WIRB-Copernicus Group Chief Medical Officer Explores Surgical Innovation Oversight in Academic Surgery Departments

"Guidance for the development of innovative surgical procedures and techniques is much less clear than guidance for the development of new medications and medical devices," said Dr. McNair. "It has long been a challenge for those who are responsible for maintaining the protection of research participants to be able to clearly identify when the assessment of the outcomes of innovative procedures becomes true clinical research requiring independent oversight and involvement of Institutional Review Boards (IRBs)."

Entitled "Assessing Awareness and Implementation of a Recommendation for Surgical Innovation Committees (SICs): A Survey of Academic Institutions," this paper examines adoption of the recommendations in the 2008 Society of University Surgeons (SUS) position statement which stated that institutional SICs should be created to ensure that there is appropriate oversight of surgical innovations. One of the responsibilities of the SIC would be to ensure that projects were referred to the IRB for review when appropriate.

Drs. McNair and Biffl surveyed the chairpersons of the surgery departments in academic medical centers to find out if they were aware of this SUS recommendation and determine how they usually manage surgical innovation oversight.

Although most chairs (84 percent) reported that surgical innovation was an institutional strength, only 23 percent of their organizations had an SIC. A further 20 percent had discussed or planned to establish one. Most respondents used other methods of oversight, such as morbidity/mortality conferences (88 percent), and monitoring peer-review publications (77 percent) and outcomes registries (51 percent). These methods do not provide independent or prospective review of surgical plans, nor do they ensure that patients are provided information about non-standard procedures in the informed consent process. Concerns still exist about whether innovative procedures have appropriate oversight, and whether clinical research involving innovative surgical procedures is being routed to Institutional Review Committees for review appropriately.

About WIRB-Copernicus Group

WIRB-Copernicus Group (WCG) is one of the world's leading providers of solutions that measurably improve the quality and efficiency of clinical research. The industry's first Clinical Services Organization (CSO), WCG enables biopharmaceutical companies, contract research organizations and institutions to accelerate the delivery of new treatments and therapies to patients, while maintaining the highest standards of human subject protections.

WCG solutions include contract and budget negotiation, study start-up acceleration, regulatory and ethical review services, oversight of research involving gene therapy, and lab safety consulting. Powered by a suite of proprietary technologies, WCG solutions help clients to increase regulatory compliance and support the digital management of clinical trials. For more information, please visit www.wcgclinical.com or follow us on Twitter @WCGClinical.

Logo - http://photos.prnewswire.com/prnh/20140422/77410

SOURCE WIRB-Copernicus Group

Related Links

http://www.wcgclinical.com