Research and Sedation Reports
In the spirit of transparency and continuous learning, Hennepin Healthcare System is releasing the results of independent external and internal reviews of the use of sedation by Emergency Medical Services and its Institutional Review Board’s (IRB) research review and approval processes. These reviews were conducted by highly-credentialed bioethicists, and respected medical and legal professionals.
Hennepin Healthcare System understands and acknowledges community concern around this research. We can and must do better. While our reviewers found that the use of pre-hospital sedation (the use of ketamine) was consistent with medical standards and that the IRB and associated research did not pose a significant risk to the health and safety of patients, there is room for changes and there are areas for improvement. It is clear that better communication and engagement with the community around research and medical studies like this one are needed and we are committed to that.
In keeping with our mission, our goal was, and still is, to bring the benefits of and access to scientifically valid medical studies to all of the communities we serve and partner with. Toward that end, Hennepin Healthcare has made improvements in these critical areas.
Reports and Next Steps
The following documents are in PDF format.
What we are doing to improve
Over the past six months Hennepin Healthcare has reviewed its research review processes to find ways to be more clear and transparent about how decisions are made, examined the training paramedics receive and identified opportunities to offer more training in responding to mental health emergencies and looked at how the organization engages with the communities it serves and has taken steps to connect with those communities.
Community Outreach & Engagement
- Created a Public Research Advisory Board (PRAB) that is representative of the communities that we serve to advise researchers and the Institutional Review Board, inform and engage our communities about ongoing research, and ensure that research is conducted in a culturally appropriate manner.
- Created a Community Advisory Board (CAB) to connect the healthcare system to a diverse representation of consumers, caregivers, and community members to foster a better understanding of community needs.
- Enhanced public communications about medical studies by sharing more information online, onsite in our facilities, and in person at public events in order to improve public awareness and community education about research.
Professional Education for Researchers
- IRB members will participate in enhanced continuing education and ongoing training to remain informed and up-to-date on the current requirements and rapidly evolving topics in research.
- In addition to the required training investigators and IRB members receive today, professional education and training led by experts in human subject research ethics and regulations will be offered to investigators and research personnel, IRB members, advisory board members, and administrators on topics including study designs, types of applications, consenting, and regulatory changes.
IRB Processes and Tools
- Templates for investigator-initiated studies have been redesigned and standardized to support a more uniform review of design, research-related interventions, study procedures, justification for conducting research in vulnerable populations, and consent procedures with justification for waiver of consent, if applicable.
- We will explore transitioning to an electronic system to provide comprehensive electronic submission and ongoing review of protocols to improve check-and-balance for initial and continuing review of studies.
EMS Training and Quality Assurance
- Increased quality assurance reviews from random sampling of pre-hospital sedation cases to mandatory review of all pre-hospital sedation cases. Review of cases will ensure integrity of documentation, quality of clinical care, adherence to clinical guidelines, and identify trends that may lead to additional training and/or process improvement.
- Partnered with the National Alliance on Mental Illness (NAMI) to provide Mental Health for First Responders training to all EMS personnel. This training will include de-escalation techniques and provide additional tools for EMS providers to use in the treatment of patients in the throes of a mental health crisis.
- Will be providing implicit bias training for all EMS and security personnel that will lay the groundwork to better understand the conditions that have led to fear and a lack of trust of first responders and security personnel within communities of color. This training will help define and identify ways to combat implicit bias and will explicitly build trust between Hennepin EMS, security and communities of color.
Reaccreditation awarded to Hennepin Healthcare for research program involving human participants.