Research and sedation community resources
Hennepin Healthcare and the Hennepin Healthcare Research Institute are committed to improving patient care and the health of our community through research and education.
For the past year, Hennepin Healthcare has been working with new independent community boards to bring more transparency to how and why we conduct medical studies and how we serve the community. As part of this work, new resources are being created and shared to provide insight into what we've learned thus far and our commitment to partnering with the patients and families who rely on us for quality healthcare. We are sharing those resources below and we also continue to make the reviews and reports available for all to read.
Resources and Reports
Rebuilding Community Trust, Source: YouTube
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.