Promoting trustworthy oversight of regenerative medicine by understanding the role of professional regulation and its challenges
Groups that regulate professionals, like the ones that oversee doctors, are meant to protect the public. However, because regenerative medicine (RM) is a new and developing field, there can be important questions about what protecting the public really means and requires in this context. Also, who or what is responsible for overseeing a new RM treatment will often depend on whether that treatment is considered to be a drug, a medical device, or a type of clinical innovation, and on whether it is being provided as a part of a research study or in a different context. A challenge is that the boundaries between these different concepts are not always clear. Our work is exploring these and related areas, with the goal of informing future policy to help ensure that the clinical progress of RM is supported by strong and well-fitting systems of oversight.
