County of Monterey - File #: 17-1147

• File #: 17-1147
• Name: Natividad Medical Center Authorization for Local IRB Program
• Type: General Agenda Item
• Status: Passed
• File created: 11/1/2017
• In control: Board of Supervisors
• On agenda: 11/14/2017
• Final action: 11/14/2017
• Title: a. Authorize NMC to create a Local Institutional Review Board (IRB) to act as the local oversight for research projects approved by Central IRB partners with at least one member of the local IRB to have certification in Human Subjects Research. b. Authorize NMC to apply for a Federal-wide Assurance (FWA) registration for the Protection of Human Rights Subjects with US Department of Health and Human Services, which enables NMC to enter into agreements with Central Institutional Review Boards (IRBs) to pursue Human Subjects Research projects under Central IRB oversight.

Date	Action By	Action	Result
11/14/2017	Board of Supervisors

Title
a. Authorize NMC to create a Local Institutional Review Board (IRB) to act as the local oversight for research projects approved by Central IRB partners with at least one member of the local IRB to have certification in Human Subjects Research.
b. Authorize NMC to apply for a Federal-wide Assurance (FWA) registration for the Protection of Human Rights Subjects with US Department of Health and Human Services, which enables NMC to enter into agreements with Central Institutional Review Boards (IRBs) to pursue Human Subjects Research projects under Central IRB oversight.
Report
RECOMMENDATION:

It is recommended the Board of Supervisors:

a. Authorize NMC to create a Local Institutional Review Board (IRB) to act as the local oversight for research projects approved by Central IRB partners with at least one member of the local IRB to have certification in Human Subjects Research.
b. Authorize NMC to apply for a Federal-wide Assurance (FWA) registration for the Protection of Human Rights Subjects with US Department of Health and Human Services, which enables NMC to enter into agreements with Central Institutional Review Boards (IRBs) to pursue Human Subjects Research projects under Central IRB oversight.

SUMMARY/DISCUSSION:

Human Subject Research supports various quality improvement initiatives, academic programs and scholarly research publications and presentations. In order to be seen as an accomplished physician, nurse or other health professional in a particular field of medicine, publication in scholarly journals such as The New England Journal of Medicine or, presentations at academic meetings and societies is essential. Only formal research studies or case reviews with IRB oversight is accepted into such publications or presentations.

At this time, most County hospitals participate in some type of research activity. Salinas Valley Memorial Hospital and Community Hospital of Monterey Peninsula (CHOMP) have their own Institutional Review Boards ...