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: Paul Calabresi Career Development Award For Clinical Oncology (K12)

Announcement Type
This is a reissue of PAR-04-096, which was previously released April 23, 2004.

Update: The following updates relating to this announcement have been issued:

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

Program Announcement (PA) Number: PAR-06-449

Catalog of Federal Domestic Assistance Number(s)
93.398

Key Dates

Release Date: June 7, 2006
Letters of Intent Receipt Date(s): 30 days before Application Receipt Date(s)
Application Receipt Date(s): Standard dates of Receipt/Submission Cycle II apply (please see http://grants.nih.gov/grants/funding/submissionschedule.htm)
New Application Receipt Date(s):  June 1, 2007; June 12, 2008; June 12, 2009
Competing Continuation, Revised, Supplemental Application Receipt Date(s):  July 1, 2007; July 12, 2008; July 12, 2009
Peer Review Date(s): Standard dates of Receipt/Submission Cycle II apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): Standard dates of Receipt/Submission Cycle II apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date(s): Standard dates of Receipt/Submission Cycle II apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Additional Information To Be Available Date (Url Activation Date): Not applicable.
Expiration Date:   (Now Expired March 24, 2010 per NOT-OD-10-069), New Date July 13, 2010 (per NOT-CA-09-030) Original Date: July 13, 2009

Additional Information:
NCI Cancer Training Branch Website for the K12 (go to http://www.nci.nih.gov/researchandfunding/training/K12).

Due Dates for E.O. 12372
Not Applicable.

Additional Overview Content


Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research 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. Receipt and 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. Review and Selection Process
  2. Criteria
    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 Objectives

The objectives of the Paul Calabresi Award for Clinical Oncology are to:

For the purposes of this award, and in agreement with the recommendations of the NIH Director’s Panel on Clinical Research, (http://www.nih.gov/news/crp/97report/index.htm), patient-oriented research is defined as research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator directly interacts with human subjects.  This area of research includes: 1) mechanisms of human disease; 2) therapeutic interventions; 3) clinical trials; and 4) the development of new technologies.  Studies falling under exemption 4 for human subjects research are not included in this definition.

In 1991, the NCI recognized the need for establishing formal training programs that would prepare the next generation of clinical scientists to participate more effectively in translational research.  The NCI embarked on a pilot program initiative that would prepare clinical oncologists to be effective scientific partners with basic research/behavioral scientists in the movement of discoveries in the laboratory into patient research settings or, conversely, back into a laboratory research setting.  These well-trained clinical oncology researchers would be expected to communicate, interact, and collaborate with basic research /behavioral scientists in the design and implementation of clinical trials that were hypothesis driven and based on an understanding of biological mechanisms.  This pilot program initiative was implemented through two successive Requests for Applications (RFAs ) in 1992 and 1997.

The initial pilot program was highly successful and generated considerable interest in the cancer research community.  It therefore became clear that NCI objectives would be better served by making this grant mechanism open to investigator-initiated applications on a regular basis using a Program Announcement (PA).  As a result, in 1998 the NCI established the Institutional Clinical Oncology Research Career Development Program (K12) as an ongoing PA with a once-per-year submission date.  In 1999, the NCI extended eligibility for an appointment to an NCI K12 grant to include doctoral-level oncology registered nurses, in recognition of the critical role of nursing in general and oncology nursing in particular in clinical cancer research and care.  Finally, in view of the continuing commitment of the NCI to increase the participation of individuals from underrepresented minority groups in biomedical and behavioral research and the critical need for more underrepresented minorities in clinical oncology research, the PA was reissued in 2003 and required that all competing applications for the Institutional Clinical Oncology Career Development Program (K12) grant include a specific plan to recruit and retain underrepresented minorities as award recipients.

The focus of this program has always been the career development of medical doctors in translational therapeutic research, with a focus on the patient rather than the laboratory-based aspect of translational research.   To this end, the program specifically required that clinical candidates obtain a basic science research experience.  The intent of this requirement was to enhance their ability to collaborate and communicate with basic research scientists successfully in the translational research process, not to enhance their ability to pursue a laboratory-focused career in basic science or translational research. It is now clear that translational therapeutic research of the future will require both dedicated clinician scientists and basic research scientists working in team research settings.  Consequently, in 1994 the Program was changed from supporting only clinician scientists to one that supports both clinician scientists and basic research scientists as a collective in order to further enhance career development that emphasizes basic research /clinical scientific interactions and team research concepts.  Additionally, the program was renamed the Paul Calabresi Award in Clinical Oncology in honor of the late Dr. Paul Calabresi, who was a pioneer in the pharmacological treatment of cancer and early translational research. This honor is in recognition of Dr. Calabresi’s humanity, dedication to his patients, mentorship of young clinical oncologists, contributions to understanding and treating cancer, tireless efforts to promote and develop the field of clinical oncology; and ceaseless service to the National Cancer Institute including his participation in the strategic development of the Nation’s War on Cancer.  Most of all, this award is intended to symbolize the quality and excellence of  physician scientists and the non-clinician translational researchers that NCI hopes will become critical contributors to the future elimination of death and suffering from cancer.

The NCI Paul Calabresi Award in Clinical Oncology (K12) is consistent with the objective of the NIH Roadmap Initiative to build a strong clinical research infrastructure and increase interactions between clinical and basic research scientists in translational research.  Appointees to the program will be referred to as Paul Calabresi “Scholars”.

Individuals with clinical doctoral degrees seeking a career development experience exclusively in laboratory-based research should refer to the NIH Mentored Clinical Scientist Career Development Award or K08 at the following website: http://grants.nih.gov/grants/guide/pa-files/PA-00-003.html.  Individuals with clinical degrees interested in patient-oriented research should refer to the NIH Mentored Patient-Oriented Research Career Development Award or K23 at the following website: http://grants.nih.gov/grants/guide/pa-files/PA-05-143.html. Postdoctoral individuals (e.g., Ph.D.’s) trained in basic science research, who wish to change direction and focus their research careers on human cancer, should refer to the NIH Pathway To Independence (PI) Award (K99/R00): http://grants.nih.gov/grants/guide/pa-files/PA-06-133.html.

Key elements to the award in addition to the PI/program leader, Advisory Committee, faculty, mentors, and scholars are:

Environment: The research environment should be one in which there are active science/clinical research collaborations that exemplify a dynamic two-way exchange of information and ideas between research and clinical scientists.

Career Development Program for Individual Scholars: The award provides a minimum of two and up to seven consecutive 12-month appointments.  At least 75 percent of the appointee’s full-time professional effort must be devoted to the program, although 100 percent effort may be requested.  The remainder of the scholar’s time should be devoted to other research-related and/or teaching pursuits consistent with the objectives of the award.  The scholar is expected to develop knowledge, skills, and expertise in POR relevant to her/his career goals and the objectives of the PCACO.  The program for each scholar should be tailored to their specific needs in terms of prior research/clinical experience, core requirements of the PCACO and the career goals of the scholar. 

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 NIH Mentored Clinical Scientist Development Program Award  (K12) institutional award  mechanism.

As an applicant, the PI will be solely responsible for planning, directing, and executing the proposed institutional career development program.


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 (see  http://grants.nih.gov/grants/funding/phs398/phs398.html).  A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

Because the nature and scope of the proposed career development /research program will vary from application to application, it is anticipated that the size and duration of each award will also vary.  Awards are made for 5 years and are renewable.  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

1. Direct cost limits:  An application which supports only clinician scholars must not exceed $750,000 for  direct costs per year.  An application which supports both clinician scholars and basic science scholars must not exceed $1,050,000 for direct costs per year.

2. Scholar Salary: The NCI will provide support for each scholar position up to $75,000 salary and associated fringe benefits per year based on a full-time professional 12-month effort commensurate with the applicant institution’s salary structure for persons of equivalent qualifications, experience, and rank.

The total salary requested must be based on a full-time, 12-month staff appointment and requires  scholars   to devote a minimum of 75 percent of full-time professional effort to conducting career development and 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://grants.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 the staff person in the relevant Institute prior to preparing an application to discuss their eligibility.

The proposed salary must be consistent both with the established salary structure at the institution and salaries actually provided by the institution from its own funds to other staff members of 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 appropriately related to the existing salary structure.  Confirmation of salaries may be 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. Additional PHS funds may not be used for salary supplementation.  Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the K12 award.  However, under expanded authorities, 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.

Effective for all competing research grants submitted for the February 1, 2004, deadlines and beyond, mentored career award recipients in the last 2 years of career award support may hold concurrent support from their career award and a competing NIH research grant when recognized as a PI or subproject director.  This new policy can be found at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html.

3. Research and Development Support:  Up to $30,000 per individual scholar may be provided for the following types of expenses: (a) research expenses, such as supplies, equipment and technical personnel; (b) tuition and fees related to required career development courses and activities; (c) travel to research meetings or training; and (d) statistical services including personnel and computer time.  These costs must be specifically documented for each individual scholar and must be specifically and directly related to the scholar's research activities.  They cannot be pooled and used for advertising, recruiting, or other programs unrelated or indirectly related to the research activities of individual scholars.  It is expected that the K12 scholars will be working in a funded research environment and that support provided by the K12 grant will augment existing research support to include the scholar.

4. Other Costs: This category is capped at $50,000, and up to 10 percent of the PI/ program leader’s salary plus fringe benefits will be provided for leadership, management, coordination, and evaluation of the program in accordance to the percent effort commitment to the program. Some partial salary  plus fringe benefits may be provided for a dedicated administrator.  Minimal costs can be allocated for advertising and recruitment in order to attract the best candidates nationally.  While mentors may not receive salaries or fringe benefits on this career development award, any lab fees associated with their mentorship may be included in this “other costs” category.

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

6. Facilities and administrative 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.

7. Carryover of unobligated balances: Although the K12 is subject to expanded authorities, the carryover of funds from one budget period to the next requires prior written approval by NCI.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

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

 Foreign institutions are not eligible to apply.

1.B. Eligible Principal investigators

The program leader is the PI.  The program leader must be an established investigator in patient-oriented research who is able to provide both administrative and scientific leadership to the program.

1.C. Eligible Candidates For Appointments

Clinician Candidates (required):  All clinician candidates must currently be physicians holding the M.D. or D.O. degrees, or be nurses with a Ph.D. degree; and must have completed the necessary  clinical training (i.e., completed residency and are board eligible) to engage in clinical oncology research.

Basic Science Candidates (encouraged but optional):  All basic science candidates must have doctoral-level degrees (e.g., Ph.D., D.V.M.) or the equivalent, a minimum of 2 years of postdoctoral research training, and a total basic science research experience that is clearly preparatory (e.g., experience with animal models or preclinical research) for devoting a career to human therapeutic cancer research.

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 an appointment to the K12 program.  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 support.

Individuals who may have been or currently are a PI of an NIH R03 or R21 grant or a PHS or non-Federal award that duplicates the provisions of an R03 or R21 grant  remain eligible for an NCI K12 appointment.

Individuals are NOT eligible for an appointment if they:

Due to the emphasis of the K12 on patient-focused research, clinician scholars appointed to a K12 grant are encouraged to subsequently apply for a K23 and not a K08 if they need additional mentored career development; a K99/R00 if they need additional mentored career development (K99) and will then transition to the independent stage of their research career (R00); or for a patient-oriented NCI K22 if they need protected time to develop their independent patient-oriented research or patient-focused translational research program in their first independent research position. 

Recipients of a K12 appointment may hold concurrent research support (and under certain circumstances (see Allowable Costs below) salary support) from their appointment and a competing NIH research project grant (RPG) when recognized as a PI or subproject director of the RPG (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html) if they have first completed at least 2 years of training supported by the K12 grant. 

Applicants are strongly encouraged to consult with the 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

Cost sharing, matching, or cost participation is not required.

3. Other-Special Eligibility Criteria

All clinician and basic science Ph.D. scholars must satisfy the following additional requirements:

Special Requirements

·         Other training programs:  Where there already exists an active Ruth L. Kirschstein (T32) National Research Service Award (NRSA) or other institutional career development program (e.g., NCI and NIH Roadmap K12, K30, General Clinical Research Core [GCRC] Scholars Program) overlap between these programs must be eliminated and/or the NCI Paul Calabresi Award for Clinical Oncology (K12) structured in a way to complement and take advantage of these other career development/training programs.  This may require merging components of other programs with the NCI K12 or linking curriculum programs (e.g., K30) with the core requirements of the NCI K12.  

Special Program 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 GrantsInfo; 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 current PHS 398 research grant application instructions and forms.  Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

Applicants 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:

SUPPLEMENTARY INSTRUCTIONS

The instructions in the Form PHS 398 do not fully apply to the special needs of this grant application. Therefore, follow the modified instructions below in preparing an application for an NCI Paul Calabresi Clinical Oncology Award (K12). These instructions have been adapted to accommodate the Form PHS 398 and the special needs of the K12 grant application.

1.  Face Page:  Use Form Page 1 of the Form PHS 398.  On Line 1, include the title that best represents the nature of the career development  program.  On Line 2, provide the number of this Program Announcement beginning with “PAR-“, and the title "Paul Calabresi Clinical Oncology Award" of the Program Announcement.  The Program leader will be the PI of the grant application.

2. The Description/ Performance site(s)/ Key personnel (Form Page 2 of Form PHS 398): Complete as directed in the Form PHS 398.  The information provided should include the PI, Advisory Committee members, mentors, and other faculty participating in the program.

3. Table of Contents to be organized as follows:

Detailed instructions for Table of Contents Section I:

Item 4. Statement of Commitment: This statement should guarantee that all scholars participating in this Program Announcement will commit a minimum of 75 percent of a full-time professional effort to research and research career development.

Item 5.  Detailed Budget for the Initial Budget Period: Provide detailed budget information with regard to salary and fringe benefits, supplies, travel etc. specified for each scholar by name or by position, if there is no one available to fill the position. Note that there is an upper limit of salary of $75,000 plus fringe benefits, an upper limit for other costs of $30,000 per scholar; and a required minimum 75 percent effort.

Item 7.  Biographical Sketches: Provide biographical sketches using the Biographical Sketch Format Page of the Form PHS 398.  Group the biosketches into the following five sections: (1) PI; (2) K12 Advisory Committee Members; (3) Mentors; (4) Other Faculty; and (5) Scholars

(when available). 

Item 8. Research Base/Resources and Facilities:  Provide in a tabular format the information described below. Suggested tabular formats for this information can be found under "Summary Information on Program" as a Word document (http://www.cancer.gov/images/Documents/05e19eb1-9d9c-4168-88e8-fddc0e7bbf5f/k12table.doc or as an Acrobat file (http://www.cancer.gov/images/Documents/05e19eb1-9d9c-4168-88e8-fddc0e7bbf5f/k12table.pdf)

Progress Report.  Briefly describe the accomplishments of the training program. State the period covered.

  1. Describe for each year of the current project period, the program's actual assignment of awarded scholar positions. Provide: (1) the total number of appointments in each year; (2) the medical subspecialties of the scholars and the number of scholars in each subspecialty; (3) the academic status of each scholar, and for individuals in fellowship training the year of their training; (4) months of support committed.  Do not include individuals supported by a CURE supplement to the K12 program.
  2. List all scholars who were, or are, supported by this institutional career development grant during the past 5 years. Do not include individuals supported by a CURE supplement to the K12 program.  For each scholar, provide  (1) the name; (2) year of initial appointment; (3) degree(s) at time of initial appointment; (4) medical specialty (subspecialty) at time of entry into the program; (5) prior institution; (6) the source of support during each year of career development/training, e.g., this career development  grant, another (specify) training grant, research grant, university fellowship, individual (specify) fellowship, etc.; (7) the research topic and the research mentor; and (8) for scholars who have completed the program, their current position title and institutional affiliations.  For the convenience of the reviewers, it could be useful to generate an accompanying summary table showing by medical subspecialty, the numbers of scholars  going into academics, government, industry or clinical practice after leaving the K12 program (do not include in this summary trainees supported by a K12 CURE supplement).
  3. Summarize the achievements of the K12 scholars during the past 5 years.  Provide: (1) the name of the scholar; (2) the names of the scholars’s clinical mentor(s) and basic science research mentor(s); (3) full citations of publications resulting directly from the K12 institutional career development program; and (4) descriptive titles of clinical trials developed and/or implemented by the scholar as a direct result of the K12 program, including the trial type (Phase I, Phase, II, Phase III), and the role of the scholar in the trial (Pi, co-PI, etc.).

Detailed instructions for Table of Contents Section II.

Item 1. Part b.  Purpose and Objectives: Briefly describe the background, purpose and objectives of this career development Program.  This description should identify two or more clinical oncology disciplines represented in the Program and a discussion of the strategies to be used to ensure that the representation in each discipline in the mentor population and the trainee population will satisfy the intent of this NCI requirement. The description should clearly show how the purpose and objectives of the Program will meet the broader objectives and intent of the NCI to prepare clinician and where appropriate basic science scholars who can design and implement all phases of clinical trials and who can effectively work together in team research settings in patient-oriented therapeutic cancer research.

Item 1. Part c. Research Environment:

Research Base: Describe the existing funded laboratory and patient-oriented research activities and the interactive nature of the research environment that will meet and sustain needs of this Program. Include in this description the number and types of early to late phase clinical therapeutic clinical trials being conducted in the institution, the general range of activities in these trials and, wherever present, the hypothesis-based translational nature of these activities.

Resources and Facilities: Describe the research infrastructure, patient populations, facilities, etc., that are available and accessible to this Program.

Mentors: Describe the pertinent research experience and track record in training cancer clinician scientists (and, for combined clinician-basic scientist programs, translational Ph.D. cancer researchers) of each mentor participating in the Program.

Item 1. Part d. Description of Didactic, Clinical, and Basic Science Research Core Requirements:

Describe separately the core didactic, core clinical research, and core basic science research experiences that each clinician and basic science scholar must complete to satisfy the overall Core Requirements of the Program. If there are existing institutional K30 or GCRC Scholar programs, or an NIH Roadmap K12 or other NIH K12 programs, explain how the NCI K12 Program will link with and make use of these programs to meet the objectives of the NCI K12 core didactic component.  Using specific, real, or hypothetical examples, describe how individualized scholar career development plans will be developed that take into account past experiences and competencies before providing new experiences and skills by the Program.  Describe the official degree or certification that scholars will receive FROM THE INSTITUTION after completing the Didactic, Clinical Research, and Basic Science Research Core Requirements.

Item 1. Part e, i.  Principal Investigator:

Describe the qualifications and role of the PI to provide scientific and administrative leadership and coordination of the Program.

Item 1. Part e, ii. General Recruitment Strategies:

Describe the selection criteria for clinician scholars and, where appropriate, basic science scholars recruited to this Program.  Describe the various strategies that will be used to ensure that the different clinical oncology disciplines represented by the Program are included and to ensure an adequate scholar pool.  Address the nature of any other competing institutional Programs that might limit the number of scholars and describe the strategies for addressing this competition.

Item 1. Part e, iii: Recruitment and Retention Plan to Enhance Diversity:

Describe strategies for recruitment of individuals from underrepresented groups and from groups that may have been disadvantaged because of disability, economic, educational or any other circumstance that has inhibited their ability to pursue a career in health-related research and how these strategies will be implemented.  For the purpose of the K12, an individual is from an underrepresented group if he or she belongs to a particular ethnic and racial group that has been determined by the grantee institution to be underrepresented in cancer-related biomedical, behavioral, clinical, or social sciences research.

Item 1. Part e, iv: Evaluation Plan:

Describe the plans for ongoing evaluation of the scholars, mentors, PI, Advisory Committee (AC), and the overall program. Provide criteria that will be used for this evaluation and describe how the results of the evaluation will be used.

Item 1 Part e, v: Advisory Committee (AC):

Describe how the AC will function in providing oversight of the development, implementation, and evaluation of recruitment strategies in the recruitment and selection of scholars; in the evaluation of special curricula and/or links to curricula developed through a K30 grant (if present); in the monitoring and evaluation of each scholar's progress with recommendations for changes in the training plan, if necessary, or termination of a scholar who is not making adequate progress; and in monitoring and evaluation of the overall effectiveness of the Program.

Item 1. Part e, vi. Individual Career Development/Training Plans:

Provide brief summaries/examples of individual career development/training plans that the Program will employ or has been able to achieve (for competing renewal applications) in preparing clinician and (if relevant) Ph.D. scholars to design, implement, and participate in patient-oriented, therapeutic research and collaborate effectively with each other in translating basic science discoveries into therapeutic clinical trials. If relevant to your K12 program, provide examples of plans for short-term (2 years) appointments.

Item 1.  Part e, vii:  A progress report (for competitive renewal applications) must be submitted describing:

Item 2 Human Subjects: Follow the instructions in Form PHS 398.  If an award is made, human subjects may not be involved and appointees may not participate in human subjects related research until a certification of the date of IRB approval or a designation of an exemption has been submitted to the NCI and accepted.

If a clinical trial will be involved, the PI will need to follow current NIH and NCI policies on providing information on data and safety monitoring (DSM).  Refer to the following website for information on NCI policies on data and safety monitoring for training awards:

http://www.nci.nih.gov/clinicaltrials/conducting/dsm-guidelines/page4#grants

A detailed DSM plan is not required at the time of application.  The application must, however, document an existing procedure for DSM of clinical trials at the sponsoring institution.  At the time an award is offered, applicants will need to contact NCI staff for specific instructions on how to fully comply with the requirements for DSM.

Item 3. Vertebrate Animals: Follow the instructions in Form PHS 398. If an award is made, vertebrate animals may not be involved until a certification of the date of the Institutional Animal Care and Use Committee (IACUC) approval has been submitted to the NCI and accepted.

3. Submission Dates and Times

3.A. Submission, Review, and Anticipated Start Dates

Letters of Intent Receipt Date(s): 30 days before Application Receipt Date(s)
Application Receipt Date(s): Standard dates of Receipt/Submission Cycle II apply (please see http://grants.nih.gov/grants/funding/submissionschedule.htm):
New Application Receipt Date(s):  June 1, 2007; June 12, 2008; June 12, 2009
Competing Continuation, Revised, Supplemental Application Receipt Date(s):  July 1, 2007; July 12, 2008; July 12, 2009
Peer Review Date(s): Standard dates of Receipt/Submission Cycle II apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): Standard dates of Receipt/Submission Cycle II apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date(s): Standard dates of Receipt/Submission Cycle II apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIH IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Dorkina Myrick, M.D., Ph.D.
Cancer Training Branch
Office of Centers, Training, and Resources
National Cancer Institute
6116 Executive Blvd., Suite 7019, MSC 8346
Bethesda, MD 20892-8346 (for U.S. Postal Service express or regular mail)Express Mail: Rockville, MD 20852 (for express/courier delivery; non-USPS service)
Telephone: (301) 496-8580
FAX: (301) 402-4472
Email: myrickd@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant and research career award (RCA) application forms found in the PHS 398 instructions. Submit a signed, typewritten original of the application, including the checklist, 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 the appendix material 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 received on or before the application receipt/submission date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review.

Upon receipt applications will be evaluated for completeness by NCI staff. Incomplete applications will not be reviewed.

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

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 or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement at http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

Concurrent Awards:  Applicants must be aware of the NIH policies associated with other federally sponsored support.   An NIH policy change (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html) now allows NIH mentored career development award recipients in the final two years of their award, to receive salary support from both their K award and an NIH research grant or subproject.  This includes scholars selected to K12 grants.  The K-award recipient (K12 scholar) must be the named PI on a competing NIH research project grant (R01, R03, R15, R21, R34, etc.), or be the sub-project director on a competing multi-component research or center grant or cooperative agreement (P01, P50, U01, etc.).  Individuals appointed as sub-project director on competing multi-component research or center grant or cooperative agreement after a competing award has been made are not eligible.

The salary requested for the PI and the K12 scholar must be consistent with both the established salary structure for full-time staff appointments and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the applicable department.  The research development support costs allowed for this program must be carefully justified annually and must be consistent with the stage of development of the candidate and the proportion of time to be spend in research or career development activities. These costs are to be associated with each K12 scholar and are not to be regarded as a pooled resource.

Salaries for ancillary personnel support, such as mentors, secretaries, and administrative assistants, are not allowed.  Partial salary for a dedicated administrator is allowable.  Minimal costs can be allocated for advertising and recruitment in order to attract the best candidates nationally. See “Other costs” in Section II, 2. Funds Available.

6. Other Submission Requirements

K12 applications do not follow Modular Grant instructions.

Since the PAR states allowable direct costs per year in excess of $500,000, applicants are not required to seek prior approval from NCI programs staff for submission of a K12 application.

In addition to the Supplementary Instructions in the PHS 398 for Research Career Awards (Instructions, Part III, starting on page 44), the following information must be included in the application:

Training in the Responsible Conduct of Research

Applications must include a description of a program to receive formal or informal instruction in scientific integrity or 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 web site (http://www.nih.gov/sigs/bioethics/researchethics.html) for additional guidance.

Document prior instruction in or propose plans for 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.

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/archive/archive/grants/policy/nihgps_2003/index.htm and at http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131. Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan 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 to the NCI.

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

As part of the initial merit review, all applications:

Applications will compete for available funds with all other approved career development award applications. The following will be considered in making funding decisions:

The goal of the NCI K12 initiative is to generate a cadre’ of patient-oriented clinician researchers who can work with Ph.D. basic research scientists (and, optionally, basic Ph.D. research scientists who can work with clinician researchers) to develop and implement all phases (Phase I, II, III) of hypothesis-driven therapeutic clinical trials.  In the written comments, reviewers will be asked to evaluate applications in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals.  The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application.

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.

Principal investigator (PI)

Advisory Committee

Career Development Program Core/Requirements

Environment

Mentors

Candidate Scholars

Institutional Commitment

Integration with Other Programs

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 both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

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

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

2.B. Additional Review Considerations

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

2.C. Sharing Research Data

A data sharing plan is not required.

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/newspages/rtguide_final.html. Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

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 awardee before recommending funding of an application. The final version of the  resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. 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/archive/grants/policy/nihgps_2003/index.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization.  The NoA signed by the grants management officer is the authorizing document.  Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.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 NCI.

C. Special Leave

Leave of a K12 scholar to another institution, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award.  Only local institutional approval is required if such leave does not exceed 3 months.  For longer periods, prior written approval of the NIH funding institute or center 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/archive/grants/policy/nihgps_2003/index.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 the NIH component institute and will be granted only in unusual situations.

Support from other sources is permissible during the period of leave without award support.  Such leave does not reduce the total number of months of program support for which an individual is eligible.

Under unusual and pressing circumstances, a K12 scholar 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 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 appointee must submit assurance of his/her intention to return to at least 75 percent effort as soon as possible.  During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly.

D. Change of Institution

The Paul Calabresi Award for Clinical Oncology (K12) cannot be transferred from one institution to another.

E. Change of PI

If the PI moves to another institution or resigns from the position, support of the award may be continued with NCI prior approval provided:

F. Changes in Research or Career Development Program

Awards are made to a specific institution for a specific program under the guidance of a particular PI.  Changes in any of these parameters require prior approval by the NCI.  A scientific rationale must be provided for any proposed changes in the aims of the original peer reviewed program.  The new program will be evaluated by NCI staff to ensure that the program remains within the scope of the original peer reviewed research program.  If the new program does not satisfy this requirement, support could be withheld or the award could be suspended or terminated.

G. Termination

When a grantee institution plans to terminate an award, the NCI must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. 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 recipients 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.

Special Reporting Requirements

The K12 grant, as administered by the NCI, is not subject to the Streamlined Noncompeting Application Process (SNAP).  In general, this means that all reporting of budgetary information and program progress are provided in greater detail in an annual progress report.  This includes inclusion of the names of scholars in the budget for the proposed budget period.

An Annual Progress Report for the grant is required.  This report should provide information about changes in the Program, an evaluation of the Program made by the Advisory Committee, and a description of the research and career progress of each scholar.  These Annual Reports will be closely monitored by NCI staff to ensure that the grant is achieving the goals of the K12 initiative.

Since the Form PHS 2590 does not apply easily to the K12 grant award, adapt the application for continuation to contain the following information:

A final progress report, invention statement, and Financial Status Report are required upon either completion of an award or relinquishment of an award.

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:

Dorkina Myrick, M.D., Ph.D.
Program Director
Cancer Training Branch
National Cancer Institute
6116 Executive Blvd., Suite 7019, MSC 8346
Bethesda, MD 20892-8346 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery; non-USPS service)
Phone: (301) 496-8580
FAX: (301) 402-4472
E-mail: myrickd@mail.nih.gov

2. Peer Review Contacts:

Sonya V. Roberson, Ph.D.
Division of Extramural Activities
National Cancer Institute
6116 Executive Blvd., Room 8037, MSC 8326
Bethesda, MD 20892-8326 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery; non-USPS service)
Telephone: (301) 594-1182
Email: robersos@mail.nih.gov

3. Financial or Grants Management Contacts:

Kimery B. Griffin
Office of Grants Administration
National Cancer Institute
6120 Executive Blvd., EPS Room 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery; non-USPS service)
Telephone: (301) 496-3196
FAX: (301) 496-8601
Email: griffink3@mail.nih.gov

Section VIII. Other Information


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 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 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/publicaccessManual.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/ 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/.


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NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


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