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We undertook a qualitative e-mail survey of federally-funded principal investigators of their views of the US human subjects protection system, intended to identify the range of investigator attitudes. This was an exploratory study with a 14% response rate. Twenty-eight principal investigators responded; their comments were analyzed to show underlying themes, which are here presented along with supporting quotations.There was consensus that it is important to protect human subjects from research abuse, but disagreement over how well the IRB system is functioning. Some researchers felt that the system is effective and serves its purpose well. Of those who support the system, some endorse its methods, purpose, and daily functioning, as they experience it, without reservation. Others, while expressing some frustration, feel that the purpose is important and their local IRB does its best to make a difficult system work well.Those investigators who were more harshly critical commented on multiple flaws in the system, including (1) consent forms that are inappropriate and incomprehensible, (2) an emphasis on minutiae, and (3) concern with protecting the institution more than research subjects. Respondents told us that the IRB system is a particular burden for research in neurology, emergency medical conditions, repositories, and social sciences in general; a more comprehensive study might identify other problematic areas. Significant concern was expressed about the cost, inefficiency, and irrationality of IRB review. The IRB system works well for some researchers, but our results indicate that other investigators feel the costs outweigh the benefits.

A case-control study was conducted among 205 women in Michigan and Ohio who were diagnosed with undifferentiated connective tissue disease (UCTD) to investigate the significance of self-reported past exposures to implanted silicone-containing or non-silicone-containing medical devices. The 205 UCTD cases were compared with 2,095 controls who were sampled by random digit dialing. When silicone-containing devices, including shunts and catheters, were analyzed collectively, a significant association was observed (odds ratio (OR) = 2.81, 95% confidence interval (CI): 1.34, 5.89). The odds ratio for exposure to breast implants was increased, but not significantly (OR = 2.22, 95% CI: 0.65, 7.57). Among the non-silicone-containing devices, artificial joints (OR = 5.01, 95% CI: 1.60, 15.71) and orthopedic metallic fixation devices (OR = 1.95, 95% CI: 1.05, 3.60) were associated with UCTD. The estimations of risk associated with implanted medical devices in UCTD cases were explored in a comparison with 660 scleroderma patients who were ascertained concurrently in Michigan and Ohio. In general, the associations that were observed with non-silicone-containing devices, and more specifically with the fixation devices, persisted in the comparison of UCTD cases with scleroderma patients. The studies conducted among populations in Michigan and Ohio are intended to stimulate new hypotheses, innovative approaches, and the fostering of understanding of the environmental determinants of autoimmune disease.

Objective: To ascertain the views of physicians and physician leaders toward the legalization of physician-assisted suicide., Design: Confidential mail questionnaire., Participants: A nationwide random sample of physicians of all ages and specialties, and all members of the American Medical Association (AMA) House of Delegates as of April 1996., Measurements: Demographic and practice characteristics and attitude toward legalization of physician-assisted suicide., Main Results: Usable questionnaires were returned by 658 of 930 eligible physicians in the nationwide random sample (71%) and 315 of 390 eligible physicians in the House of Delegates (81%). In the nationwide random sample, 44.5% favored legalization (16.4% definitely and 28.1% probably), 33.9% opposed legalization (20.4% definitely and 13.5% probably), and 22% were unsure. Opposition to legalization was strongly associated with self-defined politically conservative beliefs, religious affiliation, and the importance of religion to the respondent (P <.001). Among members of the AMA House of Delegates, 23.5% favored legalization (7.3% definitely and 16.2% probably), 61.6% opposed legalization (43.5% definitely and 18.1% probably), and 15% were unsure; their views differed significantly from those of the nationwide random sample (P <.001). Given the choice, a majority of both groups would prefer no law at all, with physician-assisted suicide being neither legal nor illegal., Conclusions: Members of the AMA House of Delegates strongly oppose physician-assisted suicide, but rank-and-file physicians show no consensus either for or against its legalization. Although the debate is sometimes adversarial, most physicians in the United States are uncertain or endorse moderate views on assisted suicide.

In January 1997, the Michigan State Medical Society began a series of interdisciplinary forums to discuss guidelines and safeguards for physician-assisted suicide as part of its ongoing analysis of that vexing issue. The forums derive from the minority statement in the MSMS official position, from physicians who would approve of assisting suicide in a limited number of cases, but only upon the patient's voluntary request and as a last resort. Is it possible to develop guidelines which would succeed in limiting the practice of physician-assisted suicide to that small group of patients? Or, as opponents charge, would guidelines predictably fail to contain the practice and lead to the feared slippery slope?

In 1994, as the Michigan legislature considered whether to continue a law banning physician-assisted suicide, we conducted a series of surveys on this topic. One of these surveys, conducted in Detroit, was designed to measure the attitudes of a largely black population toward physician-assisted suicide. Questionnaires were mailed to 500 residents of Detroit. The questionnaire described a plan for legalizing physician-assisted suicide, called Plan A, that incorporated eligibility standards and safeguards to minimize abuse. Attitudes on three issues were investigated: 1) Should physician-assisted suicide be banned or legalized? 2) Should voluntary euthanasia also be permitted? 3) Might respondents request legalized physician-assisted suicide for themselves? Majorities of both whites and blacks supported Plan A; however, support was much lower among blacks than whites. Blacks were also less likely to support voluntary euthanasia or to envision asking for physician-assisted suicide themselves. Our analysis indicates that when age and sex are held constant, strength of religious commitment may account for much of the black-white difference in attitudes. We also consider alternative explanations based on cultural attitudes and degree of trust in the medical system.

Objective: To investigate the relationship between exposure to silicone (including breast implants) and silica and the development of scleroderma (systemic sclerosis, SSc) among women., Methods: A population based case-control study was conducted among women in Michigan. 274 confirmed cases of SSc diagnosed between 1985 and 1991 were identified by contacting rheumatologists, hospitals, and a scleroderma support group. These cases and 1184 controls were interviewed by telephone to ascertain past exposures to silicone or silica., Results: Silicone in the form of breast implants was not associated with significantly increased risk of SSc (adjusted odds ratio, 1.30; 95% confidence interval, 0.27 to 6.23). Among 20 other potential silicone exposure surveyed, self-reported exposure to silicone based glues, sealants, and caulks, manufacture or repair of windows or windshields, repairing or frequently using photocopy machines, consumption of simethicone-containing antacids, and implanted medication delivery pumps were significantly associated with SSc. However, blinded assessment of all job and hobby descriptions in terms of their potential for silicone exposure failed to support the first 3 associations, antacid consumption may have been confounded by esophageal dysmotility before the diagnosis of SSc, and other silicone containing device categories (pacemakers, central nervous system shunts, other shunts and catheters) were not significantly associated with SSc. Surgically implanted metallic fixation devices were associated with significantly reduced risk for SSc. No association was detected between SSc and silica dust exposure., Conclusion: Consistent with other studies, we found no increased risk of SSc among women with silicone breast implants, equivocal evidence of risk from other silicone exposures, and no evidence of risk from silica exposure.

Background: There has been a continuing public debate about assisted suicide and the proper role, if any, of physicians in this practice. Legislative bans and various forms of legalization have been proposed., Methods: We mailed questionnaires to three stratified random samples of Michigan physicians in specialties likely to involve the care of terminally ill patients: 500 in the spring of 1994, 500 in the summer of 1994, and 600 in the spring of 1995. Similar questionnaires were mailed to stratified random samples of Michigan adults: 449 in the spring of 1994 and 899 in the summer of 1994. Several different questionnaire forms were used, all of which included questions about whether physician-assisted suicide should be banned in Michigan or legalized under certain conditions., Results: Usable questionnaires were returned by 1119 of 1518 physicians eligible for the study (74 percent), and 998 of 1307 eligible adults in the sample of the general public (76 percent). Asked to choose between legalization of physician-assisted suicide and an explicit ban, 56 percent of physicians and 66 percent of the public support legalization, 37 percent of physicians and 26 percent of the public preferred a ban, and 8 percent of each group were uncertain. When the physicians were given a wider range of choices, 40 percent preferred legalization, 37 percent preferred "no law" (i.e., no government regulation), 17 percent favored prohibition, and 5 percent were uncertain. If physician-assisted suicide were legal, 35 percent of physicians said they might participate if requested--22 percent would participate in either assisted suicide or voluntary euthanasia, and 13 percent would participate only in assisted suicide. Support for physician-assisted suicide was lowest among the strongly religious., Conclusions: Most Michigan physicians prefer either the legalization of physician-assisted suicide or no law at all; fewer than one fifth prefer a complete ban on the practice. Given a choice between legalization and a ban, two thirds of the Michigan public prefer legalization and one quarter prefer a ban.

Investigators continue to debate whether the Dexamethasone Suppression Test (DST) reflects clinical severity or degree of melancholia ("endogeneity"). To evaluate this question, we studied 73 drug-free inpatients diagnosed with Schedule for Affective Disorders and Schizophrenia/Research Diagnostic Criteria (SADS/RDC) as having major depressive disorder (MDD). We compared absolute and dichotomous DST values (DST suppression versus nonsuppression) with absolute and dichotomous measures of endogeneity (as measured by operationally defined RDC items) and with Hamilton Rating Scale for Depression (HRSD) scores that were collected immediately prior to treatment. We found that degree of endogeneity correlated moderately (r = 0.27) but significantly (p = 0.02) with absolute DST values; DST nonsuppression increased proportionately with changes in categorical endogenous subtype (0% of the nonendogenous patients were nonsuppressives, 52% of probable endogenous, and 61% of subjects definitely endogenous); mean values for maximum DST concentrations increased steadily with categorical endogeneity (nonendogenous, 1.44 microgram/dl; probable endogenous, 7.65 micrograms/dl; definite, 10.93 micrograms/dl; p = 0.01); HRSD scores correlated more strongly (r = 0.45, p = 0.000) with maximum DST levels than did the degree of endogeneity. Age and weight changes did not account for the relationship of endogeneity to DST values. These data suggest that maximum postdexamethasone plasma cortisol levels reflect overall severity of depression and endogeneity and that endogeneity per se is highly confounded with severity.

This retrospective cohort study was designed to investigate the relationship of male occupational exposure to elemental mercury and several reproductive outcomes. All subjects worked at least 4 months between 1953 and 1966 at a plant that used elemental mercury; 247 white male employees who had the highest exposures were compared to 255 matched nonexposed employees. Individual exposure to mercury was estimated from urinary mercury measurement records. Information on reproductive history and potential confounding variables was obtained through personal interview with each of the employees and with a subset of their wives. No associations were demonstrated between mercury exposure and decreased fertility or increased rates of major malformations or serious childhood illnesses. After controlling for previous miscarriage history, mercury exposure was not a significant risk factor for miscarriage. Because of this study's potential problems with long-term recall, further studies of the effect of mercury on pregnancy outcome are warranted in other populations.