and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov/)
Title: Phased Innovation Awards (R21/R33) in AIDS Vaccine Research
Announcement Type
This Program Announcement is a reissue and modification of PA-03-082, which was previously released March 20, 2003.
Update: The following update relating to this announcement has been issued:
Looking Ahead: As part of the Department of Health and Human Services' implementation of e-Government, during FY 2006 the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using Grants.gov. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html). Specific funding opportunity announcements will also clearly indicate if Grants.gov submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site (http://grants.nih.gov/grants/forms.htm) for the most current information when preparing a grant application.
Program Announcement (PA) Number: PA-06-109
Catalog of Federal Domestic Assistance Number(s)
93.855, 93.856
Key Dates
Release Date: December 23, 2005
Application Submission Dates(s): May 1, 2006
Peer Review Date(s): June/July 2006
Council Review Date(s): September 2006
Earliest Anticipated Start Date: October 1, 2006
Expiration Date: May 2, 2006 (NOTE: This announcement will be reissued for submission dates beyond May 1, 2006 because electronic submission of SF424 (R&R) applications via Grants.Gov will be required.)
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].
Telecommunications for the hearing impaired is available at: TTY 301-451-5936
Table of ContentsPart I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information - Required Federal Citations
1. Research Objectives
BACKGROUND
Every year approximately five million people worldwide are infected with the human immunodeficiency virus (HIV), the virus that causes the Acquired Immunodeficiency Disease Syndrome (AIDS). Almost 14,000 people become newly infected each day and 45 million additional infections are projected to occur by 2010 unless more effective measures are taken to prevent new infections. The human and economic toll of HIV/AIDS has made the development of a safe and effective prophylactic vaccine against HIV/AIDS one of the highest priorities of the National Institutes of Health (NIH). Within NIH, the NIAID has a lead role in this endeavor and supports a number of research programs using multiple grant and contract funding mechanisms. The Innovation Grant Program for AIDS Vaccine Research is one among several such programs, and since 1997 has served as the main entry point and solicitation source of applications for exploring as yet untested novel approaches. More research is needed to understand the immune parameters required for vaccine-elicited protection, AIDS vaccine design, and development of adjuvants that focus on inducting persistent mucosal and systemic immune responses against this virus.
PURPOSE OF THIS PA
This program announcement (PA), Phased Innovation Awards (PIA) in AIDS Vaccine Research, is a continuation and modification of the previous Innovation Grant Program for AIDS Vaccine Research, implemented by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS). This program will support prophylactic vaccine research projects that are innovative, novel, may be high risk/high impact, and that exhibit the potential to advance AIDS prophylactic vaccine design or evaluation. This PA uses the NIH Phased Innovation Award mechanism (R21/R33). Awarded projects will first be tested in milestone-driven exploratory/feasibility proof of concept studies (R21 phase); and then, if eligible, will be reviewed for the expanded development (R33 phase) award without the need of submitting an additional grant application. The phased R21/R33 mechanism offers the potentially successful PI the opportunity to devote full attention to the research project without the burden of additional grant writing for continued support, and will permit promising research to continue with no lapse in funding. Only applications for the combined mechanism (R21/R33) will be deemed responsive to this PA.
Applications targeting any scientific area(s) related to HIV/AIDS prophylactic vaccine research are encouraged. Applications for therapeutic vaccine research are excluded. Before application receipt dates, scientific areas of particular programmatic interest may be posted on the NIAID website http://www.niaid.nih.gov/daids/vaccine/innovation.htm. Periodically, highly focused scientific areas are posted upon the recommendation of the AIDS Vaccine Research Working Group (AVRWG), or may emerge from meetings, workshops, and discussions with program staff. Applicants are strongly encouraged to contact program staff (see Agency Contacts: Scientific/Research) and visit the website before submitting an application.
RESEARCH OBJECTIVES
All relevant areas of investigation contributing to the development of an efficacious prophylactic HIV/AIDS vaccine are welcome. These may include but are not limited to: structural studies of HIV envelope proteins to aid immunogen design; strategies to induce broadly reactive neutralizing antibodies to primary isolates; approaches to enhance HIV vaccine-induced immunologic memory; vaccine approaches that induce mucosal immunity; improving HIV vaccines by harnessing innate immunity and regulatory T cell responses; methods to enhance antigen presentation/processing; vaccine approaches that use adjuvants or immuno-modulators to increase or improve immunogenicity of HIV vaccines; mobilizing antigen presenting cells to vaccination sites; novel approaches in nucleic acid vaccination; recombinant vectors; and pseudovirion approaches. Within the R21 phase, successful applicants are expected to generate proof of concept feasibility data that meet well-defined measurable goals (quantitative milestones). Research on therapeutic vaccine approaches is not within the scope of this PA.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Section II. Award Information1. Mechanism(s) of Support
Support for this program will be through the National Institutes of Health (NIH) Phased Innovation Award (R21/R33).
The combined R21/R33 application offers two advantages: (1) single submission and evaluation of both the R21 and the R33 in one application, and (2) expedited transition and minimal or no funding gap between the R21 feasibility and R33 development phases for successful applicants.
Although applicants are solely responsible for planning, directing, and executing the proposed project, the transition from the R21 feasibility phase, and eligibility for award of the R33 development phase, will be determined by NIAID program staff based on successful completion of scientific milestones, program priorities, and availability of funds. For the R21/R33 Phased Innovation Award, the R21 phase must include one to three clear, well-defined measurable goals (quantifiable milestones) that can be used to judge the success of the proposed research, as well as a credible developmental research plan for the R33 phase. The Phased Innovation Award application must have a section labeled "Milestones" which must include: (1) one to three well-defined objective quantifiable scientific milestones for completion of the R21 phase, (2) a discussion of the suitability of the proposed milestones for assessing success in the R21 phase, and (3) a discussion of the implications of successful completion of these milestones for the proposed R33 study.
Under this PA applicants may only submit for the combined R21/R33 (Phased Innovation Award). Applications for R21 support alone are not accepted under this PA. Investigators seeking support solely through the R21 mechanism are encouraged to apply for the NIH-wide R21 exploratory program (see http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html), or other announcements. Early communication with program staff is important to determine appropriateness of a potential application . Contact the program staff listed under Agency Contacts: Scientific/Research for further information.
This PA uses the just-in-time procedure for certain information. It also uses the modular budgeting format (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise follow the instructions for non-modular research grant applications. For R21/R33 applications which exceed $250,000 in any given year of the R33 phase, the R21 portion should be submitted with a modular budget and the R33 phase with a detailed budget. The non-modular budget format is described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.
2. Funds Available
For this phased R21/R33 PA, funding for the R21 phase cannot extend beyond 2 years, and funding for the R33 phase cannot extend beyond 3 years. Thus, funding for the total project period for an application submitted in response to this PA may not exceed 5 years.
Applicants may request up to two years of support for the R21 feasibility phase limited to $275,000 direct costs over the two year award period. Budgetary support for the R33 phase will be limited to $300,000 per annum in direct costs.
NIAID anticipates a maximum of fifty percent (50%) of the initially funded applications will eventually progress to the R33 phase.
Funding of the R33 phase will be based on program priorities, on the availability of funds, and successful completion of negotiated scientific milestones within the R21 phase, as determined by program staff in the context of peer review recommendations. It is strongly recommended that applicants communicate with program staff at an early stage of the application process to discuss programmatic suitability of the proposed project. Refer to Agency Contacts: Scientific/Research for further information.
Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.
Section III. Eligibility Information1. Eligible Applicants
1.A. Eligible Institutions
You may submit (an) application(s) if your organization has any of the following characteristics:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution 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 programs.
2. Cost Sharing or Matching
Cost sharing is not required for applicants to this program announcement.
The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.
3. Other-Special Eligibility Criteria
Clinical trials or first-time-in human studies will not be supported under this Program Announcement. Clinical research, including research that uses clinical specimens, is responsive to this announcement.
Section IV. Application and Submission Information1. Address to Request Application Information
The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.
The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.
Applicants may submit more than one application, provided they are judged scientifically distinct by program staff.
SPECIFIC INSTRUCTIONS FOR PREPARING THE NIH PHASED INNOVATION AWARD (R21/R33) APPLICATION (READ INSTRUCTIONS CAREFULLY)
The R21/R33 Phased Innovation Award application must be submitted as a single application, with one face page. Although it is submitted as a single application, it should be clearly organized into two phases. To accomplish a clear distinction between the two phases, applicants are directed to complete Sections a, c and d of the Research Plan twice: one write-up of Sections a-d and milestones for the R21 phase, and a second write-up of sections a, c and d for the R33 phase. Section b, the significance section, need not be repeated if no change is anticipated in proceeding from the R21 phase to the R33 phase. The PHS form 398 Table of Contents should be modified to show sections a-d for each separate phase (R21 and R33) as well as the milestones. There is a 25 page limit for the entire Research Plan that encompasses the combined section a-d and milestones for the R21 and sections a-d for the R33.
In preparing the R21/R33 application investigators should consider the fact that applications will be assigned a single priority score. Thus, clarity and completeness of the R21/R33 application with regard to specific goals and the feasibility of milestones is critical. Though innovation is paramount, milestones should be sufficiently rigorous scientifically to be valid for assessing progress in the R21 phase, and will reflect the scientific judgment and experience of the applicant.
1. Face Page of the application
Item 2. Check the box marked "YES" and enter the number and title of this program announcement.
Item 7a. Direct cost Requested for Initial Period of Support
For the R21 phase of the combined R21/R33 application, direct cost is limited to a maximum of $275,000 in direct costs over the two year grant duration.
2. Page 2 - Description
As part of the description, identify concisely the fundamental research and/or technology or approach be developed, its innovative nature, its relationship to presently available capabilities, and its expected impact on HIV/AIDS vaccine development.
3. Research Plan
For applications submitted for the R21/R33 mechanism the following should be included:
Item a: Specific Aims
This section should answer the question, "What specifically will be done during the proposed funding periods?" The applicant must present specific aims that he/she considers to be scientifically appropriate for the relevant phases of the project.
Item b: Background and Significance
This section should answer the question, "Why is the proposed research important?" Elaborate on the innovative nature of the proposed research.
Clarify how the fundamental research, technologies, or approaches to be developed as proposed in this project will result in a significant improvement over existing approaches. Explain the potential of the proposed technology/approach for having a broad impact on HIV/AIDS vaccine development. Clearly identify how the project, if successful, would result in a new vaccine approach or improved capabilities for AIDS vaccine research, the immediacy of the opportunity, and how any proposed technologies or approaches would differ from those that presently exist.
Item c: Preliminary Studies/Progress Report
This section should answer the question, "What have you done to demonstrate the feasibility of the proposed research?" While preliminary data are not required or expected for submission of the R21 phase, this section should demonstrate creative thinking and knowledge of the field to reinforce the feasibility of the R21 phase. The R33 need not repeat information already provided in the R21 portion of the application.
Item d: Research Design and Methods
This section should answer the question, "How will the specific aims be accomplished?" Follow the instructions in the PHS 398 booklet. For this particular program the applicant should also address plans to make the products, tools, or technologies forthcoming from this research available to the relevant biomedical research user community. In addition, for the R21 phase only, applications must include a specific section labeled Milestones as a final section of Item d.
Milestones should be well described, quantifiable, and scientifically justified and not simply a restatement of the specific aims. A discussion of the milestones relative to the success of the R21 phase, as well as implications for successful completion of milestones in the R33 phase should be included. The page numbers for the milestone section should be included in the Table of Contents.
Applications lacking this information, as determined by DAIDS program staff, will be non-responsive to the program announcement and returned to the applicant without review.
For funded applications, completion of the R21 milestones will prompt an Institute-expedited review that will determine whether or not the R33 should be awarded. The release of R33 funds will be based on successful completion of negotiated milestones, program priorities and the availability of funds. The expedited review may result in additional negotiations prior to award.
Foreign Organizations
Several special provisions apply to applications submitted by foreign organizations:
Proposed research should provide a unique research opportunity not available in the U.S.
3. Submission Dates and Times
See Section IV.3.A for details.
3.A. Submission, Review and Anticipated Start Dates
Application Submission Dates(s): May 1, 2006
Peer Review Date(s): June/July 2006
Council Review Date(s): September 2006
Earliest Anticipated Start Date: October 1, 2006
Expiration Date: May 2, 2006 (NOTE; This announcement will be reissued for submission dates beyond May 1, 2006 because electronic submission of SF424 (R&R) applications via Grants.Gov will be required.)
3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.
3.B. Sending an Application to the NIH
Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
3.C. Application Processing
Applications must be submitted on or before the application receipt/submission dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.
Upon receipt applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.
Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.
4. Intergovernmental Review
This initiative is not subject to intergovernmental review.
5. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.
The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
Applications must include clear, well-defined quantifiable scientific milestones that can be used to judge the success of the proposed research, as well as a credible plan for the development of the R33 phase project. The NIH Phased Innovation Award application must have a section labeled "Milestones" at the end of the Research Plan of the R21 section of the application. This section must include well-defined quantifiable milestones for completion of the R21 part of the application, a discussion of the suitability of the proposed milestones for assessing success in the R21 phase, and a discussion of the implications for successful completion of these milestones for the proposed R33 study.
Specific Instructions for Modular Grant applications
Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (see http://grants.nih.gov/grants/funding/phs398/phs398.html) includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm. Otherwise, follow the instructions for non-modular research grant applications. The non-modular budget format is described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). For R21/R33 applications which exceed $250,000 in any given year of the R33 phase, the R21 portion should be submitted with a modular budget and the R33 phase with a detailed budget. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.
Plan for Sharing Research Data
All applicants must include a plan for sharing research data in their application. The NIH data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.
The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.
The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.
Sharing Research Resources
NIH policy requires that grant award recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.
1. Criteria
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established PHS referral guidelines.
Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.
As part of the initial merit review, all applications will:
The following will be considered in making funding decisions:
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.
Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are the proposed milestones well-defined, quantitative, and appropriate for assessing the success in the R21 phase of the application? Is it clear how the R33 phase of the study will develop and expand once the R21 milestones are achieved?
Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?
Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?
2.A. Additional Review Criteria:
In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:
Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).
Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.
Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.
2.B. Additional Review Considerations
Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.
2.C. Sharing Research Data
Data Sharing Plan: Investigators submitting an application in response to this announcement are required to include a plan for data sharing or to state why data sharing is not possible. (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). Applicants are encouraged to discuss their data sharing plan with the program contact prior to submission of their application. Program staff will be responsible for overseeing the data sharing policy and for assessing the appropriateness and adequacy of the proposed data-sharing plan.
The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.
2.D. Sharing Research Resources
NIH policy requires that grant award recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.
Distribution of Unique Research Resources: It is the policy of PHS to make available to the public the results and accomplishments of the activities that it funds (http://ott.od.nih.gov/researchtool/apxd3.html). Unique research resources produced with funds awarded in response to this solicitation are to be made readily available for research purposes to qualified individuals within the scientific community no later than publication of the associated research finding.
The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.
3. Anticipated Announcement and Award Dates
Not applicable
1. Award Notices
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.
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 they are considered allowable pre-award costs. See also Section IV.5. Funding Restrictions.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of Award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
3. Reporting
Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.
We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:
1. Scientific/Research Contacts:
Jon Warren, Ph.D.
Director, Innovation Grant Program for AIDS Vaccine Research
Division of AIDS (DAIDS)
National Institute of Allergy and Infectious Diseases, NIH
6700B Rockledge Drive, Room 5124
Bethesda, MD 20892-7628
Telephone: (301) 402-0633
FAX: (301) 402-3684
Email: [email protected]
2. Peer Review Contacts:
Not applicable
3. Financial or Grants Management Contacts:
Mary Ledford
Grants Management Branch
DEA, NIAID, NIH
6700B Rockledge Drive, Room 2129
Bethesda, MD 20892-7614
Telephone: (301) 402-6446
FAX: (301) 493-0597
Email: [email protected]
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.
Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct cost in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.
Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.
Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.
All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct cost from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.
NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct cost from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.
For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_manual.htm).
Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ in the following citations: No. 93.855, Immunology, Allergy and Transplantation Research and No. 93.856, Microbiology and Infectious Diseases Research, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
|
| ||||||
|
|
|
Department of Health and Human Services (HHS) |
|
|||
|
NIH... Turning Discovery Into Health® |
||||||