Part I Overview Information


Department of Health and Human Services

Participating Organization
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-02-018 which was previously released November 15, 2001.

Update: The following update relating to this announcement has been issued:

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).

Program Announcement (PA) Number: PAR-07-347

Catalog of Federal Domestic Assistance Number(s)
93.855, 93.856

Key Dates
Release Date: April 2, 2007
Letters of Intent Receipt Date(s): Not required       
Application Receipt Date (s): Standard dates, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Peer Review Date(s): Standard dates, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Council Review Date(s): Standard dates, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Earliest Anticipated Start Date(s): Standard dates, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Additional Information To Be Available Date (URL Activation Date): Not applicable
Expiration Date: New Date January 8, 2009 (per issuance of PAR-09-068), Original Date: May 8, 2010

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

The primary, long-term goal of the NIAID Research Scholar Development Award (RSDA) program is to increase and maintain a strong cohort of new and talented NIH-supported independent investigators that will address the health needs of the Nation.  The NIAID RSDA is specifically designed to facilitate the transition from a postdoctoral research position to an independent research position.

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
   1. Research Objectives

Section II. Award Information
   1. Mechanism(s) of Support
   2. Funds Available

Section III. Eligibility Information
   1. Eligible Applicants
     A. Eligible Institutions
     B. Eligible Individuals
   2.Cost Sharing or Matching
   3. Other - Special Eligibility Criteria

 Section IV. Application and Submission Information
   1. Address to Request Application Information
   2. Content and Form of Application Submission
   3. Submission Dates and Times
     A. Submission, Review and Anticipated Start Dates
       1. Letter of Intent
     B. Sending an Application to the NIH
     C. Application Processing
   4. Intergovernmental Review
   5. Funding Restrictions
   6. Other Submission Requirements
   7. Application Contents

Section V. Application Review Information
   1. Criteria
   2. Review and Selection Process
     A. Additional Review Criteria
     B. Additional Review Considerations
     C. Sharing Research Data
     D. Sharing Research Resources
   3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
   1. Award Notices
   2. Administrative and National Policy Requirements
   3. Reporting

Section VII. Agency Contact(s)
   1. Scientific/Research Contact(s)
   2. Peer Review Contact(s)
   3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Career Objectives

Background and Objective

The primary goal of this initiative 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 Nation’s 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 Nation’s 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 for 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


1. Mechanism(s) of Support

This funding opportunity will use the K22 funding mechanism.  The applicant (Principal Investigator) is responsible for planning, directing, and executing the proposed research.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions. The applicant should follow the instructions for budget information described in the PHS 398, Section III, providing only the total direct costs requested for each year and the entire proposed period of support and budget justification information. 

2. Funds Available

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 Investigator’s 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 applicant 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

Salary Policies Applicable to the Phase 2 K22 Award

For information regarding NIH policy on determining full-time professional effort for career awards see NOT-OD-04-056. The requested salary must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members with equivalent 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 http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html 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 institution’s rate and the percent of effort are provided in addition to the salary.

Candidates who have VA appointments may not consider part of the VA effort toward satisfying the “full time” requirement at the applicant institution (see: NOT-OD-04-056). Candidates with VA appointments should contact the appropriate staff person in Section VII Agency Contacts prior to preparing an application to discuss their eligibility.

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.

Research-Related Expenses for the Phase 2 K22 Award

These include salaries for technical support, consultant costs, equipment, supplies, travel, and other research-related expenses. Salary for secretarial or administrative assistance is not allowed.

3.  Transition to the Phase 2 of the NIAID K22 Award 

After the review of the Phase 1 application, funding is NOT automatic and is subject to several conditions described in Section VI, item 4.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

Eligible applicant institutions for the Phase 1 and 2 of the NIAID K22 Research Scholar Development Award include domestic academic institutions such as universities, colleges, and hospitals, as well as research institutes and non-profit organizations.  NIH intramural laboratories are not eligible to apply for Phase 2 of this mechanism on behalf of intramural candidates.  In addition, agencies of the federal government and foreign institutions are not eligible to apply for Phase 2.

1.B. Eligible Individuals

Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to develop an application for support.

Only U.S. citizens or non-citizen nationals, or individuals lawfully admitted for permanent residence who possess an Alien Registration Receipt Card (I-151 or I-551), or some other verification of legal admission as a permanent resident prior to the time of award, are eligible for the NIAID K22. 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.Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

This award is intended for and limited to postdoctoral scientists who are in mentored training positions and do not have sufficient research training experience or institutional authority to lead an independent research program. Intramural and extramural postdoctoral scientists are eligible to apply for Phase 1.

At time of Phase 1 application submission (or any resubmissions), applicants must:

Individuals are NOT eligible if they:

Ph.D. applicants 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.  Applicants in such positions are encouraged to obtain confirmation of their eligibility before they begin to prepare their applications.  It is incumbent upon the applicant 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.

Applicants 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 (http://grants.nih.gov/grants/guide/contacts/pa-06-133_contacts.htm).

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

A candidate for the NIAID K22 award may not simultaneously submit or have an application pending for any other NIH fellowship, career award (K) or research award. Ineligible individuals include current and former principal investigators on NIH research grants (e.g. R01, R03, R21), comparable individual NIH career development awards (e.g., K01, K07, K08, K23, K25), equivalent non-PHS peer-reviewed career development awards, or non-

PHS peer-reviewed research grants over $100,000 direct costs per year, or project leaders on multi-project grants and cooperative agreements.

NIAID K22 award recipients are expected to apply for NIH or other independent research grant support during the second year of the K22 award.  Recipients of a K22 award may hold concurrent research support, and under certain circumstances (see Funds Available above) salary support from their K22 award and a competing NIH research project grant when recognized as a Principal Investigator or subproject Director of the research project grant. 

NIH intramural laboratories are not eligible to receive funding from a Phase 2 K22 award.

Section IV. Application and Submission Information


1. Address to Request Application Information           

The PHS 398 application instructions are in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact Grants Info., Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a Dun &Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the D&B Website. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the “YES” box must be checked.  Applicants should use the substitute Table of Contents for Career Development Awards, and report their citizenship status in the appropriate box at the bottom of that page. 

Please note that applications responding to this announcement must include at least three sealed letters of reference attached to the face page of the original application. One of these letters must be from the applicant’s latest postdoctoral mentor.  Applications submitted without the required number of reference letters will be considered incomplete and will not be reviewed. 

2. Submission Dates and Times

See Section IV.3.A for details.

3. A. Submission, Review and Anticipated Start Dates

Application Receipt Date: Standard dates, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Peer Review Date(s): Standard dates, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Council Review Date(s): Standard dates, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Earliest Anticipated Start Date(s): Standard dates, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details

3. A.1. Letter of Intent

A letter of intent is not required for this funding opportunity.  However, applicants are encouraged to contact the scientific research/program contact at the relevant awarding component (See Section VII and http://grants.nih.gov/grants/guide/contacts/pa-06-133_contacts.htm), prior to submitting an application, to discuss issues of eligibility and review the specific provisions of this award.

3. B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies of the application and any appendix materials (NOT-OD-07-018) in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see NOT-OD-03-040).

3. C. Application Processing

Applications must be submitted on or before the application receipt/submission dates described above (Section IV.3.A.) and at Submission Dates/Deadlines. Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review (CSR).

The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

Information on the status of an application should be checked by the applicant in the eRA Commons.

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.

Ruth L. Kirschstein National Research Service Award (NRSA) recipients that are selected for PI award funding must terminate their NRSA support prior to receiving support from the PI award. 

Pre-award costs are allowable. A grantee may, at his/her own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a 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

Applicants should follow the instructions in the PHS 398 application for Individual Research Career Development Awards (Section III) 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:

7. Application Contents

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 applicant may not have identified a sponsoring institution at the time of submitting the Phase I portion of the application.  Thus, the front page of PHS 398 will not require a sponsoring institution or institutional official’s information or signature.

The following items on form PHS-398 application are required for the first phase of an RSDA application:

Biographical Sketch

a. A biographical sketch is required for the applicant 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 Development Plan

Research Plan

Mentor(s)

Training in the Responsible Conduct of Research

Applications must include a description of a program to receive formal or informal instruction in scientific integrity and the responsible conduct of research. Applications without plans for instructions in the responsible conduct of research will be considered incomplete and may be returned to the applicant without review. Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, policies regarding the use of human and animal subjects, and data management. Applicants must follow the application instructions found on page 49 of the PHS-398 application package and refer to the NIH's Bioethics Resources on the Web  for additional guidance.

Document prior instruction in or proposed plans to obtain instruction in the responsible conduct of research in terms of subject matter and duration of instruction.  An award cannot be made if an application lacks this component.

Letters of Reference

Include with the application three or more sealed independent letters of reference from well-established scientists which address the application content areas and any other evidence that the candidate has a high potential for becoming a successful candidate for this K22 award program.  One of the letters MUST be from the applicant’s latest postdoctoral mentor.

Plan for Sharing Research Data

A plan for sharing research data is not required.

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication: NIH Grants Policy Statement: Availability of Research Results: Publications, Intellectual PropertyRights, and Sharing Research Resources. Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report. (PHS 2590). See Section VI.3. Reporting.

Section V. Application Review Information


1. Criteria

(Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

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 (see also: Submission and Assignment Process).

Applications that are complete will be evaluated for scientific and technical merit by an appropriate review group convened by the NIAID in accordance with the review criteria stated below.

Applications that are incomplete will be returned to the applicant without review.

As part of the initial merit review, all applications:

Applicants can check the status of their application at each stage and receive the written critique through the eRA Commons.

The following will be considered in making funding decisions:

The goal of the PI award is to facilitate a new investigator’s transition from a postdoctoral status to an independent scientist with the ability to successfully compete for an R01 award.  In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research and career development plans will have a substantial impact on the pursuit of these goals:

The following review criteria will be applied in Phase 1 of the review process:

1.  Candidate:  Is the candidate appropriately trained and suited to the proposed career development activities, i.e., well trained and productive in his or her current field and prepared for the proposed research activities?

2. Career Development Plan: Is the career development plan proposed one that will give the candidate sufficient background and experience in research such that the candidate can establish an independent research career?

3.  Research Plan: All candidates for this award must have had previous research experience as postdoctoral scientists.  A strong research plan that is consistent with the career development plan and the candidate"s level of research development should be provided.

4.  Significance:  Does this project address an important problem?  How well does the proposed research experience complement the proposed career development activities?

5.  Approach:  Are the methods adequately developed, well integrated, and appropriate to the research plan and career development goals of the candidate? Does the candidate acknowledge potential problem areas and consider alternative tactics?

The following review criteria will be applied in Phase 2 of the review process:

The present Program Announcement includes the new requirement of a Career Development Plan in the Phase 1 application. The Career Development Plan is required to satisfy the reviewers’ need to understand how the applicant’s future professional  and career will develop during the time of the K22 award and beyond.

Candidate:

Career Development Plan:

Research Plan:

Environment and Institutional Commitment to the Candidate

Training in the Responsible Conduct of Research:

2. A. Additional Review Criteria:

In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, adequacy of the proposed protection will be assessed.

2. B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research transition award program. The priority score should not be affected by the evaluation of the budget.

2. C. Sharing Research Data

A plan for sharing research data is not required. 

2. D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. NIH Grants Policy Statement and Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice. Investigators responding to this FOA should include a plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the resource sharing plans with the Principal Investigator before recommending funding of an application. The final version of the resources sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report. (PHS 2590). See Section VI.3. Reporting.  

3. Anticipated Announcement and Award Dates

Not Applicable.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the applicant (Principal Investigator) will be able to access his or her Summary Statement (written critique) via the eRA Commons.

No award will be issued for successful Phase 1 applications, see Section VI.4 for details on notification of NIAID’s commitment to make an award and the requirements for submission of the Phase 2 application.

If the Phase 2 application is approved for award, a formal Notice of Award (NoA) will be issued. 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 Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. 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..

Evaluation

In carrying out its stewardship of human resource-related program, 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.

Changes in Research Program

A change in the specified scientific area of the research component requires prior approval of the NIAID.  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 NIAID staff to ensure that the plan remains within the overall 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.

Change of Institution or Termination

Consultation with NIAID program and grants management staff is strongly encouraged when either a change of institution or termination is being considered.

A change of sponsoring institution will be permitted only when all of the terms and benefits attributable to the original award can be assured.  Consultation with NIAID program and grants management staff responsible for the programmatic and administrative management of the award is strongly encouraged when a change of institution is being considered.  A change may be made without peer review, provided the 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 NIAID may disapprove the request and, if appropriate, terminate the award.

3. Reporting

NIAID K22 awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form PHS 2590 annually and financial statements as required in the http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct 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 IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NHMS) system (http://www.nihms.nih.gov) at Pub Med Central (PMC) an electronic version of the author’s final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH.  The author’s final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005.  The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings.  Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Author’s Manual (http://publicaccess.nih.gov/publicaccess_manual.htm).

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.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ in the following citations: No. 93.855, Immunology, Allergy, and Transplantation Research and No. 93.856, Microbiology and Infectious Diseases Research, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

The 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 2 years to the research. For further information, please see: http://www.lrp.nih.gov/.


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