TSFRE: NCI K03 and K23 Awards

Thoracic Surgery Foundation
For Research and Education and
The National Cancer Institute Jointly Sponsored
Mentored Clinical Scientist Development Award (K08) and
Mentored Patient Oriented Research Career Development Award (K23)

The Thoracic Surgery Foundation for Research and Education (TSFRE) and the National Cancer Institute (NCI) wish to announce a program of jointly sponsored Mentored Clinical Scientist Development Awards (K08), and Mentored Patient Oriented Research Career Development Awards (K23) directed at thoracic surgeons in the early stages of their research careers.

Mentored Clinical Scientist Development Awards (K08)

PURPOSE
The purpose of the Mentored Clinical Scientist Development Award (MCSDA) is to support the development of outstanding research scientists. This mechanism provides support for clinically trained professionals who are committed to a career in laboratory or field-based research and have the potential to develop into independent investigators.

The award supports a 5 year period of supervised research experience that integrates didactic studies with laboratory or clinically-based research. The proposed research should have both intrinsic research importance and be a vehicle for learning the methodology, theories, and conceptualizations necessary for career development of an independent researcher.

Because of the focus on progression to independence, the prospective candidate should propose a period of study and development consistent with this goal and his or her previous research and clinical experience. For example, a candidate with limited experience in a given field of research may find a phased developmental program lasting for 5 years, which includes a designated period of didactic training and supervised research experience, the most efficient means of attaining independence. A candidate with substantial previous research experience may require a shorter period for class work and supervised training and more time for laboratory work appropriate for the transition to independence. The entire program should be comparable in scope and rigor to meeting the requirements of an advanced research degree.

ELIGIBILITY REQUIREMENTS
The candidate must have an M.D. degree or its equivalent, and assurance that he/she will be either enrolled in an approved postgraduate training program and/or in a faculty position at the time of the award. The candidate may either have initiated (or may be on temporary leave of absence for the purpose of this award) in an approved postgraduate training program in thoracic surgery, or be within 10 years after completion of an approved training program in thoracic surgery. Candidates who are enrolled in an approved postgraduate program prior to starting an approved thoracic surgery residency will be eligible to apply. Candidates must identify a mentor or mentors with extensive research experience and a track record of independent research support, and must be willing to spend a minimum of 75 percent of full time professional effort conducting research and research career development.

For the purposes of this TSFRE-NCI Program, applications may be submitted on behalf of candidates by domestic non-Federal organizations, public or private, such as medical or other institutions of higher education. Minorities and women are encouraged to apply. Candidates must be U.S. citizens or noncitizen nationals, or must have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-151 or I-551) or some other verification of legal admission as a permanent resident. Noncitizen nationals, though 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.

For the purposes of this TSFRE-NCI Program, former principal investigators of NIH research project grants are not eligible. Questions regarding eligibility requirements should be directed to the NCI contact listed at the end of this announcement.

MECHANISM OF SUPPORT
Awards in response to this program announcement for the MCSDA will use the K08 mechanism. Planning, direction, and execution of the program will be the responsibility of the candidate and his/her mentor on behalf of the applicant institution. The project period will be 5 years. Awards are not renewable.

RESEARCH OBJECTIVES
A. Environment: The institution must have a well established research and clinical career development program and a qualified faculty in clinical and basic research to serve as mentors. The institution must be able to demonstrate a commitment to the development of the candidate as a productive, independent investigator. The candidate, mentor and institution must be able to describe a multi-disciplinary career development program that will maximize the use of relevant research and educational resources.

B. MCSDA Program: Generally, the Award provides 5 consecutive 12 month appointments. At least 75 percent of the recipient’s full-time professional effort must be devoted to the program and the remainder devoted to other clinical and teaching pursuits consonant with the objectives of the award. The basic science component must develop knowledge and research skills in scientific areas relevant to the career goals of the candidate.

C. Mentor(s): The MCSDA recipient must receive appropriate mentoring throughout the 5 year program. Where feasible, women and minority mentors should be involved as role models.

D. Allowable Costs: TSFRE and NCI will each award salary up to $75,000 per year. In the application to the NIH, the applicant may also request funds for research development support up to $30,000 per year. The applicant must submit a categorical budget; modular budgets will not be accepted. Annual escalation, if any, will be determined by the current NCI policy.

1. Salary Support: TSFRE and the NCI will each provide salary up to $75,000 per year and NCI will award fringe benefits on each salary it awards. It is anticipated that up to $150,000 a year will be used for salary for the award recipient. The institution may supplement the contribution of TSFRE and NCI 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 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 MCSDA.

2. Research Development Support: Research development support up to $30,000 per year of the NCI award is allowable for research-related expenses including: a) tuition, fees, and books related to career development; b) research expenses, such as supplies, equipment, and technical personnel; c) travel to research meetings or training; and d) statistical services including personnel and computer time.

3. Facilities and Administrative (F&A) Costs: F&A costs will be reimbursed at 8 percent of the allowable direct costs contributed by the NCI. TSFRE will not reimburse F&A costs.

Mentored Patient Oriented Research Career Development Award (K23)

PURPOSE
This award is designed to support the training of clinically trained professionals who have made a commitment to focus on patient-oriented research. For the purpose of this award, patient-oriented research is research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator interacts directly with human subjects. This award may also be used to support a patient-oriented research focused career development and research training experience in translational research. (Translational research uses knowledge of human biology to develop and test the feasibility of cancer-relevant interventions in humans AND/OR determines the biological basis for observations made in individuals with cancer or in populations at risk for cancer.)

ELIGIBILITY REQUIREMENTS
For purposes of TSFRE-NCI Program the candidate must have an M.D. degree or its equivalent, must either have initiated postgraduate clinical training in thoracic surgery or be within 10 years after completion of an approved training program in thoracic surgery. Candidates who are enrolled in an approved postgraduate program prior to starting an approved thoracic surgery residency will be eligible to apply. Candidates must identify a mentor with extensive research experience and must be willing to spend a minimum of 75 percent of full time professional effort conducting research and research career development.

For the purposes of this TSFRE-NCI Program, applications may be submitted on behalf of candidates by domestic, non-Federal organizations, public or private, such as medical or other institutions of higher education. Minorities and women are encouraged to apply. Candidates must be U.S. citizens or noncitizen nationals, or must have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-151 or I-551) or some other verification of legal admission as a permanent resident. Non-citizen nationals, though 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.

For the purposes of this TSFRE-NCI Program, former principal investigators of NIH research project grants are not eligible. Questions regarding eligibility should be directed to the NCI contact at the end of this announcement.

MECHANISM OF SUPPORT
Awards in response to this program announcement for the Mentored Patient-Oriented Research Career Development Award will use the K23 mechanism. Planning, direction, and execution of the program will be the responsibility of the candidate and his/her mentor on behalf of the applicant institution. The project period will be 5 years. Awards are not renewable.

RESEARCH OBJECTIVES
A. Environment: The institution must have a well established research and clinical career development program and a qualified faculty in clinical research with an emphasis on patient-oriented research to serve as mentors. The institution must be able to demonstrate a commitment to the development of the candidate as a productive, independent investigator. And, the candidate, mentor and institution must be able to describe a multi-disciplinary career development program that will maximize the use of relevant research and educational resources.

B. Program: The Award provides 5 consecutive 12 month appointments. At least 75 percent of the recipient’s full-time professional effort must be devoted to the program and the remainder devoted to other clinical and teaching pursuits consonant with the objectives of the award. The basic science component must develop knowledge and research skills in scientific areas relevant to the career goals of the candidate.

C. Mentor(s): The K23 recipient must receive appropriate mentoring throughout the 5 year program. Where feasible, women and minority mentors should be involved as role models.

1. Salary Support: TSFRE and the NCI will each provide salary up to $75,000 per year and NCI will award fringe benefits on each salary it awards. It is anticipated that up to $150,000 a year will be used for salary for the award recipient. The institution may supplement the contribution of TSFRE and NCI 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. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the MCSDA.

2. Research Development Support: It is anticipated that up to $30,000 per year is allowable for research related expenses including: a) tuition, fees, and books related to career development; b) research expenses, such as supplies, equipment, and technical personnel; c) travel to research meetings or training; and d) statistical services including personnel and computer time.

3. Facilities and Administrative (F&A) Costs: F&A costs will be reimbursed at 8 percent of the allowable direct costs contributed by the NCI. TSFRE will not reimburse F&A costs.

APPLICATION PROCEDURES
Applications should conform to the guidelines published in the NIH Guide for Grants and Contracts for the Mentored Clinical Scientist Development Award (K08) (http://grants.nih.gov/grants/guide/pa-files/PA-09-042.html ) or the Mentored Patient-Oriented Research Career Development Award (K23) (http://grants.nih.gov/grants/guide/pa-files/PA-09-043.html). Thoracic surgeon applicants are also encouraged to consult the NCI's website, http://cancer.gov/cancertraining, and NCI staff before submitting an application.

Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 11/2007 or subsequent revisions) and instructions found under Section IV "Research Career Award" in the Table of Contents. The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html. Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm . Application deadlines are also indicated in the PHS 398 application kit.

To identify the application as a response to this Program Announcement, check “YES” on item 2 of page 1 of the application and for the K08 enter “PA-09-042., Mentored Clinical Scientist Development Award: Assign to NCI.” And for the K23 enter PA -09-043: Assign to NCI. Submit a signed, typewritten original of the application with Checklist and five 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 (20817-7710 for express/courier service) and three signed photocopies to TSFRE Research Committee, 900 Cummings Center, Suite 221-U, Beverly, Massachusetts 01915. In addition, send one photocopy to Lester Gorelic, Ph. D., Program Director, Cancer Training Branch, National Cancer Institute, 6116 Executive Boulevard, Suite 7025, Bethesda, MD 20892-8346 (for express/courier service, Rockville, MD 20852). gorelicl@mail.nih.gov.

REVIEW CONSIDERATIONS
Applications will be reviewed for completeness by the NIH Center for Scientific Review and for responsiveness to the NIH program announcement by the NCI. Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened at the NCI in accordance to the standard NIH peer review procedures. As part of the initial merit review, all applicants will receive a written critique or Summary Statement and undergo a process in which only those applications deemed to have highest scientific merit, generally the top half of those under review, will be discussed, assigned a priority score, and receive a second level review by the National Cancer Advisory Board. TSFRE will provide salary support for those applications that funds allow, based upon priority ranking by the TSFRE Board of Directors upon advice from the TSFRE Research Committee.

AWARD PROCESS
Shortly after the NCI National Cancer Advisory Board meets, the applicant will be sent a Summary Statement which is the written scientific evaluation of the peer reviewers. Upon permission of the applicant the NCI will send the Summary Statement to the TSFRE. The NCI will notify the applicant of its intent to make an award. After its review, the TSFRE will contact the applicant directly concerning its intent to make a separate salary award from the TSFRE that augments the NCI award per the joint agreement of the NCI and the TSFRE.

The TSFRE–NCI program will sponsor as many K08 and K23 awards each year as available funds will allow.

DEADLINE
Applications are to be submitted to NCI on form HJPS 398 and will be accepted on or before the receipt deadlines of February 12, June 12, and October 12. Applications for the TSFRE matching grant are due at the TSFRE offices on or before February 12, June 12, and October 12.

CONTACTS
For questions regarding eligibility requirements and the K08 and K23 application process:

Lester Gorelic, Ph.D.
Program Director
Cancer Training Branch
6116 Executive Boulevard, Suite 7025
Bethesda, MD 20892-8346
Phone: 301-496-8580
Fax: 301-402-4472
Email: gorelicl@mail.nih.gov

For questions regarding TSFRE:
Rebecca Bonsaint
Director of Administration
The Thoracic Surgery Foundation
For Research and Education
900 Cummings Center, Suite 221-U
Beverly, MA 01915
Phone: 978-927-8330
Fax: 978-524-8890