ESTABLISHED INVESTIGATOR AWARD IN CANCER PREVENTION, CONTROL, BEHAVIORAL, AND 
POPULATION SCIENCES

RELEASE DATE:  July 8, 2003

PA NUMBER:  PAR-03-149 (This PAR has been reissued, see PAR-05-145)

EXPIRATION DATE:  June 2, 2005, unless reissued.

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

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS:  93.393, 93.398, 93.399

This Program Announcement (PAR) replaces PAR-00-039, which was published in 
the National Institutes of Health (NIH) Guide on January 10, 2000.

THIS PAR CONTAINS THE FOLLOWING INFORMATION

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

PURPOSE OF THIS PAR

The purpose of the NCI Established Investigator Award in Cancer Prevention, 
Control, Behavioral and Population Research (K05) is to provide established 
investigators protected time to devote to research and to act as mentors for 
new investigators and junior faculty members.  The target candidates are 
outstanding established scientists who have demonstrated a sustained, high 
level of research productivity and significant contributions to cancer 
prevention, control, behavioral and/or population cancer research.  They must 
demonstrate the need to develop and enhance their own research and a 
commitment to serve as mentors to new scientists.  The award provides salary 
support for up to five years and it is renewable for one additional five-year 
period. The NCI is especially interested in training and retaining scientists 
who conduct high-quality research in cancer prevention, control, behavioral, 
and population sciences.  Accordingly, this award is an important part of the 
NCI Strategic Training Plan to relieve researchers from administrative and/or 
clinical responsibilities in order to help them focus on mentoring and 
research.

Examples of disciplines relevant to this PAR include any aspect of human 
cancer prevention (health promotion, modifiable risk factors, new animal 
models and extrapolation of these models to human cancer, genetic 
predisposition to cancer, detection of precursor lesions, chemoprevention 
trials in human populations, behavioral research and behavioral intervention 
trials), epidemiology (classic, genetic, molecular), biostatistics, human 
cancer genetics, human nutrition, health services and health policy research, 
medical decision analysis, survivorship and quality of life as they relate to 
cancer, and basic and applied research in the behavioral sciences that 
independently or in combination with biomedical approaches, reduces cancer 
risk, incidence, morbidity, and mortality over the lifespan and across the 
entire process of carcinogenesis from primary behavioral prevention in youth, 
to screening, treatment, and survivorship.

OBJECTIVES

A. Background:  In 1998, the National Cancer Institute completed major 
external reviews of its cancer prevention and control sciences programs.  The 
scientific experts conducting these reviews recommended strengthening the 
NCI-supported cancer prevention program by increasing support of research on 
modifiable risk factors, new animal models and extrapolation of these models 
to human cancer, genetic predisposition to cancer, detection of precursor 
lesions, chemoprevention trials in human populations, and behavioral research 
and behavioral intervention trials in cancer prevention.  Recommendations 
made by the scientific experts for research areas of emphasis in cancer 
control included: basic behavioral and social research, communications and 
informatics, rehabilitation and survivorship, quality of life, screening 
research, and applied cancer control research, including health services and 
health policy research.  These groups also recommended bringing senior 
scientists into the NCI for short periods of time to collaborate with the NCI 
researchers and program staff.

The cancer prevention and cancer control review groups independently 
identified the current level of support for training in cancer prevention and 
cancer control as being inadequate to take full advantage of the new 
opportunities for reducing cancer incidence, morbidity and mortality.  The 
scientific experts on these review groups recommended expanding current NCI 
support of education/training programs in cancer prevention and cancer 
control, and multidisciplinary training of basic and clinical scientists in 
highly interdisciplinary and collaborative environments.  Other NCI advisory 
groups have made similar recommendations.

The NCI Cancer Training Branch responded to these recommendations in 1998 
with the NCI Strategic Training Plan.  A major focus of this plan was to 
provide new training and career development opportunities for young 
investigators in the cancer prevention, control and population sciences.  
Additionally, to address the projected needs of the mentors for these young 
investigators, the strategic plan proposed the use of a career award grant 
mechanism to provide senior investigators "protected" time to stabilize their 
research programs and for mentoring new investigators.

B. Program: The award provides five consecutive 12-month appointments.  At 
least 25 percent and up to 50 percent of the recipient's full-time 
professional effort must be devoted to the program and the remainder devoted 
to other research-related and/or teaching pursuits consistent with the 
objectives of the award.

C. Environment:  The institution must have a well-established research and 
career development program in cancer prevention, control, and population 
sciences.  The institution must be able to demonstrate a commitment to the 
candidate as a productive, independent investigator. The candidate and 
institution must certify that the candidate will be released from other 
duties and be able to devote 25 to 50 percent effort to achieve the research 
and mentoring objectives of this award.  The institution must also document 
an adequate pool of candidates for mentoring.

MECHANISM OF SUPPORT 

This PAR will use the NIH K05 award mechanism.  The Established Investigator 
Award in Cancer Prevention, Control, Behavioral and Population Research is a 
special NCI modification of the NIH Senior Scientist Award or K05 grant 
mechanism. As an applicant, you will be solely responsible for planning, 
directing, and executing the proposed project. In addition, the institution 
must demonstrate a commitment to the candidate and the candidate's goals for 
career development.  The project period may be for up to five years (at least 
three years are required). Awards are renewable for one additional five-year 
period if the candidate still meets the stated requirements.

This PAR uses the "just-in-time" application procedures and the Streamlined 
Non-competing Application Process (SNAP).  

ELIGIBLE INSTITUTIONS 

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

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

Foreign institutions are not eligible to apply.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Candidates for this award must meet the following requirements:

o  Must be established cancer scientists with a strong track record of 
publications and successful competition for cancer research support.
o  Must have peer-reviewed, independent research support at the time of, and 
during the entire duration of, the award.  This support could include NIH 
awards (e.g., R01) or awards from other sources, as long as they are 
equivalent to NIH R01 type grants in complexity and duration.  Individuals 
holding small grants (R03s) or developmental grants (R21s) are not eligible.  
However, scientists whose work is primarily theoretical may apply for this 
award in the absence of research grant support, if the institutional 
commitment includes stability of salary and research support.
o  Must have a record of supervising junior researchers.
o  Must demonstrate the need for protected time to advance their research 
careers and mentoring activities.
o  Must be U.S. citizens or non-citizen 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.  Non-citizen nationals, although not U.S. citizens, owe 
permanent allegiance to the U.S.  They are usually born in lands that are not 
states but under U.S. sovereignty, jurisdiction or administration. 
Individuals on temporary or student visas are not eligible.

Individuals from underrepresented racial and ethnic groups as well as 
individuals with disabilities are always encouraged to apply for NIH 
programs.

A candidate for this award may not concurrently apply for any other PHS award 
that duplicates the provisions of this award.

ALLOWABLE COSTS

1. Salary:  The NCI will provide salary for the award recipient up to the 
current Federal salary rate limit plus commensurate fringe benefits for up to 
50 percent effort.  The institution may supplement the NIH contribution up to 
a level that is consistent with the institution's salary scale.  
Institutional supplementation of salary must not require extra duties or 
responsibilities that would interfere with the purpose of the award. 

The total salary requested must be based on a full-time, 12-month staff 
appointment and the level of effort proposed.  It must be consistent both 
with the established salary structure at the institution and with salaries 
actually provided by the institution from its own funds to other staff 
members of equivalent qualifications, rank, and responsibilities in the 
department concerned. If full-time, 12-month salaries are not currently paid 
to comparable staff members, the salary proposed must be appropriately 
related to the existing salary structure. The award will also provide fringe 
benefits on the calculated base salary at the established institutional rate.

Recipients of this award may derive additional compensation for the effort 
associated with other federal sources or awards provided the total salary 
derived from all Federal sources does not exceed the current Federal salary 
rate limit and their total percent effort on all awards does not exceed 100 
percent.  Direct salary is exclusive of fringe benefits, indirect costs/ 
facilities, and administrative expenses.

2. Research Development Support:  It is expected that candidates for a K05 
award will have active, independent research support at the time of the award 
(see eligibility requirements).  However, the K05 award provides additional 
funds up to $25,000 direct costs per year for the following expenses:  (a) 
tuition, fees, and books related to career development; (b) research 
expenses, such as supplies, equipment and technical personnel; (c) 
statistical and computational services including personnel and computer time; 
and (d) travel to research meetings or training. 
 
3. Ancillary Personnel Support: Salaries for secretaries, administrative 
assistants and other ancillary personnel are not allowed.

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

5. 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 funds must be assigned to the grantee institution for 
disposition by any of the following methods:

o  The funds may be expended by the grantee institution in accordance with 
NIH policy on supplementation of career award salaries and to provide fringe 
benefits in proportion to such supplementation.  Such salary supplementation 
and fringe benefit payments must be within the established policies of the 
grantee institution.
o  The funds may be used for health-related research purposes.
o  The funds may be paid to miscellaneous recipients of the U.S. Treasury.  
Checks should be made payable to the Department of Health and Human Services 
(DHHS), NIH, and forwarded to the Director, Division of Financial Management, 
NIH, Bethesda, Maryland 20892.  Checks must identify the relevant award 
account and reason for payment.
o  Awardees may retain royalties and fees for activities such as scholarly 
writing, service on advisory groups, or honoraria from other institutions for 
lectures or seminars, provided these activities remain incidental and 
provided that the retention of such pay is consistent with the policies and 
practices of the grantee institution.

SPECIAL REQUIREMENTS

1. Special Leave:  Leave to another institution, including a foreign 
laboratory, may be permitted if directly related to the purpose of the award.  
Awardees planning a period of leave must submit a written request to the NCI 
in advance of the leave.  This request must be countersigned by the 
appropriate business official at the grantee's institution and at the new 
institution/facility.  This request must include the reasons for the leave 
and must provide a description of the provisions that will be made to ensure 
that the awardee will be able to continue meeting the special requirements of 
this award for a suitable research environment and for opportunities to 
mentor junior investigators during the period of leave.  NCI staff will 
review the request and notify the principal investigator and the new grantee 
institution of the results of this evaluation.  If the request is approved, 
support will continue during the leave period.

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

2. Termination or Change of Institution: When the grantee institution plans 
to terminate the award, the NCI 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  A new  application for a K05 award is submitted by the new institution.
o  All conditions of the award are met at the new institution.
o  The period of support requested is no more than the time remaining within 
the existing award period.
o  The new application is submitted far enough in advance of the requested 
effective date to allow the necessary time for NCI review.  Review of these 
materials is usually carried out by NCI staff.  However, depending upon the 
circumstances, the NCI may also require a review by an initial review group 
and/or the National Cancer Advisory Board.

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

3. Final Progress Report: 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.

4. Evaluation by NCI: In carrying out its stewardship of human resource 
related programs, NCI may request information essential to an assessment of 
the effectiveness of this program.  Accordingly, recipients are hereby 
notified that they may be contacted after the completion of this award for 
periodic updates on various aspects of 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.

WHERE TO SEND INQUIRIES

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

o Direct your questions about scientific/research issues to:

Dr. Maria Agelli
Cancer Training Branch 
National Cancer Institute
Building 6116, Room 7021
Bethesda, MD 20892
Rockville, MD 20852 (express courier)
Telephone:  (301) 496-8580
FAX:  301-402-4472
Email: ma215e@nih.gov

o Direct your questions about peer review issues to:

Referral Officer 
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Telephone: (301) 496-3428
FAX: (301) 402-0275 
Email:  ncirefof@dea.nci.nih.gov

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

Ms. Catherine Blount
National Cancer Institute
Grants Administration Branch
6120 Executive Blvd.
Room EPS 243
Bethesda, MD 20892
Phone: (301) 496-3179
Fax: (301) 496-8601
E-mail: blountc@mail.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 

http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

Form PHS 398 gives specific instruction for Research Career Awards (section 
IV, pages 55-62) and provides an alternative table of content that should be 
used.  In general, the instructions provided by PHS 398 should be followed. 

To make sure that the application is identified as a response to this program 
announcement, check "YES" on item 2 of the face page (page 1) of the 
application and enter the title and the number of this PAR.

Following the alternative table of content provided by PHS, specific 
suggestions are given to clarify NCI specific requirements for this award.

Section I: Basic Administrative Data
Point 6: indicate all other support of applicant.
Please note that to be eligible for the K05 award the candidate must have 
other research support when s/he applies and for the entire period of the 
award. A complete list of all sources of active research support and pending 
research support must be provided.

Section II: Specialized Information
Point 2: Letters of reference are not required.

Point 3A: Candidate background should be split in: a) candidate research 
background and b) candidate mentoring background

Point 3C: Career development activities during Award period. Justification of 
the need for this award should be included.

It is important to convey to the reviewers your reasons for needing protected 
time to continue a vital research program and continue to engage in the 
mentoring of new scientists.  It should be clear that this award will allow 
you to spend more time on research and mentoring and less time on 
administrative and clinical responsibilities for the institution.

Point 4: Statement by sponsor(s), consultant(s), and collaborator(s) is not 
required.

Point 5: Environmental and Institutional Commitment to Candidate
It will be helpful to the reviewers to understand what duties and 
responsibilities in the institution you are being relieved of to focus on 
research and mentoring AND how the institution will accommodate these 
activities with other staff.

Point 6: Research Plan
Candidate must specify the overall percent of effort that s/he will dedicate 
to research and the specific percent effort on this award (K05) that will be 
committed to currently supported research.  Candidate should present such 
effort as instructed in form PHS 398.  There is no need to provide extensive 
detail with regard to ongoing, funded research.  However, enough information 
should be provided in the areas of Hypothesis and Specific Aims; Background, 
Significance and Rationale; Preliminary Studies and Results; and Research 
Design and Methods for the reviewers to evaluate the extent, special 
features, and general quality of the research activities.

In addition, candidate should describe a research plan for new research to be 
specifically supported by this grant (K05), inclusive of   
- Hypothesis and Specific Aims
- Significance and Rationale
- Research Design and Methods
  
It is likely that most of the described research will be ongoing; however, 
the candidate must provide documentation that all issues related to human 
subjects and/or to vertebrate animals have already been adequately addressed 
in ongoing research. For each new research project, the candidate must 
provide the information required and described in the General Instructions in 
PHS Form 398 and demonstrate that the inclusion of women, members of minority 
groups and their subpopulations, and children, has been adequately addressed. 
If vertebrate animals are to be used in the project, the five items described 
under Section f of the PHS 398 research grant application instructions (rev. 
5/2001) should be addressed.  

ADD new point 7: Mentoring Plan
Specify the percent effort to be committed to mentoring on this grant (K05), 
including:
- Availability of candidates that will be recruited for mentoring. Please 
describe: degree, specialization, and previous training of these individuals. 
- A plan for recruitment and supervision.
- Educational and research experiences that will be provided.
- Specific role as mentor for trainees and for junior faculty members to 
guide them in achieving a successful, independent research career in cancer 
prevention, control, behavioral, and population sciences.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which 
are available at http://grants.nih.gov/grants/dates.htm.  Application 
deadlines are also indicated in the PHS 398 application kit.

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

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

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

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Blvd., Room 8062 – MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service)

APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER INSTITUTE 
WILL NO LONGER BE ACCEPTED.  This policy does not apply to courier deliveries 
(i.e. FEDEX, UPS, DHL, etc.)
(http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html)  
This change in practice is effective immediately.  
This policy is similar to and consistent with the policy for applications 
addressed to Centers for Scientific Review as published in the NIH Guide 
Notice http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.

APPLICATION PROCESSING: Applications must be mailed on or before the receipt 
dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not 
accept any application in response to this PAR that is essentially the same 
as one currently pending initial review unless the applicant withdraws the 
pending application.  The CSR will not accept any application that is 
essentially the same as one already reviewed.  This does not preclude the 
submission of a substantial revision of an application already reviewed, but 
such application must include an Introduction addressing the previous 
critique.  

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the Center 
for Scientific Review and for adherence to the guidelines of this PAR by NCI 
staff. Applications that are incomplete, as determined by the Center for 
Scientific Review, and that do not adhere to the guidelines of this PAR, as 
determined by NCI staff, will not receive further consideration.  

Applications that are complete and adhere to the guidelines of this PAR will 
be evaluated for scientific and technical merit by an appropriate peer review 
group convened by the Division of Extramural Activities of the NCI in 
accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

o  Receive a written critique
o  Undergo a selection process in which only those applications deemed to 
have the highest scientific merit, generally the top half of applications 
under review, will be discussed and assigned a priority score
o  Receive a second level review by the National Cancer Advisory Board to 
ensure that the proposed program meets the broad programmatic needs of the 
NCI and the National Cancer Program. 

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 discuss the following 
aspects of the application in order to judge the likelihood that the proposed 
research will have a substantial impact on the pursuit of these goals: 
  
1. Candidate:
o  Quality of the candidate's academic and research record, and track record 
as a leader of a productive research program.
o  Evidence of ongoing high-quality research in cancer prevention, control, 
behavioral, or population sciences and the relationship of that research to 
the proposed K05 program.
o  A strong track record of obtaining research support in the cancer 
prevention, control, behavioral, or population sciences.
o  A demonstrated record of mentoring or training of investigators, or a 
demonstration of the capability to provide mentoring to junior investigators.

2. Justification:
o  Demonstration that the proposed program and protected time will relieve 
the candidate of existing administrative (and where appropriate, clinical) 
duties to permit additional time for research and mentoring.

3. Career and research plan:
o  Appropriateness of the research plan as a vehicle for developing and 
refining skills and capabilities in cancer prevention, control, behavioral, 
and population sciences research.
o  Scientific and technical merit of the ongoing and newly proposed research.
o  Likelihood of research contributing significantly to the scientific 
knowledge base.
o  Appropriateness of the duration of the proposed research program.
o  Availability of adequate resources to conduct the research program.
o  Appropriateness of proposed level of effort committed to the Research 
Plan.

4. Mentoring Plan:
o  Experience and potential of the candidate to serve as a mentor.
o  Adequacy of the plans for mentoring or supervising junior investigators in 
cancer prevention, control, behavioral, or population sciences research.
o  Appropriateness of the proposed level of effort committed to the Mentoring 
Plan.

5. Environment and Institutional Commitment:
o  Quality and relevance of the environment for scientific and professional 
development of the candidate and trainees pursuing research in cancer 
prevention, control, behavioral, and population sciences.
o  Adequacy of the applicant institution's commitment to provide protected 
time for conduct of the research and the mentoring programs and to the career 
development of the candidate. 

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

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 
subjects and protections from research risk relating to their participation 
in the proposed research will be assessed. (See criteria included in the 
section on Federal Citations, below).

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of 
plans to include subjects from both genders, all racial and ethnic groups 
(and subgroups), and children as appropriate for the scientific goals of the 
research will be assessed.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the sections on 
Federal Citations, below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to 
be used in the project, the five items described under Section f of the PHS 
398 research grant application instructions (rev. 5/2001) will be assessed.  

ADDITIONAL CONSIDERATIONS 

DATA SHARING:  The adequacy of the proposed plan to share data. 

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

AWARD CRITERIA

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

o  Scientific merit of the proposed project as determined by peer review
o  Availability of funds 
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.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 

MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

Clinical trials supported or performed by NCI require special considerations.  
The method and degree of monitoring should be commensurate with the degree of 
risk involved in participation and the size and complexity of the clinical 
trial.  Monitoring exists on a continuum from monitoring by the principal 
investigator/project manager or NCI program staff or a Data and Safety 
Monitoring Board (DSMB).  These monitoring activities are distinct from the 
requirement for study review and approval by an Institutional review Board 
(IRB).  For details about the Policy for the NCI for Data and Safety 
Monitoring of Clinical trials see: 
http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm.  For Phase I and II 
clinical trials, investigators must submit a general description of the data 
and safety monitoring plan as part of the research application.  See NIH 
Guide Notice on "Further Guidance on a Data and Safety Monitoring for Phase I 
and II Trials" for additional information: 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html.  
Information concerning essential elements of data safety monitoring plans for 
clinical trials funded by the NCI is available:  
http://www.cancer.gov/clinical_trials/

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of 
the research. This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43).

All investigators proposing clinical research should read the "NIH Guidelines 
for Inclusion of Women and Minorities as Subjects in Clinical Research - 
Amended, October, 2001," published in the NIH Guide for Grants and Contracts 
on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them. This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.  A 
continuing education program in the protection of human participants in 
research is available online at: http://cme.nci.nih.gov/

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research 
on hESCs can be found at http://stemcells.nih.gov/index.asp and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).  
It is the responsibility of the applicant to provide the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review. 

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

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

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modification to 
the "Standards for Privacy of Individually Identifiable Health Information", 
the "Privacy Rule," on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR).  Those who must comply with the Privacy Rule (classified 
under the Rule as "covered entities") must do so by April 14, 2003 (with the 
exception of small health plans which have an extra year to comply).  

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

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

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

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

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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Research (OER)
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and Human Services (HHS)
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