Time always seems to fly by between newsletters. In the last newsletter, I gave a brief recap on the 2015 Research day and today I am excited to remind folks to save the date for Research Day 2016—April 5th from 9am-5pm. We are hoping to top our 300 participants and get the same high-quality scientific presentations from our students, residents, pharmacists, physicians, faculty, and nurses! I’m also really excited that we have one of our fantastic clinical nurse researchers—Dr. Phyllis Whitehead—to provide the keynote lecture. Dr. Whitehead has done some fascinating work in the areas of moral distress, patient preferences, and end of life education and we are lucky to have her give the talk for us.
The main message of my note this month is related to our burgeoning Clinical Research Review Committee and ongoing efforts to make the approval process for both research and quality improvement/quality assurance more efficient.
As many of you have already noticed, we have implemented a new Research and Development (R&D) application form. It currently has all of the information we need to determine the scientific quality of the application, its data and analytic feasibility, and its feasibility in terms of investigator research time and personnel requests. Our folks in compliance are working on the final component of the application—data security and privacy—which should be added to the form shortly.
We’ve had good feedback on the changes from folks working on research projects, but less positive feedback from folks doing QA/QI—the form includes a lot of information that is simply not applicable to QA/QI projects.
To address this we have worked with the IRB to have a modified process for QA/QI projects-- There is now a new process for proposed QA/QI projects. First, those who are submitting a QA/QI projects will begin the process with the IRB QA/QI Determination Application. As part of that process, applications will be required to have approval from a departmental or institutional committee that vets QA/QI projects OR it must be approved by the project leader's manager/director or other appropriate institutional leader.
Those projects deemed to be QA/QI by the IRB will be forwarded on to R&D for institutional approval. We anticipate this will be a very fast process for any project that is contained within a single department and with no external collaborators (for example, most resident QA/QI projects)—a 2-3 day window is our goal. For those that have external collaborators and need collaborative agreements completed, R&D will continue to complete these services and provide timely approval once all agreements are signed.
I anticipate this will be a temporary process until the institutional Quality Improvement group led by Mike Parish has a process in place to approve and track these applications for the institution.
Of course, if a project is determined not to be QA/QI, but rather to be human subjects research, then the project leader will be notified to submit a R&D application as well as an IRB research application.
Feel free to reach out to me with your ideas and to volunteer to help out as we keep moving towards a high quality and high efficiency research program at Carilion Clinic!
Paul Estabrooks, PhD
Senior Director for Research, Carilion Clinic
Professor of Human Nutrition, Foods, & Exercise, Virginia Tech
Professor of Family Medicine, Virginia Tech Carilion School of Medicine