Research ethics committee auditing: the experience of a university hospital.

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.

[Workers with alcohol and drug addiction problems. Consensus Document of the Study Group on Hazardous Workers].

Background: Italian Law 81/08 (so-called "Unified Text of Laws on Health and Safety at Work"), came into force on 15 May 2008 and incorporates provisions related to medical surveillance of drug and alcohol dependency at the workplace.

Objectives: Occupational health traditionally addresses the issue of protection of worker from occupational hazards. The issue of protection of third parties from behaviour of workers resulting from drug and alcohol dependency implies an original methodological approach, involving full cooperation of employer, employees, and health and safety consultants.

[Critical aspects of the management of "hazardous" health care workers. Consensus document].

Background: A worker is considered to be hazardous to others when, in the course of performing a specific work task, his/her health problems (e.g., substance dependence, emotional disorders, physical disability, transmissible diseases) pose a risk for other workers' or the public's health and safety, or begins to interfere with ability to function in profession life.