This Program Announcement expires on February 22, 2003, unless 
otherwise specified.

COHORT STUDIES IN CANCER EPIDEMIOLOGY
 
Release Date:  October 11, 2001 (see addenda NOT-CA-02-026, NOT-CA-03-030)
 
PA NUMBER:  PAS-02-009 (see replacement PAR-04-011)
 
National Cancer Institute

Letter of Intent Dates:     January 18, 2002, and January 17, 2003
Application Receipt Dates:  February 21, 2002, and February 21, 2003

PURPOSE

The Division of Cancer Control and Population Sciences (DCCPS) of the 
National Cancer Institute (NCI) announces an annual receipt date for R01 
grant applications from investigators intending to initiate, competitively 
supplement, or competitively renew epidemiologic cohort studies of human 
cancers.  The purpose of this Program Announcement (PA) is to coordinate the 
submission, review, and funding of epidemiologic cohort studies, and covers 
applications characterized by their cohort design and direct costs of 
$500,000 or more in any study year.  This PA represents a change in NCI 
policy, in that NCI will no longer accept unsolicited applications at these 
budget levels for epidemiologic cohorts.  All usual NIH Grants policies apply 
to these awards.  It is anticipated that this PA will be issued annually.

RESEARCH OBJECTIVES

There has been a rapid increase in the average costs of grants submitted to 
the NCI as well as similar growth in the number of grants with direct costs 
of $500,000 and higher.  A substantial number of these more expensive grants 
are cohort studies.  This research is increasingly expensive and may vary 
widely in terms of cost per year per participant.  In light of recent 
acceleration in the number of applications submitted to establish new cohorts 
and their escalating costs, the NCI is instituting a new approach for 
acceptance of such applications. 

Cohort designs are one of the mainstays of epidemiologic inquiry, and have 
the clear advantage over retrospective study designs of unbiased assessment 
of pre-diagnostic exposures and the ability to assess multiple outcomes.  
They are, however, substantially more time-consuming and expensive than most 
case-control approaches and less suitable for study of more uncommon 
outcomes, which may include certain cancers.  Once an epidemiologic cohort is 
established, and data and biospecimens become available, it typically becomes 
an attractive infrastructure for additions or supplements to address new 
areas of scientific investigation.  Sometimes, the cohort can be used to 
study diseases in addition to cancer. 

Rigorous scientific inquiry in gene-gene and gene-environment interactions 
has raised the awareness of the role of cohorts, with a concomitant increase 
in number, scale, and costs of the research grants. While cohort studies have 
been tremendously useful tools, cohort research proposals are frequently 
submitted without full acknowledgement of existing cohorts.  For these 
reasons, integrating, prioritizing, and funding epidemiologic cohort studies 
has become an issue for the NCI.  Issues of key interest to the Institute 
with regard to these population resources include continuity of funding, 
balance of important cohort characteristics, quality of design, rigor of 
exposure assessment, response and follow-up rates, biospecimen collection and 
storage, bioinformatics, availability of biospecimen resources to outside 
qualified investigators, and other areas.  

Because of constraints on the NCI budget resulting from the existence of 
numerous epidemiologic cohort studies, and the necessity for consistency in 
the review of these large projects, the NCI has decided to accept 
applications once a year in response to an annually issued PA.

RESEARCH OBJECTIVES

This PA covers epidemiologic cohort applications requesting $500,000 or more 
in direct costs (including third-party facility and administrative, formerly 
indirect, costs) in any project year.  Examples of applications that MUST be 
submitted under this solicitation include the following:

--applications for new epidemiologic cohort studies of human cancers 
requesting $500,000 direct costs or more in any one project year

--applications for competitive supplements to an NCI-funded epidemiologic 
cohorts that would result in a cohort study costing $500,000 direct costs or 
more in any one project year

--requests for competitive supplements to an NCI-funded epidemiologic cohort 
study currently funded for $500,000 direct costs or more in any one project 
year

--applications for competitive renewal (Type 2) of an NCI-funded 
epidemiologic cohort study requesting $500,000 direct costs or more in any 
one project year 

This solicitation specifically EXCLUDES the following:

--applications for new and existing epidemiologic cohort studies of HIV-
related malignancies, which will continue to be submitted and reviewed under 
existing NIH guidelines for AIDS-related research and under PA-00-086, 
Molecular Epidemiology of HIV-Associated Cancers

--requests for administrative supplements such as those resulting from 
unexpected loss of equipment or increase in costs of a test

MECHANISM OF SUPPORT

This PA will use the National Institutes of Health (NIH) investigator-
initiated (R01) grant mechanism.  Responsibility for planning, direction, and 
execution of the proposed project will be solely that of the applicant.  The 
total project period for an application submitted in response to the PA may 
not exceed FIVE years.  The earliest anticipated award date is December, 
2002.  

Revisions of unsuccessful applications submitted under this PA will ONLY be 
accepted in response to future re-issuances of this PA.  The next submission 
date is February 21, 2003.  Revised versions of unsuccessful applications may 
NOT be submitted under other mechanisms, including submission of revised 
applications to the NIH Center for Scientific Review (CSR) for the standard 
R01 receipt dates.  NCI will no longer accept unsolicited applications, 
including revisions, for cohort studies costing $500,000 or more in any study 
year.  Applicants are strongly encouraged to discuss revisions with program 
staff.

Though the size of award may vary with the scope of research proposed, 
applications must stay within the NCI budgetary guidelines for R01 
investigator-initiated competing projects.  Applications for competitive 
renewal of existing cohorts (Type 2 applications) will be limited to a 20 
percent increase (including third-party facility and administrative, formerly 
indirect, costs) over the most-costly Type 5 year.  Further information on 
NCI policy in this area may be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-CA-01-016.html.  Budgets 
will be an important consideration in funding decisions, and applicants are 
strongly encouraged to discuss their budgets with program staff. Letters of 
Intent are due January 18, 2002 (for the first receipt date), and January 17, 
2003 (for the second receipt date), and are strongly encouraged.

FUNDS AVAILABLE

The NCI intends to allocate up to $12 million (total costs) in first-year 
costs for this initiative in this solicitation cycle, with the allocation for 
first-year costs in the second cycle still to be determined. Other things 
being equal, cost may be considered in making awards.  Because the nature and 
scope of the research proposed will vary, it is anticipated that the size of 
each award also will vary.  Although the financial plan of NCI provides 
support for this program, awards pursuant to this PA are contingent upon the 
availability of funds and receipt of a sufficient number of applications of 
high scientific and technical merit.  

ELIGIBILITY REQUIREMENTS
 
Applications pursuant to this PA are limited to epidemiologic cohort studies 
of human cancers.  Applications may be submitted by foreign and domestic for-
profit and non-profit organizations, public and private, such as 
universities, colleges, hospitals, laboratories, units of State and local 
governments, and eligible agencies of the Federal government.  Racial/ethnic 
minority individuals, women, and persons with disabilities are encouraged to 
apply as principal investigators. 

INQUIRIES
 
Inquiries are encouraged.  The opportunity to clarify any issues or questions 
from potential applicants is welcome.
 
Direct inquiries regarding programmatic issues to:

Sandra L. Melnick, Dr. P.H.
Chief, Analytic Epidemiology Research Branch
Epidemiology and Genetics Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
Executive Plaza North, Room 5100, MSC 7324
Bethesda, MD  20892-7324
Telephone:  (301) 435-4914
Fax:  (301) 402-4279
Email:  sm33k@nih.gov

Direct inquiries regarding fiscal matters to:
 
Crystal Wolfrey
Lead Grants Management Specialist, BPS Section
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243, MSC 7150
Bethesda, Maryland  20892-7150
Telephone:  (301) 496-8634
Fax:  (301) 496-8601
Email:  wolfreyc@gab.nci.nih.gov 

Direct inquiries regarding review issues to:

David Monsees, Ph.D.
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive,  Room 3150, MSC 7770
Bethesda, MD  20892-7770
Bethesda, MD  20817 (for express/courier service)
Telephone:  (301) 435-0684
Fax:  (301) 480-3962
Email:  monseesd@csr.nih.gov

LETTER OF INTENT 

Prospective applicants are strongly encouraged to submit, by January 18, 2002 
(for the first receipt date), and January 17, 2003 (for the second receipt 
date), a Letter of Intent that includes a descriptive title of the proposed 
research, the name, address, and telephone number of the Principal 
Investigator, the identities of other key personnel and participating 
institutions, the number and title of the PA to which the application is 
being submitted. 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 NIH staff to estimate the potential 
review workload and plan the review.
 
The Letter of Intent is due by January 18, 2002 (for the first receipt date), 
and January 17, 2003 (for the second receipt date), to Dr. Sandra L. Melnick, 
listed under INQUIRIES.

SCHEDULE 

1st Letter of Intent Receipt:                  January 18, 2002
1st Application Receipt:                       February 21, 2002
1st Peer Review Date:                          June/July, 2002
1st Review by National Cancer Advisory Board:  September, 2002
1st Earliest Anticipated Start Date:           December, 2002

2nd Letter of Intent Receipt:                  January 17, 2003
2nd Application Receipt:                       February 21, 2003
2nd Peer Review Date:                          June/July, 2003
2nd Review by National Cancer Advisory Board:  September, 2003
2nd Earliest Anticipated Start Date:           December, 2003


APPLICATION PROCEDURES

The PHS 398 research grant application instructions and forms (rev. 5/2001) 
at http://grants.nih.gov/grants/funding/phs398/phs398.html must be used in 
applying for these grants and will be accepted at the standard application 
deadlines (http://grants.nih.gov/grants/dates.htm) as indicated in the 
application kit.  This version of the PHS 398 is available in an interactive, 
searchable format.  For further assistance contact GrantsInfo, Telephone 
301/435-0714, Email: GrantsInfo@nih.gov.

Consistent with NCI policies, funds requested in the budgets for competitive 
renewals of existing cohorts (Type 2 applications) will be limited to 20 
percent above the highest Type 5 year.  Further information may be obtained 
at http://grants.nih.gov/grants/guide/notice-files/NOT-CA-01-016.html.  
Budget will be an important consideration in funding decisions

Submit a signed, typewritten original of the application, including the 
checklist, and five 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)

Applications must be received by February 21, 2002 (for the first receipt 
date), and February 21, 2003 (for the second receipt date).  If an 
application is received after that date, it will be returned to the applicant 
without review.  The NCI will no longer accept unsolicited applications for 
epidemiologic cohorts costing $500,000 or more in direct costs in any study 
year. The Center for Scientific Review (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 substantial 
revisions of applications already reviewed, but such applications must 
include an introduction addressing the previous critique.
 
REVIEW CONSIDERATIONS
 
Upon receipt, applications will be reviewed for completeness by CSR and for 
adherence to the guidelines of this PA by the NCI.  Incomplete applications 
will be returned to the applicant without further consideration.  

Applications that are complete and adhere to the guidelines of this PA will 
be evaluated for scientific and technical merit by the Center for Scientific 
Review, National Institutes of Health in accordance with the review criteria 
stated below.  As part of the initial merit review, all applications will 
receive a written critique and undergo a process in which only those 
applications deemed to have the highest scientific merit, generally the top 
half of the applications under review, will be discussed, assigned a priority 
score, and receive a second level review by the National Cancer Advisory 
Board of the National Cancer Institute.

Review Criteria
 
The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  The 
reviewers will comment on the following aspects of the application in their 
written critiques in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals.  Each of these 
criteria will be addressed and considered by the reviewers in assigning the 
overall score weighting them as appropriate for each application.  Note that 
the application does not need to be strong in all categories to be judged 
likely to have a major scientific impact and thus deserve a high priority 
score.  For example, an investigator may propose to carry out important work 
that by its nature is not innovative but is essential to move a field 
forward.

The five criteria to be used in the evaluation of NIH grant applications are 
listed below.

1.  Significance.  Does this study address an important problem?  If the aims 
of the application are achieved, how will scientific knowledge be advanced?  
What will be the effect of these studies on the concepts or methods that 
drive this field

2.  Approach.  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?

 3.  Innovation.  Does the project employ novel concepts, approaches, or 
methods?  Are the aims original and innovative?  Does the project challenge 
existing paradigms or develop new methodologies or technologies?  
 
4.  Investigator.  Is the investigator appropriately trained and well suited 
to carry out this work?  Is the work proposed appropriate to the experience 
level of the principal investigator and other researchers (if any).

5. Environment.  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements? Is there evidence of institutional 
support?   

6.  The initial review group will also examine the appropriateness of the 
proposed budget and duration of the study; the adequacy of plans to include 
both genders and minorities, and their subgroups, as well as children as 
appropriate for the scientific goals of the research and plans for the 
recruitment and retention of subjects; the provisions for the protection of 
human and animal subjects; and the safety of the research environment.

AWARD CRITERIA
 
Applications will compete for available funds with all other recommended 
applications.  The following will be considered in making funding decisions:  
Quality of the proposed project as determined by peer review, availability of 
funds, and program priority.

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

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 RFA 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 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.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

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 Program Announcement 
(PA), Cohort Studies in Cancer Epidemiology, 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 No. 
93.393.  Awards are made under 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 52 and 45 CFR Parts 
74 and 92.  This program is not subject to the intergovernmental review 
requirements of Executive Order 12372 or Health Systems Agency review.

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


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