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The question of whether it is possible to withdraw a feeding system from a patient who is in a persistent vegetative state raises serious legal and ethical issues which have recently been discussed in the High Court. This article discusses the issues and the Court's conclusions in this particular case.
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UNLABELLED: In 1991 the authority of psychiatric committees responsible for judicial decisions concerning mentally ill individuals hospitalized compulsorily was greatly extended. The committees' work procedures have gradually been established despite lack of binding rules and regulations, often evolving from the dynamics of the field. METHODS: The study population included 92 hospitalized patients. The examination was performed by administering a questionnaire, reading a protocol of the latest committee hearing and perusing the patient record. RESULTS: The committee tends to decide gradually about discharge from hospitalization and sometimes to include it as part of a rehabilitation process. The reasoning leading to discharge is generally from the field of law. CONCLUSIONS: Tension between medical and legal approaches often underlies psychiatric committee work. Generally, the committee tends to accept the position of the treating physicians. This may indicate that the two approaches are drawing closer to one another and that they have learned to work together cooperatively and fruitfully.
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PURPOSE: This study explores the ethical issues contained in warning letters (WLs) issued to institutional review boards (IRBs) by the United States Food and Drug Administration (FDA). METHODS: The online FDA Warning Letter Index was reviewed for letters issued to IRBs in the United States under the violation categories "Institutional Review Board" and "IRB" for the period January 1997 through July 2004. The resultant letters were evaluated for violations in 4 regulatory themes: having and following written procedures for research review; documentation of research review; IRB membership and conflict of interest; and informed consent. RESULTS: Fifty-two (52) FDA WLs were issued to IRBs during this period. Hospital/medical centre IRBs received the most letters (n = 34), followed by university IRBs (n = 9) and private IRBs (n = 9). The most common regulatory violations were failure to have and follow adequate written procedures about how the review of research is conducted (50 WLs); failure to prepare and maintain adequate documentation of IRB activities (47 WLs); and failure to provide adequate continuing review of approved studies (36 WLs). Nineteen WLs were issued for consent form issues. CONCLUSIONS: Warning letters are informative with regard to clinical research regulations and research subject protection. The content of these letters consistently indicates weaknesses in review and documentation activities of audited IRBs, potentially signalling similar issues among IRBs across the United States. Our findings, in a setting of overburdened IRBs who, in general, passively monitor studies, raise concerns about study oversight and optimal protection of research subjects.
During the summer of 1999, twenty-eight interviews with some of the leading authorities on the euthanasia policy were conducted in the Netherlands. The discussion begins with providing some background information on the guidelines for conducting euthanasia. Next, I explain the research methodology and move on to discuss the interviewees' responses to the question whether it is preferable to legislate euthanasia. The interviewees exhibited split views on the issue. Some were in favor of legislation for instrumental and symbolic reasons. Others utilized different instrumental and symbolic reasons to argue against legislation. Three interviewees preferred to wait for some years before changing the law.
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Mr. R appealed for a decision by the Court to overturn the refusal of the Medical Director of Health to her request that health information in medical records pertaining to herdeceased father should not be entered into the Health Sector Database. Furthermore, she called for recognition of her right to prohibit the transfer of such information into a database. Article 8 of Act No 139/1998 on a Health Sector Database provides for the right of patients to refuse permission, by notification to the Medical Director of Health, for information concerning them to be entered into the Health Sector Database. The Court concluded that R could not exercise this right acting as a substitute of her deceased father, but it was recognised that she might, on the basis of her right to protection of privacy, have an interest in preventing the transfer of health data concerning her father into the database, as information could be inferred from such data relating to the hereditary characteristics of her father which might also apply to herself. It was revealed in the course of proceedings that extensive information concerning people's health is entered into medical records, e.g. medical treatment, life-style and social conditions, employment and family circumstances, together with a detailed identification of the person that the information concerns. It was recognised as unequivocal that the provisions of Paragraph 1 of Article 71 of the Constitution applied to such information and guaranteed to every person the right to protection of privacy in this respect. The Court concluded that the opinion of the District Court, which, inter alia, was based on the opinion of an assessor, to the effect that so-called one-way encryption could be carried out in such a secure manner that it would be virtually impossible to read the encrypted data, had not been refuted. It was noted, however, that Act No. 139/1998 provides no details as to what information from medical records is required to be encrypted in this manner prior to transfer into the database or whether certain information contained in the medical records will not be transferred into the database. The documents of the case indicate that only the identity number of the patient would be encrypted in the database, and that names, both those of the patient and his relatives, as well as the precise address, would be omitted. It is obvious that information on these items is not the only information appearing in the medical records which could, in certain cases, unequivocally identify the person concerned. Act No. 139/1998 also provides for authorisation to the licensee to process information from the medical records transferred into the database. The Act stipulates that certain specified public entities must approve procedures and process methods and monitor all queries and processing of information in the database. However, there is no clear definition of what type of queries will be directed to the database or in what form the replies to such queries will appear. The Court concluded that even though individual provisions of Act No 139/1998 repeatedly stipulate that health information in the Health Sector Database should be non-personally identifiable, it is far from adequately ensured under statutory law that this stated objective will be achieved. In light of the obligations imposed on the legislature by Paragraph 1 of Article 71 of the Constitution, the Court concluded that various forms of monitoring of the creation and, operation of the database are no substitute in this respect without foundation in definite statutory norms. In light of these circumstances, and taking into account the principles of Icelandic law concerning the confidentiality and protection of privacy, the Court concluded that the right of R in this matter must be recognised, and her court claims, therefore, upheld.
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Under New York State's unique do-not-resuscitate law, patients admitted to a hospital are assumed to consent to cardiopulmonary resuscitation unless a do-not-resuscitate order has been written in accordance with specific stipulations. This study was undertaken to determine if the law would significantly change the use of cardiopulmonary resuscitation. The charts of 952 patients who died on the medical services of Bellevue, New York University, and New York Veterans hospitals during the 12-month periods before and after the law went into effect were reviewed. The proportion of patients undergoing cardiopulmonary resuscitation was determined. To take into account the effects of potential confounders (ie, hospital, sex, race or ethnic group, age, diagnosis), a multiple logistic regression analysis was performed. The relative risk for cardiopulmonary resuscitation was found to be 0.81, (95% confidence interval: 0.59-1.10) after the law as compared with before, which was not statistically significant. Although patients with chronic or potentially reversible illness were much more likely than those with hopeless illness to undergo cardiopulmonary resuscitation (relative risk of 7.08 [3.23-15.54] and 12.89 [8.71-19.07], respectively), the data failed to show that the law had an impact on the use of cardiopulmonary resuscitation in any of the disease categories. Total use of formal do-not-resuscitate orders increased from 32.7% to 83.9% (p less than .0001), although at Bellevue, where documentation was high before the law, no further increase occurred.(ABSTRACT TRUNCATED AT 250 WORDS)
The ability of psychiatric patients and prisoners to provide informed consent to participate in clinical research has given rise to much debate. Forensic psychiatric patients present a particular concern regarding their competence to consent to research, as they are both patients and prisoners. The primary goal of this research was to evaluate whether, by employing structured assessments of capacity to consent to research, we could determine if this combined vulnerability leads to differences in competence from the published abilities of nonforensic psychiatric patients. Subjects deemed incapable of providing informed consent scored differently and lower than the other consent groups on three aspects of the decision-making process. Diagnosis evidenced only a slight relationship to decision-making abilities, and this difference was only in the ability to understand the basic procedural elements of the research. Psychiatric symptoms were modestly related to decision-making. Positive symptoms were associated with poorer performance on the Understanding subscale of the MacCAT-CR, and negative symptoms were associated with lowered performance on the Reasoning subscale. These results are in accord with several published studies of nonforensic psychiatric patients and suggest that concerns regarding both forensic and nonforensic psychiatric patients' ability to provide informed consent may be unwarranted, especially in patients with few active symptoms.
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