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 on Alcohol Abuse and Alcoholism
(NIAAA), (http://www.niaaa.nih.gov)
Title: NIAAA Career
Transition Award (K22)
Announcement Type
This is a reissue of PAR-06-096.
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)
93.271
Key Dates
Release/Posted Date: December 18, 2008
Opening Date: January 12, 2009 (Earliest date an application may
be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not
applicable; See Section IV.
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://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard
dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Standard dates apply,
please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply,
please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard
dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (URL
Activation Date): Not Applicable.
Expiration Date: January 8, 2012
Due Dates for E.O. 12372
Not Applicable.
Additional Overview Content
Executive Summary
The overall goal of NIH-supported career development programs are to help ensure that a diverse pool of highly trained scientists are available in adequate numbers and in appropriate research areas to address the Nation's biomedical, behavioral, and clinical research needs.
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 overall goal of the NIH Research Career Development Award program is
to prepare qualified individuals for careers that have a significant impact
on the health-related research needs of the Nation.
A key objective of the NIAAA is to develop the next generation of exceptionally talented new scientists who are committed to conducting basic or clinical research related to the health risks and benefits of alcohol consumption, and the prevention and treatment of alcohol-related problems. The purpose of the NIAAA Career Transition (K22) Award is to facilitate the transition of postdoctoral fellows into fully independent faculty positions. This will be achieved by providing salary and research support for up to three years after candidates receive appointments at academic research institutions. The program is designed for: 1) advanced postdoctoral fellows at extramural research institutions who are currently supported by an NIAAA-sponsored Ruth L. Kirschstein National Research Service Award (NRSA) for Individual Postdoctoral Fellows (F32) or an NIAAA Institutional Research Training Grant (T32); 2) current Intramural Research Training Awardees (IRTA) or equivalent staff fellows in the NIAAA Division of Intramural Clinical and Biological Research (DICBR).
Eligible individuals should apply while they are still in a "mentored" postdoctoral position. Successful applicants will be given up to 18 months to identify an independent faculty position at a sponsoring institution before the award can be activated. The purpose of the award is to provide core salary and research support while candidates develop their independent research capabilities and begin obtaining preliminary data. After establishing the research program, the K22 recipient is expected to apply for an investigator-initiated research grant (R01, R03, R21) in a research area relevant to the mission of the NIAAA.
BACKGROUND
One of the most important goals of NIAAA is to ensure the development of highly qualified new investigators in alcohol-related research. To accomplish this objective, NIAAA sponsors fellowship training and career development programs in a variety of basic and clinical research disciplines, including social, behavioral, biological, and mathematical sciences. Pre- and postdoctoral support is provided via Ruth L. Kirschstein National Research Service Awards (NRSA). NRSA awards are made as individual fellowships (F30 and F31 predoctoral fellowships, F32 postdoctoral fellowships) or as institutional programs that support multiple trainees (T32 Institutional Research Training Grants).
Postdoctoral training can also be obtained in the Division of Intramural Clinical and Biological Research (DICBR) at NIAAA. Basic and clinical scientists in the intramural laboratories conduct a broad array of alcohol-related research activities including: basic neuroscience investigations conducted at molecular, cellular, systems, and behavioral levels; studies on alcohol metabolism, alcohol-related liver disorders, and structural analysis of membrane proteins; and clinical investigations into the diagnosis, treatment and prevention of alcohol abuse and alcoholism. Detailed information about intramural investigators and their research programs can be obtained at http://www.niaaa.nih.gov/ResearchInformation/IntramuralResearch/.
For those seeking an academic research career at a university or medical school, the next stage in career development is to obtain a faculty position and launch a research program with independent grant support. This transition is one of the foremost challenges facing aspiring new investigators. Many postdoctoral fellows continue to be supported in their mentors laboratories for several years after completing their NRSA or IRTA programs. Finding a faculty position can be a long and difficult process. For those who do find a position, developing a successful research program is often impeded by teaching and administrative responsibilities. Lack of experience in writing grant applications may also be a barrier for new investigators.
The NIAAA Career Transition Award is a non-mentored award designed to facilitate the transition of postdoctoral fellows as they acquire new faculty positions and secure research independence. The award is intended for fellows who have completed, or are nearing completion of, their formal mentored training programs. In general, applicants will have completed at least two, but no more than six years of postdoctoral training at the time of application. Eligible individuals should apply while they are still in a mentored position.
Applications will be evaluated for scientific and technical merit by an appropriate review group convened by NIAAA in accordance with the review criteria outlined in Section V. of this announcement. Applicants selected for potential funding will receive a Letter of Intent to Commit Funds from NIAAA. Applicants will then have up to 18 months to activate the award. Activation requires a formal offer of appointment to an independent faculty position. In addition, the proposed institution must demonstrate a commitment to the candidates career development by 1) assuring 75% protected time for research or career-related activities, and 2) providing a supportive environment and adequate facilities to carry out the project. The K22 award provides the core resources and protected time needed for beginning faculty to develop independent research programs. It is anticipated that the awardee will use the award to obtain preliminary data that will become the basis for a future research grant application.
Individuals considering the K22 mechanism should consult Program Announcements for other Career Development Awards (K-awards) to determine which program is most appropriate to their academic background and level of research experience. NIAAA offers a variety of K-awards to support investigators at specific stages of their careers (see http://www.niaaa.nih.gov/ResearchInformation/ExtramuralResearch/#training). In particular, prospective applicants should consider the K99-R00 Pathway to Independence Award (http://grants.nih.gov/grants/guide/pa-files/PA-07-297.html). The K99-R00 is an NIH-wide transition award which has objectives similar to the K22 but with somewhat different eligibility requirements. For example, the K99-R00 is the only K-award mechanism for which non-US citizens are eligible. Other career awards such as the K01, K08, and K23 are designed for individuals who seek further research career development under the mentorship of an established Principal Investigator. Such career awards are for a term of 3 - 5 years. Many senior postdoctoral fellows and new investigators are eligible for more than one of these career development award mechanisms. Interested individuals are strongly encouraged to contact NIAAA Program Staff to obtain more specific guidance on funding mechanisms and career planning.
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 Applicant or Candidate) and his/her mentor will be solely responsible for planning, directing, and executing the proposed project.
The award will provide support for up to three years after appointment to an academic research position. K22 awards are not renewable.
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
Because the nature and scope of the proposed K22 award program will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NIAAA 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. NIAAA anticipates 2 - 5 new K22 awards per year.
2.A. Allowable Costs
The salary requested for the candidate 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.
Salary support for K22 awards may range from 75% effort to a maximum of 100% effort not to exceed $105,000 per year.
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 NIAAA 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 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. The K22 award will provide a maximum of $75,000 per year for research-related expenses.
Ancillary Personnel Support: Salary for mentors, secretarial and administrative assistance, etc., is not allowed.
Indirect Costs: These costs also known 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:
NIH intramural laboratories are eligible to apply for the K22 mechanism on behalf of intramural candidates; however, NIH intramural laboratories are not eligible to sponsor the candidate once the award is activated. 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 Applicant or 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.
The candidate for the Career Transition Award must be an outstanding basic science or clinical investigator with demonstrated potential for a highly productive career in alcohol research. Eligible individuals include: 1) advanced postdoctoral fellows at extramural research institutions who are currently supported by an NIAAA-sponsored Ruth L. Kirschstein National Research Service Award (NRSA) for Individual Postdoctoral Fellows (F32) or an Institutional Research Training Grant (T32); 2) current Intramural Research Training Awardees (IRTA) or equivalent staff fellows in the NIAAA Division of Intramural Clinical and Biological Research (DICBR). Candidates must have completed at least two, but no more than six years of postdoctoral training at the time of application. This includes individuals with postdoctoral research experience in any environment (e.g., academic, industry, and government). In unusual circumstances, exceptions to the six year limitation may be granted by NIAAA. Such waivers will be considered on a case by case basis, and must accompany the initial application packet. Years of clinical training will not count against the six years of relevant research experience.
To activate the award, candidates must be appointed to a faculty position at a U.S. academic institution. Candidates will have up to 18 months to activate the award. The institution sponsoring the faculty appointment must submit a request for activation on behalf of the candidate. The application will receive an administrative review by NIAAA program staff.
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: Applicants 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.
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 NIAAA 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
K22 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 support, and under certain circumstances, salary support from the final two years of their K22 award and 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.
Each K22 career development program must be tailored to meet the individual needs of the Candidate. The Candidate and mentor are responsible jointly for the preparation of the plan for the career development and research program. The sponsoring institution for the independent phase must provide an appropriate scientific environment for the Candidate and demonstrate a commitment to the development of the candidate as a productive, independent investigator.
Applications must be relevant to the mission or to the research priorities of the NIAAA.
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
301-451-5936.
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): Not applicable;
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://grants.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply, please
see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please
see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard
dates apply, please see http://grants.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).
All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts.
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
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
6.C. Statement of Support
Statement by Mentor, Co-Mentors, Consultants, 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:
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, including 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 the required letters of reference may be delayed in the review process or not accepted.
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:
Cover Component (Section 4.2): For the Proposed Project (Start and Ending Date), indicate the total period of support being requested (3 years maximum).
Budget at Postdoctoral institution: Salary and research costs prior to activation of the K22 award are to be supported by the intramural or extramural institution where postdoctoral work is being conducted. Budgetary information is not required for this period.
Budget During Award Phase: For candidates who receive approval to activate the K22 award, a detailed budget will be required from the academic institution of employment. For purposes of the initial application, the pages specifying Detailed Budget for the Initial Budget Period and Budget for Entire Proposed Period of Support should only include yearly projections of salary and research expenses. See specific instructions above for allowable costs. (See Section VI.4, Transition to the Independent Phase.
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 submitted for this funding opportunity will be
assigned on the basis of established PHS referral guidelines to the ICs
for funding consideration.
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://grants.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:
2.A. Additional Review Criteria
Resubmissions: 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.
Applicants who have competed successfully for funding will be issued a "Letter of Intent to Commit Funds" from the NIAAA. This letter states the conditional intent of the NIAAA to make a grant award and may be used by the applicant when entering into negotiations for a position with a suitable institution to document potential grant support for the applicants research project. Applicants will then have up to 18 months from the date of the letter to identify a tenure track or equivalent faculty position at a domestic, sponsoring extramural institution/organization (sponsoring grantee institution). Salary and research costs prior to activation of the K22 award are to be supported by the intramural or extramural institution where postdoctoral work is being conducted.
The institution sponsoring the new faculty appointment must request that the K22 award be activated according to procedures described below (Section VI.4. Transition to the Independent Phase). The application for activation must include a brief update of progress and any proposed changes to the Specific Aims, as well as a detailed budget for the duration of the K22 award. The application must include an institutional commitment agreement signed by an authorized official that describes the type of faculty appointment and certifies that the candidate will be able to commit 75 percent of full-time professional effort toward research and career development activities. These materials are to be submitted to the NIAAA Grants Management Branch at the address listed below and in the Letter of Intent to Commit Funds.
The application to activate the K22 award will be used by NIAAA program and grants management staff to assess the appropriateness of the proposed arrangement. The institution will be evaluated for its ability to make a significant commitment of resources, time and other factors conducive to the research project and career development of the investigator.
While the application is under consideration for funding, NIAAA may 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.
Subject to NIAAA approval of the application, a formal notification in the form of a Notice of Award (NoA) will be transmitted 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 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.
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.
At the time the K22 is awarded
to the grantee institution, any current award held or other support provided
for the mentored training of the candidate will be terminated. Candidates
receiving support through an NRSA fellowship (F32 or T32) must submit
a termination notice to prior to activation of the K22 award.
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 NIAAA 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 NIAAA 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 NIAAA 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:
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.
4. Transition to the Independent Phase (Activation)
The NIAAA Career Transition (K22) Award is a single-phase, transition only award. The award is not activated until the candidate is appointed to a tenure track or equivalent faculty position. Postdoctoral candidates who are approved for the K22 program will have up to 18 months to find and accept a faculty position. Salary and research costs prior to activation of the K22 award are to be supported by the intramural or extramural institution where postdoctoral work is being conducted. The candidate is expected to relocate to a different research intensive institution when the award is activated. Arrangements in which a candidate moves from a postdoctoral position to that of an Assistant Professor at the same institution must be justified convincingly to NIAAA program staff in order to be considered for K22 support.
The new sponsoring institution must request activation of the K22 award by submitting a PHS 398 application at least two months prior to the anticipated activation date. The application must be endorsed by the appropriate authorized official, and must include the following information:
a. List the name, role on project and percent effort for all project personnel (salaried and unsalaried) and provide a narrative justification for each person.
b. Identify all consultants by name and organizational affiliation and describe the services to be performed.
c. Provide a narrative justification for any major budget items, other than personnel, that are requested for the conduct of the project.
d. Describe specific resources committed by the sponsoring institution to support the Candidates research.
An institutional commitment agreement will be required at the time of submission of the PHS 398 application. The commitment agreement from the sponsoring institution must include the following:
The institutional commitment must be dated and signed by the person who is authorized to commit the institution to the agreements and assurances listed above. In most cases, this will be the dean or the chairman of the department. The sponsoring institution, through its signatures on the Face Page and in the institutional commitment, certifies that all items outlined above will be provided and that the institution will abide by the applicable assurances and PHS policies. If the research involves human or animal subjects, certification that the protocols were approved by the appropriate institutional committee of the designated grantee institution must be provided.
The PHS 398 application and supporting documents must be submitted no later than 2 months prior to the proposed activation date to the NIAAA Grants Management Branch. These materials will be used by NIAAA staff to assess the appropriateness of the proposed arrangement in relation to the objectives of the K22 program. Activation of the award is not automatic. NIAAA will not activate the award if the faculty appointment or institutional commitments are deemed inadequate.
Upon approval of the application and resolution of all administrative issues, the NIAAA Grants Management Officer will transmit a Notice of Award (NoA) to the applicant organization.
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):
Max Guo, Ph.D.
Program Director
Division of Metabolism and Health Effects
National Institute on Alcohol Abuse and Alcoholism
Room 2021
5635 Fishers Lane
MSC 9304
Bethesda, MD 20892
Phone: (301) 443-0639
Fax: (301) 443- 594-0673
E-mail: [email protected]
2. Peer Review Contact(s):
Abraham P. Bautista, Ph.D.
Chief, Extramural Project
Review Branch
National Institute on Alcohol Abuse and Alcoholism
Room 3039
5635 Fishers Lane
MSC 9304
Bethesda MD 20892
Phone: (301) 443-9737
Fax: (301) 443-6077
E-mail: [email protected]
3. Financial/Grants Management Contact(s):
Judy Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
Room 3023
5635 Fishers Lane
MSC 9304
Bethesda, MD 20892-9304
Phone: (301) 443-4704
Fax: (301) 443-3891
E-mail: [email protected]
Section VIII. Other Information
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/.
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