Apply & Reports

The CBCRP application submission deadline is:
Main Deadline, ALL applications, except CRC: Thursday, January 8, 2004
Community Research Collaboration (CRC) only: Thursday, February 26, 2004

Send completed applications (original and all copies) to:
California Breast Cancer Research Program
University of California, Office of the President
300 Lakeside Drive, 6th Floor
Oakland, CA 94612-3550

We will not accept online, e-mail, or fax submissions

You may download application packets, forms, and instructions from the section Apply and Reports

Deadline for Receipt Policy
Applications must be received by 6:00 P.M. on the specified dates. Because unforeseen circumstances can occur and because we cannot extend the deadline, we recommend that you allow at least 48 hours for express delivery. Applicants who choose to hand deliver the materials to us will not be allowed extra time due to traffic, copying problems, or other issues that could have been avoided by more timely preparation. An application received after the deadline may be acceptable if it carries, or if the applicant can provide upon request, a legible proof-of-mailing date assigned by the carrier and the proof-of-mailing date is not later than 2 days prior to the deadline date. Private postage meter marks are not acceptable

Cycle X Application Information Packet

This document provides key information on:

Download as PDF file (345kB)

The forms and associated instructions are found in a separate document and will be available after October 6.

Table of Contents

Section  

Subject

---

At a Glance

1

Invitation to Submit Applications

2

Research Priority Issues

  Special California Data Sources for Breast Cancer Research
CSO Coding for 2004 Grant Applications

3

Overview of Award Types

4

Application Evaluation and Award Process

  Award Type Descriptions

5

Scientific Perspectives Research Collaboration (SPRC) Awards

6

Community Research Collaboration (CRC) Awards

7

Translational Research Collaboration (TRC) Awards

8

Joining Forces Conference Awards (JFCA)

9

Requests for Applications (RFAs)

10

Innovative Research Awards (IDEA & STEP)

11

Career Development Awards

 

12

Submission Requirements and Revised Applications

13

Conditions of Awards

14

Appeals

15

Application Form Overview

16

Examples of Programmatic Review Forms

CBCRP Cycle X / 2004—At a Glance

What’s New

Priority Issues and Award Types

Application Forms

Other Important Reminders

New awards begin July 1, 2004. We will contact you with the funding decision in early June 2004. Information on funding status will not be provided any sooner!

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1. INVITATION TO SUBMIT APPLICATIONS

The California Breast Cancer Research Program (CBCRP) is pleased to invite applications for research grants for 2004 Cycle X funding. We expect to have available approximately $13-14 million to award new grants beginning July 1, 2004. In this booklet you will find information to help you select the proper research topic category (Priority Issue), award type, and understand our evaluation and funding process. We hope this will encourage you to apply and to direct your research aims to match the interests of the CBCRP. Our overall commitment is to fund research that will result in rapid advances in breast cancer prevention, detection, treatment, and cure. We welcome current CBCRP grant recipients to apply with new projects, and we invite researchers new to our Program to bring your expertise to our cause. The CBCRP supports research only in California from funds obtained through:

  1. A portion of a 2 cents per pack State cigarette tax
  2. A State income tax check-off
  3. The generous contributions from concerned community members dedicated to defeating breast cancer

All grant applications will be first evaluated and rated for scientific merit in a peer review process. Applications having sufficient merit are then reviewed for programmatic relevance by our advisory Council. It is a combination of both scientific merit and programmatic interest that determines funding. All applicants will receive a detailed written critique.

Who May Apply?

1. Any individual or organization in California may submit an application. The research must be conducted primarily in California. We welcome investigators from community organizations, public or privately-owned corporations and other businesses, volunteer health organizations, health maintenance organizations, hospitals, laboratories, research institutions, colleges, and universities.

2. We encourage researchers new to breast cancer to apply. We recommend that applicants, who have limited experience in scientific research or in scientific grant-writing, collaborate with established researchers. Applicants are urged to consider the suitability of their research ideas under the CBCRP's collaboration award types.

3. Previously funded PIs. You are welcome to apply for the funding of new projects with aims distinct from previous CBCRP grants.

4. Re-submissions. Individuals who submitted "not funded" applications can revise them and re-submit in the current cycle. Already funded PIs may submit new applications in Cycle IX that are distinct from the previously funded research. Refer to the instructions in Section 12.

5. Multiple applications and grant limits for PIs. An investigator may submit more than one application, but each application must have unique specific aims. A PI can only receive one non-collaboration award type grant. In addition, however, and new for this year, a PI may also receive one grant as a co-PI for a collaboration award type (CRC, TRC, or SPRC).

Note: Principal investigators with current CBCRP grant support will not be eligible to apply for additional funding unless the required scientific and fiscal reports are up-to-date. See Section 13, "Policy on Applications from PIs with Delinquent CBCRP Grant Reports."

Application Deadlines

The CBCRP has only one funding cycle per year. Submitted Applications must be complete with all forms, copies, and in a format consistent with our instructions. Please read our instructions carefully, and use the new forms for this funding cycle. The application forms and instructions are available from our Web site: www.cbcrp.org/ or by e-mail. All materials, originals and copies, must arrive in our office before 6:00 PM on the date it is due.

1

Main Deadline: Thursday, January 8, 2004
ALL applications except CRC and Joining Forces Conference Awards

Deadlines for Community Research Collaboration (CRC) and Conference Awards:

2

Community Research Collaboration (CRC) Awards
Thursday, November 6, 2003 for pre-application Concept Papers (required)

Thursday, February 26, 2004 for full applications. applications

 

3

Joining Forces Conference Awards
Anytime before July 1, 2004 (contact us before submitting)

Special exception: Recipients of Cycle IX TRC Pilot Awards and SPRC Exploratory Awards may submit a full TRC Research Award or full SPRC Research Award application up until February 26, 2004, if a Letter of Request is submitted by January 8, 2004. Call for instructions.

See section 12 for the deadline policy statement and the detailed submission requirements.

We encourage you to contact us with any questions about our research topic Priority Issues and/or available award types.

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2. RESEARCH PRIORITY ISSUES

The FIRST STEP in applying to the CBCRP for grant funding is to examine our Priority Issues and Award Types. Answer the question, "How do my research interests, type of project, and career level match the CBCRP Priority Issues and Award Types?"

Funded research must address:

"The mission of the CBCRP is to eliminate breast cancer by leading innovation in research, communication, and collaboration in the California scientific and lay communities."

To establish the CBCRP's priorities and advance our mission, our advisory Council identified these key criteria and goals for our funded research:

The nine (9) Priority Issues listed below are the broad research topics designated by the Program for Cycle X. They are arranged as four larger groups to better integrate those that are closely related. The individual priority issues are defined and the "bullets" are some examples of research topics that are encouraged. Your application must incorporate a main research topic that corresponds to one of the CBCRP's "Priority Issues." If your research overlaps more than one Priority Issue, then choose the best match to enter on Forms 1 and 5. Explain the relevance of the other Priority Issue(s) in the indicated relevance text using Form 5.

Note: The CBCRP is a member of a cancer funding consortium that has developed a research topic classification scheme and grant portfolio database Web site: www.cancerportfolio.org/. The purpose of the CSO is to better analyze our applications and funded grant portfolio, compare our funding with other agencies, and identify promising new research topics. Thus, we require our applicants to provide CSO (Common Scientific Outline) classification code(s) that match the main topics of the research. There are seven numbered major categories, each with several sub-categories. These are listed and defined in the above Web site, and the existing CSO database can be searched by PI name or word to gain insight in how to classify your application. Please read though the description of the CSO at the end of this section, and follow the instructions in Section 12 for entering the appropriate code number(s) on Form 1 (cover page). We appreciate your help.

Primary vs. Complementary Priority Issues

Please note that six of the CBCRP priority issues are "primary" and these will be given first consideration for funding. The reasons are to:

The remaining three "complementary" Priority Issues are well represented in the CBCRP funded portfolio and include topics commonly funded by other agencies. We will continue to fund applications submitted in these Priority Issues, especially those having high impact and innovation.

Note: After application submission and during the review and funding process, the CBCRP will examine applications for their appropriate match to the selected priority issue and award type. We reserve the right to switch applications to a different priority issue or award type. In general, this inspection occurs during the peer review, and committees have the option of changing award type and priority issue by majority vote. In addition, the Program staff and/or advisory Council can make these changes during the programmatic review.

I. The Community Impact of Breast Cancer: the social context

Overview: Beyond access to medical treatment, a woman diagnosed with breast cancer needs: (1) an effective healthcare system that meets the special needs of breast cancer patients, (2) an individualized social support framework, and (3) the recognition that key differences in various racial and ethnic groups that can serve to create disparities. The CBCRP supports research and formulation of public policy alternatives that would contribute to breast cancer prevention and improve outcome. The CBCRP recognizes the need for reducing inequities in access to prevention, detection, treatment, and survivorship services for underserved populations. Finally, we encourage sociocultural, psychological, and behavioral research to reduce the impact of breast cancer on each woman.

1. Health Policy and Health Services: Better Serving Women's Needs (Primary Priority Issue)

A. Health Policy

Exploring either public policy change or health outcomes with regard to breast cancer treatment, prevention, earlier detection, and racial/ethnic differences in breast cancer. Topics of special interest include:

B. Health Services

The development of public policy strategies to most effectively deliver services to women, including preventing breast cancer and eliminating the barriers to service delivery. Topics of special interest include:

2. Sociocultural, Behavioral and Psychological Issues Relevant to Breast Cancer: The Human Side (Primary Priority Issue)

Qualitative or quantitative research into sociocultural, behavioral, and psychological issues of women affected by breast cancer or at high risk for the disease. Topics of special interest include:

3. Racial/Ethnic Differences in Breast Cancer: Eliminating Disparity (Primary Priority Issue)

Research addressing the underlying differences in breast cancer biology, incidence, morbidity and mortality, or treatment. Topics of special interest include:

Note: The Racial/Ethnic Differences priority issue overlaps other CBCRP topics. The first bullet listed above is linked to the Health Policy and Health Services priority issue. The second bullet is linked to the Sociocultural, Behavioral and Psychological Issues priority issue. The third and fourth bullets are linked to Etiology and Prevention. Finally, the last bullet is linked to Pathogenesis.

II. Prevention and Risk Reduction: the environment of the disease

Overview: What are environmental and biological factors that interact to increase a woman's risk of developing breast cancer? The disease seemingly strikes women at random despite the efforts to identify causative genes and risk factors. We especially encourage new California-based studies to understand the environmental causes of breast cancer, and how these increase risk and impact different communities of women in California. Two CBCRP Priority Issues are included in this group.

4. Etiology: Finding the Causes (Primary Priority Issue)

Investigating breast cancer initiation that may be due to environmental exposures that subject women to agents that they, as individuals, cannot control. To date, there has been intensive study into the contributions of behavior and lifestyle to breast cancer. We wish instead to focus on the external physical factors that contribute to the disease. Our goal is to understand the underlying cancer-initiating biology that may result from exposures, which include pesticides and other known or suspected carcinogens found in air, food, water, medications, etc. Topics of special interest include:

Note: Cell and tumor model-based studies of the role of specific genes, gene combinations and cellular pathways initiating breast cancer should be submitted under the CBCRP priority issue of Pathogenesis.

5. Prevention and Risk Reduction: Ending the Danger of Breast Cancer (Primary Priority Issue)

Methods to prevent breast cancer or reduce risk, including elimination of external causative factors and the identification of surrogate markers for use in prevention trials. Topics of special interest include:

Note: By "Prevention," we refer only to the PRIMARY prevention of breast cancer (prevention of the occurrence of the disease).

III. Biology of the Breast Cell: the basic science of the disease

Overview: There is a need to move beyond the "static picture" of breast cancer in tumor cell lines and current animal models. New research is needed to understand the pre-neoplastic, causative events of the disease at the tissue level, including the stroma. The genetic changes in disease progression and the heterogeneity seen in the clinic need clarification at the basic science level. Lab researchers and clinicians are encouraged to engage in more "cross-disciplinary" research projects to link discovery efforts with the clinical issues important to breast cancer. We must understand the genetic and molecular signatures of the disease to treat it effectively.

6. Biology of the Normal Breast: The Starting Point (Primary Priority Issue)

Aspects of normal breast biology that could provide insights into new approaches to prevent, detect, or treat breast cancer. Topics of special interest include:

Note: Studies that develop tumor models or use cell lines derived from tumors should be submitted under the Pathogenesis priority issue.

7. Pathogenesis: Understanding the Disease

Focused on breast cancer tumor biology, including (1) relevant proteins and genes and (2) key cell signaling, growth control, cell cycle, apoptosis, and regulatory pathways. Topics of special interest include:

IV. Diagnosis and Treatment: delivering clinical solutions

Overview: Early detection does not guarantee a cure, and the limitations of mammography require women to undergo unnecessary biopsies and emotional strain. Ultimately patients and physicians have too few options for treatment. New breast cancer specific and individualized therapies require investigation. Lab researchers and clinicians are encouraged to engage in more cross-disciplinary research projects to link discovery efforts with the clinical issues important to breast cancer.

8. Earlier Detection: Improving the Chances for a Cure

Finding new, cost-effective technological and biological approaches to early detection of primary breast cancer at the individual and population level. Topics of special interest include:

9. Innovative Treatment Modalities: Search for a Cure

Developing new, more effective therapies for breast cancer. Topics of special interest include:

Note: Studies of new combinations of standard chemotherapeutic agents will not be considered responsive.

Special California Data Sources for Breast Cancer Research

CBCRP encourages research that explores new hypotheses using existing data sources (from previously funded studies, tissue banks, or from databases such as the California Cancer Registry) especially that take advantage of the ethnic diversity of the state to explore differences between ethnic populations. Three opportunities are:

1. Cancer Information Service
The Cancer Information Service (CIS) at http://cis.nci.nih.gov/ is a national information and education network, is a free public service of the National Cancer Institute. The CIS program for California is administered by the Northern California Cancer Center (NCCC). It maintains a database of CIS call and outreach contact information, and can serve as a "laboratory" for testing new interventions.

2. California Cancer Detection Section
The Cancer Detection Section (CDS) of the California Department of Health Services (www.dhs.cahwnet.gov/cancerdetection/) is pleased to announce the availability of its breast and cervical cancer early detection services data for scientific research.

Since 1991, CDS has received federal funding to implement the Breast and Cervical Cancer Control Program (BCCCP), which provides free breast and cervical cancer screening and diagnostic services to eligible women in several locations around the state. Since 1994, an increase in the state tobacco tax has funded the CDS-administered Breast Cancer Early Detection Program (BCEDP), which provides breast cancer screening and diagnostic services to eligible women throughout the state. As of October 1, 2002, the two programs' billing and data systems have been unified into one program called Cancer Detection Programs: Every Woman Counts. To be eligible for breast cancer detection services, women must be 40 years or older, have a household income at or below 200% Federal Poverty Level (FPL), and have no or limited health insurance. To be eligible for cervical cancer detection services, women must meet the same income and health insurance criteria and be 25 years or older.

Since program inception (1991) to June 30, 2001, CDS has provided 526,931 clinical breast exams; 496,524 mammograms; and 153,158 Pap tests. Program data include procedure, date of service, outcome, cancer stage, payment, client demographics, and provider information. The most accurate historical clinical data is BCCCP screening and diagnostic outcome information. After October 1, 2002, the same information with improved data integrity will be available.

Also available from CDS is data collected from callers to CDS' statewide consumer 800 number (1-800-511-2300). CDS has contracted with the Northern California Cancer Center (NCCC) since 1995 to operate its 800 number. Women call the 800 number to determine their eligibility for breast cancer screening services, receive a program application, and get referrals to local providers. The 800 number assists callers who speak English, Spanish, Mandarin, Cantonese, Vietnamese, and Korean.

Data from NCCC include caller demographics, reason for call, and follow-up call information. From the program inception in 1995 through August 31, 2003, there have been approximately 114,000 calls made to the toll free number; about one-half of the callers were eligible to receive breast cancer screening services.

In order to assure client privacy and compliance with HIPAA requirements, confidential client identifiers are available only for scientifically-valid research projects that have been approved by a certified Institutional Review Board (Human Subjects Committee), follow HIPAA requirements and are consistent with the CDS mission: "saving lives by preventing and reducing the devastating effects of cancer for all Californians through early detection, diagnosis and treatment, with special emphasis on the underserved."

CDS welcomes research ideas and analyses of CDS data for research or evaluation purposes. Due to the complexity of the CDS data, collaboration with CDS staff would be necessary to communicate the strength and limitations of the data. CDS foresees the degree CDS and researchers collaborate would vary depending on the research/evaluation project and researchers’ preference. Collaboration with CDS would be efficacious at the beginning to enable the researchers and CDS to determine the resources needed and to plan accordingly. It is expected that funding agencies, such as BCRP, should require a letter of support from CDS for proposals involving use of CDS data. To request CDS data, a request form must be completed and submitted to CDS. This form can be obtained from CDS at Department of Health Services, Cancer Detection Section, Evaluation and Research Unit, P.O. Box 942732 MS 428, Sacramento, CA 94234-7320 or can be downloaded from the Web: www.dhs.ca.gov/publications/forms/cancer.htm

3. California Health Interview Survey
The California Health Interview Survey (CHIS) is the largest telephone health survey in the country. This survey takes place every two years. The first survey, CHIS 2001, interviewed over 57,000 California adults in six languages between November 2000 and September 2001. CHIS is a random digit dial (RDD) survey incorporating a geographically stratified sample so that county-level estimates are possible for counties and groups of counties with population sizes of 100,000 or more. Additionally, CHIS 2001 over-sampled three cities (Berkeley, Pasadena, Long Beach), over-sampled California's urban and rural American Indian/Alaska Native population, as well as five Asian groups (Japanese, Korean, Vietnamese, Asian Indian, and Cambodian). Large samples of Latinos, African Americans, Chinese and Filipinos are also in the data file. An NCI sponsored cancer control topical module with breast cancer history, mammography screening, and the Gail risk model variables was included in the CHIS 2001 survey. Zip code information is collected for all respondents plus geocode coordinates for Los Angeles and San Diego counties. Detailed race/ethnic information is collected, including allowance for recording multiple race/ethnic groups. The data are weighted using the 2000 Census. Public use files are available free on the CHIS Web site. More detailed and more confidential information is accessible by application through special data access centers located at the UCLA Center for Health Policy Research in Los Angeles (fees may apply) and at the Department of Health Services in Sacramento for state researchers. An application mechanism exists for researchers to conduct follow-back studies with CHIS participants. CHIS 2003 is collecting data between August 2003 and January 2004. The CHIS 2003 survey also addresses cancer screening and will be fully geocoded statewide. For more information, visit the researcher's page at www.chis.ucla.edu.

Interested researchers are invited to contact Walter Price at (510) 987-9886 or walter.price@ucop.edu

If a proposed project requires access to data from the California Cancer Registry (http://www.ccrcal.org/), then the application must include a letter of collaboration from a Registry official. If you have questions, please contact William E. Wright, Ph.D., (916) 779-0300, Chief, Research and Surveillance Program, Department of Health Services Cancer Surveillance Section.

4. CSO Coding for 2004 Grant Applications
Beginning with 2004/Cycle X, the CBCRP will require all applicants to code the research area of their application using the Common Scientific Outline (CSO) classification. The requested information is mainly for statistical purposes, and is not part of the scientific review.

Background
The CSO is intended to enable funding agencies to accurately index grants in their portfolio in order to facilitate information sharing, enable informative analysis and evaluation of agency portfolios and goals, and targeting of unmet research needs.

CSO data from the CDMRP, the NCI and the Cancer Research Institute of the United Kingdom (NCRI) is online at www.cancerportfolio.org. The CBCRP will follow in the fall of 2003.

Many applicants will be familiar with the CSO code from other funding organizations. There are two coding elements: a Primary and a Secondary Code. Choose a primary code that best describes the total intent of the application. Then use a secondary code, if the research cannot be adequately described by one code.

Enter the codes for your application in the space(s) provided in the upper right hand corner of Form 1, just below the words "Cover Page".

The detailed instructions are provided in Section 12 and the instructions for Forms 1A-C.

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3. OVERVIEW OF AWARD TYPES

After considering our Priority Issues in the previous section, each applicant needs to select the appropriate CBCRP award type. They fall into four broad categories: (1) multi-PI collaboration research, (2) topic-targeted research (RFAs), (3) innovative research, and (4) career development. The award types have specific caps for project duration and direct costs that are listed below.

Note: The award type budget caps are listed for direct costs only. To request indirect costs there are two things to keep in mind. First, we do not offer indirect costs to the nine University of California campuses. Second, indirect cost allowances and caps vary by award type. Each non-UC institution that applies must include Form 20, which shows the indirect rate being requested and the "base" of budget categories to be used to calculate indirect costs.

The CBCRP award types are grouped into "Primary" and "Complementary" categories:

Primary Award Types. These will be given first consideration for funding and include the three types of collaboration awards: Community Research Collaboration (CRC) (see below), Translational Research Collaboration (TRC), Scientific Perspectives Research Collaboration (SPRC), and Joining Forces Conference Awards (JFCA). The Requests for Applications (RFAs), also Primary Awards, are available only in the "Primary Priority Issues."

Complementary Award Types. These include the innovative award types, IDEA and STEP; and the career development award types (postdoctoral fellowships, dissertation, new investigator awards, mentored scholar, career enrichment, and training program). Fostering innovation and careers in breast cancer research are the focus in the "complementary" category. RFAs are not available in the three Complementary Priority Issues: Earlier Detection, Innovative Treatment Modalities, or Pathogenesis.

Summary: When you prepare the application, indicate the Award Type on Form 1A or B and explain the relevance of your project or research career level to the award type selected using Form 5.

The award type descriptions are covered in the following Sections in detail. The chart below summarizes the key duration, budget, PI, and evaluation criteria distinctions.

Some key points to keep in mind while comparing the award type data are:

Overview of CBCRP Award Types and Evaluation Criteria

Community Research Collaboration (CRC) and Joining Forces Conference Awards (JFCA) are not shown. See Sections 7-8.

 

IDEA

STEP

RFA

Post-doc

New Invest.

Career Enrich.

Dissertn.

Mentor Scholar

Training

TRC- Pilot

TRC- Full

SPRC- Explor.

SPRC- Full

Primary (P) or Complementary (C)

C

C

P

C

C

C

C

C

C

P

P

P

P

Number of  Principal Investigators

1

1

1

1

1

1

1

1

1

2 or 3

2 or 3

2 or 3

2 or 3

Maximum duration

1.5 yrs

2 yrs

3 yrs

2 yrs

3 yrs

1 yr

1-2 yrs**

2 yrs

3 yrs

1.5 yrs

3 yrs

1.5 yrs

3 yrs

Maximum direct costs (total project)

$75K to $100K*

$150K to $250K*

No Cap

$90K

$300K

$100K + salary

$60K + other**

$70K + other^

$300K

$100K

$500K

$100K

No Cap

Budget: Maximum Equipment

$5,000

No Cap

 No Cap

$2,500

$5,000

No Cap

 None

No Cap

No Cap

No Cap

No Cap

No Cap

No Cap

Minimum PI Effort on Project

5%

5%

10%

80%

25%

25%

80%

50%

10%

10%^^

10%^^

10%^^

10%^^

Indirect Costs (non-UC only)

Full

Full

Full

None

8%

8%

None

8%

8%

Full

Full

Full

Full

Priority Issue Addressed

Any

Any

Primary Only

Any

Any

Any

Any

Any

Any

Any

Any

Any

Any

Scientific Merit Score includes the following components:

Innovativeness

Impact

 

 

Approach

Feasibility

Career Development

 

 

 

 

 

 

 

 

Translational Potential

 

 

 

 

 

 

 

 

 

 

 

Cross-Disciplinary

 

 

 

 

 

 

 

 

 

 

 

Synergistic Potential

 

 

 

 

 

 

 

 

 

 

 

 

*See Section 10 for IDEA and STEP direct costs caps that depend on the usage of animal and human subjects in the project.

**1 year for master's program; 2 years for doctoral program. Maximum of $30K/yr.

^ See Section 11 for complete budget details.

^^ For each co-PI.

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4. APPLICATION EVALUATION AND AWARD PROCESS

Applicants should carefully consider how their projects will be evaluated and the criteria involved. The Program takes pride in the detail of the review process, the accuracy of review scoring, and the communication of scores and application evaluations to the PIs. The CBCRP uses a two-tiered review process. First, the peer review committees rate applications for scientific merit. Second, the Program's advisory Breast Cancer Research Council evaluates those applications with "sufficient merit" for several criteria of programmatic relevance. The Council consists of 16 members from the advocacy, clinical, research, health care, and industry communities.

Peer Review Committees

Review Committees (i.e., study sections) are assembled around specific award types and/or priority issues. Scientific and breast cancer advocate reviewers are chosen from outside California to minimize possible conflicts of interest. The reviewers have demonstrated expertise in breast cancer and/or the specific research topics in the applications. Scientist reviewers are a mixture of senior and more junior researchers, and they are selected from academic, nonprofit institutions, biotech/industry, and clinical research settings. Advocates often have training and/or prior experience in application review. The Committee Chair is usually a more senior researcher with significant review committee experience. The Chair may assist in recruiting reviewers and assigning applications. The Program conducts the Review Committees consistent with NIH practice.

Applications are evaluated by three scientific reviewers (primary, secondary, and tertiary) and an advocate reviewer. Each reviewer prepares written comments that concentrate on the strengths and weaknesses of the proposed research with respect to the scientific merit scoring criteria specific for each award type. In addition, the application is examined by the committee Chair. Applicants will receive a detailed written evaluation. This evaluation is primarily derived from the written comments of the assigned reviewers, but also includes key points from the committee discussion and Programmatic Review process. Both funded and non-funded research stands to benefit by a careful study of the results of the review process. The Committee ballots and final score calculations are verified by the University of California Auditor.

Note: PIs that have been previously funded by the CBCRP should inspect our Web site (www.cbcrp.org/research/) to read through the posted abstracts for their grant(s). Reviewers are instructed to look though previous CBCRP funding to evaluate whether new applications are novel and innovative additions to previously funded research. We advise PIs to address the distinction of new applications using Form 16.

Scientific Merit Criteria

There are distinct components of scientific merit and they are scored independently to reflect the requirements inherent in each award type. In the award type sections to follow, these scientific merit score components are listed and described in detail. The use of merit score components allows the Program and the Breast Cancer Research Council to better judge the strengths and weaknesses of each application. When preparing the application, please consider how your application has addressed the specific merit score components in the award type you have chosen.

When all applications have been peer reviewed, the Program will calculate the average scientific merit scores that combines all the merit components equally. The average scientific merit scores for all applications are ranked, and the lowest third (approximately) of applications are excluded from further consideration for funding. Thus, applications with a "sufficient scientific merit" are eligible for the Programmatic Review described below.

Note: The scientific merit assigned by review committees does not distinguish between "primary" and "complementary" Priority Issues and Award Types as discussed in Sections 2 and 3. This distinction only occurs in the Programmatic Review described below.

The following will be evaluated by the scientific peer review committee and Program staff, but they are not included in the scientific merit score:

Budget/Duration and Overlap: The appropriateness of the requested direct cost budget and duration of the project will be reviewed. Awards may be made contingent upon acceptance by the investigator(s) of a revised budget, as recommended by the Review Committee. Note the specific allowed budgetary items and caps for each award type. Equipment is defined as: (1) non-expendable, tangible, personal property, (2) having an acquisition value of $1,500 or more, (3) free standing, and (4) with a normal life expectancy of 2 years or more. The maximum allowable costs for equipment in each award type are discussed in the following sections and the instructions for Form 7.

PIs and other key personnel are required to report other non-research (Form 14) and research (Form 15) funding, and state the distinction between the application and other research funding on Form 16. The review committee and Council will examine these items and make comments on research overlap.

Research Risks: If a project proposes activities that pose unacceptable potential for human and animal subjects risks, then a recommendation either not to fund or to delay funding until the issue is resolved may result. The application information for IRB and Animal Welfare approval should be included on Forms 18 and 19 with the application. The Program will require full institutional approval prior to the release of any funds. Clinical trials may be required to provide a data and safety monitoring board (DSMB) as described in the NICI policy release, http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm (see also Form 18). The DSMB is in addition to institutional IRB approval, and provides a multi-disciplinary approach to ensure patient safety, confidentiality, and study monitoring.

Programmatic Review

The Programmatic Review is conducted by the advisory Breast Cancer Research Council and involves analyzing applications with a "sufficient scientific merit" score for the criteria listed below.

Programmatic Criteria

Application Form

. Priority Issue Responsiveness

Form 5

. Award Type Responsiveness

Form 5

. Multidisciplinary approach

Form 6

. Translational potential

Form 6

. Focus on the underserved

Form 6

. Balance in the overall portfolio

Forms 3, 4, and 16

. Emphasis on relatively underfunded areas

Forms 3, 4, and 16

. Quality of the Lay Abstract--see discussion below

Form 3

. Inclusion of advocates and sensitivity to advocacy concerns

Forms 6 and 3

The individuals on the Council performing this review include advocates, clinicians, and scientists from a variety of disciplines. In performing the Programmatic Review the advisory Council first evaluates only a portion of the application forms, which are submitted as an Executive Summary. These forms, except for Form 4 (Scientific Abstract), should be prepared using a style and language comprehensible to the general public. Thus it is critical for applicant(s) to pay special attention to the instructions for these forms. This is especially true for the Lay Abstract (Form 3), which must be a non-technical description of the research using the criteria provided in the instructions and listed on the form itself. Examples of Lay Abstracts are shown in Section 16. In addition, the PI(s) must sign Form 3 to acknowledge that a failure to follow the instructions on the form could adversely affect the Programmatic Review score. On Form 5 applicants explicate the link between the proposed research and the chosen priority issue and award type. On Form 6 applicants address the issues of multidisciplinary approach, inclusion and relevance to the underserved, the translational potential, and advocacy involvement in the proposed research. Form 16 (and Form 17 for career development only) enable the PI(s) to make a distinction of the proposed research from the other funded research of the PI(s). Applicants are encouraged to state whether they believe the research is underfunded or would contribute to the balance in the CBCRP's portfolio. The Program's funded research from the previous seven cycles is listed on our Web site: www.cbcrp.org under the link "Research Reports." The titles and detailed abstracts for more than 550 funded projects can be accessed by either Priority Issue/sub-topic or by PI.

Note: Please refer to Section 16 for examples of quality presentations on the key application forms used for the Programmatic Review. Each year we choose not to fund applications that have been assigned high peer review merit scores, but the applicant(s) fail to connect the research to the stated CBCRP research interests, funding priorities, and mission.

After the Council assigns a programmatic score to each application using the criteria described above, they will examine the average scientific merit score, ranking within each committee by award type, and the strengths and weaknesses in the individual components (e.g., innovativeness, impact, career development). Thus, it is a combination of (1) the programmatic evaluation, and (2) strengths and weaknesses in both the average scientific merit and individual components of scientific merit that determines a decision to recommend funding.

Finally, the applications in the "primary" category for either the Priority Issue or the Award Type are given "first consideration for funding." This means that a decision to fund or not to fund the "primary" applications will occur prior to consideration of the "complementary" applications.

Other Funding Issues and Information

How does an applicant's choice of Priority Issue and Award Type ultimately impact funding success? First, an application is considered "primary", if it addresses either a "primary" Priority Issue or Award Type. Secondly, after application submission, and during the review and funding process, the CBCRP will examine applications for their appropriate match to the selected Priority Issue and Award Type. Thus, we reserve the right to switch applications to a different Priority Issue or Award Type. In general, this inspection occurs during the peer review, and committees have the option of changing award type and priority issue by majority vote. In addition, the Program staff and/or advisory Council can make these changes during the programmatic review.

In 2003 (Cycle IX) we evaluated 221 applications in peer review committees and eliminated 80 on the basis of low scientific merit. Of the remaining 141 applications having sufficient scientific merit, the advisory Council in its programmatic review (we omit applications falling in the botom third of scientific merit scores from the programmatic review) recommended 50% (29) of the "primary" and 23% (19) of the "complementary" applications for funding. A more detailed presentation of 2003 CBCRP funding will be presented in a publication called "CBCRP 2003 Compendium of Awards" and it will posted on our Web site under the link "Publications".

Award Decisions and Pre-Funding Requirements

The final approval for funding is made by the Executive Director of the Special Research Programs at the University of California, Office of the President, Dr. Charles L. Gruder.

Applicants will be notified by mail in early June 2004 of their funding status. The written application evaluation from the review committee, the merit score average, component scores, and percentile ranking are provided at a later time. Some applications could be placed on a 'waiting list' for possible later funding.

Pre-funding requirements: Prior to initial funding disbursement we require grant recipients and/or the contracts and grants officials to: (1) inform the Program in a timely manner of their acceptance of funding, (2) resolve any issues of research funding overlap, (3) provide up-to-date human subject and animal approval documents, (4) provide up-to-date indirect cost rate (ICR) agreements for non-UC institutions, (5) edit and submit an acceptable lay abstract and/or revised project title, and (6) resolve any issues of reduced project budget/duration or other Program requirements. Distribution of funding is done separately for each project year.

Confidentiality

The CBCRP maintains confidentiality for all submitted applications with respect to the identity of applicants and applicant organizations, all contents of every application, and the outcome of reviews.

For those applications that are funded, the CBCRP makes public the title, principal investigator(s), the name of the organization, and award amount in a Compendium of research distributed for each funding cycle. In addition, the costs (both direct and indirect) are published in the CBCRP's Annual Report. The project abstract and progress report abstracts are displayed on the CBCRP Web site. If the Program receives a request for additional information on a funded grant, the principal investigator and institution will be notified prior to the Program's response to the request. Any sensitive or proprietary intellectual property in a grant will be edited and approved by the PI(s) and institution prior to release of the requested information.

No information will be released for any application that is not funded.

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5. SCIENTIFIC PERSPECTIVES RESEARCH COLLABORATION (SPRC) AWARDS

Critical expertise to solve breast cancer exists outside of the current legion of researchers studying the disease. Thus, the CBCRP seeks to create the opportunity for breast cancer researchers and clinicians to collaborate with scientists outside the breast cancer research community to explore creative ways to combat the disease. The SPRC requires an interactive partnership between an investigator experienced in research in a discipline outside breast cancer research and an experienced breast cancer researcher. The project's problem or research hypothesis must be focused on breast cancer and use tools and theories from another discipline to generate and explore new paradigms. Some examples of other disciplines that might prove valuable in the fight against breast cancer include economics, sociology, mathematics, physics, engineering, environmental science, psychology, women's studies, ethnic studies, and political science. The key point is that the non-breast cancer research partner must contribute a separate body of knowledge/expertise not before utilized to tackle problems in breast cancer. We envision two major opportunities for projects using the SPRC award type approach. First, we anticipate there will be a potential for synergism in problem-solving and concepts that can be incorporated into such a research project. Second, individuals and groups can gain the basis for interaction that might not otherwise be possible from other funding agencies. We encourage our applicants for this award type to expand their research horizons to find what is possible and needed to defeat breast cancer.

As part of this initiative, a Joining Forces Conference Award (Section 8) is offered to stimulate ideas and interactions around breast cancer that could be the basis for SPRC collaborations.

Award Description

The SPRC Awards are designed to stimulate, facilitate and fund research that brings insights, tools, and ideas from research disciplines not now integrated into breast cancer research to bear on the intractable problems of breast cancer. Such disciplines could include computer modeling, mathematics, economics, sociology, physics, engineering, environmental science, social marketing, psychology, women's studies, ethnic studies, etc. To be responsive to the SPRC award type, the research partnership should: (i) define and explicate in the grant application how the collaboration is focused on breast cancer as the ultimate goal, (ii) identify the resources made possible by the interaction leading to synergism and a novel approach, and (iii) explain how this research funding would create the opportunity for such a collaboration. The SPRC award type has two levels of support:

The SPRC Exploratory Award is for a maximum of $100,000 direct costs for a period of up to 18 months and is intended to explore the potential of the highly speculative concepts that are expected to arise from these partnerships. Activities can include supporting the initial phase of the partnership, including solidifying the organizational structure and processes of the partnership, determining the locus of the responsibility for the research efforts, detailing the research plan and methods, and collecting any pilot data necessary. An outcome of the exploratory grant would include an application for a SPRC Full Research Award or an award from another funding source.

The SPRC Full Research Award is for a period of up to three years with no dollar cap (a total of $2 million will be available for these awards). The research plan should be fully developed. The purpose of the SPRC Full Research Award is to stimulate and support an innovative, synergistic research project involving a collaborative team of breast cancer researchers and scientists from other disciplines. We anticipate the goal of a SPRC award to be to create a new conceptual framework for understanding breast cancer.

Award Requirements

To be judged responsive to this award type, a SPRC application requires an interactive research partnership between an experienced breast cancer researcher and researcher experienced in another discipline not yet integrated into breast cancer research.

The breast cancer partner should be knowledgeable in the basic science, clinical or public health aspects of breast cancer and be experienced in research in one of these areas.

The non-breast cancer partner should be an accomplished researcher in a field that is not now integrated into breast cancer research (see examples above), with ideas and/or methods from his/her field that could move breast cancer research forward.

A competitive SPRC Award application must demonstrate the potential (for the Exploratory Award) or the ability (for the Full Research Award) to conduct high quality, innovative, collaborative research combined with the ability or potential to illuminate intractable problems in breast cancer with insights, tools and ideas from another discipline.

Each co-PI must commit at least a 10% FTE research effort to the project.

The application must identify one of the nine Program priority issues as the prime focus of the partnership. This is performed on Form 5. Refer to the research topic examples for the different priority issues as listed in Section 2. Contact the CBCRP if you need further assistance in this phase of the application.

Evaluation Criteria

SPRC applications are peer reviewed and rated independently for five separate components, which collectively determine the scientific merit.

A. Innovativeness: The originality of the research questions and the approach taken in the investigation. The unique features of the cross-disciplinary team and the integration of tools and ideas from other disciplines.

B. Impact: The extent to which the project, if successfully carried out, would make an original and important contribution to the defeat of breast cancer or to an improvement in quality of life for breast cancer patients and survivors.

C. Approach: The extent to which the conceptual framework, design, methods, and analyses are developed, well-integrated, and appropriate to the aims of the project. The relative importance of the partners in the overall project. The ways the disciplines in the partnership are integrated into the overall project design and success. Is there a balance between the breast cancer expertise and issues and the capability and potential of the non-breast cancer partner?

D. Feasibility: The extent to which the investigators have maximized their chances for success through demonstrated skill, knowledge, expertise, and appropriate resources.

E. Synergistic Potential: The potential to open new and fruitful avenues of research. The potential for the partnership to generate new paradigms for breast cancer research. The extent to which the proposed project integrates the background, expertise, and abilities of the partners and provides the opportunity for advanced understanding of issues related to breast cancer.

The Review Committee will evaluate the application for budget and duration, human/animal research risks and institutional approval, and overlapping research support.

The Programmatic Review is conducted by the advisory Breast Cancer Research Council and involves analyzing applications with an acceptable scientific merit score for the programmatic review criteria as described in Section 4 and submitted by the PI as an Executive Summary (see Section 12). All SPRC applications are considered "primary" and will receive first consideration for funding.

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6. COMMUNITY RESEARCH COLLABORATION (CRC) AWARDS

Note: There is a separate 2004 CRC Call for Applications, Application Packet, and Forms. These are provided on our Web site. The information provided below is just an overview of this award type.

The CBCRP believes that communities should be active participants in research about themselves—in deciding what issues are important and how to study them, in gathering and interpreting data, in communicating findings with other community members, and in developing ways to address community issues. The CBCRP also recognizes that scientific research, if the results are to be reliable and able to be applied to other communities, requires the expertise of well-trained and experienced research scientists.

The CRC Award was developed by the CBCRP to bring community members and experienced research scientists together to study breast cancer-related issues that are of interest to both. We believe that combining the knowledge and interest of communities with the expertise and resources of research scientists will lead to innovative and important research that will reduce the impact of breast cancer.

To support the CRC awards a Joining Forces Conference Award (Section 8) is offered to stimulate ideas and interactions around breast cancer that could be the basis for collaborations.

What are the CRC Awards?

The CRC Awards are grants given to teams composed of community organizations/members and experienced research scientists to perform research. There are two types of CRC Awards:

Both Awards have the following requirements:

  1. A research question with a hypothesis and work plan. While the specific aims and methods must be much further developed and described for the Full Research Award than for the Pilot, the presence of a hypothesis and methods to test it are critical to both applications.

  2. Evidence of active community interest and participation in the development and implementation of the research project. This can be demonstrated by formation of a community advisory group, description of activities community members have undertaken, letters of support from community member organizations/agencies.

  3. Two or three Co-Principal Investigators.

    • One Co-PI must be a representative of the community organization or group involved in the project. This person leads the community involvement in the project.

    • One Co-PI must be a research scientist with documented experience in the methods to be used in the research. This person is responsible for guiding the scientific aspects of the project. Other scientific expertise should be added as appropriate (as other key personnel or consultants).

    • A third community or scientist partner may be added, if desired.

Award Details

CRC Pilot Award:

CRC Full Research Award (a previously awarded pilot project is not required):

Subject Matter

Applicants may apply for an award addressing any issue that has been identified by a community as important to breast cancer in that community. However, there must be a well-defined research question. This question could include testing of health service delivery, but priorities such as service delivery, program development, evaluation and outreach must be well justified in the context of the research question. For example, a project with service delivery as its primary objective, supplemented by a program evaluation component would not be considered appropriate for this Award. Areas of particular interest to the CBCRP that are appropriate for a CRC Award are:

How to Apply and Deadlines

Contact the CBCRP to obtain the CRC Application Packet covering the above items in more detail. The CRC application requires special forms not present in this booklet. CBCRP staff will meet upon request with prospective applicants to assist with any issues they have on research topics, collaborations, and application procedures.

CRC Submission Deadlines:
November 6, 2003 (Thursday) CRC Concept Papers due (required)
February 26, 2004 (Thursday) CRC Applications due

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7. TRANSLATIONAL RESEARCH COLLABORATION (TRC) AWARDS

The TRC award type is intended to maximize CBCRP’s impact on breast cancer in California by enabling novel research that incorporates a cross-disciplinary partnership between independent investigators experienced in at least two of the four broad scientific disciplines of interest. These disciplines include: epidemiology; social, behavioral, or psychological research; basic laboratory; or clinical research. The collaborative partnership and research project aims must focus on translation into practical applications for combating breast cancer. It is a combination of the cross-disciplinary expertise and the research plan/translational goals that make an application responsive to the TRC award type.

To support the TRC awards a Joining Forces Conference Award (Section 8) is offered to stimulate ideas and interactions around breast cancer that could be the basis for collaborations.

Award Description

The purpose of the TRC Awards is to encourage inter- and intra-institutional commitment to innovative, translational research utilizing a cross-disciplinary approach. The term "translational" is intended to emphasize the closeness of research to application in a clinical, community, educational, or other appropriate setting. The intent of the TRC Award is to assist the translation of research from epidemiologic, psychological, social/behavioral, basic laboratory or clinical studies into the healthcare and lay community through a synergy of several scientific disciplines and/or organizations.

The term cross-disciplinary is used instead of multidisciplinary to emphasize the need to include conceptual and methodological viewpoints not normally brought together. Thus, while a typical multidisciplinary epidemiologic study of dietary factors might involve a statistician, an expert in food-intake survey instruments, and an epidemiologist, the thrust of the TRC is to encourage team building that might, for example, involve biochemists, sociologists, medical anthropologists, or social psychologists, in addition to the above-mentioned disciplines. Combinations of university research, biotechnology, and healthcare communities are especially encouraged. Carefully note the distinctions between the two levels of TRC awards.

TRC Pilot Award: for a maximum of $100,000 direct costs for a period of up to 18 months, intended to support the initial phase of the project, including solidifying the organizational structure and processes of the collaborative partnership, and determining the locus of the responsibility for the research efforts, detailing the research plan and methods, and collecting any pilot data necessary. Such issues might include: (1) identification and development of pertinent research issues as defining research questions, including the gathering of pilot data, or analyzing existing data, (2) full research application preparation, (3) identification of institutional and/or community resources necessary for translational research, (4) identification of the expertise needed for innovative cross-disciplinary approaches to translational research, and (5) fostering the collaboration necessary to utilize this expertise on a research question with strong translational potential. Outcomes of the pilot grant would include an application for a TRC Full Research Award, applications for other CBCRP grants, or applications to other funding sources, and an ongoing intra- or inter-institutional cross-disciplinary effort aimed at translational research in breast cancer. It is expected that awardees would be in a position to submit a future CBCRP TRC Full Research Award application or applications to other funding sources.

TRC Full Research Award: for a maximum of $500,000 direct costs for a period of up to three years, in which a research plan that has already undergone some development (with the TRC Pilot Award or through other means) is completed. The purpose of the TRC Full Research Award is to stimulate and support innovative, scientifically rigorous research involving a team from several disciplines with the goal of translating results of the research project into practical applications. Research originating from epidemiologic, social/behavioral, psychological, basic laboratory, and/or clinical studies should therefore be used as the source for such studies. The expected outcome is prevention, detection, treatment or public health intervention that is intended to be rapidly implemented to improve the lives of women with, or at risk for, breast cancer. This is distinct from projects leading only to further research applications, which would be considered 'non-responsive' to this award type. Thus, a TRC Full Award application that does not have a specific translational goal and would lead only to other research grant applications is not considered responsive to this award type.

Award Requirements

To be judged responsive to this award type, a TRC application requires a collaborative research partnership between independent co-investigators experienced in at least two of four broad scientific disciplines (cross-disciplinary) of interest:

The project focus and direction should be to translate research from these areas into practical applications. The co-PIs can be from the same or separate organizations, but all co-PIs must be from California. The co-PIs must each commit at least a 10% FTE research effort to the project.

A competitive TRC Award application must demonstrate the potential (Pilot Award) or the ability (TRC Full Research Award) to conduct high quality, innovative, collaborative research combined with the ability or potential to translate basic research findings into a clinical, community, educational, or other appropriate setting.

The application must identify one of the nine Program priority issues as the prime focus of the research. This is performed on Form 5. Refer to the research topic examples for the different priority issues as listed in Section 2. Contact the CBCRP if you need further assistance in this phase of the application.

Evaluation Criteria

TRC applications are peer reviewed and rated independently for five separate components, which collectively determine the scientific merit. Applicants should carefully consider how their project specifically addresses these criteria.

A. Innovativeness: The originality of the research questions and the approach taken in their investigation. The unique features of the cross-disciplinary team and the translational approach. Is there a balance between innovation and the wish for translation, application, and diffusion?

B. Approach: Integration of the cross-disciplinary approach with a coherent hypothesis and specific aims. The importance of the research questions and their basis in the scientific literature.

C. Feasibility: The likelihood of successful completion of the study based on the research design, background and experience of the investigators, and available resources.

D. Translational Potential: The potential and time needed for the proposed work to have an impact on reducing the incidence, morbidity (including quality of life issues), or mortality of breast cancer. The potential for general diffusion of the research results into basic research, clinical, or public health practice. The ease of translation in terms of costs and expertise needed. Potential impact for underserved populations.

E. Cross-disciplinary nature of the research team: The knowledge, skills, research tools, and experience of the research team in relation to the scientific, translational and innovative potential of the work. The extent to which the composition of the team provides the potential for original research solutions and applications The Review Committee will evaluate the application for budget and duration, human/animal research risks and institutional approval, and overlapping research support.

The Review Committee will also evaluate the application for budget and duration, human/animal research risks and institutional approval, and overlapping research support.

The Programmatic Review is conducted by the advisory Breast Cancer Research Council and involves analyzing applications with an acceptable scientific merit score for the programmatic review criteria as described in Section 4 and submitted by the PI as an Executive Summary (see Section 12). All TRC applications are considered "primary" and will receive first consideration for funding.

In addition, the TRC application can include as an optional participant an advocate/community partner as a Key Personnel. This person should be experienced in breast cancer advocacy issues/concerns, and be affiliated with a community-based advocacy organization. This advocate/community partner should be listed on Form 10B, a biosketch included (Form 11), and a letter of support and project involvement included in the appendix. The advocate/community partner should be discussed using Form 5 and in the Lay and Scientific abstracts.

Note: The CBCRP will allow the recipients of Cycle IX (2003 only!) TRC Pilot Awards an extended Cycle IX application submission deadline of February 26, 2004 only for submission of a TRC Full Research Award based on results of the Pilot Award. The PIs must submit a Letter of Intent to the Program prior to January 8, 2004 to request this extended deadline.

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8. JOINING FORCES CONFERENCE AWARDS

The purpose of the Joining Forces Conference Awards is to increase interest, stimulate ideas, foster research, and facilitate grant applications for the three collaboration awards offered by the CBCRP—the SPRC, CRC, and TRC awards. These meetings should have a primary focus on breast cancer and facilitate contacts between individuals capable of future collaborative research activities. We have named this award type "Joining Forces" to reflect our intention to break down the barriers to multidisciplinary and cross-disciplinary research, and to recruit community and lay groups in the fight against breast cancer.

For the SPRC Awards (Section 5) these conferences should be designed to:

For the CRC Awards (Section 6) these conferences should be designed to:

For the TRC Awards (Section 7) these conferences should be designed to:

Some suggested formats for a joining forces conference are (1) a symposium with formal presentations and targeted breakout sessions, (2) a retreat that emphasizes less formal interactions, or (3) a conference style 'roundtable' discussion of pertinent issues without pre-existing leadership roles established. It is expected that the CBCRP, breast cancer advocates/activists, and the general public will be included in the meeting planning, organization and participation.

The Joining Forces Conference awards are limited to $25,000 in direct costs. Indirect costs will not be given for the Conference Awards.

Application deadline

Applications for Joining Forces Conference awards may be submitted at any time prior to July 1, 2004. Joining Forces applications will not normally be peer reviewed. Instead, they will be evaluated by the Breast Cancer Research Council and funding decisions will be made within 90 days of submission. We recommend that you submit the application six months prior to the meeting date.

Evaluation criteria

The Breast Cancer Research Council will evaluate the Joining Forces Conference Award applications according to the following review criteria:

Special conditions

The CBCRP staff must also be integrated into conference planning and implementation, and attendance by members of Program staff and Council must be permitted.

The CBCRP will require a written report upon the completion of conference activities within 60 days of the final meeting, and a fiscal report is due within 90 days.

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9. REQUESTS FOR APPLICATIONS (RFAs)

RFA awards are intended to support fully developed research proposals for which there is solid background information and promising preliminary studies. In general, the applicant will have experience in breast cancer research and the research questions will be of central importance in a particular discipline or topic area. Projects that are: (1) more speculative or high-risk, (2) performed by research teams new to breast cancer research, or (3) from less established investigators should consider the Program’s other award types, especially the Innovative Research Awards (Section 10). However, we still encourage RFA applications to address and discuss project elements related to innovativeness, multidisciplinary approach, translational goals, and the needs of women who are underserved.

RFAs must address one or more of the six "primary" Priority Issues described in Section 2 and listed below. These are RFA research topics of special importance to the advisory Council.

Note: RFA awards are not available on the three CBCRP "complementary" priority issues—Earlier Detection, Innovative Treatment Modalities, and Pathogenesis.

There is no specified budgetary cap on requested direct costs for the RFAs. However, $1 million is set aside for each of the six RFAs. The Program and Council will weigh the available resources versus the costs of the competitive applications submitted in making the final funding decisions. The duration limit is three years. The minimum time commitment for the PI is 10% FTE.

Evaluation Criteria

RFA applications are peer reviewed and rated independently for four separate components, which collectively determine the scientific merit.

A. Innovativeness: The extent to which the basic hypothesis represents a new and potentially useful way of formulating, investigating, or evaluating the problem under consideration.

B. Impact: The extent to which the project, if successfully carried out, would make an original and important contribution to the eradication of breast cancer or to an improvement in quality of life for breast cancer patients and survivors. This evaluation will include issues of practicality in terms of proposed approaches. Thus, for example, an intervention for prevention should be readily available, affordable, and acceptable to the population addressed, and medically reasonable for healthy women.

C. Approach: The extent to which the conceptual framework, design, methods, and analyses are developed, well integrated and appropriate to the aims of the project.

D. Feasibility: The likelihood that the proposed work can be accomplished by the investigators given their documented experience and expertise, past progress, preliminary data, requested and available resources, institutional commitment, and (if appropriate) documented access to special technologies or subject populations. Are there adequate plans for the recruitment and retention of subjects (Racial/Ethnic Differences and Sociocultural RFAs)? This scoring component includes consideration of the match between the resources and the scope of the proposed work.

The Review Committee will also evaluate the application for budget and duration, human/animal research risks and institutional approval, and overlapping research support.

The Programmatic Review is conducted by the advisory Breast Cancer Research Council and involves analyzing applications with an acceptable scientific merit score for the programmatic review criteria as described in Section 4 and submitted by the PI as an Executive Summary (see Section 12). All RFA applications are considered "primary" and will receive first consideration for funding.

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10. INNOVATIVE RESEARCH AWARDS

The intent of these CBCRP innovative awards is to encourage our applicants to think beyond the conservative, "incremental advances" that are typical of most research proposals. Thus, we are receptive to funding research, although untested, may reveal breakthroughs or new avenues of investigation. For the purpose of the Program "innovative" is defined as:

The Innovative Research Awards allow established researchers to enter the breast cancer field, and it allows existing breast cancer researchers to try new methods and approaches to study the disease.

These projects should be self-contained, hypothesis-driven research. They are not intended: (1) to fund smaller portions of a larger, R-01-type project, (2) for data collecting, incremental, or correlative research aims, or (3) for the compression of a larger project into a smaller time frame. Think of these projects as high risk-high reward.

There are two distinct innovative research award types:

Note: Researchers who are testing new hypotheses on breast cancer that are based on research (1) on another cancer type, or (2) from a non-breast cancer research area should apply for the IDEA. In contrast, the STEP Award should be based on preliminary data in breast cancer. Note to basic science applicants: If a molecular pathway has not been established to be relevant to breast cancer, then the primary point of the study should be to test this relevance.

Upon project completion of either of these award types the PI should have either: (1) opened a new area of investigation, (2) satisfactorily tested a novel or innovative hypothesis, or (3) have viable data for preparation of a full-scale research grant application to the Program or other agency.

Award Cap Guidelines

IDEA and STEP Award applications using human and/or vertebrate animal subjects may request a higher award cap. Use the following guidelines for placing your project into the appropriate award cap category:

Higher cap: IDEA is $100,000 (animal or human subjects) and STEP Award is $200,000 (animal) or $250,000 (human subjects) for studies where the use of human or vertebrate subjects is integral to the specific aims of the project. Specifically:

Lower cap: IDEA is $75,000 and STEP Award is $150,000 is for studies that use:

The application must identify one of the nine Program priority issues (Section 2) as the prime focus of the research. This is performed on Form 5. Refer to the research topic examples for the different priority issues listed in Section 2.

The minimum PI effort must be at least 5% FTE of total research effort. Allowable expenses include salaries, fringe benefits, domestic travel, and a $5,000 maximum for equipment for IDEAs. Full indirect costs (non-UC only) are allowed for IDEA and STEP awards.

Evaluation Criteria

IDEA and STEP Award applications are peer reviewed and rated independently for four separate components, which collectively determine the scientific merit.

A. Innovativeness: The extent to which the basic concept and hypotheses are speculative, exploratory, develop new paradigms, and are high risk/high reward.

B. Impact: The extent to which the project, if successfully carried out, would make an original and important contribution to the defeat of breast cancer or to an improvement in quality of life for breast cancer patients and survivors. Note to basic science applicants: If a molecular pathway has not been established to be relevant to breast cancer, then the primary point of the study should be to test this relevance.

C. Approach: The extent to which the conceptual framework, design, methods and analyses are developed, well integrated and appropriate to the aims of the project.

D. Feasibility: For the IDEA and STEP Award it is the extent to which the investigators have maximized their chances for success through demonstrated skill, knowledge, expertise, appropriate resources, and collaborations. For STEP awards, this criterion also includes the relevance of the preliminary data in breast cancer.

The Review Committee will also evaluate the budget and duration, human/animal research risks and institutional approval.

The Programmatic Review is conducted by the advisory Breast Cancer Research Council and involves analyzing applications with an acceptable scientific merit score for the programmatic review criteria as described in Section 4 and submitted by the PI as an Executive Summary (see Section 12). IDEA and STEP applications can be classified as "primary" only if they address one of the six "primary" CBCRP priority issues (see Section 2). Otherwise, all other IDEA and STEP applications are classified as "complementary." For example, a STEP application in the Pathogenesis priority issue is classified as "complementary", while a STEP application in Prevention and Risk Reduction is classified as "primary."

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11. CAREER DEVELOPMENT AWARDS

The CBCRP strongly supports opportunities in career development for established and new investigators, postdoctoral fellows, and for the training of undergraduate and graduate students. This brings fresh ideas and approaches to our evolving understanding of the disease.

The CBCRP offers six distinct types of career development awards to support:

Note: We require that Postdoctoral Fellowship, Dissertation, and Mentored Scholar application abstracts (Forms 3 & 4), Forms 5 & 6, the Research Plan (Form 12), and Career Plan (Form 17) be prepared by the applicant. It is appropriate for the mentor to: (1) assist the applicant in prioritizing the aims, (2) help organize a training plan that focuses on breast cancer, (3) match the scope of work to the duration and skills of the applicant and research group, and (4) help with "grantsmanship" issues.

New Investigator Awards: to support newly independent investigators to enable them to initiate their own research programs in breast cancer. Applicants must have an advanced degree and have less than three years experience as an independent investigator (either less than three years from completion of training, or less than three years from a change in career that involves beginning independent research). Eligible applicants cannot have received prior funding as principal investigators for major research grants, such as NIH 'R-01-type' awards; New Investigator awards from the CBCRP, other UC Special Research Programs, or similar funding from other agencies. Allowable prior funding would include this Program's awards, postdoctoral fellowships, and similar smaller-scale grants. The institution sponsoring the applicant must provide a non-temporary appointment indicating research independence and sufficient resources and support to the applicant in a research program. A letter of support from the applicant's departmental director addresses the issues of research independence, facilities available, and institutional support. This award provides direct costs of up to $300,000 for up to three years. The PI must devote at least 25% FTE to the project. Allowable expenses include salaries, supplies, fringe benefits, travel, and a $5,000 maximum for equipment. Indirect costs are capped at 8% for non-UC institutions. The award is not transferable to another PI.

Postdoctoral Fellowship Awards: for individuals with current or expected (before 12/31/04) doctoral degrees (Ph.D. or M.D.) to obtain research training in a field of breast cancer research with a designated mentor for up to two years and $45,000 (average costs) per year. The letter of support from the mentor will address the issues of the applicant's background, role in the laboratory, focus of the project and laboratory on breast cancer, commitment of the mentor, and the PI's potential for developing