In times of uncertainty, we seek answers. Whether that uncertainty is health-related or otherwise, it is in our nature to ask questions. The Research Institute of Penn Medicine Lancaster General Health was founded on that questioning nature and actively seeks to find the answers through a variety of studies. From study start-up to close-out, the Research Institute relies on the efforts of dedicated people invested in research and furthering the health of patients locally and around the world.
Historically, the Research Institute got involved in new studies through an external sponsor, like a pharmaceutical or medical device company, inviting Lancaster General Health to participate in a multi-center study. The start-up process for a sponsored study involves contract and budget negotiations, regulatory document completion, and sponsor visits to the site. Each step requires coordination between research coordinators and teams including the health system’s legal team, billing specialists, EPIC technicians, Information Security, the principal investigator, and any additional sub-investigators and their related departments.
Obtaining IRB Approval and Assembling the Team
Before any study activities can begin though, the study must be submitted to the Institutional Review Board (IRB). This group reviews projects and studies to ensure they are conducted safely, legally, and efficiently. The IRB meets once a month to review new studies, monitor ongoing studies, and make changes to current studies as new information becomes available.
The Human Research Protection Program works in conjunction with the IRB approval process, mandating all personnel complete training to ensure researchers are conducting research ethically and in compliance with all regulations and policies.
Depending on the type of study, research coordinators require support from the MRI Group, Pharmacy, EP and Cath lab teams, Radiology, Neurology, hospitalists, echo techs, administrative and nursing specialists, and more to keep the process running smoothly. Workflows are created to aid in the process of conducting these studies with minimal interruption to daily responsibilities.
While sponsored studies comprise approximately 60 percent of our current studies, more health-care professionals are asking and answering the questions themselves. The process for conducting an investigator-initiated study is largely the same as a sponsored study; the primary difference is that there is not a sponsor to drive the process. The research project manager manages all start-up elements, relying even more heavily on all of the aforementioned departments to facilitate the organization, approval, and implementation of the study.
Depending on the study design, more Research Institute team members can be brought in to support and manage the research participant side of study implementation.
The Impact of COVID-19 on Research
With the local emergence of COVID-19 in early 2020, the Research Institute made dramatic shifts to meet the needs of research participants and the institution. The department paused nearly all of its sponsored research to ensure patient safety. Along with that pause came an influx in COVID-19 research projects, many of which were developed by Lancaster General Health providers. These projects run the gamut of straight-forward data collection all the way through investigational drug treatments. In addition, the team collaborated on various studies with institutions and organizations across the county including the Mayo Clinic, AstraZeneca, and University of Pennsylvania.
Research is Always Evolving
Research is not a linear process. It requires regular re-evaluation to adjust workflows, streamline processes, or implement changes provided by the sponsor. What keeps the process moving forward is the commitment to a common goal—helping patients in our community and around the world.