Apply for Research Funding

Cycle 11 Application Information Packet

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The CBCRP application submission deadlines:
Community Research Collaboration (CRC) concept papers only: Thursday, November 4, 2004
Dissertation, Postdoctoral Fellowship, IDEA applications and IDEA competitive renewal letters of intent: Thursday, January 13, 2005
IDEA competitive renewal applications and CRC applications: Thursday, February 24, 2005

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, email, or fax submissions

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

Table of Contents

Overview
At a Glance
Invitation to Submit Applications
Research Priority Issues
Overview of Award Types
Application Evaluation and Award Process
Community Research Collaboration (CRC) Awards
Joining Forces Conference Awards (JFCA)
Innovative, Developmental and Exploratory Awards (IDEA)
Career Development Awards
Submission Requirements and Revised Applications
Conditions of Awards
Appeals
Application Form Overview
Special California Data Sources for Breast Cancer Research

OVERVIEW

This booklet provides key information on the:

The applications forms and instructions will be posted after October 6, 2004 on our Web site: www.cbcrp.org/ under the link Apply.

Application Deadlines

The CBCRP has only one funding cycle per year. All materials, originals and copies, must arrive in our office before 6:00 P.M. on the submission deadline date. Note the dates that are specific for each CBCRP award type.

Submission due date

Award Type

Thursday, November 4, 2004

Community Research Collaboration (CRC) concept papers only

Thursday, January 13, 2005

Dissertation, Postdoctoral Fellowship, and IDEA applications
IDEA competitive renewals submit a letter of intent

Thursday, February 24, 2005

IDEA competitive renewal applications

Community Research Collaboration (CRC) applications (must have submitted a concept paper in November)

Anytime before July 1, 2005

Joining Forces Conference Award applications (contact us before submitting)

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2005 CBCRP Cycle 11—AT A GLANCE

What's New

Application Forms

Criteria for Application Rejection
  1. Submission to our office is after the stated deadline
  2. Formatting requirements (i.e., page limits, font size, character/line spacing) are violated
  3. The PI is delinquent for report submission on existing CBCRP grants

Other Important Reminders

New awards begin July 1, 2005. We will contact you with the funding decision in early June 2005. Information on funding status will not be provided any sooner!

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INVITATION TO SUBMIT APPLICATIONS

The California Breast Cancer Research Program (CBCRP) is pleased to invite research grant applications for Cycle 11 funding. We expect to have available at least $7.5 million to award new grants beginning July 1, 2005. In this booklet you will find information to help you select the proper research topic (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. Voluntary contributions on State tax form 540
  3. Generous contributions from concerned individuals 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 rated for programmatic responsiveness by our advisory Council. It is a combination of both scientific merit and programmatic responsiveness that determines funding. All applicants will receive a detailed written evaluation summary.

Summary of Program Changes for 2005

The CBCRP and our advisory Council have instituted substantial changes to our research grant program for 2005, which depart from our previous research topics, award types, and Program strategies for funding. We are taking two paths to support critical breast cancer research in California.

The CBCRP will set aside 30 percent of our funding for the next five years to tackle research questions that California is uniquely positioned to address. Through an intensive evaluation, we identified the following critical research topics: (1) defining the influence of the environment and lifestyle on breast cancer and (2) uncovering the reasons for the unequal burden of breast cancer. Over the next year, we will convene a task force comprised of researchers and advocates from across the country to identify the knowledge gaps and available California resources in these areas. With the help of the task force, we will determine how California's resources can be leveraged to make the biggest leaps forward in tackling breast cancer and launch high impact program initiatives. At present we are not soliciting grant applications for these initiatives.

The remaining 70 percent of our research funding will support traditional grant applications. We are focusing our "core funding" efforts in the areas of innovative research, career development, and community participation. The remainder of this booklet is a description of the revised award types, research priority issues, and significant changes for the "core funding" segment of our Program.

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 strongly recommend that applicants who have limited experience in breast cancer research collaborate with established breast cancer researchers.

  3. Previously funded PIs. You are welcome to submit applications for new projects with aims distinct from previously funded CBCRP grants. Use application Form 7 to describe these distinctions.

    Note: Principal investigators who received IDEA grants in cycles IX and X (2003-2004) are eligible to apply for an IDEA competitive renewal award. The process is described in Section 7.

  4. Re-submissions. Individuals who submitted unfunded CRC, postdoctoral fellowship, dissertation, or IDEA applications can revise them and re-submit in the current cycle. Unfunded applications in all other award types are not eligible for re-submission. Already-funded PIs may submit new applications in Cycle 11 that are distinct from the previously funded research.

  5. Multiple applications and grant limits for PIs. An investigator may submit more than one application, but each application must have unique specific aims. In Cycle 11 a PI is limited to one IDEA grant, one IDEA competitive renewal grant, and one co-PI award as part of a CRC grant.

    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 9 under "Policy on Applications from PIs with Delinquent CBCRP Grant Reports."

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RESEARCH PRIORITY ISSUES

“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 the Program's mission, our founding legislation and advisory Council have established these key criteria and goals for our funded research:

The four (4) priority issues listed below are the broad research topics designated by the Program for Cycle 11. The individual priority issues are defined and we list 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 4. Explain the relevance of the additional Priority Issue(s) using Form 4.

Note: The CBCRP is a member of a new cancer funding consortium, called The International Cancer Research Partners (ICRP), that has developed a research topic classification scheme (the CSO-common scientific outline) and grant portfolio database Web site: www.cancerportfolio.org/.

The purpose of the CSO is to better analyze cancer grant funding, compare cancer research funding across agencies, and to identify established and emerging research topics. 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 look through the ICRP Web site and follow the instructions in Section 9 for entering the appropriate code number(s) on Form 1 (cover page). We appreciate your help.

The four CBCRP priority issues are broad breast cancer topics that define our critical research needs. To be responsive and eligible for funding, each applicant must explain the relevance of their proposed research (Form 4) to breast cancer using the priority issues as a guide. The descriptive text is included to provide examples, which are not intended to be inclusive.

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

Overview: What are factors that contribute to the unequal burden of breast cancer among diverse communities? Are there policy alternatives that would contribute to reducing disparities in access to prevention, detection, treatment, support, and/or survivorship services for California's underserved populations? What is the influence of poverty, race/ethnicity, and environmental factors on breast cancer? What are the sociocultural, behavioral, and psychological issues of those affected by breast cancer and what services are needed to reduce the suffering caused by the disease? We encourage health policy; health services; and sociocultural, behavioral, and psychological research that address disparities and the burden of breast cancer among California's diverse communities. Specific topics include:

Health Policy: Serving Women's Needs
We encourage research examining the impact of public and private health policy on issues related to prevention, detection, and treatment of breast cancer as well as research into the formulation of policy alternatives that would reduce disparities related to prevention, detection, and treatment of breast cancer.

Health Services: Serving Women's Needs
We encourage research examining the delivery of breast cancer-related services and how to most effectively deliver services, especially to the underserved.

Sociocultural, Behavioral, and Psychological Issues Relevant to Breast Cancer: The Human Side
We encourage research into the sociocultural, behavioral, and psychological issues of those affected by breast cancer or at high risk for the disease. Research that examines patient and practitioner interactions, enhancing quality of life, long-term survival, and participation in clinical research is encouraged, especially research addressing the needs of high-risk and underserved populations.

Disparities: Eliminating the Unequal Burden of Breast Cancer
We encourage research that aims to reduce disparities in breast cancer incidence, morbidity, and mortality, access to prevention, treatment, and/or survivorship services based on factors related to race/ethnicity, socioeconomic status, geographic location, sexual orientation, ability, age, occupation, and/or other factors. Intervention research that reduces disparities is encouraged.

2. Etiology and Prevention: finding the underlying causes

Overview: What environmental and biological factors interact to increase the risk of developing breast cancer? What approaches can be used to reduce or eliminate breast cancer risk? We especially encourage new California-based studies that seek an understanding of the environmental and lifestyle causes of breast cancer and how these increase risk and impact different communities in California. Specific topics include:

Etiology: The Role of Environment and Lifestyle
We encourage studies on breast cancer initiation that may be due to environmental exposures that subject women to agents that they, as individuals, cannot control. Other key topics of interest include breast cancer causes related to lifestyle (e.g., diet, exercise) and the underlying metabolic, hormonal, and environmental interactions. Studies on causative gene-environment interactions specific to breast cancer, especially those having the potential to lead to prevention strategies, are encouraged.

Prevention and Risk Reduction: Ending the Danger of Breast Cancer
Research exploring 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 are encouraged. Examples include nutritional factors, xenoestrogens, exercise, studies of genetic variation, and methods to modify known breast cancer genes and risk factors.

Note: Basic science research (e.g., using molecular, cell, and animal models) on the genetic, "mechanistic" causes of breast cancer (e.g., p53 and BRCA genes) should be submitted under the Biology of the Breast Cell topic.

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

Overview: Although basic science research in cancer is well-supported by other agencies, there remains a critical need to understand the pre-neoplastic, causative events of breast cancer at the tissue level, including the stroma. The genetic changes in disease progression and the tumor heterogeneity need clarification at the basic science level. Breast cancer stem cell research is especially encouraged. Specific topics include:

Biology of the Normal Breast: The Starting Point
Research should explore aspects of normal breast biology (e.g., aging) that are linked to the earliest stages of breast cancer, and which could provide insights into new approaches to prevent, detect, or treat the disease.

Pathogenesis: Understanding the Disease
Research must specifically focus on breast cancer tumor and stromal biology, including: (1) studies of relevant proteins and genes with an emphasis on their relationship to the actual disease, and (2) elucidating key cell signaling, growth control, cell cycle, and apoptosis pathways. We especially encourage new research on the process of metastasis and the development of tools and models to better understand the key metastatic events that impact patient survival.

Note: We encourage basic science hypothesis-building projects. We welcome researchers from other cancer types and fields of biology to apply, but obtaining breast cancer data and establishing breast cancer relevance must be the primary aims of the project. The CBCRP is less interested in basic science research that involves (1) the incremental advance of a general basic science hypothesis, (2) a lateral study from another cancer type or within breast cancer that uses different cell lines, and (3) the use of existing assays to further characterize a model system. We discourage applications with an entirely "reductionist" rationale (i.e., the concept that the entire subject of breast cancer can be understood solely by analysis at the molecular level). It is necessary for basic science researchers to justify the discovery and study of each piece of the puzzle by explaining it in the landscape of breast cancer. Tell us why the proposed research is on a critical path (Form 5) to translation and impact on those with or at risk for breast cancer.

4. Detection, Prognosis, and Treatment: delivering clinical solutions

Overview: Clinical advances for breast cancer will utilize novel imaging technologies, new biomarkers, and genomic/proteomic approaches for more accurate diagnosis and prognosis. We encourage projects whose aims are on the critical path for translation. We support research into less toxic and more individualized therapies, mechanisms of drug resistance, and studies to evaluate alternative medicines and natural products. Specific topics include:

Imaging, Biomarkers, and Molecular Pathology: Improving Detection and Diagnosis
We encourage research into new, cost-effective technological and biological approaches for molecular imaging and new approaches for tumor analysis at the individual patient level. This includes advanced types of molecular classification, new biomarker development, and improved technologies for patient diagnosis and prognosis, especially using techniques to replace the current practice of screening mammography and biopsy.

Innovative Treatment Modalities: Search for a Cure
Promising leads from biology-based studies are encouraged to begin the critical path to clinical translation. Examples include immunotherapy, delivery technologies, gene therapy, new drug development/testing, and new approaches to clinical decision-making. Testing investigational anti-breast cancer agents for mechanism of action and identifying target patient populations are encouraged.

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OVERVIEW OF AWARD TYPES

The CBCRP award types are discussed in detail in Sections 5-8.

Note: The award type budget caps listed are for direct costs only. To request indirect (F&A) costs there are two things to keep in mind. First, we do not offer indirect costs to University of California campuses. Second, we only allow F&A costs on IDEAs and CRCs.

 

  IDEA IDEA - Competitive Renewal Postdoc Dissertation CRC-Pilot CRC-Full JFCA^^
Purpose Innovation, exploratory research Developmental, high-reward research Training, career development Training, career development Community-based research Community-based research Conference support
Maximum duration 1.5yrs 2yrs 3yrs** 1-2^ 1.5yrs 3yrs n/a
Maximum direct costs
(total project)		 $100K to $150K* $200K to $250K* $135K** $76K $100K $500K $25K
Budget: Maximum Equipment $5,000 $5,000 $2,500 None No Cap No Cap None
Minimum PI Effort on Project 5% 5% 80% 80% 10% 10% n/a
Indirect (F&A) Costs
for non-UC only		 Full Full None None Full Full None
Priority Issue Addressed Any Any Any Any Any Any Any
Scientific Merit Score
includes the following components:		              
Innovativeness Included   Included Included     ^^
Progress   Included          
Impact Included Included Included Included      
Approach Included Included Included Included      
Feasibility Included Included Included Included Included Included  
Career     Included Included      
Partnership         Included Included  
Community Benefit         Included Included  
Research Quality         Included Included  

* See Section 7 for IDEA direct costs caps that depend on the use of animal and human subjects.
** Note the five year postdoctoral tenure policy in Section 8. $45,000 per year (average direct costs).
^ 1 year for master's program; 2 years for doctoral program. Maximum of $38,000 per year.
^^ Joining Forces Conference Awards are evaluated by the CBCRP advisory Council. See Section 6 for criteria.

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APPLICATION EVALUATION AND AWARD PROCESS

Applicants should carefully consider how their projects will be evaluated and the scientific merit 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 funding 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 read by the committee chair. Each application is discussed at a meeting of the entire review committee and final scores are assigned. Applicants will receive a detailed written evaluation. This is primarily derived from the written comments of the assigned reviewers, but also includes key points from the committee discussion and programmatic review evaluation. 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 applications are novel and worthwhile additions to previously funded research. We advise PIs to address the distinction of their new applications from previously-funded CBCRP grants using Form 7.

Scientific Merit Criteria

There are distinct components of scientific merit and they are scored independently by our peer reviewers to reflect the requirements inherent in each award type. The components specific to each award type are listed in the Table on the preceding page. In the award type sections to follow, these scientific merit score components are 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 combine 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" (i.e., upper 2/3 of average scientific merit) are eligible for 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 by the Program staff and the review committee. The Program can require changes in duration and award amount to any grant, and awards are contingent upon acceptance by the investigator(s) of a revised budget. 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 two years or more. The maximum allowable costs for equipment in each award type are discussed in the following sections and the instructions for Form 8. PIs need to state the distinction between the application and other research funding on Form 7. The review committee and Council will examine these items and make comments on research overlap.

Human subjects and Vertebrate animal use: 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. Human Subjects and vertebrate animal use must be declared on the application cover page (Form 1). IRB approval, human subjects "exemption" approval, or animal assurance documentation must be provided prior to funding, but is not needed for application review. Clinical trials may be required to provide a data and safety monitoring board (DSMB) as described in the NCI policy release, http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. 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

Note: Applicants sometimes fail to get funded because they pay too little attention in addressing the criteria for the programmatic review. Please pay careful attention to application Forms 1-7 and follow the instructions. This is especially true for your statements on advocacy involvement and sensitivity to the concerns of breast cancer advocates. It is not enough to mention breast cancer incidence and death rates as a rationale for more research. Develop your thinking on the underlying scientific and community barriers that limit our current abilities to understand, prevent, detect, and treat the disease. Consider the additional burden that breast cancer places on certain communities. Find the connections between your research topic and ways it might be translated and impact the lives of women with breast cancer and those at risk. Think about how to involve advocates directly in your research program. The instructions attached to Form 2 (Lay Abstract), Form 5A (Critical Path/Additional Criteria), and Form 5B (Additional Criteria) will have more detailed information regarding advocacy sensitivity and involvement.

The programmatic review is conducted by the advisory Breast Cancer Research Council and involves analyzing applications with a sufficient scientific merit (i.e., upper 2/3 or average scientific merit for all applications reviewed and scored) for the criteria listed below. 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 3 (Scientific Abstract), should be prepared using a style and language comprehensible to the general public. Pay careful attention to the instructions for each form.

Relationships between the Programmatic Review criteria and award types/application forms

Programmatic Criteria: Award Type Application Forms Used* (Major ones in bold)
    2 3 4 5A 5B 6 7
Response to Priorities All X X X        
Response to Award Type All     X        
Career plan/mentoring Dissertation and Postdoc           X  
Critical path/translation IDEA       X      
Dissemination and translation potential CRC              
CBCRP "balance" or underfunded All             X
Quality of the Lay Abstract All X            
Addressing the needs of the underserved All       X X    
Advocacy- sensitivity and inclusion All X X   X X    
Scientific merit component score** All              

* See the CRC Application Packet for the correct form for Community Research Collaboration awards.
** This item is considered after the criteria above it are rated. It involves inspecting the peer review scoring and giving additional credit for a high rating for "innovation" (IDEA), "career development" (Dissertation and Postdoctoral Fellowship), or "community benefit" (CRC). The Council assesses these criteria according to the application's ranking within each peer review committee by award type.

Programmatic criteria definitions:

It is a combination of (i) the programmatic rating and (ii) strengths and weaknesses in both the average scientific merit and individual components of scientific merit that determines a decision to recommend funding. For competitive renewals of IDEA grants the advisory Council will make a funding recommendation based only on: (i) the programmatic review score for the original IDEA application, (ii) efforts made to increase advocacy involvement in the research, and (iii) the scientific merit score, especially "progress", for the renewal application.

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 2005 of their funding status. The written application evaluation from the review committee, the merit score average, component scores, percentile ranking, and programmatic evaluation 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) provide a complete, current list of other grant support to address funding overlap and FTE percentage by key personnel, (3) provide up-to-date human subject and animal approval documents, (4) provide up-to-date indirect cost rate (F&A) 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, (i) the title, principal investigator(s), the name of the organization, and award amount in a Compendium of Research for each funding cycle, (ii) the costs (both direct and indirect) in the CBCRP's Advances annual report, (iii) the project abstract and progress report abstracts 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 without prior approval from the PI for any application that is not funded.

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COMMUNITY RESEARCH COLLABORATION (CRC) AWARDS

CONCEPT PAPER REQUIRED! Deadline: Thursday November 4, 2004.

Note: There are separate 2005 CRC Call for Applications and CRC Application Packet & Forms. These are provided on our Web site. The information provided below is an overview of this award type. Those interested, please contact Walter Price, Dr.P.H. at 510 987-9886 or Cathyn Fan, M.P.H. at 510 987-0646.

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 usable by 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 6) 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 meet the following requirements:

  1. A research question with a hypothesis and work plan. While the specific aims and methods must be 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 participation in the research development by community members, and/or 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 breast cancer directed 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.

Examples of 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, in person or by teleconference, upon request with prospective applicants to assist with any issues they have on research topics, collaborations, and application procedures.

The CBCRP also will hold technical assistance workshops in January 2005 to assist applicants with the implications of the review comments. Information on these workshops will be sent to concept paper applicants in December 2004.

CRC Submission Deadlines:
November 4, 2004 (Thursday) CRC Concept Papers due (required)
February 24, 2005 (Thursday) CRC Applications due

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JOINING FORCES CONFERENCE AWARDS (JFCA)

Joining Forces Conference award (JFCA) applications may be submitted at any time prior to July 1, 2005. Please contact us at least six months prior to your planned meeting to set up an appropriate submission and funding decision schedule.

Purpose/Requirements: The JFCAs are intended to increase interest, stimulate ideas, foster research, and facilitate grant applications specific to breast cancer. We have named this award type "joining forces" to break down barriers and build bridges to foster to multidisciplinary and cross-disciplinary research, and we encourage researchers to recruit community and lay groups in the fight against breast cancer. We especially welcome the participation of breast cancer advocates in research conferences. These conferences should be designed to:

Some suggested formats for a JFCA include: (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.

CBCRP staff must be included in the conference planning and implementation, and attendance by members of CBCRP 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.

Budget: The JFCA are limited to $25,000 in direct costs. No indirect costs will be given for conference awards.

Evaluation criteria: JFCA applications will not normally be peer reviewed. The CBCRP's advisory Council will evaluate them according to the following criteria:

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INNOVATIVE, DEVELOPMENTAL, AND EXPLORATORY AWARDS (IDEA)

The intent of the IDEA is to encourage researchers to pursue new, innovative projects and to think beyond the incremental advances that are typical of most grant applications. We wish to inspire research that, although untested, may reveal breakthroughs or new avenues of investigation. For this purpose we define "innovative" as:

In addition, we encourage junior investigators to initiate their own innovative projects and researchers new to breast cancer to enter the breast cancer field.

Key Changes for 2005

The CBCRP has revised our innovative research funding mechanism:

IDEAs

Purpose/Requirements: The intent of the IDEA is to support speculative, exploratory, high-risk/high-reward projects with a primary focus on breast cancer. Applications for this award type should either: (i) challenge existing paradigms, or (ii) encourage innovation by the incorporation of techniques, approaches, and collaborations not yet well represented in mainstream breast cancer research. We encourage researchers to attempt breakthroughs that, if successful, could be leveraged into more substantial funding. Preliminary data in breast cancer is not required for an IDEA application, but we encourage PIs to include sufficient data (obtained in their laboratory or research group) to demonstrate feasibility for the proposed research. It is not an absolute requirement for an IDEA project to be hypothesis-driven, and we consider correlative and data-gathering projects to be responsive to this award type. However, to be maximally responsive to the IDEA funding mechanism, the applicant must either be previously trained and have published in breast cancer or collaborate with an established breast cancer researcher. The Program and peer review committees will consider applications from researchers outside of breast cancer who propose novel research, but we require them to establish breast cancer relevance as the primary aim and to describe the critical path that links their research to breast cancer. To qualify for future consideration for an IDEA competitive renewal, the applicant should identify the milestones to be completed in the first phase of the project using Form 13.

Examples of research not responsive to the IDEA are projects that: (1) propose incremental advances for the underlying topic, (2) duplicate the aims of completed or funded research to the PI derived from non-breast cancer studies without incorporating detailed breast cancer-specific justification, (3) overlap in topic and aims with current grant support to the applicant, or (4) represent portions of existing grants or are derived from cut-down larger, R01-type projects.

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. Make this aim #1 in your application. We discourage applications with an entirely reductionist rationale (i.e., the concept that the entire subject of breast cancer can be understood solely by analysis at the molecular level). It is necessary for basic science researchers to justify the discovery and study of each piece of the puzzle by explaining it in the landscape of breast cancer. Use Form 5 to tell us why the proposed research is on a critical path to translation and impact on those with or at risk for breast cancer.

Junior investigators: On the submission date, the PI should be at a career level past postdoctoral fellowship (or equivalent) and less than three years as an independent investigator (e.g., Assistant Professor or equivalent). This category is not intended for career development. If the applicant is working in a common facility or research group and under the direction of a senior researcher, then the proposed research must be distinct from the grant support to the supervisor. Thus, the application cannot contain duplicate aims or overlap with the supervisor's other grant support. Check the box on Form 1A (Cover Page), if you are applying under this IDEA category. Next, the applicant should address their qualifications for the "junior investigator" designation using Form 4 (Program Responsiveness), Part II. During the application's peer review the junior investigator status of the PI will be taken into consideration. Primarily, the review committee will use special criteria when scoring the "feasibility" component of the merit score. This will place less weight on the PI's track record, and more weight on resources and collaborations. Finally, if you are working under the supervision of a more senior researcher, then name this person on Form 17 (Appendix Cover Sheet), and provide this person's other grant support in the appendix.

Duration/budget: The maximum duration is 1.5 years and the direct costs budget cap is $100,000 or $150,000 (projects using animal or human subjects). Use the following guidelines for placing your project into the appropriate IDEA award cap category:

Higher cap: $150,000 (animal or human subjects) for studies where the use of human or vertebrate subjects is integral to the specific aims of the project. Specifically:

  • Human subjects studies, surveys, and data acquisition requiring institutional IRB-approval and an informed consent form.
  • Use of vertebrate subjects and experiments that require an institutional animal assurance approval. This would include animal tumor and metastasis models, knock-out mice, and studies where tumor growth/metastasis is inhibited by novel therapies.

Lower cap: $100,000 for studies not using animal or human subjects and for those using animal and human subjects as follows:

  • Vertebrate subjects used in a minor portion of the project, such as generation of antibodies.
  • Using existing data sources, such as patient and cancer databases.
  • Use of archival breast cancer material, such as ATCC-type cell lines or stored tumor materials, generally under the "exempt" categories of IRB approval.

Full indirect costs are allowed for IDEAs only to non-UC institutions. The minimum PI effort must be at least 5% FTE. IDEA grants have a $5,000 cap for equipment.

Evaluation criteria: New and revised IDEA applications, including those from junior investigators, are peer reviewed and rated independently for four separate components.

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

The Programmatic Review for IDEAs is conducted by the advisory Breast Cancer Research Council and involves analyzing applications with a "sufficient scientific merit" (i.e., upper 2/3 or average scientific merit for all applications reviewed and scored) for the criteria listed below. 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 3 (Scientific Abstract), should be prepared using a style and language comprehensible to the general public. Pay careful attention to the instructions for each form.

Relationships between the Programmatic Review criteria and IDEA application forms

Programmatic Criteria: Application Forms Used*
(Major ones in bold)
  2 3 4 5A 7
Response to Priorities X X X    
Response to Award Type     X    
Critical path/translation       X  
CBCRP "balance" or underfunded         X
Quality of the Lay Abstract X        
Addressing the needs of the underserved       X  
Advocacy- sensitivity and inclusion X X   X  
Scientific merit component score*          

*This item is considered after the criteria above it are rated. It involves inspecting the peer review scoring and giving additional credit for a high rating for "innovation." The Council assesses this item according to the application's ranking within each peer review committee.

Programmatic criteria definitions:

It is a combination of (i) the programmatic rating and (ii) strengths and weaknesses in both the average scientific merit and individual components of scientific merit that determines a decision to recommend funding.

IDEA Competitive Renewals

Important competitive renewal requirements and conditions:

  1. CBCRP IDEA grants funded in either Cycles IX or X (2003-2004) are eligible to apply for a competitive renewal in Cycle 11.
  2. The PI must submit a letter of intent to the CBCRP by the January 13, 2005, deadline to notify us of a pending application. The application is due by February 24, 2005.
  3. A funded IDEA may apply for renewal in either of the next two CBCRP funding cycles. Alternatively, if initial award funding is delayed, then the renewal must be submitted within two years of receipt of initial funding disbursement.
  4. Only one (1) IDEA renewal, "full application" submission is allowed. If a renewal application is unfunded, then it cannot be resubmitted.
  5. Submit the Research Plan from the original IDEA in the Appendix (see Form 17).

Purpose/Requirements: To allow continued CBCRP support for IDEAs that show excellent progress and are ready to move from the exploratory phase into the developmental phase of the project. To compete for a renewal, the PI in the initial award period must satisfy proof-of-principle for the central topic under investigation. Preliminary data in breast cancer is required for a competitive renewal and these results should be expanded in the renewal, high reward phase to focus on breast cancer models and systems. The competitive renewal IDEA submission will consist of an abbreviated application. The Renewal Report (Form 14) with the revised aims and an outline of the proposed work for the renewal period provides key information on progress and future research plans. An IDEA project that deviates significantly from the originally proposed research should not be submitted as a competitive renewal.

Duration/budget: For the IDEA competitive renewal only, the maximum duration is 2 years and the direct costs budget cap is $200,000 or $250,000 (projects using animal or human subjects). Full indirect costs are allowed for non-UC institutions. The minimum PI effort must be at least 5% FTE. IDEA grants have $5,000 cap for equipment.

Evaluation criteria: As part of the new scientific review, the peer reviewers will receive copies of the original IDEA research plan (supplied by the PI in the appendix) and the evaluation summary from the previous peer review (supplied by the CBCRP).

Competitive renewal IDEA applications are peer reviewed and rated independently for four separate criteria:

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

The Programmatic Review for IDEA competitive renewals is based on: (i) the programmatic review score for the original IDEA application, (ii) efforts made to increase advocacy involvement in the research, and (iii) the scientific merit score, especially "progress", for the renewal application.

IDEA and Competitive Renewal Timeline*

Item Date Description
New IDEA Grant begins (Cycle 11) July 1, 2005

Initial IDEA grant is awarded. Grant duration can extend for 12 or 18 months.
Next CBCRP submission date January 2006

The PI can first apply for a competitive renewal at the start of the next grant cycle. The applicant submits a letter of intent to the Program.
Renewal application due February 2006

The renewal submission is delayed by 6 weeks to allow the PI to obtain data for the upcoming review.
Peer review March-April 2006

Peer review has unique merit criteria and the committee considers the original research plan, evaluation summary from the previous review, and the renewal report from the PI.

NOTE: If a competitive renewal is not selected for funding, then it may not be resubmitted.

Complete IDEA grant- Year #1 June 30, 2006

Original grant ends (12-month duration)
Start competitive renewal, if funded July 1, 2007

Congratulations!
Next CBCRP submission deadline (Cycle 13) January 2007

Last opportunity to submit a "letter of intent" for competitive renewal for a Cycle 11 IDEA. To avoid a gap in funding the PI can extend the original award period by 6 to 12 months.
Renewal application due February 2007

Same as above
Peer Review March-April 2007

Same as above
End of Original IDEA June 30, 2007

18-month award + 6-month extension
Start of competitive renewal in option #2 July 1, 2007

Congratulations!

* When determining the requested duration period for the original IDEA application (Cycle 11), the PI should consider the anticipated submission of the renewal. If the project can achieve the critical milestones in 6-7 months, then the original application should request a duration of one year. However, if the milestones require more than 7-8 months to complete, then the original IDEA should request a duration of 18-mos and plan for a 6-month extension to avoid a gap in funding.

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CAREER DEVELOPMENT AWARDS

Note: The CBCRP has discontinued the following career development award types: New Investigator, Career Enrichment, Mentored Scholar, and Training Program.

The CBCRP strongly supports opportunities in career development for postdoctoral fellows and the completion of dissertation research for graduate students. This brings fresh ideas and approaches to our evolving understanding of the disease.

Important requirements and award conditions

  1. Postdoctoral tenure. The combination of proposed CBCRP fellowship grant funding and all prior total postdoctoral fellowship training cannot exceed five years. For example, to request the maximum of three years of funding, the PI must have been a postdoc for less than two years as of July 1, 2005. Time spent in clinical training (M.D.) does not apply to the postdoctoral tenure limit. Contact the CBCRP if you have questions regarding this policy. In summary, applicants can apply for one, two, or three years of fellowship grant funding based on the nature of their project, career goals, and the five-year tenure limit.

  2. The application must be prepared by the postdoctoral fellow or graduate student PI. This includes the abstracts (Forms 2 & 3), Form 4, Form 5B, and the Research Plan (Form 12). It is appropriate for the mentor to assist the applicant in: (i) prioritizing the aims, (ii) matching the amount of work (i.e., avoid overambitious projects) to the project duration and skills of the applicant, (iii) proofreading the text and correcting any improper English usage, (iv) organizing a training plan that focuses on breast cancer (Form 11C), and (v) identifying the distinctions of the current application from other work in the mentor's lab for Form 7. The mentor should prepare and sign Form 11C.

  3. Letters of support/recommendation should be arranged prior to the submission of the application on January 13, 2005. Have the references mail these letters to the PI and include them unopened in their sealed envelopes with the application at the time of submission. Refer to the instructions at the end of this section.

  4. Postdoctoral fellows can delay the start of their project for up to six months to finish another funded project or to complete their doctoral training. They must notify the Program in writing after an offer of funding (June 2005) to execute a delayed start date.

  5. If the PI graduates during a dissertation award, then the grant must be resigned. We will allow a brief period of continued support, not to exceed three months, if the PI continues working on the CBCRP-funded project in the mentor's lab.

Dissertation Awards

Purpose/Requirements: To support the completion of dissertation research for Masters or Doctoral-level graduate students. The applicant (PI) is the student, who must prepare the application and should have advanced to the appropriate degree candidacy level by the award start date (July 1, 2005). The mentor must be an independent, full-time faculty (or equivalent) at the institution. To be maximally responsive to this award type, the mentor should either be experienced and have published in breast cancer or collaborate with a breast cancer researcher. The mentor must include a training plan focused on breast cancer. The research project can be supported, in part, by the mentor's existing funding, but should incorporate innovative aims tailored to the skills and dissertation requirements of the applicant.

Duration/budget: The maximum duration is one year (Masters level) or two years (Doctoral level). The budget cap is $38,000 per year for stipend/fringe benefits, tuition/fee remission, supplies, and travel. The student stipend request for the budget should be consistent with NIH National Research Service Award (NRSA) stipend levels (http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-04-023.html). No indirect (F&A) costs are allowed for this award type. The award is not transferable to another PI.

Evaluation criteria: Dissertation Award applications are peer reviewed and rated independently for five separate criteria:

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

The Programmatic Review for dissertation awards is conducted by the advisory Breast Cancer Research Council and involves analyzing applications with a sufficient scientific merit (i.e., upper 2/3 or average scientific merit for all applications reviewed and scored) for the criteria listed below. 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 3 (Scientific Abstract), should be prepared using a style and language comprehensible to the general public. Pay careful attention to the instructions for each form.

Relationships between the Programmatic Review criteria and Dissertation application forms

Programmatic Criteria: Application Forms Used
(Major ones in bold)
  2 3 4 5B 6 7
Response to Priorities X X X      
Response to Award Type     X      
Career plan/mentoring         X  
CBCRP "balance" or underfunded           X
Quality of the Lay Abstract X          
Addressing the needs of the underserved       X    
Advocacy - sensitivity and inclusion X X   X    
Scientific merit component score*            

Programmatic criteria definitions:

It is a combination of (i) the programmatic rating and (ii) strengths and weaknesses in both the average scientific merit and individual components of scientific merit that determines a decision to recommend funding.

Postdoctoral Fellowship Awards

Purpose/Requirements: To support advanced training in a field of breast cancer research with a designated mentor for individuals with current or expected (before 12/31/05) doctoral degrees (Ph.D., M.D., or equivalent). To be maximally responsive to this award type, the mentor should either be experienced and have published in breast cancer or collaborate with a breast cancer researcher. The mentor must include a training plan focused on breast cancer. The research project can be supported, in part, by the mentor's existing funding, but should incorporate innovative aims tailored to the skills and career development of the applicant. We encourage applicants who are within two years of completing their doctoral degree, or those individuals in recent transition to breast cancer research from another field. Prior recipients of CBCRP postdoctoral funding are not eligible under this award type. The peer review committee will examine the prior postdoctoral training/funding of the applicant to assess the additional career development benefits of the present CBCRP application and training. Please note the postdoctoral tenure policy (item #1 on the first page of this section).

Duration/budget: The maximum fellowship duration is three years and total direct costs budget cap is $45,000 (average costs) per year. The PI must devote at least 80% FTE to the project. Allowable expenses include salaries, fringe benefits, travel, and a $2,500 maximum for equipment. The fellow's salary request for the budget should be consistent with NIH National Research Service Award (NRSA) stipend levels (http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-04-023.html). No indirect (F&A) costs are allowed for this award type. The award is not transferable to another PI.

Evaluation criteria: Postdoctoral Fellowship applications are peer reviewed and rated independently for five separate criteria:

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

The Programmatic Review for postdoctoral fellowship awards is conducted by the advisory Breast Cancer Research Council and involves analyzing applications with a "sufficient scientific merit" (i.e., upper 2/3 or average scientific merit for all applications reviewed and scored) for the criteria listed below. 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 3 (Scientific Abstract), should be prepared using a style and language comprehensible to the general public. Pay careful attention to the instructions for each form.

Relationships between the Programmatic Review criteria and Postdoctoral application forms

Programmatic Criteria: Application Forms Used
(Major ones in bold)
  2 3 4 5B 6 7
Response to Priorities X X X      
Response to Award Type     X      
Career plan/mentoring         X  
CBCRP "balance" or underfunded           X
Quality of the Lay Abstract X          
Addressing the needs of the underserved       X    
Advocacy - sensitivity and inclusion X X   X    
Scientific merit component score*            

*This item is considered after the criteria above it are rated. It involves inspecting the peer review scoring and giving additional credit for a high rating "career development." The Council assesses this item according to the application's ranking within each peer review committee.

Programmatic criteria definitions:

It is a combination of (i) the programmatic rating and (ii) strengths and weaknesses in both the average scientific merit and individual components of scientific merit that determines a decision to recommend funding.

Instructions for Letters of Support/Recommendation

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SUBMISSION REQUIREMENTS AND REVISED APPLICATIONS

It is the responsibility of the applicants to submit the required forms (see Section 12 for lists), follow the detailed instructions for preparing the forms, submit a signed original and the correct number of copies, and meet the submission deadline.

Criteria for Application Rejection

  1. Submission to our office is after the stated deadline
  2. Formatting requirements (i.e., page limits, font size, character/line spacing) are violated
  3. The PI is delinquent for report submission on existing CBCRP grants

Deadlines for Receipt of Applications & Policy Statement

The CBCRP has only one funding cycle per year. All materials, originals and copies, must arrive in our office before 6:00 PM on the submission deadline date. Note the dates that are specific for each CBCRP award type.

Submission due date

Award Type

Thursday, November 4, 2004

Community Research Collaboration (CRC) concept papers only

Thursday, January 13, 2005

Dissertation, Postdoctoral Fellowship, and IDEA applications
IDEA competitive renewals submit a letter of intent

Thursday, February 24, 2005

IDEA competitive renewal applications

Community Research Collaboration (CRC) applications (must have submitted a concept paper in November)

Anytime before July 1, 2005

Joining Forces Conference Award applications (contact us before submitting)

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. Deliver all applications to:

California Breast Cancer Research Program
University of California, Office of the President
300 Lakeside Drive, 6th Floor
Oakland, CA 94612-3550
Phone: 510 987-9884

We are located in the Kaiser Building, three blocks east (towards Lake Merritt) from the 19th Street BART station when traveling on 20th St. If you drive, then short-term parking is available in front of the building off Lakeside Drive and in the adjacent parking garage.

Policy on Applications from PIs with Delinquent CBCRP Grant Reports

PIs with current CBCRP grant support will not be eligible to apply for additional funding unless the required scientific and fiscal reports on their existing grants are up to date. This means that Progress/Final Scientific Reports or Fiscal Reports that are more than one month overdue may subject a Cycle 11 application to possible disqualification unless the issue is either addressed by the PI and Institution within one month of notification, or the PI and Institution have received written permission from the CBCRP to allow an extension of any report deadlines.

General Items

APPLICATION FORMAT REQUIREMENTS

Note: All Research Plans (Form 12) will be screened to identify those that violate the formatting criteria (number of pages, font size, text density, and margins). If there is any violation, the PI will be notified that the application will not be submitted for peer review and is ineligible for funding.

  1. All applicant-prepared text on pre-formatted forms and the continuation pages (those for Forms 4, 5A, 5B, 9, 11B, 11C, 12, and 14) must conform to the following four requirements:

    1. The height of the letters must not be smaller than 11 point. Times New Roman or Arial are the suggested fonts.
    2. Type density, including characters and spaces, must be no more than 15 characters per inch (cpi).
    3. Line spacing must be no more than 6 lines of type within a vertical inch.
    4. Page margins, in all directions, must be at least ½ inch.
       

  2. Applicant-prepared continuation pages should be on plain 8½ x 11 inch paper. Include the PI name (last name, first name) on the upper right and the page number on the lower center of each page.

  3. Deviations from the page format, font size, specifications and page limitations, especially the page limit for the Research Plan, will be grounds for the CBCRP to reject and return the entire application without peer review.

  4. Do not use photo reduction for preparing either the original application or the photocopies. Prepare all graphs, diagrams, tables, and charts in black ink.

  5. The application (main body Forms 1-16, exclusive of Appendix) must contain only material that reproduces well when photocopied in black and white. Items that cannot be easily photocopied should be submitted in the appendix. It is permissible for applicants to include color photos, graphs, or tables in the original and application copies, if the items are necessary to explain the research project.

The Complete Application Submission

Please submit the following:

Joining Forces Conference award application need to include one single-sided signed original and 20 double-sided copies.

Appendix Guidelines

The Research Plan (Form 12) or Renewal Report (Form 14) should be self-contained and understandable without referring to the appendix. The appendix is used for human and vertebrate animal subjects approval documents, any contractual budget, letters of collaboration, supporting materials (i.e. publications), and the previous Research Plan for IDEA competitive renewals. These items are described in more detail on Form 17 (Appendix Cover Sheet). The supporting materials could also include supplemental tables or figures related to the project background and preliminary data, and publications and pre-prints to support the investigator's background and capability to conduct the research. The appendix size is limited to 20 pages.

Each appendix copy should begin with Form 17 to list the contents. Attach the appendix copy to the original application and the 11 application copies with a removable clamp or rubber band.

Do not staple the application forms and appendix copies together!

Executive summary (for the Programmatic Review)

Two single-sided copies of an Executive Summary must be submitted with the application. The Executive Summary consists of Forms 1-8. No executive summary is required for Joining Forces Conference Award applications.

Submission of Additional Materials

No supplemental application materials (e.g., manuscripts or publications) will be accepted after the deadline, unless explicitly requested and approved in advance by the CBCRP.

Required Signatures

The principal investigator(s) must sign the original copy Form 1A, B, or C (Cover Page) and Form 2 (Lay Abstract). The mentor for dissertation and postdoctoral fellowship applications signs Form 1B and Form 11B. If the application is submitted by an organization, it must be approved by the applicant organization's contracts and grants office, or comparable unit, and signed by a designated institutional official on Form 1A, B, or C (Cover Page). "Proxy" or stamped signatures are not accepted.

CSO Coding Instructions

Enter the CSO codes for your application's research topic in the space(s) provided in the upper right hand corner of Form 1, just below the words Cover Page. Coding is best done by the individual writing the research plan and abstracts. To identify the best CSO code match, please consider:

The CSO coding scheme is presented in the Web site: www.cancerportfolio.org/cso.jsp. There are seven major CSO categories, and each of these is divided into 4-9 sub-categories. First, familiarize yourself with the major heading under which you think you research belongs. For example, CBCRP's priority issue "Pathogenesis" matched the CSO category of "Biology". Epidemiology studies most likely will be under either "Etiology" or "Prevention." There may not be an exact CSO and CBCRP topic correspondence, but the bullets on the CSO Web site and those under our priority issues listings in Section 2 should allow you to make a rational selection.

Next, you can use either one or two CSO codes to best categorize your application:

Here are two examples from CBCRP's grant coding:

Revised Application Guidelines

A revised application requests support for a CRC, IDEA, dissertation, or postdoctoral fellowship proposal that was reviewed previously by the CBCRP, but unfunded. Previous applications for all other CBCRP award types cannot submit revisions. A revised application must have the same principal investigator as the original application. When possible it should have the same title as the original application. However, if the specific aims of the project have changed sufficiently, then a modified title may be chosen. A revision must include a section of not more than two pages immediately preceding the Research Plan (Form 12). This section is a summary of the substantial additions, deletions, and changes that have been made. It must also include responses to criticisms in the previous Review Committee evaluation. This material does not count towards the normal page limit for the Research Plan. We also recommend emphasizing in the Research Plan any relevant work done since the previous application.

Investigators submitting revised applications are advised to carefully review this application packet. There are new elements and guidelines for Cycle 11.

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CONDITIONS OF AWARDS

Details concerning the requirements for grant recipients are available in a separate publication, the University of California, Office of the President, Special Research Programs Grant Administration Manual 2004-2005. This manual is updated and re-issued yearly. It is sent to every grant recipient principal investigator, contracts and grants official, and the accounting contact. The manual can be obtained from the Program's office or viewed on our Web site.

Policy on Grants Allowed per PI

We limit the number of grants that a PI can receive in any single funding cycle. We have revised our policy in Cycle 11 to allow a PI to receive more than one grant, but the rules are very specific. An investigator may submit more than one application, but each application must have unique specific aims. In Cycle 11 a PI is limited to one IDEA grant, one IDEA competitive renewal grant, and one co-PI award as part of a CRC grant.

General Conditions of Award

The Program encumbers all funds for a grant in the year it is awarded; thus full funding of a multi-year project is assured.

Enabling legislation (AB 2055 and AB 478 of 1993, as amended by AB 3391 of 1994) authorizes the appropriation of public monies to the University of California for the CBCRP. Awardees are expected to account for the expenditure of grant funds and for the performance of work as agreed upon in a timely manner, so that the CBCRP may file reports and answer inquiries from the legislature and the public. They are also expected to adhere to the stated goals of the legislation, which include the systematic dissemination of research results to the public and to the healthcare community and the facilitation of translation of research results into commercial, alternate technological, and other applications. The Institutional Official's and Principal Investigator's signatures on the cover page of the application signify that the individuals are aware of the conditions for receiving a grant from the Program.

Grants to conduct research or research career development activities in California may be awarded to qualifying (see below) California individuals or organizations, which may be public or private, for-profit or not-for-profit. Eligible organizational awardees include, but are not limited to: community organizations, publicly or privately owned corporations and other businesses, volunteer health organizations, health maintenance organizations, hospitals, laboratories, research institutions, colleges, and universities. Applicants who have limited experience in scientific research or in scientific grant writing are encouraged to collaborate with established researchers in the design of studies and the preparation of applications in order to present the most well designed application possible.

To ensure the proper management of these public funds (as described above), a prospective grant recipient must satisfy the following standard requirements before an award will be made:

A grant recipient may satisfy modified requirements, if this is determined to be appropriate upon review by the University of California's Office of Research Administration, Office of Risk Management and General Counsel. Individuals who are to be awarded grants may meet these requirements directly or by making arrangements with a research organization that does. These requirements include satisfactory fiscal management, accounting practices, liability insurance, bonding, indemnification of the UC Regents, nondiscrimination in employment, and assurances regarding the treatment of animal or human subjects and research safety and ethics.

Though the research must be conducted primarily in California by California investigators, part of the work may be done outside California if the need to do so is well justified (i.e., it is integral to the achievement of a specific aim and cannot reasonably be performed in California) and the results of such work may be applied to furthering the achievement of the Program's goals and Priority Issues.

Grant awardees must agree to:

Following notification by the CBCRP of an offer of funding, the PI and applicant organization must accept and satisfy normal funding requirements in a timely manner. Common pre-funding items include:

Award Period and Indirect Costs

The start date for the CBCRP Cycle 11 awards will be July 1, 2005. Continuation funding for additional project years is released upon receipt of an Annual Progress Report showing research effort/progress, no overlap with Other Support, maintenance of sufficient FTE% by the (PIs), continuing approval of Human and Animal subjects use, submission of publications copies, and reporting any changes in Key Personnel. If funding is delayed or if all funds are not expended in the normal award period, then the investigator(s) may request a no-cost time extension for a maximum of one year in order to complete the project.

Postdoctoral fellows can delay the start of their project for up to 6 months to finish another project or to complete their doctoral training. They must notify the program in writing to activate a delayed start. However, the fiscal year will remain July 1-June 30, and a no-cost extension will be needed to finish a full two-year project.

The CBCRP encumbers the funds for all approved years of an award from the appropriation in the year the grant is awarded; thus full funding of a multi-year project is assured, dependent only on timely submission of the required reports. Funds will be disbursed annually, contingent on receipt of required progress and fiscal reports. For one-year projects, and for the final budget year of multiyear projects, 20% of the approved budget is withheld (non-UC institutions only) and paid in arrears upon receipt and acceptance by the Program of all required final reports.

Direct Costs
CBCRP award funds may be used only for expenditures necessary to carry out the approved project, as specified in the approved budget. Significant changes in proposed expenditures must be approved in advance by a CBCRP Research Administrator. Please follow the guidelines in the SRP Grant Administration Manual.

Allowable direct cost expenditures may include administrative costs only if the following two conditions are satisfied: (a) the services, functions, or activities are directly necessary for the conduct of the grant research and (b) these administrative costs have not been included in the calculation of the recipient institutions indirect cost rate agreement approved by the Federal government. In other words, the Program policy does not prohibit administrative costs, but it is careful to ensure that costs meet both conditions (a) and (b).

Indirect (F&A) Costs
Individuals without an institutional affiliation will not be eligible for indirect costs as grant recipients or subcontractors.

Non-UC Institutions:
For organizations other than University of California Campuses the CBCRP will pay indirect costs (overhead) based on the approved direct cost budget. Full indirect costs on IDEAs and CRCs are computed on a "direct cost basis" at the recipient organization's appropriate federally approved indirect cost recovery ("indirect" or F&A) rate. If the institution has an approved rate from the Department of Health and Human Services, it must be used. In the absence of a federally approved rate, an alternative documented indirect rate for the institution may be used. In the absence of any documented indirect rate, one will be negotiated by the University and the recipient organization.

No indirect costs will be allowed for the Postdoctoral Fellowship, Dissertation, and Joining Forces Conference Awards.

Provisional or pending increases in indirect rates will be included in awards only if they are documented prior to execution of the award agreement and disbursement of year one funding. The maximum indirect costs which CBCRP pays is the lesser of (a) the federally approved rate current for the budget year or (b) the rate provided for in the final approved budget.

Under no circumstances will funded projects be supplemented to reflect an unanticipated increase in the indirect rate; nor can funds originally awarded as direct costs be shifted to cover increases in the indirect rate. If the indirect rate decreases below that provided for in the approved budget, the CBCRP will pay overhead at the new lower rate starting on the date of change, and will decrease the award to the institution by the difference between the originally approved amount and the amount to be accrued at the new rate.

Both to initiate funding and for continuation funding of existing awards, the Program requires a copy of the institution's current indirect cost agreement annually.

University of California Campuses:
Campuses of the University of California will not be paid indirect costs as grant recipients or as subcontractors. Research institutes and foundations that are affiliated with the University of California, but which are legally separate entities (e.g., National Laboratories), may be paid indirect costs.

In accord with University of California policy, investigators who are University employees and who receive any part of their salary through the University must submit grant proposals through their campus contracts and grants office ("Policy on the Requirement to Submit Proposals and to Receive Awards for Grants and Contracts through the University," Office of the President, December 15, 1994). Exceptions must be approved by the UC campus where the investigator is employed.

Policy Regarding Scientific Misconduct

The University of California manages the California CBCRP, Tobacco-Related Disease Research Program (TRDRP), and the Universitywide AIDS Research Program (UARP) within its Special Research Programs in general accord with the policies and procedures employed by the National Institutes of Health (NIH), including those that apply to scientific misconduct. The Department of Health and Human Services' (HHS) Office of Research Integrity is responsible for implementing HHS regulations regarding scientific misconduct in research conducted with NIH and other support from the US Public Health Service.

The administrative actions imposed by HHS include the following: correction of the scientific literature; special plan of supervision to ensure integrity of the scientific research; certification of the accuracy of the scientific data; certification of the accuracy of sources and contributions for scientific ideas and writings; prohibition against service on PHS advisory committees or as a consultant; and, debarment from receipt of Federal funds. These actions are for a specified duration, depending on the nature and seriousness of the misconduct.

Applicants for or recipients of grants from the Special Research Programs (SRP) must promptly inform the University of an administrative action for scientific misconduct that is imposed by HHS by providing a copy of the final notice of the administrative action (i.e., after the disposition of any appeal), either at the time of application or within 30 days of the imposition of the administrative action. In general, the University will apply the same administrative action. For example, if HHS has debarred an investigator from applying for or receiving NIH awards for a specified period of time, that investigator would also be excluded from applying for or receiving awards from any of the SRP programs. To take another example, if an investigator has entered into a voluntary agreement with HHS for special oversight and supervision of the investigator's grant applications, research, and publications, that agreement would apply to that investigator's grant applications to, or awards from, the SRP.

Grant applicants or recipients may request that HHS administrative actions be waived or modified with respect to a grant application or award from the SRP. In such case, the applicant must present a justification for the request.

Fraud or Misuse of CBCRP Funds

Report fraud or misuse of CBCRP funds to either the CBCRP Director, Dr. Marion Kavanaugh-Lynch, at (510) 987-9878, or to the Office of the University Auditor, at 510 987-0478 or www.ucop.edu/audit/.

For-Profit Reimbursement of Awards

It is the goal of the CBCRP to discover new information, which can lead to the prevention, control and eradication of breast cancer. Hence, it is anticipated that some CBCRP grant recipients will conduct clinical trials and ultimately develop profitable products or services from work funded in part or in whole by the CBCRP. The Program strongly encourages, but does not require that, such individuals or institutions/companies consider:

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APPEALS

An appeal regarding the funding decision of a grant application may be made only on the basis of an alleged error in, or deviation from, a stated procedure (e.g., undeclared reviewer conflict of interest or mishandling of an application). Details concerning the appeals procedure may be obtained from the appropriate Research Administrator (with whom the applicant is encouraged to discuss his/her concerns), the Director, or by contacting us through the CBCRP Web site: www.cbcrp.org/. The period open for the appeal process is within 90 days of receipt of the application evaluation from the Program office.

Applicants who disagree with the scientific review evaluation are invited to submit revised applications in a subsequent grant cycle with a detailed response to the review.

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APPLICATION FORM OVERVIEW

Application forms can be downloaded after October 4th from our web site: www.cbcrp.org/ under the link Apply. Follow the instructions on the forms and in the separate form instructions. Listed below are the required forms for each award type. Note that Forms 1-8 are submitted as an Executive Summary.

IDEA Applications
# Exec.Sum. Form Name
1A x IDEA Cover Page
2 x Lay Abstract
3 x Scientific Abstract
4 x Program Responsiveness*
5A x Critical Path & Additional Criteria*
7 x Distinction from Other Funding
8 x Budget Summary
9   Budget Justification/Facilities*
10   Key Personnel
11A   Principal Investigator Profile
11B^   Biographical Sketch*
12   Research Plan (7 page limit)
13   Milestones
15   Human Subjects*
16   Vertebrate Animal Subjects*
17   Appendix Cover Sheet
IDEA competitive renewal only
# Exec.Sum. Form Name
1A x IDEA Cover Page
2 x Lay Abstract
3 x Scientific Abstract
5 x Critical Path & Additional Criteria*
7 x Distinction from Other Funding
8 x Budget Summary
9   Budget Justification/Facilities*
10   Key Personnel
11B^   Biographical Sketch*
14   Renewal Report (7 page limit)
15   Human Subjects*
16   Vertebrate Animal Subjects*
17^^   Appendix Cover Sheet
Dissertation & Postdocs
# Exec.Sum. Form Name
1B x Career Development Cover Page
2 x Lay Abstract
3 x Scientific Abstract
4 x Program Responsiveness*
5B x Additional Criteria
6 x Career Plan
7 x Distinction from Other Funding
8 x Budget Summary
9   Budget Justification/Facilities*
11B   Biographical Sketch*
11C   Mentor Profile/Training Plan*
12   Research Plan (7 page limit for dissertation; 10 pages for postdoc)
15   Human Subjects*
16   Vertebrate Animal Subjects*
17   Appendix Cover Sheet^^
--   Support Letter Attachment#
Joining Forces Conference Award
#   Form Name
1C   Conference Award Cover Page
2   Lay Abstract
4   Program Responsiveness*
8   Budget Summary
9   Budget Justification/Facilities*
10   Key Personnel
11B^   Biographical Sketch*
12   Research Plan (7 page limit)
17   Appendix Cover Sheet

* These forms allow one (1) additional continuation page.
^ We will allow submission of the comparable NIH 398 Form for Biosketch as accessed from the NIH Website.
^^ Include the research plan from the original IDEA award. List the names of people supplying letters of recommendation/support.
#Letters can be submitted using this form or by having your references follow the criteria on the form.

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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. Two opportunities are:

  1. Cancer Information Service
    The Cancer Information Service (CIS) at http://cis.nci.nih.gov/, 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). The CIS maintains a database of public inquiries as well as community-based projects developed and implemented in collaboration with the CIS partnership program. The CIS research program focuses on testing health communication interventions with the public.

  2. California Health Interview Survey
    The California Health Interview Survey (CHIS) is the largest telephone health survey in the country. Conducted every two years, the first survey, CHIS 2001, collected information from more than over 57,000 California households, and the second, CHIS 2003, surveyed over 42,000 households. CHIS interviews a sample adult in every household and, where present, a sample adolescent and, for a sample child, a parent who is most knowledgeable about that child. CHIS is a random digit dial (RDD) survey incorporating a geographically stratified sample so that estimates are possible for individual counties or groups of counties. Additionally, CHIS 2001 over-sampled three cities (Berkeley, Pasadena, Long Beach), and has generated represented samples for Los Angeles County's Service Planning Areas (SPAs) and Health Districts. CHIS includes large samples of Latinos and several Latino ethnic groups, African Americans, American Indian/Alaska Natives (urban and rural sub-samples in 2001), and Asians (including large sub-samples for Chinese, Filipinos, Japanese, Korean, Vietnamese, Asian Indians, and, in 2001, Cambodians). CHIS 2001 was conducted in six languages and CHIS 2003 in five languages. NCI and CDC sponsored a cancer control topical module with breast cancer history, mammography screening, and the Gail risk model variables in the CHIS 2001 survey. NCI sponsored a substantial cancer screening module in CHIS 2003. Zip code information is collected for all respondents plus geocode coordinates for the entire sample (although in CHIS 2001, only Los Angeles and San Diego counties were geocoded). Detailed race/ethnic information is collected, including allowance for recording multiple race/ethnic groups, as well as other extensive information on immigration status and demographics. The data are weighted at the stratum and statewide levels. 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. Follow-back studies with CHIS participants have been conducted with the 2001 and 2003 samples. CHIS is a collaborative project of the UCLA Center for Health Policy Research, the California Department of Health Services, and the Public Health Institute. For more information, visit: 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 (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.

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