University of Virginia Health System

U.VA. BIOETHICISTS STUDY NEED FOR REGULATING INNOVATIVE SURGERY

When does innovative surgery cross the line and become a research experiment? In the June issue of the Journal of the American College of Surgeons, researchers at the University of Virginia Health System report results from a survey of surgeons that addresses this unregulated area of medicine.

Unlike drugs, surgical procedures are not covered by the Food and Drug Administration, although surgical devices are, said study co-author Jonathan Moreno, director of the U.Va. Center for Biomedical Ethics. There are no generally accepted standards for determining if they constitute research or not. We believe it's important to have guidelines on this, because otherwise people may be getting procedures that are damaging or useless, and which may create unnecessary costs.

For example, liver transplantation involving grafts from living donors -- originally designed to be a procedure in children -- is a surgical innovation now used for adults with growing frequency without having been formally researched using adult subjects, according to Moreno and study co-author Dr. Angelique Reitsma, research associate at the U.Va. Center for Biomedical Ethics.

The researchers sent a written survey to surgeons who had authored articles about new surgical procedures that appeared in medical journals between 1992 and 2000. The surgeons, who were affiliated with university and non-university hospitals, were asked if they considered their new procedures to have been researched in terms of federal definitions based on information supplied with the questionnaires.

All medical research institutions that receive federal funding are required by the National Research Act of 1974 to have institutional review boards (IRBs). These boards ensure that the institution's medical research studies with human subjects comply with federal standards for such experiments. The regulations, enforced by the Office for Human Research Protections of the Department of Health and Human Services, include the requirement that clinical study participants be informed of any safety issues before they consent to become enrolled in the trial. IRBs also are responsible for monitoring trials at their institutions. Private research studies conducted without federal funds do not always have IRB review.

It is presumably wrong to put somebody into an experiment without receiving their consent. Moreno said. That is the reason for IRBs. Our concern is whether research in surgery has been out of this loop of IRB review and how to make the rules suitable for the setting of surgery.

Innovations in surgery happen all the time, he said. Although two people might have the same procedure, it's actually going to be done a little bit differently based on each patient's anatomy and condition. However, what begins in the operating room (OR) as an innovation can turn into an experimental procedure.

Distinguishing between gradual implementation of minor surgical modifications and more permanent or extensive alterations of a technique is a challenge, the authors wrote. This is especially true when modifications are made on an as-needed basis, for the benefit of the individual patient….However, a surgeon may begin to change his or her standard OR technique more permanently based upon experiences with individual cases.

If he or she then decides to publish results of the new technique, the line is clearly crossed and even originally spontaneous and patient-centered modifications become research in retrospect, justifying IRB review and sometimes informed consent of patients, who have now become research subjects.

Reitsma said that some survey respondents expressed annoyance at the prospect of increased regulation, as well as doubt that federal regulators would know enough to make decisions affecting innovative surgery. But others thought guidelines, especially if partly developed by a peer-review process led by a professional society such as the American College of Surgeons, would actually help protect surgeons. Many were not trained to think in terms of complying with research regulations, she said.

We weren't trying to challenge surgeons or imply they don't care about their patients' well being, Reitsma said. Innovative surgery is done especially with desperate patients, who surgeons want to help, Reitsma said. They might say, we've never done this before, we think this might help, let's go ahead and do it. So a lot of it comes from that enthusiasm and desire to help the patient, which is not a bad thing, as long as you explain that to your patient. But if you subject 10 patients to that new procedure specifically to determine its yet unknown efficacy, in my mind it becomes a research experiment, especially if you write about it and send it to a journal. Surgical innovation starts with a desire to help patients, but somewhere along the line it may become research when it didn't start out that way.

We hope to proceed into this new territory with surgeons' cooperation, she said. I think that the majority of surgeons will see that following standardized guidelines and clear definitions for new procedures is in their best interests as well as patients'.

June 1, 2002