The desperate case: CARE (costs, applicability, research, ethics)

Article Abstract:

Two recent case reports of surgical evisceration and transplantation of organs from cadavers are considered. Four desperately ill children who had experienced severe damage to abdominal organs were treated by surgical technique in which the entire system of abdominal organs was replaced as a unit. Two of the patients died soon after the surgery from loss of blood; one after requiring 122 units. Of those who survived the surgery, one lived for 109 days and the other for 193 days. Both patients' physical condition continuously deteriorated, and at autopsy, they showed extensive growth of tumors in the lymphatic system. This was not surprising, because they had been treated with cyclosporine, a drug wich suppresses the immune system in order to reduce the likelihood of organ rejection. While immunosuppressive drug therapy is required to ward off the problems of rejection and graft-vs-host disease, it similarly suppresses the body's ability to fight off the production of Epstein-Barr virus, which is found in most people and which as been associated with the development of some lymphomas. Startling new developments in surgery, such as those involving the children, carry a high financial price and an even higher one in pain and suffering of the patients and their families. In light of these experiences, it is clear that these procedures should be withheld from widespread use until animal models have been perfected that will permit further evaluation of the procedures. Whether or not the procedures pose a special risk for the development of lymphoma because of Epstein-Barr virus must also be addressed. The emotional and ethical issues at play that pushed these two research groups to carry out these procedures on children should also be considered. Lastly, the cost to society of performing such drastic surgery should be addressed. Such surgery on desperately ill patients must be based on a realistic hope of prolonged life of some quality and not merely pain, suffering and cost.

Social aspects, Finance, Organ transplantation, Pediatric surgery, Surgical research, editorial, Transplantation of organs, tissues, etc. in children, Surgery, Experimental

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Challenges to Human Subject Protections in US Medical Research

Article Abstract:

Many of the regulations protecting humans who participate in medical research are under attack. These protections are encoded primarily in the Nuremberg Code and the Declaration of Helsinki. According to The Declaration of Helsinki, the interests of the research subject must always prevail over the interests of science and society. Current trends in medical research are creating situations where these protections could be weakened. The National Bioethics Advisory Commission will review the US system of protections governing human subjects participating in medical research.

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Institutional review board approval and publication of human research results

Article Abstract:

Many biomedical journals do not require a statement from authors of a research manuscript that the study was approved by an institutional review board (IRB). IRBs review all research proposals at their institution that involve human subjects to make sure informed consent was obtained. A review of the editorial policies of 102 English-language biomedical research journals revealed that only 47% required IRB approval of studies under consideration for publication. Three-quarters of these journals required an IRB statement in the manuscript.

Standards, Publishing industry, Medical publishing, Manuscripts

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