and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute of Allergy and Infectious Diseases (NIAID) |
|
Funding Opportunity Title |
Leadership Group for a Clinical Research Network on Therapeutics for HIV/AIDS and HIV-associated Infections in Adults (UM1) |
Activity Code |
UM1 Multi-Component Research Project Cooperative Agreements |
Announcement Type |
Reissue of RFA-AI-05-001 |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
RFA-AI-12-004 |
Companion FOA |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.855; 93.856; 93.865; 93.121; 93.242; 93.853; 93.393; 93.394; 93.395; 93.396; 93.399 |
FOA Purpose |
The purpose of this FOA is to encourage applications for the Leadership Group for a Clinical Research Network on Therapeutics for HIV/AIDS and HIV-associated Infections in Adults. The Leadership Group (LG) will have overall responsibility for developing, implementing and adapting the network’s clinical research agenda to address NIAID’s HIV/AIDS scientific priorities described below (Part 2, Section I, #3). Applications for the LG must be comprised of three separate linked UM1 applications: a Leadership and Operations Center (LOC), a Laboratory Center (LC) and a Statistical and Data Management Center (SDMC). |
Posted Date |
January 27, 2012 |
Letter of Intent Due Date |
August 28, 2012 |
Application Due Date(s) |
September 28, 2012 |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
March, 2013 |
Advisory Council Review |
October, 2013 |
Earliest Start Date(s) |
December, 2013 |
Expiration Date |
September 29, 2012 |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the PHS398 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.
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 purpose of this FOA is to encourage applications for the Leadership Group (LG) for a Clinical Research Network on Therapeutics for HIV/AIDS and HIV-associated Infections in Adults. The LG will have overall responsibility for: (i) developing, implementing and adapting the network s clinical research agenda to address NIAID’s HIV/AIDS scientific priorities described below in Part 2, Section I, #3, (ii) overseeing and managing the network’s scientific/clinical research activities and associated laboratory and statistical/data management support functions, (iii) allocating network resources, and (iv) evaluating network performance using a LG proposed/Division of AIDS (DAIDS) approved process and evaluation standards.
The Program Director(s)/Principal Investigator(s) PD(s)/PI(s) and senior/key personnel of the LOC, LC and SDMC together form the LG. The LG coupled with the Program Directors/Principal Investigators PD(s)/PI(s) and senior/key personnel of the affiliated Clinical Trial Units/Clinical Research Sites (CTUs/CRSs) collectively constitute the Clinical Research Network on Therapeutics for HIV/AIDS and HIV-associated Infections in Adults (herein referred to as the network ). The three different parts of the LG (LOC, LC and SDMC) will be required to work together collaboratively and with the network-affiliated CTUs/CRSs to carry out the activities that are essential to achieving the network’s clinical research agenda.
Clinical Trial Units (CTUs) provide the scientific and administrative expertise as well as the infrastructure to contribute to NIAID Clinical Research Networks. A CTU is an organization/institution 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 Research Networks. The CTU PD(s)/PI(s) is/are responsible for all CTU/CRS activities and performance, and also serve(s) as scientific and administrative representative(s) to the CTU s affiliated network(s).
A Clinical Research Site (CRS) is a component of a CTU and is defined as a discrete location (e.g. hospital, outpatient clinic, community health center, private practice, local health department clinic) with appropriate identified and characterized potential trial participants (e.g. demographics, incidence and prevalence of HIV/AIDS) where participant recruitment and retention, protocol management and other clinical research activities are conducted. The CRS must be staffed by qualified professionals capable of conducting clinical research for one or more clinical research networks in accordance with Good Clinical Practice (GCP), local regulatory requirements, and other applicable NIH requirements. In addition, each CRS must participate in one or more HIV/AIDS clinical research network(s). The activities of each CRS will be directed by a CRS Leader with the experience and qualifications to oversee clinical activities and the day-to-day clinic operations will be overseen by a CRS Coordinator with relevant clinical research experience and qualifications. An individual CRS and/or CRS Leader may be proposed in only one CTU application.
NIAID currently supports six HIV/AIDS clinical research 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), the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), and the Microbicide Trials Network (MTN).
Over the past 30 years, HIV/AIDS research has led to phenomenal scientific advances. Scientists uncovered the structure and genetic organization of HIV and began to understand the mechanisms by which HIV causes disease. This understanding led to the development of (i) tests to detect HIV infection, measure HIV viral load and monitor immune function, and (ii) highly active antiretroviral therapies (HAART).
Despite these scientific advances, according to the Joint United Nations Programme on HIV/AIDS (UNAIDS), 33 million people globally are estimated to be living with HIV, of whom 22 million are living in sub-Saharan Africa. Slightly more than half of all people living with HIV are women and girls. In sub-Saharan Africa, more women than men are living with HIV, and young women aged 15 24 years are as much as eight times more likely than men to be HIV-infected.
The NIAID therapeutics networks have played a pivotal role in improving the clinical management of HIV infection and its co-morbidities throughout the world. They contributed to the development of guidelines for: 1) treatment of HIV infection and associated infections; 2) prophylactic regimens for secondary infections; 3) use of biological markers, such as CD4+ cell counts and HIV viral load, for monitoring response to therapy and disease progression; and 4) the use of antiretroviral drugs for preventing mother-to-child transmission.
In the vast majority of infected individuals adherent to treatment, combination antiretroviral regimens are capable of suppressing HIV viral load and partially restoring immune function, reducing HIV morbidity and mortality. Nevertheless, HIV infection has not been cured by antiretroviral therapy and the virus persists even in patients who are adherent to their HAART regimens. The persistence of HIV infection has been attributed to latent but replication-competent provirus in resting CD4+ lymphocytes, cryptic viral expression below the limits of detection and viral sanctuary sites, and leads to chronic immune activation and inflammation. To find a cure, all HIV reservoirs must be identified and eliminated. Alternatively, in the absence of complete sterilization, a functional cure would achieve viral suppression without the need for antiretroviral therapy.
Inhibition of HIV replication by antiretroviral drugs leads to a reduction in the levels of markers of immune activation, but the levels remain above those seen in individuals without HIV infection. Chronic immune activation leads to immune senescence, with eventual loss of response to antigens and increased frequency of infectious diseases. Loss of integrity of the enteric barrier permitting microbial translocation and dysfunctional response to enteric flora may also contribute to chronic inflammation. Chronic inflammation, in turn, appears to contribute to disruption of tissue architecture, leading to impaired end-organ function, with the resulting higher risk for AIDS and non-AIDS related co-morbidities.
A large number of biomarkers are being studied to identify correlates of risk for end-organ disease, such as cardiovascular, liver, renal and neurologic disease outcomes, that have been seen to accompany HIV expression, immune activation, pro-inflammatory cytokine release and adhesion molecule expression. It may be that chronic inflammation also is a factor in the increased rates of virally induced malignancies, which are seen in HIV infected individuals. Research in HIV-disease therapeutics must expand to include novel approaches targeting one or more steps in this disease cascade.
Tuberculosis (TB) research is a high priority for NIAID. Globally, HIV and TB are the first and second most common causes of death by single infectious agents overall and TB is the leading cause of death for HIV-infected persons. Mycobacterium tuberculosis, the causative agent of TB, is readily transmissible, with one-third of the world’s population thought to be infected. The convergence of the HIV and TB epidemics has substantially increased the incidence, morbidity and mortality of TB, and in turn, TB accelerates progression of HIV disease. Increasing rates of drug resistance, including the emergence of multi-drug resistant (MDR) and extensively drug resistant (XDR) M. tuberculosis strains, have greatly diminished the success rate of standard therapy for TB and have significantly increased the duration and cost of treatment. Together, escalating rates of HIV-associated TB and both MDR and XDR TB threaten global TB and HIV control. There is an urgent need therefore to investigate better diagnostics, treatments and prevention methods.
Infectious hepatitis research also is a high priority for NIAID. As reported by the CDC, more than 1.2 million Americans have chronic hepatitis B infection (HBV) and more than 3.2 million have chronic hepatitis C infection (HCV). As compared to the general population, a significantly higher proportion of people living with HIV also have HBV or HCV. Those co-infected with HIV/HBV or HIV/HCV may have a more rapid progression of liver disease, a tendency to respond less well to current hepatitis treatment and the course and management of HIV disease may be negatively impacted. Developing effective and better tolerated treatment strategies, vaccines and diagnostics remains an urgent need.
In recognition of the frequent occurrence of HIV related oral diseases, both in treated and untreated HIV infected individuals, the NIAID in collaboration with the National Institute of Dental and Craniofacial Research (NIDCR) seeks for the inclusion and implementation of an oral health research agenda, in which clinical interventions are linked to, and integrated within, the HIV/AIDS research priority areas.
In summary, with the use of many classes of antiretroviral drugs, HIV has become a chronic disease with its own challenges. HIV-infected people are living longer and are experiencing conditions associated with aging at younger ages than non-infected individuals. Thus, in addition to developing strategies for cure and/or functional cure, and mitigating sequelae of HIV-induced immune activation and chronic inflammation, it is essential to continue research both in the U.S. and internationally to discover and develop novel therapeutic agents with improved delivery, decreased toxicity, different resistance profiles and readily accessible to those at greatest need, as well as to test novel approaches and interventions to promote durable viral suppression including through sustained antiretroviral adherence. Furthermore, as co-infection of HIV and tuberculosis has become common in limited resource settings and treating co-infection with HIV and viral hepatitis has gained importance in higher resource settings, new treatment modalities for these infections also are urgently needed. These needs have led NIAID to refocus the HIV/AIDS adult therapeutics research agenda.
The clinical research on therapeutics for HIV/AIDS and HIV-associated infections in adults will be conducted in HIV-infected individuals and, where informative to NIAID’s research priorities in this area, in HIV-uninfected individuals.
NIAID has identified four overarching scientific priorities:
Options for Scope of Application
The three linked applications must address all four of NIAID’s scientific priorities listed above. The scope of responsive research that will promote achieving the above scientific priorities includes, but is not limited to:
Cure and/or Functional Cure of HIV:
This unique activity for a clinical trials network will require different skill sets, assays and types of trials than those required for the other scientific areas.
Tuberculosis:
Research may be conducted in HIV-infected or uninfected individuals.
Infectious Hepatitis:
Research may be conducted in HIV-infected or uninfected individuals.
Non-infectious Co-morbidities/Novel interventions targeting HIV infection:
Non-infectious Co-morbidities
Novel interventions targeting HIV infection
The network’s research agenda in the required four areas described above will be peer reviewed, and post award, will be reviewed and potentially revised by NIAID staff to ensure optimal synergy with existing programs in the DAIDS and the Division of Microbiology and Infectious Diseases (DMID), particularly in the areas of TB and viral hepatitis.
It is expected that treatment-related protocols will incorporate valid assessments of treatment adherence, strategies to promote adherence to clinical trial protocols and investigational therapies, and concurrent scientific expertise, where appropriate.
In relation to the HIV related oral disease research agenda, special emphasis will be placed on addressing: 1) oral immune activation (IRIS), oral inflammation and oral immune dysregulation; 2) oral mucosal lesions including oral fungal-, HIV- and viral-opportunistic infections as well as eradication of these infections from oral mucosal reservoirs; 3) viral-related tumors and malignancies of the oral cavity.
In addition, the network will be required to contribute to the scientific agenda and provide capacity for trials that support the development of vaccines against infectious diseases that impact populations burdened by HIV, primarily TB and hepatitis C virus. The scientific agenda for those efforts will be developed post-award through cross-network, joint leadership efforts in conjunction with DAIDS and DMID and should not be included here.
The LG will be responsible for all network activities and will ensure that all the constituent parts of the network fulfill their respective responsibilities in the most efficient and effective manner possible. Each linked application of the LG (LOC, LC, and SDMC) is expected to demonstrate scientific leadership, effective management and efficient utilization of resources.
Leadership Time Commitment. When a single PD(s)/PI(s) is proposed in any of the three LG applications, the PD(s)/PI(s) will be required to devote at least 6 person months effort to the project. Applications proposing multiple PD(s)/PI(s) are permitted, but the roles and responsibilities of multiple PD(s)/PI(s) should be clearly delineated and justified. If two or more PD(s)/PI(s) are named in any application, each PD(s)/PI(s) must devote at least 3.6 person months effort to the project. The governance and organizational structure of the LG leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PD(s)/PI(s) and other collaborators.
Research Agenda. The LG’s clinical research agenda should be clearly articulated and directly related to achieving NIAID’s scientific priorities. The LG is required to monitor and evaluate the need to refine and revise the research agenda. As part of this process, the LG is required to actively engage and solicit input from researchers and HIV-affected communities.
Governance and Management. The LOC, LC and SDMC, in their area of responsibility, must establish and define effective communication and decision making processes, identify clear lines of authority, and coordinate and collaborate effectively both within the network and with other NIH-supported networks or other Federal and private sector clinical research programs as appropriate to avoid redundancies and ensure efficiencies. Governance or management by committees is permitted. The governance and management should utilize effective approaches to project management, including project plans with identified key milestones; ongoing evaluation of projections against actual data and adjustments to project plans; and development and implementation of contingency plans. In addition, the LOC, LC and SDMC, in their area of responsibility, must establish processes to identify and resolve operational issues and develop training and education programs within the context of the network’s research agenda for network members, including new researchers, particularly from under-represented populations and those in low and middle income countries.
Bylaws, policies and standard operating procedures should not be included in the application, but must be provided, for approval, to NIAID within 90 days of Notice of Award.
Resource Utilization and Allocation. The LOC, LC and SDMC, in their area of responsibility, must ensure optimal resource utilization and ensure that resource allocation supports the clinical research agenda.
Collaborative Responsibilities. The LG will be strongly encouraged to collaborate with other NIH-supported networks and other Federal and private sector clinical research programs, and to interact with government and non-government organizations, including the private sector, and committees to effectively develop and implement a clinically relevant, interdisciplinary and cost-efficient clinical research network. Such collaborations and interactions are essential for the development and implementation of a comprehensive research agenda that utilizes the strengths, experience and expertise of the various collaborating organizations. The sharing of expertise, resources and procedures is expected in key areas, including: development of clinical infrastructure in low-income countries; harmonization of laboratory resources and specimen management; harmonization of common data elements and data entry interfaces; community engagement, including development, training and support of community advisory boards. Examples of additional entities the LG will need to collaborate and/or communicate with include, but are not limited to: the NIAID Strategic Working Group (SWG), Scientific Review Committees (SRCs), network LG Program Officers (NLGPOs) and Project Scientists, the DAIDS Enterprise System (DAIDS-ES), Office of Clinical Site Oversight (OCSO), the DAIDS Clinical Laboratory Oversight Team (DCLOT), the HIV/AIDS Network Coordination Office (HANC), other HIV/AIDS Clinical Research Network groups and the non-HIV/AIDS Research Network.
In addition to the requirements described above, each linked application of the LG has the following specific responsibilities:
Leadership and Operations Center (LOC)
The LOC provides overall scientific and administrative leadership for the network and coordination of the LG with the network-affiliated CTUs/CRSs. The PD(s)/PI(s) of the LOC thus have primary responsibility for the network. The LOC is responsible for: (i) overseeing research concept prioritization, protocol development and implementation, completion of final study reports, and timely publication and communication of results; (ii) developing and implementing network governance and resource management policies and procedures; (iii) fostering and ensuring engagement and effective partnership with affected communities in strategic planning; (iv) evaluating and revising the network’s research agenda; (v) overseeing and evaluating the performance of each linked application of the LG and network-affiliated CTUs/CRSs; and, (vi) allocating network resources (as described below in Section I.6. Core and Protocol Funds).
Laboratory Center (LC)
The LC contributes to the development of the network s research agenda, and leads the laboratory activities that are required to carry out the research agenda. The LC is responsible for (i) managing, monitoring and evaluating all LG-supported laboratory services, any network specimen repositories, and laboratory quality management programs and (ii) fostering collaboration and harmonization of laboratory activities within the network, at network-affiliated CTUs/CRSs laboratories, and with other NIH-supported networks or other Federal and private sector clinical trial programs engaged in similar research.
Statistical and Data Management Center (SDMC)
The SDMC assists with the development of the network s clinical research agenda and provides biostatistical leadership in study design, analysis, interpretation and publication of results, along with state-of-the-art clinical and laboratory data management systems to ensure complete, high quality data. The SDMC is responsible for: (i) ensuring the integrity of study design, data management, data analyses and compliance with regulatory requirements, as appropriate; (ii) providing effective data communication systems for the network; (iii) providing data management training for network-affiliated CTUs/CRSs investigators and laboratory staff; (iv) standardizing and harmonizing statistical and data management activities both within the network and with other NIH-supported networks or other Federal and private sector clinical trial programs when required; and, (vi) collecting and storing data in accordance with standards of the Clinical Data Interchange Standards Consortium (C-DISC) requirements.
Funding to carry out the network’s clinical research agenda falls into two categories:
A more expansive definition of Core and PF can be found at the web site listed in Section VII of this FOA.
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.
Distribution of Protocol Funds to Network-Affiliated CTUs/CRSs
PF funding will be distributed to CTUs prior to enrollment of study subjects via one of two possible routes. The PD(s)/PI(s) of the LOC are required to state in their application which of the two routes they choose for disbursement of protocol funds to network-affiliated CTUs/CRSs:
Regardless which route is chosen, the LOC will be required annually to determine protocol milestones and estimate the amount of PF needed to meet these milestones. The LOC should estimate its PF needs annually and submit a budget request to NIAID. Following discussions between NIAID and the LOC, NIAID will determine the amount of PF to be provided in the coming grant year. If the network chooses Route 2 above for PF distribution, budgets received from CTUs must be shared with, and approved by NIAID prior to disbursement to CTUs/CRSs. Changes in PF allocation will be made during the award period if key milestones are not met. Whether funds may be routed directly from the LOC to a network-affiliated CRS will be determined after the CTU competition is complete. Regardless of the arrangement of PF distribution, the CTUs will have the primary responsibility for PF accounting.
Funding Instrument |
Cooperative Agreement |
Application Types Allowed |
New The OER Glossary and the PHS398 Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
NIAID and partner components intend to commit up to an estimated total of $35.93M, depending on funds availability, in Core funding in FY14 to fund 1 award each for the LOC, LC, SDMC comprising the Leadership Group for a Clinical Research Network on Therapeutics for HIV/AIDS and HIV- associated Infections in Adults. . |
Award Budget |
Total costs are limited to $35.93M for FY14 to be disbursed, as Core funding, among the three awards constituting the LG . |
Award 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 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
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 eligible to apply.
Foreign components, as defined in the NIH
Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations as described in the PHS398 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 Director(s)/Principal Investigator(s) (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 least4-6 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.
For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.
When a single PD(s)/PI(s) is proposed in any of the three linked applications for the LG, the PD(s)/PI(s) will be required to devote at least 6 person months effort to the project. If two or more PD(s)/PI(s) are named in any application, each PD(s)/PI(s) must devote at least 3.6 person months effort to the project.
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.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.
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 PHS398 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 signed by the PD(s)/PI(s) for each of the LOC, LC, and SDMC applications. Each letter should include the following information:
The letter of intent should be sent to:
Peter R. Jackson, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3133, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (for Express Mail 20817)
Telephone 301-496-8426
FAX: 301-480-2310
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:
Peter R. Jackson, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3133, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (for Express Mail 20817)
Telephone 301-496-8426
FAX: 301-480-2310
Email: [email protected]
Applicants responding to this FOA must submit three separate linked applications: (1) a Leadership and Operations Center (LOC) application, (2) a Laboratory Center (LC) application, and (3) a Statistical and Data Management Center (SDMC) application. These three separate linked applications can be a combination of new or renewal applications. A separate Cover Letter must be included with each of the three linked applications, including: a listing of all the applications that are a part of the set of linked UM1s being submitted, including for each: 1) the name(s) of the PD(s)/PI(s), 2) the Title (tagging each application LOC 1/3, LC 2/3, and SDMC 3/3), and 3) the Applicant Institution. Each of the three applications must be submitted as a separate package. Submissions that do not contain the required three linked applications will be considered nonresponsive to this FOA and will not be reviewed. Each of the three applications, if successful, will receive a separate grant award.
All three separate linked applications must be submitted separately, including a separate Cover Letter listing all the applications that are a part of the set of linked UM1s being submitted.. The three separate linked applications include:
Each of the above listed applications must have a common title, provided by the applicant, item #1 on the PHS 398 Face Page. The title of each application should begin with a tag denoting which part of the LG (i.e., Leadership and Operations Center, Laboratory Center or Statistical and Data Management Center) is represented in that application. Abbreviations of LOC, LC and SDMC may be used in the title. Titles may not exceed 81 characters including the tag, title, spaces and punctuation.
A separate cover letter is required for each of the three linked applications. In addition to the Cover Letter instructions in Part I, Section 3.1 of the PHS 398 Grant Application instructions, each separate Cover Letter must include: a listing of all the applications that are a part of the set of linked UM1s being submitted, including for each: 1) the name(s) of the PD(s)/PI(s), 2) the Title (tagging each application LOC 1/3, LC 2/3, and SDMC 3/3), and 3) the Applicant Institution. Each of the three applications must be submitted as a separate package.
All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirement:
All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:
Supplemental Instructions for the Preparation of Linked Multi-Component Applications
The following section provides supplemental instructions to the PHS398 Grant Application instructions for the preparation of linked multi-component applications (UM1). This section is divided into three subsections, with specific and detailed instructions for the linked applications, LOC, LC and SDMC. NOTE: To be responsive to this FOA, applicants must submit three separate linked UM1 applications consisting of the LOC, LC and SDMC. Each of these three linked applications must be submitted as a separate package with a separate cover letter tagged with: LOC (1/3), LC (2/3), and the SDMC (3/3). These three separate, linked applications should be submitted as a single package in the following order: LOC, LC, and SDMC. Each application must have a common base title plus a tag at the beginning of the project that denotes the linked application (e.g., Leadership and Operations Center or the abbreviation LOC may be used). Titles need to be succinct so that they do not exceed 81 characters. A separate cover letter must be included with each application package and contain a listing of the three linked applications, the PD(s)/PI(s), the titles (including the tag) and the applicant institution(s). The information included in the cover letter must also be an attachment in each application.
Applicants should follow the instructions in the PHS398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html), incorporating the following deviations from the PHS398 instructions noted under the specific headings below for each of the three separate, linked multi-component UM1 applications.
NOTE: The Leadership Group Overview must be included as Component 1 within each of the three linked applications and the content of the Leadership Group Overview must be identical in each.
Use the table of contents below as a supplemental guide to the PHS398 application guide instructions to assemble the multi-component LOC application.
ITEM |
Application 1 of 3: Leadership and Operations Center (LOC) |
Copy of Application Package Cover Letter |
Face Page LOC (PHS 398 Form Page 1). This is the first page of the LOC application; number all succeeding pages consecutively. |
Description, Project/Performance Sites, Senior/key personnel, Other Significant Contributors, Human Embryonic Stem Cell statement if applicable (PHS 398 Form Page 2). Make sure the abstract describes how the proposed components will contribute to the LOC objectives. |
Detailed Budget for First Year (PHS 398 Form Page 4). Proposed budgets should be for CORE cost only, not to include any protocol costs (PF) |
Composite Budget for All Years of Proposed Period of Support. (use PHS 398 Form Page 5 and continuation pages of Form Page 5) |
A separate page of Detailed Budgets for Consortium Agreements to be summed as a line item on PHS 398 Form Page 4 |
Biographical Sketch (Biographical Sketch Format Page). Provide biographical sketches of all senior/key professional personnel for all LOC components at the end of the application. Place PD(s)/PI(s) biographical sketches first, followed by those of other senior/key personnel in alphabetical order. |
Resources (Resources Format Page). Complete the resources available for each component |
Note: For each component below, include a Cover Page and other information as described under detailed component headings. Do not use PHS 398 Form Page 1. |
LOC, LC and SDMC Component 1. Leadership Group Overview. |
LOC Component 2: Research Agenda/Strategies |
LOC Component 3: Protocol Development and Implementation |
LOC Component 4: Structure and Governance |
LOC Component 5: Resource Management and Protocol Funds |
LOC Component 6: Research Capacity |
LOC Component 7: Evaluation, Improvement and Training |
LOC Component 8: Communications and Collaborations |
Resource Sharing Plan |
Appendix |
Checklist LOC (checklist Form Page) |
Component 1 will be identical for all three linked applications and must be included in the LC and SDMC applications.
Specific Aims (Limited to 1 page): List the scientific aims of the Leadership Group (the combined scientific aims of the LOC, LC and SDMC).
Research Overview for Component 1 (Limited to 30 pages)
Provide a brief history and background of the field of clinical research overall, including a discussion of knowledge gaps and future opportunities, and briefly summarize the proposed scope of research for the LG.
Describe in detail (i) the overall clinical research agenda of the proposed LG; (ii) the significance of each priority area as outlined in the Research Priority Areas, (Part 2 Section I, #3); and (iii) how the scientific agenda will help improve the treatment of HIV/AIDS, especially in populations disproportionately impacted by HIV/AIDS. Summarize (i) the proposed approach(s) to making high level scientific and management decisions for the LG; (ii) research prioritization, reassessment, redirection, and involvement of key stakeholders and external expertise; and (iii) how decisions will be linked to cost effective management of network resources.
Briefly summarize the structure and organization of the three linked applications for the LG. Include (i) a description of the proposed approach to integrating the functions of the linked applications and plans for coordinating with the network-affiliated CTUs/CRSs and CRS-affiliated laboratories; (ii) an organizational chart(s) showing senior/key personnel with level of effort for leadership or decision-making positions in the LOC, LC and SDMC, and briefly describe how they will relate to each other and to the network-affiliated CTUs/CRSs; (iii) a description of the roles and responsibilities of the PD(s)/PI(s) of each application, or multiple PD(s)/PI(s) if proposed, and the experience of each in leading and managing a complex clinical trials program; and (iv) plans to ensure adequate representation of early career investigators, investigators of both genders, and investigators representative of populations disproportionately affected by HIV/AIDS.
Performance and Applicant Experience. For renewal applications, (i) expand upon accomplishments of the LG during the current award period, including key contributions to the field and scientific strengths; (ii) identify areas for improvement; (iii) describe collaborations established and implemented with other NIAID- and NIH-sponsored clinical trial networks and/or other clinical researchers/research programs and the value of these collaborations to the field; and (iv) describe any innovative scientific or administrative approaches undertaken during the current award. For new applications, provide the information identified above pertinent to the PD(s)/PI(s) expertise during the past 5 years leading a clinical trials program of similar scope and complexity in this area of research.
Additional Instructions and Page Limits for the Specific Aims and Research Strategy Section of Each Individual Component of the Leadership and Operations Center (LOC) Application
Specific Aims (Limited to 1 page): List and describe the scientific aims of the LOC
Research Strategy (Limited to 30 pages)
Organize this section in the order specified in the PHS 398 Instructions Section 5.5. Make sure to start each section with the appropriate section heading in order, addressing Significance, Innovation, and Approach, and including the appropriate information. Explicit experimental details should be cited using the Bibliography and Reference Cited section and need not be detailed in the Research Strategy.
Experience. Describe the relevant experience of the LOC in directing, overseeing and managing a clinical trials leadership and operations group.
Research Agenda. Provide a focused research agenda for each of the four scientific priority areas stated in Part 2, Section I.3. Research Priority Areas above. Identify agenda areas of highest priority and the significance and anticipated contributions to the field during the period of award. Include (i) specific strategies or approaches; (ii) process and procedures for developing milestones and timelines for completing key studies; and (iii) preliminary data/documentation of the feasibility of the proposed approaches.
Prioritization of Research Agenda.
Performance and Applicant Experience. Within the Approach section, for renewal applications, (i) expand upon past performance of the LOC; (ii) identify strengths and areas for improvement; and (iii) provide improvement plans. For new applications, provide the information identified above pertinent to the PD(s)/PI(s) expertise during the past 5 years leading a clinical trials program of similar scope and complexity in this area of research.
(i) Explain how performance will be managed using standard principles of project management, including processes and procedures to ensure that protocols are developed, initiated, completed and results disseminated on schedule. (ii) Define roles and responsibilities of staff for Component 3 and how the LOC will achieve synergism among the LOC, LC and SDMC. Do not name staff or investigators here (see Component 4 below). (iii) Describe the approach to developing approved research concepts into protocols, including go/no-go criteria, contingency plans, decision and communication processes, and plans for ensuring adherence to NIAID/DAIDS and network policies and procedures. (iv) Describe the approach to protocol implementation and completion, including: critical protocol implementation milestones/timelines; plans for modifying protocol implementation milestones/timelines. (v) Describe the processes and timelines for completing final study reports and publication. In addition, describe the process for fast tracking both the development and implementation of high priority protocols and managing the impact on other protocols.
Describe in detail the plans for network governance and LOC management and structure. Tables, diagrams, flow charts and organizational charts are strongly recommended. Describe how the LOC will be governed, including: (i) lines of authority; (ii) decision making processes; (iii) any proposed governance/decision making committees and their authorities; (iv) senior/key personnel (level of effort, experience/qualifications) involved in network-wide governance and/or committees; and (v) process for setting network meeting: agendas, frequency, participants and location.
Bylaws, policies and standard operating procedures should not be included in the application, but must be provided for approval to NIAID within 90 days of issuance of the Notice of Award.
Describe how (i) performance of the LOC, LC, SDMC and network-affiliated CTUs/CRSs will be evaluated; (ii) CRSs will be prepared for protocol implementation including responsible parties; and (iii) training needs for network members will be determined, provided, and evaluated, and necessary changes in training programs/approaches will be decided and implemented.
Provide proposed LOC communication and collaboration plans, including the roles and responsibilities of involved individuals.
Resource Sharing Plan
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 PHS398 Application Guide, with the following modification:
Appendix
Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide, with the following modifications:
Use the table of contents below as a supplemental guide to the PHS398 application guide instructions to assemble the multi-component LC application.
ITEM |
Application 2 of 3: Laboratory Center (LC) |
Copy of Application Package Cover Letter |
Face Page LC (PHS 398 Form Page 1). This is the first page of the LC application; number all succeeding pages consecutively. |
Description, Project/Performance Sites, Senior/key personnel, Other Significant Contributors, Human Embryonic Stem Cell statement if applicable (PHS 398 Form Page 2). Make sure the abstract describes how the proposed components will contribute to the LC objectives. |
Detailed Budget for First Year (PHS 398 Form Page 4). Proposed budgets should be for CORE cost only, not to include any protocol cost (PF) |
Composite Budget for All Years of Proposed Period of Support (use PHS 398 Form Page 5 and continuation pages of Form Page 5) |
A separate page of Detailed Budgets for Consortium Agreements to be summed as a line item on PHS 398 Form Page 4 |
Biographical Sketch (Biographical Sketch Format Page). Provide biographical sketches of all senior/key professional personnel for all LC components at the end of the application. Place PD(s)/PI(s) biographical sketches first, followed by those of other senior/key personnel in alphabetical order. |
Resources (Resources Format Page). Complete the resources available for each component. |
Note: For each component below, include a Cover Page and other information as described under detailed component headings. Do not use PHS 398 Form Page 1. |
LOC, LC and SDMC Component 1. Leadership Group Overview |
LC Component 2: Research Strategy and Methodologies |
LC Component 3: Structure and Governance |
LC Component 4: Quality Management, Evaluation and Improvements |
LC Component 5: Research Capacity |
LC Component 6: Communications and Collaborations |
Resource Sharing Plan |
Appendix |
Checklist LC (Checklist Form Page). |
Component 1 will be identical for all three linked applications and must be included in the LOC and SDMC applications.
Specific Aims (Limited to 1 page): List the scientific aims of the Leadership Group (the combined scientific aims of the LOC, LC and SDMC).
Research Overview for Component 1 (Limited to 30 pages)
Provide a brief history and background of the field of clinical research overall, including a discussion of knowledge gaps and future opportunities, and briefly summarize the proposed scope of research for the LG.
Describe in detail (i) the overall clinical research agenda of the proposed LG; (ii) the significance of each priority area as outlined in the Research Priority Areas, (Part 2 Section I, #3); and (iii) how the scientific agenda will help improve the treatment of HIV/AIDS, especially in populations disproportionately impacted by HIV/AIDS. Summarize (i) the proposed approach(s) to making high level scientific and management decisions for the LG; (ii) research prioritization, reassessment, redirection, and involvement of key stakeholders and external expertise; and (iii) how decisions will be linked to cost effective management of network resources.
Briefly summarize the structure and organization of the three linked applications for the LG. Include (i) a description of the proposed approach to integrating the functions of the linked applications and plans for coordinating with the network-affiliated CTUs/CRSs and CRS-affiliated laboratories; (ii) an organizational chart(s) showing senior/key personnel with level of effort for leadership or decision-making positions in the LOC, LC and SDMC, and briefly describe how they will relate to each other and to the network-affiliated CTUs/CRSs; (iii) a description of the roles and responsibilities of the PD/PI of each application, or multiple PD(s)/PI(s) if proposed, and the experience of each in leading and managing a complex clinical trials program; and (iv) plans to ensure adequate representation of early career investigators, investigators of both genders, and investigators representative of populations disproportionately affected by HIV/AIDS.
Performance and Applicant Experience. For renewal applications, (i) expand upon accomplishments of the LG during the current award period, including key contributions to the field and scientific strengths; (ii) identify areas for improvement; (iii) describe collaborations established and implemented with other NIAID- and NIH-sponsored clinical trial networks and/or other clinical researchers/research programs and the value of these collaborations to the field; and (iv) describe any innovative scientific or administrative approaches undertaken during the current award. For new applications, provide the information identified above pertinent to expertise of the PD(s)/PI(s) during the past 5 years leading a clinical trials program of similar scope and complexity in this area of research.
Additional Instructions and Page Limits for the Specific Aims and Research Strategy Section of Each Individual Component of the Laboratory Center (LC) Application
Specific Aims (Limited to 1 page): List and describe the scientific aims of the LC
Research Strategy (Limited to 30 pages)
Organize this section in the specified order stated in the PHS 398 Instructions Section 5.5. Make sure to start each section with the appropriate section heading in order, addressing Significance, Innovation, and Approach, including the appropriate information. Explicit experimental details should be cited using the Bibliography and Reference Cited section and need not be detailed in the Research Strategy.
Performance and Applicant Experience. Within the Approach section, for renewal applications, (i) expand upon the accomplishments of the LC during the current award period, including key contributions to the field; (ii) identify areas for improvement; (iii) describe collaborations established and implemented with other NIAID- and NIH-supported clinical trial networks and/or other clinical researcher/research programs, and the value of these collaborations to the field and any innovative scientific approaches; and (iv) document the utility and effectiveness of any repositories supported by the LC. For new applications, provide the information identified above pertinent to expertise of the PD(s)/PI(s) during the past 5 years leading a clinical trials program of similar scope and complexity in this area of research.
Describe in detail the proposed organizational structure of the LC and plans for governance.
Bylaws, policies and standard operating procedures should not be included in the application, but must be provided to NIAID within 90 days of issuance of the Notice of Award for approval.
Describe (i) how all aspects of the LC will be evaluated and improved, including the process, metrics and frequency for evaluating the entire LC effort and resolving problems/deficiencies; (ii) laboratory quality management procedures, including requirements for external quality assurance (EQA), validations, reference range studies and laboratory audits; and (iii) the processes for determining the need for and development and implementation of alternative EQA, and how the LC will interact with DAIDS quality assurance contracts. Do not include names of external advisors other than those supported by the LOC, LC and SDMC.
Describe the procedures and interactions among laboratories and other parts of the network for performing routine, non-specialized testing, collecting and processing specimens when necessary, and shipping to one or more laboratories within and outside the LC for specialized testing or to a repository. Additionally, describe and discuss CTU/CRS data input methodology, how assay capacity assessment and training will be accomplished, how CTU/CRS affiliated laboratories will be evaluated, and problem resolution processes and procedures. Describe procedures and requirements to minimize redundancies for training staff at CTU/CRS-affiliated laboratories associated with multiple networks.
Describe how the LC will establish and maintain clear lines of communication and procedures for collaborating within the network and with other NIH-supported networks, HANC or other Federal or private sector clinical programs to achieve assay harmonization, minimize costs and avoid test redundancies. Discuss the ability, capacity and willingness of the LC to perform testing and provide training on specific assays for laboratory personnel for other NIH-supported clinical trial networks.
Resource Sharing Plan
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 PHS398 Application Guide, with the following modification:
Appendix
Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide, with the following modifications:
Use the table of contents below as a supplemental guide to the PHS398 application guide instructions to assemble the multi-component SDMC application.
ITEM |
Application 3 of 3: Statistical and Data Management Center (SDMC) |
Copy of Application Package Cover Letter |
Face Page SDMC (PHS 398 Form Page 1). This is the first page of the SDMC application; number all succeeding pages consecutively. |
Description, Project/Performance Sites, Senior/key personnel, Other Significant Contributors, Human Embryonic Stem Cell statement if applicable (PHS 398 Form Page 2). Make sure the abstract describes how the proposed components will contribute to the SDMC objectives. |
Detailed Budget for First Year (PHS 398 Form Page 4). Proposed budgets should be for CORE cost only, not to include any protocol cost (PF) |
Composite Budget for All Years of Proposed Period of Support (use PHS 398 Form Page 5 and continuation pages of Form Page 5) |
A separate page of Detailed Budgets for Consortium Agreements to be summed as a line item on PHS 398 Form Page 4 |
Note: For each component below, include a Cover Page and other information as described under detailed component headings. Do not use PHS 398 Form Page 1 |
LOC, LC and SDMC Component 1. Leadership Group Overview |
SDMC Component 2: Methodologies and Technical Capabilities |
SDMC Component 3: Structure and Governance |
SDMC Component 4: Research Capacity |
SDMC Component 5: Communications and Collaborations |
Resource Sharing Plan |
Appendix |
Checklist-SDMC (Checklist Form Page) |
Component 1 will be identical for all three linked applications and must be included in the LOC and LC applications.
Specific Aims (Limited to 1 page): List the scientific aims of the Leadership Group (the combined scientific aims of the LOC, LC and SDMC).
Research Overview for Component 1 (Limited to 30 pages)
Provide a brief history and background of the field of clinical research overall, including a discussion of knowledge gaps and future opportunities, and briefly summarize the proposed scope of research for the LG.
Describe in detail (i) the overall clinical research agenda of the proposed LG; (ii) the significance of each priority area as outlined in the Research Priority Areas, (Part 2 Section I, #3); and (iii) how the scientific agenda will help improve the treatment of HIV/AIDS, especially in populations disproportionately impacted by HIV/AIDS. Summarize (i) the proposed approach(s) to making high level scientific and management decisions for the LG; (ii) research prioritization, reassessment, redirection, and involvement of key stakeholders and external expertise; and (iii) how decisions will be linked to cost effective management of network resources.
Briefly summarize the structure and organization of the three linked applications for the LG. Include (i) a description of the proposed approach to integrating the functions of the linked applications and plans for coordinating with the network-affiliated CTUs/CRSs and CRS-affiliated laboratories; (ii) an organizational chart(s) showing senior/key personnel with level of effort for leadership or decision-making positions in the LOC, LC and SDMC, and briefly describe how they will relate to each other and to the network-affiliated CTUs/CRSs; (iii) a description of the roles and responsibilities of the PD/PI of each application, or multiple PD(s)/PI(s) if proposed, and the experience of each in leading and managing a complex clinical trials program; and (iv) plans to ensure adequate representation of early career investigators, investigators of both genders, and investigators representative of populations disproportionately affected by HIV/AIDS.
Performance and Applicant Experience. For renewal applications, (i) expand upon accomplishments of the LG during the current award period, including key contributions to the field and scientific strengths; (ii) identify areas for improvement; (iii) describe collaborations established and implemented with other NIAID- and NIH-sponsored clinical trial networks and/or other clinical researchers/research programs and the value of these collaborations to the field; and (iv) describe any innovative scientific or administrative approaches undertaken during the current award. For new applications, provide the information identified above pertinent to the PD(s)/PI(s) expertise during the past 5 years leading a clinical trials program of similar scope and complexity in this area of research.
Additional Instructions and Page Limits for the Specific Aims and Research Strategy Section of Each Individual Component of the Statistical and Data Management Center (SDMC) Application
Specific Aims (Limited to 1 page): List and describe the scientific aims of the SDMC
Strategy (Limited to 30 pages)
Organize this section in the specified order stated in the PHS 398 Instructions Section 5.5. Make sure to start each section with the appropriate section heading in order, Significance, Innovation, Approach, and include the appropriate information. Explicit experimental details should be cited using the Bibliography and Reference Cited section and need not be detailed in the Research Strategy.
Research Approach. Describe (i) the roles and responsibilities of SDMC staff in providing general support for network activities, including, but not limited to: protocol design and development, data analysis, preparation of data summaries (within and across protocols), and publication of results; (ii) development of data collection systems, forms and formats, and generic and protocol-specific instruments (paper and/or electronic) and (iii) how statistical methodologies and/or database systems and structures will be adapted to accommodate the Network’s needs and with other NIH-supported networks or other Federal, or Non Government Organization (NGO) or private sector clinical programs when required.
Data Management Plans and Systems.
Performance and Applicant Experience. Within the Approach section, for renewal applications, (i) expand upon the accomplishment of the SDMC during the current award period, including key contributions to the field; (ii) identify areas for improvement; (iii) describe collaborations established and implemented with other NIAID- and NIH-supported clinical trial networks and/or other clinical researcher/research programs, the value of these collaborations to the field and any innovative scientific approaches; and (iv) describe experience in developing and validating data systems to support controlled clinical trials. For new applications, provide the information identified above pertinent to the PI(s)/PD(s) expertise during the past 5 years leading a clinical trials program of similar scope and complexity in this area of research.
Describe in detail the proposed organizational structure of the SDMC and plans for governance.
Bylaws, policies and standard operating procedures should not be included in the application, but must be provided to NIAID within 90 days of issuance of the Notice of Award for approval.
Describe (i) the procedures and interactions among the SDMC, other parts of the network the LG, and CTUs/CRSs for data collection and transmission to the SDMC, and for data collection from the LC when laboratory data are generated; (ii) procedures and methodologies to be used to assess the capabilities and readiness of network-affiliated CTUs/CRSs including new protocol-specific CRSs for data collection, processing, analysis (if appropriate) and transmission; (iii) the requirements and procedures for the overall evaluation of data collection, transmission and management processes within the SDMC and between the SDMC and the network-affiliated CTUs/CRSs; and (iv) how SDMC training needs for network members will be determined and provided, how the training will be evaluated and how necessary changes in training will be decided and implemented.
Provide a plan for efficient SDMC communication within the network and with other NIH-supported networks or other Federal, NGO and private sector clinical programs and NIH staff, including methods for SDMC communication with the DAIDS-ES to automate data transfer and resolve any data transfer issues/problems that arise, including those affecting data integrity and timeliness of submission.
Resource Sharing Plan
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 PHS398 Application Guide, with the following modifications:
Appendix
Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 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 PHS398
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 NIAID, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.
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.
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the LOC to exert a strong sustained influence on the research field involved, in consideration of the following review criteria (as applicable for the LG proposed).
Review Criteria
Considering the overall goals, plans, and approaches outlined in the Leadership Group Overview in Component 1, in conjunction with the specific information in Components 2-8, is the LOC application cohesive? Is there evidence of synergistic interactions among the Components that enhance the likelihood of LOC success?
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the LOC, as presented in the Overview, to exert a strong sustained influence on the research field involved, in consideration of the following review criteria and additional review criteria (as applicable for the LOC proposed).
Review Criteria
Is the proposed clinical research agenda meritorious,
innovative, feasible and sufficiently flexible to address future scientific
opportunities to help improve the treatment of HIV/AIDS? Are all four of the
NIAID scientific priority areas addressed adequately? Are the 1st year scientific
and management plans timely and appropriate? With respect to the four NIAID
priority research areas, does the application depict an ability to adjust to
future requirements and activities? Does the proposed research plan have the
potential to be applicable to the groups most disproportionately impacted by
HIV/AIDS, including women, adolescents, and racial/ethnic minorities? Are there
adequate plans to obtain input from representatives of highly impacted
communities at every stage of research development? Where appropriate are there
adequate and feasible plans to ensure the involvement of new and early career
investigators, foster the participation of women and racial/ethnic minorities
as researchers, and ensure their participation in network activities at all
levels? Do the proposed PD(s)/PI(s) have adequate scientific and organizational
qualifications, time commitment, experience and vision for the concept,
coordination, and direction of the network and the LOC? Are there appropriate
plans for making scientific and management decisions regarding research
priorities and the assessment/reassessment, and cost effective use of network
resources? If multiple PD(s)/PI(s) are proposed, does their expertise match
their roles, and are individual responsibilities clearly delineated?
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the successful implementation of the research agenda/strategies 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 LOC 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.)
Significance
Does the research agenda address an important problem or a critical barrier to progress in the field? If the aims of the network 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?
For each of the four scientific priority areas stated in Part 2, Section I. 3, does the proposed research agenda have the potential to achieve advances in HIV treatment, prevention and clinical care?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the research agenda? If Early Stage Investigators or New Investigators, or are 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 LOC is collaborative or multiple PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the research agenda for LOC?
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?
Approach
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the network?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the network is in the early stages of development, will the LOC s
strategy establish feasibility and will particularly risky aspects be
managed?
Are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders justified in terms of the scientific goals and research strategy proposed?
Are there sound and feasible proposed network processes to assess, evaluate and redirect the scientific priorities as the field evolves?
Where appropriate, are there adequate plans to solicit external and internal input and assessments of the research agenda and for prioritizing research concepts? Do the plans include adequate processes for the integration of novel ideas and expertise from inside and outside the network and the field?
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 research agenda proposed? Will the implementation of the research agenda benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Reviewers will consider each of the criteria but will not give separate scores for these items below in the determination of scientific merit and will give an overall score for each Component 3-8.
For Protocol Development and Implementation (LOC Component 3) reviewers will consider:
For Structure and Governance (LOC Component 4) reviewers will consider:
For Research Management and Protocol Funds (LOC Component 5) reviewers will consider:
For Research Capacity (LOC Component 6) reviewers will consider:
For Evaluation, Improvement and Training (LOC Component 7) reviewers will consider:
For Communication and Collaborations (LOC Component 8) reviewers will consider:
As applicable for the LOC proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority 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 Network 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
For Renewals, the committee will consider the progress made in the last funding period.
Revisions
Not Applicable
As applicable for the LOC 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/priority 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.
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the LC to exert a strong sustained influence on the research field involved, in consideration of the following review criteria (as applicable for the LG proposed).
Review Criteria
Considering the overall goals, plans, and approaches outlined in the Leadership Group Overview in Component 1, in conjunction with the specific information in Components 2-6, is the LC application cohesive? Is there evidence of synergistic interactions among the Components that enhance the likelihood of LC success?
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the LC, as presented in the Overview, to exert a strong sustained influence on the research field involved, in consideration of the following review criteria and additional review criteria (as applicable for the LC proposed).
Review Criteria
Are the proposed laboratory activities meritorious, innovative, feasible and sufficiently flexible to address the Research Agenda of the proposed Network? Does the LC application depict an ability to adjust to future scientific opportunities, requirements and activities? Does the proposed research plan have potential for applicability to the groups most disproportionately impacted by HIV/AIDS, including women, adolescents, and racial/ethnic minorities? Are there adequate plans to obtain input from representatives of highly impacted communities at every stage of research development? Do the proposed PD(s)/PI(s) have adequate scientific and organizational qualifications, time commitment, experience and vision for the concept, coordination, and direction of the network and the LC? If multiple PD(s)/PI(s) are proposed, does their expertise match their roles and are individual responsibilities clearly delineated?
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the successful implementation of the research strategy and methodologies 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 LC 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.
Significance
Do the research strategy and methodologies address an important problem or a critical barrier to progress in the field? If the aims of the LC 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 proposed laboratory research aims and strategies meritorious, innovative, feasible and sufficiently flexible for addressing the network’s clinical research agenda? Do the proposed laboratory research activities have the potential to advance HIV treatment, prevention and clinical care?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to implement the research strategy and employ methodologies of the LC? 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 LC is collaborative or multiple PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the research strategy and methodologies of the LC?
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?
Approach
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the network? Are potential problems, alternative strategies, and benchmarks for success presented? If the network is in the early stages of development, will the LC s strategy establish feasibility and will particularly risky aspects be managed?
Are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders justified in terms of the scientific goals and research strategy proposed?
Do the proposed process for determining the need for new assays or methodology, and the plan for development, assessment and implementation of new laboratory assays and technologies have appropriate scientific and technical merit?
Is there a clear plan for the integration within the network and will this plan lead to synergism?
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 investigators adequate for the research strategy and methodologies proposed? Will the implementation of the research strategy and methodologies benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Are the proposed number, type and location of laboratories and network specimen repositories adequate and appropriate to meet network research plans?
Reviewers will consider each of the criteria but will not give separate scores for these items below in the determination of scientific merit and will give an overall score for each Component 3-6.
For Structure and Governance (LC Component 3) reviewers will consider:
For Quality Management, Evaluation and Improvements (LC Component 4) reviewers will consider:
For Research Capacity (LC Component 5) reviewers will consider:
For Communications and Collaboration (LC Component 6) reviewers will consider:
As applicable for the LC proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority 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 Network 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
For Renewals, the committee will consider the progress made in the last funding period.
Revisions
Not Applicable.
As applicable for the LC 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/priority 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.
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the SDMC to exert a strong sustained influence on the research field involved, in consideration of the following review criteria (as applicable for the LG proposed).
Review Criteria
Considering the overall goals, plans, and approaches outlined in the Leadership Group Overview in Component 1, in conjunction with the specific information in Components 2-5, is the SDMC application cohesive? Is there evidence of synergistic interactions among the Components that enhance the likelihood of SDMC success?
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the SDMC, as presented in the Overview, to exert a strong sustained influence on the research field involved, in consideration of the following review criteria and additional review criteria (as applicable for the SDMC proposed).
Review Criteria
Is the proposed biostatistical management agenda meritorious, innovative, feasible and sufficiently flexible to address the Network research plans? Does the SDMC application depict an ability to adjust to future scientific opportunities, requirements and activities? Does the proposed research plan have potential for applicability to the groups most disproportionately impacted by HIV/AIDS, including women, adolescents, and racial/ethnic minorities? Are there adequate plans to obtain input from representatives of highly impacted communities at every stage of research development? Do the proposed PD(s)/PI(s) have adequate scientific and organizational qualifications, time commitment, experience and vision for the concept, coordination, and direction of the network and the SDMC? If multiple PD(s)/PI(s) are proposed, does their expertise match their roles and are individual responsibilities clearly delineated?
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the collective methodologies and technical capabilities of the SDMC to exert a sustained, powerful influence on the research field involved, in consideration of the following review criteria and additional review criteria (as applicable for the proposed SDMC).
Reviewers will consider each of the 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.
Significance
Do the methodologies and technical capabilities enable the SDMC address an important problem or a critical barrier to progress in the field? If the aims of the SDMC 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?
Is there potential for scientific contributions to the clinical research agenda through SDMC participation in the design, conduct, analysis and publication of clinical research?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the SDMC? 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? If the SDMC is collaborative or multiple PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the SDMC?
Do the proposed PD(s)/PI(s) possess adequate qualifications, level of commitment, experience and availability to provide the scientific and administrative direction of a multi-network clinical trials statistical and data management center?
Is there adequate and appropriate leadership in biostatistics, clinical systems, study design, data analysis, data management, and result interpretation to ensure complete and high quality research data?
If multiple PD(s)/PI(s) are proposed, does their expertise match their roles and are individual responsibilities clearly delineated?
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?
Approach
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the network?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the network is in the early stages of development, will the
SDMC’s strategy establish feasibility and will particularly risky aspects be
managed?
Are the plans for 1) protection of human subjects from research risks, and 2)
inclusion of minorities and members of both sexes/genders justified in terms
of the scientific goals and research strategy proposed?
Are there strong, meritorious, appropriate and feasible plans and procedures for providing all data management services required, including database design, security, confidentiality and administration, participant randomization/registration, data collection, quality control, data retrieval, safety data reconciliation between clinical sites and DAERS, report generation, and site training?
Are the plans to assure compliance with regulatory requirements for data management, including compliance with CDISC, adequate?
Is there a clear plan for integration within the network and will this lead to synergism?
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 proposed SDMC? Will the SDMC benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Reviewers will consider each of the criteria but will not give separate scores for these items below in the determination of scientific merit and will give an overall score for each Component 3-5.
For Structure, and Governance (SDMC Component 3) reviewers will consider:
For Research Capacity (SDMC Component 4) reviewers will consider:
For Communication and Collaboration (SDMC Component 5) reviewers will consider:
As applicable for the SDMC proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority 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 Network 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
For Renewals, the committee will consider the progress made in the last funding period.
Revisions
Not Applicable.
As applicable for the SDMC 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/priority 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 National Institute of Allergy and Infectious Diseases, NIH, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments 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 response to this FOA.
NIAID reserves the right to conduct site visits or reverse site visits prior to award when deemed essential. .
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 appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD(s)/PI(s) 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,
CCR 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 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 74 and 92 (Part 92 is
applicable when State and local Governments are eligible to apply), 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 as a whole, although specific tasks
and activities may be shared among the awardees and the NIH as defined below.
PD(s)/PI(s) of the Leadership Group (LOC, LC and SDMC) will have primary responsibility for the overall performance of the network, including, but not limited to:
Each leadership group will have the responsibility to collaborate and promote inter network interactions, including but not limited to:
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:
Collecting storing and providing all data in accordance with C-DISC requirements
NIH staff will have substantial programmatic involvement that is above and beyond the normal stewardship role for these awards, as described below as applicable to the specific applications:
Program Official and Project Scientists. NIAID staff assistance will be provided by a DAIDS Program Official and Project Scientists along with other NIH staff. These staff will be identified at the time of award and their roles and responsibilities will be addressed in the NoA. These staff members will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination above and beyond the normal program stewardship role for grants:
Clinical Trials Agreements. NIAID staff will serve as a liaison between pharmaceutical companies (or other providers of investigational agents) and network investigators, and will lead the negotiation of Clinical Trials Agreements (CTAs).
Trial Sponsorship. NIAID staff will have the option to independently file an IND on investigational agents or an IDE on investigational devices evaluated in NIAID-supported clinical studies. NIAID will advise the investigators on the specific regulatory requirements for IND sponsorship. In situations where NIAID is the IND sponsor, NIAID through its contractors will also assemble, review, and submit the required regulatory documents to the FDA. When holding an IND or IDE, NIAID has responsibility for the reporting of safety information in accordance with FDA requirements and preferences. In order to provide for consistent reporting of serious adverse experiences across the NIAID-supported clinical trial networks, NIAID will provide current policies and procedures that govern the reporting of adverse events in NIAID-supported trials.
Trial Monitoring. NIAID staff oversees an external clinical site monitoring contract that evaluates GCP, regulatory compliance, protocol implementation, internal quality assurance, and test article accountability at the network-affiliated CRSs. The monitoring contractor, with or without accompanying NIAID staff, will visit network-affiliated CTUs/CRSs periodically to review selected protocols, provide training on general protocol conduct, review internal QA/QC plans, and audit pharmacies.
Laboratory Oversight. NIAID staff and NIAID contract resources will provide oversight and monitoring of CRS-affiliated laboratories for GCLP and for the quality of subject diagnosis (e.g. HIV, TB), and safety tests (e.g. hematology, chemistry, liver function), as well as the quality of pharmacological tests (e.g. drug levels, drug interactions), end point tests (e.g. CD4, HIV viral load) and blood processing.
Training. NIAID staff will provide a variety of training activities to appropriate network personnel to help the network ensure that consistent standards for protection of human subjects and clinical trial conduct and documentation are achieved across the NIAID-supported HIV/AIDS clinical trials networks. Training areas include, but are not limited to, regulatory requirements, GCP, adverse event reporting, human subject protections, informed consent, and NIAID and NIH policies and procedures.
Protocol approval. NIAID staff will review and approve all protocols. The Program Officer or designee will return comments and recommendations to the network after review. The network must address in writing all safety, regulatory, ethical, and conflict of interest concerns raised by NIAID to the satisfaction of NIAID before participant enrollment can begin. If a protocol is disapproved, NIAID will not provide investigational products or permit expenditure of NIH funds for the proposed investigation. If a protocol is not initiated within twelve months of NIAID approval, re-review and approval by NIAID will be required.
Safety Monitoring. NIAID staff will participate in the development of appropriate safety monitoring plans for all planned clinical trials and must approve the plan for all trials involving investigational drugs, devices, or biologics and other clinical research perceived to involve more than a minimal risk. The frequency and intensity of safety monitoring will be based on individual study characteristics and past experience with study products and may require review by an Independent Safety Monitor, Independent Monitoring Committee (IMC) or Safety Monitoring Committee (SMC) or Data and Safety Monitoring Board (DSMB). NIAID Medical Officers will be part of network organized protocol safety review teams to monitor the safety and efficacy of the intervention(s) for ongoing studies, and will be provided with appropriate reports. Approval of the final monitoring plan, including the composition of the review committee, by NIAID is required prior to study initiation. NIAID independently supports Data and Safety Monitoring Boards (DSMB) that oversee Phase IIb/III and other select clinical trials at the discretion of NIAID.
Study Termination. NIAID staff reserves the right to terminate or curtail a clinical study for any reason, including but not limited to the following:
Data Access. NIH will have the right of 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 sponsor. NIAID staff 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 the primary analysis and publication. NIAID staff will develop a memorandum of agreement with the owners/providers of applications/systems that share data/information with the DAIDS-ES.
External Advisors. NIAID staff in conjunction with the LG will seek evaluation, advice and recommendations concerning ongoing and planned research activities of the network from external advisory groups. Such review activity may occur through the advisory working group's attendance at a regular network meeting organized by the LOC, and/or at separate meetings arranged by NIAID. Network investigators will participate in these reviews with support for attendance provided through the LOC budget, and will provide written materials and oral presentations regarding the status of ongoing research activities, future plans (including proposed new research activities/investigators), and plans to curtail, discontinue and/or modify current research activities.
Areas of Joint Responsibility between NIH and Awardees include:
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.
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 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 awardees. This special dispute resolution procedure does not alter the awardees' 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 Non-Competing Continuation Grant Progress Report (PHS 2590) 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.
Additional information and definitions of terms can be found at the following
website:http://www.niaid.nih.gov/labsandresources/restructuring/pages/default.aspx
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]
NIAID:
Ellen DeCarlo, BSN
National Institute of Allergy and Infectious Diseases
(NIAID)
Telephone: 301-496-8212
Email: [email protected]
NIDCR:
Isaac Rodriguez-Chavez, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-7985
Email: [email protected]
NIDA:
Shoshana Kahana, M.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-2261
Email: [email protected]
NIMH:
Pim Brouwers Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-4526
Email: [email protected]
NINDS:
May Wong, Ph.D.
National Institute of
Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1431
Email: [email protected]
Peter R. Jackson, Ph.D.
National Institute of Allergy and Infectious Diseases
(NIAID)
Telephone: 301-496-8426
Email: [email protected]
NIAID:
Devon Bumbray-Quarles
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-402-6213
Email: [email protected]
NIDCR:
Mary Greenwood
National Institute of Dental and Craniofacial Research
(NIDCR)
Telephone: 301-594-4808
Email: [email protected]
NIDA:
Pam Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-253-8729
Email: [email protected]
NIMH:
Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: [email protected]
NINDS:
Tijuanna DeCoster, MPA
National Institute of
Neurological Disorders and Stroke (NINDS)
Telephone: 301- 496-9231
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.
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NIH Funding Opportunities and Notices
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