Title
a. Approve and authorize the Director of Health Services or designee to execute a non-standard agreement (“Agreement”) with the Board of Trustees of the California State University through its campus Cal Poly Corporation, dba Cal Poly Partners, San Luis Obispo, to work with the County of Monterey to promote and study cardiovascular health among pregnant women and infants, effective upon execution, through June 1, 2030 with no exchange of funds;
b. Approve non-standard liability provisions of the Agreement as recommended by the Director of Health Services or designee;
c. Approve a non-standard Letter of Indemnification between the County of Monterey and the Johns Hopkins University School of Medicine (Reviewing [Internal Review Board] (IRB)) associated with the Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) study, with no exchange of funds, as recommended by the Director of Health Services;
d. Approve the execution of the non-standard SMART IRB Master Common Reciprocal Institutional Review Board Authorization Agreement associated with the ENRICH study with Johns Hopkins University School of Medicine serving as the Reviewing IRB, with no exchange of funds, as recommended by the Director of Health Services; and
e. Approve and authorize the Director of Health Services or designee to sign up to three (3) future amendments to the Agreement, provided that these amendments do not substantially change the Scope of Services and do not result in an increase in funds, and with approval from the Office of the County Counsel.
Report
RECOMMENDATION:
It is recommended that the County of Monterey Board of Supervisors:
a. Approve and authorize the Director of Health Services or designee to execute a non-standard agreement (“Agreement”) with the Board of Trustees of the California State University through its campus Cal Poly Corporation, dba Cal Poly Partners, San Luis Obispo, to work with the County of Monterey to promote and study cardiovascular health among pregnant women and infants, effective upon execution, through June 1, 2030 with no exchange of funds;
b. Approve non-standard liability provisions of the Agreement as recommended by the Director of Health Services or designee;
c. Approve a non-standard Letter of Indemnification between the County of Monterey and the Johns Hopkins University School of Medicine (Reviewing [Internal Review Board] (IRB)) associated with the Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) study, with no exchange of funds, as recommended by the Director of Health Services;
d. Approve the execution of the non-standard SMART IRB Master Common Reciprocal Institutional Review Board Authorization Agreement associated with the ENRICH study with Johns Hopkins University School of Medicine serving as the Reviewing IRB, with no exchange of funds, as recommended by the Director of Health Services; and
e. Approve and authorize the Director of Health Services or designee to sign up to three (3) future amendments to the Agreement, provided that these amendments do not substantially change the Scope of Services and do not result in an increase in funds, and with approval from the Office of the County Counsel.
SUMMARY:
Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) is a research study that aims to address rising rates of maternal morbidity and mortality in the U.S. ENRICH looks at the effectiveness of a cardiovascular intervention and address cardiovascular health disparities in both mothers and children less than 3 years of age. The intervention is provided by evidence-based home visiting programs like Nurse Family Partnership (NFP) during the perinatal period and through the child’s second birthday.
DISCUSSION:
The County of Monterey Public Health Bureau’s NFP is an evidence-based program that pairs a nurse with a first-time parent to provide support starting in pregnancy and continuing until the child is two years old, supporting parents achieve their own goals so safe, strong, and thriving families prosper. Since January 2019, 218 families have enrolled in the County of Monterey’s NFP services, and 50 families have graduated when the child turned 2 years old.
Nurse Family Partnership staff will provide their clients with ENRICH program brochures and offer clients the opportunity to participate in ENRICH. NFP staff may refer interested clients to the ENRICH program. Cal Poly Partners will enroll consenting NFP clients into the ENRICH study to further support the cardiovascular health of the families. NFP staff will provide clients that enroll in the study education and evidence-based interventions intended to improve cardiovascular health and reduce cardiovascular health disparities. Cal Poly Partners will conduct all research-related activities. The research study has Institutional Review Board approval for compliance with federal human subjects protection requirements and with Health Insurance Portability and Accountability Act (HIPAA). The cyber risk exposure to County systems or data arising from this agreement is low. As a result, the Health Department is not requiring cyber liability insurance under this agreement.
The SMART IRB Agreement is a national reliance framework used to facilitate IRB reliance among participating institutions. When reliance is based on the SMART IRB Agreement, execution of both the SMART IRB Agreement and a separate Letter of Indemnification (LOI) is required. Johns Hopkins Medicine (JHM) requires the LOI because the SMART IRB Agreement does not include indemnification provisions. The LOI is executed a single time between Johns Hopkins and each organization on which Johns Hopkins relies under the SMART IRB Agreement, and no subsequent executions are required for future reliance arrangements with the same organization.
OTHER AGENCY INVOLVEMENT/COMMITTEE ACTIONS:
The Office of the County Counsel and Auditor-Controller have reviewed and approved this Agreement as to legal form and fiscal provisions, respectively.
FINANCING:
There is no exchange of funds with this agreement. There are sufficient appropriations in the Health Department’s (001-4000-8124-HEA003) FY 2025-26 Adopted Budget.
BOARD OF SUPERVISORS STRATEGIC PLAN GOALS:
This MOU aligns with the Strategic Plan Goal of Well-Being and Quality of Life and Safe and Resilient Communities, specifically key objective of Services: Provide service enhancements to support well-being and quality of life. The partnership promotes and studies the cardiovascular health among pregnant women and infants in socially disadvantaged populations at high risk of cardiovascular disease morbidity and mortality through a home visiting intervention.
Mark a check next to the related Board of Supervisors Strategic Plan Goals:
X Well-Being and Quality of Life
____ Sustainable Infrastructure for the Present and Future
X Safe and Resilient Communities
____ Diverse and Thriving Economy
____ Dynamic Organization and Employer of Choice
Prepared by: Patricia Velarde, Management Analyst II, 796-1377
Approved by: Elsa Mendoza Jimenez, Director of Health Services, 755-4526
Attachments:
Board Report
Memorandum of Understanding
SMART IRB agreement (sample)
Letter of Indemnification JHUSOM Reviewing IRB