Self-report and official measures: A further examination of the validity issue

The relationship between self-report and official measures of crime remains unclarified. Adequate examinations of the comparability of the two measures have been limited because of the difficulty of obtaining both official and self-report data on the same subjects. In the present study, the authors use police records and self-report data on police contacts for members of a birth cohort, and find a substantial level of agreement between the two data sources. However, by incorporating data on police contact seriousness and a variety of demographic characteristics, the authors find some evidence of under- and over-reporting by various groups of cohort members. The authors suggest reasons for both the over- and under-reporting, and offer suggestions for future research.     

Medical device warning letter draft pilot; availability--FDA. Notice

The Food and Drug Administration (FDA) is planning to initiate a pilot program involving the medical device industry that is a continuation of the "medical device industry initiatives." This draft pilot concerns the issuance of warning letters for quality system, premarket notification submission (510(k)), and labeling violations. This draft pilot is intended to optimize resource utilization, enhance communication between industry and FDA, and provide firms with incentives to promptly correct violations or deficiencies. The draft pilot includes eligibility criteria and procedures for the issuance of warning letters and will not be implemented until after the public comment period has expired.     

Medical device warning letter pilot. Food and Drug Administration, HHS. Notice

The Food and Drug Administration (FDA) is initiating a pilot program involving the medical device industry that is a continuation of the "medical device industry initiatives." This pilot concerns the issuance of warning letters for quality system, premarket notification submission (510(k)), and labeling violations. This pilot is intended to optimize resource utilization, enhance communication between industry and FDA, and provide firms with incentives to promptly correct violations or deficiencies. The pilot includes eligibility criteria and procedures for the issuance of warning letters.     

Electrophoresis reliability: I. The contaminant issue

The effects of the common contaminants--soil, oil, gasoline, salt, acid, base, bleach, and detergent--on various forensically used genetic marker systems were studied. The predicted effects of the various contaminants on the proteins and the electrophoretic separations agreed with the observed results. A contaminant that affected protein conformation also adversely affected the integrity of the electrophoretic system, thus signalling an anomaly. It also was pointed out that the ideal control study for the effects of contaminants on genetic markers in evidentiary material is often provided to forensic scientists--that is victim's blood on victim's clothing and other substrata. The data presented in this paper support the validity and reliability of electrophoretic analyses of evidentiary material with respect to the contaminant issue.     

Research malpractice and the issue of incidental findings.

Human subject research involving brain imaging is likely to reveal significant incidental findings of abnormal brain morphology. Because of this fact and because of the fiduciary relationship between researcher and subject, board-certified or board-eligible radiologists should review the scans to look for any abnormality, the scans should be conducted in accordance with standard medical practice for reviewing the clinical status of the whole brain, and the informed consent process should disclose the possibility that incidental findings may be revealed and what consequences will follow. In the event such findings are revealed, qualified physicians should explain to the subject the significance of the findings and the alternatives available.     

A burning issue. The Japanese "fire basin"

This article presents two deaths due to acute carbon monoxide poisoning that occurred when charcoal-burning hibachis were used as heating sources in enclosed camping facilities. In both deaths, the levels of blood carbon monoxide saturation were at or slightly below the expected lethal level. Coronary arteriosclerosis may have contributed to one death, while oxygen depletion may have been a contributing factor in the other. These cases illustrate the danger of using such heating sources in enclosed spaces, due to their carbon monoxide-generating capability. We suggest that suitable warnings be placed on the hibachis themselves.