The Clinical Research Unit
From recruiting patients to handling institutional review board submissions, the MCIRCC Clinical Research Unit connects investigators to the resources they need to engineer tomorrow’s advancements in critical care.
When conducting clinical research, there are a host of institutional and federal regulations that all researchers must comply with. For example, in trials that involve human subjects, researchers are required to process informed consent documents in order to protect the rights and welfare of their participants. It is the duty of clinical research coordinators to ensure that all testing is carried out in compliance with these regulations.
It may seem like a lot to consider, but MCIRCC’s Clinical Research unit stands ready to help.
The Clinical Research unit was formed in 2014 with the goal of aiding investigators in carrying out their research without the responsibility of hiring and maintaining their own coordinators. What differentiates the Clinical Research unit from others like it, however, is that it emphasizes work on proof-of-concept and feasibility studies as opposed to clinical trials. To that end, the unit assists researchers in a number of ways:
Providing all of the regulatory requirements needed for clinical research;
Collecting and processing data and biological samples;
Screening and consenting patients following good clinical practice guidelines;
Mining data from patients’ medical records and providing this information de-identified and coded.
MCIRCC’s Clinical Research unit has created several institutional review board approved protocols for critical care that are strategically flexible and allow for the freedom to test many different technologies and obtain biosamples on a diverse population of critically ill and injured patients. To ensure the data they gather in these studies is accurate, the Clinical Research unit operates hand-in-hand with MCIRCC’s own Data Science team. Unit manager Amanda Pennington notes, “We are able to enter patients into the database, and the Data Science team captures physiologic monitoring and other pertinent electronic health record data in real time.”
The Clinical Research Unit’s Continued Success
In the five years since it was formed, MCIRCC’s Clinical Research unit has seen exponential growth, jumping from only a handful of studies to managing and recruiting for more than twenty. The unit has recorded some of the highest recruitment and enrollment success in the institution.
Today, the unit hosts four full-time coordinators as well as many University of Michigan student staff members and volunteers. The unit is expected to experience significant growth in the next year.
Dr. Kevin Ward, MCIRCC’s Executive Director, says “MCIRCC’s Clinical Research Unit has been vital in lowering the energy barrier in our ability to create greater integration of multidisciplinary investigators across the University to engage in critical care research. The unit has allowed for significant participation in clinical research by our engineering and basic science members. The data produced by our strategically designed protocols has resulted in our ability to successfully compete for millions of dollars in federal (NIH, NSF, DoD) and industry funding as well as create and test a number of new technologies resulting in new patents, technology licenses, and even the creation of new companies”.