Vermont - New Hampshire

Date: January 22, 2020

Time: Noon - 1PM

Course Title: Hennepin Healthcare Ketamine Research: A Case Study

Presenter: Luann Graves, BS MT, CCRP

Summary: In 2018, The Minneapolis Star Tribune and Public Citizen reported on human subject research being conducted by Hennepin Healthcare involving the use of Ketamine as pre-hospital sedation in agitated patients.  This presentation reviews the case, findings from the FDA investigation, Hennepin corrective actions, a review of definitions of different types of research and federal regulations governing IRB review and waiver of consent.

Learning Objectives:

1.  To review the federal regulations regarding minimal risk, expedited review, waiver of consent, investigational new drug, vulnerable subjects' protection.
2.  To gain a better understanding of the importance of the completeness of IRB submission and review, what constitutes "research procedures" and the importance of community engagement in human subject research, especially in the emergency setting.
3.  To review definitions and considerations for the following: comparative effectiveness research, observational research, pragmatic research, cluster-randomized trial, community based participatory research.

Length of Course: 1 hour

Credit: SOCRA Members may claim 1 CE towards SOCRA Recertification. SOCRA members will receive a certificate of attendance

Location:  VA Medical Center, 215 North Main Street, White River Junction, VT 05009

RSVP: Cathy J Lombardo, cathy.lombardo@va.gov