CVRN New Project Proposal Guidelines
A new CVRN project proposal is one that leverages patients and/or information from participating CVRN sites, and which differs from or adds to the aims of existing, funded CVRN projects. It is anticipated that a typical new project proposal will propose to:
1. Analyze existing CVRN project datasets;
2. Extract and analyze new data elements from CVRN health system existing electronic health records
3. Conduct new primary data collection from patients at CVRN sites for an observational study; or
4. Perform a clinical trial at the patient, provider or health system level.
New project proposals may be submitted by the investigators within the CVRN or by investigators without a prior relationship with the CVRN. For the purposes of formal review, we will consider projects that include two (2) or more CVRN sites as requiring review by members of the Steering Committee.
All new projects will require external funding. Examples include studies funded by investigator-initiated NIH research awards (e.g., RO1s), and grants from academic institutions or private sources (e.g., private foundations or industry sources). Any new project must have sufficient funding to cover the costs incurred by the relevant CVRN cores and individual participating CVRN sites, as well as any expenses incurred from external sources (e.g., research laboratories, imaging, etc.). Project proposals must obtain CVRN approval before submission to a funding agency.
Timing of Project Proposal Requests
All new project proposals that require additional funding must be submitted to the Research Console before submission to any funding agency. Proposals submitted for review less than four (4) weeks before a funding application deadline may not receive approval, although the CVRN Steering Committee will maximize flexibility when a release date of a RFA or RFP requires a shorter response time. Under specific conditions (e.g. an imminent funding deadline) the Executive Committee may serve as the proxy for the Steering Committee.
The Review Process
- New CVRN project proposal forms should be submitted online through the Research Console. The submission will be reviewed to ensure the form is completed satisfactorily.
- Members of the CVRN Steering Committee will review the submission to see if it is aligned with the goals and new proposal policy of the CVRN.
- If reviewer concerns are major, comments will be sent back to the initial investigator for response and modification of the proposal if desired.
- A decision and feedback to the Investigator will be provided no more than four (4) weeks after submission of the proposal.
- If a proposal is approved, the CVRN Director will provide a letter of support upon request.
Before submitting a new project proposal for review, the new project investigator must consider CVRN sites and investigator participation. A complete list of current CVRN sites and investigators is available on the website (CVRN Centers), and the Executive Committee members can also be readily contacted for this information. We recognize that there will be times when a new project proposal cannot accommodate all interested CVRN investigators and sites because of budgetary constraints, and the Executive Committee and Steering Committee will ultimately arbitrate any unresolved situation regarding a new project proposal and site or investigator exclusion based on budget (or any other) constraints.
An online request for approval of a new project proposal should be submitted through the Research Console. The online submission will contain questions relevant to a Principal Investigator's proposal. Please see below some examples of questions that will be required to be completed.
- Study Team and Administrative Information
a) Proposal title
b) Principal investigator(s) contact information
c) Planned starting date and project timeline
d) Funding plans and estimated cost
e) Co-investigators, and other CVRN co-investigator(s)
- Study Design and Methods
a) Specific aims and hypotheses
b) Brief background and rationale
c) Specific data collection methodology, including any questionnaires and coding forms, if available.
- Specific Answers to the Following Questions
a) What collaboration with CVRN investigator(s) is planned? With whom? Has the collaborating investigator(s) approved the proposal?
b) What is the sampling time frame and follow-up period, if any? Specify length of time and events to be ascertained.
c) How many participants are required (including studies utilizing only existing data)?
d) Will the project propose patient recruitment and new data collection and/or interventions? If so, what is the expected burden to participants? What are the time burdens, discomfort and expected participation rates?
e) How will the new project be funded?
i) Would any additional un-reimbursed work or personnel time be expected of the CVRN cores or individual CVRN sites?
f) What are the specific data elements that will be included in the proposed analyses?
ii) How will the new project budget cover demands on CVRN personnel time and central or site resources?
g) What are the analysis plans?
h) Where will the data analyses be conducted?
i) How will confidentiality and other aspects of the protection of human subjects be maintained?
j) If datasets will be analyzed outside a CVRN site, when and in what form will a complete data set be returned to the CVRN Administrative Core?
New proposal applicants are strongly encouraged to contact the CVRN Project Director for any questions related to New Proposal Submissions.
Changes to a New Project Proposal
Once a new project proposal is approved, any change in the structure or concept of the project must be disclosed to the Executive Committee for review and approval before the proposal is submitted (or re-submitted) to a funding agency. This includes any change in the data elements to be collected or analyzed, or any significant change or addition to study aims.
Consideration for Approval
Several criteria will be considered in the reviews, including:
- The proposed project must be of high scientific merit.
- The proposed project must be consistent with the overall goals and objectives of the CVRN.
- The proposed project must include two (2) or more CVRN sites.
- The proposed project must meet certain participant burden criteria (for any new primary data collection involving subjects), including:
- Acceptable to the subjects (e.g., risks, time, discomfort, privacy);
- Not hinder or disrupt clinical care provided by CVRN sites; and
- Leverage the strengths of the CVRN to accomplish its goals.
- The proposed project's investigators must plan for adequate resources to effectively complete the project, including:
- Sufficient budget to cover costs of personnel and supplies; and
- Staff possessing the requisite expertise to meet the objectives of the project.
- The proposed project must not interfere with the completion of the principal or emerging research projects of the CVRN.
- The proposed project should document any involvement of CVRN investigators as part of the research team.
Please contact the CVRN Project Director, Sue Hee Sung (; 510-891-3476), with any questions.
Download the CVRN New Proposal Policy