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. 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.

[Workers with alcohol and drug addiction problems. Consensus Document of the Study Group on Hazardous Workers]. / Lavoratori con problemi di alcol e dipendenze. Documento di Consenso del gruppo La.R.A. (Lavoratori Rischiosi per gli Altri).

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. METHODS: A consensus development meeting was organized under the leadership of the Italian Study Group on Hazardous Workers (La.R.A. group). The meeting brought together physicians of different specialties, legal experts and bioethicists, labour and management policy-makers, to discuss the issue and define the research data available, the standards that were appropriate, and which policies were fair. RESULTS: The efficacy of medical surveillance, including workplace drug-testing, relies on a comprehensive policy, including written and verbal information on the use of alcohol and drugs on the job, training for supervisors and management, employee education, and employee assistance structures. Sample collection and testing should be carried out in accordance with standardized and tested procedures. Small businesses will need assistance, including development of model policies, setting up consortia for testing services and if necessary request for National Insurance benefits to reduce costs. CONCLUSIONS: The recently introduced Italian legislation on occupational safety and health closely resembles Finnish law since it consists of a "double channel" for workplace drug testing. At recruitment, the employer is entitled to ask a job applicant for a certificate of "Job fitness", including drug tests, that can be issued only by a public health institution, where the job applicant works on a well-defined set of tasks which require accuracy, trustworthiness, independent judgement or a very good reaction capacity. The employer may also refer the employee to the public health institution to obtain a certificate in the course of an employment contract when there is a legitimate suspicion that the employee is working while under the effects of drugs or alcohol or that the employee is a drug addict. After recruitment, the physician responsible for medical surveillance of workers (the so-called "Competent Physician") is entitled to perform drug tests on employees. The need for a test is decided by the health care professional, not by the employer, and only a general report on the health of the employee ("fit", fit with restrictions" or "unfit") may be given to the employer. Workers positive for drug tests will be referred to a public health institution for re-testing and treatment.

[Critical aspects of the management of "hazardous" health care workers. Consensus document]. / Aspetti critici della gestione dei "lavoratori rischiosi" nei servizi sanitari. Documento di consenso.

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. The presence of certain illnesses or the fact that a health care worker is impaired because of them do not necessarily imply that he, or she, is hazardous for others. Working in health care increases the probability that an impaired worker being hazardous for others. Management of hazardous workers requires new techniques and procedures, and specific policies. OBJECTIVE AND METHODS: An interdisciplinary group of experts from medical, bioethical, legal and administrative disciplines, together with trade union and employers' representatives, is currently attempting to define a way to put prevention measures into practice in accordance with state laws and individual rights. RESULTS: A consensus document is presented, covering critical aspects such as: social responsibility of the employer, risk management, informed consent, non compliance, confidentiality, responsibility of workers, disclosure of risk to patients, non-discrimination, counselling and recovery of impaired workers, effectiveness of international guidelines. CONCLUSIONS: Occupational health professionals are obliged to adhere to ethical principles in the management of "hazardous" workers; the assessment of ethical costs and benefits for the stakeholders is the basis for appropriate decisions.