We encountered evidence of myocardial infarction due to coronary thrombosis in an autopsy of an occasional marijuana smoker. These findings prompted us to perform a narrative review of the literature to determine when post-mortem toxicological tests may support a temporal relationship between marijuana smoking and cardiovascular disease. Toxicological examination showed the presence of Δ-9-tetrahydrocannabinol, its main metabolite and cannabinol in blood and urine. Quali-quantitative analysis revealed that Δ-9-tetrahydrocannabinol was taken within 2 h of the onset of cardiovascular symptoms, according to circumstantial data. Post-mortem toxicological results must take into account the degradation and post-mortem redistribution of analytes. However, for any inference about the specific cardiovascular triggering effect of Δ-9-tetrahydrocannabinol intake, we maintain that cannabinoid analysis in blood samples must be considered an essential requirement to estimate the time of last intake and avoid incomplete documentation. The literature, combined with the present case report, highlights an association between marijuana use and negative cardiovascular events, although few authors have supported their conclusions with toxicological results. Thus, additional research is needed.
The authors report the first Italian experience of a research ethics committee (REC) audit focused on the evaluation of the REC's compliance with standard operating procedures, requirements in insurance coverage, informed consent, protection of privacy and confidentiality, predictable risks/harms, selection of subjects, withdrawal criteria and other issues, such as advertisement details and justification of placebo. The internal audit was conducted over a two-year period (March 2009-February 2011) divided into quarters to better value the influence of the new insurance coverage regulation that came into effect in March 2010 (Ministerial Decree of 14 July, 2009) and expand the requirements to safeguard participants in clinical drug trials including other critical items as information and consent and the risks to benefits ratio. Out of a total of 639 REC's opinions and research studies, 316 were reviewed. Regarding the insurance policy requirements, Auditor/REC non-compliance occurred only in one case. The highest number of Auditor/REC non-compliance was in regard to information and consent, which should have incurred a suspended decision rather than a favorable opinion. This internal audit shows the importance and the difficulty of the review process. For this reason, specific courses for members of the research ethics committee and for those who aspire to become auditors will be provided. There may also be efforts to improve the standard operating procedures already in place.
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