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: NIAID
Research Scholar Development Award (K22)
Announcement Type
This is a reissue of PAR-07-347.
Update: The following updates relating to this announcement have been issued:
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.
Catalog of Federal Domestic Assistance
Number(s)
93.855, 93.856
Key Dates
Release/Posted Date: December 30, 2008
Opening Date: January 12, 2009 (Earliest date an application may
be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not
required.
NOTE: On-time submission requires that applications be successfully submitted
to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s): Standard
dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard
dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Standard dates apply,
please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply,
please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard
dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (URL
Activation Date): Not Applicable.
Expiration Date: (Extended to May 8, 2012 per NOT-AI-12-022), Original Date February 11, 2012
Due Dates for E.O. 12372
Not Applicable.
Additional Overview Content
Executive Summary
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Career Objectives
Section II. Award Information
1. Mechanism 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. 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. Submitting an Application
Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
4. Transition to Independent Phase
Section VII. Agency Contacts
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Career Objectives
The primary goal of the NIAID RSDA is to help post-doctoral scientists make
the transition to positions of assistant professor or equivalent, and initiate
a successful biomedical career as an independent research scientist.
One of the most challenging transitions in any research career is the one from postdoctoral trainee to independent scientist. Recent reports from the National Research Council of the National Academies of Science Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research, and Advancing the Nations Health Needs: NIH Research Training Programs have highlighted the need for enhanced efforts to foster the transition of postdoctoral scientists from mentored environments to independence.
NIH believes that the creativity and innovation of new independent investigators in their early career stages play an integral role in addressing our Nations biomedical, behavioral, and clinical research needs. However, the average age of first-time (new) Principal Investigators obtaining R01 research funding from the NIH has risen to 42 years of Ph.D. degree holders and 44 years for M.D. and M.D./Ph.D. degree holders. The intent of the NIAID K22 program is to help alleviate this trend and to assist new investigators in transitioning to stable independent research positions at an earlier age and with an enhanced probability of success in obtaining independent NIH or other independent research support.
Nature of the career/research transition opportunity
The Phase 2 of the K22 award will provide two years of support to conduct research as an independent scientist at an extramural sponsoring institution/organization to which the individual has been recruited, been offered and has accepted a tenure-track full-time assistant professor position (or equivalent). This support is to allow the individual to continue to work toward establishing his/her own independent research program and prepare an application for regular research grant support (R01).
The K22 application is submitted in two phases in order to allow the applicant to have the project peer reviewed for scientific merit (Phase 1) before becoming a tenure-track full-time assistant professor or equivalent. Once the assistant professor position has been secured, NIAID will review the Phase 2 of the application to ensure that all programmatic requirements are met prior to the award.
See Section VIII, Other Information - Required Federal Citations,
for policies related to this announcement.
Section II. Award Information
This Funding Opportunity Announcement (FOA) will utilize the NIH Career Transition Award (K22) mechanism. The Project Director/Principal Investigator (PD/PI) (also referred to as the Candidate) and his/her mentor will be solely responsible for planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts (see SF424 (R&R) Application Guide). It also uses non-modular budget format.
The candidate should follow the instructions for budget information described in Section IV (6.F) as well as in PHS 398 Career Development Award Supplemental form Section 7.4.6 of the R&R 424 instructions, and budget justification information.
2. Funds Available
Although the financial plans of the NIAID provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. The NIAID K22 award consists of two years of support and is based on a successful Phase 1 application together with the fulfillment of the programmatic requirements set forth in the Phase 2 application. It is the successful submission of the Phase 2 application that will determine whether the K22 will be awarded. In the first year of the Phase 2 of the K22 award, the PI may request $150,000 (direct costs), and $100,000 (direct costs) in the second year. The PI will have discretion to utilize the award as needed by the research described in the application. However, no more than $50,000 per year of the award may be utilized to support the Principal Investigators salary. The facilities and administrative (F&A) costs will be limited to eight percent of modified total direct costs (exclusive of tuition, fees, and equipment).
The candidate is required to devote a total of 75% (9 person months) of their full-time 12 month professional effort to research (i.e., a full-time 9 person months). See eligibility below. However, it may not be feasible to support this entire effort through the NIAID K22 award alone. Please note that a reduction of time devoted to a project by 25% or more from the level in an approved application will require NIH prior approval as described in the NIH Grants Policy Statement.
2.A. Allowable Costs
The salary requested for the candidate in Phase 2 must be consistent with both the established salary structure for 12-month full-time staff appointments and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the applicable department.
The K22 does not require that salary support be derived from the award; use of the entire direct costs for research-related expenses is allowed and encouraged. If no salary funds are requested in the Phase 2 application, a statement should be included indicating the source and amount of salary support. If an institution commits its own funds to support the salary of the K22 awardee, NIAID will view that as further evidence of institutional commitment.
Salary and Professional Effort: The total salary requested must be based on a full-time, 12-month staff appointment requiring candidates to devote a minimum of 75% effort of full-time professional effort to conducting health-related research with the remaining effort being devoted to activities related to the development of a successful research career. For information regarding NIH policy on determining full-time professional effort for career awards, see NOT-OD-04-056. Candidates who have U.S. Veterans Administration (VA) appointments may not consider part of the VA effort toward satisfying the full-time requirement at the applicant institution. Candidates with VA appointments should contact the NIAID staff (Section VII) prior to preparing an application to discuss their eligibility, qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be related appropriately to the existing salary structure. Confirmation of salary may be required prior to the issuance of an award. Fringe benefits based on the sponsoring institutions rate and the percent of effort are provided in addition to salary. Salary support from the NIAID K22 award may not exceed $50,000.
Salary Supplementation: The sponsoring institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale. However, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may additional PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the K22 award. Under expanded authorities, however, institutions may re-budget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. The total salary, however, may not exceed the legislatively mandated salary cap.
Research-Related Expenses: These include salaries for technical support, consultant costs, equipment, supplies, travel to scientific meetings and training, statistical services, and other research-related expenses. The research development support costs must be justified and be consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities.
Ancillary Personnel Support: Salary for mentors, secretarial and administrative assistance, etc., is not allowed.
Indirect Costs: These costs also know as Facilities and Administrative (F&A) costs, will be reimbursed at eight percent (8%) of modified total direct costs only for the independent phase of the award.
NIH Grants Policy: 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.
Section III. Eligibility Information
1. Eligible Applicants
1.A.
Eligible Institutions
The following organizations/institutions are eligible
to apply:
Applicants from NIH intramural laboratories are eligible to apply for the K22; however, NIH intramural laboratories are not eligible to sponsor a K22 candidate once the award has been made. Agencies of the Federal Government are also not eligible to apply for independent phase of the K22 award.
Foreign institutions are not eligible to apply.
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI 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.
Project Director/Principal Investigator (PD/PI): Also referred to as the Candidate, individuals with the skills, knowledge, and resources necessary to carry out the proposed research and career development activities are invited to work with their mentor and sponsoring institution to develop an application for support. Individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds are always encouraged to apply for NIH support.
At time of Phase 1 application submission (or any resubmissions), candidates must:
Individuals are NOT eligible if they:
Ph.D. candidates in positions other than postdoctoral fellow positions
It is recognized that some institutions appoint postdoctoral fellows in positions with other titles although they are still in non-independent training positions. Candidates in such positions are encouraged to obtain confirmation of their eligibility before they begin to prepare their applications. It is incumbent upon the candidate to provide evidence that the position he/she is in complies with the intent of this eligibility requirement. Evidence of non-independence may include:
Clinicians (including those with M.D., D.D.S, D.V.M. and other licensed professionals) in positions not designated as postdoctoral positions
Following clinical training or fellowship training periods, clinicians often obtain a clinical faculty position that denotes independence in clinical responsibilities but not in research. A clinical faculty member who does not hold an independent research faculty position may be eligible for the NIAID K22 award, and should contact the appropriate staff person in Section VII Agency Contacts for guidance. Clinicians in such positions are encouraged to obtain confirmation of their eligibility before they begin to prepare their applications. Clinicians holding tenure-track faculty positions of any kind are not eligible for this award. Such individuals are encouraged to consider other career awards intended for support of junior faculty development. See: K Kiosk - Information about NIH Career Development Awards.
Candidates are strongly encouraged to consult with the appropriate staff person in Section VII Agency Contacts of this announcement prior to the submission of an application to discuss eligibility and program requirements.
Individuals affiliated with an NIH Intramural Laboratory may also apply. Please see http://odoerdb2.od.nih.gov/ElectronicSubmission/reg_ic.htm for specific information for intramural candidates.
Citizenship and Residency: Only U.S. citizens or non-citizen nationals, or an individual lawfully admitted for permanent residence who possesses an Alien Registration Receipt Card (I-151 or I-551), or some other verification of legal admission as a permanent resident, are eligible for this award. Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states, but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible.
Degree and Research: Candidates must have earned a terminal clinical or research doctorate (including Ph.D., M.D., D.O. D.C., N.D., D.D.S., D.V.M., Sc.D., D.N.S., Pharm.D., or equivalent doctoral degree, or a combined clinical and research doctoral degree. In addition, candidates must have no more than 5 years of research training experience since completing the requirements of the doctoral degree (resubmissions must also comply with this requirement).
Level of Effort: Candidates must be able to commit a minimum of 9 calendar months (75% of full-time professional effort) conducting research career development activities associated with this award. The remaining 3 months (25% effort) can be divided among other research, clinical, and teaching activities only if these activities are consistent with the goals of the K22 award. For information regarding NIH policy on determining full-time professional effort for career awards, see NOT-OD-04-056.
At the time of award, the candidate must have a full-time appointment at the academic institution that is the applicant institution. Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the NIAID staff prior to preparing an application to discuss their eligibility.
Individuals are NOT eligible if they:
2. Cost Sharing or Matching
This program does not require cost sharing as defined in the current NIH Grants Policy Statement.
3. Other-Special Eligibility Criteria
3.A. Special Requirements
NIAID RSDA award recipients are expected to apply for NIH or other independent research grant support during the independent phase of the award. Recipients may hold concurrent research and salary support during the tenure of their K22 award from a competing NIH research project grant when recognized as the PD/PI or subproject Director of the research project grant. See NOT-OD-08-065.
Section IV. Application and Submission Information
Registration:
Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered ?on-time? (see 3.C.1 for more information about on-time submission).
To download a SF424 (R&R)
Application Package and SF424 (R&R) Application Guide for completing
the SF424 (R&R) forms for this FOA, use the Apply for Grant Electronically button
in this FOA or link to http://www.grants.gov/Apply/ and follow
the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
The PD/PI should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.
Several additional separate actions are required before an applicant can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
The PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note: If a PD/PI is also an NIH peer-reviewer the DUNS number obtained and used in the reviewer role may NOT be used and is not applicable to any Grant Application to the Federal Government. This DUNS number is different from the DUNS number used by the applicant organization. The individual DUNS number should be used only for the purposes of personal reimbursement.
Several of the steps of the registration process could take four weeks or more. Therefore, the applicant should immediately check with his/her business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request
Application Information
Applicants must download the SF424 (R&R) application
forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package
directly attached to a specific FOA can be used. You will not be able
to use any other SF424 (R&R) forms (e.g., sample forms, forms from
another FOA), although some of the "Attachment" files may be
useable for more than one FOA.
For further assistance, contact GrantsInfo -- Telephone
301-710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY
301-451-5939.
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PIs assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:
Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
SF424 (R&R) Detailed Budget
PHS398 Cover Letter
PHS398 Cover Page Supplement
PHS398 Career Development Award Supplemental Form
PHS398 Checklist
3. Submission Dates and Times
See Section IV.3.A. for details.
3.A. Submission, Review, and Anticipated Start Dates
Opening Date: January 12, 2009 (Earliest date an application may
be submitted to Grants.gov)
Letter of Intent Receipt Date(s): See below
Application Due Date(s):
Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply, please
see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please
see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard
dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.
3.B. Submitting an Application
Electronically to the NIH
To submit an application in response to this FOA, applicants should access
this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and
follow Steps 1-4. Note: Applications must only be submitted electronically. PAPER
APPLICATIONS WILL NOT BE ACCEPTED.
3.C. Application Processing
Applications may be submitted on or after
the opening date and must be successfully received by Grants.gov
no later than 5:00 p.m. local time (of the applicant
institution/organization) on the application
due date(s). (See above for all dates.) If an application is not
submitted by the due date(s) and time, the application may be delayed in
the review process or not reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the application image to determine if any further action is necessary.
Upon receipt, applications
will be evaluated for completeness by the Center for Scientific Review,
NIH. Incomplete applications will not be reviewed.
There will be an acknowledgement of receipt
of applications from Grants.gov and the Commons. The submitting AOR/SO receives
the Grants.gov acknowledgments. The AOR/SO and the PD/PI receive Commons
acknowledgments. Information related to the assignment of an application
to a Scientific Review Group is also in the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.
The NIH will not accept any application in response to this FOA 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. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.
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.
Citizenship: Applicants must meet the citizenship requirements as described in the Eligibility section of this announcement (see Section III) at the time of award.
Concurrent Awards: Applicants must be aware of the NIH policies associated with other federally sponsored support (see NOT-OD-08-065).
Pre-Award Costs: 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 if such costs: 1) are necessary to conduct the project,
and 2) 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.
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.
6. Other Submission Requirements and Information
All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements (see http://grants.nih.gov/grants/funding/424/index.htm):
PD/PI Credential (e.g., Agency Login): The NIH requires the PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.
Organizational DUNS: The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
Cover Letter: The PHS398 cover letter must include the list of referees (including name, department affiliation, and institution).
Other Project Information Component (Section 4.4): For Project Summary/Abstract briefly describe your current research AND the research you propose to continue in the independent phase.
Senior/Key Person Profile (Section 4.5): Following the standard instructions for this section, delineate under separate headings entitled mentored phase and independent phase, the key personnel you plan to request for the mentored phase and the projected types of key personnel you plan to request in the independent phase of the Award. Please note that a mentor is required only for the mentored phase.
The following information must be included in the application in accordance with the Supplementary Instructions for Research Career Awards in the SF424 (R&R) Application Guide (See Part I.7.5).
PHS 398 Career Development Award Supplemental Form Component Sections: Items 2-5 (Candidate's Background, Career Goals and Objectives, Career Development/Training Activities During Award Period, and Training in the Responsible Conduct of Research) and Item 11 (Research Strategy) are limited to a combined total of 12 pages.
Applicants should follow the instructions in the SF424 (R&R) Application Guide and complete all the required sections with the following modifications:
Section D. Basic Administrative Data
For the Phase 1 of the application for an NIAID K22, complete ALL sections with the following modifications:
Appendix Materials:
Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).
Do not use the Appendix to circumvent the page limitations. An application that does not comply with the required page limitations may be delayed in the review process.
6.A. Candidate Information and Career Development Plan
As described above, applications responding to this Program Announcement will be submitted in two Phases, and will follow these specific instructions.
PHASE I OF THE NIAID K22 APPLICATION:
Because of the nature of this award, the candidate may not have identified a sponsoring institution at the time of submitting the Phase I portion of the application. Thus, the front page of SF424 (R&R) will not require a sponsoring institution or institutional officials information or signature.
The following items on form SF424 (R&R) application are required for the first phase of an RSDA application:
Biographical Sketch
A. A biographical sketch is required for the candidate following the instructions below.
B. Complete the education block at the top of the form page.
C. List current position(s) and those previous positions directly relevant to the application.
D. List peer-reviewed publications directly relevant to the proposed project with full citation.
E. Provide information on research projects completed during the last five years that are relevant to the proposed project.
Candidate
Career Goals and Objectives
Mentor(s)
Candidates Background:
Career Goals and Objectives:
Career Development/Training Activities:
Training in the Responsible Conduct of Research:
The background, rationale and more detail about instruction in the
responsible conduct of research can be found in
NOT-OD-10-019.
6.B. Research Plan
Data and Safety Monitoring: Candidates proposing to conduct clinical trials should consult with the NIAID staff (Section VII). Plans for data and safety monitoring must be included in research plans involving Phase I or Phase II clinical trials (see Federal Citations in Section VIII): Generally, this requirement may be satisfied in the submitted application by providing documentation that the sponsoring institution has an approved plan in place and providing a brief description of the key elements of the plan.
6.C. Statement of Support
Statement by Consultants and Other Contributors (All statements/letters should be appended to each other and uploaded as a single pdf document):
6.D. Environment and Institutional Commitment to the Candidate
Description of Institutional Environment (applicable only in Phase 2 of the application process:
Institutional Commitment to Candidates Research Career Development:
6.E. Letters of Reference
[ January 20, 2011 - Please see NOT-OD-11-036 informing applicants that the Letters of Reference are due by the application receipt deadline date. ]
Electronic submission of reference letters is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons and do not use Grants.gov. Therefore, candidates must follow the Supplemental Instructions in the SF424 R&R Application Guide for Research Career Awards (Instructions, Part 7.3) (see http://grants.nih.gov/grants/funding/424/index.htm).
Letters of reference are an important component of the application for the K22 award. Applicants must arrange to have at least three (but no more than five) letters of reference submitted on their behalf to the NIH eRA Commons Web site at https://public.era.nih.gov/commons/public/reference/submitReferenceLetter.do?mode=new. The letters should be from well-established scientists (referees) addressing the qualities of the candidate as well as their potential for becoming an independent investigator. These letters should be from individuals not directly involved in the application, but who are familiar with the candidates qualifications, training, and interests. A letter of reference may be submitted by an individual not directly involved in the proposed research project; e.g., advisory committee members (if applicable).
The mentor/co-mentor(s) may also submit letters of reference, but these letters will be considered independently of the three required reference letters. Revised applications must include new letters of reference.
Applications that are missing letters of reference may be considered non-responsive and may not be reviewed.
6.F. Budget for the Entire Proposed Period of Support
Completing the SF 424 Research and Related (R&R) Forms
Complete ALL sections with the following modifications:
For the Phase I of the NIAID K22
For the Phase 1 of the application for an NIAID K22, complete ALL sections with the following modifications:
For the Phase II of the NIAID K22:
If the candidate receives a fundable score after the review of Phase I of the application, she/he will be notified in writing of NIAIDs commitment to make an award. The candidate will then have a period of up to 12 months to identify a suitable position as an assistant professor or equivalent at a domestic academic institution and negotiate an acceptable start-up package. As soon as negotiations between the candidate and the institution are complete, the Phase 2 application must be submitted.
The Phase 2 application must include the following items:
1. An acceptable start-up package for an NIAID K22 MUST consist of:
a. A position as assistant professor or equivalent
b. Adequate independent laboratory space
c. Significant funds and resources made available to the candidate
2. Budget- A detailed budget for the Initial Budget Period should be completed using form page 4 of the PHS 398 (rev. 4/06).
Budget for Entire Proposed Period of Support - complete the categorical budget table on form page 5 in the PHS 398 (rev. 4/06) for up to two years of support.
3. Budget Justification
Begin the budget justification on form page 5, using continuation pages as needed.
4. Environment and Institutional Commitment
The sponsoring institution must document a strong, well-established research program in biomedical l research. The sponsoring institution also must provide a detailed statement of institutional resources committed to foster the candidates development into a productive, independent investigator. The candidate and an appropriate official (Dean, departmental Chair, or equivalent) of the sponsoring institution must satisfactorily describe the elements of a research program that will maximize the candidates chances for a successful research career in an academic setting.
5. Checklist page
Cover Component (Section 4.2): For Proposed Project (Start and Ending Date) indicate the total period of support being requested including the mentored phase and the independent phase.
Budget Component (Section 4.7): The first year's budget must be the mentored phase budget. Intramural candidates should not request a budget for the mentored phase of the award because the budget will be negotiated with NIAID intramural program. If a dollar amount is required, enter 0 (zero) in the appropriate box. There will be no extramural grant award associated with intramural phase for the K22 award.
Budget Component Extramural (Section 4.7): For intramural awardees who receive approval to transition to the non-mentored extramural phase, a budget will be required at that time as part of the application (see Section VI.4, Transition to the Independent Phase.
For extramural candidates a budget will be required for phase 2 as part of the original application, as follows:
Use the SF424 (R&R) Detailed Budget component and review the instructions found in Part I.4.7(R&R Budget Component) of the Application Guide. However for K applications only limited budget information is required; therefore, candidates will also need to follow the special instructions in Part I.7.4 of the SF 424 (R&R) [Supplemental Instructions for Career Development Awards], noting the special instructions that modify Section 4.7. In budget section A (Senior/Key Persons) include base salary, person months and requested salary and fringe benefit information for only the candidate. Base salary, and requested salary and fringe benefits should reflect actual levels. Any adjustments based on IC policy limits will be made at the time of the award. Sections B-E should be left blank. If a dollar amount is required, enter 0 (zero) in the appropriate box. The total Research Development Support amount requested for each year will be entered in Section F, Materials and Supplies. In Section H enter Modified Total Direct Costs under Indirect Cost Type. The Indirect Cost rate is 8% of modified total direct cost. The Indirect Cost amount should be entered under Funds Requested. Totals for Sections F, G, and H will be calculated automatically for each year as well as for the Cumulative Budget. Within the direct cost limitation for research development support, provide a detailed description with justification for all equipment, supplies and personnel that will be used to help achieve the career development and research objectives of this award.
6.G. Resource Sharing Plan(s)
NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.)
(a) Data Sharing Plan: Not Applicable.
(b) Sharing Model Organisms: Regardless of the amount requested, all applications in which the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible (see Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.)
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (NOT-OD-07-088) and http://grants.nih.gov/grants/gwas/.
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
Applications that are complete will be evaluated for
scientific and technical merit by (an) appropriate scientific review group(s) in
accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using
the review criteria stated below.
As part of the scientific peer review, all applications will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
Review Criteria
The overall goal of NIH-supported career development programs is to help ensure that diverse pools of highly trained scientists are available in adequate numbers and in appropriate research areas to address the Nations biomedical, behavioral, and clinical research needs. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application.
Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the candidate to maintain a strong research program, in consideration of the following five core review criteria, and additional review criteria. An application does not need to be strong in all categories to have a major impact.
Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each.
Candidate:
Career Development Plan:
Research Plan:
Consultant(s), Collaborator(s):
Environment and Institutional Commitment to the Candidate (This section is only applicable in the Phase 2 of the application): Please refer to section 6.F. Budget for the Entire Proposed Period of Support.
2.A. Additional Review Criteria
Letters of reference: Do the letters of reference from at least three well-established scientists address the above review criteria, and do they demonstrate evidence that the candidate has a high potential for becoming an independent investigator?
Plans to Evaluate Progress: Are there adequate plans for monitoring and evaluating the career development awardees progress toward independence?
Resubmission Applications: When reviewing a Resubmission application (formerly called an amended application), 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.
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.
Inclusion of Women, Minorities, and Children: When the proposed project 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. part I, 5.5.
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.
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
Additional Review Considerations. As applicable for the project proposed, reviewers will address 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.
Training in the Responsible
Conduct of Research: Reviewers will evaluate plans for
instruction in responsible conduct of research as well as the past record of
instruction in responsible conduct of research, where applicable.
Reviewers will specifically address the five Instructional Components (Format,
Subject Matter, and Frequency of instruction as detailed in
NOT-OD-10-019. The review of this consideration will be guided by the
principles set forth in
NOT-OD-10-019. Plans and past record will be rated as ACCEPTABLE or
UNACCEPTABLE.
2.C. Resource Sharing Plans
When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or impact/priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.
3. Anticipated Announcement and
Award Dates
Not Applicable.
Section VI. Award Administration
Information
1. Award Notices
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 NIH
eRA Commons.
If the application is under consideration
for funding, NIH will request
"just-in-time" information from the applicant. JIT includes, but
is not limited to, updated salary information and confirmation, current
Other Support as well as Human Subjects and Animal certifications. Activation
of the JIT link in the eRA Commons is not an indication of a request for
Just in Time information. The applicant organization will be contacted
by NIH grants administration staff if this information is required. For
details, applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General.
A formal NoA will be provided as part of the extramural
mentored phase of the K22 award conducted at a domestic, sponsoring extramural
institution/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
12 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.
There will not be a formal Notice of Award (NoA) associated with the mentored phase of the K22 award conducted in the NIH intramural program. The awarding Institute will transmit to the successful applicant an approval letter which will include the terms and conditions of the NIH intramural K22 award, as well as expectations for the transition to the independent phase of the award.
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.
See 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 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.
The following related administrative policies apply to NIH Research Career Award (K) programs:
A. Evaluation: In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.
B. Other Income: Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, honoraria from other institutions for lectures or seminars, fees resulting from clinical practice, professional consultation or other comparable activities, provided these activities remain incidental, are not required by the research and research-related activities of this award, and provided that the retention of such pay is consistent with the policies and practices of the grantee institution.
All other income and fees, not included in the preceding paragraph as retainable, may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods:
Usually, funds budgeted in an NIH supported research grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted. The awarding component will give consideration to approval for the use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of a career award must receive prior written approval of the NIH awarding component.
C. Leave Policies: Leave to another institution, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award. Only local institutional approval is required if such leave does not exceed 3 months. For longer periods, prior written approval of the NIH funding component is required. Details on the process for submission of prior approval requests can be founds in the NIHGPS (rev. 12/03), Requests for Prior Approval, at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600130. However, because of the relatively short duration of the mentored phase of the program, awardees are cautioned about the impact of any leave on their ability to make sufficient progress to warrant transition to independence.
A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the career award will continue during such leave.
Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the NIH component Institute or Center and will be granted only in unusual situations.
Support from other sources is permissible during the period of leave without award support. Such leave does not reduce the total number of months of program support for which an individual is eligible.
D. Percent Effort Policies: Under certain circumstances, an awardee may submit a written request to the awarding component requesting a reduction in professional effort below 75 percent (equivalent to 9 person months). Such requests will be considered on a case-by-case basis during the award period. In no case will it be permissible to work at less than 50 percent effort (equivalent to 6 person months). The nature of the circumstances requiring a change in the appointment status or percent effort might include personal or family situations such as parental leave, child care, elder care, medical conditions, or a disability. Permission to reduce the level of effort will not be approved to accommodate job opportunities, clinical practice, or clinical training. In each situation, the grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to the scientific development of the awardee. In addition, the awardee must submit assurance of his/her intention to return to at least 75 percent effort as soon as possible. During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly.
E. Changes in Research or Career Development Program: Consultation with the NIAID Program staff is strongly encouraged when a change in the approved career development program and/or research plan is being considered.
Individual awards are made for career development at a specific institution in a specific research program. A change in the specified scientific area of the research component of the career development program requires prior approval of the awarding NIH Institute or Center. A scientific rationale must be provided for any proposed changes in the aims of the original peer-reviewed research plan. The new research plan will be evaluated by the NIAID staff to ensure that the plan remains within the scope of the original peer-reviewed research program. If the new plan does not satisfy this requirement, staff could recommend that the award be terminated.
F. Change of Institution or Termination: Consultation with the NIAID Program and/or Grants Management staff is strongly encouraged when either termination or a change of institution is being considered.
A change of grantee institution normally will be permitted only when all of the benefits attributable to the original grant can be transferred, including equipment purchased in whole or in part with grant funds. In reviewing a request to transfer a grant, NIH will consider whether there is a continued need for the grant-supported project or activity and the impact of any proposed changes in the scope of the project. A change may be made without peer review, provided the PD/PI plans no significant change in research and career development objectives and the facilities and resources at the new organization will allow for successful performance of the project. If these conditions or other programmatic or administrative requirements are not met, the NIH awarding office may require peer review or may disapprove the request and, if appropriate, terminate the award.
If the K awardee is moving to another eligible institution, career award support may be continued provided:
When a grantee institution plans to terminate an award, the Grants Management Specialist listed on the Notice of Award (NoA) must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. The Director of the NIH awarding component may terminate an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, NIH shall notify the grantee institution in writing of this determination, the reasons, the effective date, and the right to appeal the decision.
Awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement. (Note that the instructions for Research Career Development applications must be followed for this program).
The Progress Report must include Sections (A) through (F) as described in Section 2.2.6 (Progress Report Summary) in the general PHS form 2590 instructions, as well as sections G through J as described in Section 5 of the 2590 instructions. Evaluation of the awardees progress will encompass the following (see below: Transition to the Independent Phase):
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished, when a recipient changes institutions, or when an award is terminated.
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 (program), peer review, and financial or grants management issues:
1. Scientific/Research Contact(s):
Milton J. Hernndez, Ph.D.
Director, Office of Special Populations and Research
Training
National Institute of Allergy and Infectious Diseases
6700B Rockledge Drive,
Room 2149,
MSC 7614
Bethesda, MD 20892
Phone: (301) 496-3775
Fax: (301) 496-8729
E-mail: [email protected]
2. Peer Review Contact(s):
Edward W. Schroeder, Ph.D.
Chief, Microbiology Review Branch
National Institute of Allergy and Infectious Diseases
Scientific Review Program, DEA
6700B Rockledge Drive,
Room 3116, MSC 7616
Bethesda, MD 20892
Phone: (301) 435-8537
Fax: (301) 480-2310
E-mail: [email protected]
3. Financial/Grants Management
Contact(s):
Julie Waugh
Grants Management Specialist
National Institute of Allergy and Infectious Diseases
6700B Rockledge Drive, Room 2239, MSC 7614
Bethesda, MD 20892
Phone: (301) 451-7381
Fax: (301) 493-0527
E-mail: [email protected]
Section VIII. Other Information
Required Federal Citations
Vertebrate Animals: 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 (45 CFR 46) 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 costs 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 institutional review board (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 impact/priority score.
Policy for Genome-Wide Association Studies (GWAS): NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.
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. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal 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.
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.
Inclusion of Women, Minorities, and Children: 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 SF424 (R&R) application; 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-09-116.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 Requirement: In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicines PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.
Standards for Privacy of Individually
Identifiable Health Information: The Department of Health and Human Services (HHS) 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 HHS 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. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.
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 FOA 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/ and is not subject to the intergovernmental review
requirements of Executive Order 12372. 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. All awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants
Policy Statement.
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® |
||||||