NCI MENTORED CAREER DEVELOPMENT AWARD FOR UNDERREPRESENTED MINORITIES (K01)

Release Date:  November 13, 2000 (see replacement PAR-03-016)

PA NUMBER: PAR-01-016

National Cancer Institute

This Program Announcement (PAR) replaces PAR-98-103, which was published in 
the NIH Guide on September 18, 1998.

PURPOSE

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 career development 
award applications (K01) from underrepresented minority research scientists 
who have been recipients of uninterrupted support from an NIH Research 
Supplement for Underrepresented Minority Award or any National Research 
Service Award (individual F31/F32 or institutional T32) or can demonstrate 
that they have been supported by any peer reviewed research project grant 
mechanism (e.g., R01, P01, ACS).  This award is for candidates who seek 
additional support in the basic, clinical and/or population sciences in a 
mentored research environment with the option to continue with bridging 
support for their first independent research 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 to prepare other grant applications (e.g., R01; R03; R21).

This award is a novel program that is intended to support and enhance the 
likelihood of success for underrepresented minority investigators who have 
committed to basic, clinical, and prevention and population-based research 
careers in cancer.

This PA will expire on October 2, 2002, unless reissued.  NIH Grants policies 
apply to these awards.

CAREER DEVELOPMENT OBJECTIVES

Environment:  The institution must have well-established basic, clinical, 
and/or prevention and population-based cancer research programs and qualified 
faculty to serve as mentors.  The candidate, mentor and institutional 
representative must be able to propose an appropriate cancer research/career 
development program that will maximize the use of relevant cancer research and 
educational resources.

Program:  The NCI Mentored Career Development Award (K01) for Underrepresented 
Minorities can be used by postdoctoral candidates who need five full years of 
mentored support or by more advanced postdoctoral candidates who need 
additional mentored research experiences but also plan to use the award to 
make a transition to an independent position.  Accordingly, the award provides 
up to five consecutive 12-month appointments with the option of involving one 
or two phases: A mentored phase (Phase I) for one to five years or a mentored 
phase of one or more years followed by a transition to an independent position 
(Phase II) in subsequent years. Candidates choosing to apply for Phase I or a 
combination of Phase I and Phase II must include the appropriate phases in 
their research plan.  Candidates will participate in mentored research 
activities, which should include writing and submitting manuscripts for 
publication and presenting at scientific meetings.  In addition, candidates 
will be expected to observe or participate (depending upon prior research 
experience and/or level of independence and without additional compensation) 
in the NCI/NIH peer review process, as well as to participate annually in 
workshops focused on preparing, writing and submitting NIH grant applications; 
these activities will be coordinated and/or sponsored by the CMBB.

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 knowledge in the 
basic, clinical, prevention or population-based sciences and the research 
skills relevant to her/his cancer research field(s). 

Mentor:  The application must include mentoring appropriate to both Phase I 
and Phase II of the award; that is, mentoring in preparation to become an 
independent scientist and mentoring to guide the candidate in an independent 
position in the development of a research program competitive for peer-
reviewed research support.  The mentor must be a senior or mid-level faculty 
member with research competence and/or experience appropriate to his/her role.  
Where feasible, women and underrepresented minority mentors should be involved 
as role models.

Allowable Costs:

Salary:  This award 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.  The candidate must spend a minimum of 75 percent 
effort conducting cancer research studies, 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 K01.  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:  During Phase I of the award, $30,000 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; d) travel to research meetings or for training, and e) 
travel to an annual two-day NCI awardee meeting and/or peer review related and 
training expenses.  The amount of this support will increase to $50,000 in 
Phase II when the Principal Investigator moves to an independent research 
environment, as opposed to the environment provided by a mentor.  This could 
be an independent research position either at the same institution or at a 
different institution.

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

Facilities and Administration 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 NCI/CMBB 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, provided that 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 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 NCI 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.

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, which must be 
countersigned by his or her department head and the appropriate institutional 
official.  A copy of a letter or other evidence from the institution at which 
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 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, for 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.

Termination or Change of Institution:  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 purposes 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 there for the effective date, and the right to 
appeal the decision.

Awardees planning a change of institution must submit to the NCI in advance of 
the change a written request for transfer, which is countersigned by the 
appropriate institutional business official including a statement of the 
reasons for the change and the new sponsor's name and biographical sketch.  
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.  Additionally, the new sponsor 
must have the appropriate research expertise to supervise the program and 
sufficient research support to ensure continuation of the research program to 
the end of the award (initial award) period.  Staff within the NCI will review 
this request and may require a review by an initial review group and/or the 
National Cancer Advisory Board.  Upon approval of this request, a new career 
award PHS-398 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 for the time 
remaining within the existing award period.

Change of Mentor:  When a mentor at the grantee institution is to be replaced, 
the institution must submit a letter from the proposed mentor to document the 
need for substitution, the new mentor's qualifications for supervising the 
program, and the level of support for the candidate's career development.  The 
letter must also document that the specific aims of the research program will 
remain within the scope of the original peer reviewed research program.  NCI 
staff will review the request and will notify the grantee institution of the 
results of the evaluation.  A final progress report, invention statement, and 
Financial Status Report are required upon either termination of an award or 
relinquishing of an award in a situation involving a change of institution.

MECHANISM OF SUPPORT

Support for this program will be provided through the NIH K01 career 
development award mechanism.  Planning, direction, and execution of the 
program will be the responsibility of the candidate and her/his mentor on 
behalf of the applicant institution.  Applicants may request up to five years 
of support.  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.

ELIGIBILITY REQUIREMENTS

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.

Candidates must meet the following eligibility requirements:

o  Qualify as an underrepresented minority individual defined as belonging to 
a particular ethnic or racial group that has formally been determined by the 
applicant institution to be underrepresented in biomedical and behavioral 
research (e.g., African Americans, Hispanic Americans, American Indian and 
Alaska Natives, and Native Hawaiian and Other Pacific Islanders);

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

o  Have been a recipient of uninterrupted support from either an NIH Research 
Supplement for Underrepresented Minorities Award, any NIH National Research 
Service Award (e.g., F31, F32, or T32), or any project grant equivalent to an 
NIH peer-reviewed research grant (e.g., R01, P01, ACS research grant).

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

Former recipients of any K-series Award (e.g., K07, K08, K23), former or 
current principal investigators on NIH Small Grants (e.g., R03s) or 
Exploratory/Developmental Grants (e.g., R21s) former or current principal 
investigators on NIH research projects (e.g., R01s), FIRST Awards (e.g., 
R29s), sub-projects on Program Project Grants (e.g., P01s) or center grants 
(e.g., P50s) and their equivalents are NOT ELIGIBLE. 

Applications may be submitted on behalf of candidates by domestic, non-profit 
and for profit organizations, public and private, such as universities, 
colleges, hospitals, laboratories, units of State or local government, and 
eligible agencies of the Federal government or comparable institutions.  
Applications from foreign organizations are excluded from applying for this 
program announcement.  Awards will be limited to individuals who are citizens 
or non-citizen alien nationals, and permanent residents of the United States.  
Individuals on temporary or student visas are not eligible.  Women and persons 
with disabilities are encouraged to apply as principal investigators.

INQUIRIES

Written, telephone, fax, and E-mail inquiries concerning this PA are 
encouraged, especially during the planning phase of the application.  The 
opportunity to clarify any issues or questions from potential applicants is 
welcome.

Direct inquiries regarding programmatic issues to:

Sanya A. Springfield, Ph.D.
Chief, Comprehensive Minority Biomedical Branch
National Cancer Institute
6116 Executive Boulevard, Suite 7080
Bethesda, MD  20892-7405
Rockville, MD  20852 (express/courier service)
Telephone: (301) 496-7344
FAX:  (301) 402-4551
Email: ss165i@nih.gov

Direct inquiries regarding fiscal 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) 496-8626
FAX:  (301) 496-8601
Email: bfisher@mail.nih.gov

Direct inquiries regarding review matters to:

Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Suite 8109, MSC-8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (express/courier service)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: tf12w@nih.gov

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev. 
4/98) and will be accepted at the standard application deadlines as indicated 
in the application kit (October 1,  February 1, and June 1).  Applications 
should be organized using the Research Career Award, Section IV of the PHS 
398, Just-In-Time procedures.  Application kits are available at most 
institutional offices of sponsored research; from the Division of Extramural 
Outreach and Information Resources, National Institutes of Health, 6701 
Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, 
email: grantsinfo@nih.gov.  The title (MENTORED CAREER DEVELOPMENT AWARD FOR 
UNDERREPRESENTED MINORITIES) and number of the PA must be typed in Section 2 
on 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/forms.htm.

Applicants must provide evidence that they received uninterrupted support as 
noted under ELIGIBILITY REQUIREMENTS above.

Three sealed letters of recommendation addressing the candidate's potential 
for the research career must be included as part of the application.  Submit a 
signed, typewritten original of the application, reference letters, current 
curriculum vitae with complete bibliography, including the checklist, and 
three signed photocopies, in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040 - MSC 7710
Bethesda, MD 20892-7710
Rockville, MD 20817 (express/courier service)

At 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, Suite 8109, MSC-8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (express/courier service)

The candidate must address the following issues and include the following 
information in the application:

Candidate

o  Describe the candidate's commitment to a career in basic, clinical and/or 
population cancer research (candidates with clinical degrees (e.g., M.D.) 
should consider the Minorities in Clinical Oncology (K08) Award and candidates 
interested in patient-oriented  research should consider the Mentored Patient-
Oriented Research for Underrrepresented Minorities Career Development Award 
(K23);

o  Present evidence of the candidate's ability to interact and collaborate 
with other scientists;

o  Discuss prior training and how it relates to the objectives and plans of 
the candidate;

o  Discuss the innovativeness and quality of the candidate's research efforts 
to this point in his/her research career;

o  Provide letters of recommendation.  Three sealed letters of recommendation 
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.

Career Development Plan

o  Present a systematic plan that covers Phase I (mentored, dependent) and, if 
appropriate, Phase II (mentored, independent) of this Program.  This plan 
should incorporate the prior research training and experience of the candidate 
to provide a basis for the need for further career development to become an 
independent investigator focusing on research that is clearly relevant to 
cancer.  The plan should provide a description of the research and training 
experiences that will occur during Phase I and Phase II of the proposed period 
of support, and the candidate must present a convincing case that, he/she will 
have a high probability of developing the research skills and ability needed 
to work in a collaborative environment and become a successful, independently 
supported investigator.  The plan must include a statement regarding the 
proposed length of the phases; if Phase II is proposed in the application, it 
must begin on the anniversary award date of the second, third or fourth year 
of the grant.

o  Document prior instruction in or proposed plans for instruction in the 
responsible conduct of research in terms of subject matter and duration of 
instruction.  (NO AWARD CAN BE MADE IF AN APPLICATION LACKS THIS COMPONENT).

Research Plan

o  Describe the research plan using Form PHS 398 (rev. 4/98 or subsequent 
revisions) following instructions for the  Specific Aims, Background and 
Significance, Progress Report/Preliminary Studies, Research Design and 
Methods.  The candidate must consult with the mentor regarding the development 
of this section.  The research plan must be clearly relevant to cancer 
biology, etiology, pathogenesis, prevention, diagnosis, and/or treatment.  It 
must be clear as to whether all or parts of the Research Plan will remain as 
activities of the candidate when the transition to an independent position is 
made or whether the candidate will be expected to develop an entirely new 
project in the independent position.

Mentor's Statement

o  Include a signed statement from the mentor(s) with information on research 
qualifications and previous experience as a research supervisor.  The 
applications must also include information to describe the mentor's research 
support as related to the candidate's research plan and the specific nature of 
the supervision and mentoring that the candidate will receive during Phase I 
of the proposed award period;

o  Provide similar information by any co-mentor.  If more than one mentor is 
proposed, the respective areas of expertise and responsibility should be 
described;

o  Describe in this statement specifically whether all or parts of the 
research project being conducted by the candidate will remain as activities of  
that individual when the transition to an independent position is made or 
whether the candidate will be expected to develop an entirely new project in 
the independent position.

Environment and Institutional Commitment

o  Describe the resources and facilities that will be 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

o  A biographical sketch is required for the candidate and mentor(s).  For the 
candidate, include information on research projects completed and/or research 
grants participated in during the last five years that are relevant to the 
proposed project and demonstrate an uninterrupted involvement of research 
before submitting this application (see ELIGIBILITY REQUIREMENTS).

Budget

The total direct costs requested must be consistent with this K01 program 
announcement and the award limits of the NCI.  Applications seeking 
information on award limits should contact the fiscal representative listed in 
the INQUIRIES section at the end of this announcement.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the Center for 
Scientific Review and for adherence to the ELIGIBILITY REQUIREMENTS of  this 
program announcement by the NCI staff.  Incomplete applications will be 
returned without further consideration.  Applications that are complete and 
adhere to the guidelines of this PAR will be evaluated for scientific and 
technical merit by an appropriate peer review group convened by the National 
Cancer Institute in accordance with standard NIH peer review procedures.  As 
part of the initial merit review, all applications will receive a written 
critique, and may 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. 

The following review criteria will be applied:

Candidate (Principal Investigator)

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

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

o  Quality and breadth of prior scientific training and experience;

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

Career Development Plan

o  Likelihood that the plan will contribute substantially to the scientific 
development of the candidate and the achievement of an independent cancer 
research program:

- Candidate's prior training and research experience;

- Appropriateness of the goals and scope of the plan to complement prior 
training/research experience and achieve the stated training and research 
objectives;.

o  Appropriateness of the proposed durations of Phase I and, if requested, 
Phase II; 

o  Appropriateness of the activities proposed during Phase I and, if 
requested, anticipated for Phase II for a five year award; 

o  Adequacy of prior or proposed training in the responsible conduct of 
research;

o  Likelihood of successful planning, writing and submitting of traditional 
grant applications.

Research Plan

o  Degree of relevance of the research plan to developing an independent 
cancer research program as it relates to the cancer biology, etiology, 
pathogenesis, prevention, diagnosis, and/or treatment;

o  A sound research project that is consistent with the development plan for 
an independent career in cancer research and commensurate with the candidate's 
level of research development;

o  Usefulness of the research project as a vehicle for enhancing existing 
research skills as described in the career development plan;

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  Attention to and implications of what aspects of the project will remain 
with the candidate as an independent investigator;

o  Adequacy of plans for the provisions 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.

Mentor/Co-Mentor

o  Appropriateness of the mentor's research qualifications in the area of the 
proposed research;

o  Quality and extent of the mentor's proposed role in providing guidance and 
advice to the candidate;

o  Quality and time commitment to supervising and guiding the candidate during 
the entire period of the award;

o  Previous experience in fostering and developing cancer researchers;

o  History of research productivity and peer reviewed support;

o  Adequacy of existing support for the Phase I of the proposed research 
project.

o  Adequacy and clarity of the mentor's statement describing what aspects of 
the Research Plan that will remain with the candidate when his/her transition 
is made to an independent position.

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 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.

Budget

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

AWARD CRITERIA

Applications will compete for available funds with all other recommended 
applications.  The NCI will notify the applicant of the National Cancer 
Advisory Board’s action shortly after its meeting.  The following will be 
considered in making decisions: scientific and technical merit of the proposed 
project as determined by the initial review group, the results of the 
secondary review by the NCAB, availability of funds, program balance and 
priority. 

SUPPLEMENTAL GUIDELINES FOR TRANSITION TO PHASE II (INDEPENDENT)

These guidelines apply only to the non-competing years in which a transition 
to an independent position is requested.  Other non-competing applications 
should be completed in accordance with the guidelines for streamlined (SNAP) 
applications outlines in PHS form 2590.

Application Procedure:

The application procedure for the initial NCI Mentored Career Development 
Award for Underrepresented Minorities cannot be used for the transition to 
Phase II independent status.  Therefore, follow the supplemental application 
guidelines below for this aspect of the Award:

When the candidate is remaining in the same institution, transition 
applications are to be submitted on the Application for Continuation Grant 
Form PHS 2590 (rev. 4/98 and subsequent revisions), including the additional 
instructions for Research Career Award Applications starting on page IV-1.  

When the candidate is changing institution, the application form to use is the 
Form PHS 398, and it should be submitted from the new grantee institution.  

However, the NCI (see INQUIRIES) will provide a transfer application kit, 
which includes the Form PHS 398, for this purpose.  Transition applications 
MUST be submitted two months prior to the anniversary date of the second, 
third or fourth year of the award.

Submit a signed, typewritten original of the signed application and two signed 
photocopies in one package to:

Records Management Center
Grants Administration
National Cancer Institute
Executive Plaza South, Suite T-42 MSC 7107
Bethesda, MD 20892-7107

Special instructions for completion of the application:

o  To associate the application with a transition request, enter "NCI MENTORED 
CAREER DEVELOPMENT AWARD FOR UNDERREPRESENTED MINORITIES (K01) PHASE II" on 
Line 1, Form Page 1;

o  Provide an itemized listing with associated projected costs for all items 
on Form Page 2 (DETAILED BUDGET FOR NEXT BUDGET PERIOD).  Also see 
Instructions;

o  Biographical Sketch (Form Page 4):  Provide for all key personnel to be 
involved in the research project.  Provide information on research projects 
completed and/or research grants participated in during the last five years 
that are relevant to the proposed project.

o  Progress Report Summary (Form Page 5): Follow guidelines in Instructions.

Additional instructions:

- This section should be as short as possible.  However, because of the unique 
reporting requirements for the "Phase II" application, the section may exceed 
two pages;

- Studies and Results (Item b):  The information provided must clearly justify 
a transition to the  Phase II of the award;

- Plans (Item b): Follow the guidelines in the Instructions.  Additional 
information to be provided is as follows:

o  Describe how the scope of the independent project initiated during Phase II 
will be changed in comparison with Phase I of this award.  Provide detailed 
research plans if there is a major change in research scope of the original 
peer reviewed research plan;

o  Describe the relevance of the research plan to cancer biology, etiology, 
pathogenesis, prevention, diagnosis, and/or treatment;

o  Describe how the proposed research and research-related activities should 
contribute to the scientific development of the candidate and the development 
of an independently funded research program;

o  Describe long-term research career goals, including the timing of 
submission of applications for investigator-initiated research grants; 

o  Provide a statement, from the Chairperson of the department to which the 
awardee has been recruited, describing the type of faculty position offered 
and if it is a tenure-track position (or equivalent); the responsibilities of 
the position; the research facilities that will be provided for exclusive use 
by the awardee, (and, if the transition does not involve a change of 
sponsoring institution, the relationship of these facilities to those of the 
applicant's Phase I mentor); additional non-PHS research related 
departmental/institutional support that will be provided for technical support 
staff, equipment, animals, etc; relationship of the awardee's research program
to ongoing programs within the department; career plans for the awardee;

o  Provide a statement from the institution ensuring 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 research career;

o  If the independent position involves a change of sponsoring institution, 
officials from the new institution must additionally document a strong, well-
established program in biomedical research related to cancer, including a high 
quality research environment with staff capable of productive collaboration 
with the candidate.

(Candidates planning a change of institution must contact NCI program staff 
prior to submission of the Phase II application).

o  Provide a sealed statement from the Phase I mentor recommending the 
candidate for the transition.  This recommendation should be based on the 
scientific productivity of the candidate under his/her mentorship and on the 
mentor's detailed evaluation that the candidate is ready to develop an 
innovative and independently-supported research program.  This letter should 
be mailed directly to the NCI Program Director.

Review Considerations for a "Phase II" Application:

Applications received will require NCI staff approval before the transition 
award to an independent position is activated.  Depending upon the scope of 
changes in the research plan as compared with the original peer reviewed grant 
application, the application could receive a second level of review by an IRG.  
Approval will be based upon the following criteria:

o  A statement from the mentor(s) verifying that the candidate is ready to 
pursue an independent research career;

o  The clear relevance of the new Research Plan to cancer biology, etiology, 
pathogenesis, prevention, control, diagnosis and treatment;

o  The soundness of the "Letter of Commitment" from the institution, in 
providing the candidate with protected time (i.e., with no less than 75 
percent effort dedicated to the development of a research program and with the 
remaining effort to be used in research related activities) and describing 
arrangements with the candidate regarding 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;

o  The adequacy of the plans for inclusion of women, children, and minorities 
in any clinical or population research activities, as applicable;

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

Award Criteria for a "Phase II" Application:

Funding decisions will be made by NCI program staff on the basis of 
successfully addressing the review considerations above.  NCI program staff 
will notify the applicant for the Phase II to independent status of their 
action on the application.  The transition to Phase II will take effect on the 
anniversary date of the grant.

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 to indicate that inclusion 
is inappropriate with respect to the health of the subjects or the purpose of 
the research.  This new 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 are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.  The 
revisions relate to the NIH defined Phase III clinical trials and require: a) 
all applications or proposal and/or protocols to provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and 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 (e.g., 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 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 also may obtain copies of the policy from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications for NIH funding must be self-contained within specific 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 the view the Internet 
sites.  Reviewers are cautioned 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 Program Announcement (PA) Mentored 
Career Development Award for Underrepresented Minorities, is related to the 
priority area of human resource development in cancer research. Potential 
applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople/.

AUTHORITY AND REGULATION

This program is described in the catalog of Federal Domestic Assistance No. 
93.398.  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 and Federal Regulations 42 CFR 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 PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and promote the non-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.


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