As head of a department, your faculty wants to try a new treatment involving intraocular injection of an experimental drug that has never been done at your centre. How do you address this concern?
Introduction of innovation is an important component of high quality care. However, there is often little control over the introduction of innovation into clinical care. Institutional Review Boards control the introduction and evaluation of major innovations, particularly if research is involved. However, many innovations are not the subject of research and a process is needed to ensure clinical innovations are safely introduced. Innovation can include a significant change in clinical procedure, techniques, technology, treatment/therapy which have been used elsewhere, but not at your institution. Innovations that involve significant cost and/or risk to patients and/or staff are of particular concern.
A policy and procedure is needed to address these innovations. Sometimes discussion with Research Ethics is needed to define the division between clinical care and research. Ideally, the process for approving a clinical innovation should be relatively simple and rapid (consistent with the needs and/or timelines of the clinical situation).
A one-page form or checklist can ensure all necessary steps have been completed. Patients must be informed that the procedure is innovative and their specific consent documented. The treating physician must also document and disclose to patients any conflicts of interest regarding the innovation. The clinicians and hospital must have appropriate equipment, knowledge and skill to administer the innovation. Evidence supporting reasonable use should support the application to use the innovation, as well as provide a rationale for its use in the specific clinical context. Any application must articulate risks with mitigating strategies. To ensure the request is reasonable, peer review may be helpful. Also, documentation of outcome and periodic review after the innovation has been tried, ensures risks are catalogued. Finally, any cost implication needs to be approved by the relevant clinician/manager.
In summary, policies are needed to encourage, but also to maintain the safe introduction of innovation.