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

CANCER PREVENTION, CONTROL, BEHAVIORAL AND POPULATION SCIENCES CAREER 
DEVELOPMENT AWARD

Release Date:  September 4, 2001

PAR NUMBER:  PAR-01-135 (see replacement PAR-04-055)

National Cancer Institute

This program announcement replaces PAR-99-108, which was published in the NIH 
Guide on June 3, 1999.

PURPOSE

The purpose of the Cancer Prevention, Control. Behavioral and Population 
Sciences Career Development Award (K07) is to support the career development 
of investigators who have made a commitment to focus their research endeavors 
on cancer prevention, control, behavioral and the population sciences.  This 
mechanism provides support for three to five years of specialized didactic 
study and mentored research for individuals with a health professional or 
science doctoral degree who are not fully established investigators and who 
want to pursue research careers in the cancer prevention, control, population 
and/or behavioral sciences.  Examples of relevant disciplines for this 
Program Announcement (PA) include any aspect of human cancer prevention 
(modifiable risk factors, new animal models and extrapolation of these models 
to human cancer, genetic predisposition to cancer and detection of precursor 
lesions, chemoprevention trials in human populations, and behavioral research 
and behavioral intervention trials in cancer prevention), epidemiology 
(biochemical, genetic, molecular), biostatistics, human cancer genetics, 
clinical oncology, human nutrition, behavioral and social sciences, health 
promotion, health services and health policy research, and medical decision 
analysis, survivorship and quality of life as they relate to cancer.

For the purpose of this PAR, cancer control research is defined as "basic and 
applied research in the behavioral sciences that independently or in 
combination with biomedical approaches, reduces cancer risk, incidence, 
morbidity, and mortality across the lifespan and over the entire process of 
carcinogenesis from primary behavioral prevention in youth, to screening, 
treatment, and survivorship" (Report of the NCI Cancer Control Progress 
Review Group, 1998).

RESEARCH OBJECTIVES

Background

Recognizing a need for training researchers in preventive oncology and the 
lack of multidisciplinary curricula that would be needed for this purpose, in 
1982 the National Cancer Institute (NCI) published the announcement titled 
"Preventive Oncology Academic Award" (NIH Guide for Grants and Contracts, 
Vol. 11, No. 5, April 23, 1982).  This award (POAA) provided support for the 
development of institutional preventive oncology curricula focusing 
specifically on etiologic studies and primary prevention of cancer.  In 1985 
the NCI, made two significant changes in the award.  First, the emphasis on 
support for institutional curriculum development was changed to support of 
research and career development of individuals wanting to make a transition 
to cancer prevention and control research and to individuals already trained 
in cancer prevention and control who are not yet fully independent 
investigators.  Second, the original focus on cancer etiology and primary 
cancer prevention was expanded to include all cancer prevention and control 
sciences and technologies from hypothesis development through demonstration.

In 1998, the National Cancer Institute completed major external reviews of 
its programs in cancer prevention and control sciences.  The scientific 
experts conducting these reviews identified the current level of support for 
training in cancer prevention and cancer control and the single discipline 
emphasis of these programs as being completely inadequate to take advantage 
of the new opportunities for reducing cancer incidence, morbidity and 
mortality. These experts recommended increasing the current level of NCI 
support of education/training programs in cancer prevention and cancer 
control and generating new opportunities for multidisciplinary training in 
these disciplines of basic and clinical scientists in highly 
interdisciplinary and collaborative environments.  Similar recommendations 
regarding training opportunities in cancer prevention and control have been 
made by other NCI advisory groups.  In 1999, the NCI published a new program 
announcement incorporating the recommendations made by these experts.  

Goals and Scope

The award provides support for up to five consecutive 12-month periods.  A 
minimum of 75 percent effort must be devoted to the program.  The remaining 
25 percent can be divided among other clinical and teaching activities and 
coursework only if these activities are consistent with the program goals, 
i.e. the candidate"s development into an independent investigator.  Both the 
didactic and the research phases of the award are expected to develop 
necessary knowledge and research skills in scientific areas relevant to the 
career goals of the candidate in cancer prevention, cancer control, and 
behavioral and population sciences research.  Candidates lacking skills in 
data management, statistics, epidemiology, study design, clinical trial 
design, hypothesis development, etc. can be provided the opportunity to 
participate in courses designed to overcome these deficiencies.

The Cancer Prevention, Control, Behavioral and Population Sciences Career 
Development Award provides a career development opportunity for: 1) 
individuals already proficient in general epidemiology, the behavioral 
sciences, or other relevant disciplines, and 2) individuals already trained 
in cancer epidemiology, etiology, prevention, control and the behavioral and 
population sciences to become fully independent investigators.  The scope of 
the research/didactic training may extend from the development and 
experimental testing of hypotheses, through the stage of confirming results 
using defined populations, to the development and demonstration of technology 
as applied to epidemiology, cancer prevention, cancer control, and the 
behavioral and population sciences as they relate to cancer.

The recipient must receive appropriate mentoring throughout the duration of 
the program.  Where feasible, women, minority individuals and individuals 
with disabilities should be involved as mentors and serve as role models.  
Candidates must name a primary mentor who, together with the applicant, is 
responsible for the planning, direction, and execution of the program.  The 
primary mentor should have sufficient independent research support to provide 
for any research costs of the candidate"s research program in excess of the 
research support provided by this award.  Candidates may also nominate 
co-mentors as appropriate to the goals of the program.

Allowable Costs

Salary: The K07 award can provide salary up to $75,000 plus fringe benefits.  
The total salary requested must be based on a full-time, 12-month appointment 
requiring the candidate to devote a minimum of 75 percent effort to 
conducting cancer research with the remaining effort being devoted to 
activities related to the development of a successful research career.  The 
salary must be consistent both with the established salary structure at the 
institution and with salaries actually provided by the institution from its 
own funds to other staff members of equivalent qualifications, rank, and 
responsibilities in the department concerned.  If full-time, 12-month 
salaries are not currently paid to comparable staff members, the salary 
proposed must be appropriately related to the existing salary structure.

Research Development Support:  Up to $30,000 per year can be provided for the 
following types of expenses: (a) research expenses, such as supplies, 
equipment, and technical personnel, (b) statistical services including 
personnel and computer time, (c) tuition, fees, and books related to career 
development, and (d) travel to research meetings or for training.

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

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

Evaluation

In carrying out its stewardship of human resource-related programs, the NIH 
may 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 their employment history, publications, support from research 
grants or contracts, honors and awards, professional activities, and other 
information helpful in evaluating the impact of the program.

Other Income

Fees resulting from clinical practice, professional consultation, or other 
comparable activities required by the research and research-related 
activities of this award may not be retained by the career award recipient. 
Such fees must be assigned to the grantee institution for disposition by any 
of the following methods:

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 benefits 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, Division 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, or honoraria from other institutions for 
lectures or seminars, and fees resulting from clinical practice, professional 
consultation or other comparable activities, provided these activities remain 
incidental, are not required by the research and research-related activities 
of this award, and provided that the retention of such pay is consistent with 
the policies and practices of the grantee institution.

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

Special Leave

Leave to another institution, including a foreign laboratory, with award 
support may be permitted if directly related to the purpose of the award.  
Only local, institutional approval is required if such leave does not exceed 
3 months.  For longer periods, prior written approval of the NCI is required.  
To obtain prior approval, the award recipient must submit a letter to the 
Grants Management Specialist listed on the Notice of Grant Award, 
countersigned by his or her department head and the appropriate institutional 
official, describing the reason for leave, and the accommodations that will 
be made at the new institution to ensure that the didactic training and 
research objectives at the new institution remain within the scope of the 
award.  THE AWARD RECIPIENT SHOULD CONTACT THE NCI PROGRAM DIRECTOR LISTED IN 
INQUIRIES BEFORE SUBMITTING THE LETTER.

Leave without award support may not exceed 12 months. Such leave requires the 
prior written approval of the NCI and will be granted only in unusual 
situations.  Support from other sources is permissible during the period of 
leave.  Such leave does not reduce the total number of months of program 
support for which an individual is eligible.  Parental leave will be granted 
consistent with the policies of the grantee institution.

Termination or Change of Institution:  When a grantee institution plans to 
terminate an award, the NCI Grants Management Specialist listed on the Notice 
of Grant Award must be notified in writing at the earliest possible time so 
that appropriate instructions can be given for termination.  If the 
individual is moving to another eligible institution, career award support 
may be continued provided:

o  The awardee has submitted to the NCI a written request for a transfer, 
countersigned by the appropriate institutional business official, describing 
the reasons for the transfer and including the new sponsor"s name and 
biosketch.  The awardee must establish in this request that the specific aims 
of the research program to be conducted at the new institution are within the 
scope of the original peer-reviewed research program, and that a new sponsor 
has been identified who has the appropriate research expertise and support to 
provide adequate guidance to the awardee and research support for the 
awardee"s research program.  The awardee should contact the NCI Program 
Director listed in INQUIRIES prior to submitting the request,

o  The NCI Program Director has recommended approval of the request and has 
forwarded the request for further evaluation to the Grants Management 
Specialist listed on the Notice of Grant Award,

o  A completed transfer application has been submitted to the Grants 
Management Specialist listed in the Notice of Grant Award far enough in 
advance of the requested effective date to allow the necessary time for 
review, establishing that all conditions of the initial award will be met at 
the new institution including the presence of a qualified mentor, and that 
the period of support requested does not exceed the time remaining within the 
existing award period.

Changes in Research Program

Individual awards are made for career development at a specific institution 
in a specific research program.  A change in the specified scientific area of 
the research component of the career development program requires prior 
approval of the NCI.

A scientific rationale must be provided for any proposed changes in the aims 
of the original peer-reviewed research plan.  The new research plan will be 
evaluated by NCI staff to ensure that the plan remains within the scope of 
the original peer-reviewed research program.  If the new plan does not 
satisfy this requirement, the award could be terminated.

In the event an award is terminated, the Director of the NIH shall notify the 
grantee institution and career award recipient in writing of this 
determination, the reasons therefore, the effective date, and the right to 
appeal the decision.

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

MECHANISM OF SUPPORT

This PA will use the National Institutes of Health (NIH) K07 award mechanism.  
Planning, direction, and execution of the program will be the responsibility 
of the candidate and her/his mentor on behalf of the applicant institution.  
The total project period for an application submitted in response to this PA 
may not exceed 5 years.  Awards made for a five-year project period, or 
recommended by peer review for a shorter project period, are not renewable.

ELIGIBILITY REQUIREMENTS

The candidate must have a Ph.D. degree, a health professional doctoral degree 
(M.D., Dr.PH., D.D.S., D.O., D.V.M., Pharm. D.) or equivalent, or be a 
doctorally prepared oncology nurse, and must have a research or academic 
appointment in the sponsoring institution at the time of award.  The 
candidate must be able to devote a minimum of 75 percent full-time 
professional effort conducting research and research career development 
activities during the period of the award.

Applications may be submitted on behalf of candidates by domestic, 
non-Federal organizations, public or private, such as medical, dental or 
nursing schools or other institutions of higher education.  Racial/ethnic 
minority individuals, women, and persons with disabilities are encouraged to 
apply as principal investigators.  Candidates must be U.S. citizens or 
noncitizen nationals, or must have been lawfully admitted for permanent 
residence and possess an Alien Registration Receipt Card (I-151 or I-551) or 
some other verification of legal admission as a permanent resident.  
Noncitizen nationals, although not U.S. citizens, owe permanent allegiance to 
the U.S.  They are usually born in lands that are not states, but are under 
U.S. sovereignty, jurisdiction, or administration.  Individuals on temporary 
or student visas are not eligible.

Current and former principal investigators on NIH Small Grants (R03) or 
Exploratory/Developmental Grants (R21) are eligible.  However, current and 
former principal investigators on NIH research project (R01), FIRST Awards 
(R29), sub-projects of program project (P01) or center grants (P50), or the 
equivalent, are not eligible.  A candidate for the K07 may not simultaneously 
submit or have pending an application for another career award (K01, K08, 
K23), a research project grant (R01, R03), or any other PHS award that 
duplicates the provisions of this award.  Awardees may submit an application 
for an NCI Transition Career Development Award (K22), and are encouraged to 
actively seek independent support of their research programs through 
investigator-initiated grants during the term of this award.

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Dr. Brian W. Kimes
Cancer Training Branch
National Cancer Institute
6116 Executive Boulevard, Suite 7001, MSC 8345
Bethesda, MD  20892-8346
Telephone:  (301) 496-8537
FAX:  (301) 402-0181
E-mail:  bk34t@nih.gov   

Direct inquiries regarding fiscal matters to:

Ms. Catherine Blount
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, MD  20892
Telephone:  (301) 496-3179
FAX:  (301) 496-8601
Email:  cb136g@nih.gov

Direct inquiries regarding review matters to:

Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8109, MSC 8329  
Bethesda, MD  20892-8329
Telephone:  (301) 496-3428
FAX:  (301) 402-0275
Email:  tf12w@nih.gov

APPLICATION PROCEDURES

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

This version of the PHS 398 is available in an interactive, searchable PDF 
format. Although applicants are strongly encouraged to begin using the 5/2001 
revision of the PHS 398 as soon as possible, the NIH will continue to accept 
applications prepared using the 4/1998 revision until January 9, 2002. 
Beginning January 10, 2002, however, the NIH will return applications that 
are not submitted on the 5/2001 version.  For further assistance contact 
GrantsInfo, Telephone 301/435-0714, Email: GrantsInfo@nih.gov.

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

All clinical trials supported or performed by NCI require some form of 
monitoring.  The method and degree of monitoring should be commensurate with 
the degree of risk involved in participation and the size and complexity of 
the clinical trial.  Monitoring exists on a continuum from monitoring by the 
principal investigator/project manager or NCI program staff to a Data and 
Safety Monitoring Board (DSMB).  These monitoring activities are distinct 
from the requirement for study review and approval by an Institutional Review 
Board (IRB).  For details about the Policy of the NCI for Data Safety 
Monitoring of Clinical Trials see 
http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm.  For Phase I and II 
clinical trials, investigators must submit a general description of the data 
and safety monitoring plan as part of the research application.  See NIH 
Guide Notice on “Further Guidance on a Data and Safety Monitoring for Phase I 
and II Trials” for additional information:  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html.  
Finally, for details on the essential elements of  a data and safety 
monitoring plan for clinical trials funded by the National Cancer Institute 
and for how the NIH/NCI policies on data safety and monitoring apply to NCI 
K-awards, see: 
http://nci.nih.gov/clinicaltrials/conducting/dsm-guidelines.

Submit a signed, typewritten original of the application, including the 
checklist, and three signed exact, single-sided photocopies, in one package 
to:

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

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

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

The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application. The 
CSR will not accept any application that is essentially the same as one 
already reviewed. This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must 
include an introduction addressing the previous critique.

The information summarized below must be provided in the application: 

Candidate

o  Describe the candidate"s commitment to an academic career in cancer 
prevention, cancer control, epidemiology, or the behavioral/ population 
sciences as these disciplines relate to cancer prevention and control,

o  Present evidence of the candidate"s ability to interact and collaborate 
with other scientists,

o  Discuss prior training and how it relates to the objectives and career 
plans of the candidate,
 
o  Discuss the candidate"s research efforts to this point in his/her research 
career,

o  Letters of recommendation.  Include three sealed letters of recommendation 
from well-established scientists with the application addressing the above 
areas and any other evidence that the candidate has a high potential for 
becoming an independent investigator in cancer research. The mentor(s) may 
also submit letters of reference, but these letters will be considered 
independently of the three recommendations. All letters should be attached to 
the front page of the application.

Career Development Plan

o  Present a systematic plan that shows a logical progression from the 
candidate’s prior research and training experiences to the training and 
research experiences that will occur during the K07 award period to 
independent investigator status.  This plan must provide justification of the 
need for further career development to become an independent investigator,

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

Research Plan

o  Describe the research plan using Form PHS 398 (rev. 5/01 or subsequent 
revisions) following instructions for the Specific Aims, Background and 
Significance, Progress Report/Preliminary Studies, Research Design and 
Methods.  The candidate should consult with the mentor regarding the 
development of this section.  A sound research project that is consistent 
with the candidate"s level of research development and objectives of their 
career development plan must be provided.

Mentor"s Statement

o  The application must include a statement from the mentor providing 
information on their research qualifications and previous experience as a 
research supervisor.  Information on the mentor’s active/pending research 
support related to the candidate’s research plan should not be included in 
this statement, but should be provided in the mentor’s biosketch. 
o  Similar information must be provided by any co-mentor. If more than one 
mentor is proposed, the respective areas of expertise and responsibility of 
each should be described.

Environment and Institutional Commitment

o  Describe the resources and facilities that will be available to the 
candidate,

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

o  In a clear statement, provide assurances that the candidate will be able 
to devote a minimum of 75 percent of his/her full-time professional effort in 
the development of his/her research program, with the remaining percent 
effort being devoted to activities related to the development of their 
research career.

Biographical Sketch

A biographical sketch is required for the applicant and all key personnel.  
Provide information on research projects completed and/or research grants 
participated in during the last five years that are relevant to the proposed 
project.

Budget

Provide a detailed description, with justification, for all equipment, 
supplies and personnel that will be used to help achieve the career 
development and research objectives of this award.

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS referral 
guidelines.  Applications will be reviewed for completeness by the Center for 
Scientific Review and for adherence to guidelines by the National Cancer 
Institute.  Incomplete or non-responsive applications will be returned to the 
applicant without further consideration.  Applications that are complete and 
responsive to the program announcement will be evaluated for scientific and 
technical merit by an appropriate scientific review group convened by the 
Division of Extramural Activities of the National Cancer Institute in 
accordance with the standard NIH peer review procedures.  As part of the 
initial merit review, all applications will receive a written critique, and 
may undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of applications under 
review, will be discussed, assigned a priority score, and receive a second 
level review by the National Cancer Advisory Board.

The following review criteria will be applied:

Candidate

o  Commitment of the candidate to an academic career in cancer prevention, 
cancer control, epidemiology, or to the behavioral or population sciences as 
these disciplines relate to cancer prevention and control,

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

o  Quality of the prior scientific training and experience, including 
publications that establish the innovativeness of the candidate"s research 
and a high potential for an independent research career,

o  Recommendations of three well-established scientists attesting to the 
special potential of the individual to pursue an independent career in cancer 
research.  Letters of reference submitted by mentor(s)/ co-mentor(s) will be 
considered independently of the three recommendations. 

Career Development Plan

o  Likelihood that the plan will contribute substantially to the scientific 
development of the candidate, based on:
- Candidate"s prior training and research experience,
- Appropriateness of the goals and scope of the plan to complement prior 
training/research experience and achieve the stated training and research 
objectives,

o  Appropriateness of the proposed activities for the proposed award period,

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

Research Plan

o  Degree of relevance of the research plan to developing an independent 
research program focused on cancer prevention, cancer control, epidemiology, 
or the behavioral/population sciences as they relate cancer prevention and 
control,

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

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

Mentor/Co-Mentor (s)

o  Appropriateness of the mentor"s research qualifications in the area of the 
proposed research,

o  Previous experience in fostering the development of cancer researchers,

o  History of research productivity and peer-reviewed support,

o  Adequacy of active/pending support for the proposed research project.

Environment and Institutional Commitment

o  Clear commitment of the institution to ensure that a minimum of 75 percent 
of the candidate"s full-time professional effort will be devoted directly to 
research, with the remaining percent effort being devoted to activities 
related to the successful development of a research career,

o  Adequacy of research facilities and training opportunities,

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

Budget

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

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o  scientific merit (as determined by peer review)
o  availability of funds
o  programmatic priorities.

The NCI will notify the applicant of the National Cancer Advisory Board"s 
(NCAB) action.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

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

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by 
NIH, unless there are clear and compelling scientific and ethical reasons not 
to include them.  This policy applies to all initial (Type 1) applications 
submitted for receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy And Guidelines on The Inclusion of Children as Participants in 
Research Involving Human Subjects" that was published in the NIH Guide For 
Grants And Contracts, March 6, 1998 and is available at the following URL 
address:  http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

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

REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

All investigators proposing research involving human subjects should read the 
NIH policy on education in the protection of human research participants now 
required for all investigators, which is published in the NIH Guide for 
Grants and Contracts, June 5, 2000 (Revised August 25, 2000), available at 
the following URL address:  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.  
A continuing education program in the protection 
of human participants in research is now available online at 
http://cme.nci.nih.gov/.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT 

The Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.  
Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.  

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained within 
specified page limitations.  Unless otherwise specified in a NIH 
solicitation, Internet addresses (URLs) should not be used to provide 
information necessary to the review because reviewers are under no obligation 
to view the Internet sites.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site 
(see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-004.html).

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

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2010," a PHS-
led national activity for setting priority areas.  This PA, “Cancer 
Prevention, Control, Behavioral and Population Sciences Career Development 
Award”, is related to the priority area of human resource development.  
Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople/

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance 
Number 93.398, Cancer Research Manpower.  Awards are made under the 
authorization of Sections 301 and 405 of the Public Health Service Act as 
amended (42 USC 241 and 284) and administered under NIH grants policies and 
Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.  This program 
is not subject to the intergovernmental review requirements of Executive 
Order 12372 or Health Systems Agency review.

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



Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
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Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
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