NCI TRANSITION CAREER DEVELOPMENT AWARD FOR UNDERREPRESENTED MINORITIES (K22)

RELEASE DATE:  April 9, 2003 (replaced by PAR-05-011)

PA NUMBER:  PAR-03-101 

EXPIRATION DATE:  November 2, 2004  

National Cancer Institute (NCI)
 (http://www.nci.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER (S):  93.398

This Program Announcement (PA) replaces PAR-01-074, which was published in 
the NIH Guide on March 30, 2001.

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA

The Comprehensive Minority Biomedical Branch (CMBB), Office of Centers, 
Training and Resources (OCTR), Office of the Deputy Director for Extramural 
Sciences (ODDES), National Cancer Institute (NCI), invites transition career 
development award applications from recipients of the NCI Mentored Career 
Development Award for Underrepresented Minorities or from underrepresented 
minority individuals who are advanced postdoctoral and/or newly independent 
research scientists who have been in an independent position for less than 
two years at the time of the application.  The purpose of the NCI Transition 
Career Development Award for Underrepresented Minorities (K22) is to provide 
"protected time" to develop and receive support for their initial cancer 
research program.  This award is intended to facilitate the transition of a 
minority postdoctoral research scientist from the mentored to the independent 
stage of their careers in cancer research.  The unique feature of this award 
is that the individuals may apply without a sponsoring institution while they 
are still in a mentored position.  Successful candidates will be provided 
with special opportunities to enhance their knowledge and understanding of 
the NIH/NCI peer review system and to develop the skills required for 
preparing competitive research project grants.

This award is a novel program that is intended to support and enhance the 
likelihood of success for underrepresented minority postdoctoral and newly 
independent investigators who have committed to basic, clinical, and 
prevention and population-based research careers in cancer.  Awardees must 
apply for an R01 research grant or equivalent prior to the end of the second
year of the award.

RESEARCH OBJECTIVES

Substantial national and local efforts have been made and are continuing to 
be made to reduce cancer morbidity and mortality in the general population. 
However, in spite of these efforts, projections made for 2002 indicated that 
1,284,900 cancers were expected to be diagnosed in the United States and 
555,500 Americans were expected to die of this disease.

Past patterns of cancer incidence and mortality predict that a 
disproportionate share of this increase in U.S. cancer incidence and 
mortality will be borne by minorities. Specifically, past and current SEER 
data show that Hispanic Americans have excessive cancer incidences of the
prostate, breast, lung and bronchus, colon and rectum, and cervix. Native 
Americans from New Mexico show excessive cancer rates for prostate, breast, 
colon and rectum, ovary, kidney, and renal pelvis cancers, with the incidence 
rate for gall bladder cancer being the highest of any racial group.  Alaska 
Natives have the highest cancer incidence rates among any racial group for 
cancer of the colon and rectum. Finally, cancer mortality rates for all sites 
for African Americans are almost 1.4 times greater than for Caucasians.

A reduction in the overall cancer mortality rate in minority populations 
would substantially impact known cancer statistics.  A major obstacle to 
developing a stronger national minority cancer research effort has been the 
lack of significant strategic training programs for minority students and 
scientists in cancer research.  Greater involvement of minority candidates, 
who possess the appropriate cultural perspectives, is integral to a 
successful national minority cancer research effort involving more minority 
patients and populations.  Prior to 2000, progress in realizing a significant 
increase in the number of competitive minority cancer researchers had been 
disappointing.  This K22 mechanism establishes a unique pathway of recruiting 
and retaining advanced postdoctoral student and new investigators into 
research fields that address problems pertinent to the biology, etiology, 
pathogenesis, prevention, diagnosis, control and treatment of human cancer 
and who can conduct independent competitive cancer programs.  

MECHANISM OF SUPPORT

Awards in response to this program announcement will be made through the 
Transition Career Development Award (K22) mechanism. Planning, direction, and 
the execution of the proposed training program will be the responsibilities 
of the applicant on behalf of the applicant institution.

The total project period for an application submitted in response to this PA 
may not exceed 3 years. Grants are not transferable from one principal 
investigator to another.  Funding beyond the first year is contingent upon 
satisfactory progress during the preceding year, as documented in the 
required progress report (refer to "Non-Competing Renewals").  Awards are not 
renewable.

ELIGIBLE INSTITUTIONS

Although applications may be submitted for peer-review without institutional 
representation, if approved for funding, applications must be resubmitted on 
behalf of candidates by an institution that has any of the following 
characteristics:

o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals, 
  and laboratories
o Units of State and local governments
o Domestic

The institution must be able to demonstrate a commitment to the development 
of the research careers of junior underrepresented minority research 
scientists in biomedical cancer research.  Applications from foreign 
organizations are excluded from applying to this program announcement.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Applicants are encouraged to contact the NCI program staff listed under 
INQUIRIES regarding their eligibility for this award prior to the preparation 
of an application.  Recipients of the NCI Mentored Career Development Award 
for Underrepresented Minorities and/or candidates who meet the following 
requirements are eligible to apply:

o Qualify as an underrepresented minority individual defined as individuals 
belonging to particular ethnic, racial and other groups determined by the 
grantee institution to be underrepresented in biomedical, behavioral, 
clinical or social sciences, e.g., first generation college 
students/graduates, socio-economically disadvantaged.

o Possess a research or health professional doctoral degree (or its 
equivalent) that is suitable preparation for a productive research career.

o Have been in or currently in a "mentored" research postdoctoral position 
and have completed two years or more of research in this capacity at the time 
of the application, or be in a suitable independent position for less than 
two years with continuous previous postdoctoral research training at the time 
of the application.  Exceptions to this condition will require explicit 
written permission from the NCI.

o Intend to conduct a research project highly relevant to cancer biology, 
etiology, pathogenesis, prevention, diagnosis and treatment that has the 
potential for establishing an independent research program.

o Candidates must be U.S. citizens or non-citizen nationals, or must have 
been lawfully admitted for permanent residence by the time of award.  
Individuals admitted for permanent residence must be able to produce 
documentation of their immigration status such as an Alien Registration 
Receipt Card (I-551) or some other verification of legal admission as a 
permanent resident.  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 for this award.  
Federal employees are ineligible for this program.  Women and persons with 
disabilities are encouraged to apply as principal investigators.

SPECIAL REQUIREMENTS

A.  Program

The NCI Transition Career Development Award (K22) for Underrepresented 
Minorities can be used by more advanced postdoctoral and newly independent 
minority candidates who need protected time to establish their initial cancer 
research program.  Accordingly, the award provides up to three consecutive 
12-month appointments to recipients who must devote a minimum of 75 percent 
effort to the proposed basic, clinical or population science research 
program.  The remaining 25 percent can be divided among other activities only 
if they are consistent with the program goals, i.e. the candidate's 
development into an independent investigator.

Candidate:  Candidates must devote at least 75 percent of their professional 
effort to cancer-related research and peer review activities consistent with 
the objectives of this award.  The candidate must develop advanced knowledge 
in the basic, clinical, prevention or population-based sciences and the 
advanced research skills relevant to her/his cancer research field(s).

Recipients of an NCI Transition Career Development Award for Underrepresented 
Minorities (K22) must submit a competitive research grant application to the 
NIH/NCI, or an R01 equivalent research grant application to an equivalent 
funding organization (for example, an American Cancer Society Research 
Project Grant) for peer review and funding consideration prior to the end of 
the second year of support.

Environment:  The sponsoring institution, once identified, must have well- 
established basic, clinical, and/or prevention and population-based cancer 
research programs.  The candidate's proposed cancer research program should 
benefit from the relevant cancer research and educational resources that are 
available.  The sponsoring institution must also demonstrate a commitment to 
the development of junior faculty as productive, independent investigators.

B.  Allowable Costs

Salary:  The NCI Transition Career Development Award for Underrepresented 
Minorities (K22) will provide salary up to $75,000 annually plus fringe 
benefits.  The total salary requested must be based annually on a full-time, 
12 month staff appointment requiring the candidate to spend a minimum of 75 
percent effort conducting cancer research with the remaining effort being 
devoted to activities related to the development of a successful research
career.  The salary must be consistent both with the established salary 
structure at the institution and with salaries actually provided by the 
institution from its own funds to other staff members 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.

The institution may supplement the NCI 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.  Because the salary amount 
provided by this award is based on the full-time institutional salary, no 
other PHS funds may be used for salary supplementation. Institutional 
supplementation of salary must not require extra duties or responsibilities 
that would interfere with the purpose of the K22.  Under expanded 
authorities, however, institutions may rebudget funds within the total costs 
awarded to cover salaries consistent with the institution's salary scale.

Research Development Support:  Up to $50,000 per year will be provided for 
the following types of expenses: (a) research expenses, such as supplies, 
equipment, and technical personnel; (b) statistical services including 
personnel and computer time; (c) tuition, fees, and books related to career 
development; and (d) travel to research meetings or for training.  The level 
of research development support may be negotiated downward with the 
acquisition of any independent grant support from any source.

Ancillary Personnel  Support:  Salary for mentors, secretarial and 
administrative assistance, etc., is not allowed.

Facilities and Administrative Costs:  These costs, which were formerly called 
indirect costs, will be reimbursed at 8 percent of modified total direct 
costs.

C.  Evaluation

In carrying out its stewardship of human resource related programs, the NCI 
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.

D.  Other Income

Fees resulting from clinical practice, professional consultation, or other 
comparable activities required by the research and research-related 
activities of this award 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:

o The funds may be expended by the grantee institution in accordance with the 
NIH policy on supplementation of career award salaries and to provide fringe 
benefits in proportion to such supplementation. Such salary supplementation 
and fringe benefit payments must be within the established policies of the 
grantee institution;

o The funds may be used for health-related research purposes;

o The funds may be paid to miscellaneous receipts of the U.S. Treasury. 
Checks should be made payable to the Department of Health and Human Services, 
NIH and forwarded to the Director, Division of Financial Management, NIH, 
Bethesda, Maryland 20892.  Checks must identify the relevant award account 
and reason for the payment;

o Awardees may retain royalties and fees for activities such as scholarly 
writing, service on advisory groups, or honoraria from other institutions for 
lectures or seminars, provided these activities remain incidental and 
provided that the retention of such pay is consistent with the policies and 
practices of the grantee institution.

Usually, funds budgeted in a 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.

E.  Special Leave

Leave to another institution, including a foreign laboratory, may be 
permitted if the proposed experience is directly related to the purpose of 
the award.  Only local, institutional approval is required if such leave does 
not exceed 3 months.  For longer periods, prior written approval
of the NCI is required.  To obtain prior approval, the award recipient must 
submit a letter to the NCI describing the plan, countersigned by his or her 
department head and the appropriate institutional official.  A copy of a 
letter or other evidence from the institution where the leave is to be taken 
must be submitted to assure that satisfactory arrangements have been made. 
Support from the career award will continue during such leave.

Leave without award support may not exceed 12 months.  Such leave requires 
the prior written approval of NCI and will be granted only in unusual 
situations.  Support from other sources is permissible during the period of 
leave.  Such leave does not reduce the total number of months of program 
support for which an individual is eligible.  Under unusual and pressing 
circumstances, an awardee may submit a written request to the awarding 
component, requesting a reduction in professional effort below 75 percent. 
Such requests will be considered on a case-by-case basis during the award 
period.  In no case will it be permissible to work at a rate of less than 50 
percent effort.  The nature of the circumstances requiring reduced effort 
might include medical conditions, disability, or pressing personal or family 
situations such as child or elder care.

Permission to reduce the level of effort will not be approved to accommodate 
other sources of funding, job opportunities, clinical practice, or clinical 
training.  In each situation, the grantee institution must submit 
documentation supporting the need for reduced effort along with assurance of 
a continuing commitment to the scientific development of the awardee.

Furthermore, the awardee must submit assurance of his or her intention to 
return to full-time professional effort (at least 75 percent) as soon as 
possible.  During the period of reduced effort, the salary and other costs 
supported by the award will be reduced accordingly.

F.  Termination or Change of Institution

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 Director of the NCI 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 NCI shall notify the grantee institution and career award 
recipient in writing of this determination, the reasons therefore, the 
effective date, and the right to appeal the decision.

Awardees planning a change of institution are urged to contact the NCI 
Program Director (name listed in Notice of Grant Award) to discuss the 
transfer and obtain instructions.  The required paperwork must be submitted 
by the new institution far enough in advance of the requested effective date 
to permit review. The period of support requested at the new institution must 
be no more than the time remaining within the existing award period.

A final progress report, invention statement, and Financial Status Report are 
required upon either termination of an award or relinquishment of an award in 
a change of institution situation.

G. Reporting Requirements

If the application is funded, additional reporting requirements for 
continuation of this project are listed in the section titled "Non-Competing 
Renewals". 

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA 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:

o Direct your questions about scientific/research issues to:

Ms. Belinda M. Locke
Program Director, Comprehensive Minority Biomedical Branch
National Cancer Institute
6116 Executive Boulevard, Suite 7031
Bethesda, MD 20892-8350
Rockville, MD 20852 (express/courier service)
Telephone:  (301) 496-7344
FAX:  301-402-4551
Email: lockeb@mail.nih.gov

o Direct your questions about peer review issues to:

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov

o Direct your questions about financial or grants management matters to:

Ms. Barbara Fisher
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Room 243
Bethesda, MD 20892-7150
Rockville, MD 20852 (express/courier service)
Telephone:  301-846-1015
FAX:  301-846-5720
Email: fisherb@gab.nci.nih.gov

SUBMITTING AN APPLICATION

Potential candidates are strongly encouraged to contact the program staff 
person listed under INQUIRIES. Such contact should occur early in the 
planning phase of application preparation. Such contact will help ensure that 
applications are responsive to the goals and policies of this announcement.

Applications must be prepared using Section IV, "Research Career Awards" 
(RCA), instructions to complete the PHS 398 research grant application (rev. 
5/2001).  The PHS 398 and Section IV instructions are available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov

Applicants who will be using the resources within a General Clinical Research 
Center (GCRC) during the course of the award should include a letter of 
agreement from either the GCRC program director or the principal investigator 
for the application.

To identify the application as a response to this program announcement, check 
"YES" on item 2 of page one of the application and enter the title and number 
of this PA.

APPLICATION RECEIPT DATES: 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.

SPECIFIC INSTRUCTIONS:

The application must address the following issues:

Candidate

For applicants already in an independent position:

o Describe immediate and long-term career goals, explaining how the award 
will contribute to their attainment;

o Describe the current position in terms of its ability to enable the 
candidate to pursue an independent career in cancer research;

All Candidates

o Describe immediate and long-term career goals, explaining how the award 
will contribute to their attainment;

o Describe all activities during the "mentored" period (postdoctoral, 
previous K-award, etc.) of cancer research training.  Include all research 
experiences and mentors, any pertinent didactic experiences and any other 
experiences designed to acquire critical skills, techniques and scientific 
perspectives for pursuing an independent career in the chosen area of cancer 
research (e.g., basic research, clinical or patient-oriented research, and 
prevention, control and population research);

o Describe scientific productivity during the mentored period of career 
development;

o Establish the potential to manage an independent research program;

o Establish the ability to become an independent investigator during the 
three year term of the award;

o Describe the ability to interact and collaborate with other scientists;

o Establish the ability to make a commitment of at least 75 percent effort to 
the objectives of this award;

o Submit three letters of recommendation from established scientists familiar 
with the candidate's potential and capability to become a successful 
independent investigator in which the following issues are addressed:

- the adequacy of the candidate's scientific background for the proposed 
research and career goals;

- the quality of the candidate's scientific productivity and achievements 
(e.g., publications, intellectual contributions to the research environment);

- the candidate's ability to work with other scientists in various 
interactive situations (e.g., seminars, journal clubs), on collaborative 
research projects, and with support staff (e.g., technicians, nurses, 
secretaries etc.);

- evidence of the candidate's originality and innovativeness in pursuing a 
research problem;

- VERY IMPORTANTLY, the candidate's special potential to develop, establish 
and manage an independent research program.

Research Plan

o Describe the research plan using Form PHS 398 (rev. 5/2001 or subsequent 
revisions) following instructions for the Specific Aims, Background and 
Significance, Progress Report/Preliminary Studies, Research Design and 
Methods.  The research plan must be clearly relevant to cancer biology, 
etiology, pathogenesis, prevention, diagnosis, and/or treatment;

o Describe how the proposed research extends the mentored research training 
that has been completed into new concepts and ideas;

o Describe the equipment, specialized facilities and personnel resources that 
will be needed to conduct the proposed research;

o Describe the plans for inclusion of women, minorities and children in any 
clinical or population research activities;

o Describe the plans for protection of humans, animals or the environment to 
the extent they may be adversely affected by activities proposed in the 
application.

Previous Mentor's Statement

o Include a signed statement from the previous mentor(s) with information on 
potential and capability of the candidate to become a successful independent 
investigator in which the following issues are addressed:

- The adequacy of the candidate's scientific background for the proposed 
research and career goals;

- The quality of the candidate's scientific productivity and achievements 
(e.g., publications, intellectual contributions to the research environment);

- The candidate's ability to work with other scientists in various 
interactive situations (e.g., seminars, journal clubs), on collaborative 
research projects, and with support staff (e.g., technicians, nurses, 
secretaries etc.); research qualifications and previous experience as a 
postdoctoral researcher.  The application must also include information to 
describe the previous mentor's research support as related to the candidate's 
research plan.

Environment and Institutional Commitment

o Describe the resources and facilities available to the candidate;

o Describe how the research environment of the institution is particularly 
suited for the development of the candidate's research career and the pursuit 
of the proposed research plan;

o In a clear statement, provide assurances that the candidate will be able to 
spend a minimum of 75 percent effort in the conduct of his/her research 
activities, with the remaining percent effort devoted to activities related 
to the development of a research career.

Biographical Sketch

A biographical sketch is required for the candidate, including information on 
research projects completed and/or research grants participated in during the 
postdoctoral or mentored phase that are relevant to the proposed project.

Training in the Responsible Conduct of Research

Candidates must describe previous training in the responsible conduct of 
research or if the candidate has not had such training, must describe plans 
to receive instruction in the responsible conduct of research. These plans 
must detail the subject matter, format, frequency, and duration of 
instruction. No award will be made if an application lacks this component.

Budget

The total direct costs requested must be consistent with this K22 program 
announcement and the award limits of the NCI.  Provide a detailed 
description, with justification, for all equipment, supplies and personnel 
that are required to achieve the research objectives of this award.

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, 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
Bethesda, MD  20817 (for express/courier service)

At the time of submission, two additional copies of the application must be 
sent to:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD  20892-8329
Rockville, MD  20852 (for express/courier service)

APPLICATION PROCESSING: Applications must be received by or mailed before the 
receipt date(s) described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.  The CSR will 
not accept any application in response to this PA that is essentially the 
same as one currently pending initial review unless the applicant withdraws 
the pending application.  The CSR 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.

APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER INSTITUTE 
WILL NO LONGER BE ACCEPTED.  This policy does not apply to courier deliveries 
(i.e. FEDEX, UPS, DHL, etc.) http://grants.nih.gov/grants/guide/notice-
files/NOT-CA-02-002.html.  This change in practice is effective immediately.  
This policy is similar to and consistent with the policy for applications 
addressed to Centers for Scientific Review as published in the NIH Guide 
Notice http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and 
for adherence to the guidelines of this PA by the NCI program staff.  
Applications not adhering to the guidelines of this PA, and those 
applications that are incomplete as determined by CSR or by NCI program 
staff, will be returned to the applicant without review.

Applications that are complete and adhere to the guidelines of this PA will 
be evaluated for scientific and technical merit by an appropriate peer review 
group convened by the Division of Extramural Activities of the NCI in 
accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

o  Receive a written critique

o Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications under 
review, will be discussed and assigned a priority score

o Those that receive a priority score will undergo a second level review by 
the National Cancer Advisory Board.

REVIEW CRITERIA

The following review criteria will be applied:

Candidate (Principal Investigator)

For candidates already in an independent position:

o Suitability of the position for the candidate to pursue an independent 
research career;

For all Candidates:

o Quality of the mentored period of cancer research training in terms of 
research experience(s), didactic experiences and other experiences (e.g., 
special skills, perspectives, techniques) that will enhance the candidate's 
ability to pursue an independent cancer research career in the chosen area of 
research (e.g., basic research; clinical or patient oriented research; or 
prevention, control and population research);

o Scientific productivity during the mentored period of cancer research 
training;

o Commitment of the candidate to an independent cancer research career that 
will be focused on problems clearly relevant to cancer;

o Potential ability to successfully manage an independent research project;

o Ability of the candidate to interact and collaborate with other scientists;

o Recommendations of three well-established scientists attesting to the 
special potential of the individual to pursue an independent career in cancer 
research.

Research Plan

o Adequacy of the proposed research plan for developing an independent cancer 
research program as it relates to the basic, clinical or patient-oriented 
and/or prevention control and population cancer research and commensurate 
with the candidate's level of research development;

o The originality and quality of the research hypothesis/question, design and 
methodology, judged in the context of the candidate's previous training and 
experience;

o Adequacy of plans for the protection of human and animal subjects and the 
safety of the research environment and conformance with the NIH Guidelines 
for Inclusion of Women and Minorities as Subjects in Clinical Research and 
Inclusion of Children Participating in Research Involving Human Subjects.  
(See criteria included in the section on Federal Citations, below.)

Previous Mentor/Co-Mentor

o Adequacy and clarity of the previous mentor's statement describing the 
potential and capability of the candidate to become a successful independent 
investigator.

Institutional Environment and Commitment

o Clear commitment of the institution to ensure that a minimum of 75 percent 
of the candidate's effort will be devoted directly to research, with the 
remaining percent effort being devoted to activities related to the 
successful development of a independent research career;

o Adequacy of research facilities and training opportunities;

o Quality and relevance of the environment for scientific and professional 
development of the candidate.

Training in the Responsible Conduct of Research 

Quality of the proposed/previous training in the responsible conduct

Budget

o Justification of the requested budget in relation to career development 
goals and research aims and plans;

o Adequacy of the proposed budget items for the achievement of the career 
development and research objectives of the award.

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, applications 
will also be reviewed with respect to the following:

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 criteria included in the 
section on Federal Citations, below).

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 Inclusion Criteria in the sections on 
Federal Citations, below).

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 
398 research grant application instructions (rev. 5/2001) will be assessed.  

AWARD CRITERIA

Applications submitted in response to a PA will compete for available funds 
with all other recommended applications.  The NCI staff will notify the 
applicant of the National Cancer
Advisory Board's action shortly after its meeting.   The following will be 
considered in making funding decisions:

o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities

Candidates who have competed successfully for funding that do not have an 
institution at the time funding decisions are made will be notified by the 
NCI with a "Letter of Intent to Commit Funds."  Candidates in a postdoctoral 
position will then have one-year from the date of the letter to find an 
institution that offers a position, preferably tenure-track, suitable for 
enhancing a research career.  Candidates who have already identified 
positions will not reveive the "Letter of Intent to Commit", but will be 
asked to submit the "Statement of Environment and Institutional Commitment" 
and to submit the Just-In-Time documents (detailed budget for first year, 
detailed budget for entire project period, other support and checklist).  For 
candidates who already have a position in a sponsoring institution, 
negotiation with the institution will begin without delay.

Negotiations will be initiated by asking the candidate's institution to 
submit a "Statement of Environment and Institutional Commitment" to the NCI.  
This statement will be evaluated by NCI staff using the following criteria:

o Documentation of a strong, well-established research program related to the 
candidate's area of interest including a high-quality research environment 
with staff capable of productive collaboration with the candidate;

o Agreement of the institution's statement of commitment of equipment, 
physical and personnel resources with the peer-reviewed recommendation of 
needs;

o Adequacy of the arrangements with the candidate to provide a permanent 
preferably tenure-track position, adequate facilities for conducting a 
research program, and additional resources conducive to the development of a 
research project and establishment of a successful research career.

For postdoctoral candidates, if the NCI approves the "Statement of 
Environment and Institutional Commitment" offered by the institution, the 
institution will be asked to submit a completed PHS Form 398 application. For 
candidates who already have a position in a sponsoring institution, the NCI 
only needs to approve the Statement.  After NCI approval and subject to the 
availability of funds, the institution will receive an award.  At the time of 
the award to the grantee institution in support of the K22, any current award 
held or other support provided for the mentored training of the candidate 
will be terminated.

An award can be terminated prior to the end of the third year by the NCI if 
the candidate does not submit an R01 type grant application or equivalent for 
peer review before the end of the second year (See SPECIAL REQUIREMENTS).

Non-Competing Renewals

Funding beyond the first year of the award is contingent upon satisfactory 
progress during the preceding year, as documented in the required Progress 
Report.  In addition to the information requested in the Application for 
Continuation Grant form PHS 2590 (Rev. 5/01), documentation must be provided 
with the Progress Report for the third year of the award showing that the 
awardee has submitted a competitive research grant (or equivalent) for 
funding.  This documentation should minimally be a copy of the face page of 
the application with all required institutional signatures. The Progress 
Report (PHS form 2590) will be evaluated based upon and should include:

o Demonstration of scientific progress toward the aims of the research.  The 
candidate is responsible for a brief summary of the studies and results 
obtained during the prior funding period;

o A list of accomplishments such as publications, inventions, or project- 
generated resources should be provided;

o A brief explanation of plans to address the specific aims during the next 
year of support;

o Description of similar activities for the next year of support with a clear 
indication of percent effort devoted to research/research training and other 
activities respectively; and

REQUIRED FEDERAL CITATIONS

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.

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD:  Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Clinical trials supported or performed by NCI require special considerations.  
The method and degree of monitoring should be commensurate with the degree of 
risk involved in participation and the size and complexity of the clinical 
trial.  Monitoring exists on a continuum from monitoring by the principal 
investigator/project manager or NCI program staff or a Data and Safety 
Monitoring Board (DSMB).  These monitoring activities are distinct from the 
requirement for study review and approval by an Institutional review Board 
(IRB).  For details about the Policy for the NCI for Data and Safety 
Monitoring of Clinical trials see: 
http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm.  For Phase I and II 
clinical trials, investigators must submit a general description of the data 
and safety monitoring plan as part of the research application.  See NIH 
Guide Notice on "Further Guidance on a Data and Safety Monitoring for Phase I 
and II Trials" for additional information: 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html.  
Information concerning essential elements of data safety monitoring plans for 
clinical trials funded by the NCI is available:  
http://www.cancer.gov/clinical_trials/

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 AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 http://grants.nih.gov/grants/guide/notice
-files/NOT-OD-02-001.html; a complete copy of the updated Guidelines are 
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 RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them. This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

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 that is available at 
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 proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.  A 
continuing education program in the protection of human participants in 
research in now available online at: http://cme.nci.nih.gov/

HUMAN EMBRYONIC STEM CELLS (hESC):  Criteria for federal funding of research 
on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Guidance 
for investigators and institutional review boards regarding research 
involving human embryonic stem cells, germ cells, and stem cell-derived test 
articles can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-
OD-02-044.html. Only research using hESC lines that are registered in the 
NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding 
(see http://escr.nih.gov).   It is the 
responsibility of the applicant to provide 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.

PUBLIC 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 public 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 PA 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). Those who must comply with the Privacy Rule (classified 
under the Rule as "covered entities") must do so by April 14, 2003  (with the 
exception of small health plans which have an extra year to comply).  

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 authorization of Sections 301 
and 405 of the Public Health Service Act as amended by Public Law 99-158 (42 
USC 241 and 284) and administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92.

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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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