Surgical databases: ethics in evolution.

The federal government’s Office for Human Research Protections (OHRP) has recently adopted and begun to selectively enforce a requirement that surgical databases with potential future application as research sources must be reviewed and approved by local Institutional Review Boards (IRBs). Compilers of the database must now obtain the written informed consent of individual patients before data entry. This is a fundamental departure from past practices, and is likely to affect the future availability of such important information sources. Is this decision an unwarranted and possibly harmful intrusion on the conduct of medical science, or a needed correction of an ethical blind spot within the surgical profession? Confidentiality of medical information is a fundamental patient right and a physician’s ethical obligation. The concept of confidentiality derives from the fundamental right of privacy, which entitles patients alone to control access to their medical records [1]. By observing confidentiality, we exercise respect for one another’s autonomy. Confidentiality is not only about data; it is also about the trust in which the physician-patient relationship is based [2]. Without strict confidentiality in the practice of medicine, patients would be unlikely to communicate to physicians the sensitive personal information that is often essential to diagnosis and treatment. The ethic and practice of doctor-patient confidentiality can be traced at least as far back as the Hippocratic Oath in the 4th century BC. Physicians subscribing to the Oath promised that, “Whatever, in connection with my professional practice, or not in connection with it, I see or hear, in the life of men, which ought not to be spoken of abroad, I will not divulge, as reckoning that all such should be kept secret.” The American College of Surgeons’ statement on confidentially includes a modernized version of this section of the Oath: “The surgeon should maintain the confidentiality of information from and about the patient, except as such information must be communicated for the patient’s proper care or as is required by law [3].” The OHRP’s ruling is intended as a response to concern that clinical databases with research applications have the potential to breach patient confidentiality. Most surgeons function in a continuous quality improvement mode, trying to advance their knowledge and performance by critically examining the outcome of every operation. Accordingly, surgeons recognize the importance of large clinical data samples and evidencebased conclusions. Thoracic surgeons have developed several multicenter groups to pool data on patients who have received thoracic operative procedures [4 – 6]. The Society of Thoracic Surgery (STS) has created the largest of these surgical databases, with the patient demographics and operative outcomes of more than one million cases gathered from across the US and Canada [4]. The fundamental intent of such a large data pool is to enable thoracic surgeons to trend outcomes over time and to establish benchmarks against which to measure and refine their work. Similar data are often gathered by clinical quality assurance programs within individual hospitals. When collected and evaluated by surgeons, outcome trending statistics can become a powerful clinical research tool. The Division of Thoracic Surgery at the University of Missouri-Columbia began participating in the STS database in 1979, with continuous enrollment of its cardiac surgery patients now totalling more than 20,000 cases. Security has been maintained by a single highly trained data manager and an assistant with controlled and monitored access to patient information. Patients are registered in the research pool by coded number and are not otherwise identifiable in any material contributed to the STS file. No special interviews or other impositions upon patients are involved, and all data are obtained directly from the medical record. The consequences of the information age are everywhere in medicine. The relative ease of electronic data gathering and transmission has stimulated the market for information, and government agencies, third-party payers, researchers, hospital committees, and in-house quality management specialists all believe they have an entitlement to patient data in ever-growing abundance. Preventing distribution of one’s observations or protecting paper files from unauthorized readers has become increasingly complex. The electronic medical record that is now emerging throughout the profession is unconfined by space and time, and can conceivably be accessed and reproduced by clever and unscrupulous hackers. Communication devices such as facsimile machines, the Internet, telemedicine, and even cell phones carry highly sensitive, highly vulnerable information across insecure lines. Patients now perceive that infringements on their privacy are common in medicine, and they deliberately seek physicians and institutions they believe can be trusted with sensitive information about their sexually transmitted diseases, substance abuse histories, and genetic predispositions [7]. Advances in genetic screening for active or impending congenital disorders have provoked intense fears that employment candidacy or insurance eligibility could be adversely affected by unautho