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1
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0017942172
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Protecting the “animal of necessity”: limits to inquiry in clinical investigation
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(1978)
Daedulus
, vol.107
, pp. 129
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Swazey1
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11
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0010030912
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Philisophical reflections on experimenting with human subjects
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(1969)
Daedulus
, vol.98
, pp. 229
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Jonas1
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14
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84913842448
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Under current DHHS regulations promulgated in 1981, certain categories of research involving human subjects may be exempted from IRB review or be eligible for expedited review. Some of these studies may not require subject informed consent to be undertaken. These include, in the biomedical area, research using hair and nail clippings, excreta, small collections of blood by venipuncture or pathological specimens (see Ref. [15]).
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17
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7144259003
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Restructuring informed consent legal therapy for the doctor-patient relationship
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(1970)
The Yale Law Journal
, vol.79
, pp. 1533
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Glass1
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20
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0017196293
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Informed consent of the mentally disabled: a failing fiction
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(1976)
Psychiat. Annls
, vol.6
, pp. 82
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Chayet1
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22
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0016838939
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Some observations on informed consent in non-therapeutic research
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(1975)
J. Med. Eth.
, vol.1
, pp. 138
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Garnham1
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29
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0020862599
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Toward an informed discussion of informed consent: a review and critique of the empirical studies
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(1983)
Arizona Law Rev.
, vol.25
, pp. 265
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Mesiel1
Roth2
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34
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84913884915
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An enpirical study of legal and ethical issues of informed consent in psychiatric research by William J. Winslade, Ph.D., Medicine, Law and Human Values Program, University of California, Los Angeles; and Loren H. Roth, M.D., M.P.H., Law and Psychiatry Program, University of Pittsburgh School of Medicine, Principal Co-Investigators.
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35
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84913860451
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A preliminary examination of informed consent processes and subject understanding in the two northeastern studies has been prepared and recently published (see[41]).
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36
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84913847379
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Tardive dyskinesia is a neurologic condition characterized by involuntary muscle movement, especially the face, mouth and limbs, that may occur as a result of antipsychotic drug treatment. In many cases the syndrome appears to be irreversible and at present no effective treatment for the condition is available. The best data regarding the disorder suggests that tardive dyskinesia occurs in 10–20% of those using antipsychotic medication [52]. While problematic, most cases are not severe.
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37
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84913820321
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Many depression study and most schizophrenia study subjects were treated with medication prior to their entry into research. These individuals probably would have continued on medication regardless of their research status. For this reason, it is not entirely accurate, with these subjects, to view medication benefits and risks as strictly research related. Since subjects are randomly assigned ti different drug treatment groups, however, it is possible that subjects may accrue specific additional research benefits or risks depending on the treatment group they are assigned to. These benefits or risks may be general to the entire treatment group or specific to an individual subject due to an idiosyncratic response to a particular drug or dose.From knowledge gained from the two studies we believe that their principal research risk is the potential deterioration of subjects' clinical condition due to drug-free periods in the research. The principal research [[Truncated]]
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38
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84913855176
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The co-investigator in the depression project, ‘Dr Smith’: (a pseudonym), is a young research psychiatrist. The study was originally formulated by his superior at the hospitals. By the time we began to observe the study, however, Dr Smith had taken over the day-to-day mechanics of the project, including obtaining subject consents.
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39
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84913826055
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In most cases, some investigator subject discussion concerning the psychiatric research took place prior to the taped disclosure sessions that serve as the basis for our analysis of investigator information disclosure. Although some of these informal conversations between investigators and subjects were observed and recorded, many of them were not. From our observations, as well as discussions with investigators and subjects, it appears that, generally, few details regarding the studies were communicated to subjecrts prior to the formal disclosure. Subjects were usually asked if they were interested in participating in a drug study of treatment program and informed that the program involved a comparison of antipsychotic or antidepressant drug treatments. In the schizophrenia study, prospective subjects were also usually informed that study participation involved receiving medication by injection. If the prospective subject showed any interest, an appointment [[Truncated]]
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40
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84913814053
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In addition to verbal disclosure of research information, prsopective subjects in both studies were given a written form (which they were asked to sign) explaining the nature, purpose, risks and benefits of the investigation, in addition to other information. It should be noted, however, that the written informed consent form for the depression study, while detailing important information, fails to mention the potential risks to subjects associated with the study's drug-free periods.
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42
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84913837665
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It is clear that the depression study co-investigator viewed his project as primarily therapeutic in terms of its impact on his patient/subjects. Nearly all the prospective subjects observed in the depression study (as well as the schizophrenia study) were actively receiving psychiatric treatment at the time of their entry into the study. In the view of the depression study co- investigator, the research component of the program was a minor add-on which placed tha patients at no additional risk. The co-investigator's perception of the therapeutic character of his research undoubtedly influenced his disclosure practices and probably, in part, accounts for the relative paucity of information provided to prospective subjects.
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43
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84913882697
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The schizophrenia study consent from notes: “I understand that I may be treated with a dose of antipsychotic drug which is lower than the dose usually given to patients and that this dose may not be enough to control my symptoms. I understand, however, that should this dose be inadequate, I will be changed to a dose which a doctor thinks would be better for me”.
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44
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84913828312
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Drug dose within the two randomized groups can also be decreased by one-half the original dose if significant subject side effects due to overmedication occur. This event, however, was found to be rare.
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45
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84913869109
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A score of 0 (poor understanding) was given to an unacceptable response, one that was factually wrong, irrelevant to the question or delusional. A score of 1 (fair understanding) was given to a partially correct response, one that wa uncomplete or based on a conviction held with marked ambivalence. A score of 2 (good understanding) was given for an acceptable (although not necessarily fully complete) response. A subject's understanding of study risks would be scored, for example, in the following manner: 0 = no response, completely incorrect response, delusional or incoherent response. If the study could recall one study risk (e.g. a drug side effect), a score of ‘1’ would be given: if the subject could recall 2 or more risks, a score of ‘2’ would be given. Interrater reliability in the scoring of depression study subjects was 0.99; in the schizophrenia study, 0.95 (Kendall τ coefficients).
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46
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84913814613
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‘Total subject understanding scores’ for each study were constructed by summing subject scores on 15 individual items (13 of which are displayed in Table 2) asked during the subject's initial understanding interview. Possible subject scores range from 0 to 30.
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47
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84913823457
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Subjects' belief that their treatment was unlimited in any way by research participation is understandable since they were routinely informed by investigators that they were fully eligible to receive all non-research related forms of treatment appropriate for them and offered by the hospital. In this sence, subjects' treatment was unlimited. The form and scope of subjects' drug treatment, however, were contrained in accord with the research protocols of the 2 studies. In this sense, subjects' treatment options were clearly limited by their research involvement.
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48
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0019066579
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Physician-investigator/patient-subject: exploring the logic and the tension
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(1980)
J. med. Philos.
, vol.5
, pp. 215
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Churchill1
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50
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0347135792
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Random auditing: a modest proposal for reforming the regulation of research
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(1983)
Clin. Res.
, vol.31
, pp. 142
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Caplan1
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52
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0018954859
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Tardive dyskinesia: summary of a task force report of the American Psychiatric Association
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(1981)
Am. J. Psychiat.
, vol.137
, pp. 1163
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Baldessarini1
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