (competing continuation) and/or supplemental applications when necessary.
Areas of Joint Responsibility include:
CHTN Coordinating Committee. To oversee and coordinate the operations of the Network, awardees and involved NCI staff members will jointly establish the CHTN Coordinating Committee. The Coordinating Committee will act as the governing body of the CHTN. All CHTN awardees/participants will be bound by the decisions/actions of the Coordinating Committee.
Coordinating Committee Membership. The Coordinating Committee will consist of two members from each Division (one of whom must be the PD/PI) and one member representing the NCI (a Program Director, who will serve as the Project Scientist). Voting rights are restricted to the PDs/PIs on individual CHTN awards (or their designees, if necessary, i.e., one vote per each awardee) and one vote for the NCI represented by Project Scientist. The chairperson (who may not be an NCI employee and/or representative) and Executive Coordinator of the Coordinating Committee are elected by a majority vote of its members and serve for one calendar year. Additional members (without voting rights) may be added to the committee by majority vote of the existing committee members.
Coordinating Committee Responsibilities.
The Coordinating Committee shall:
The Coordinating Committee will meet initially to plan for integration of the awarded CHTN Divisions and to review and accept or modify currently established operating procedures and policies. The Coordinating Committee will meet at least twice a year.
Subcommittees. Membership on subcommittees is not limited to voting members of the Coordinating Committee. The NCI Project Scientist will be a voting member and participant in each subcommittee. The chairperson of each subcommittee (who may not be the NCI representative) will be elected by a majority vote of the Coordinating Committee. Voting Membership on subcommittees is not limited to members of the Coordinating Committee. However, only voting members of the Coordinating Committees will have voting rights, except on the following subcommittees: strategic planning, quality control, and regulatory affairs. Other subcommittees may grant voting rights also to individuals other than voting members of the Coordinating Committee, where the voting member must be the awarded PD/PI. The Marketing (Operations) subcommittee includes (but is not limited to) the coordinators from each of the cooperating CHTN each of the cooperative institutions, who also serve as the voting members.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]
eRA Commons Help Desk (Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]
Rodrigo Chuaqui, M.D.
Program Director
Cancer Diagnosis Program
Division of Cancer Treatment and Diagnosis (DCTD)
National Cancer Institute, Shady Grove Campus
9609 Medical Center Drive, Rockville, MD 20850-9730
Room: 4W450
Phone: 240-276-5910
FAX: 240-276-7889
Email:[email protected]
Referral Officer
Division of Extramural Activities
National Cancer Institute
9609 Medical Center Drive, Room 7W412
Bethesda, Maryland 20892-9750 (for Express mail, use Rockville, MD 20850)
Telephone: 240-276-6390
Fax: 240-276-7682
E-mail: [email protected]
Ms. Lan Nguyen
Office of Grants Administration
National Cancer Institute, NIH
8490 Progress Drive, Suite 4078
Frederick, MD 21701
Phone: (301) 631-3006
Fax: (301) 631-3030
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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