Part I Overview Information


Department of Health and Human Services

Participating Organization
National Institutes of Health (NIH) (http://www.nih.gov/)

Component of Participating Organization
National Cancer Institute (NCI) (http://www.nci.nih.gov/)

Title: The NCI Transition Career Development Award (K22)

Announcement Type
This Funding Opportunity Announcement (FOA) is a reissue of PAR-04-040, which was previously released on December 16, 2003.

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

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government, during FY 2006 the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using Grants.gov.. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html). Specific funding opportunity announcements will also clearly indicate if Grants.gov submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site (http://grants.nih.gov/grants/forms.htm) for the most current information when preparing a grant application.

Program Announcement Number: PAR-06-455

Catalog of Federal Domestic Assistance Number
93.398

Key Dates
Release Date: June 12, 2006
Letters of Intent Receipt Date(s): Not applicable.
Application Submission Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Additional Information To Be Available Date (Url Activation Date): Not applicable.
Expiration Date: New Date January 24, 2009 (per issuance of PAR-09-089) (Original Expiration Date: July 2, 2009, changed to September 8, 2009 per NOT-OD-07-093)

Due Dates for E.O. 12372
Not Applicable.

Additional Overview Content

Executive Summary

This Funding Opportunity Announcement (FOA) represents the continuation of an NCI program to facilitate the transition of investigators, primarily those with clinical doctoral degrees as well as those with doctoral degrees working in the areas of cancer prevention, control, behavioral, or population science research, from the mentored stage of career development in academic cancer research to the independent stage. This goal is achieved by providing protected time through salary and research support for 3 years to: postdoctoral individuals or junior faculty in mentored positions transitioning into their first independent position; and investigators within the first 2 years of their first independent cancer research position, to initiate and develop their independently-supported cancer research programs.

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

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
1. Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Career Objectives

Background

A critical mass of clinically-trained cancer researchers, and researchers in cancer prevention, control, behavioral, and population sciences capable of working with basic science researchers is needed to ensure effective translation of basic research discoveries into patient and population research settings if there is to be optimal progress in reducing cancer incidence, mortality, and morbidity. Many individuals in these fields need protected time to develop successful independent research programs. This situation is particularly true for medically trained individuals, in general, and for doctoral level and medically trained individuals pursuing cancer research careers in the prevention, control, behavioral, and population sciences. Individuals in these research career tracks often require extended periods of mentored research training beyond their original doctoral degrees (e.g., M.D., Ph.D.). As a result, upon completion of their mentored research training, these individuals are often at a competitive disadvantage in obtaining independent research support relative to their traditional basic science, Ph.D. counterparts, who generally have many more combined years of research training and experience in their field of expertise. Finally, the “survival” of clinician and Ph.D. researchers in these critical research areas is being threatened by the current economics of medical care, which is increasingly emphasizing revenue-generating clinical practice at the expense of clinical research; and by a corporate culture of many of the nation's academic institutions that does not provide academic homes and tenure-track positions for prevention, control, behavioral, and population scientists in the beginning stages of the independent phase of their research careers.

There is also a need for basic science researchers trained in human cancer research who are capable of working with clinicians conducting cancer research and with researchers in cancer prevention, control, behavioral, and population sciences. These individuals are generally trained in the basic sciences and have a substantial number of combined years of training and accumulated expertise in these areas of research upon and shortly after completion of their doctoral degree requirements. However, these individuals need additional protected time during the transition to their first independent research programs in human cancer. Basic postdoctoral scientists training in non-Federal institutions have access to the Howard Temin Pathway to Independence Award in Cancer Research (K99/R00) for this purpose. However, postdoctoral scientists who are Federal Employees (e.g., NIH intramural scientists) are not eligible for these awards. In order to overcome this barrier, Federal Employees pursuing human cancer research may apply for the K22. Finally, the NCI Career Development Award for Quantitative Scientists (K25) (http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-04-016.html ) will be providing quantitative scientists their first experience in applying their research and technical skills to biomedical cancer research.

These scientists may therefore require an additional period of protected time after the completion of the NCI K25 award to develop their first independent program in biomedical cancer research. Consequently, quantitative scientists who have been supported by the NCI K25 may also apply for the NCI Transition Career Development Award.

Purpose

The major objective of the NCI Transition Career Development Award program is two-fold: (i) to provide a mechanism for stabilizing the career tracks of the most promising of investigators while they are establishing their first independent research programs and (ii) to create equal access to extramural career development opportunities to postdoctoral scientists in basic human cancer research working as Federal employees.

See Section VIII, Other Information for policies related to this announcement.

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity uses the NIH Career Transition (K22) funding mechanism. As an applicant, the candidate will be responsible for planning, directing, and executing the proposed research project and career development plan. Applicants must request 3 years of support. Awards are not renewable. This funding opportunity uses NIH just-in-time budget concepts. It also uses the Career Development Award budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 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

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary. Although the financial plans of the NCI 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.

Allowable Costs

Direct costs are limited to up to $75,000 per annum salary and up to $50,000 per annum for research support costs. Fringe benefits based on the sponsoring institution’s rate are provided in addition to the salary. Research support costs may include: tuition and fees related to the career development of the PI; supplies, equipment and technical personnel; travel to research meetings or training; and statistical services including personnel and computer time. The level of research support costs may be negotiated downward with the acquisition of any independent grant support from any source.

The total salary requested must be based on a full-time, 12-month staff appointment requiring candidates to devote a minimum of 75 percent 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 http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-056.html. 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 NCI 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 is required prior to the issuance of an award.

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.

Ancillary personnel support: Salary for secretarial and administrative assistance, etc., is NOT allowed.

Facilities and Administrative (F&A) costs will be reimbursed at 8 percent of modified total direct costs.

F&A costs requested by consortium participants are included in the total cost limitation; see NOT-OD-05-004. Such costs, however, are limited to 8 percent of modified direct costs.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application(s) if your organization has any of the following characteristics:

The K22 award is for domestic institutions/organizations only. Foreign institutions are not eligible to apply for this grant. Applicants may apply for this award WITHOUT an institutional affiliation. Therefore, individuals working at agencies of the Federal government, including the NIH intramural program, may apply for this award. However, they must accept an independent faculty position at an extramural (i.e., non-Federal) institution to activate this award as outlined in Section VI. To be eligible for award, an institution at which applicant accepts an independent faculty position must have any of the characteristics specified in the bulleted list above.

1.B. Eligible Individuals

Eligible candidates must be: 1) individuals with a clinical doctoral degree, such as M.D., D.V.M., D.O., oncology nurses holding a doctoral degree, or doctoral level clinical psychologists pursuing basic science cancer research careers or careers in patient-oriented cancer research; or 2) individuals holding a doctoral degree (e.g., Ph.D., M.D., Dr.P.H.) in the areas of cancer prevention, control, behavioral, or population science. Federally employed basic scientists holding a doctoral degree (e.g., Ph.D., M.D.) are eligible candidates if they are working in human cancer research. However, non-Federally employed basic research scientists are not eligible for this award. Non-Federally employed basic researchers should consider applying for the NCI K01 Howard Temin Award (http://grants1.nih.gov/grants/guide/pa-files/PA-03-104.html), if they are pursuing careers in human cancer research, or for the NIH Pathway to Independence Award (http://grants1.nih.gov/grants/guide/pa-files/PA-06-133.html).

Individuals who meet the requirements stated above must have completed a minimum of 2 YEARS of postdoctoral CANCER research training and be ready to pursue an independent career at the time of application OR be in an independent faculty position for LESS THAN 2 YEARS with continuous previous postdoctoral CANCER research training at the time of the application.

Eligible candidates must also be able to devote a minimum of 75 percent of full-time professional effort to the Award. The remaining 25 percent can be divided among other research, clinical and teaching activities only if these activities are consistent with the goals of the K22 Award, i.e., the candidate's development into an independent investigator.

Applicants may apply for this award WITHOUT an institutional affiliation.

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.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities and individuals from disadvantaged backgrounds are always encouraged to apply for NIH programs.

An individual is NOT eligible if he/she:

Applicants are strongly encouraged to consult with the NCI scientific/research contact person listed in Section VII of this announcement prior to the submission of an application to discuss eligibility and program requirements.

2. Cost Sharing or Matching
Not applicable. The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

Special Requirements

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance, contact 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 web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form. Candidates applying without an institutional affiliation will not need to provide this information until the award is ready to be activated.

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 follow the instructions in the PHS 398 application for Individual Research Career Development Awards (Section III in http://grants.nih.gov/grants/funding/phs398/phs398.pdf)) and complete ALL the required sections with the following modifications:

Note that new and revised applications responding to this announcement must include at least three sealed letters of reference attached to the face page of the original application. Applications submitted without the required number of reference letters will be considered incomplete and will be returned without review.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates
Application Submission Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Peer Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Council Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Earliest Anticipated Start Date(s): Standard dates apply, 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 (see Section VII), 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 career development award (CDA) application forms found in the PHS 398 instructions for preparing a research career award application. Submit a signed, typewritten original of the application, including the checklist, three original sealed letters of reference, and three signed photocopies in one package to:

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

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission two additional copies of the application, including copies of all appendix materials, must be sent to:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)

Appendices should be comprised of single-sided, unbound materials, with separators between documents.

3.C. Application Processing

Applications must be submitted on or before the application receipt/submission dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm. Upon receipt, applications will be evaluated for completeness by NCI staff.

The NIH will not accept any application in response to this funding opportunity 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 Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/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 which can be found at http://grants.nih.gov/grants/policy/policy.htm.

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new 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 the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

The NCI is developing a policy that will require Clinical Terms of Awards for clinical studies and trials when they are a component of the proposed research. The policy will require that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. The new policy will be posted in the NIH Guide within a few weeks. All funded applicants will be expected to adhere to the new policy.

6. Other Submission Requirements

Applicants must follow the Supplementary Instructions for “Preparing and Individual CDA Application” in the PHS 398 Instruction Files (http://grants.nih.gov/grants/funding/phs398/phs398.pdf, Part I, Section III, starting on page 51). In addition, the following information must be included in the indicated sections/form pages of the application:

Budget (Form Page 5)

Biographical Sketch (Form Page 6)

Letters of Reference

Introduction to revised/Resubmission Application

Sections listed under Career Development Plan (Section F in “Preparing and Individual CDA Application” in the PHS 398 Instruction Files (http://grants.nih.gov/grants/funding/phs398/phs398.pdf,), including:

The Candidate (Section 1)

Identify how you meet the eligibility criteria: whether you hold a clinical doctoral degree and are pursuing a basic science career; hold a clinical doctoral degree and are pursuing a clinical research/translational research career; hold a doctoral degree and are pursuing a career in prevention, control, behavioral, or population research; or are a postdoctoral candidate working in basic research as a Federal employee.

Applicants already in an independent position:

Statement(s) by Consultant(s)/ Contributor(s) (Section 2)

Environment and Institutional Commitment to the Candidate (Section 3)

(Required at the time of application for candidates who have identified a sponsoring institution.)

The sponsoring institution must provide the following:

Research Plan (Section 4)

Training in the Responsible Conduct of Research

Applicants must either: document receiving prior instruction covering the responsible conduct of research; or outline plans how and when they expect to receive such instruction. The plans should include a description of a formal program or informal training (in terms of subject matter and duration of instruction) on scientific integrity and the responsible conduct of research.

Applications without either documented prior training or plans for instructions in the responsible conduct of research will be considered incomplete and may be returned to the applicant without review. An award cannot be made if an application lacks this component.

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 Web site (http://www.nih.gov/sigs/bioethics/researchethics.html) for additional guidance.

Plan for Sharing Research Data

A plan for sharing research data is not required.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. See the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131. Applicants must acknowledge in application that unique research resources generated with the NIH support will be subject to sharing in accordance with the NIH policies or explain why sharing of certain resources might not be possible.

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

Clinical Terms of Awards

The NCI is developing a policy that will require Clinical Terms of Awards for clinical studies and trials when they are a component of the proposed research. The policy will require that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. The new policy will be posted in the NIH Guide within a few weeks. All funded applicants will be expected to adhere to the new policy.

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).

Not applicable.

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned on the basis of established PHS referral guidelines.

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

As part of the initial merit review, all applications:

The following will be considered in making funding decisions:

Review Criteria

The goal of this initiative is to facilitate a new investigator’s ability to transition from a mentored investigator stage of career development in academic cancer research to an independent scientist capable of applying for and receiving their first independent Research Project grant award and securing a stable research position. In their written critiques, reviewers will be asked to evaluate each of the following criteria in order to judge the likelihood that the proposed research and other aspects of career development plans will have a substantial positive impact on the pursuit of these goals. The application does not need to be strong in all categories to deserve a high priority score. These criteria are listed in logical order and not in order of priority.

A. Candidate
B. Career Development Plan
C. Research Plan
D. Environment and Institutional Commitment to the Candidate
E. Letters of Reference
F. Training in the Responsible Conduct of Research

A. Candidate

B. Career Development Plan

Quality of the plan for Career Development and Training Activities in terms of research experience(s), didactic experiences and other experiences (e.g., special skills, perspectives, techniques) that will enhance the candidate's ability to pursue an independent CANCER research career in the chosen area of research (e.g., basic research; clinical or patient oriented research; or prevention, control, behavioral, and population sciences research).

C. Research Plan

D. Environment and Institutional Commitment to the Candidate (only for applicants with a sponsoring institution in which they secured an independent position)

E. Letters of Reference

F. Training in the Responsible Conduct of Research

2.A. Additional Review Criteria

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

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

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

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

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

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

2.C. Sharing Research Data

Not applicable.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. See the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps and at http://ott.od.nih.gov/policy/rt_guide_final.html. Applicants must acknowledge in application that unique research resources generated with the NIH support will be subject to sharing in accordance with the NIH policies or explain why sharing of certain resources might not be possible.

The adequacy of the resources sharing statement 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 statement with the PI before recommending funding of an application. 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 PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is approved for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

The NCI will notify candidates without a sponsoring institution who have competed successfully for funding with a "Letter of Intent to Commit Funds." Candidates will then have one year from the date of the letter to accept an appointment with an institution that has offered a position at the Assistant Professor level or an equivalent permanent faculty position (e.g., Assistant Member, Laboratory Head, Principal Investigator, etc.), at which the candidate is expected to establish his/her own independent research program, prepare applications for regular (non-career development) research funding, and act as a PI on such independent research projects.

After the candidate notifies the NCI about accepting a faculty level appointment, the NCI will contact the candidate's institution to request a "Statement of Environment and Institutional Commitment." This statement will be evaluated by NCI staff using the following criteria:

Grantee institutions may supplement a candidate’s salary so that the salary is consistent with salaries of individuals in comparable positions at the institution. However, performing or assuming additional responsibilities that would interfere with the required 75% effort on the PI Award is not permitted.

If the NCI approves the "Statement of Environment and Institutional Commitment" offered by the institution, the institution will be asked to finalize the submission process by sending in a complete PHS Form 398 application with all the required institution-specific information and form pages.

For a candidate who already has a faculty position and applied with a sponsoring institution, negotiations with the institution will begin without delay.

After NCI approval and subject to the availability of funds, the institution will receive an award. At the time of the award to the grantee institution in support of the K22, any current award held or other support provided for the mentored training of the candidate will be terminated.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 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 NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following related administrative policies apply generally to NIH Research Career Award (“K”) programs:

A. Evaluation

In carrying out its stewardship of human resource-related programs, the NIH may begin requesting 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 or research training 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. Special Leave:

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 three months. For longer periods, prior written approval of the NCI is required. Details on the process for submission of prior approval requests can be found in the NIHGPS (rev. 12/03), Requests for Prior Approval, at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600130.

To obtain prior approval, the award recipient must submit a letter to NCI describing the plan, countersigned by his/her mentor and the appropriate institutional official. 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 NCI and will be granted only in unusual situations.

Support from other sources is permissible during the period of leave. Such leave does not reduce the total number of months of program support for which an individual is eligible.

Under unusual and pressing circumstances, an awardee may submit a written request to the awarding component requesting a reduction in professional effort below 75 percent. 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. The nature of the circumstances requiring reduced effort might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission to reduce the level of effort will not be approved to accommodate other sources of funding, 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) as soon as possible. During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly.

D. Changes in Research or Career Development Program:

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 NCI. 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 NCI 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, NCI staff could recommend that the award be terminated.

E. Change of Institution or Termination

If the individual is moving to another eligible institution, career award support may be continued provided:

When a grantee institution plans to terminate an award, the NCI Grants Management Specialist listed on the 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 may discontinue an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, the Director of the NIH shall notify the grantee institution and career award recipient in writing of this determination, the reasons therefore, the effective date, and the right to appeal the decision.

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590, annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

The Progress Report must include Sections a through f as described in the general PHS Form 2590 instructions, as well as sections g through i as described in Section IV of the 2590 instructions. Evaluation of the awardee’s progress will depend on the following:

Note: Since an NCI K22 grant is a non-mentored award, an annual evaluation statement of the candidate's progress [mentioned in the PHS 2590 continuation application instructions (item j. Sponsor's Report) for mentored career development awards] is not required.

Additionally, funding beyond the second year of the award is contingent upon submission of an R01 research grant application to the NIH, or an R01 equivalent research grant application to an equivalent funding organization (for example, an American Cancer Society Research Project Grant) for peer review and funding consideration prior to the end of the second year of support. Documentation that the awardee has submitted an R01-type research grant application for funding should minimally be a copy of the face page of the application with all required institutional signatures.

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.

The NCI is developing a policy that will require Clinical Terms of Awards for clinical studies and trials when they are a component of the proposed research. The policy will require that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. The new policy will be posted in the NIH Guide within a few weeks. All funded applicants will be expected to adhere to the new policy.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Sonia Jakowlew, Ph.D.  
Program Director
Cancer Training Branch
Office of Centers, Training and Resources, NCI 
6116 Executive Blvd., Suite 7019  
MSC 8346 
Bethesda, MD 20892-8346 
Telephone: (301) 496-8580
Fax: (301) 402-4472
E-mail: jakowles@mail.nih.gov

2. Peer Review Contacts:

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-3428
Fax: (301) 402-0275
E-mail: ncirefof@dea.nci.nih.gov

3. Financial or Grants Management Contacts:

Ms. Kimery Griffin
Office of Grants Administration
National Cancer Institute
6120 Executive Boulevard, Room 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: 301-496-3196
Fax: 301-496-8601
E-mail: griffink3@mail.nih.gov

Section VIII. Other Information


1. Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals ( http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

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

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); and 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 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 at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004, receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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

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

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

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

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

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author’s final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct 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).

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/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50 percent 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/.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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