EXPIRED
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human
Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
HIV/AIDS Clinical Trials Networks Statistical and Data Management Centers (UM1 Clinical Trial Required)
UM1 Research Project with Complex Structure Cooperative Agreement
Reissue of RFA-AI-12-001; RFA-AI-12-004; RFA-AI-12-011; RFA-AI-12-012
RFA-AI-19-002
RFA-AI-19-045, HIV/AIDS Clinical Trials Units (UM1 Clinical Trial Required)
RFA-AI-19-001; HIV/AIDS Clinical Trials Networks Laboratory Centers (UM1 Clinical Trial Required)
RFA-AI-19-003; HIV/AIDS Adult Therapeutics Clinical Trials Network Leadership and Operations Center (UM1 Clinical Trial Required)
RFA-AI-19-004; HIV/AIDS Maternal, Adolescent and Pediatric Therapeutics Clinical Trials Network Leadership and Operations Center (UM1 Clinical Trial Required)
RFA-AI-19-005; HIV Prevention Clinical Trials Network Leadership and Operations Center (UM1 Clinical Trial Required)
RFA-AI-19-006; HIV Vaccines Clinical Trials Network Leadership and Operations Center (UM1 Clinical Trial Required)
93.855; 93.865; 93.279; 93.121; 93.242; 93.853
The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications for HIV/AIDS Clinical Trials Networks Statistical and Data Management Centers (SDMCs). The SDMCs will be responsible for the statistical and data management leadership and coordination critical to the NIAID HIV/AIDS Clinical Trials Networks.
January 24, 2019
July 1, 2019
30 days prior to the application due date
Only accepting applications for the AIDS application Due Date listed below.
August 1, 2019, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on this date.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
March 2020
October 2020
December 2020
August 2, 2019
Not Applicable
It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) 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. 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.
Part
1. Overview Information
Part 2. Full Text of the
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 purpose of this Funding Opportunity Announcement (FOA) is to solicit applications for Statistical and Data Management Centers (SDMCs) for the HIV/AIDS Clinical Trials Networks. The SDMCs will be responsible for the statistical and data management leadership and coordination critical to the NIAID HIV/AIDS Clinical Trials Networks.
The National Institute of Allergy and Infectious Diseases (NIAID) and its IC partners currently support five HIV/AIDS clinical trials networks: the AIDS Clinical Trials Group (ACTG), the HIV Prevention Trials Network (HPTN), the HIV Vaccine Trials Network (HVTN), the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT), and the Microbicide Trials Network (MTN). NIAID is soliciting applications for FY21 award consideration for the following four HIV/AIDS Clinical Trials Networks: HIV Prevention Clinical Trials Network, HIV Vaccines Clinical Trials Network, HIV/AIDS Adult Therapeutics Clinical Trials Network, HIV/AIDS Maternal, Adolescent and Pediatric Therapeutics Clinical Trials Network.
Since the beginning of the HIV/AIDS pandemic, the National Institutes of Health (NIH) has advanced understanding of disease mechanisms and used basic science to create opportunities for the discovery, development, and clinical evaluation of novel prevention and treatment strategies. With this approach, the scientific community has created an array of effective tools to treat and prevent HIV infection. Over the last 35 years, these interventions have been made safer and more effective. However, according to the latest Joint United Nations Programme on HIV/AIDS (UNAIDS) Global summary of the AIDS epidemic, there are approximately 36.9 million people living with HIV, 25.7 million of whom are living in sub-Saharan Africa, with 1.8 million new infections per year across the world. Significant challenges remain in delivering treatments and methods of prevention to the people who need them most. Although rates of death due to HIV/AIDS and rates of new HIV infections are declining in many areas of the world, these declines vary by region and in many places are slower than anticipated in reaching 2020 goals. In many parts of the world with generalized HIV/AIDS epidemics, new HIV infections far outpace access to effective antiretroviral treatment (ART). Even in the U.S. and other industrialized nations, where the HIV epidemic continues unabated particularly in most at-risk populations, a large portion of individuals who meet treatment guidelines do not have access to ART.
The success of the NIAID HIV/AIDS Clinical Trials Networks rests on the foundation provided by the SDMCs; strong data management and statistical leadership and expertise, and robust, flexible data management systems that support a large number of clinical and laboratory studies undertaken in both resource-rich and resource-limited settings.
As a result of rapidly evolving information technology and regulatory requirements, clinical data management systems and regulatory agencies increasingly require electronic submissions of standardized data compliant with regulatory standards (e.g., 21 CFR Part 11) and international guidelines (e.g., ICH E6(R2)). The need for cost-effective clinical data management has driven the need for electronic data capture (EDC) and remote data capture (RDC) to facilitate high-quality data, ability to support remote monitoring, and to use electronic communication tools to query and resolve data issues. Finally, the ability to exchange and analyze multiple large complex data sets holds promise for learning more from existing and future clinical trials. In this context, the SDMCs adopted an industry-leading electronic clinical data management system using EDC that supports flexible data models for downstream reporting and manipulation of clinical trials data. The SDMCs develop and deploy global electronic case report form (eCRF) libraries to support Clinical Data Interchange Standards Consortium (CDISC) standards using EDC. This is a multipronged effort with specific focus on producing CDISC-compatible data sets from existing noncompatible databases. To support efficiency, the SDMCs and the clinical trials networks adopted beginning-to-end CDISC compatibility for new studies implemented in the clinical data management system. The SDMCs continue to participate in development of CDISC Standards for HIV providing subject matter expertise for specific data and analytic components.
The SDMCs have provided laboratory data management support for i) the network Laboratory Centers (LC) operations to accommodate millions of records consisting of assay results on primary and secondary protocol objectives, ii) a validated specimen management system, and iii) the development of pipelines for transfer of LC data from new assays for storage, analysis and reporting.
The SDMCs continue to play a central role in harmonizing statistical and data management activities across studies and clinical trials networks, both to allow cross-study data analyses and to maximize the efficiency with which studies can be developed and implemented.
The SDMCs have developed and refined practices and procedures to share data with other network awards, other NIAID HIV Clinical Research networks, and researchers outside the network structure.
The SDMCs provide the networks in-depth understanding of statistical and epidemiological theory, broad practical experience in the design and analysis of clinical trials, observational studies, and assay validation, standardization, and optimization. The SDMCs have also provided expertise for studies that contribute to knowledge of pathogenesis and of mechanisms of drug action, studies evaluating new diagnostic methods, as well as interventions for prevention or treatment, which may include studies in every phase of product development. Examples include refinement of i) study endpoints (for measuring safety, infection, viremia and disease progression), ii) clinical trial adaptive design sequential monitoring procedures, which optimize ethics, scientific integrity, resources and adaptivity, iii) statistical methods to assess durability of vaccine efficacy, iv) methods to compare vaccine efficacy and durability among different vaccine arms within a trial compared to one placebo group, post-infection vaccine effects, host genetics and risk behavior and adherence. The SDMCs have also played a pivotal role in the development and refinement of novel quantitative methods (such as integrating biostatistics, bioinformatics, and computational immunology) for assessing and developing immune correlates of protection against HIV-1 infection and post-infection endpoints for regimens showing efficacy, including immune response biomarker optimization, assessment of correlates of risk (CoRs) and correlates of protection (CoPs) and sieve analysis.
Finally, the SDMCs collaborate to address issues that span multiple networks, such as those related to Medical Dictionary for Regulatory Activities (MedDRA) coding in network studies; the FDA Electronic Data Capture guidance; and cross-network laboratory data activities and standardization. They have contributed to the trial issues related to adherence to treatments; and standardization of ascertainment of gender/transgender across networks.
NIAID is soliciting applications for FY21 award consideration for the following HIV/AIDS Clinical Trials Networks:
Research Priority Areas for each of the HIV/AIDS Clinical Trials Networks can be found on the NIAID website here.
NIAID plans to fund one SDMC award for each network. Each application in response to this FOA must address only the research priority areas of ONE HIV/AIDS Clinical Trials Network. Applications addressing the research priorities areas of more than one HIV/AIDS Clinical Trials Network will be considered non-responsive and will not be reviewed.
Each HIV/AIDS Clinical Trials Network is composed collectively of a Leadership and Operations Center (LOC), a Laboratory Center (LC), a Statistical and Data Management Center (SDMC) and affiliated Clinical Trials Units (CTUs) and Clinical Research Sites (CRSs). Each will be funded via an independently-solicited FOA and each will contribute specific essential functions necessary to support a large-scale, complex clinical research program. While the emphasis of each network is on clinical trials, clinical research studies that aren't NIH-defined clinical trials are also in scope when undertaken to support the program. For the purpose of this FOA, the term "clinical study" refers to both clinical trials and clinical research studies, and "clinical trial" is used to refer to clinical trials only.
The LOC will manage the network’s scientific priorities and the corresponding alignment of clinical studies with those priorities. The LOC has primary responsibility for the prioritization, selection and development of clinical protocols and project management of the full spectrum of activities needed to plan and conduct clinical trials including the coordination of efforts by the LC and SDMC, and clinical sites. The LOC has responsibility to assure that the research is conducted according to principles of Good Clinical Practice (GCP).
The LC will lead the development, implementation and evaluation of the laboratory activities that are required to carry out the network research agenda. The LC will ensure that there are relevant state-of-the-art expertise and technologies to provide clinically useful study data and enable sound product development decisions. The LC will oversee laboratory operations that allow for consistent and reproducible laboratory results that can support study reconstruction.
The SDMC will provide comprehensive data management and data analyses for network clinical studies in compliance with regulatory standards. The SDMC will provide leadership and services for biostatistics, study design, analysis, interpretation and publication of results, including innovative statistical methods, along with state-of-the-art clinical trial management systems and laboratory information management systems to ensure complete, high-quality data.
The CTUs will provide scientific and administrative expertise as well as the infrastructure to conduct clinical studies within the network. A CTU is composed of at least one, but no more than eight, Clinical Research Site(s) (CRSs) that can contribute to at least two HIV/AIDS Clinical Trials Networks.
Each Clinical Trials Network will have an Executive Management Committee (EMC) to coordinate the activities of the Network's LOC, LC and SDMC. The EMC will include the PDs/PIs from the LOC, LC and SDMC and will be chaired by the PDs/PIs from the LOC.
Additional Resources provided by NIAID:
The SDMC provides a framework for statistical and data management leadership, services, and systems that contribute to the development and implementation of its network's research agenda. A research agenda is a broad strategic plan to address the stated research priority areas of the network. The LOC, in collaboration with the LC and SDMC, articulates the network's scientific agenda, establishes a framework for the initial studies, and plans for future studies. The SDMC collaborates and coordinates with the LOC, LC and CTU/CRS to support the research priority areas of the network (as described in the companion FOAs) through development, implementation, and sharing the results of clinical studies. The SDMC provides leadership, services and systems for clinical and laboratory data collection and management required for complete, high-quality data, and leadership and services for biostatistical analysis, study design, analysis, interpretation and publication of results, including innovative statistical methods.
The SDMC is responsible for the integrity of study design and statistical analysis for all clinical studies. The SDMC is responsible for compliance with all applicable federal regulatory standards and international guidelines that apply to studies conducted under an Investigational New Drug or Device Exemption (IND/IDE). The SDMC has a central role in standardizing and harmonizing data management and statistical activities within the network and coordinating with other NIH-sponsored programs. Other SDMC responsibilities for governance include:
Data Collection and Management
The SDMC provides, maintains, supports and updates commercial off-the-shelf (COTS) clinical trial management systems that include electronic data capture (EDC) and are interoperable with the laboratory information management systems (LIMS). These systems provide data collection, exchange, storage, tracking and retrieval of clinical and laboratory data for the network including CTUs/CRSs and Protocol-Specific sites.
Both clinical trial management systems and laboratory information management systems must be 21CFR part 11 and ICH E6 compliant. DAIDS reserves the right to audit the vendors and their sub-contractors.
As needed, the SDMC interfaces, integrates or adapts its information system(s) to be interoperable with NIAID systems.
The SDMC supports collecting, storing and providing data in accordance with regulatory requirements as defined by FDA and ICH and collaborating with other DAIDS-affiliated SDMCs in the development of data elements that do not currently exist within CDISC.
The SDMC provides specific capabilities including:
The SDMC may establish procedures for alternative data capture (e.g., a system for off-line data entry when internet connection is not available) as described in NIAID DAIDS policies.
When Electronic Health Record (EHR) Systems are used the SDMC will ensure the interoperability of the EHR data and the EDC system and maintain a record of EHR systems used by each clinical research site and status of data sharing agreements.
The SDMC provides timely data access, statistical analysis and reports for:
Regulatory Compliance/Adherence to Regulations and Standards
Under the coordination of the LOC, the SDMC has primary responsibility for compliance with 21 CFR and ICH guidelines as they relate to clinical trial data management at the SDMC, LC and CTU/CRS and statistical aspects of study design.
The SDMC provides the necessary SOPs, personnel, data management, statistical, and communications expertise and systems, and follows U.S. regulations, Good Documentation Practice, Good Clinical Data Management Practices, and relevant international guidelines (ICHE6R2) to support network operations and meet NIAID requirements, to include:
The SDMC operates in compliance with:
Data Quality Management, Assurance, and Control
The purpose of Quality Management is to ensure protocol regulatory compliance, ensure human subjects protection and data integrity, and compliance with all applicable regulatory requirements. The SDMC will maintain a Quality Management Plan (QMP) including Quality Assurance and Quality Control processes and procedures for monitoring the accuracy, completeness and timeliness of the data entered into the SDMC clinical data system by CTU/CRS and PSS sites from study initiation/subject enrollment to database lock. The system needs to allow verification of study data and the following capabilities:
The SDMC will participate in independent quality audits initiated by NIAID DAIDS.
The SDMC works cooperatively with counterparts from other NIH-supported clinical trials networks to conduct collaborative research projects and provide capability for cross-protocol and cross-network data analysis through:
The SDMC provides validated data storage for studies conducted through the network and other datasets upon request by NIAID.
Data sharing is expected to increase the value of the significant public investment in the HIV/AIDS Clinical Trials Networks. NIH expects that datasets will be shared with the scientific community for research, while carefully observing standards of patient privacy, confidentiality, and management of health information. Information such as study protocols, descriptions, and publications are expected to be made available through open access public web sites, and publication in the scientific literature.
SDMCs are expected to prepare and transfer data to NIAID-approved controlled-access repositories when requested, as appropriate and consistent with achieving the goals of the program.
Clinical Site and Laboratory Training, Assessment and Technical Assistance
The SDMC serves as a network resource for CTU/CRS and protocol-specific sites for assessment, training and evaluation with respect to data collection and management. The SDMC:
Study Design, Data Analysis, Data Reporting
The SDMC provides leadership and expertise for protocol selection and development, informing experimental study designs, and providing statistical advice concerning issues such as approach, power, sample size, and impact of interim analyses. The biostatisticians support early-phase and late-phase, multi-institutional clinical trials including integral and integrated biomarker/correlative science studies. When needed, the SDMC develops new applications of statistical or information science theory.
External Interactions and Opportunities. The SDMC will be strongly encouraged to coordinate with other HIV/AIDS Clinical Trials Networks, their respective SDMCs and other NIH-supported networks and other Federal and private sector clinical research programs, and to interact with government, non-government and community organizations (including the private and non-profit sector), to maximize the impact of research efforts and effective use of resources. Opportunities for such synergy include development of clinical infrastructure in resource-limited settings and harmonization of common data elements and data entry interfaces.
The SDMC will need to coordinate with NIAID groups including but not limited to: the NIAID Strategic Working Group (SWG), DAIDS Office of Clinical Site Oversight (OCSO), the DAIDS Clinical Laboratory Oversight Team (DCLOT) and the Office of HIV/AIDS Network Coordination (HANC).
Funding to carry out the network's research agenda falls into two categories:
Core Funds. NIAID will provide core funds directly to the LOC, LC, SDMC and network-affiliated CTUs on an annual basis. Core funding is the initial fixed-base funding and provides infrastructure and salary support that is not protocol-specific. Examples include, but are not limited to:
Protocol Funds (PF). NIAID will provide PF to the LOC, LC and SDMC on an annual basis. In addition, NIAID anticipates providing PF directly to network-affiliated CTUs on an annual basis. PF provides support to conduct protocols, including protocol-specific infrastructure or other requirements needed to conduct protocols at a site. PF varies annually, depending on costs of ongoing protocols and will be awarded to cover expenses attributable to protocol development, implementation or close-out of a clinical trial. Protocol funds include, but are not limited to, the following protocol-specific expenses:
NIAID expects that equipment and services funded via Core or PF will be made available, as appropriate, for other NIAID-funded network activities regardless of how funds were initially provided to purchase those items.
Based on communications with the LC, SDMC and CTUs/CRSs, the LOC will estimate protocol funding needs for the network (salary and non-salary PF) annually and submit a budget request to NIAID. NIAID will then determine the amount of PF to be provided in the coming grant year. Adjustments in PF allocation will be made at regular intervals during each budget period, based on both performance and availability of funds.
Distribution of Protocol Funds to Network-Affiliated SDMCs
PF will be distributed to SDMCs directly from NIAID prior to enrollment of study participants following the process described above.
PF may also be provided to the LOC for its use and distribution to the SDMC to provide additional support for protocol-related expenses for activities that are not directly related to participant accrual.
Note: For further information please visit the following website for general information and questions and answers.
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
New
Renewal
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Required: Only accepting applications that propose clinical trial(s)
Need help determining whether you are doing a clinical trial?
Issuing NIAID and partner components intend to commit an estimated total of up to $35.5M, depending on funds availability, in Core funding in FY21 for 4 Statistical and Data Management Centers.
Application budgets for FY21 are limited to the following direct cost amounts, to be disbursed as Core funding:
SDMC (HIV Prevention Clinical Trials Network): $5.5M
SDMC (HIV Vaccines Clinical Trials Network): $6.5M
SDMC (HIV/AIDS Adult Therapeutics Clinical Trials Network): $12.5M
SDMC (HIV/AIDS Maternal, Adolescent and Pediatric Therapeutics Clinical Trials Network): $3.7M
The scope of the proposed project should determine the project period. The maximum project period is 7 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from 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:
o Hispanic-serving Institutions
o Historically Black Colleges and Universities (HBCUs)
o Tribally Controlled Colleges and Universities (TCCUs)
o Alaska Native and Native Hawaiian Serving Institutions
o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Other
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 allowed.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
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.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) 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:
Kumud K. Singh, Ph.D.
Telephone: 301-761-7830
Email: kumud.singh@nih.gov
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following additional instructions.
The Research Strategy must consist of the following sub-sections with the indicated page limits:
Sub-section A. SDMC Overview, Structure and Governance - one required - 30 pages
Sub-section B. Data Collection and Management- one required - 12 pages
Sub-section C. Regulatory Compliance/Adherence to Regulations and Standards - one required - 12 pages
Sub-section D. Data Quality Management, Assurance and Control- one required - 12 pages
Sub-section E. Data Access and Storage- one required - 12 pages
Sub-section F. Clinical Site and Laboratory Training, Assessment and Technical Assistance - one required - 12 pages
Sub-section G. Study Design, Data Analysis, Data Reporting one required - 12 pages
Sub-section H. External Interactions and Opportunities - one required - 6 pages
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions.
Other Attachments: Applicants must provide the following additional material specified below. The attachment should be uploaded as a separate PDF using the indicated filename (which will serve as an application bookmark).
Attachment 1. Quality Management Plan
Provide a full SDMC Quality Management Plan including quality control, quality assurance and quality improvement. If appropriate, provide an example protocol-specific Quality Plan for a protocol opened for enrollment since March 2018. (use filename: Quality Management Plan)
All instructions in the SF424 (R&R) Application Guide must be followed , with the following additional instructions.
In the biosketch, describe the relevant experience of the PD/PIs in leading and managing a Statistical and Data Management Center for multi-center clinical trials in a complex structure, including the roles and responsibilities served. Describe the experience of the PD/PIs and other key personnel in implementing and using a COTS clinical trial management system that includes an electronic data capture (EDC) system and development of electronic case report forms.
All instructions in the SF424 (R&R) Application Guide must be followed , with the following additional instructions.
The applicant should only request Core funding. Core funding is the initial fixed-base funding and provides infrastructure and salary support that is not protocol-specific. Examples include, but are not limited to:
Protocol Funds (PF) should not be requested; PF will be determined and provided as protocols are initiated through a collaborative process between the NIAID and awardees as previously described.
If a single PD/PI is proposed, the PD/PI will be required to devote at least 6 person-months effort to the project. If two or more PD(s)/PI(s) are named, each PD/PI must devote at least 3.6 person- months effort to the project.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Specific Aims: Describe the scientific aims of the Statistical and Data Management Center. The applicant must state which one of the four HIV/AIDS Clinical Trials Networks the SDMC proposes to support. (Research priority areas for the networks, including the cross-collaborative areas, are listed on this website.)
Research Strategy: The Research Strategy section must consist of subsections A-H as designated below.
Sub-section A. SDMC Overview, Structure and Governance
For renewal applications: Progress Report should be included in sub-section A.
Sub-section B. Data Collection and Management
Sub-section C. Regulatory Compliance/Adherence to Regulations and Standards
Sub-section D. Data Quality Management, Assurance and Control
Sub-section E. Data Access and Storage
Sub-section F. Clinical Site and Laboratory Training, Assessment and Technical Assistance
Sub-section G. Study Design, Data Analysis, Data Reporting
Sub-section H. External Interactions and Opportunities
Letters of Support:
Provide appropriate letters of support, including any letters necessary to demonstrate the support of collaborators. Note that letters establishing intra-network and cross-network collaborations are not necessary.
Include a letter from the applicant organization(s) describing the role of institutional support of the following:
Progress Report Publication List:
Provide the requested information in the application instructions with the most recent publications and patents first.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
Other Requested Information
For Renewal applications with ongoing clinical studies, applicants must include a list of all ongoing clinical studies and/or the unique ClinicalTrials.gov identifiers. All information must be combined in one single attachment using the filename "Ongoing Clinical Studies". If appropriate, please indicate for each study the NIAID Division of AIDS (DAIDS)-defined study status (https://rsc.niaid.nih.gov/networks-protocol-teams/developing-protocols).
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:
Although applicants must be prepared for clinical trials, definite plans for such involvement will not be possible at time of application. A Study Record MUST not be completed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Both Renewal and New Applications must add and complete the Delayed Onset Study record and must check box "Anticipated Clinical Trial?".
Study Title-- use: "Multiple Delayed-Onset Studies"
Justification Attachment: Indicate each clinical study protocol developed during the project period will be subject to approval through a procedure that involves an initial concept submission and subsequent review by the HIV/AIDS Clinical Trials Network. If the concept receives approval, the next stage will be development of the protocol, which also must undergo review and approval prior to implementation through the HIV/AIDS Clinical Trials Network.
All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
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 submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Only the review criteria described below will be considered in the review process.
Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project 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 project 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 project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project 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?
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
How well does the application balance needs for data management and statistical support? How well does the application demonstrate evidence of data management systems compliance with the necessary regulations and are the systems interoperable across all the duties and responsibilities of the SDMC and the network? Is the biostatistical research agenda novel, feasible and sufficiently flexible to address the clinical studies for the network it will support? Does the SDMC application depict an ability to adjust to future regulatory and other requirements, scientific opportunities, and activities?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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 project?
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Specific to this FOA:
How well does the data management team address the evolving regulated environment within which the SDMC must operate? Is the expertise of the data management staff appropriate for the types and phases of trials in the network research agenda it will support? Does the data management team demonstrate current knowledge of regulatory standards and guidelines?
Are the biostatisticians appropriate for the types and phases of trials being designed and conducted? Is documentation provided to support that investigators work as a cohesive research team to efficiently develop the statistical analysis plans for clinical trials as well as analyze results from completed trials? Does/Do the PD(s)/PI(s) plan to devote sufficient effort to perform his/her role within the SDMC?
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?
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Specific to this FOA:
Does the applicant propose any innovations in adapting information systems and structures to accommodate network or collaborator needs? Are innovations proposed in statistical methodologies, e.g., study design, control/comparison groups, sample size/power estimates, endpoints, stratification/blocking methods, that may broadly impact the field of HIV clinical research and improve the ability to understand HIV?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address
1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Does the application adequately address the following, if applicable?
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Specific to this FOA:
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?
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
Specific to this FOA:
Do the Information Systems described support the scale and scope of the data management and data analysis required for the network research agenda? Are information security and integrity well addressed? Are the software and hardware maintenance plans well aligned with the scope and scale of the network?
As applicable for the project 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.
Study Timeline
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
For research that involves human subjects but does not involve one of the 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 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 Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
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.
Not Applicable
For Renewals, the committee will consider the progress made in the last funding period.
Not Applicable
As applicable for the project 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.
Not Applicable
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).
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) Genomic Data Sharing Plan (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
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 National Institute of Allergy and Infectious Diseases, 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 on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications 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 Advisory Allergy and Infectious Diseases Council. 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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
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.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and
not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB)
administrative guidelines, U.S. Department of Health and Human Services (DHHS)
grant administration regulations at 45 CFR Parts 75, and other HHS, PHS, and
NIH grant administration policies.
The administrative and funding instrument used for this program will be the
cooperative agreement, an "assistance" mechanism (rather than an
"acquisition" mechanism), in which 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, although specific tasks and
activities may be shared among the awardees and the NIH as defined below.
PD(s)/PI(s) of the LOC, LC, and SDMC will have primary responsibility for the overall performance of the network, including, but not limited to the following within their individual awards:
Grantees are required to work closely with Clinical Monitors or Regulatory Auditors to ensure proper completion of all actions and steps associated with on-site monitoring or auditing, including review of corrective and preventative action plans when problems are detected.
If NIAID determines that a grantee fails to comply adequately with NIAID guidelines for the conduct of clinical trials, PD(s)/PI(s) will assure that the accrual of new patients to network protocols is immediately suspended and that the suspension remains in effect until notified that NIAID has conducted any required audit and the audit report or remedial action is accepted by NIAID. The PD(s)/PI(s) will assure that during the suspension period, no funds from this award are allowed for new accruals.
PD(s)/PI(s) of the Leadership and Operations Center (LOC) will have primary responsibility for the scientific leadership, administration and coordination of all network activities and the LOC, including, but not limited to:
PD(s)/PI(s) of the Laboratory Center (LC) will have the primary responsibility for the overall planning, execution and review of all laboratory center activities including, but not limited to:
PD(s)/PI(s) of the Statistical and Data Management Center (SDMC) will have primary responsibility for the biostatistical and data management activities, including, but are not limited to:
Each network will have the responsibility to collaborate and promote inter-network interactions, including but not limited to:
Coordinating with other NIAID- and NIH-supported clinical trials networks to:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
Data Access. The awardees retain the rights to the data, consistent with current DHHS, PHS, NIH and NIAID policies; however, NIH will have access to all data generated (raw and analyzed) and may periodically review it. This includes a review of data as recorded on the case report forms or in the central database, and external checking against the original source documentation as required by federal regulation and NIAID as the IND/IDE sponsor. NIAID may request from the network specific data analysis needed for programmatic activities or for issues related to NIAID plans with other partners. The NIH may provide public access to selected data sets generated with the use of public funds within a reasonable time after primary analysis and publication. Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
Areas of Joint Responsibility include:
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16
When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final RPPR, 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.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred
method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information
(Questions regarding application instructions, application processes, and NIH
grant resources)
Email: GrantsInfo@nih.gov (preferred
method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support (Questions regarding
Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Phillip Renzullo, Ph.D.
National Institute of Allergy and
Infectious Diseases (NIAID)
Telephone: 240-627-3041
Email: prenzullo@niaid.nih.gov
Eric Lorenzo, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health
and Human Development (NICHD)
Telephone: 301-443-4993
Email: eric.lorenzo@nih.gov
Raul N. Mandler, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-480-2541
Email: mandlerr@mail.nih.gov
Gallya Gannot, DMD, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-451-5096
Email: gallya.gannot@nih.gov
Pim Brouwers, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 240-627-3863
Email: ebrouwer@mail.nih.gov
May Wong, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1431
Email: wongm@ninds.nih.gov
Kumud K. Singh, Ph.D.
National Institute of Allergy and Infectious Diseases
(NIAID)
Telephone: 301-761-7830
Email: kumud.singh@nih.gov
Jenny Greer
National Institute of Allergy and Infectious Diseases
(NIAID)
Telephone: 240-669-2949
Email: jenny.greer@nih.gov
Bryan Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov
Pam Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-480-1159
Email: pfleming@nida.nih.gov
Diana Rutberg, M.B.A.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: rutbergd@mail.nih.gov
Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: siscor@mail.nih.gov
Tijuanna DeCoster, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9531
Email: Tijuanna.DeCoster@ninds.nih.gov
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 Part 75.