Postapproval Monitoring Practices at Biomedical Research Facilities.

Federal regulations and policies require institutions to establish procedures for ongoing IACUC oversight of approved animal care and use program activities including animal procedures. To fulfill these requirements, research institutions implement postapproval monitoring (PAM) programs designed to assure compliance in animal activities. Although several references commenting on the requirement to conduct PAM are available, few publications discuss actual best practices for accomplishing PAM. Here we use information collected through a survey of large academic research institutions to identify common practices for conducting PAM reviews. Many similarities and differences exist between institutions, which may or may not influence the overall quality of an institution's PAM program.

Hatching Fish-When Should Animal Tracking Begin?

The National Institutes of Health: Final Report to Office of Laboratory Animal Welfare (OLAW) on Euthanasia of Zebrafish (2009) established for the first time a policy for the developmental stage at which zebrafish would qualify for animal oversight by OLAW interpretation of Public Health Service policy. This policy established the time point based on a comparison with chicken/avian hatching. For zebrafish, this is 3 days postfertilization (dpf). This is in contrast to the traditional time established within the community as 7 dpf. There are significant implications for this policy not the least of which is the demand to account for all embryo and larvae at all stages. This narrative provides a situational context based on a synthesis of real experience with this policy. The hope is that it provides a starting point for a community conversation on the hatching time point as the appropriate established policy for the future.

An ethics for the living world: operation methods of Animal Ethics Committees in Italy.

INTRODUCTION AND OBJECTIVES: Coinciding with the recent implementation in Italy of the "Directive 2010/63/EU, regarding the protection of animals used for scientific purposes", the Authors would like to analyse the topic of the introduction of ethical committees for animal experimentation in Italy. This paper furthermore aims to underline some critical aspects concerning the actions taken by Italian institutions to comply with the provisions of EU. RESULTS AND DISCUSSION: The implementation of the recent Italian law (Decreto Legislativo n. 26 on 4 March 2014 Implementation of the Directive 2010/63/EU on the protection of animals used for scientific purposes) leans towards a restrictive interpretation of the European provisions about composition and responsibilities of "Ethical Committee for Animal Experimentation". In the composition of the bodies mentioned, we note a tendency to restrict the composition to few professional figures contemplated by Italian law, without guaranteeing the independence of each committee; also, an absence of hierarchical relationship between a research institution and his committee is apparent. Moreover, a critical aspect is the lack of decision-making powers of these new organisms in terms of ethical evaluation of protocols and research projects. CONCLUSIONS: What EU legislation imposes on the member states is to set up an animal-welfare body (art. 26). This represents a strong incentive for Italy to follow the steps of many other European Countries, where ad hoc ethical committees have been working for a long time. The proper functioning of these bodies may contribute to guarantee the safety and welfare of the animals inside the laboratories, and to balance the protection of animal life and the interests of research.