This PAR will expire on October 2, 2003 unless reissued.

NCI TRANSITION CAREER DEVELOPMENT AWARD (K22)

Release Date:  September 4, 2001

PAR NUMBER:  PAR-01-134 (see replacement PAR-04-040)

National Cancer Institute

This program announcement replaces PAR-99-094, which was published in the NIH 
Guide on May 10, 1999.

PURPOSE

This K22 award is intended to facilitate the transition of investigators from 
the mentored to the independent stage of their careers in CANCER research, by 
providing  "protected time" for newly independent investigators to develop 
and receive support for their initial CANCER research programs.  The award 
applies to clinicians who are pursuing basic science careers, clinicians who 
are pursuing careers in patient-oriented research, and to individuals 
pursuing careers in the prevention, control and population sciences.  To 
apply, a candidate must have completed TWO YEARS OR MORE of postdoctoral, 
mentored research or have been in an independent position for LESS THAN TWO 
YEARS at the time the application is submitted.  The unique feature of this 
award is that individuals may apply without a sponsoring institution while 
they are still in a "mentored" position.  Successful postdoctoral applicants 
will be given up to 12 months to identify an independent, preferably tenure-
track, position at a sponsoring institution before an award can be activated.  
For postdoctoral applicants, the sponsoring institution for a K22 award can 
be their current institution or a new institution.

This PA incorporates the previously announced (NIH Guide, NOTICE CA-00-011, 
February 23, 2000) expansion of eligible candidates to include postdoctoral 
scientists working in basic research as Federal employees.  Additionally, 
candidates already in their first independent research position may now apply 
for this award in the second year of this position, whereas in PAR-99-094, 
these candidates were eligible to apply only if they were in their first year 
of the position.  

RESEARCH OBJECTIVES

Background

Many individuals in fields critically important to the future of cancer 
research need protected time to develop successful independent research 
programs.  This is particularly true for medically trained individuals in 
general and for doctorally degreed and medically trained individuals pursuing 
cancer research careers in the prevention, control, behavioral and population 
sciences.  Individuals in these research career tracks often require extended 
periods of mentored research training beyond their original doctoral degrees 
(e.g., M.D., Dr.PH).  In addition, upon completion of their mentored research 
training, these individuals are often at a competitive disadvantage in 
obtaining independent research support relative to their traditional basic 
science Ph.D. counterparts, who generally have many more combined years of 
research training and experience in their field of expertise. Finally, the 
survival of clinician and Ph.D. researchers in these critical research areas 
is being threatened by the current economics of medical care, which is 
increasingly emphasizing revenue-generating clinical practice at the expense 
of clinical research, and by a corporate culture of many of the nation"s 
academic institutions that continues not to provide academic homes and 
tenure-track positions for prevention, control, behavioral and population 
scientists in the beginning stages of the independent phase of their research 
careers.

A critical mass of clinician cancer researchers and researchers in cancer 
prevention, control, behavioral and the population sciences capable of 
interacting with basic science researchers is needed to ensure effective 
translation of basic research discoveries into patient and population 
research settings if there is to be optimal progress in reducing cancer 
incidence, mortality and morbidity.  The NCI Transition Career Development 
Award was developed to address this need and the issues raised earlier, by 
providing a mechanism for stabilizing the career tracks of the most promising 
of these investigators while they are establishing their first independent 
research programs.  This award focused on individuals with health 
professional degrees and in a basic science or patient-oriented research 
career development track, and individuals with a science or clinical doctoral 
degree in a cancer prevention, control, behavioral or population sciences 
research career development track.  Federal employees in relevant positions, 
viz. NIH intramural scientists or fellows, were initially not eligible 
candidates for this award.  However, in order to create equal access of 
postdoctoral scientists working as Federal employees to extramural career 
development opportunities, the National Cancer Institute (NCI) subsequently 
announced in 2000 a specialized expansion of the eligibility requirements of 
the Transition Career Development Award (K22) to include postdoctoral 
scientists working in basic research as Federal employees and who proposed 
research directly relevant to human cancer.  

Goals and Scope

The award provides support for three years to individuals who are currently 
postdoctoral trainees in CANCER research or have just started in an 
independent position (See ELIGIBILITY REQUIREMENTS).  Recipients of this 
award must devote a minimum of 75 percent effort to the proposed basic, 
clinical or population science research program.  The remaining 25 percent 
effort can be divided among other clinical and teaching activities only if 
they are consistent with the program goals, i.e. the candidate"s development 
into an independent clinical investigator or investigator in cancer 
prevention, control, behavioral and the population sciences.

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.  
Further, 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.

The sponsoring institution must have well-established research programs in 
basic, clinical and or cancer prevention/control/behavioral/population 
sciences.  This research environment should be one in which there are active 
research collaborations that exemplify a dynamic two-way exchange of 
information and ideas between laboratory and clinical and/or population 
research settings.  The sponsoring institution must also demonstrate a 
commitment to the development of junior faculty as productive, independent 
investigators.

Allowable Costs

Salary:  The Transition Career Development Award (K22) will provide salary up 
to $75,000 plus fringe benefits.  The total salary requested must be based on 
a full-time, 12 month staff appointment requiring the candidate to devote a 
minimum of 75 percent effort to 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 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.  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.

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.

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, and 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.

Usually, funds budgeted in an NIH supported research or research training 
grant for the salaries or fringe benefits of individuals, but freed as a 
result of a career award, may not be rebudgeted.  The awarding component will 
give consideration to approval for the use of released funds only under 
unusual circumstances.  Any proposed retention of funds released as a result 
of a career award must receive prior written approval of the NIH awarding 
component.

Special Leave

Leave to another institution, including a foreign laboratory, with award 
support 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 component is required.  To obtain prior approval, 
the award recipient must submit a letter to the NIH funding component 
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 the NIH funding component 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.

Parental leave will be granted consistent with the policies of the grantee 
institution.

Termination of Award

When a grantee institution plans to terminate an award, the NIH funding 
component must be notified in writing at the earliest possible time so that 
appropriate instructions can be given for termination. The Director of the 
NIH may discontinue an award upon determination that the purpose or terms of 
the award are not being fulfilled.  In the event an award is terminated, the 
Director of the NIH shall notify the grantee institution and career award 
recipient in writing of this determination, the reasons therefore, the 
effective date, and the right to appeal the decision.

Change of Institution

Individuals planning a change of institution AFTER AN AWARD HAS BEEN 
INITIATED (see Award Criteria and Procedures below) must submit to the NCI in 
advance of the change a written request for transfer, countersigned by the 
appropriate institutional business official, describing the reasons for the 
change.  The awardee must establish in this request that the specific aims of 
the research program to be conducted at the new institution are within the 
scope of the original peer reviewed research program. Staff within the NCI 
will review this request and may require a review by an initial review group 
and the appropriate National Cancer Advisory Board. Upon approval of this 
request the new institution must follow all of the procedures outlined in the 
section on AWARD CRITERIA AND PROCEDURES for submission and NCI approval of a 
"Statement of Environment and Institutional Commitment." Upon approval of the 
"Statement" a new career award application must be submitted by the new 
institution far enough in advance of the requested effective date to permit 
review.  The period of support requested in the new application 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.

Special Restrictions

Recipients of an NCI Transition Career Development Award (K22) must submit an 
R01 research grant application to the National Institutes of Health, 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.

MECHANISM OF SUPPORT

This PA will use the National Institutes of Health (NIH) K22 award mechanism.   
The total project period for an application submitted in response to this PA 
may not exceed 3 years.  Planning, direction, and execution of the program 
will be the responsibility of the candidate.  Awards are not renewable.

ELIGIBILITY REQUIREMENTS

Eligible candidates are doctorally degreed individuals who have been educated 
as clinicians (e.g. M.D.s, Oncology Nurses) or as prevention, control and 
population scientists (e.g., PhDs, Dr.PHs, M.D.s) and are ready to pursue 
independent careers in CANCER research.  The Transition Career Development 
Award (K22) is NOT for basic scientists following a traditional basic science 
research career track (e.g., Ph.D.s in molecular biology).  Individuals 
pursuing basic science cancer research careers should apply for the Howard 
Temin Award (K01).  Candidates should refer to the following URL addresses 
for information on the Howard Temin Award: 
http://grants.nih.gov/grants/guide/pa-files/PAR-00-066.html,   
http://cancertraining.nci.nih.gov/research/basicphd/phdk01.html.

Candidates must currently be in a "mentored" CANCER 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 CANCER research 
training at the time of the application.  Postdoctoral scientists working in 
basic research as Federal employees and who have at least three years of 
mentored postdoctoral research experience at the time of award, may also 
apply as long as the proposed research is directly relevant to human cancer.  
Candidates in a postdoctoral position are eligible to apply for an NCI 
Transition Career Development Award (K22) WITHOUT an institutional 
affiliation (See Application Procedures).  

A candidate for a K22 may not simultaneously submit or have pending an 
application for any other PHS award that duplicates any of the provisions of 
this award.  Former or current principal investigators on any NIH research 
grants or non-PHS peer reviewed grants that are over $100,000 direct costs 
per year or project leaders on sub-projects of program project (P01) or 
center grants (P50) are NOT eligible to apply.

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, 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.

Only domestic non-Federal organizations, public or private, such as medical, 
dental or nursing schools or other institutions of higher education, may 
accept an award on behalf of an applicant.

INQUIRIES

Inquiries are encouraged. The opportunity to clarify any issues or questions 
from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

In the Clinical Sciences:
Dr. Lester S. Gorelic 
Cancer Training Branch
National Cancer Institute
6116 Executive Boulevard, Suite 7025, MSC 8346
Bethesda, MD  20892-7390
Telephone:  (301) 496-8580
FAX:  (301) 402-4472
Email:  [email protected]

In the Basic Sciences:
Dr. Cynthia Pond
Cancer Training Branch
National Cancer Institute
6116 Executive Boulevard, Suite 7023, MSC 8346
Bethesda, MD  20892-7390
Telephone:  (301) 496-8580
FAX:  (301) 402-4472
Email:  [email protected] 

In Cancer Prevention, Control, Behavioral, Population Sciences:
Dr. Brian W. Kimes 
Cancer Training Branch 
National Cancer Institute
6116 Executive Boulevard, Suite 7001, MSC 8346
Bethesda, MD  20892-8346
Telephone:  (301) 496-8537
FAX:  (301) 402-0181
Email:  [email protected]   

Direct inquiries regarding fiscal matters to:

Ms. Catherine Blount
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, MD  20892
Telephone:  (301)-496-3179
FAX:  (301)496-8601
Email:  [email protected]

Direct inquiries regarding review matters to:

Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8109, MSC 8329
Bethesda, MD  20892-8329
Telephone:  (301) 496-3428
FAX:  (301) 402-0275
Email:  [email protected]

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev. 
5/2001) (http://grants.nih.gov/grants/funding/phs398/phs398.html) and should 
use the instructions in Section IV of the application kit.  The application 
will be accepted at the standard application deadlines for other K-awards as 
indicated in the application kit. 

Applications for which the candidate already has a position must be completed 
as directed.  Postdoctoral candidates with no sponsoring institution may 
leave out all information that is the grantee institution"s responsibility to 
provide, this information must be provided at a later time if the candidate 
is selected for funding (See section on AWARD CRITERIA AND PROCEDURES).  

This version of the PHS 398 is available in an interactive, searchable PDF 
format. Although applicants are strongly encouraged to begin using the 5/2001 
revision of the PHS 398 as soon as possible, the NIH will continue to accept 
applications prepared using the 4/1998 revision until January 9, 2002. 
Beginning January 10, 2002, however, the NIH will return applications that 
are not submitted on the 5/2001 version.  For further assistance contact 
GrantsInfo, Telephone 301/710-0267, Email: [email protected].

The title and number of the program announcement must be typed in Section 2 
of the face page of the application. The YES box must be marked.  For those 
applicants with Internet access, the 398 kit may be found at:  
http://grants.nih.gov/grants/funding/phs398/phs398.html.

All clinical trials supported or performed by NCI require some form of 
monitoring.  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 to 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 of the NCI for Data 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.  
Finally, for details on the essential elements of a data and safety 
monitoring plan for clinical trials funded by the National Cancer Institute 
and for how the NIH/NCI policies on data safety and monitoring apply to NCI 
K-awards, see:  
http://nci.nih.gov/clinicaltrials/conducting/dsm-guidelines.

Submit a signed, typewritten original of the application, including the 
checklist, and three signed exact, single-sided 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 for express service)

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

Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8109, MSC 8329
Rockville, MD  20852 (express courier)
Bethesda, MD  20892-8329

The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA 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 substantial 
revisions of applications already reviewed, but such applications must 
include an introduction addressing the previous critique.

The information summarized below must be provided in the application: 

Candidate

o  (Only for applicants already in an independent position) Describe the 
current position in terms of its ability to enable the candidate to pursue an 
INDEPENDENT career in CANCER research,

o  Identify whether you are a clinician pursuing a basic science career, a 
clinician pursuing a clinical research/translational research career or an 
individual pursuing a career in prevention, control, behavioral or population 
research,

o  Describe all activities during the "mentored" period 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 career objectives of this award,

o  Three letters of recommendation from established scientists familiar with 
the candidate"s potential and capability to become a successful independent 
investigator. These letters should be provided in sealed envelopes attached 
to the front page of the application.

Research Plan

o  Describe an original research plan in basic, clinical, cancer prevention 
or cancer control research, or in the behavioral or population sciences 
research directly related to cancer.  The research plan must be described as 
outlined in form PHS 398 including sections on the Specific Aims, Background 
and Significance, Progress Report/Preliminary Studies, Research Design and 
Methods,

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.

Budget

o  Within the limitation of $50,000 direct costs for research development 
support, provide a detailed description, with justification, for all 
equipment, supplies and personnel that will be used to help achieve the 
career development and research objectives of this award.

Non-Competing renewals

o  In addition to the information requested in the Application for 
Continuation Grant form PHS 2590 (Rev. 5/2001), documentation must be 
provided with the Progress Report for the second year of the award showing 
that the awardee has submitted an R01-type research grant application for 
funding.  This documentation should minimally be a copy of the face page of 
the application with all required institutional signatures.

REVIEW CONSIDERATIONS

Applications will be reviewed for completeness by the Center for Scientific 
Review and for adherence to guidelines by the National Cancer Institute.  
Incomplete or non-responsive applications will be returned to the applicant 
without further consideration.  Applications that are not eligible (See 
ELIGIBILITY REQUIREMENTS), as judged by NCI staff will be returned without 
further consideration.  Applications that are complete and responsive to the 
program announcement will be evaluated for scientific and technical merit by 
a peer review group convened by the Division of Extramural Activities of the 
National Cancer Institute.  As part of the initial merit review, all 
applications will receive a written critique and undergo a process in which 
only those applications deemed to have the highest scientific merit, 
generally the top half of applications under review, will be discussed, 
assigned a priority score, and receive a second level review by the National 
Cancer Advisory Board to ensure that the proposed program meets the broad 
programmatic needs of the National Cancer Institute and the National Cancer 
Program.

The following review criteria will be applied:

Candidate

o  (Only for candidates already in an independent position) Suitability of 
the position for the candidate to pursue an independent research career,

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, behavioral and population sciences research),

o  Scientific productivity during the mentored period of career development,

o  Potential ability to successfully manage an independent research project,

o  Ability to interact and collaborate with other scientists,

o  The potential to become a successful independent investigator during the 
3-year term of this award,

o  Letters of reference on behalf of the candidate.

Research Plan

o  The originality, innovativeness and scientific merit of the proposed 
Research Plan relative to the experience level of the applicant,

o  Extent to which the research plan goes beyond the mentored environment and 
will test new concepts and ideas,

o  The medical and/or health significance of the Research Plan to Cancer,

o  The adequacy of plans to include women, children and minorities in any 
clinical or population research activities,

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

Budget

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

Non-Competing Renewals

o  Adequacy of the progress towards achieving the research and career 
development objectives of the program,

o  Adequacy of the efforts to obtain R01-type research grant support for the 
research program.

AWARD CRITERIA AND PROCEDURES

Applications will compete for available funds with all other recommended 
applications.  The NCI will notify candidates who have competed successfully 
for funding 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.  For a candidate who already has a position 
in a sponsoring institution, negotiations 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 institutional commitment to the required 75 percent effort 
requirement of this award for the development of an independently funded 
research program,

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)

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and 
their subpopulations must be included in all NIH supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification is provided 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 research involving human subjects should read the 
UPDATED "NIH Guidelines For Inclusion of Women and Minorities as Subjects in 
Clinical Research", published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), 
a complete copy of the updated Guidelines is available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.  The 
revisions relate to NIH defined Phase III clinical trials and require: a) all 
applications or proposals and/or protocols to 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) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.  

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by 
NIH, unless there are clear and compelling 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 was published in the NIH Guide For 
Grants And Contracts, March 6, 1998 and is available at the following URL 
address:  http://grants.nih.gov/grants/guide/notice-files/not98-024.html

Investigators may also obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

All investigators proposing research involving human subjects should read the 
NIH policy on education in the protection of human research participants now 
required for all investigators, which is published in the NIH Guide for 
Grants and Contracts, June 5, 2000 (Revised August 25, 2000), available at 
the following URL address:  
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 is now available online at 
http://cme.nci.nih.gov/.

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.

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 a 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.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.  
(see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-004.html).

REQUIREMENTS FOR SHARING RESEARCH RESOURCES
 
NIH policy requires that investigators make unique research resources readily 
available for research purposes to qualified individuals within the 
scientific community when they have been published.  All investigators should 
read the Guidelines available at the following URL address:  
(http://grants.nih.gov/grants/policy/nihgps_2001/part_iia_6.htm).  See 
also:   NIH Grants Policy Statement 
(http://grants.nih.gov/grants/policy/nihgps_2001/) and Sharing Biomedical 
Research Resources: Principles and Guidelines for Recipients of NIH Research 
Grants and Contracts: Final Notice, December 1999 
(http://www.nih.gov/od/ott/RTguide_final.htm).  It is expected that 
biomaterials and other patentable research resources (examples could be, but 
are not limited to, vectors, embryonic cell lines, mutant mice, etc.) 
produced in projects funded by this initiative will be made available and 
distributed to the broader scientific community. 

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, The NCI 
Transition Career Development Award, is related to the priority area of human 
resource development.  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 
Number 93.398, Cancer Research Manpower.  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 administered under NIH grants policies and 
Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.  This program 
is not subject to the intergovernmental review requirements of Executive 
Order 12372 or Health Systems Agency review.

The Public Health Service strongly encourages all grant recipients to provide 
a smoke-free workplace and promote the non-use of 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 for children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.

REFERENCES

1.  National Research Council, Committee on Dimensions, Causes, and 
Implications of Recent Trends in the Careers of Life Scientists.  Trends in 
the Early Careers of life Scientists.  Washington, D.C.: National Academy 
Press, 1998.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

			Department of Health and Human Services (HHS)
NIH... Turning Discovery Into Health®