Publication of unethical research studies: the importance of informed consent.
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Biomedical subjects
Publications and source records attributed to Robert M Sade.
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BACKGROUND: Members of the Southern Thoracic Surgical Association (STSA) have presented important pediatric cardiothoracic surgery papers at the annual meetings over the last 50 years. In order to determine the influence of these presentations on the practice of surgery, a review was undertaken. Early papers were characterized by emerging advances in open-heart surgery, anatomic congenital heart studies, and electrophysiologic discoveries that extended life with pacemakers. Later years were characterized by innovative myocardial preservation methods, improved cardiopulmonary bypass techniques, expanded homograft availability, emphasis on accurate repairs, intraoperative transesophageal echocardiography, and cardiopulmonary transplantation. METHODS: All but one of the scientific programs of the annual meetings (that of 1964) were located. The programs were reviewed and 180 presentations were identified on topics in congenital heart disease, pediatric thoracic disease, and pediatric thoracic wall abnormalities. Of those 180 oral presentations, 155 manuscripts (86%) were eventually published or in press and available for critical review and analysis. Manuscripts were grouped by diagnosis or therapeutic intervention. We determined a "cumulative citation frequency" (CCF), which measures the number of times an article is cited in the bibliography of related papers in the universe of participating journals. The selected manuscripts were compared with the historic landmark contributions and the existing trends at the time, and the number of articles both by individual authors and from institutions were tallied. RESULTS: Grouping by authors and institutions showed that 100 of 155 pediatric cardiothoracic manuscripts (65%) originated from 13 institutions. The CCF for the 20 leading articles ranged from 26 to 93. CONCLUSIONS: This historical STSA 50-year record of pediatric cardiothoracic advances was accomplished in a milieu of collegial respect and camaraderie. Our annual meetings over the years have provided a venue for thoracic surgeons to share their ideas, innovations, and scientific inquiry. These contributions have significantly affected the practice of pediatric cardiothoracic surgery. The STSA has worked for 50 years and we trust that it will work for another 50 years and beyond.
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BACKGROUND: Organ donation rates nationally have changed little in the last 15 years, despite a growing waiting list. About 6000 patients die each year for lack of a donated organ. South Carolina's organ procurement organization, LifePoint, recently restructured itself in an effort to increase donation and transplantation rates. The main change was division of the procurement coordinator position into five new positions. A unique innovation was the creation of a bereavement counseling and education service to provide families of potential donors emotional support and education regarding brain death and the value of transplantation. METHODS: We retrospectively reviewed data of the Association of Organ Procurement Organizations and LifePoint's in-house databases, covering the period from 1997 to 2001. RESULTS: From 1997 to 2001, the donation rate within LifePoint's service area increased from 18.2 to 33.6 donors per million of population (83%), and transplantation rate increased from 54.8 to 108.6 transplants per million of population (97%), while the national rates were virtually unchanged (P<0.01 and P<0.001, respectively). CONCLUSIONS: Division of procurement function into several separate positions, including family bereavement counseling and education, can substantially increase donation and transplantation rates. If these innovations could be effectively adapted by other organ procurement organizations, the number of patients nationally who die on waiting lists could be substantially reduced.
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The interaction between medical research and for-profit corporations is not new, but it has expanded considerably in recent years. Some of the recent trends may accelerate the research process, particularly when large clinical trials are required. However, a renewed commitment to the application of high ethical standards is essential to ensure that societal trust in research is not eroded, subjects enrolled in trials do not become merely a means to an end, and medical research is efficiently translated into clinical advances that will benefit future patients. This article focuses on the analysis of conflicts of interest in the conduct of clinical trials in both academic and community-based settings. Specifically, it discusses how the roles of research scientists and clinical practitioners differ and the importance of ensuring that participants' consent to enroll in clinical trials is not the result of confusion about the goals of an experimental treatment that may resemble clinical care. The article also discusses the potential conflicts of interest that can arise when clinicians stand to gain from enrolling their own patients as subjects in clinical trials and examines various instances in which disclosure of information regarding funding and compensation may serve to minimize such conflicts. This article emphasizes that to preserve the integrity of research and to protect the welfare of human subjects who enroll in trials, physicians should have adequate training in the conduct of research and be familiar with the ethics of research. When a physician has treated or continues to treat a patient who is eligible to enroll as a subject in a clinical trial conducted by the same physician, someone other than the treating physician should obtain the participant's informed consent. Finally, the article addresses disclosure of financial incentives and related funding issues.
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We argue that healthy people should be allowed to sell one of their kidneys while they are alive--that the current prohibition on payment for kidneys ought to be overturned. Our argument has three parts. First, we argue that the moral basis for the current policy on live kidney donations and on the sale of other kinds of tissue implies that we ought to legalize the sale of kidneys. Second, we address the objection that the sale of kidneys is intrinsically wrong because it violates the Kantian duty of respect for humanity. Third, we address a range of consequentialist objections based on the idea that kidney sales will be exploitative. Throughout the paper, we argue only that it ought to be legal for an individual to receive payment for a kidney. We do not argue that it ought to be legal for an individual to buy a kidney.
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