PAUL CALABRESI AWARD FOR CLINICAL ONCOLOGY (K12)

RELEASE DATE:  April 23, 2004

PA NUMBER:  PAR-04-096 (Reissued as PAR-06-449)

EXPIRATION DATE:  June 2, 2006, (Change in receipt and expiration dates, see NOT-CA-05-025)

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION: 
National Institutes of Health (NIH) 
 (http://www.nih.gov)
 
COMPONENT OF PARTICIPATING ORGANIZATION:  
National Cancer Institute (NCI)
 (http://www.nci.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.398

LETTER OF INTENT RECEIPT DATE:  June 1, 2004, May 2, 2005
APPLICATION RECEIPT DATE:    July 1, 2004, June 1, 2005

This Program Announcement (PA) replaces PAR-03-083, Clinical Oncology 
Research Career Development Program, which was published in the NIH 
Guide on March 20, 2003.

THIS PA CONTAINS THE FOLLOWING INFORMATION

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

PURPOSE

This PA announces the replacement of the NCI  Institutional Clinical 
Oncology Research Career Development (K12) Program  (PAR-03-083 at 
http://grants.nih.gov/grants/guide/pa-files/PAR-03-083.html) with the 
 Paul Calabresi Award for Clinical Oncology (K12)  or PCACO.   The 
purpose of the PCACO is to increase the number of medical doctors 
(M.D.'s, D.O.'s), and doctorally-degreed nurses (Ph.D.’s or 
equivalents) and basic scientists (Ph.D.’s D.V.M. s, or equivalents) 
who are highly-motivated and trained to: 1) perform clinical oncology 
therapeutic research that develops and tests scientific hypotheses 
based on fundamental and clinical research findings; 2) design and test 
hypothesis-based, clinical therapeutic protocols and adjunct biological 
analyses and for clinician candidates to administer all phases (i.e., 
pilot/Phase I, Phase II, and Phase III) of cancer therapeutic clinical 
trials, and (3) conduct cancer therapeutic research in team research 
settings in which basic and clinical scientists collaborate and 
interact to expedite the translation of basic research discoveries into 
patient-oriented therapeutic cancer research. The PCACO is not intended 
to train laboratory-based scientists whose research will emphasize the 
use of animal or other model systems. 

For the purposes of this award, and in agreement with the 
recommendations of the NIH Director’s Panel on Clinical Research, 
(http://www.nih.gov/news/crp/97report/index.htm), patient-oriented 
research is defined as research conducted with human subjects (or on 
material of human origin such as tissues, specimens and cognitive 
phenomena) for which an investigator directly interacts with human 
subjects.  This area of research includes 1) mechanisms of human 
disease; 2) therapeutic interventions; 3) clinical trials, and; 4) the 
development of new technologies.  Studies falling under Exemption 4 for 
human subjects research are not included in this definition.

The NCI has named this award in honor of the late Dr. Paul Calabresi, 
who was a pioneer in the pharmacological treatment of cancer and early 
translational research. It recognizes him for his humanity, dedication 
to his patients, mentorship of young clinical oncologists, 
contributions to understanding and curing of cancer, untiring efforts 
to promote and develop the field of clinical oncology, and ceaseless 
service to the National Cancer Institute including his participation in 
the strategic development of the Nation’s War on Cancer. Most of all, 
this award is intended to symbolize the quality and excellence of the 
physician scientists and the non-clinician translational researchers 
that NCI hopes will become critical contributors to the future 
elimination of death and suffering from cancer. 

Individuals with medical degrees seeking a career development 
experience exclusively in laboratory-based research should refer to the 
NIH Mentored Clinical Scientist Career Development Award or K08 at the 
following website: http://grants.nih.gov/grants/guide/pa-files/PA-00-003.html.
Individuals with medical degrees interested in patient-
oriented research should refer to the NIH Mentored Patient-Oriented 
Research Career Development Award or K23 at the following website: 
http://grants.nih.gov/grants/guide/pa-files/PA-00-004.html. 
Postdoctoral individuals (e.g., Ph.D. s) trained in laboratory-based 
research, who wish to change direction and focus their research careers 
on human cancer, should refer to the NCI Howard Temin Award or K01 at 
the following website: 
http://grants.nih.gov/grants/guide/pa-files/PAR-03-104.html. 

RESEARCH OBJECTIVES

Background

In 1991, the NCI recognized the need for establishing formal training 
programs that would prepare the next generation of clinical scientists 
to participate more effectively in translational research. The NCI 
embarked on a pilot program initiative that would prepare clinical 
oncologists to be effective scientific partners with basic/behavioral 
scientists in the movement of discoveries in the laboratory into 
patient research settings or in the reverse process of taking 
observations in the clinic back into a laboratory research setting. 
These well-trained clinical oncology researchers would be expected to 
communicate, interact, and collaborate with basic/behavioral scientists 
in the design and implementation of clinical trials that were 
hypothesis driven and based on an understanding of biological 
mechanisms.  This pilot program initiative was implemented through two 
successive RFAs in 1992 and 1997. 

The initial pilot Program was highly successful and generated 
considerable interest in the cancer research community.  It therefore 
became clear that NCI objectives would be better served by making this 
grant mechanism open to investigator-initiated applications on a 
regular basis using a Program Announcement (PA).  As a result, in 1998 
the NCI established the Institutional Clinical Oncology Research Career 
Development Program (K12) as an ongoing PA with a once-a-year 
submission date.  In 1999, the NCI extended eligibility for an 
appointment to an NCI K12 grant to include doctorally-prepared Oncology 
Registered Nurses, in recognition of the critical role of nursing in 
general and oncology nursing in particular in clinical cancer research 
and care.  Finally, in view of the continuing commitment of the NCI to 
increase the participation of individuals from underrepresented 
minority groups in biomedical and behavioral research and the critical 
need for more underrepresented minorities in clinical oncology 
research, the PA was reissued in 2003 and required that all competing 
applications for the Institutional Clinical Oncology Career Development 
Program(K12) Grant include a specific plan to recruit and retain 
underrepresented minorities as trainees. 

The focus of this Program has always been the career development of 
medical doctors in translational therapeutic research. To this end, the 
Program specifically required that clinical candidates obtain a basic 
research experience as a means of increasing their ability to 
collaborate and communicate with basic scientists successfully in the 
translational research process. It is now clear that the translational 
therapeutic research of the future will require both dedicated 
clinician scientists and basic scientists working in team research 
settings.  The NCI Paul Calabresi Award in Clinical Oncology (K12) 
changes the Program from supporting only clinician scientists to one 
that can support both clinician scientists and basic scientists as a 
cohort in order to further enhance career development that emphasizes 
basic/clinical scientific interactions and team research concepts.  

The NCI Paul Calabresi Award in Clinical Oncology (K12) is consistent 
with the objective of the NIH Roadmap Initiative to build a strong 
clinical research infrastructure and increase interactions between 
basic and clinical scientists.

Program objectives

The objectives of the Paul Calabresi Award for Clinical Oncology are 
to:
o Encourage medical doctors to dedicate their careers to the design and 
conduct of hypothesis-based clinical therapeutic research;
o Encourage basic research scientists to dedicate their careers to 
patient-oriented, clinical therapeutic research; and 
o Develop a cadre of medical doctors and basic science researchers who 
know how to work effectively in collaborative, team research settings. 

MECHANISM OF SUPPORT

This PA will use the NIH Mentored Clinical Scientist Development 
Program Award or K12 grant mechanism.  Planning, direction, and/or 
execution of the program will be the responsibility of the Program 
Leader/Principal Investigator (PI) and the Advisory Committee on behalf 
of the applicant institution. Applicants must request 5 years of 
support.  Awards are renewable. 

Awards will be administered under the NIH grants policy as stated in 
the National Institutes of Health Grants Policy Statement (Revised, 
12/03) and described on  
http://grants.nih.gov./grants/policy/nihgps_2003/index.htm.  However, the K12 
award, as administered by the National Cancer Institute, is not subject 
to the  Just-in-time  application procedures or to the Streamlined 
Noncompeting Application Process (SNAP).  The K12 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 if your institution has any of the 
following characteristics: 

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, 
hospitals, and laboratories  
o Domestic institutions/organizations 
o Foreign institutions are not eligible to apply

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS 

The Program Leader is the Principal Investigator.  The Program Leader 
must be an established investigator in patient-oriented research and 
must 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.  

ELIGIBLE CANDIDATES 

Clinician Candidates (required):  All clinician candidates or trainees 
must currently be physicians holding the M.D. or D.O. degrees, or be 
nurses with a Ph.D. degree; and must have completed the necessary 
clinical training (i.e., completed residency and are board eligible) to 
engage in clinical oncology research. 

Basic Science Candidates (encouraged but optional):  All basic science 
candidates must have doctoral-level degrees (e.g., Ph.D., D.V.M.) or 
the equivalent, a minimum of 2 years of postdoctoral research training, 
and a total basic research experience that is clearly preparatory 
(e.g., experience with animal models or preclinical research) for 
devoting a career to human therapeutic cancer research.

All Clinician and Basic Science Candidates must satisfy the following:

They must be committed to a minimum of 75 percent full-time 
professional effort conducting research and engaging in activities 
directly related to research career development, which includes all 
relevant didactic activities during the period of the award.

They must be 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 are not eligible.

Candidates may be former or current principal investigators on NIH 
Small Grants (R03) or Development and Innovation Grants (R21 or non-NIH 
equivalents to these grants/awards. 

Candidates may not be current or former principal investigators on an 
NCI K01 (Temin Award),an NCI K07 or an NIH K08 grant, NIH Research 
Project Grants (R01, R29) and subproject leaders on Program Project 
Grants (P01) and Center Grants (P50), or non-NIH equivalents to these 
grants/awards. 

Candidates may also not be current or former principal investigators on 
an NIH K23 grant, an NCI K22 grant or non-NIH equivalent grants/awards. 
However, clinician candidates appointed to a K12 grant are encouraged 
to apply for these grants/awards.

SPECIAL REQUIREMENTS

Special NCI Programmatic Requirements

o Where there already exists an active Ruth L. Kirschstein (T32) 
National Research Service Award (NRSA) or other institutional career 
development program (e.g., K12s, K30s, General Clinical Research Core  
(GCRC) Scholars Program) overlap between these programs must be 
eliminated and/or the NCI Paul Calabresi Award for Clinical Oncology 
(K12) structured in a way to complement and take advantage of these 
other career development/training programs.  This may require merging 
components of other programs with the NCI K12 or linking curriculum 
programs (e.g., K30) with the core requirements of the NCI K12. 

o Institution: The institution must have substantial support for peer-
reviewed basic and clinical research and faculty qualified in patient-
oriented therapeutic research , translational research and basic cancer 
research to serve as mentors in the proposed Program.  Institutions 
require NCI approval to submit an application if another NCI K12 exists 
at the institution.

o Environment: The research environment should be one in which there 
are active basic/clinical research collaborations that exemplify a 
dynamic two-way exchange of information and ideas between basic and 
clinical scientists.

o Program: 

1. Program Management: The PI must use an Advisory Committee (AC) to 
provide an oversight function and annual evaluation of the Program as a 
whole.  The committee's responsibilities should include but are not 
limited to: selecting clinician, nurse and basic candidates (Note: 
basic candidates are encouraged as part of these Programs but they are 
optional), assigning preceptors, approving each candidate's career 
development plan, evaluating each candidate's progress, authorizing the 
termination of a candidate who is not performing, monitoring the 
overall effectiveness of the program and recommending mid-course 
changes when needed.  A detailed description of the committee's 
composition, function, and frequency of meetings should be provided. 
Plans for an annual evaluation of the program by the AC should be 
described, and annual written reports from the AC are required that 
describe the progress (e.g., success of candidates in achieving core 
didactic and research requirements) of the Program, evaluate its 
effectiveness (e.g., recruitment methods, effectiveness of mentors, 
effectiveness and appropriateness of curriculum), and provide 
recommendations for improvements.  This annual report must also address 
the recruitment and retention of underrepresented minorities in the 
Program (see 7 below).

2.  The Program may be completely devoted to clinician candidates.  If 
basic candidates are included (and this is encouraged), the ratio of 
clinician candidates to basic candidates must not go below 2:1 at any 
time.
 
3. The Program must involve clinical mentors and candidates 
representing at least two clinical oncology disciplines such as medical 
oncology, surgical oncology, radiation oncology, pediatric oncology, 
gynecologic oncology and oncology nursing. Clinical candidates from 
non-oncology medical subspecialties may also be represented in the 
Programs.  However, these subspecialties should have direct relevance 
to cancer (e.g., thoracic surgery, pulmonology) and the individualized 
career development plans developed for these candidates must be focused 
on clinical oncology research.

4. Appointees to the Program must be designated  Paul Calabresi 
Scholars.   

5. The Program must motivate and train candidates to: 1) perform 
clinical oncology therapeutic research that develops and tests 
scientific hypotheses based on fundamental and clinical research 
findings; 2) design and test hypothesis-based clinical therapeutic 
protocols and adjunct biological analyses and for clinician candidates 
to administer all phases (i.e., pilot/Phase I, Phase II, and Phase III) 
of cancer therapeutic clinical trials, and (3) conduct cancer 
therapeutic research in team research settings in which basic and 
clinical scientists collaborate and interact to expedite the 
translation of basic research discoveries into patient-oriented 
therapeutic cancer research.   

6. Programs should have the flexibility to accommodate candidates with 
different levels of research experience and competence. (See number 9 
below regarding  Core Requirements. ) 

7. A specific plan must be provided to recruit and retain individuals 
from underrepresented and disadvantaged groups in the Program. In 
addition, all future Non-competing Grant Progress Reports must include 
a separate section in the annual written report of the AC (see 1 above) 
that reports on the recruitment and retention of individuals from 
underrepresented and disadvantaged groups during the previous award 
period and makes recommendations for altering the plan, as necessary, 
to improve its effectiveness.  

8. Appointments of candidates to the program should be for a minimum of 
TWO years.  As long as a K12 has been renewed, individual CLINICIAN 
candidates can be supported for up to 7 years.  All candidates must be 
able to commit a minimum of 75 percent of a full-time professional 
effort to the Program.  The remaining 25 percent can be divided among 
other clinical and teaching activities only if they are consistent with 
the Program goals (i.e., the candidates  development into effective 
scientists as either independent clinical investigators and/or 
clinician/basic co-leaders able to assemble and manage effective 
therapeutic research teams).

9. The Program should include specific Core Requirements that each 
candidate is expected to complete in order to meet the Program's 
training objectives.  All candidates graduating from the program must 
complete all of these requirements either directly in this Program or 
through a combination of past training experience and work conducted in 
this Program. These requirements should include the following:

a.  A DIDACTIC CORE REQUIREMENT(e.g., formal courses in clinical trial 
design, biostatistics, informed consent, Institutional Review Boards, 
data safety and monitoring, lecture series, seminars, and journal 
clubs) based on the experience and needs of each candidate.  The 
requirements for this core component should be the same for all 
candidates whether or not they have clinician or basic research 
backgrounds.

b.  A CLINICAL RESEARCH CORE REQUIREMENT that provides "hands-on" 
experience (e.g., protocol development; preparation of IRB 
applications; administration of clinical trials including patient 
accrual, analysis of outcomes) in all aspects of Phase I, Phase II and 
where possible Phase III clinical trials.  Except for the 
administration of treatment to patients, this component should be the 
same for all candidates whether or not they have clinical backgrounds 
or basic research backgrounds.  Basic science candidates are expected 
to be full partners with clinicians and become equally proficient in 
the design and the evaluation of results from translational, 
therapeutic clinical trials.

c.  A BASIC RESEARCH CORE REQUIREMENT that provides a hands-on research 
experience for CLINICIAN candidates for up to 2 years that results in a 
peer-reviewed publication(s) and that clearly serves as a tool for 
ensuring that these candidates are fully prepared to communicate, 
coordinate and collaborate with basic scientists in the conduct of 
hypothesis-driven cancer therapeutic research.  Ideally, this 
experience should be linked to the core clinical research component.

Although the submission of applications by candidates for investigator-
initiated research project grants is encouraged, the core requirements 
cannot mandate candidates  receipt of an investigator-initiated 
research project grant.

The expectation of the NCI is that clinician and basic science 
candidates will enter the Program with different levels of experience  
that already satisfy many of the Didactic, Clinical Research, and Basic 
Research Core Requirements.  Thus, individual candidates will need to 
complete only those additional didactic and research experiences that 
help them meet all of the core requirements of the Program and are 
likely to be supported by the Program for different periods of time. 

10.  All candidates are expected to receive either some formal degree 
(e.g., Masters in Clinical Research) or special certification in 
clinical research from the parent institution.

11.  If basic science candidates are included in the Program, special 
efforts must be made to treat the clinician and basic science 
candidates as a COHORT with regard to sharing, presenting and 
discussing their research and training experiences.  

Special Administrative Requirements

o Special Leave:  Leave of a trainee to another institution, 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 up to 1 
year, prior written approval of NCI staff is required.  To obtain prior 
approval, the trainee must submit a letter to the NCI Grants 
Administration Branch with a copy to the NCI Program Director 
describing the plan, countersigned by his or her department head and 
the appropriate institutional official.  A copy of a letter or other 
evidence from the institution where the leave is to be taken must be 
submitted to assure that satisfactory arrangements have been made for 
the leave and for the return of the trainee to the Program. Support 
from the 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.  Parental leave will be granted consistent 
with the policies of the grantee institution.

o 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. The NIH may 
discontinue an award upon determination that the purpose or terms of 
the award are not being fulfilled. In the event an award is terminated, 
the Director of the NIH shall notify the grantee institution and career 
award recipients in writing of this determination, the reasons 
therefore, the effective date, and the right to appeal the decision. 

o Change of Institution:  The Paul Calabresi Award for Clinical 
Oncology (K12) cannot be transferred from one institution to another. 

o Change of PI:  If the PI moves to another institution or resigns from 
the position, support of the award may be continued with NCI prior 
approval provided:

1. The current PI or the awardee institution has submitted a written 
request for change of PI, countersigned by the appropriate 
institutional business official, to the NCI Grants Administration 
Branch with a copy to the NCI Program Director describing the reasons 
for the change; the biosketch of the proposed new PI, 
including a complete listing of active research grant support, is 
provided; the information in the request establishes that the specific 
aims of the original peer reviewed career development program to be 
conducted under the direction of the new PI will remain unchanged; and 
that the new PI has the appropriate research and administrative 
expertise to lead the program; and

2. The request is submitted far enough in advance of the requested 
effective date to allow the necessary time for review.

o Changes of Program:  Awards are made to a specific institution for a 
specific program under the guidance of a particular PI.  Changes in any 
of these parameters requires prior approval by the 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, support could be withheld or 
the award could be suspended or terminated.

Budget and Related Issues

o Allowable costs:
 
1. Direct cost caps:  If an application is to support only clinician 
candidates, it must not exceed $750,000 in direct costs per annum.  If 
an application is to support both clinician candidates and basic 
science candidates, it must not exceed  $1,050,000 in direct costs per 
annum, AND the ratio of clinician candidates to basic candidates 
supported by the Program cannot go below 2:1 at any time. 

2. Candidate Salary: The NCI will provide support for each candidate 
position up to $75,000 salary and associated fringe benefits per annum 
based on a full-time professional 12-month effort commensurate with the 
applicant institution’s salary structure for persons of equivalent 
qualifications, experience, and rank. 

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 K12.  Under expanded authorities, however, institutions 
may rebudget funds within the total costs awarded to cover salaries 
consistent with the institution's salary scale.

3. Research and Development Support: No more than $30,000 per 
individual candidate can be provided for 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.  They cannot be pooled and used for advertising, 
recruiting, or other programs unrelated or indirectly related to the 
research activities of individual candidates or trainees.  It is 
expected that the K12 trainees will be working in a funded research 
environment and that support provided by the K12 grant will augment 
existing research support to include the trainee. 

4. Other Costs: This category is capped at $50,000.  Up to 10 percent 
of the Principal Investigator/Program Leader’s salary plus fringe 
benefits will be provided for leadership, management, coordination and 
evaluation of the Program, in accordance with the percent effort 
commitment to the Program. Some partial salary plus fringe benefits may 
be provided for a dedicated administrator.  Minimal costs can be 
allocated for advertising and recruitment in order to attract the best 
candidates nationally. 

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

6. 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: 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.

The funds may be used for health-related research purposes.

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, Office of Financial 
Management, NIH, Bethesda, Maryland 20892.  Checks must identify the 
relevant award account and reason for the payment.

Awardees may retain royalties and fees for activities such as scholarly 
writing, service on advisory groups, honoraria from other institutions 
for lectures or seminars, and fees resulting from clinical practice, 
professional consultation or other comparable activities, provided 
these activities remain incidental, are not required by the research 
and research-related activities of this award, and provided that the 
retention of such pay is consistent with the policies and practices of 
the grantee institution.

Funds budgeted in an NIH-supported research or research training grant 
for the salaries and/or fringe benefits of individuals, but freed as a 
result of a K12 award, may not be rebudgeted and may not be used for 
any other purpose without prior NIH approval.

7. Carryover of unobligated balances: Although the K12 is subject to 
Expanded Authorities, the carryover of funds from one budget period to 
the next requires prior written approval by NCI.  

Special Reporting Requirements

o The K12 grant, as administered by the NCI, is not subject to the 
Streamlined Noncompeting Application Process (SNAP).  In general, this 
means that all reporting of budgetary information and program progress 
are provided in greater detail in an annual progress report.  

o Progress Reports:  An Annual Progress Report for the grant is 
required.  This report should provide information about changes in the 
Program, an evaluation of the Program made by the Advisory Committee, 
and a description of the research and career progress of each 
candidate.  These Annual Reports will be closely monitored by NCI staff 
to ensure that the grant is achieving the goals of the K12 initiative. 

Progress reports are submitted using the Form PHS 2590, which can be 
obtained at the following website address:  
http://grants.nih.gov/grants/funding/2590/2590.htm.   The procedure for 
obtaining the face page for the application is described on the 
following website: 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-066.html.

Since the Form PHS 2590 does not apply easily to the K12 grant, adapt 
the application for continuation to contain the following information: 

1. Appropriate face page (Form Page 1) as instructed in the Form PHS 
2590;

2. A budget page (Form Page 2) that provides the salary and fringe 
benefits for each candidate or trainee by name or by position if no 
individual is filling the position at the time of the application.  
Provide all other budgetary information (e.g., supplies, travel, 
technical help) by trainee name or by the position broken out 
specifically for each candidate and/or trainee up to the $30,000 limit;

3. A brief description of the Objectives and Goals of the Program; and

4. A brief summary listing by name delineating which faculty, mentors, 
and Advisory Committee members have left the Program and which new 
individuals have been added or are taking their places.  Include for 
each person their degree and department affiliation (or equivalent).

5. Biographical sketches of  
i.    New Faculty
ii.   New Mentors
iii.  New Advisory Committee (AC) Members
iv.   New Trainees

The biosketches for each trainee should include any Board Eligibilities 
or Certifications.  The biosketches for new faculty/mentors/AC members 
should include a listing of all active research grant support for which 
they are the PI or co-investigator.

6. Progress of Individual Trainees: For each trainee, provide the start 
date (month/year) of the appointment to the Program and the cumulative 
number of years supported by the K12 grant; the names of the basic and 
clinical research  mentors; and a brief paragraph for each candidate or 
trainee describing progress toward satisfying the Didactic, Clinical 
Research, and Basic Research Core Requirements of the Program and the 
projected timetable for completing the remaining Core Requirements. The 
individual reports should also include: 1) A list of publications for 
the trainee resulting from their work in the Program; and 2) 
Descriptive titles of clinical trials developed and/or implemented by 
each trainee and resulting from their work in the program, identifying 
the role of the trainee in each of the trials. 

7. A separately attached report from the AC summarizing the actions of 
the AC during the last year, evaluating the performance of individual 
candidates and the Program as a whole in meeting its objectives and the 
intent of the NCI, evaluating the effectiveness of recruitment 
strategies, and providing recommendations for improving the Program 
(e.g., new mentors, changes in Core Requirements, changes in 
recruitment strategies etc.) should be included.  A special section 
should be devoted to evaluating the  required  plan for recruiting and 
retaining underrepresented minorities with recommendations for changing 
the plan to improve its effectiveness. 

8. Evaluation:  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 (PI's, individual candidates/trainees) 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.

9. A final progress report, invention statement, and Financial Status 
Report are required upon either completion of an award or 
relinquishment of an award. 

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the 
opportunity to answer questions from potential applicants.  Inquiries 
may fall into three areas:  scientific/research, peer review, and 
financial or grants management issues:

o Direct your questions about scientific/research issues to:

Lester S. Gorelic, Ph.D. 
Cancer Training Branch
National Cancer Institute
6116 Executive Boulevard, Suite 7025, MSC 8346
Bethesda, MD  20892-7390
Rockville, MD 20852 (express/courier service)
Telephone:  (301) 496-8580
Fax:  (301) 402-4472
Email:  [email protected]

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
Rockville, MD 20852 (express/courier service)
Telephone: (301) 496-3428
Fax: (301) 402-0275 
Email:  [email protected]

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

Ms. Kimery Griffin
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, EPS Room 243, MSC 7150
Bethesda, MD 20892-7150
Rockville, MD 20852 (express/courier service)
Telephone:  301-496-3196
Fax:  301-496-8601
Email: [email protected]

LETTER OF INTENT  

Prospective applicants are asked to submit a letter of intent that 
includes the following information:

o Descriptive title of the proposed research;
o Name, address, and telephone number of the Principal Investigator;
o Names of other key personnel; 
o Participating institutions; and
o Number and title of this PA. 

Although a letter of intent is not required, is not binding, and does 
not enter into the review of a subsequent application, the information 
that it contains allows NCI staff to estimate the potential review 
workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning 
of this document.  The letter of intent should be sent to:

Lester S. Gorelic, Ph.D. 
Cancer Training Branch
National Cancer Institute
6116 Executive Boulevard, Suite 7025, MSC 8346
Bethesda, MD  20892-7390
Rockville, MD 20852 (express/courier service)
Telephone:  (301) 496-8580
Fax:  (301) 402-4472
Email:  [email protected]

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001)updated 9/9/03.  
Applicants are advised that these instructions are provided under the 
section titled "Table of Contents" following the tables providing 
individual PHS Form 398 pages.  Applications must have a Dun and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the 
Universal Identifier when applying for Federal grants or cooperative 
agreements.  The DUNS number can be obtained by calling (866) 705-5711 
or through the website at http://www.dunnandbradstreet.com/.  The DUNS 
number should be entered on line 11 of the face page of the PHS 398 
Form.  The PHS 398 document is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an 
interactive format.  For further assistance, contact GrantsInfo, 
Telephone: (301) 710-0267, Email: [email protected].

The title and number of this program announcement must be typed on line 
2 of the face of the application form and the YES box must be checked.

SUPPLEMENTARY INSTRUCTIONS 

The instructions in the Form PHS 398 do not fully apply to the special 
needs of this grant application. Therefore, follow the modified 
instructions below in preparing an application for an NCI Paul 
Calabresi Clinical Oncology Award (K12). These instructions have been 
adapted to accommodate the Form PHS 398 and the special needs of the 
K12 grant:

1.  Face Page:  Use Form Page 1 of the Form PHS 398.  On Line 1, 
include the title that best represents the nature of the training 
program.  On Line 2, provide the number of this Program Announcement 
beginning with PAR-04-096, and the title "Paul Calabresi Clinical 
Oncology Award" of the Program Announcement.  The Program Leader will 
be the principal investigator (PI) of the grant application.

2. The Description/ Performance site(s)/ Key personnel (Form Page 2 of 
Form PHS 398): Complete as directed in the Form PHS 398.  The 
information provided should include the P.I., Advisory Committee 
members, mentors, and other faculty participating in the program.

3.  Table of Contents to be organized as follows: 

Section I. Basic Administrative Information: 

1.  Face Page
2.  Description/Key Personnel
3.  Table of Contents
4.  Statement of Commitment
5.  Detailed Budget Page for the initial budget period.
6.  Budget for Entire Proposed Period of Support
7.  Biographical Sketches (not to exceed two pages per individual)
a. Principal Investigator
b. Advisory Committee Members
c. Mentors, Other Faculty
d. Trainees (if available)
8.  Research Base/Resources and Facilities 

Section II.  Specialized Information

1. Career Development/Training Plan (There is no page limit, but it is 
suggested that applicants be as clear and brief as possible; tables 
should be included in the text, not as appendices)
a. Introduction to Revised Application (when applicable, not to exceed 
3 pages)
b. Purpose and Objectives
c. Research Environment
d. Description of Didactic, Clinical Research, and Basic Research Core 
Requirements

2.  Program Management
a. Principal Investigator
b. General Recruitment Strategies 
c. Recruitment of underrepresented minorities
d. Evaluation Plan

3.  Advisory Committee
4.  Individual Training Plans
5.  Human Subjects
6.  Vertebrate Animals
7.  Checklist
8.  Appendices

Detailed instructions for Table of Contents Section I: 

Item 4. Statement of Commitment: This statement should guarantee that 
all candidates participating in this Program Announcement will commit a 
minimum of 75 percent of a full-time professional effort to research 
and research career development. 

Item 5.  Detailed Budget for the Initial Budget Period: Provide 
detailed budget information with regard to salary and fringe benefits, 
supplies, travel etc. specified for each trainee by name or by 
position, if there is no one available to fill the position. Note that 
there is an upper limit of salary of $75,000 plus fringe benefits, an 
upper limit for other costs of $30,000 per trainee; and a required 
minimum 75 percent effort.

Item 7.  Biographical Sketches: Provide biographical sketches using the 
Biographical Sketch Format Page of the Form PHS 398.  Group the 
biosketches into the following five sections: (1) PI; (2) K12 Advisory 
Committee Members; (3) Mentors; (4) Other Faculty; and (5) Trainees 
(when available).

Item 8. Research Base/Resources and Facilities: (Suggested tabular 
formats for this information can be found under "Summary Information on 
Program" at 
http://cancertraining.nci.nih.gov/research/clinical/k12full.html#app.  
This should include support from other training programs that relate to 
this application (e.g., other K12 Awards, K30 Awards, T32 Awards, R25T 
Awards).

Detailed instructions for Table of Contents Section II. 

Item 1. Part b.  Purpose and Objectives: Briefly describe the 
background, purpose and objectives of this career development Program.  
This description should identify two or more clinical oncology 
disciplines represented in the Program and a discussion of the 
strategies to be used to ensure that the representation in each 
discipline in the mentor population and the trainee population will 
satisfy the intent of this NCI requirement. The description should 
clearly show how the purpose and objectives of the Program will meet 
the broader objectives and intent of the NCI to prepare clinician and 
where appropriate basic candidates who can design and implement all 
phases of clinical trials and who can effectively work together in team 
research settings in patient-oriented therapeutic cancer research.

Item 1. Part c. Research Environment:
  
Research Base: Describe the existing funded laboratory and patient-
oriented research activities and the interactive nature of the research 
environment that will meet and sustain needs of this Program. Include 
in this description the number and types of early to late phase 
clinical therapeutic clinical trials being conducted in the 
institution, the general range of activities in these trials and, 
wherever present, the hypothesis-based translational nature of these 
activities. 

Resources and Facilities: Describe the research infrastructure, patient 
populations, facilities, etc., that are available and accessible to 
this Program.

Mentors: Describe the pertinent research experience and track record in 
training cancer clinician scientists (and, for combined clinician-basic 
scientist programs, translational cancer researchers) of each mentor 
participating in the Program.

Item 1. Part d. Description of Didactic Clinical Research Core 
Requirements:

Describe separately the core didactic, core clinical research, and core 
basic research experiences that each clinician and basic candidate must 
complete to satisfy the overall Core Requirements of the Program. If 
there are existing institutional K30 or GCRC Scholar programs, explain 
how the K12 Program will link with and make use of these programs to 
meet the objectives of the K12 core didactic component.  Using 
specific, real, or hypothetical examples, describe how individualized 
trainee career development plans will be developed that take into 
account past experiences and competencies before providing new 
experiences and skills by the Program.  Describe the official degree or 
certification that candidates will receive FROM THE INSTITUTION after 
completing the Didactic, Clinical Research, and Basic Research Core 
Requirements. 

Item 2. Part a.  Principal Investigator: 

Describe the qualifications and role of the PI to provide scientific 
and administrative leadership and coordination of the Program.

Item 2. Part b. General Recruitment Strategies: 

Describe the selection criteria for clinician candidates and, where 
appropriate, basic candidates recruited to this Program.  Describe the 
various strategies that will be used to ensure that the different 
clinical oncology disciplines represented by the Program are included 
and to ensure an adequate candidate pool.  Address the nature of any 
other competing institutional Programs that might limit the number of 
candidates and describe the strategies for addressing this competition.  

Item 2. Part c: Recruitment of Underrepresented Minorities: 

Describe strategies for recruitment of individuals from 
underrepresented groups and from groups that may have been 
disadvantaged because of disability, economic, educational or any other 
circumstance that has inhibited their ability to pursue a career in 
health-related research and how these strategies will be implemented. 
For the purpose of the K12 an individual is from an underrepresented 
group if he or she belongs to a particular ethnic and racial group that 
has been determined by the grantee institution to
be underrepresented in cancer-related biomedical, behavioral, clinical 
or social sciences research.

Item 2. Part d: Evaluation Plan:

Describe the plans for ongoing evaluation of the trainees, mentors, PI, 
Advisory Committee (AC) and the overall program. Provide criteria that 
will be used for this evaluation and describe how the results of the 
evaluation will be used.  

Section II. Item 3. Advisory Committee (AC): 

Describe how the AC will function in providing oversight of the 
development, implementation, and evaluation of recruitment strategies 
in the recruitment and selection of candidates; in the evaluation of  
special curricula and/or links to curricula developed through a K30 
grant (if present); in the monitoring and evaluation of each 
candidate's progress with recommendations for changes in the training 
plan, if necessary, or termination of a candidate who is not making 
adequate progress; and in monitoring and evaluation of the overall 
effectiveness of the Program.

Section II. Item 4. Individual Training Plans: 

Provide brief summaries/examples of individual training plans that the 
Program will employ or has been able to achieve (for competing renewal 
applications) in preparing clinician and (if relevant) Ph.D. candidates 
to design, implement, and participate in patient-oriented, therapeutic 
research and collaborate effectively with each other in translating 
basic science discoveries into therapeutic clinical trials. If relevant 
to your K12 program, provide examples of plans for short-term (2 years) 
appointments.

Section II. Item 5. Human Subjects: Follow the instructions in Form PHS 
398.  If an award is made, human subjects may not be involved and 
appointees may not participate in human subjects related research until 
a certification of the date of IRB approval or a designation of an 
exemption has been submitted to the NCI and accepted. 

If a clinical trial will be involved, the PI will need to follow 
current NIH and NCI policies on providing information on data and 
safety monitoring.  Refer to the following website for information on 
NCI policies on data and safety monitoring for training awards: 
http://www.cancer.gov/clinicaltrials/conducting/dsm-guidelines/page4.

A detailed plan for data and safety monitoring (D&SM) is not required 
at the time of application.  The application must, however, document an 
existing procedure for D&SM of clinical trials at the sponsoring 
institution.  At the time an award is offered, applicants must contact 
NCI staff for specific instructions on how to fully comply with the 
requirements for D&SM. 

Section II. Item 6. Vertebrate Animals: Follow the instructions in Form 
PHS 398. If an award is made, vertebrate animals may not be involved 
until a certification of the date of IUCAC approval has been submitted 
to the NCI and accepted. 

APPLICATION RECEIPT DATES: Applications submitted in response to this 
program announcement will be accepted by the receipt dates listed at 
the beginning of this program announcement. 

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 (CSR)
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 and 
all five copies of the appendices must be sent to:
 
Referral Officer 
Division of Extramural Activities 
National Cancer Institute 
6116 Executive Blvd., Room 8041, MSC-8329
Rockville, MD 20852 (express courier)
Bethesda MD 20892-8329

Appendices should be comprised of single-sided, unbound materials, with 
separators between documents.  

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 policy is similar to and consistent with the policy for 
applications addressed to Centers for Scientific Review as published as 
a Notice in the NIH Guide at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html. 

APPLICATION PROCESSING: Applications must be received on or before the 
receipt date on the first page of this PA. The CSR will not accept any 
application in response to this PA that is essentially the same as one 
currently pending initial review unless the applicant withdraws the 
pending application.  The CSR will not accept any application that is 
essentially the same as one already reviewed.  This does not preclude 
the submission of a substantial revision of an unfunded version 
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 responsiveness by NCI.  Incomplete and/or non-responsive 
applications will not be reviewed. 

Applications that are complete and responsive to the PAR will be 
evaluated for scientific and technical merit by an appropriate peer 
review group convened by the Division of Extramural Activities of the 
NCI in accordance with the review criteria stated below.  As part of 
the initial merit review, all applications will:
As part of the initial merit review, all applications will:

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 written critique
o Receive a second level review by the National Cancer Advisory Board.  

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  
In the written comments, reviewers will be asked to evaluate 
applications in order to judge the likelihood that the proposed Program 
will have a substantial impact on the pursuit of these goals.  The 
scientific review group will address and consider each of the following 
criteria in assigning the application's overall score, weighting them 
as appropriate for each application.  

o Principal Investigator 
o Advisory Committee
o Program/ Core Requirements
o Environment
o Mentors
o Candidates
o Institutional Commitment
o Integration with other programs 

The application does not need to be strong in all categories to deserve 
a high priority score. These criteria are listed in logical order and 
not in order of priority

PRINCIPAL INVESTIGATOR: Qualifications (and track record for competing 
renewal applications) of the PI 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.  Additionally, for competing renewal applications, 
adequacy of addressing any concerns expressed in the Summary Statement 
for the prior 5 year award.

PROGRAM/CORE REQUIREMENTS: Overall merit of the Program (and track 
record for competing renewal applications).  Appropriateness and 
adequacy of the Didactic Core Requirements, Basic Research Core 
Requirements, and Clinical Core Requirements including the end points 
for completion of the K12 appointment, to train patient-oriented 
clinical and basic research scientists who can work effectively with 
each other in a translational, team research setting, in the design and 
conduct of all phases (e.g., Phase I, Phase II, and Phase III) of 
hypothesis-driven, therapeutic cancer clinical trials and adjunct 
biological analyses. 

ENVIRONMENT: Quality, sufficiency, and interactiveness of the basic and 
clinical research of the institution to provide the environment 
necessary for the Program to meet its goals and objectives.

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 representing at least 
two oncology disciplines. Adequacy of the plans (and track record for 
competing renewal applications) for recruiting basic science candidates 
with prior basic research experience that is clearly preparatory (e.g., 
experience with animal models or preclinical research) for devoting a 
career to human therapeutic cancer research. Adequacy of the specific 
measures proposed or taken (for competing renewal applications) to 
recruit underrepresented minority candidates to the Program. This does 
not include Continuing Umbrella of Research Experiences (CURE) 
supplements to the K12 program.

INSTITUTIONAL COMMITMENT: The strength of the institution's commitment 
to the Program, especially with regard to ensuring that each candidate 
will have protected time to commit 75 percent of a full-time 
professional effort to research career development.

INTEGRATION WITH OTHER PROGRAMS: The degree to which this program is 
effectively integrated with other existing training and career 
development programs to avoid duplication and achieve maximum 
complementarily. 

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 G 
of the PHS 398 research grant application instructions (rev. 5/2001) 
updated 9/9/2003 will be assessed.  

ADDITIONAL REVIEW CONSIDERATIONS

BUDGET:  The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed objectives of the K12 
Program.

AWARD CRITERIA

Applications submitted in response to a PA will compete for available 
funds with all other recommended applications.  The following will be 
considered in making funding decisions:  

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

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

DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required 
for all types of clinical trials, including physiologic, toxicity, and 
dose-finding studies (phase I); efficacy studies (phase II), efficacy, 
effectiveness and comparative trials (phase III). The establishment of 
data and safety monitoring boards (DSMBs) is required for multi-site 
clinical trials involving interventions that entail potential risk to 
the participants. (See NIH Policy for Data and Safety Monitoring, NIH 
Guide for Grants and Contracts, June 12, 1998; at 
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.  For additional information, see NIH Guide Notice on 
"Further Guidance on a Data and Safety Monitoring for Phase I and II 
Trials" for additional information at 
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 at 
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 NIH, unless there are clear and compelling 
scientific and ethical reasons not to include them.  
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 IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS: 
NIH policy requires education on the protection of human subjects 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, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.  

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, in the project description, and elsewhere in the 
application as appropriate, the official NIH identifier(s) for the hESC 
line(s) to be used in the proposed research.  Applications that do not 
provide this information will be returned without review. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: 
The Office of Management and Budget (OMB) Circular A-110 has been 
revised to provide public access to research data through the Freedom 
of Information Act (FOIA) under some circumstances.  Data that are (1) 
first produced in a project that is supported in whole or in part with 
Federal funds and (2) cited publicly and officially by a Federal agency 
in support of an action that has the force and effect of law (i.e., a 
regulation) may be accessed through FOIA.  It is important for 
applicants to understand the basic scope of this amendment.  NIH has 
provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application 
should include a description of the archiving plan in the study design 
and include information about this in the budget justification section 
of the application. In addition, applicants should think about how to 
structure informed consent statements and other human subjects 
procedures given the potential for wider use of data collected under 
this award.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  
The Department of Health and Human Services (DHHS) issued final 
modification to the  Standards for Privacy of Individually Identifiable 
Health Information,  the  Privacy Rule,  on August 14, 2002.  The 
Privacy Rule is a federal regulation under the Health Insurance 
Portability and Accountability Act (HIPAA) of 1996 that governs the 
protection of individually identifiable health information, and is 
administered and enforced by the DHHS Office for Civil Rights (OCR). 

Decisions about applicability and implementation of the Privacy Rule 
reside with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, 
including a complete Regulation Text and a set of decision tools on  Am 
I a covered entity?   Information on the impact of the HIPAA Privacy 
Rule on NIH processes involving the review, funding, and progress 
monitoring of grants, cooperative agreements, and research contracts 
can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and 
proposals for NIH funding must be self-contained within specified page 
limitations. Unless otherwise specified in an NIH solicitation, 
Internet addresses (URLs) should not be used to provide information 
necessary to the review because reviewers are under no obligation to 
view the Internet sites. Furthermore, we caution reviewers that their 
anonymity may be compromised when they directly access an Internet 
site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of 
"Healthy People 2010," a PHS-led national activity for setting priority 
areas. This PA is related to one or more of the priority areas. 
Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.healthypeople.gov/.

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.

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