Statement from Hennepin Healthcare
From the beginning, the intent of the sedation research conducted at Hennepin Healthcare has been to save lives. For many years, sedatives, including ketamine, have been important lifesaving medications used both inside the hospital and outside and they have been shown to prevent deaths. While the intent of this work was always clear to us, the communities we serve were not aware of this research and its purpose. The lack of engagement on our part before implementing research has understandably created mistrust.
Hennepin Healthcare apologizes for not involving the community in a proactive way in the research and design discussions before we began these studies. We deeply regret this and we are committed to engaging a cross-section of community members as we evaluate potential research projects.
We have already taken important first steps to improve:
- The community is now at the table. The new Public Research Advisory Board (PRAB) is a group of informed, engaged community members who bring the eyes and ears of the public directly into our research review process. They started meeting in January.
- A Community Advisory Board (CAB) brings multiple perspectives from the community to help our organization better understand community needs beyond research.
- We have required our entire research staff to receive additional professional education and training led by experts in human subject research ethics and regulations.
- We improved tools and processes used by researchers to apply for and receive Institutional Review Board (IRB) approval and we are modifying how medical studies are monitored.
- We provided Mental Health for First Responders training to all EMS staff in partnership with NAMI and we will be providing implicit bias and de-escalation training for all EMS and security personnel.
- We are being transparent as we learn by making information about what has happened in the past available for all to see, including the outside reviews that are posted on the front page of our public website, hennepinhealthcare.org, along with a complete list of changes that we have made.
Hennepin Healthcare, the FDA, and the communities we serve share a common goal; to safely develop better ways to treat our patients, always with the patients’ best interests in mind. As a public research institution, we embrace a culture of continuous improvement and look forward to continuing to partner with the community to learn together and improve patient care.
Reports and Next Steps
The following documents are in PDF format.
- Statement from Hennepin Healthcare
- Assessment of Hennepin Healthcare’s Response to Prehospital Sedation Concerns
- Review of EMS clinical protocols and practice
- Review of the IRB process and waiver of consent
- Summary of the group review of body camera footage of incidents cited in the OPCR draft report
- Statement from Hennepin Healthcare
- August 23, 2018 FDA 483 Inspectional Observations and Hennepin Healthcare Response; FEI Number 2127118
- April 26, 2019 FDA 483 Inspectional Observations and Hennepin Healthcare Response; FEI Number 3015212514
- April 23, 2019 FDA 483 Inspectional Observations and Hennepin Healthcare Response; FEI Number 3015213291
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 we serve to advise researchers and the Institutional Review Board on how to better inform and engage our communities about ongoing research, and help 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 early May 2019, professional education and training led by experts in human subject research ethics and regulations was provided for investigators and research personnel, IRB members, advisory board members, and administrators on topics including study designs, types of applications, informed 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 are exploring a transition 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 a random sampling of pre-hospital sedation cases to a mandatory review of all pre-hospital sedation cases. Review of cases will ensure the 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.