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Ann Thorac Surg 2002;74:983-985
© 2002 The Society of Thoracic Surgeons

Ethics in cardiothoracic surgery

Surgical databases: ethics in evolution

James W. Jones, MD, PhD*a

a Department of Surgery, University of Missouri, Columbia, Missouri, USA

* Address reprint requests to Dr Jones, Department of Surgery, M580 Health Sciences Center, University of Missouri School of Medicine, One Hospital Dr, Columbia, MO 65212 USA
e-mail: jonesjw@health.missouri.edu

The first 300 words of the full text of this article appear below.

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 . . . [Full Text of this Article]






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