Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute of Allergy and Infectious Diseases (NIAID) |
|
Funding Opportunity Title |
Centers for AIDS Research and Developmental Centers for AIDS Research (P30) |
Activity Code |
P30 Center Core Grants |
Announcement Type |
Reissue of PAR-11-108 |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
PAR-14-041 |
Companion Funding Opportunity |
None |
Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility. |
|
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.855; 93.856; 93.847; 93.865; 93.989; 93.399; 93.396; 93.395; 93.394; 93.393; 93.866; 93.242; 93.859; 93.279; 93.837; 93.838; 93.839; 93.307 |
Funding Opportunity Purpose |
The purpose of this FOA is to invite applications for the Centers for AIDS Research (CFAR) program to provide administrative and shared research support to enhance HIV/AIDS research. Applications are invited for both standard CFARs and for developmental CFARs (D-CFARs). Standard and D-CFARs provide core facilities, expertise, resources, and services not readily obtained otherwise through more traditional funding mechanisms. Additionally, D-CFARs provide support to assist investigators in the development of a competitive standard CFAR. The program emphasizes interdisciplinary collaboration, especially between basic and clinical investigators, translational research between the laboratory and the clinic, inclusion of investigators from diverse backgrounds, and inclusion of prevention and behavioral change research. |
Posted Date |
December 18, 2013 |
Open Date (Earliest Submission Date) |
June 27, 2014 |
Letter of Intent Due Date(s) |
30 days before the application due date |
Application Due Date(s) |
July 28, 2014; July 28, 2015; July 28, 2016, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. |
AIDS Application Due Date(s) |
July 28, 2014; July 28, 2015; July 28, 2016, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. |
Scientific Merit Review |
September 2014; September 2015; September 2016 |
Advisory Council Review |
January 2015; January 2016; January 2017 |
Earliest Start Date |
March 2015; March 2016; March 2017 |
Expiration Date |
July 29, 2016 |
Due Dates for E.O. 12372 |
Not Applicable |
NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
Participating Institutes of the National Institutes of Health (NIH) invite applications for Center Core grants (P30) to support Centers for AIDS Research (CFAR) as either Standard CFARs or Developmental CFARs (D-CFARs). CFAR and D-CFAR cores provide infrastructure and promote basic, clinical, behavioral and translational HIV/AIDS research activities at institutions that receive significant HIV/AIDS funding from NIH Institutes or Centers. CFARs and D-CFARs should foster synergy and improve coordination of research, support emerging research opportunities, and promote efficiencies through resources shared by multiple independent laboratories. CFARs and D-CFARs are intended to promote all HIV/AIDS research efforts at CFAR institutions. D-CFARs provide support to assist investigators in the development of a competitive standard CFAR.
This FOA will use the NIH Center Core grant (P30) award mechanism. This award mechanism provides support for shared resources and facilities for a multidisciplinary research team or group of investigators focusing on a common research topic. Funded independently of a center's component or program projects, the core grant provides accessible resources and services necessary to support the science.
This FOA describes two types of CFAR awards. The first is for a Developmental CFAR (D-CFAR) for HIV/AIDS investigators at an institution that is eligible, but does not yet have a CFAR. The D-CFAR will provide the support necessary to develop a collaborative network that may permit the institution to be more competitive for a standard CFAR award. The second type of award is for a standard CFAR (CFAR). Both the D-CFAR and the CFAR are funded through the P30 mechanism for infrastructure development. This FOA describes requirements for both types of CFARs.
Developmental CFARs (D-CFAR). The purpose of the D-CFAR is to provide support for applicants ultimately seeking a standard CFAR in order to develop collaborations, experiment with core facilities that may be important to support HIV/AIDS investigators at the institution, and to build and strengthen any deficiencies that might adversely affect an application for a standard CFAR award and to ultimately lead to the development of a competitive standard CFAR application. The emphasis expected in a D-CFAR application will be the identification and clear description of gaps or deficiencies that would hinder development of a competitive CFAR application, and Core facilities that would reduce or eliminate these gaps. D-CFARs are not renewable.
Like the standard CFAR award, a D-CFAR provides funding to foster synergy and improve coordination of research, to support emerging research opportunities, and to promote economy of scale through resources shared by multiple independent laboratories. D-CFARs also encourage other activities that serve the requirements of HIV/AIDS research (see below under Additional CFAR-Supported Activities section). Any of these activities may be fostered through a D-CFAR award.
The funded research base (FRB) is defined as the amount of Total Cost funding from NIH for HIV/AIDS funded research at the applicant institution(s). The FRB is limited to one fiscal year (October 1 to September 30) preceding the calendar year of application submission.
D-CFARs qualify for a base of no more than $750,000 total costs in the first year, as determined by the $10M minimum required FRB for the institution.
Standard CFARs qualify for three tiers of funding based on the FRB for the institution.
- Tier 1: For institutions with a minimum of $10M, but less than $40M FRB, a CFAR award will use a base of $1.5M total cost in the first year of the competing segment.
- Tier 2: For institutions with a minimum of $40M but less than $80M FRB, a CFAR award will use a base of $2.25M total cost in the first year of the competing segment.
- Tier 3: For institutions with a minimum of $80M FRB, a CFAR award will use a base of $3M total cost in the first year of the competing segment.
D-CFAR and CFAR comparisons are as follows:
D-CFAR
- FRB/BASE FUNDING: =$10M of FRB/$750K Annual Total Cost in first year
- FUNDING PERIOD: 5 years
- RENEWAL: Not allowed
- FOCUS: to be competitive for a standard CFAR
CFAR
- FRB/BASE FUNDING:
- =$10M/$1.5M Annual Total Cost in first year
- =$40M/$2.25M Annual Total Cost in first year
- =$80M/$3M Annual Total Cost in first year
- FUNDING PERIOD: 5 years
- RENEWAL: Allowed
- FOCUS: support NIH HIV/AIDS investigators at an institution
Throughout this FOA, the terminology used for P30 applications for both CFARs and D-CFARs is "CFAR applications" and the corresponding terminology for P30 awards to support CFARs and D-CFARs is "CFAR awards." "Core" or "core facilities" are defined as entities providing services or expertise to be shared by multiple independent laboratories. All eligibility requirements and specific descriptions provided in this FOA for the CFAR applications also apply to D-CFAR applications. The FOA does, however, provide some specific review criteria that apply only to D-CFAR applications. Standard CFAR and D-CFAR applications have the same minimum required number and types of Cores, namely: one Administrative, one Developmental, one Basic Science and one Clinical Science Core.
CFARs will be awarded and administered by the NIAID. However, a CFAR award will consist of funds from multiple NIH Institutes and Centers. Management oversight of the CFAR grants will be provided through an NIH CFAR Steering Committee composed of representatives from the co-funding and participating NIH Institutes and Centers and from the NIH Office of AIDS Research (OAR). It is therefore suggested that the applicant contact the Program representatives listed under Scientific/Research Contact(s) to discuss general CFAR issues and how CFARs can enhance the HIV/AIDS research mission of the co-funding NIH Institutes and Centers.
The FOA also describes the concept of a Scientific Working Group. A Scientific Working Group is defined as a specific area of scientific focus that has been identified by the CFAR investigators with the aim of bringing new investigators into the field and ultimately developing fundable research projects.
Scientific Working Groups are optional for both CFAR and D-CFAR applications.
The CFAR program was established in 1988 and renewed in 1993, 1997, 2000, 2004, 2006, 2009, and 2011. The mission of the CFAR program and mechanisms for achieving the mission were developed by the CFAR Directors (http://www.niaid.nih.gov/LabsAndResources/resources/cfar/about/Pages/mission.aspx).
The mission of CFAR is to support multi-disciplinary environments that promote basic, clinical, epidemiological, behavioral, and translational research in the prevention, detection, and treatment of HIV infection and its comorbidities. The CFAR program accomplishes this mission by:
- Providing scientific leadership and institutional infrastructure dedicated to HIV/AIDS research
- Stimulating scientific collaboration in interdisciplinary and translational research
- Strengthening capacity for HIV/AIDS research in resource-limited settings
- Fostering scientific communication
- Sponsoring training and education
- Promoting knowledge of CFAR research findings and the importance of HIV/AIDS research through community outreach
- Promoting and supporting innovative NIH HIV/AIDS research initiatives
- Establishing collaborative research between and among CFARs, and supporting HIV/AIDS research networks
- Facilitating technology transfer and development through promotion of scientific interactions between CFARs and industry
- Supporting research on prevention and treatment of HIV infection in hard-to-reach populations, especially inner city, rural poor, and disadvantaged minorities.
Added value. CFARs are expected to provide added value to the applicant institution's HIV/AIDS research efforts through support of activities that cannot easily be provided through standard research grant awards. The added value contribution that the proposed CFAR will make at the institution(s) should go beyond what would be expected from the pre-existing AIDS funded research. CFARs should promote and encourage activities that enhance collaboration and coordination of HIV/AIDS research. An appropriate goal for CFARs is to promote translational research activities, i.e., basic scientists provide clinicians with new tools for use in patients and for assessment of their impact; clinical researchers make novel observations about the nature and progression of disease that often stimulates basic investigations; and social and behavioral researchers provide understanding of the contexts within which clinical services are provided and the psychosocial factors that influence physical outcomes.
Some examples of how added value can be measured include:
- Developmental Core awards resulting in collaborations, publications, or successful major research grants
- Interdisciplinary publications
- Evidence of CFAR enhancement and support of existing programs at the institution
- Research activities initiated to address prevention and treatment questions in hard-to-reach populations (inner city, rural poor, and disadvantaged minorities)
- Development and utilization of a program income mechanism (see Program Income System in the Research Strategy section of the Basic Science Core in Section IV.2) for Cores
- The initiation of institutional support for activities previously supported by the CFAR.
- Mentoring and training of early stage investigators.
- Promoting and supporting new collaboration and moving the HIV/AIDS field forward through CFAR-sponsored meetings and activities.
Scientific and fiscal flexibility. CFARs have the responsibility to use their resources to meet the needs of their investigators. A CFAR has the authority to change allocation of resources according to the guidelines of the CFAR operating policies and procedures proposed in the application. A CFAR has considerable flexibility and authority in that they can alter funding of a Basic or Clinical Science Core, delete a core, or initiate a new core as long as the minimum required cores specified above are maintained.
The extent to which CFAR funding may leverage other resources in support of HIV/AIDS research is an important measure of a CFAR's value to HIV/AIDS investigators. Basic and Clinical Science Cores may be supported totally, or in part, by CFAR funds. Applicants are encouraged to develop creative collaborations to improve utilization of existing resources.
NIH-funded HIV/AIDS investigators at the applicant institution(s). The aims of the Cores and the services they provide should address the needs of HIV/AIDS investigators at the applicant institution(s) and be inclusive of the full range of HIV/AIDS science funded at that institution(s). The NIH-funded HIV/AIDS research base spreadsheet made available by the NIH should be used to ensure that the CFAR supports all NIH HIV/AIDS investigators at an institution.
Additional CFAR-supported activities. CFARs traditionally use a variety of strategies to achieve the objectives of the award. Examples include industry collaborations, community outreach, development of scientists from diverse backgrounds underrepresented in HIV/AIDS research, mentoring new investigators, HIV/AIDS research communications to non-scientists, CFAR-sponsored seminars and meetings, development of approaches to problems in enrollment and retention of women and minority groups in AIDS clinical trials, international collaborations, identifying additional support for ongoing NIH programs not planned in the initial award, CFAR-CFAR collaborations, and other activities that meet the HIV/AIDS research needs of applicant institutions. In addition, CFARs are encouraged to work with health departments and community service agencies as they conduct research on aspects of the local HIV epidemic.
Applicants are encouraged to explore collaborative, multi-institutional linkages with international and domestic sites, Historically Black Colleges and Universities (HBCUs) and international institutions. Examples of linkages include mentoring, collaborating, and training. Such linkages foster research training and collaborative studies and are able to meet needs that cannot be easily addressed by other funding mechanisms. Coordination with international programs funded by the Fogarty International Center (FIC) is strongly encouraged. CFARs also collaborate with each other in scientific areas of common interest to achieve economies of scale, to share unique resources and expertise, and to expand collaborative activities between CFARs, especially in areas that cannot be studied at a single CFAR site. Examples of inter-CFAR collaborations can be found on the CFAR website (see http://www.niaid.nih.gov/LABSANDRESOURCES/RESOURCES/CFAR/Pages/collaborations.aspx).
Each CFAR application must include four different types of cores: Administrative, Developmental, Basic Science, and Clinical Science. Each CFAR must have one Administrative and one Developmental Core, and a minimum of one Basic and one Clinical Science Core to optimally support the HIV/AIDS research at the applicant institution(s). CFARs can include additional cores beyond the four mandatory cores. CFARs have the option to incorporate Scientific Working Groups. CFARs are encouraged, but not required, to identify one to three Scientific Working Groups.
The following sections describe the required and optional components of CFAR applications.
Each application will include an overview for the proposed Center, which includes overarching goals and objectives, as well as proven track record and/or the potential for unique contributions to the overall HIV/AIDS research at the applicant institution(s).
Cores and Core services must be specifically targeted to HIV/AIDS research.
Administrative Core
The CFAR Administrative Core will be responsible for managing, coordinating, and supervising the entire range of Center activities, monitoring progress, and ensuring that the project milestones are being met and are being implemented effectively within the proposed timelines. The Administrative Core must provide both an organizational and administrative structure that is conducive for ensuring collaborative efforts and interaction among the Cores and Scientific Working Groups.
Developmental Core
The intent of a CFAR Developmental Core is to support scientific studies for short periods of time to develop preliminary data for peer-reviewed research applications. The Developmental Core should include plans for mentoring early stage investigators. High priority for developmental awards should be given to early stage investigators who do not have existing HIV/AIDS research funding from the NIH. The Developmental Core can also provide support for: (1) investigators who are new to HIV/AIDS research and have not previously received independent research awards such as an R01 in HIV/AIDS research, (2) feasibility studies, (3) emerging research opportunities, and (4) HIV/AIDS research activities of newly recruited faculty. Prior approval from NIH Program staff is required for developmental awards to senior investigators. The Developmental Core may be used to fund a collaborative study that encompasses two different scientific disciplines that may not have collaborated previously such as those that may come from the Scientific Working Group. Funding for these projects can be greater than for standard developmental awards, and must be fully justified and competitively reviewed. It is strongly encouraged that these projects are submitted either by early stage investigators or investigators who do not have existing HIV/AIDS research funding from the NIH.
Applicants may wish to consult with NIH staff listed in the "Scientific/Research Contact(s)" found at the end of the FOA in order to discuss how Developmental Cores are used at current CFARs. While the CFAR Administrative Core should focus on the mechanisms for allocation of developmental funds and for annual evaluation of supported activities, the CFAR Developmental Core should describe the mechanism to be used for identification, peer-review selection, and outcome evaluation of projects to be supported within this Core. The Developmental Core Director is responsible for ensuring that all developmental studies involving human or animal subjects have the appropriate approvals (i.e., annual IRB approvals, FWA, IACUC, human subjects research training, etc. in domestic and foreign institutions). The Developmental Core must inform the NIH of any awards made for developmental studies involving foreign sites prior to initiation. Developmental studies involving foreign sites cannot be initiated without first obtaining NIH clearance and approvals for foreign sites, and for protection of human subjects and animals, including specimens. Similarly, the Developmental Core must inform the NIH of clinical research studies funded by the CFAR that are above minimal risk or involve vulnerable populations for medical officer review and approval. Studies involving clinical trials are not allowed.
Basic Science Core
Basic Science Cores provide equipment, training, services, quality control, and expertise/advice for research activities that cannot easily be funded through standard research granting mechanisms. Basic Science Cores should provide economy of scale through use by multiple laboratories and should foster collaboration between basic and clinical investigators. Basic Science Cores do not substitute for resources that are obtainable commercially, or replace existing resources normally supported by individual research grants. Cores should have a clear focus, contribute to translational research, and demonstrate added value.
Clinical Science Core
Clinical Science Cores should focus clearly on providing resources for HIV/AIDS translational research between collaborating clinical, including social and behavioral, and basic scientists. The primary distinction between a Basic and Clinical Science Core is that a Clinical Science Core involves direct interaction with a human subject (e.g., a single blood draw, sample and data collection, use of behavioral study instruments) or indirect interaction (e.g., developing a database or repository for clinical specimens) with human subjects. Activities that will not be supported by a CFAR Clinical Science Core are normal patient care, including screening of clinical specimens, diagnosis, treatment, or rehabilitation.
Additional Core(s)
Additional Cores can be proposed if they are needed to advance the local HIV/AIDS research effort and if they fit within the budget limits described elsewhere in this FOA. Applicants may include additional Cores beyond the four mandatory Cores, including other basic and clinical science type cores. Some examples of additional cores include, but are not limited to: Social/Behavioral/Prevention, Biostatistical/Bioinformatics, and International.
A Scientific Working Group (SWG) is defined as a specific area of scientific focus for a group of investigators who share common research interests and goals and participate in competitively funded research. The purpose a SWG is to promote growth in a scientific area of interest. CFARs are encouraged, but not required, to identify one to three SWG(s) in order to (1) take full advantage of the ability of CFARs to organize HIV/AIDS research at an institution, (2) encourage collaboration among scientific disciplines and diverse areas of expertise, and (3) explore significant questions and problems in HIV/AIDS that are not being addressed. Each SWG should capitalize on areas of excellence at that particular CFAR and should encourage interdisciplinary collaboration among investigators who have not previously collaborated with each other, or within that area of scientific focus, including investigators outside the field of HIV/AIDS research.
A SWG serves to unite a subgroup of CFAR scientists, whereas essential Cores are used by all or most CFAR members and provide services and expertise.
Each SWG should have a named Director who is expected to encourage new collaborations and lead the SWG in identifying potential high impact studies and submitting new proposals for peer-reviewed funding. The success of a SWG ultimately will be measured by expansion of NIH-supported funding within the SWG and the publication of peer reviewed articles. The SWG Director is expected to establish collaborations within and between the SWG and CFAR Cores. Methods to develop collaborations will vary at each CFAR, but may include formal or informal planning meetings, seminars and retreats. Cores can help promote collaborations in the SWGs by providing new resources and services that may support research activities of the SWG members.
The SWG should exhibit a high degree of interaction, be encouraged to be multi-disciplinary, and should have stated goals. To ensure adequate size and quality, a proposed SWG must consist of a minimum of three independent investigators who are conducting separate peer-reviewed and funded research projects in a related scientific area. Peer-reviewed, funded research sub-projects of larger Program grants (e.g., P01s) may be counted as separate projects.
When a SWG achieves its stated goals, such as acquiring funding from new sources or additional funding, the CFAR may then decide to refocus resources on a new SWG. Specific policies and procedures for determining when and how new SWG will be initiated, terminated, or extended should be explained clearly by the applicant. Therefore, having clear outcome measures for established SWG(s) is necessary. The creation of new SWG(s) solely by the CFAR Director and Core Directors is strongly discouraged.
SWG investigators are encouraged to seek funding for research projects that are developed through new collaborations and ideas formed in the SWG. For Early Stage Investigators with no previous NIH HIV/AIDS funding or investigators outside the field of HIV/AIDS research, applications can be submitted to the Developmental Core for competitively reviewed pilot awards. Established HIV/AIDS investigators should seek opportunities for peer-reviewed externally funded research.
Funding Instrument |
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. |
Application Types Allowed |
New The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. |
Award Budget |
For D-CFAR applications, no more than $750,000 total costs per center per year will be awarded. For standard CFAR applications, up to $3M total costs per center per year will be awarded. The total amount awarded will depend on the applicant institutions NIH HIV/AIDS-funded research base. |
Award Project Period |
The scope of the proposed project should determine the project period. The maximum project period is 5 years. |
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
Other
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible
to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
- Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
- System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
- NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
- eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
- Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple
Program Director/Principal Investigator Policy and submission details in the Senior/Key
Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
- To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
- Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
- Of an application with a changed grant activity code.
CFAR- and D-CFAR-specific Eligibility Requirements:
1) NIH AIDS Funded Research Base (FRB)
To be eligible for a CFAR award an institution must have a significant NIH HIV/AIDS-funded research base (FRB). The FRB is defined as the amount of Total Cost funding from NIH for one fiscal year (October 1 to September 30) preceding the calendar year of application submission. For the D-CFAR and CFAR awards, an FRB in excess of $10M is required. In addition, CFAR applicants must maintain the required minimum FRB during the year of submission in order to be funded at the requested amount. For example, if an applicant has an FRB in 2014 that makes them eligible for $2.25M in funding, they must maintain the required FRB for funding at the $2.25M funding level in 2015 in order to be funded at that level. This applies only to competing applications.
Grandfather clause The minimum requirement of $10M represents a change from the previous eligibility requirement of $6M. For this FOA, a grandfather clause will allow currently funded CFARs submitting renewals with an FRB of less than $10M but greater than $6M to be eligible to submit an application. At the time of funding, the minimum FRB requirement must be maintained in order to receive funding. However, once funded, these CFARs must raise their FRB to $10M or more to be funded for the next renewal application.
The FRB includes NIH peer-reviewed HIV/AIDS research grants, program projects, and cooperative agreements utilizing the following mechanisms only: DP1, DP2, P01, P50 (only the NIGMS Specialized Centers for HIV/AIDS-Related Structural Biology), R00, R01, R03, R15, R21, R24, R33, R34, R35, R37, R56, U01, U10, U19, U24, and K series awards. On a case-by-case basis, the following mechanisms will be considered based on whether or not the award involves primarily research activity: KL1, KL2, N01, U54, UM1 and RC series grants. Excluded from the NIH AIDS FRB are all funds from any source other than NIH. Multi-institutional CFAR applications may combine the NIH HIV/AIDS-funded research of all the investigators at the institutions participating in the proposed CFAR to meet the NIH AIDS-FRB eligibility. A CFAR applicant cannot use the FRB of an institution that is already part of another CFAR. For grants in the FRB that are over $5M, the awarded institution can only take credit for the amount that is budgeted directly to their institution. The NIH AIDS FRB is compiled from the NIH Office of AIDS Research and can be requested by the applicant institution to determine eligibility. More information can be found in Overall Component under the heading Other Attachments.
2) One CFAR award per institution
No institution will receive more than one CFAR award. An institution participating in a multi-institutional CFAR application may not be included in any other CFAR application. Independent campuses that are part of a large multiple city university are considered to be separate institutions, and each may submit one application. Applicants are encouraged to contact NIH staff in the "Scientific/Research Contact(s) for additional guidance.
3) Guidelines for multi-institutional CFARs
In some cases two or more institutions that can demonstrate a credible plan for collaborative research networks using CFAR cores may wish to submit an application for a single CFAR award. The request for multi-institutional applications should include the following indicators:
- a demonstration of exceptional need to establish collaboration between multiple investigators at each of the applicant institutions
- evidence of unique plans, such as the development of organized communications systems to overcome the scientific and management challenges that are naturally a part of multi-institutional collaborations
- specific plans to address any anticipated budgetary challenges in the transfer of funds and resources from one institution to another
- evidence for centralized authority of the CFAR Director for the purpose of management of the CFAR facilities at other sites
Multi-institutional CFAR applications may combine the NIH HIV/AIDS-funded research of all the investigators at the institutions participating in the proposed CFAR to meet the NIH HIV/AIDS-Funded Research Base requirement. A multi-institutional CFAR application must designate a lead institution that will receive the award and provide details of agreements regarding coordination and support of cores and activities at other participating institutions.
CFARs that use a distant institution for a core facility may not use the Funded Research of that institution if they are not including all of the NIH AIDS investigators at that institution as part of the CFAR.
4) Cores outside of the CFAR institution
With appropriate justification, CFAR awards may support a core at an institution that is not part of the CFAR, including a foreign institution that provides a unique resource such as a clinical site or a primate facility. NIH AIDS funding of the investigators at this core facility is not included as part of the FRB of the CFAR (see Funded Research Base).
5) D-CFAR application
Applicants who have never received a CFAR award are eligible to apply, as are previous CFAR applicants who have not been successful in competing for an award, and previous recipients who were not successful in renewing their CFAR award. Applicants who have not received a CFAR award may choose to apply for either a standard CFAR or D-CFAR award.
Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
- Descriptive title of proposed activity
- Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
- Names of other key personnel
- Participating institution(s)
- Number and title of this funding opportunity
The letter of intent should be sent to:
Peter R. Jackson, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Room 3G20, MSC 9823
5601 Fishers Lane
Rockville, MD 20892-9823
Telephone: 240-669-5049
Email: [email protected]
Component Types Available in ASSIST |
Research Strategy/Program Plan Page Limits |
Overall |
30 pages |
Admin Core |
12 pages |
Core (use this component for each required and optional Core) |
12 pages |
SWG (use this component for each optional Scientific Working Groups) |
6 pages |
Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.
The application should consist of the following components:
- Overall: required
- Administrative Core: required
- Core(s)
- Developmental Core: required
- Basic Science Core(s) (e.g. Immunology Core, Virology Core, etc.): one is required
- Clinical Core(s): one is required
- Additional Core(s): optional
- Scientific Working Groups (SWG): optional, three maximum
Cores will be listed in the order in which they are entered into ASSIST. Please enter in ASSIST using the order listed above.
When preparing your application in ASSIST, use Component Type Overall .
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Overall)
Complete entire form.
Descriptive Title of Applicant’s Project: Applicants should clearly indicate in the application title that the application is for a CFAR or D-CFAR award. If no indication is provided, it will be assumed that the application is for a standard CFAR.
PHS 398 Cover Page Supplement (Overall)
Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.
Research & Related Other Project Information (Overall)
Follow standard instructions.
Project Summary/Abstract: Applicants should clearly indicate in the abstract that the application is for a CFAR or D-CFAR award.
Facilities and Other Resources: Commitment of the CFAR institution is particularly important for the coordination of resources across the broad areas and potential boundaries of research supported by the co-funding Institutes and Centers. Applicants should clearly demonstrate their institution s commitment to the current or proposed CFAR. Examples of the types of institutional commitment that are demonstrated at current CFARs include but are not limited to: level of institutional funding, space allocation, co-funding, endowments, faculty commitments, salary for Core staff, purchase of equipment, and designation of center program status in the institutional bylaws.
Other Attachments: The following Other Attachments should be included with the overall component in order to aid in the review of applications. The filename provided for each attachment will be the name used for the bookmark in the application image.
NIH AIDS Funded Research Base (FRB): Please title this attachment NIH FRB , and make sure the final spreadsheet is converted to a PDF file for uploading into ASSIST. NIH will provide applicants with a spreadsheet (Excel) indicating all investigators receiving NIH AIDS funding at an applicant's institution (or institutions if a multi-institution application), arranged by NIH Institute and Center. These spreadsheets are prepared by the NIH Office of AIDS Research (OAR) and are usually available in March or April. In the first column of the spreadsheet applicants should indicate those investigators who have formally agreed to participate in the CFAR, and the primary type of participation expected. Applicants should develop their own key table to abbreviate the type of participation(s) for each CFAR Member (i.e., Core Director = CD, core user = CU, attends seminars = S, etc.) and indicate the participation type in the first column. It is important that the CFAR be inclusive of the full range of HIV/AIDS research funded at a given institution. Therefore, review committees will be interested in why some investigators listed in the spreadsheet may have chosen not to be part of the CFAR. The reason for inclusion, or exclusion, of a given investigator should be addressed. A brief explanation should be included at the bottom of the table as to why investigators may not be participating as CFAR members.
Non-FRB HIV Investigators at the institution(s): Please title this attachment Other HIV/AIDS Investigators. Applicants may also indicate investigators at their institution(s) who will become part of the CFAR but who were not included in the spreadsheet (pdf file). This table should be developed by the applicant using the same columns as the FRB table to show other NIH and non-NIH funded HIV/AIDS investigators not listed on the FRB who will participate in the CFAR.
Existing Core Facilities at the Institution Applying for a CFAR Award: Please title this attachment (pdf file only for upload to ASSIST) Other Core Facilities. The NIH provides a table on the CFAR web site (http://www3.niaid.nih.gov/LabsAndResources/resources/cfar/interested/) for applicants to indicate all existing core facilities at the institution(s) and those that will be used by the CFAR.
Organizational charts
- Please title this Overall Organizational Chart and show where the CFAR fits with the overall institution(s).
- Please title this CFAR Organizational Chart and show the structure of the CFAR including the Cores, Scientific Working Groups, if applicable, and any Advisory Boards.
Project/Performance Site Location(s) (Overall)
Enter primary site only.
A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.
Research & Related Senior/Key Person Profile (Overall)
Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.
A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.
Budget (Overall)
The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.
Additional Budget Information; The size and maximum funding level of each award will depend on the type of CFAR award and the FRB of the applicant institution(s) as described below. The maximum funding level is determined by the NIH HIV/AIDS-funded research base (FRB), described in Section III, of an institution or group of institutions. A CFAR cannot use the FRB of an institution that is already part of another CFAR. The FRB of the previous fiscal year (defined as beginning October 1) to which an application is submitted will be used to determine eligibility.
D-CFAR: For institutions with a minimum FRB of $10M, a D-CFAR award will use a base of no more than $750,000 total costs in the first year.
CFAR: For institutions between the minimum FRB of $10M but less than $40M, a CFAR award will use a base of $1.5M total cost in the first year. For institutions with a minimum FRB of $40M but less than $80M, a CFAR award will use a base of $2.25M total cost in the first year. For institutions with a minimum FRB of $80M, a CFAR award will use a base of $3M total cost in the first year.
CFAR applications submitted under the grandfather clause will use a base of $1.5M total cost in the first year.
A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.
PHS 398 Research Plan (Overall)
Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component
Specific Aims: Describe aims of the overall center and outline how the different cores will contribute to these aims.
Research Strategy: Organize the Research Strategy into sections on; Significance, Innovation, and Approach. The Overall Research Strategy should describe the impact that a CFAR could have to enhance HIV/AIDS research at the applicant institution(s) and exert a sustained influence on the HIV/AIDS research field.
Use this section to describe the proposed Overall Research Strategy and the Strategic Plan of the CFAR and how it will contribute to meeting the goals and objectives of the CFAR Program as described above. Also, explain the rationale for selection of the strategies, opportunities, action plan and outcome measurements proposed to accomplish the specific aims.
Applicants are encouraged to contact the Scientific/Research Contact(s) at the end of this FOA to discuss planned strategies for fostering collaboration among HIV/AIDS investigators from divergent disciplines within the proposed CFAR. Renewal applicants should describe how any major HIV/AIDS programs at the CFAR institution supported by co-funding NIH Institutes and Centers, are assisted by CFAR. Specific programs funded by the co-funding institutes are listed in the table below.
Examples of programs are:
FIC: |
AITRP, IICHORTA-AIDS/TB, IRSDA, BIOETHICS TRAINING, INFORMATICS, BRAIN DISORDERS, GID, Fogarty HIV Training Program, Global Health Research and Research Training eCapacity Initiative, Framework Programs for Global Health Innovation, Global Health Program for Fellows and Scholars, MEPI |
NCI: |
|
NIA: |
Alzheimer's Disease Centers, Centers on the Demography and Economics of Aging, Claude D. Pepper Older Americans Independence Centers, Nathan Shock Centers of Excellence in the Basic Biology of Aging, Resource Centers for Minority Aging Research, Edward R. Roybal Centers for Translation Research in the Behavioral and Social Sciences of Aging, WHO Study on AGEing and adult health (SAGE) |
NICHD: |
|
NIDA: |
NIDA funded and co-funded programs: CTN, HIV/SU Clinical Cohorts, HIV Clinical Trials Networks, MACS, WIHS, ATN, PHACS |
NIAID: |
HIV/AIDS Clinical Trials Networks, MACS, WIHS, CHAVI, IeDEA, Martin Delaney Collaboratories |
NIGMS: |
|
NIMH: |
|
NINR: |
NINR-funded Programs |
Significance. The effect that a CFAR award would have on CFAR investigators HIV/AIDS research efforts.
- Succinctly summarize HIV/AIDS science at the institution or institutions that justifies the need for CFAR support. Renewal applicants should describe how any major HIV/AIDS programs at the CFAR institution supported by co-funding NIH Institutes and Centers, are assisted by CFAR.
- Describe how the CFAR provides added value to HIV/AIDS research conducted at the institution(s).
- Demonstrate the CFAR’s ability to support the research base, foster synergy, enhance HIV/AIDS research collaborations, and produce an economy of scale.
Innovation. The utilization of CFAR resources in unique ways to achieve the scientific goals of all HIV/AIDS investigators at the participating institution(s).
- Provide the degree of variety across the disciplines involved in HIV/AIDS research projects within the CFAR structure.
- Describe the unique ways resources (e.g., cores, cohorts, trials, technology, etc.) are incorporated and supported in the CFAR.
- Illustrate unique ways to incorporate community involvement and outreach in the CFAR.
- Identify and evaluate potential opportunities for use of CFAR funds.
Approach. The quality of the CFAR scientific planning and management process.
- Describe the CFAR organizational structure in the parent and any collaborating institutions.
- Provide an organizational chart for all CFAR components, CFAR director(s), and Core directors.
- Describe the leadership plan for the CFAR. This should include a rationale for choosing a multiple CFAR Co-Director approach if applicable. The roles and responsibilities of the CFAR Director and CFAR Core Directors should be described.
- Describe the major locations of CFAR activities, including those in collaborating institutions and discuss distances between locations. You may also wish to provide a chart or map illustrating the location and setting of the CFAR parent institution in relation to collaborating institutions, especially if there are Cores that are located outside of the parent institutions (e.g., Cores in a different country), and describe the functional relationships.
Progress Report (for renewal applications): Describe the overall accomplishments of the CFAR during the last funding period including a brief synopsis of progress in achieving the major aims of the CFAR. Identify the most significant findings that were facilitated or supported directly through CFAR infrastructure and resources. Highlight synergistic interactions with other NIH-funded HIV/AIDS programs; establishment of new collaborations; and the effectiveness of the core resources and facilities. Provide examples of how the presence of the CFAR has brought new investigators into the field and stimulated HIV/AIDS research in the last funding period.
Previous History in Support of a CFAR Application (for new applications): Describe the following in lieu of a progress report: preliminary organizational work, experience with HIV, potential for developing new and high impact research, added value to HIV/AIDS research at the institution, and specific plans for implementation of the CFAR.
Progress Report Publication List (for renewal applications): A list of published articles and reviews that acknowledge CFAR support in the previous project period should be included in the Progress Report Publication List.
Letters of Support: The applicant must provide a letter(s) from the appropriate institutional official(s) (e.g., Dean, President, or Provost) defining:
- Position, authority, and reporting responsibility (on the institution's organizational chart) for the CFAR Director
- Financial and other resource support for the CFAR that will be provided by the applicant institution(s)
Authority or influence that the CFAR Director has, and/or will have over other HIV/AIDS projects, facilities and space, as well as decision-making authority for hiring and/or approving new faculty and support personnel.
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 SF424 (R&R) Application Guide, with the following modification:
- All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When preparing your application in ASSIST, use Component Type Admin Core .
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Administrative Core)
Complete only the following fields:
- Applicant Information
- Type of Applicant (optional)
- Descriptive Title of Applicant’s Project: Use the title "Core A: Administrative Core"
- Proposed Project Start/Ending Dates
PHS 398 Cover Page Supplement (Administrative Core)
Enter Human Embryonic Stem Cells in each relevant component.
Research & Related Other Project Information (Administrative Core)
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete.
Project /Performance Site Location(s) (Administrative Core)
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Administrative Core)
- In the Project Director/Principal Investigator section of the
form, use Project Role of Other with Category of Core Director(s) and
provide a valid eRA Commons ID in the Credential field.
- In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
- Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
- If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
Budget (Administrative Core)
Budget forms appropriate for the specific component will be included in the application package.
CFAR Budget Items. Core budgets may include equipment, supplies, support contracts, and other necessary expenses. All items should be fully justified for allocation of CFAR funds.
Other administrative costs may include those necessary for the central administration and fiscal management of the CFAR, including relevant and reasonable costs for reprints, graphics, and publications for Developmental Core users.
Travel to CFAR Directors' Meeting(s). Attendance at the Annual CFAR Directors Meeting is required of the CFAR Director and the CFAR Administrator. Under extenuating circumstances a Core Director may attend in lieu of the CFAR Director. The CFAR Director is required since this is the venue for discussions on policy issues, new information related to the CFAR program and the potential for CFAR-to-CFAR scientific collaboration. One senior scientist per center may also receive financial support for the Annual CFAR Directors Meeting. Additional funds may be reallocated from the CFAR budget for other CFAR meetings during the year at the NIH, at a CFAR site, or at the site of a scientific conference that most of the Directors plan to attend. Applicants should include travel funds specifically for these meetings in the CFAR Administrative Core budget request.
Other Travel. Travel funds should not be used for travel to scientific meetings, nor should they be used for advertising and promotion. With justification, applicants may request travel to promote collaboration with CFAR Core Directors of similar cores to share operational and scientific expertise, including inter-CFAR collaborations. These additional travel funds should not exceed $40,000 annual direct costs for all other CFAR related travel. The procedures that the CFAR will follow on determining the use of these funds should be described clearly in the Policies and Procedures section of the Administrative Core.
Definition of Effort for CFAR Director and Core Directors. The effort requested should be limited to time devoted specifically to managing CFAR activities and not to research. The effort devoted to CFAR activities should be above that spent on research grants. Information documenting the level of effort on CFAR activities must be included in the application. All requested personnel costs should be carefully justified.
The effort of the CFAR Director should be justified in the context of the Director's other responsibilities. Administrative support (a secretary or an administrative assistant), which would otherwise be allowable only as a Facilities and Administrative Cost, should be requested for the CFAR office only for matters directly pertaining to the CFAR and must be well justified.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
PHS 398 Research Plan (Administrative Core)
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component
Specific Aims: Describe briefly how the Core administration will coordinate and manage activities across the CFAR and have an impact on the research infrastructure.
Research Strategy: Organize the Research Strategy into sections on: Significance, Innovation, and Approach.
Significance. Explain the role of the Administrative Core in the center as a whole and the responsibility of the Core for the overall administration, coordination and management of the Center.
Innovation. Explain the unique utilization of Core resources to achieve the scientific goals of all HIV/AIDS investigators at the participating institution(s).
Approach. A well-developed administrative plan is integral to the success of the Center and must be clearly defined in the application. The plan should include a discussion of the structure and roles of administrative staff, including the training and experience of proposed staff and the functions to be performed and a discussion on how the Center will ensure effective and timely communications between the Center and NIAID staff.
This Administrative Core should clearly identify personnel and resources needed to oversee the Center and ensure management of the Cores and Scientific Working Groups. The core must provide a clear and explicit discussion of how fiscal and other resources will be prioritized, allocated, and managed (see Policies and Procedures below). A description of how Cores and Scientific Working Groups will be managed, how communications such as periodic meetings and conference calls with minutes will be organized and managed should be provided. Each CFAR must have a well delineated organizational structure and administrative mechanisms that foster interactions among investigators, accelerate the pace of research, enable translation of basic research findings to clinical applications, and ensure a productive research effort.
An applicant's initial choice of Basic and Clinical Science Cores is an important measure of the science management process. Applicants should describe the Basic and Clinical Science Cores to be supported at the time that the CFAR is awarded, how the choice of cores was made, mechanisms for evaluating the utilization and added value contributions of proposed cores, criteria for increasing or decreasing funding of these cores, and process for adding or deleting cores during the course of the award.
Policies and Procedures. Applicants should describe policies and procedures for the current or proposed CFAR. Policies should be considered to be "a set of guiding principles of operation." There are no "correct" policies, and different CFARs may adopt different polices. Below are several examples of justifiable but not necessarily compatible policies that might be used to address funding issues. Funding issues are an example of an area that a CFAR considers in the development of policies and procedures.
- CFAR funding allocated by discipline in proportion to research performed in those disciplines
- CFAR funding allocated for projects based on a majority vote of all members in an individual CFAR
- CFAR funding allocated for projects based on majority vote of an internal advisory board
Procedures should be considered to be a set of specific actions used to conduct the affairs of the CFAR. Procedures should specify how various tasks will be accomplished within the policy guidelines of the CFAR. Policies and procedures should describe:
- the proposed roles of the CFAR Director, Core Directors, CFAR investigators, advisory boards, and institutional officials in the decision-making process
-
the annual strategic planning process; examples of issues CFAR
members should consider:
- how funds will be allocated to all types of cores and activities
- procedures for changes in support of any cores
- how CFAR-sponsored conferences, seminars, workshops, and other activities will be identified
- how priorities for communication, outreach and additional CFAR activities will be established
- how Cores, Core Directors, leaders of additional CFAR activities, internal and external advisory committees will be selected and evaluated
- the plans for leadership succession
- the authority and responsibility of internal and external advisory committees
- membership of Advisory committees
- how developmental projects are selected and evaluated
- how cores are selected and reports are developed, including the annual strategic plan and the noncompeting continuation application
- policies and procedures to add/delete Cores
- policies and procedures for identifying new Scientific Working Groups, and eliminating Scientific Working Groups after they either have achieved their goals or the Scientific Working Group has been deemed unproductive
- other mechanisms used to determine HIV/AIDS basic and clinical research core needs at the applicant institution(s), assigning priorities to potential cores, and selecting the Basic and Clinical Science Cores to be included in the application
Progress Report (for renewal applications): Describe the overall accomplishments of the Core during the last funding period including a brief synopsis of progress in achieving the major aims of the Core.
Dissemination and Access Plan. Explain how the Core s functions will be advertised and accessed by users, including outreach plans to increase Core usage. Every CFAR site should establish its own CFAR website that describes the Core facilities available at the CFAR, the services provided by each Core, and the contact information for the CFAR Director/Co-Director, Administrator, and Core Directors.
Protections of Human Subjects: All information on the protection of human subjects, and the inclusion of women, children, and minorities should be included in the section entitled Human Subjects in the Administrative Core. If there are details that pertain only to a specific Core, that additional information should also be included in the Human Subjects Section of that Core. Each Core should reference the Administrative Core section as appropriate. Human subjects protection issues on studies funded through other research grants should be addressed in those individual grant applications. For example, if the CFAR provides Virology Core services for an HIV/AIDS Clinical Trial Unit for ACTG studies, all human subjects issues will be addressed in the ACTG studies and not in the Virology Core.
All human subjects research supported by the CFAR and that uses CFAR infrastructure must follow the Office for Human Research Protections (OHRP) and NIH and NIAID guidelines for the protection of human subjects (http://grants.nih.gov/grants/policy/hs/index.htm). Thus, even though most clinical research conducted under the CFAR will be funded directly through other research grants, human subjects protection issues must be addressed not only on those grant applications, but also must be acknowledged in the CFAR application. For clinical research involving human subjects, or data/sample collection and storage that are funded directly by the CFAR, applicants must provide all required documentation demonstrating protection of human subjects and IRB approval. Please see the Clinical Science Core section for additional details. For Developmental Cores that are expected to fund future awards for clinical research it is sufficient to state the policies and procedures that are in place to address the requirements at that time. Please see the Developmental Core section for additional details.
Vertebrate Animals: All animal research supported by the CFAR and that uses CFAR infrastructure must follow the Office of Laboratory Animal Welfare (OLAW) and NIH guidelines for the protection of animals.
Letters of Support: Include letters of support if appropriate.
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 SF424 (R&R) Application Guide, with the following modification:
- All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Planned Enrollment Report (Administrative Core)
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
PHS 398 Cumulative Inclusion Enrollment Report (Administrative Core)
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
When preparing your application in ASSIST, use Component Type Core.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Developmental Core)
Complete only the following fields:
- Applicant Information
- Type of Applicant (optional)
- Descriptive Title of Applicant’s Project
- Proposed Project Start/Ending Dates
PHS 398 Cover Page Supplement (Developmental Core)
Enter Human Embryonic Stem Cells in each relevant component.
Research & Related Other Project Information (Developmental Core)
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete.
Other Attachments: Applicants who have current CFARs should include a table entitled Previous Recipients of Developmental Awards Table , which should describe the outcome evaluation of previously funded developmental projects. The time period should include all years for which the CFAR was funded. The applicant may use the Previous Recipients of Developmental Awards Table provided for this purpose on the CFAR web site (http://www3.niaid.nih.gov/LabsAndResources/resources/cfar/interested/) and upload this file (as a pdf) under "Other Attachments" with the title Previous Recipients of Developmental Awards.
Project /Performance Site Location(s) (Developmental Core)
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Developmental Core)
- In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Director and provide a valid eRA Commons ID in the Credential field.
- In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
- Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
- If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
Budget (Developmental Core)
Budget forms appropriate for the specific component will be included in the application package.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
CFAR Budget Items. Core budgets may include equipment, supplies, support contracts, and other necessary expenses. All items should be fully justified for allocation of CFAR funds.
Definition of Effort for Core Directors. The effort requested should be limited to time devoted specifically to managing CFAR activities and not to research. The effort devoted to CFAR activities should be above that spent on research grants. Information documenting the level of effort on CFAR activities must be included in the application. All requested personnel costs should be carefully justified.
The use of Developmental Core funds for junior faculty salary support is allowed. Established investigators with Research Project Grants (R01 or equivalent) are expected to have salary support from other sources.
Travel Funds. Travel funds should not be used for travel to scientific meetings, nor should they be used for advertising and promotion. The one exception is for junior investigators with no other funding who have received a CFAR developmental award. These investigators may receive CFAR funds in order to attend a meeting to present the results from their CFAR developmental award. CFAR funds cannot be used to provide travel scholarships for investigators without a CFAR developmental award.
PHS 398 Research Plan (Developmental Core)
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.
Specific Aims: Describe briefly how the Core will expand and promote the research priorities of the CFAR and how it will support the next generation of HIV/AIDS researchers.
Research Strategy: Organize the Research Strategy into sections on; Significance, Innovation, and Approach. Describe how the proposed activities will contribute to meeting the CFAR’s goals and objectives and explain the rationale for selection of the general methods and approaches proposed to accomplish the specific aims. This section should indicate the relevance of the Core to the Overall Research Strategy of the CFAR application.
Significance. The effect that a Core would have on CFAR investigators HIV/AIDS research efforts.
- Describe how the CFAR Core provides added value to HIV/AIDS research conducted at the institution(s).
- Demonstrate the Core’s ability to support the next generation of HIV/AIDS researchers and how the Core will work with other CFAR Cores to accomplish this.
- Describe the strengths of the Core.
Innovation. Explain the unique utilization of Core resources to achieve the scientific goals of all HIV/AIDS investigators at the participating institution(s).
Approach. The quality of the CFAR scientific planning and management process.
- Develop an action plan that capitalizes on the highest priority opportunities and develop a detailed plan for the first year.
- Determine how progress on action plans will be measured (i.e. outcome measurements).
- The Developmental Core section should include a plan for the use of the first year developmental funds.
- Describe how the Core plans to communicate the availability of funds for Developmental projects.
- Describe Core Policies and Procedures including:
- Roles in Decision-making Processes
- Reporting Processes
- Annual Strategic Planning Processes
- Allocation of Core budgets
Plans for managing resources to enable functioning of the Cores,
Process for reallocating funds within the Core as research needs change,
Applicants should describe decision-making policies and procedures for down-sizing the CFAR if funding is decreased in continuation years.
- Allocation of space
- Process of selecting developmental projects to be supported (e.g., the review process)
- Process for mentoring investigators who are or are not successful in obtaining developmental project funding
- Process for training early stage investigators in grant writing and scientific review
- Procedures for review and funding of projects for Scientific Working Groups, if applicable
- Outcome evaluation of developmental projects
New applicants should provide a list of potential pilot projects.
Progress Report (for renewal applications): Describe the outcomes of the Developmental Core, including publications, subsequent funding, and career advancement of the funded individuals. A renewal application should include: historical overview of the Developmental Core s pilot project program during the last funding cycle; a description of the management of the program; and a listing of all pilot projects which were supported during the last progress period. Most of this information can be included in the Previous Recipients of Developmental Awards Table. Applicants should also include a summary of activities carried out during the last funding cycle. Cleary delineate and report on the specific allocations of grant funds for pilot projects during the last funding cycle.
Protections of Human Subjects: All information on the protection of human subjects, and the inclusion of women, children, and minorities should be included in the section entitled Human Subjects in the Administrative Core. If there are details that pertain only to this specific Core, that additional information should also be included in this section.
Vertebrate Animals: All animal research supported by the CFAR and that uses CFAR infrastructure must follow the Office of Laboratory Animal Welfare (OLAW) and NIH guidelines for the protection of animals.
Letters of Support: Include letters of support if needed.
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 SF424 (R&R) Application Guide, with the following modification:
- All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Planned Enrollment Report (Developmental Core)
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
PHS 398 Cumulative Inclusion Enrollment Report (Developmental Core)
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
When preparing your application in ASSIST, use Component Type Core.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Basic Science Core)
Complete only the following fields:
- Applicant Information
- Type of Applicant (optional)
- Descriptive Title of Applicant’s Project
- Proposed Project Start/Ending Dates
PHS 398 Cover Page Supplement (Basic Science Core)
Enter Human Embryonic Stem Cells in each relevant component.
Research & Related Other Project Information (Basic Science Core)
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete.
Other Attachments: Applications should include a Core Utilization Table as a pdf file for ASSIST uploading.. The time period should include information from the most current 5-year project period of the CFAR grant. For new applicants, information on potential Core users should be provided. The applicant may use the Core Utilization Table provided for this purpose on the CFAR web site (http://www.niaid.nih.gov/LabsAndResources/resources/cfar/interested/Pages/default.aspx) and upload this file under Other Attachments with the title Core Utilization Table.
Project /Performance Site Location(s) (Basic Science Core)
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Basic Science Core)
- In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Director and provide a valid eRA Commons ID in the Credential field.
- In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
- Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
- If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
Budget (Basic Science Core)
Budget forms appropriate for the specific component will be included in the application package.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
CFAR Budget Items. Core budgets may include equipment, supplies, support contracts, and other necessary expenses. All items should be fully justified for allocation of CFAR funds.
Definition of Effort for Core Directors. The effort requested should be limited to time devoted specifically to managing CFAR activities and not to research. The effort devoted to CFAR activities should be above that spent on research grants. Information documenting the level of effort on CFAR activities must be included in the application. All requested personnel costs should be carefully justified.
Core Directors are CFAR members who are responsible for the overall technical excellence of a core facility. The CFAR-supported percent effort of Core Directors involved in research activities should only include core management time. The CFAR may support technical staff to provide CFAR services in core facilities.
Travel Funds. Travel funds should not be used for travel to scientific meetings, nor should they be used for advertising and promotion. With justification, applicants may request travel to promote collaboration with CFAR Core Directors of similar cores to share operational and scientific expertise, including inter-CFAR collaborations. Travel funds should not be used for travel to scientific meetings, nor should they be used for advertising and promotion. These additional travel funds should not exceed $40,000 annual direct costs for all other CFAR related travel.
Convincing justification is required for duplication of any Basic Science Core that exists in a similar form elsewhere in the applicant institution(s). Applicants should describe how cores with partial CFAR funding will be used to enhance the research of CFAR investigators. For example, a CFAR core supported by other funding (e.g., of an NIAID AIDS Clinical Trial Unit or an NCI Cancer Center core facility) may become more accessible to HIV/AIDS investigators through leveraging of existing resources by the CFAR.
PHS 398 Research Plan (Basic Science Core)
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.
Specific Aims: Clearly state how the core will contribute to the goals of the CFAR, how this core will provide services to HIV/AIDS research beyond what is currently available, and/or increase effectiveness by sharing expertise or centralizing labor-intensive tasks, how it will encourage and facilitate collaborative work, or provide training to new investigators.
Research Strategy: Organize the Research Strategy into sections on: Significance, Innovation, and Approach. CFAR applications should describe the Basic Science Cores to be supported at the time of the award and any changes anticipated during the course of the award. Describe how the proposed activities will contribute to meeting the CFAR’s goals and objectives and explain the rationale for selection of the general methods and approaches proposed to accomplish the specific aims. This section should indicate the relevance of the Core to the Overall Research Strategy of the CFAR application. Applicants should describe in detail the operation of each proposed Core, i.e., its quality control, procedures, safety, training, etc., and how the proposed policies and procedures protect and incorporate the divergent needs of CFAR investigators.
Significance. The effect that a Core would have on CFAR investigators HIV/AIDS research efforts.
- Describe how the CFAR Core provides added value to HIV/AIDS research conducted at the institution(s).
- Demonstrate the Core’s ability to support the research base, foster synergy, enhance HIV/AIDS research collaborations, and produce an economy of scale.
- Provide evidence that the Core enhances proposed scientific communication, outreach, training efforts, international collaborations, and collaborations with industry as applicable.
- Describe the strengths of the Core. Renewal applicants should describe how any major HIV/AIDS programs at the CFAR institution supported by co-funding NIH Institutes and Centers, are assisted by the Core.
Innovation. The utilization of Core resources in unique ways to achieve the scientific goals of all HIV/AIDS investigators at the participating institution(s).
- Describe projects supported in one paragraph.
- Cite Institute-specific programs supported by the Core, and be specific about how each Core will provide support.
Approach. The quality of the CFAR scientific planning and management process.
- Develop an action plan that capitalizes on the highest priority opportunities and develop a detailed plan for the first year.
- Determine how progress on action plans will be measured (i.e. outcome measurements).
-
Describe Core Policies and Procedures including:
- Roles in Decision-making Processes
- Reporting Processes
- Annual Strategic Planning Processes
- Allocation of Core budgets
Plans for managing resources to enable functioning of the Cores,
Process for reallocating funds within the Core as research needs change,
Applicants should describe decision-making policies and procedures for down-sizing the CFAR if funding is decreased in continuation years.
- Allocation of space
- Core usage - A Basic Science Core should be designed to support multiple HIV/AIDS investigators, and applicants should indicate the number of anticipated users and the percent time of use by each. The CFAR table on Core Utilization should be included to provide some of this information.
- Prioritization of services - Mechanisms should be described to prioritize core usage even if prioritization is not currently required, evaluate use annually, and justify level of continued CFAR support in the context of evolving scientific priorities at the applicant institution(s).
- Program Income System - Each CFAR Core, where appropriate, is encouraged to phase-in a Program Income System- a method of charging users of the Core Facility a fee commensurate with their usage of equipment, time, supplies (such as reagents) and personnel providing the service. The program income costs would then be budgeted within the users' research grants, resulting in a gradual increase in funds from this source, and a decreased cost to the CFAR over the award period. These freed funds from the CFAR award, originally allocated for the establishment of Core Support Facilities proposed in the initial application, could consequently be rebudgeted ( in consultation with NIH) to the Developmental Core, and/or be used to establish a new Core(s) or expand existing Cores as the Center evolves. Applicants should be aware that program income may be generated.
- The CFAR is strongly encouraged to establish a Program Income plan by the end of the first year of the award and to include it in the non-competing continuation application for the second year and in each subsequent non-competing year. Program income should be described for all applicable Cores year.
Progress Report (for renewal applications) - Describe the overall accomplishments of the Core during the last funding period including a brief synopsis of progress in achieving the major aims of the Core and some examples of projects supported by the Core.
Progress Report Publication List (for renewal applications): A list of published articles and reviews that acknowledge CFAR support in the previous project period should be included in the Progress Report Publication List.
Protections of Human Subjects: All information on the protection of human subjects, and the inclusion of women, children, and minorities should be included in the section entitled Human Subjects in the Administrative Core. If there are details that pertain only to this specific Core, that additional information should also be included here.
Vertebrate Animals: CFAR Cores proposing direct work with vertebrate animals must provide full Vertebrate Animals Research sections as per SF 424 (R&R) Application Instructions. All animal research supported by the CFAR and that uses CFAR infrastructure must follow the Office of Laboratory Animal Welfare (OLAW) and NIH guidelines for the protection of animals.
Letters of Support: Include letters of support if needed.
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 SF424 (R&R) Application Guide, with the following modification:
- All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Planned Enrollment Report (Basic Science Core)
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
PHS 398 Cumulative Inclusion Enrollment Report (Basic Science Core)
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
When preparing your application in ASSIST, use Component Type Core.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Clinical Science Core)
Complete only the following fields:
- Applicant Information
- Type of Applicant (optional)
- Descriptive Title of Applicant’s Project
- Proposed Project Start/Ending Dates
PHS 398 Cover Page Supplement (Clinical Science Core)
Enter Human Embryonic Stem Cells in each relevant component.
Research & Related Other Project Information (Clinical Science Core)
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete.
Other Attachments: Applications should include a Core Utilization Table as a pdf file for upload into ASSIST. The time period should include information from the most current 5-year project period of the CFAR grant. For new applicants, information on potential Core users should be provided. The applicant may use the Core Utilization Table provided for this purpose on the CFAR web site (http://www.niaid.nih.gov/LabsAndResources/resources/cfar/interested/Pages/default.aspx) and upload this file under Other Attachments with the title Core Utilization Table .
Project /Performance Site Location(s) (Clinical Science Core)
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Clinical Science Core)
- In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Director and provide a valid eRA Commons ID in the Credential field.
- In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
- Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
- If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
Budget (Clinical Science Core)
Budget forms appropriate for the specific component will be included in the application package.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
CFAR Budget Items. Core budgets may include equipment, supplies, support contracts, and other necessary expenses. All items should be fully justified for allocation of CFAR funds.
Definition of Effort for Core Directors. The effort requested should be limited to time devoted specifically to managing CFAR activities and not to research. The effort devoted to CFAR activities should be above that spent on research grants. Information documenting the level of effort on CFAR activities must be included in the application. All requested personnel costs should be carefully justified.
Core Directors are CFAR members who are responsible for the overall technical excellence of a core facility. The CFAR-supported percent effort of Core Directors involved in research activities should only include core management time. The CFAR may support technical staff to provide CFAR services in core facilities.
Travel Funds. Travel funds should not be used for travel to scientific meetings, nor should they be used for advertising and promotion. With justification, applicants may request travel to promote collaboration with CFAR Core Directors of similar cores to share operational and scientific expertise, including inter-CFAR collaborations. Travel funds should not be used for travel to scientific meetings, nor should they be used for advertising and promotion. These additional travel funds should not exceed $40,000 annual direct costs for all other CFAR related travel.
Convincing justification will be required for duplication of any Clinical Science Core that exists in a similar form elsewhere in the applicant institution(s). Applicants should describe how cores with partial CFAR funding will be used to enhance the research of CFAR investigators. For example, a CFAR core supported by other funding (e.g., of an NIAID AIDS Clinical Trial Unit or an NCI Cancer Center core facility) may become more accessible to HIV/AIDS investigators through leveraging of existing resources by the CFAR.
PHS 398 Research Plan (Clinical Science Core)
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.
Specific Aims: Clearly state how the core will contribute to the goals of the CFAR, how this core will provide services to HIV/AIDS research beyond what is currently available, and/or increase effectiveness by sharing expertise or centralizing labor-intensive tasks, how it will encourage and facilitate collaborative work, or provide training to new investigators.
Research Strategy: Organize the Research Strategy into sections on: Significance, Innovation, and Approach. CFAR applications should describe the Clinical Science Cores to be supported at the time of the award and any changes anticipated during the course of the award. Describe how the proposed activities will contribute to meeting the CFAR’s goals and objectives and explain the rationale for selection of the general methods and approaches proposed to accomplish the specific aims. This section should indicate the relevance of the Core to the Overall Research Strategy of the CFAR application. Applicants should describe in detail the operation of each proposed Core, i.e., its quality control, procedures, safety, training, etc., and how the proposed policies and procedures protect and incorporate the divergent needs of CFAR investigators.
Significance. The effect that a Core would have on CFAR investigators HIV/AIDS research efforts.
- Describe how the CFAR Core provides added value to HIV/AIDS research conducted at the institution(s).
- Demonstrate the Core’s ability to support the research base, foster synergy, enhance HIV/AIDS research collaborations, and produce an economy of scale.
- Provide evidence that the Core enhances proposed scientific communication, outreach, training efforts, international collaborations, and collaborations with industry as applicable.
- Describe the strengths of the Core. Renewal applicants should describe how any major HIV/AIDS programs at the CFAR institution supported by co-funding NIH Institutes and Centers, are assisted by the Core.
Innovation. The utilization of Core resources in unique ways to achieve the scientific goals of all HIV/AIDS investigators at the participating institution(s).
- Describe projects supported in one paragraph.
- Cite Institute-specific programs supported by the Core, and be specific about how each Core will provide support.
Approach. The quality of the CFAR scientific planning and management process.
- Develop an action plan that capitalizes on the highest priority opportunities and develop a detailed plan for the first year.
- Determine how progress on action plans will be measured (i.e. outcome measurements).
- Describe Core Policies and Procedures including:
- Roles in Decision-making Processes
- Reporting Processes
- Annual Strategic Planning Processes
- Allocation of Core budgets
Plans for managing resources to enable functioning of the Cores,
Process for reallocating funds within the Core as research needs change,
Applicants should describe decision-making policies and procedures for down-sizing the CFAR if funding is decreased in continuation years.
- Allocation of space
- Core usage - A Clinical Science Core should be designed to support multiple HIV/AIDS investigators, and applicants should indicate the number of anticipated users and the percent time of use by each. The CFAR table on Core Utilization should be included to provide some of this information.
- Prioritization of services - Mechanisms should be described to prioritize core usage even if prioritization is not currently required, evaluate use annually, and justify level of continued CFAR support in the context of evolving scientific priorities at the applicant institution(s).
- Program Income System - Each CFAR Core, where appropriate, is encouraged to phase-in a Program Income System- a method of charging users of the Core Facility a fee commensurate with their usage of equipment, time, supplies (such as reagents) and personnel providing the service. The program income costs would then be budgeted within the users' research grants, resulting in a gradual increase in funds from this source, and a decreased cost to the CFAR over the award period. These freed funds from the CFAR award, originally allocated for the establishment of Core Support Facilities proposed in the initial application, could consequently be rebudgeted ( in consultation with NIH) to the Developmental Core, and/or be used to establish a new Core(s) or expand existing Cores as the Center evolves. Applicants should be aware that program income may be generated.
- The CFAR is strongly encouraged to establish a "Program Income" plan by the end of the first year of award and to include it in the non-competing continuation application for the second year and in each subsequent non-competing year. Program income should be described for all applicable Cores.
Progress Report (for renewal applications) - Describe the overall accomplishments of the Core during the last funding period including a brief synopsis of progress in achieving the major aims of the Core and some examples of projects supported by the Core.
Progress Report Publication List (For renewal applications): A list of published articles and reviews that acknowledge CFAR support in the previous project period should be included in the Progress Report Publication List.
Protections of Human Subjects: All information on the protection of human subjects, and the inclusion of women, children, and minorities should be included in the section entitled Human Subjects in the Administrative Core. Each Core should reference the Administrative Core section as appropriate. See Administrative Core under Human Subjects for more details.
If there are details that pertain only to the Clinical Science Core, additional information should be included here in the Human Subjects Section of the Clinical Science Core.
Vertebrate Animals: All information on Animal Research should be included in the section entitled Vertebrate Animals in the Administrative Core. If there are details that pertain only to this specific Core, that additional information should also be included in this section.
Letters of Support: Include letters of support if needed.
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 SF424 (R&R) Application Guide, with the following modification:
- All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Planned Enrollment Report (Clinical Science Core)
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
PHS 398 Cumulative Inclusion Enrollment Report (Clinical Science Core)
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
When preparing your application in ASSIST, use Component Type Core.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Additional Core(s))
Complete only the following fields:
- Applicant Information
- Type of Applicant (optional)
- Descriptive Title of Applicant’s Project
- Proposed Project Start/Ending Dates
PHS 398 Cover Page Supplement (Additional Core(s))
Enter Human Embryonic Stem Cells in each relevant component.
Research & Related Other Project Information (Additional Core(s))
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete.
Other Attachments: The application should include a Core Utilization Table as a pdf file uploaded into ASSIST. The time period should include information from the most current 5-year project period of the CFAR grant. For new applicants, information on potential Core users should be provided. The applicant may use the Core Utilization Table provided for this purpose on the CFAR web site (http://www.niaid.nih.gov/LabsAndResources/resources/cfar/interested/Pages/default.aspx) and upload this file under Other Attachments with the title Core Utilization Table.
Project /Performance Site Location(s) (Additional Core(s))
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Additional Core(s))
- In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Director and provide a valid eRA Commons ID in the Credential field.
- In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
- Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
- If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
Budget (Additional Core(s))
Budget forms appropriate for the specific component will be included in the application package.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
CFAR Budget Items. Core budgets may include equipment, supplies, support contracts, and other necessary expenses. All items should be fully justified for allocation of CFAR funds.
Definition of Effort for Core Directors. The effort requested should be limited to time devoted specifically to managing CFAR activities and not to research. The effort devoted to CFAR activities should be above that spent on research grants. Information documenting the level of effort on CFAR activities must be included in the application. All requested personnel costs should be carefully justified.
Core Directors are CFAR members who are responsible for the overall technical excellence of a core facility. The CFAR-supported percent effort of Core Directors involved in research activities should only include core management time. The CFAR may support technical staff to provide CFAR services in core facilities.
Travel Funds. Travel funds should not be used for travel to scientific meetings, nor should they be used for advertising and promotion. With justification, applicants may request travel to promote collaboration with CFAR Core Directors of similar cores to share operational and scientific expertise, including inter-CFAR collaborations. Travel funds should not be used for travel to scientific meetings, nor should they be used for advertising and promotion. These additional travel funds should not exceed $40,000 annual direct costs for all other CFAR related travel.
PHS 398 Research Plan (Additional Core(s))
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.
Specific Aims: Clearly state how the core will contribute to the goals of the CFAR, how this core will provide services to HIV/AIDS research beyond what is currently available, and/or increase effectiveness by sharing expertise or centralizing labor-intensive tasks, how it will encourage and facilitate collaborative work, or provide training to new investigators.
Research Strategy: Organize the Research Strategy into sections on: Significance, Innovation, and Approach. Describe how the proposed activities will contribute to meeting the CFAR’s goals and objectives and explain the rationale for selection of the general methods and approaches proposed to accomplish the specific aims. This section should indicate the relevance of the Core to the Overall Research Strategy of the CFAR application. Applicants should describe in detail the operation of each proposed Core, i.e., its quality control, procedures, safety, training, etc., and how the proposed policies and procedures protect and incorporate the divergent needs of CFAR investigators.
Significance. The effect that a Core would have on CFAR investigators HIV/AIDS research efforts.
- Describe how the CFAR Core provides added value to HIV/AIDS research conducted at the institution(s).
- Demonstrate the Core’s ability to support the research base, foster synergy, enhance HIV/AIDS research collaborations, and produce an economy of scale.
- Provide evidence that the Core enhances proposed scientific communication, outreach, training efforts, international collaborations, and collaborations with industry as applicable.
- Describe the strengths of the Core. Renewal applicants should describe how any major HIV/AIDS programs at the CFAR institution supported by co-funding NIH Institutes and Centers, are assisted by the Core.
Innovation. The utilization of Core resources in unique ways to achieve the scientific goals of all HIV/AIDS investigators at the participating institution(s).
- Describe projects supported in one paragraph.
- Cite Institute-specific programs supported by the Core, and be specific about how each Core will provide support.
Approach. The quality of the CFAR scientific planning and management process.
- Develop an action plan that capitalizes on the highest priority opportunities and develop a detailed plan for the first year.
- Determine how progress on action plans will be measured (i.e. outcome measurements).
- Describe Core Policies and Procedures including:
- Roles in Decision-making Processes
- Reporting Processes
- Annual Strategic Planning Processes
- Allocation of Core budgets
Plans for managing resources to enable functioning of the Cores,
Process for reallocating funds within the Core as research needs change,
Applicants should describe decision-making policies and procedures for down-sizing the CFAR if funding is decreased in continuation years.
- Allocation of space
- Core usage A Core should be designed to support multiple HIV/AIDS investigators, and applicants should indicate the number of anticipated users and the percent time of use by each. The CFAR table on Core Utilization should be included to provide some of this information.
- Prioritization of services - Mechanisms should be described to prioritize core usage even if prioritization is not currently required, evaluate use annually, and justify level of continued CFAR support in the context of evolving scientific priorities at the applicant institution(s).
Progress Report (for renewal applications) - Describe the overall accomplishments of the Core during the last funding period including a brief synopsis of progress in achieving the major aims of the Core and some examples of projects supported by the Core.
Progress Report Publication List (For renewal applications): A list of published articles and reviews that acknowledge CFAR support in the previous project period should be included in the Progress Report Publication List.
Protections of Human Subjects: All information on the protection of human subjects, and the inclusion of women, children, and minorities should be included in the section entitled Human Subjects in the Administrative Core. Each Core should reference the Administrative Core section as appropriate. See Administrative Core under Human Subjects for more details.
If there are details that pertain only to this Core, additional information should be included here in the Human Subjects Section.
Vertebrate Animals: All information on Animal Research should be included in the section entitled Vertebrate Animals in the Administrative Core. If there are details that pertain only to this specific Core, that additional information should also be included in this section.
Letters of Support: Include letters of support if needed.
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 SF424 (R&R) Application Guide, with the following modification:
- All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Planned Enrollment Report (Additional Core(s))
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
PHS 398 Cumulative Inclusion Enrollment Report (Additional Core(s))
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
When preparing your application in ASSIST, use Component Type SWG.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Scientific Working Groups)
Complete only the following fields:
- Applicant Information
- Type of Applicant (optional)
- Descriptive Title of Applicant’s Project
- Proposed Project Start/Ending Dates
PHS 398 Cover Page Supplement (Scientific Working Groups)
Enter Human Embryonic Stem Cells in each relevant component.
Research & Related Other Project Information (Scientific Working Groups)
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete.
Other Attachments: A table listing Scientific Working Group members should be included under Other Attachments" with the title SWG Members. (as a pdf file into ASSIST) The table should provide enough detail to show the interdisciplinary nature of the SWG.
Project /Performance Site Location(s) (Scientific Working Groups)
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Scientific Working Groups)
- In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Scientific Working Group Director and provide a valid eRA Commons ID in the Credential field.
- To ensure adequate size and quality, a proposed SWG must consist of a minimum of three independent investigators who are conducting separate peer-reviewed and funded research projects in a related scientific area.
- In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
- Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
- If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
Budget (Scientific Working Groups)
Budget forms appropriate for the specific component will be included in the application package.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
PHS 398 Research Plan (Scientific Working Groups)
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component
Specific Aims: Clearly state how the Scientific Working Group (SWG) will contribute to the goals of the CFAR and outline interactions of the SWG with the cores (and other scientific working groups, if relevant) of the center.
Research Strategy: Organize the Research Strategy into sections on: Significance, Innovation, and Approach. Describe how the SWG will contribute to meeting the CFAR’s goals and objectives and explain the rationale for selection of the general methods and approaches proposed to accomplish the specific aims. This section should indicate the relevance of the SWG to the Overall Research Strategy of the CFAR application.
Before developing this part of the application, investigators are strongly encouraged to discuss plans with appropriate NIH representatives identified under "Scientific/Research Contact(s).
Significance. The effect that a SWG would have on CFAR investigators HIV/AIDS research efforts.
- Describe how the CFAR SWG provides added value to HIV/AIDS research conducted at the institution(s).
- Demonstrate the SWG’s ability to foster synergy and enhance HIV/AIDS research collaborations, including bringing in investigators from outside the field of HIV/AIDS research.
- Provide evidence that the SWG enhances proposed scientific communication, outreach, training efforts.
- Describe the strengths of the SWG.
Innovation. Explain the unique utilization of SWG(s) to achieve the scientific goals of the CFAR and to foster collaboration across investigators from multiple disciplines, including those outside the field of HIV/AIDS research.
Approach. The quality of the CFAR scientific planning and management process.
- Develop an action plan that capitalizes on the highest priority opportunities and develop a detailed plan for the first year.
- Determine how progress on action plans will be measured (i.e. outcome measurements).
- Describe Scientific Working Group Policies and Procedures
including:
- Roles in Decision-making Processes
- Reporting Processes
- Annual Strategic Planning Processes
- The SWG should be of adequate size and scientific quality, should exhibit a high degree of interaction, encouraged to be multi-disciplinary, and should have stated goals. Describe the stated goals, size and scientific quality of the SWG. Provide details on how the SWGs are multidisciplinary and will assure a high degree of interaction.
Progress Report (for renewal applications) - Describe the overall accomplishments of the SWGs during the last funding period including a brief synopsis of progress in achieving the major aims of the SWGs.
At the time of submission, applicants should identify a SWG Director(s), the members of the SWG(s), and specific plans that will be used to develop collaborative activities. In addition, procedures for identifying scientific studies, reviewing applications, and choosing studies to be submitted to the Developmental Core or to external funding opportunities, should be clearly identified.
Progress Report Publication List (for renewal applications): A list of published articles and reviews that acknowledge CFAR support in the previous project period should be included in the Progress Report Publication List.
Letters of Support: Include letters of support if needed.
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 SF424 (R&R) Application Guide, with the following modification:
- All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Planned Enrollment Report (Scientific Working Groups)
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
PHS 398 Cumulative Inclusion Enrollment Report (Scientific Working Groups)
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
Important
reminders:
All PD(s)/PI(s) and component Project Leads must include their
eRA Commons ID in the Credential field of the Senior/Key Person Profile
Component of the SF424(R&R) Application Package. Failure to register
in the Commons and to include a valid PD/PI Commons ID in the credential field
will prevent the successful submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management (SAM). Additional information may
be found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.
Important Update: See
NOT-OD-16-006
for updated review language for applications for due dates on or after January 25, 2016.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following: The CFAR program provides administrative and shared research support to synergistically enhance and coordinate high quality HIV/AIDS research projects. CFARs accomplish this through core facilities that provide expertise, resources, and services not otherwise readily obtained through more traditional funding mechanisms. The CFAR program emphasizes the importance of interdisciplinary collaboration to promote translational research and encourages mentoring and training of young investigators.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? How will the CFAR enhance proposed scientific communication, outreach, training efforts, international collaborations, and collaborations with industry? How does the proposed CFAR provide special synergies? Is there a significant need for coordination of HIV-related science at the institution, and will the CFAR serve as the primary coordinating unit for the institution(s)’s HIV-related science? Does the added value contribution of the CFAR go beyond what could be expected with the pre-existing HIV/AIDS research funding base? Is there a large base of investigators who will access core services and derive benefits from the CFAR?
In addition to the above, for the proposed D-CFAR, is there a high likelihood that a D-CFAR will lead to development of a competitive standard CFAR application?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Do the proposed CFAR Director(s) have appropriate managerial experience, commitment, and leadership both in HIV/AIDS research and at the applicant institution(s)?
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?
Within the CFAR structure is there sufficient diversity of topics across the disciplines involved in HIV/AIDS research projects, and are they fully committed to participation and coordination within the Center? Does the CFAR adequately describe innovative ways to integrate Cores, projects, technology, cohorts, trials etc. using CFAR and other funds in order to achieve the scientific goals stated in the application?
For D-CFARS only, the following additional questions must be addressed. Is the proposed strategy for expanding the D-CFAR’s focus an innovative utilization of resources to achieve the scientific goals of all HIV/AIDS investigators at the participating institution(s)?
Approach
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success presented?
If the project is in the early stages of development, will the strategy
establish feasibility and will particularly risky aspects be managed?
If the project involves human subjects and/or NIH-defined clinical research, are
the plans to address 1) the protection of human subjects from research risks,
and 2) inclusion (or exclusion) of individuals on the basis of sex/gender,
race, and ethnicity, as well as the inclusion or exclusion of children,
justified in terms of the scientific goals and research strategy proposed? Is
the organizational structure under which the CFAR proposes to operate
appropriate?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Does the application provide sufficient evidence that the CFAR provides added value to HIV/AIDS research conducted at the institution? Does the applicant institution have an appropriate history of translational research efforts? Are efforts towards community involvement and outreach adequately described and appropriate? Does the scientific environment at the CFAR effectively promote collaboration through Scientific Working Group(s)?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
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 Guidelines
for the Review of Human Subjects.
Inclusion of Women, Minorities, and Children
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
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
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewals
For Renewals, the committee will consider the progress made in the last funding period.
Revisions
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
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 consider each of the review criteria below in the determination of scientific merit, but will not give separate scores for these items: reviewers will provide a single overall impact/priority score per core. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a core that by its nature is not innovative may be essential to advance a field.
Significance
Does the core address an important problem or a critical barrier to progress in the field? If the aims of the core 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? Will the Cores have the ability to support the research base, foster synergy, enhance HIV/AIDS research collaborations, provide added value, and produce an economy of scale as best evidenced by specific CFAR-supported increases in research productivity across the entire NIH AIDS Funded Research Base? Are the cores and their services specifically targeted to HIV/AIDS research?
Investigator(s)
Are the PD/PIs, collaborators, and other researchers well suited to the core? 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 core is collaborative, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the core? Do the proposed Core Directors and key personnel have appropriate qualifications, competence and commitment?
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 core? Are potential problems, alternative strategies, and benchmarks for success presented? If the core is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
Does the annual strategic planning process adequately describe CFAR scientific and management plans? Are the policies and procedures for evaluating Cores, Scientific Working Group(s) and project(s), for reassigning funding priorities and for developing and utilizing outcome measurements, appropriate and do they reflect a high quality CFAR scientific planning and management process? Do the methods for selecting Basic and Clinical Science Core users and for prioritizing their use reflect a high quality CFAR scientific planning and management process? Is the management of the fiscal plan appropriate for the CFAR strategy? Are policies and procedures for obtaining assessments from HIV/AIDS investigators about the CFAR’s ability to meet their research needs adequate and appropriate?
Does the Dissemination and Access plan for the
Administrative Core ensure that the core’s resources, services and expertise
will be widely used, with easy and fair access to the appropriate users?
If the core involves clinical research, are the plans
for 1) protection of human subjects from research risks, and 2) inclusion of
minorities and members of both sexes/genders, as well as the inclusion of
children, justified in terms of the scientific goals and research strategy
proposed? Do the Developmental Core's procedures effectively demonstrate
function and effectiveness in selecting projects and performing outcome
evaluations?
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 core proposed? Will the core benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Is there adequate Institutional commitment, including space, financial support and other resources and oversight for CFAR activities? For renewals, is there a previous history of CFAR support for developmental projects and outcomes?
Additional Review Criteria Cores
As applicable for the core 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 core 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
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the core.
Renewals
For Renewals, the committee will consider the progress made in the last funding period.
Revisions
Not Applicable
As applicable for the core 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 consider each of the review criteria below in the determination of scientific merit, but will not give separate scores for these items: reviewers will provide a single overall impact/priority score for each SWG proposed. 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 SWG address an important problem or a critical barrier to progress in the field? If the aims of the SWG 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?
Investigator(s)
Are the PD/PIs, collaborators, and other researchers well suited to the SWG? 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 SWG is collaborative do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the SWG?
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 SWG? Are
potential problems, alternative strategies, and benchmarks for success
presented? If the SWG is in the early stages of development, will the strategy
establish feasibility and will particularly risky aspects be managed?
If the SWG involves clinical research, are the plans for 1) protection of human
subjects from research risks, and 2) inclusion of minorities and members of
both sexes/genders, as well as the inclusion of children, justified in terms of
the scientific goals and research strategy proposed?
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 SWG proposed? Will the SWG benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Does the scientific environment at the CFAR effectively promote collaboration through SWGs?
As applicable for the SWG 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 SWG 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
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the SWG.
Renewals
For Renewals, the committee will consider the progress made in the last funding period.
Revisions
Not Applicable
Additional Review Considerations Scientific Working Groups
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/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 NIAID, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
- Will receive a written critique.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. 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:
- Scientific and technical merit of the proposed project as determined by scientific peer review.
- Availability of funds.
- Relevance of the proposed project to program priorities.
- The extent to which the CFAR’s activities would be coordinated with similar efforts by other organizations.
- The degree to which CFAR activities will add value to the HIV/AIDS research, provide economies of scale, and create synergy at the applicant institution(s).
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to the DUNS, SAM
Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
Awardee-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation.
- The awardee institution will provide NIH with written study protocols that address risks and protections for human subjects in accordance with NIH s Instructions for Preparing the Human Subjects Section of the Research Plan.
- The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.
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.
Cooperative Agreement Terms and Conditions of Award
Not Applicable
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement. Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.
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.
eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
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regarding Grants.gov registration and submission, downloading forms and
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Telephone: 301-710-0267
TTY: 301-451-5936
Email: [email protected]
Ann Namkung Lee, M.P.H.
National Institute of Allergy and Infectious Diseases
Telephone: (240) 627-3099
Email: [email protected]
Jeanne McDermott, CNM, M.P.H., Ph.D.
Fogarty International Center
Telephone: (301) 496-1492
Email: [email protected]
Geraldina Dominguez, Ph.D.
National Cancer Institute
Telephone: (301) 496-3204
Email: [email protected]
Basil A. Eldadah, M.D., Ph.D.
National Institute on Aging
Telephone: (301) 496-6761
Email: [email protected]
Susan F. Newcomer, Ph.D.
Eunice Kennedy Shriver Kennedy National Institute of Child Health and
Human Development
Telephone: (301) 435-6981
Email: [email protected]
Paul Kimmel, M.D.
National Institute of Diabetes and Digestive Kidney Diseases
Telephone: (301) 594-1409
Email: [email protected]
Jag Khalsa, Ph.D.
National Institute on Drug Abuse
Telephone: (301) 443-2159
Email: [email protected]
Michael Sakalian, Ph.D.
National Institute of General Medical Sciences
Telephone: (301) 594-0828
Email: [email protected]
Christopher Gordon, Ph.D.
National Institute of Mental Health
Telephone: (301) 443-1613
Email: [email protected]
Francisco S. Sy, MD, DrPH
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-496-7074
Email: [email protected]
Peter R. Jackson, Ph.D.
National Institute of Allergy and Infectious Diseases
Telephone: 240-669-5049
Email: [email protected]
Leslie Boggs
National Institute of Allergy and Infectious Diseases
Telephone: 240-669-2970
Email: [email protected]
Shane Woodward
National Cancer Institute
Telephone: (240) 276-6303
Email: [email protected]
Elizabeth Whittington
Fogarty International Center
Telephone: 301.451.6830
Email: [email protected]
Deborah Stauffer
National Institute on Aging
Telephone: (301) 402-7734
Email: [email protected]
Pamela G. Fleming
National Institute of Drug Abuse
Telephone: (301) 253-8729
Email: [email protected]
E. C. Melvin
National Institute of General Medical Sciences
Telephone: (301) 594-3912
Email: [email protected]
Bryan Clark
Eunice Kennedy Shriver Kennedy National Institute of
Child Health and Human Development
Telephone: (301) 435-6975
Email: [email protected]
Diana Ly
National Institute of Diabetes and Digestive Kidney Diseases
Telephone: (301) 594-9249
Email: [email protected]
Rita Sisco
National Institute of Mental Health
Telephone: (301) 443-2805
Email: [email protected]
Priscilla Grant, J.D.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
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.
