Defining Innovation
- As stated before, the development of new surgical methods may involve innovation that is routine variation, formal human subjects research, or somewhere in between the two.
- For surgical investigations, a procedure that has never or only rarely been attempted before may be perceived as "experimental" even though it does not meet the standard definition of research. This means the division between clinical care and research remains indistinct in surgery, further complicating how the standards of human subject research apply to surgical innovations.
- Surgical innovation may be classified as human subjects' research that requires oversight and additional patient protections, or alternatively, as an activity that does not merit special consideration whose suitable implementation may be left to the surgical investigator.
- It has been proposed that the solution is to analogize surgical innovation to a spectrum, ranging from spontaneous modifications to more deliberately planned technical alterations. Innovations may be relatively simple and minor, or complex and of considerable impact, however, they are all intended to lead to the renewal, refinement, or improvement of surgical technique, whether it is tailored to an individual patient or geared towards a far more general surgical problem. Constructing a spectrum of surgical innovation that ranges from the standard of care to experimental therapies is not without ambiguity, but it is a useful working definition until professional or governmental conventions can be established.
Next - Benefits & Disadvantages to Innovation
Return to Index