California Initiative to Advance Precision Medicine Adverse Childhood Experiences Request for Proposals

• Stage 1: Letter of Intent to Submit a Concept Proposal – Applicants should submit a one-page Letter of Intent by February 5, 2020. Letters should note the expected host institutions/organizations, Lead PI, and other PIs and provide a tentative title, description (maximum 5 sentences), and total budget. Letters of Intent are not scored during the selection process but must be received by the deadline and reflect the general theme of the forthcoming concept proposal. An institutional cover letter is not required at this stage.
• Stage 2: Concept Proposals – By July 22, 2020, applicants should submit a brief 3-page Concept Proposal plus Biographical Sketches (resumes, in the NIH format) of all PIs and team members. All Concept Proposal titles will be made public on the OPR website following the selection process. An institutional cover letter is not required at this stage; however, all PIs must confirm that their institutions/organizations have committed to support the project, if awarded funding.
• Stage 3: Full Proposals – The out-of-state expert Selection Committee will identify a subset of submitted Concept Proposals by August 28, 2020 to move on to the Full Proposal stage. Instructions for submission of Full Proposal materials will be made available to finalists advancing to the next stage. Institutional cover letters will be required. Full Proposals are due January 14, 2021.

• Applicant teams must include one Lead Principal Investigator (Lead PI) from a public or private academic research institution, considered in the application as the "Primary Institution." The Lead PI will serve as the main contact. Between one and ten additional PIs may also be designated. At least one PI must represent a nonprofit community/patient organization or county health institution that provides support to people with ACEs. Additional partnerships with other nonprofit and industry partners are encouraged.
• Only one proposal per team will be accepted. An individual may serve as Lead PI for only one application; otherwise, individuals may contribute to multiple proposals.
• There will not be more than one award per Primary Institution.
• Demonstration projects should be located in California. Partners may be located outside of California if they provide their own funding.
• Research teams may only use funds for direct costs. Indirect costs will not be supported.
• Demonstration projects should aim to validate the utility of Precision Medicine approaches to improve outcomes through better prevention, diagnostics, measurements, and/or treatments for toxic stress from ACEs.

• A significant mission of the California Initiative to Advance Precision Medicine (CIAPM) is to reduce health disparities, in part by orienting the vast health research infrastructure and the emerging field of Precision Medicine toward addressing inequitable medical challenges that persist across time and geographies. In order to foster research outcomes that address the needs and concerns of patients, family members, and health care providers, authentic researchcommunity partnerships are critical.
• According to the Institute of Medicine, community-based participatory research enhances community understanding of the issues under study and improves researchers' ability to understand community priorities, the importance of addressing community priorities, and the need for culturally sensitive approaches and outreach. Part of ensuring the success of CIAPM in demonstrating the promise of Precision Medicine is ensuring vital research results are informed by and shared with those who need it most and in ways that are timely, relevant, and meaningful.
• Projects should be co-led by Principle Investigators (PIs) from at least one public or private academic institution and at least one nonprofit community/patient organization or county institution that provides support for people with ACEs. Successful proposals will also leverage contributions from other nonprofit or for-profit organizations in the community as well as industry partners.

Section 65057 of the Government Code sets forth the following selection criteria:

• The potential for tangible benefit to patients within two to five years, including the likelihood that the study will have an immediate impact on patients.
• The potential to reduce health disparities.
• The depth and breadth of data available in the disease focus areas across institutions.
• The prospects for efficient and effective data integration and analysis.
• The expertise of potential team members.
• The resources available for the project outside of the initiative, including the leveraging of non-state funding.
• The clinical and commercial potential of the project.
• The potential to scale and leverage multiple electronic health records systems.
• The potential to develop the use of tools, measurements, and data, including publicly generated and available data.

The Selection Committee will also consider additional factors in reviewing the proposals such as:

• The innovative concepts, approaches, methodologies, instrumentation, or interventions to advance precision medicine.
• The feasibility of the project (can the project be achieved within the proposed timeline).
• The quality and extent of patient/participant engagement.
• Approaches to protect privacy and personal health information.
• Methods to increase access and inclusion of populations that experience disparities.
• System interoperability.
• The quality and extent of training and educational contributions to better integrate precision medicine approaches to clinical care.
• Sharing data and/or protocols across institutions.
• Where the project is located in California to balance geographic equity of awards and diversity of awarded institutions.
• Diverse expertise and background of team members, including those underrepresented in biomedical research, including underrepresented racial and ethnic groups, persons with disabilities, and women.
• Overall impact to advance precision medicine.

Indirect Costs

No indirect costs will be supported.

Intellectual Property Agreement

Agree to terms of patent and copyright agreements that balance the State’s interests with the needs of the research team.

Funds

Funds will be disbursed monthly.

Start Date

Initiate work within 30 days of agreement execution.

Reporting

Submit biannual progress reports, work with OPR staff throughout the project on milestone and budget development and adjustments, and participate in conference calls and convening activities. Post-award expectations will be specified in award agreements.

Use of Data

Investigators and demonstration teams are expected to share data and research findings consistent with academic and state open-access standards.

Protection of Privacy and Health Information

Investigators and demonstration project teams are expected to follow state and federal law to protect privacy, personal health information, and rights of human subjects.

Precision Medicine

An emerging approach to health and disease that aims to use advanced computing tools to aggregate, integrate, and analyze vast amounts of data from research, clinical, personal, environmental, and population health settings to better understand wellbeing and develop and deliver more precise diagnostics, therapeutics, and preventative measures.

Adverse Childhood Experiences (ACEs)

Adverse Childhood Experiences (ACEs) are potentially traumatic events that occur in childhood. ACEs can include violence, abuse, and growing up in a family with mental health or substance use problems. Toxic stress from ACEs can change brain development and affect how the body responds to stress.

Health Disparities

Health disparities are preventable differences in the burden of disease, injury, and violence, or in opportunities to achieve optimal health experienced by socially disadvantaged racial, ethnic, and other population groups, and communities.

Community Engagement

The process of working collaboratively with and through groups of people affiliated by geographic proximity, special interest, or similar situations to address issues affecting the well-being of those people. It is a powerful vehicle for bringing about environmental and behavioral changes that will improve the health of the community and its members. It often involves partnerships and coalitions that help mobilize resources and influence systems, change relationships among partners, and serve as catalysts for changing policies, programs, and practices.

Authentic Partnership

Principle Investigators (PIs) responsible for leading the development of the proposal and implementation of the project are expected to work together closely and inclusively of all stakeholder voices.

Lead Principle Investigator

A researcher from a public or private academic research institution must serve as the main contact during the application process and project implementation.

Primary Institution

The public or private academic research institution with which the Lead PI is most closely affiliated.

Selection Committee

A committee will be established exclusively of out-of-state individuals that includes subject matter experts representing the breadth of stakeholders involved in the overall initiative. Selection Committee members may include nominees of the Legislature, public solicitation, or referral from the CIAPM network. Selection Committee members shall not be deemed to be interested in any contract with an applicant and will be screened for conflicts of interest consistent with standards put forth by the National Institutes of Health.