CANCER EDUCATION AND CAREER DEVELOPMENT PROGRAM

RELEASE DATE:  July 16, 2003

PA NUMBER:  PAR-03-148 - (Reissued as PAR-06-511)

EXPIRATION DATE:  July 5, 2006 (Expiration date extended, see NOT-CA-05-024)

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

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.393, 93.394, 93.395, 
93.399

THIS PAR CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PAR
o Research Objectives
o Mechanism(s) of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Individuals Eligible to Become Trainees
o Special Requirements
o Allowable Costs
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

This program announcement (PAR) replaces PAR-00-064, "Cancer Education and 
Career Development Program", which was published in the NIH guide on February 
17, 2000.

PURPOSE OF THIS PAR

The purpose of NCI Cancer Education and Career Development Program (R25) is 
to train predoctoral and postdoctoral candidates in cancer research settings 
that are highly inter-disciplinary and collaborative.  This Program requires 
sustained leadership, dedicated faculty time, specialized curriculum 
development and implementation, interdisciplinary research environments, and 
more than one mentor per trainee to achieve career development research and 
education objectives.  Areas of research particularly applicable but not all 
inclusive to interdisciplinary training are cancer prevention and control, 
nutrition, population sciences, behavioral sciences, imaging and molecular 
diagnostics.  Applicants whose programs cannot meet the Special Requirements 
stated in these guidelines should refer to the traditional Ruth L. 
Kirschstein National Research Service Award (NRSA) Institutional Training 
Grant (T32) as an alternative source of support.

RESEARCH OBJECTIVES

A. Background:  In many developing and emerging fields of cancer research 
today, scientists must function within interdisciplinary teams rather than as 
isolated investigators or in simple collaborative settings.  Preparing junior 
and more experienced basic research scientists and clinicians for this new 
type of research environment will require education and career development 
experiences in highly inter-disciplinary and collaborative cancer research 
settings that are integrated with a specialized curriculum.  These education 
and career development experiences will have to provide wide access to 
multiple scientific disciplines and methodologies, involve mentors from more 
than one discipline, and will have to be tailored to the individual education 
and training needs of the investigator.  Due to the likely breadth of the 
science involved, these experiences will frequently have to be facilitated 
and coordinated across departments, schools, centers and institutions.  
Management of programs with this kind of complexity and diversity will 
require concerted leadership and dedicated time of interdisciplinary faculty 
in order to sustain effective interactions within and coordination of the 
program.  Furthermore, for clinicians lacking any prior research training, 
these experiences may have to include the completion of requirements for an 
additional degree, viz. M.P.H., and a number of years of research experience 
beyond the degree to prepare for conducting highly interdisciplinary 
collaborative research as an independent investigator.  Prior NCI experience 
with other NIH training and career development funding mechanisms has shown 
that it takes a least 5 years of didactic and research training for 
clinicians to become competitive independent investigators, particularly in 
the highly interdisciplinary disciplines that are the focus of this grant 
mechanism.

Recognizing these special issues and needs, in 1991 the NCI piloted its first 
"Education Programs in Cancer Prevention and Control", supported by the NIH 
Education Grant (R25) mechanism and based on the concept of interdisciplinary 
education and career development. These programs afforded institutions the 
flexibility needed in both program design and cost structure to allow for the 
development of complex, multi-disciplinary education and career development 
programs.  These pilot programs proved to be extremely successful.  In 1998, 
the NCI completed major external reviews of its cancer prevention and cancer 
control sciences.  The scientific experts conducting these reviews noted a 
national shortage of cancer prevention and control researchers, and a 
pressing need for researchers educated in the new scientific paradigms that 
require collaborations with researchers in disparate disciplines (e.g., the 
quantitative sciences, cancer biology, genetics, molecular biology, 
nutrition, the social and behavioral sciences).  These groups identified the 
need for a new approach to the training of prevention and control scientists 
requiring multi-disciplinary experiences with an interdisciplinary theme and 
including laboratory experiences. These groups recommended increasing the 
availability of support mechanisms, such as the R25 mechanism, to the cancer 
prevention, control and population sciences to address this need.  More 
recently, the NCI Tobacco Research Implementation Group encouraged the 
increased development of training programs using interdisciplinary groups of 
researchers as trainers; and involving a special linkage between faculty 
leadership, curriculum development and training.

The NCI Review Groups made a number of specific training recommendations that 
reflect the complexity of the cancer research tracks that will be needed in 
the future.  For example, the NCI Cancer Control Review Group identified a 
need for Cancer Control researchers to understand the "vocabulary and 
utility" of cancer biology, quantitative methods, and social and behavioral 
science; and for basic and clinical scientists to obtain training in the 
basic behavioral sciences, epidemiology, health services and outcomes 
research, cost-effectiveness research, survivorship and Quality of Life 
research, screening and treatment, and adherence.  Additionally, behavioral 
scientists interested in cancer control research should be trained in 
biomedical fields such as nutrition, pharmacology, genetics, and health 
services research. The NCI Cancer Prevention Review Group identified a need 
for cancer prevention researchers to acquire actual laboratory experience and 
for training in areas such as cancer biology, cancer genetics, molecular 
biology, carcinogenesis, pharmacological interventions in prevention, 
biostatistics, epidemiology, health behavior, health policy, and the 
behavioral sciences.  This same group also recommended that behavioral 
scientists should be trained to function in the new scientific paradigms 
including genetics, chemoprevention, and diet/nutrition.

All of the above recommendations will facilitate the connectivity of and 
communication among disparate disciplines, and facilitate the preparation of 
investigators for effective participation in team research settings.

Recent reports from other external NCI advisory groups have made similar 
recommendations regarding training needs.  Breast Cancer scientists 
identified a need for new funding mechanisms for multidisciplinary training 
of individuals so that "they can participate effectively in multidisciplinary 
collaborations" in translational research.  In the area of imaging sciences, 
advisors identified a need for postdoctoral training in molecular imaging; 
for interdisciplinary cross-training of senior investigators in diverse 
disciplines such as molecular genetics, molecular and cell biology, chemistry 
and clinical oncology; and for the development of multidisciplinary centers 
"providing the means for bringing researchers and teams with diverse 
backgrounds together".

Similar needs for interdisciplinary training have been identified in the 
principal recommendations of a number of the latest national studies on 
science education and training and for emerging fields in the biomedical 
sciences (1-4).  One report (4) pertaining to the emerging field of Modeling 
Biological Function notes the lack of programs for addressing training in the 
integration of molecular data to predict biological behavior, and points to 
the absence of training mechanisms and institutional environment for bringing 
together critical masses of interdisciplinary researchers in disparate fields 
(viz., biology and the computer sciences).  Finally, a report from the NCI 
Imaging Sciences Working Group (5) notes that it is only at those few 
institutions where (imaging) programs "are conceived with an 
interdisciplinary goal in mind" that the communication gap between 
researchers in widely diverse areas of science can be successfully bridged.

B. Program:  The award provides support to institutions for up to 5 years for 
the principal investigator and an Advisory Committee to manage, coordinate 
and evaluate the program; for faculty to design, develop, implement and 
continually refine the program curriculum; for the salaries of predoctoral 
and postdoctoral trainees; and for other Program-related research costs.  
These Programs should provide curriculum-based, multi-disciplinary AND 
interdisciplinary didactic and cancer-related collaborative research training 
experiences for predoctoral and postdoctoral researchers.  They should also 
provide the trainees with the research and communication skills to conduct 
cancer research in an inter-disciplinary and highly collaborative team 
research setting.

C. Environment:  The participating institution(s) must have well-established 
research programs and faculty qualified in curriculum development, 
implementation and program evaluation to serve as faculty for the program.  
The research environment should be team-oriented and highly collaborative 
with a strong potential for a dynamic two-way exchange of information and 
ideas within and across diverse and disparate disciplines such as the 
physical, biomedical, behavioral, population and quantitative (mathematics, 
computer sciences, etc.) sciences.  The research environment should also be 
capable of promoting rapid translation of research outcomes into reductions 
in cancer incidence, morbidity and mortality.  Finally, the institution must 
demonstrate a commitment to provide sustained leadership and dedicated 
faculty time to the development and implementation of the program; and 
commitment to the development of junior investigators as productive, 
independent investigators.

MECHANISM OF SUPPORT 

This PAR will use the NIH R25 award mechanism(s).  Planning, direction and 
execution of the program will be the responsibility of the Principal 
Investigator and the Advisory Committee on behalf of the applicant 
institution. The project period is up to five years. Awards are renewable.

Awards will be administered under NIH grants policy as stated in the National
Institutes of Health Grants Policy Statement (Rev. 3/01) and described on
http://grants.nih.gov/grants/policy/nihgps_2001/.  However, this R25 award, as 
administered by the National Cancer Institute, is not subject to "Just-in-
time" application procedures, modular budgeting format, or to the Streamlined 
Non-competing Application Process (SNAP).  This PAR remains under "Expanded 
Authorities" except that carryover of funds from one fiscal year to the next 
requires approval by the NCI.
 
ELIGIBLE INSTITUTIONS 

You may submit (an) application(s) if your institution has any of the 
following characteristics:

o Domestic, non-federal
o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 

Foreign institutions are not eligible to apply.

Applications may include more than one institution to create a Program 
through consortium agreements (refer to the following URL for guidelines on 
these agreements: 
http://grants.nih.gov/archive/grants/policy/nihgps/part_iii_5.htm#Consortium) that 
includes all of the disciplines, research environments and mentors needed to 
accomplish the proposed educational and training objectives.  However, only 
one of the participating institutions can be the recipient of an award.

More than one application may be submitted by an institution to support 
programs in different research fields.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

The Principal Investigator must have a doctoral degree, be an established 
investigator in the field proposed for the program, and be able to provide 
both administrative and scientific leadership to the Program.  Individuals 
from underrepresented racial and ethnic groups as well as individuals with 
disabilities are always encouraged to apply for NIH programs.

INDIVIDUALS ELIGIBLE TO BECOME TRAINEES

Candidates may be at the predoctoral or postdoctoral stages of their career.  
They usually must be (see exception below) citizens or non-citizen nationals 
of the United States, or must have been lawfully admitted to the United 
States for permanent residence (i.e., in possession of a currently valid 
Alien Registration Receipt Card I-551, or other legal verification of such 
status).  Non-citizen nationals are generally persons born in outlying 
possessions of the United States (i.e., American Samoa and Swains Island).  
Individuals on temporary visas normally are not eligible.

Unlike other NCI grants that support career development and training, this 
grant does allow for the training of foreign nationals, who do not have the 
above residency certifications, under exceptional circumstances.  These 
exceptions would require NCI approval of individuals on a case-by-case basis 
and would always depend upon the special international, collaborative nature 
of the research areas that the training and career development Program 
emphasizes. 

Candidates who were former or who are current principal investigators on NIH 
Small Grants (R03s) or Exploratory/Developmental Grants (R21s) are ELIGIBLE.  
Former or current principal investigators on NIH research project grants 
(R01s), FIRST Awards (R29s), sub-projects on Program Project Grants (P01s) or 
on center grants (P50s) and the equivalent are NOT ELIGIBLE unless 
specifically approved in writing by NCI.  Candidates who have been supported 
on NIH or non-NIH career development awards are NOT ELIGIBLE.  

SPECIAL REQUIREMENTS

Special Programmatic Requirements

1. The application must include a "Statement of applicability" clearly 
explaining why the R25 grant mechanism, rather than the more traditional 
training mechanisms, such as the Ruth L. Kirschstein NRSA Institutional 
Training Grant (T32) grant mechanism, is essential for accomplishing the 
proposed educational and research career development needs of the program.  
Applicants should refer to the following website address for information on 
T32 grants: http://grants.nih.gov/grants/guide/pa-files/PA-02-109.html

2. The training program cannot significantly overlap, in total or in part, 
with any other training programs available at the institution(s). Consult NCI 
staff before submitting any application that partially overlaps or appears to 
overlap with any existing institutional training programs (e.g., T32, R25, 
K12).

3. The principal investigator, together with program faculty, must develop a 
specialized curriculum, not otherwise available at participating 
institution(s), which is linked in an essential manner to the training goals 
and objectives of the Program.

4. The principal investigator must assemble and chair a permanent 
multidisciplinary Advisory Committee (AC) representing all of the 
disciplines, departments, schools, institutions etc. involved in this 
education and training program.  The AC would be responsible for the 
recruitment and selection of candidates for the Program; the establishment 
and review of effectiveness of specialized curriculum; the approval of the 
education and training plans (e.g., curriculum, research experiences, 
mentors) for each candidate; interim monitoring and evaluation of each 
candidate's progress with recommendations for changes in the plan, if 
necessary, or termination of a candidate who is not making adequate progress; 
and monitoring and evaluation of the overall effectiveness of the Program.  
The AC would provide a summary report with each annual progress report that 
describes the committee's actions, and discusses progress of the program 
including evaluation of areas of strengths and weaknesses.

5. The Program should include Core Requirements that each candidate is 
expected to complete before meeting the program's training objectives.  These 
requirements should include the following:

a. A core didactic component (the Specialized Curriculum, and other formal 
courses such as biostatistics, informed consent, lecture and seminar series).

b. A core research component defining the different kinds of disciplinary 
research experiences each candidate must complete under different mentors to 
meet the requirements of the Program.

6. The Program must have the flexibility to provide individualized training 
experiences to accommodate the needs of trainees with different backgrounds 
and different levels of didactic and research experience, and multiple 
disciplines (see Core Requirements).

The expectation of the NCI is that candidates will enter the Program with 
different backgrounds that, initially, may satisfy some of the Core 
Requirements.  Under these circumstances, they would be provided only with 
those additional didactic and research experiences that fully meet the 
overall training objectives of the Program and that prepare them to conduct 
research in a highly collaborative research team setting.

7. A large number of mentors must be involved in cancer research or research 
methodologies clearly important to the cancer focus and objectives of the 
proposed education and career development Program.

8. Trainees must have more than one mentor during the course of their multi-
disciplinary research training.

9. Trainees are expected to engage in multi-year, long-term research 
experiences.  This is not a grant that should be used for short-term 
experiences in research.

10. As part of the research and career development experience, each 
postdoctoral trainee who is near the end of his/her tenure must prepare a 
mock application to the NIH, following the instructions provided in the PHS 
Form 398.  The faculty must provide a mock peer review.

11. Recruitment plan: (a) a recruitment plan must be submitted detailing the 
pool of candidates as well as the effort made to recruit, in the case of 
postdoctoral candidates, outside the limits of participating institution(s). 
Ideally, these multidisciplinary training programs should be unique enough to 
attract postdoctoral candidates from the entire country; and (b) a separate 
strategic plan for recruiting individuals from underserved and 
underrepresented groups, as defined by the institution, must be included 
together with an explanation on how this plan will be implemented.

12. An evaluation plan must be provided, with specific parameters and 
criteria, for determining the performance and outcomes of the Program.

13. A progress report (for competitive renewal applications) must be 
submitted describing:

a. The progress made toward achieving the objectives of this program and the 
intent of NCI.
b. Trainee track record.
c. Trainees from underserved/underrepresented groups recruiting and retention 
track record.

14. Starting with the October 1, 2003 receipt date, investigators submitting 
an application seeking $500,000 or more in direct costs in any single year 
are expected to include a plan for data sharing or state why data sharing is 
not possible.  Applicants should refer to the following website for 
information about NIH policy on data sharing: 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html

15. A final progress report, invention statement, and Financial Status Report 
are required upon termination of an award.

16. Evaluation from NCI:  In carrying out its stewardship of human resource 
related programs, the NCI may request 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 the educational program including, but 
not limited to, achievement obtained through the program, trainee 
accomplishments, publications, dissemination, honors and awards, professional 
activities, and other information helpful in evaluating the impact of the 
program.

Special Administrative Requirements

1. Special Leave:  Leave to another institution of an appointee, including a 
foreign laboratory, may be permitted if 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, a written request must be submitted 
to NCI by the Principal investigator on behalf of the trainee.  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 award will continue during such leave.  NCI Program staff 
should be contacted prior to submitting the request for 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.  Parental leave will be granted consistent with the policies of the 
NCI and the grantee institution.

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

3. Change of Institution:  The Cancer Education and Career Development 
Program cannot be transferred from one institution to another.

4. Change of Principal Investigator:  If the principal investigator moves to 
another institution or resigns from the position, support of the award may be 
continued provided that the current principal investigator or the awardee 
institution has submitted a written request for change of principal 
investigator, countersigned by the appropriate institutional business 
official, to the NCI describing the reasons for the change.  The biosketch of 
the proposed new principal investigator, including a complete listing of 
active research grant support, must also be provided.  The information 
provided must establish that the specific aims of the original peer reviewed 
research program to be conducted under the direction of the new principal 
investigator will remain unchanged, and that the new principal investigator 
has the appropriate research and administrative expertise to lead the 
program.  NCI Program staff must approve of this change and should be 
contacted prior to submission of the letter (see INQUIRIES).

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

ALLOWABLE COSTS

1. Salary

o The principal investigator will be provided salary support for leadership, 
management, coordination and evaluation of the Program, in accordance with 
the percent effort commitment to the Program.

o Faculty critical to the design, development, implementation and refinement 
of the specialized curriculum essential to the training and didactic needs of 
the Program will be provided salary support in accordance with the percent 
effort commitment to the Program.

Salary support may not be provided to program faculty for their service on 
the Advisory Committee (see SPECIAL REQUIREMENTS).

The principal investigator and Program faculty may derive additional 
compensation from other Federal sources or awards provided the additional 
compensation does not exceed the current federal salary rate limit (see 
INQUIRIES) and their total percent effort on all awards does not exceed 100 
percent.

The institution may supplement the NIH contribution to an appointee's salary 
up to a level that is consistent with the institution's salary scale.  
Institutional supplementation of a salary must not require extra duties or 
responsibilities that would interfere with the purpose of the award.

o Predoctoral and postdoctoral trainees will be awarded salaries.  Stipends 
are not allowed under this program announcement

o Predoctoral appointees can be provided salaries (stipends are not allowed) 
of up to $22,000 per year plus fringe benefits commensurate with the 
institution's full-time salary scale for persons of equivalent 
qualifications, experience and rank.

o Postdoctoral appointees can be provided salaries (stipends are not 
allowed)of up to $75,000 per year plus fringe benefits commensurate with the 
institution's full-time salary scale for persons of equivalent qualifications 
experience and rank.

2. Other Expenses: Up to $20,000 in direct costs per year per 
candidate/trainee at the predoctoral level or up to $30,000 in direct costs 
per year per candidate/trainee at the postdoctoral level can be provided. 
These expenses must be commensurate to the actual effort and time of the 
trainee in this specific training program and justified as such by the 
principal investigator. , These funds may cover the following types of 
expenses: (a) research expenses, such as supplies, equipment, and technical 
personnel; (b) tuition, fees, and books related to career development; (c) 
travel to research meetings or training; and (d) statistical services 
including personnel and computer time.  These costs must be specifically 
documented for each individual candidate and must be specifically and 
directly related to the candidate's research activities.  

3. Advertising and Recruitment Costs: A small proportion of the budget can be 
used for advertising and recruitment in order to attract the best possible 
candidates to the Program.  It is assumed that to develop this kind of multi-
disciplinary, multi-departmental, multi-institutional approach, a centralized 
fund for advertising and recruiting, NOT entertaining, will be needed.  
Consult INQUIRIES if there are questions about the use of funds for this 
purpose.

4. Ancillary Personnel Support: Because of the possible complexity of these 
programs, a small compensation for a program coordinator is allowed. Salaries 
for mentors, secretaries, administrative assistants and other ancillary 
personnel are not allowed.  

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

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PAR 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:

Dr. Maria Agelli, M.D., M.S.
National Cancer Institute
Cancer Training Branch
6116 Executive Boulevard, Suite 700
Bethesda, MD  20892
Telephone:  (301) 496-8580
Email:  ma215e@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. Catherine Blount
National Cancer Institute
Grants Administration Branch
6120 Executive Blvd.
Room EPS 243
Bethesda, MD 20892
Phone: (301) 496-3179
Fax: (301) 496-8601
e-mail: blountc@mail.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms and the modified instructions below, which take into 
account all of the special features and requirements of this grant.  The PHS 
398 (rev. 5/2001) is 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.

Modified Instructions:

1. Face Page: follow instructions of form PHS 398.

2. Description, Performance Site(s), Key Personnel: (Page 2) of the form PHS 
398): Complete as directed in the form PHS 398 instruction package; this 
should include the Principal Investigator, Advisory Committee Members, 
Mentors and other faculty participating in the program.  Please make sure 
that you denote each individual's degree and departmental affiliation (or 
equivalent) AND, if a consortia of institutions, institutional affiliation. 

3. Table of Contents: Follow PHS 398 instructions for page numbering and 
organize as follows:

a. Face Page 
b. Description, Performance Site(s), Key Personnel
c. Table of Contents 
d. Detailed Budget Page for First Year 
e. Budget for Entire Proposed Period of Support
f. Budgets pertaining to Consortium/Contractual Arrangements
g. Other sources of Institutional Training, Education, and Career Development 
Support.
h. Biographical Sketches (not to exceed 2 pages per individual) for:
o Principal Investigator
o Program faculty
o Advisory Committee Members
o Mentors            
o Other Participating Faculty
o Trainees (if known at the time of application)
i. Other Research Support of the Principal Investigator, Program Faculty, 
Mentors, and Member of Advisory Committee that is specifically relevant to 
this Education and Career Development Program
j. Statement of Applicability
k. Education and Career Development Plan (Not to exceed 25 pages, excluding 
tables, which should be included in the text, not as appendices):
o (If applicable) Introduction to Revised Application (Not to exceed 3 pages)
o Purpose and Objectives
o Core Requirements:
-Specialized curriculum
-Other didactic experiences
-Research experiences
o Research Base/Resources and Facilities/Mentors
o Program Leadership/Management:
- Principal Investigator
- Program Faculty
- Advisory Committee
- Mentors
- Recruitment Strategies:
i. For candidates in general
ii. For minority candidates
- Individual Candidate Training Plans
- Evaluation Plan  
o For competing renewal applications only:
- A complete report, in tabulate form, of the trainees enrolled in the last 5 
years of funding.  This report should specify the names and degree (e.g., 
M.D., Ph.D.) of the trainees that have completed the program or that are 
currently enrolled, with the dates of entry and exit from the program, and 
their current location and work position.
o Ethnicity of trainees that have completed or are currently in the program 
expressed in percentage of the total number of trainees for the last 5 years 
of funding.
o Human Subjects
o Vertebrate Animals
o Checklist
o Appendices

4. Detailed Budget for the First Year: Use Form Page 4 the Form PHS 398 and 
provide detailed information about salary and fringe benefits, supplies, 
travel, tuition, etc. for each trainee identified by name or by position, if 
the name of the trainee is still unknown.

5. Under PERSONNEL break out the individuals as follows with percent effort, 
salary, and fringe benefits:
o Principal Investigator
o Program Faculty paid from the Grant
o Predoctoral Candidates identified by name or by position (if the name is 
still unknown)
o Postdoctoral Candidates identified by name or by position (if the name is 
still unknown)

For Research and Development Costs, maintain a separation between predoctoral 
and postdoctoral candidates and specifically identify the requested costs 
under each budget category (e.g., supplies, travel, tuition, etc) for each 
trainee by name or position (if the position is not filled).

Note that, for 100% effort, there is an upper limit of $22,000 in salary and 
of $20,000 in other costs for predoctoral trainees and an upper limit of 
$75,000 in salary and of $30,000 in other costs for postdoctoral trainees.

There is no minimum percent effort required for trainees in this program, but 
salary must be prorated accordingly and other expenses justified by the 
principal investigator in relation to the effort and activities of the 
individual trainee.

If there is not enough space in the budget page for the separation between 
other expenses for pre-doctoral trainees, post-doctoral trainees, and 
recruitment costs, maintain/continue this separation in the budget 
justification section. 

If costs are requested for Advertising and Recruitment, make sure that these 
costs are identified under each budget category.

6. Budget for the Entire Proposed Project Period of Support:  follow the 
instructions of Form PHS 398.

7. Provide a table that lists all current and pending institutional cancer-
related training, education, and career development support available to the 
participating faculty, department(s), and institution(s). In the table, list 
first grants related in any way to the current proposal.  Examples could 
include T32, R25 or K12 grants.  Include funding source, complete identifying 
grant number, title of the program, name of the principal investigator, 
project period, number of training positions (predoctoral, postdoctoral), and 
the amount of the award.  For each grant listed, name only those 
participating faculty members who are also named in this application, and 
indicate their percent effort in those programs.

8. Biographical Sketches and other support: Provide biographical sketches and 
other support using the format and the instructions, including page limit, of 
in Form PHS 398.  Group the bios ketches as follow:  Principal Investigator, 
Program Faculty, Advisory Committee Members, Mentors, other participating 
faculty, and trainees (when available). 

9. Statement of Applicability:  Provide a clear, substantive statement 
indicating why the use of this specialized form of the R25 grant mechanism, 
in contrast to the other education/training support mechanisms (Ruth L. 
Kirschstein NRSA Institutional Training Grants) uniquely allows for the 
success of the proposed education and training program.

10. Education and Career Development Plan:

a. (If applicable) Introduction to Revised Application: If this is a revised 
application, in no more that three pages summarize how previous concerns of 
the reviewers have been addressed and what new information is available that 
might be important for the reviewers to evaluate.  Additionally, highlight 
(e.g., in bold, italics, etc.), in the text of the proposal, changes made in 
response to the concerns of the previous review of the application.

b. Purpose and Objectives: In this section provide background, purpose, and 
objectives of the Program.

c. Core Requirements.  Describe the core requirements of this Program that 
each candidate is expected to complete based on prior experience and the 
training experiences to be provided within this Program in the following 
areas:

o Specialized Curriculum: Describe the proposed core education curriculum. 
Explain how the development and implementation of this curriculum is 
critically linked to the purpose and objectives of the Program and to the 
research career development of individual candidates.  Explain how this 
curriculum is distinguished from other curricula within the existing 
educational infrastructure and framework of the applicant/participating 
institution(s).

o Other Didactic Experiences: utilization of any existing curriculum within 
the institution(s).

o Research Experiences: Outline briefly the kinds of research experiences 
each candidate should have, either from prior experience, or from the mentors 
of this Program that will prepare them as independent scientists who can 
function in complex team settings and highly multidisciplinary team research 
settings.

d. Research Base/Resources and Facilities/Mentors:  

o Research: Generally describe the funded research activities and 
methodologies offered by the mentors participating in the Program and how the 
interactive nature of the research environment will meet and sustain the 
needs and objectives of this Program.

o Resources and Facilities: Briefly describe the research infrastructure, 
access to patient populations, community populations etc., and facilities 
that are available and accessible to this Program.

o Mentors: Describe the track record in training cancer scientists of each 
mentor participating in the Program.

h. Program Leadership/Management:

o Principal Investigator: Describe the qualifications and role of the 
principal investigator to provide leadership and coordination of the Program.

o Recruitment Strategies: Within the multi-disciplinary research environment 
of this training program, describe:
- The selection criteria for participation at the predoctoral level and for 
placement in the existing degree awarding units of the institution(s) (e.g., 
PhDs, DPHs)
- The selection criteria for postdoctoral level candidates, specifying how 
the mix of postdoctoral candidates  (e.g., Ph.D.s, M.D.s and DPHs) will be 
prioritized to achieve the multi-disciplinary education and career 
development objectives of the Program.
- Describe advertising strategies.
- Comment on the expected size of the candidate pool, address the issue of 
possible competition from other institutional programs, and describe 
strategies for addressing this competition.

o Recruitment strategies for underrepresented minorities: describe plans to 
attract underrepresented minorities into the program.

o Advisory Committee:  Describe how the AC will function in providing 
oversight of the development, implementation and evaluation of recruitment 
strategies; recruitment and selection of candidates for the Program; 
establishment, implementation and evaluation of the core/specialized 
curriculum; approval of individual education and career development plans 
(e.g., curriculum, research/methodology experiences, mentors); interim 
monitoring and evaluation of each candidate's progress, including a 
determination of when a candidate has successfully completed the program, 
with recommendations for changes in the plan and, if necessary, termination 
of a candidate not making adequate progress; review of mock grant 
applications; and monitoring of the overall effectiveness of the Program.

o Individual Candidate Training Plans: Provide actual or examples of 
individual plans that the Program will employ or has been  able to achieve 
that allow it to provide a unique education and career development experience 
for candidates, preparing them to design, implement and participate in highly 
inter-disciplinary, collaborative cancer research.  Provide plans for 
conducting the required mock grant application and review process for each 
postdoctoral candidate.

i. Evaluation Plan: Describe the information that will be used in, the 
periods for, and criteria to be used in evaluating this Program.

j. Progress Report (for competing renewal applications): Describe progress 
made toward achieving the objectives of this program and the intent of the 
NCI.

11. Human Subjects: you will need to follow current NIH policy.  Pertinent 
links and information are in the PHS Form 398 application package.  Also, 
refers to NCI policies on data and safety monitoring for training awards 
(http://www.cancer.gov/clinicaltrials/conducting/dsm-guidelines);

12. Vertebrate Animals: follow instructions provided in the PHS Form 398 
application package;

13. Consortium/Contractual Arrangements: Refer to the following the following 
website for guidelines on these agreements: 
http://grants.nih.gov/archive/grants/policy/nihgps/part_iii_5.htm#Consortium.   

14. Appendices: follow instructions provided in the PHS Form 398 application 
package.  

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 FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: 
Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NCI staff member who has agreed to 
accept assignment of the application.   

Applicants requesting more than $500,000 must carry out the following steps:

1. Contact the NCI program staff at least 6 weeks before submitting the 
application, i.e., as you are developing plans for the study; 

2. Obtain agreement from the NCI staff that the NCI will accept your 
application for consideration for award; and,
  
3. Identify, in a cover letter sent with the application, the National Cancer 
Institute, and the staff member who agreed to accept assignment of the 
application.  

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised 
version of these grant application types. Additional information on this 
policy is available in the NIH Guide for Grants and Contracts, October 19, 
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. 

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, and three signed photocopies in one 
package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
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)

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.

APPLICATION PROCESSING: Applications must be mailed on or before the receipt 
dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.  The CSR will 
not accept any application in response to this PAR 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.  

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 PAR by the NCI program staff.  
Applications not adhering to the guidelines of this PAR, and those 
applications that are incomplete as determined by CSR or by NCI program 
staff, will be returned to the applicant without further consideration.

Applications that are complete and adhere to the guidelines of this PAR will 
be evaluated for scientific and technical merit, in accordance with the 
review criteria stated below, 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 selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the National Cancer Advisory Board 

REVIEW CRITERIA

The review criteria that will be applied to the application are described 
below:

STATEMENT OF APPLICABILITY: Adequacy of the Statement of Applicability 
justifying the unique use of this specialized R25 mechanism instead of 
traditional education/training mechanisms, such as the Ruth L. Kirschstein 
NRSA Institutional Training Grant, for achieving the education and career 
development objectives of the proposed program.  

PROGRAM JUSTIFICATION: Adequacy of the justification provided of the need for 
the proposed Program relative to other ongoing education, and training/career 
development activities being sponsored within the institution(s).

PRINCIPAL INVESTIGATOR: Qualifications (and track record for competing 
renewal applications) of the principal investigator to provide both 
scientific and administrative leadership of the Program.

ADVISORY COMMITTEE: Quality (and track record for competing renewal 
applications) of the Advisory Committee and appropriateness for performing its 
critical functions in recruitment of candidates, assignment of mentors, 
establishment and monitoring of individual training plans, and evaluating and 
making mid-course corrections for the Program. 

PROGRAM/CORE REQUIREMENTS: Merit of the Program (and track record for 
competing renewal applications), as defined in the didactic and research core 
requirements, to train multi- and interdisciplinary investigators in the 
proposed field.  

ENVIRONMENT: Quality, sufficiency, multidisciplinarity of the research 
environment provided by participating institution(s) for the program to meet 
its goals of training future multi- and interdisciplinary investigators.

MENTORS:  Experience and quality of the mentors to ensure a successful outcome 
of the Program.

CANDIDATES:  Adequacy of the plans for (and track record for competing renewal 
applications) recruiting high quality trainees, to ensure a supply of high 
quality trainees for the Program from different scientific disciplines.  
Adequacy of the specific measures proposed or taken to recruit candidates form 
underserved and underrepresented groups. This does not include Continuing 
Umbrella of Research Experiences (CURE) supplements to the Cancer Educational 
and Career Development Program (R25).

INSTITUTIONAL COMMITMENT: The strength of the institution's commitment to the 
Program.

OVERLAP: Absence of overlap with other existing training programs.

COMPETING RENEWAL APPLICATIONS: adequacy of addressing any concerns expressed 
in the Summary Statement for the prior five-year award.

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following 
items will be considered in the determination of scientific merit and the 
priority score:

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 
subjects and protections from research risk relating to their participation 
in the proposed research will be assessed. (See 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. 

ADDITIONAL CONSIDERATIONS

DATA SHARING:  The adequacy of the proposed plan to share data for 
applications with direct costs equal or greater than $500,000 in any given 
year.
 
BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

TRAINING IN THE RESPONSIBLE CONDUCT OF RESEARCH: The appropriateness of 
topics, format, amount and nature of faculty participation, and the frequency 
and duration of instruction. Every trainee supported by this grant must 
receive instruction in the responsible conduct of research. For more 
information on this provision, see the NIH Guide for Grants and Contracts, 
Volume 21, Number 43,November 27, 1992, see 
http://grants.nih.gov/grants/guide/notice-files/not92-236.html. Applications 
must include a description of a program to provide formal or informal 
instruction in scientific integrity or the responsible conduct of research.  
Applications without plans for instruction in the responsible conduct of 
research will be considered incomplete and will be returned to the applicant 
without further consideration. 

o Although the NIH does not establish specific curricula or formal 
requirements, all programs are encouraged to consider instruction in the 
following areas: conflict of interest, responsible authorship, policies for 
handling misconduct, data management, data sharing, and policies regarding the 
use of human and animal subjects. Within the context of training in scientific 
integrity, it is also beneficial to discuss the relationship and the specific 
responsibilities of the institution and the candidates appointed to the 
program.

o Plans must address the subject matter of the instruction, the format of the 
instruction, the degree of faculty participation, trainee attendance, and the 
frequency of instruction.

o The rationale for the proposed plan of instruction must be provided.

o Program reports on the type of instruction provided, topics covered, and 
other relevant information, such as attendance by trainees and faculty 
participation, must be included in future competing continuation and non-
competing applications. The NIH encourages institutions to provide instruction 
in the responsible conduct of research to all graduate students, post-doctoral 
fellows, and research staff regardless of their source of support.

NCI initial review groups will assess the applicant's plans on the basis of 
the appropriateness of topics, format, amount and nature of faculty 
participation, and the frequency and duration of instruction.

The plan will be discussed after the overall determination of merit, so that 
the review panel's evaluation of the plan will not be a factor in the 
determination of the priority score.  Plans will be judged as acceptable or 
unacceptable.  The acceptability of the plan will be described in an 
administrative note on the summary statement. Regardless of the priority 
score, applications with unacceptable plans will not be funded until the 
applicant provides a revised, acceptable plan.  Staff within the NIH awarding 
component will judge the acceptability of the revised plan.

AWARD CRITERIA

The National Cancer Advisory Board (NCAB) must concur with the initial peer-
review for scientific and technical merit.  Applications submitted in 
response to a PAR will compete for available funds with all other recommended 
applications.  The following will be considered in making funding decisions:  

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

NON-COMPETING RENEWAL APPLICATIONS (PROGRESS REPORTS) 

An Annual Progress Report for the grant is required.  This report should 
provide information about:
o Changes in the Program
o A summary report of the evaluation of the Advisory Committee
o A description of the research and career progress of each candidate.  These 
progress reports will be closely monitored by NCI staff to ensure that the 
Program is achieving its goals and meets the intent of the NCI for this 
specialized R25 grant mechanism.

This PAR, as administered by the NCI, is not subject to the Streamlined Non-
competing Application Process (SNAP).  In general, this means that all 
reporting of budgetary information and program progress are provided in 
greater detail in the annual progress report.

While the R25 is subject to Expanded Authorities, the one exception is that 
carryover of funds from one fiscal year to the next must be approved by NCI.  
If there is an unobligated balance greater than 25% of direct costs for the 
pertinent year and the Principal investigator wishes to carry over this 
balance to the next year of funding, the following information must be 
provided:
o  The estimated direct cost amount available for carry over
o  An explanation of how the funds were generated by budget category
o  An explanation and a plan for the projected use of funds by budget 
category
o  If appropriate, an explanation of the additional project objectives that 
will be accomplished with the use of these funds. 

Progress reports are to submitted using the Form PHS 2590, which should be 
available at most institutional offices of sponsored research or can be 
accessed directly at the following website address: 
http://grants.nih.gov/grants/funding/2590/2590.htm.  Since the Form PHS 2590 
does not easily apply to this specialized form of the R25 grant, adapt the 
application for continuation so it contains the following information:

o Appropriate Face Page

o A detailed budget page that provides all salaries, fringe benefits, and 
other budgetary information (e.g., supplies, travel, tuition, etc) 
specifically for each individual candidate by name or by position if the 
position is not occupied.

o A brief description of the Objectives and Goals of the Program

o A brief summary indicating which faculty, mentors and Advisory Committee 
members have left the Program and the names of the new individuals who are 
being added or taking their place.  Include for each new person their degree 
and department (or equivalent) and, if a multi-institutional consortium, 
their institution, and a statement about the effect that these changes will 
have on the program.

o Biographical Sketches of:

a. New faculty
b. New mentors
c. New Advisory Committee members
d. New Trainees

o Progress of Individual Trainees: A brief paragraph for each trainee 
describing the research and didactic experiences that they are engaged in or 
have completed as well as the specific future plans for each trainee in order 
to satisfy the Core Requirements of the Program.

o List of publications and presentations for each trainee resulting from 
their training experiences in the Program.

o For each postdoctoral candidate who completes training, a copy of his/her 
mock grants application and the critique of the application with the members 
of the review panel and their areas of expertise.

o Summary Information of the Program. A sample table can be obtained from NCI 
program staff (see INQUIRIES above)

o A Report from the Advisory Committee that is separately attached and 
evaluates the following: the effectiveness of the specialized curriculum 
developed for the Program and recommended changes; the effectiveness of the 
overall performance of the Program in satisfying its training and career 
development objectives with recommendations for changes that might improve 
the Program (e.g., modifications in Core Requirements, addition of new 
mentors, improved recruitment strategies) and the effectiveness of the 
minority recruitment efforts. 

A final progress report, invention statement, and Financial Status Report are 
required upon termination of an award.

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.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm .    

MONITORING PLAN AND DATA AND SAFETY 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 and Safety 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 "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 is 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://stemcells.nih.gov/index.asp and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (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 PAR 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 
PAR is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  All 
awards are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm 

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the use of all tobacco products.  In addition, 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care, or early 
childhood development services are provided to children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.

REFERENCES

1. National Institute for Science education. (1998).  Descriptions of 
programs and strategies for change: Strengthening graduate education in 
science and engineering.  Promising practices and strategies for 
implementation from the Graduate Education Forum Madison: University of 
Wisconsin: Madison.

2. 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.

3. The Association of American Universities, Committee on Postdoctoral 
Education.  Report and Recommendations, March 31, 1998.  Washington, D.C.: 
The Association of American Universities; 1998. 8p. Available from: URL: 
http://www.aau.edu/.

4. Brent, R. "Raising the Next generation of Scientific Pioneers," J NIH 
Res., 9, 37-39 (1997).

5. The NCI Imaging Sciences Working Group, Meeting of the In Vivo 
Molecular/Functional Imaging Subgroup, February 18-19, 1998.


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