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Ann Thorac Surg 2002;74:983-985
© 2002 The Society of Thoracic Surgeons
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{at}health.missouri.edu
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 evidence-based 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 unauthorized disclosures [8]. In response, the public has demanded legal guarantees that their ailments and treatments will not be made available to private or governmental organizations without their specific individual authorization, and that such information cannot be further transferred or otherwise utilized against their best interests. The Health Insurance Portability and Accountability Act of 1996 (45 CFR Parts 160 and 164) (HIPAA) proposes "to enhance the rights of the customer by providing them access to their health information and controlling inappropriate use of that information."
The basic function of the medical record is the care of the individual patient. The basic function of a surgeon’s individual database is to improve the surgeon’s ability to care for patients he will treat subsequently. The medical record has immediate benefits for the individual patient, whereas the database potentially benefits future patients, and implicitly the public at large. Korn saw this potential for benefit as a new patient obligation, to be accepted in exchange for receipt of medical care sponsored by the culture: "Since every individual benefits from the accumulated medical knowledge base, everyone should contribute to the ongoing expansion and renewal of that base" [9]. Because the individual whose information has been entered in the database does not personally benefit during the current treatment episode beyond the care already received, the argument can be advanced that there is an uneven distribution of benefits for the patient whose privacy is conceivably placed at risk by inclusion. If the information preserved in the surgeon’s database does not include patient identifiers, however, and the surgeon will neither publish nor otherwise communicate the particulars of individual patients, there is no risk to privacy and the question should be considered moot.
IRB approval of surgeons’ applications for projects like the STS database at individual institutions can be readily anticipated, but local IRB-directed modifications in scope and format could affect the uniformity, and therefore the usefulness, of data in the multicenter pool. Most patients are likely to willingly provide informed consent for anonymous inclusion of their clinical characteristics in a research enterprise intended to improve care, but some might not, and their absence would limit the comprehensiveness, and therefore the statistical integrity and applicability, of the data base.
In the nature of the data it accumulates and its intended application to the process of continual quality improvement, the surgical database is essentially identical to the quality assurance data collected by every licensed hospital in America. IRB review and approval of clinical data-gathering and review processes by hospital quality assurance offices is nowhere required, and modification of clinical practice based upon such data is not only tolerated but mandated by HCFA and such national accreditation agencies as JCAHO.
A question then arises of where one finds a distinction between the exempted studies of the hospital QA office and the surgical data-gathering project requiring IRB oversight. What additional expense or other inhibiting factors follow implementation of these requirements? More importantly, should OHRP and local IRBs have supervisory authority to shape and limit scholarly studies that pose no reasonable risk to the health or privacy of individual patients?
Most of the published surgical literature is comprised of retrospective clinical studies. Medical record reviews consolidated into computerized data files predominate. Only within the last decade have local IRBs demanded the authority to review, approve, and supervise such retrospective chart reviews. Their involvement has had a sound ethical basis in the protection of patient confidentiality. The clinical record is a privileged document, and the information within it has come to be recognized as the patient’s to control. The attending physician is expected to know the patient’s demographics, comorbidities, social history, technical operative history, clinical course, and prognosis throughout the period of active treatment and follow-up. The surgeon must honor the confidentiality of the medical record and respect the patient’s dignity and integrity when entries are made. Large-scale chart review nevertheless typically engages the attending physician’s helpers, perhaps including medical students, research assistants, transcriptionists, and other nonphysicians. As access to the record broadens during this process, there is an inevitably widening risk of lapses in confidentiality, and prior peer review of the study’s procedural methods for protection of patient privacy is well within the legitimate purview of local IRBs. Proposals without such built-in safeguards are properly returned to prospective investigators for revision. Heretofore, the written informed consent of patients included in such databases has not been required by OHRP or local IRBs. It has now been determined that patient informed consent will be an additional requirement for the conduct of these studies at the University of Missouri.
Existing active surgical databanks contain demographics, comorbidities, technical details, and outcomes. All of the information in the present STS databank is contained in the patient’s clinical record. The collection of additional data not included in the medical record would constitute a prospective study design requiring full IRB compliance. Current surgical databanks contain information that is more technical, less extensive, less personal, and better protected than the patient’s paper medical chart. The information extracted from such a databank does not include patient identification factors, and concentrates upon statistical variations within patient groups rather than individual events. IRB supervision and requirement of informed consent of this process would do nothing to further the protection of patient privacy or personal safety, and could substantially inhibit a well-functioning scientific activity.
References
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