When is surgery research? Towards an operational definition of human research

The distinction between clinical practice and surgical research may seem tr ivial, but this distinction can become a complex issue when innovative surg eries are substituted for standard care without patient knowledge. Neither the novelty nor the risk of a new surgical procedure adequately defines sur gical research. Some institutions tacitly allow the use of new surgical pro cedures in series of patients without informing individuals that they are p articipating in a scientific study, as long as no written protocol or hypot hesis exists. Institutions can justify this practice by viewing human resea rch in narrow terms as an activity outlined in a formal protocol. Applicati on of limited definitions, however, erodes patients' rights and risks losin g public confidence in how biomedical research is conducted. I propose an o perational definition of human research also be recognised. Enforcing more rigid and less ambiguous guidelines of human research may curtail enrolment into some studies, but it will also protect patients from being used as su bjects without their knowledge.