1.4.2 Adherence to legal and regulatory considerations
A. Background & Definitions
EQIPD cannot and does not intend to advise research units regarding the relevant legislation and policies.
However, EQIPD does not want to collaborate or be associated with the organizations and individuals that do not comply with applicable national and international legislation and policies.
This Toolbox item refers to one of the Core Requirements (Core Requirement 4 - "All activities must comply with relevant legislation and policies").
B. Guidance & Expectations
Process Owner is advised to discuss with the research unit members what legal regulations and policies apply (e.g. related to animal care and use, handling of genetically modified organisms (GMOs), GHS labeling, unborn life, controlled substances, radioactivity, etc.).
Process Owner may want to create an overview (e.g. checklist) to facilitate regular updating and to avoid gaps in maintaining relevant documentation, providing required training and communication, etc.
In many situations, research units are nested within larger organizations that provide centralized documentation and training support. However, even in such cases, Process Owner is advised to be informed about applicable legislation and policies as well as about her/his personal responsibility in securing the compliance.
PLEASE DO NOT FORGET
- To review applicable legislation and policies when conducting the self-assessment procedure (4.1.2 Self assessment).
- If the Process Owner and the research unit are using the EQIPD Dossier in the suggested format, information about applicable legislation and policies can be saved in the folders 1.4.2.1-1.4.2.8 of the Dossier.
- For research units conducting studies using laboratory animals in animal facilities without full accreditation by AAALAC (or equivalent), animal care and use program must be described in a standalone document prepared according to the EQIPD checklist (3.4.1 Animal characteristics, care and use).
C. Resources
to be added
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Next item: 1.4.2.1 Biosafety
