Several key regulatory barriers impact histological practices:
- Ethical Approvals: Obtaining ethical approval from an Institutional Review Board (IRB) is mandatory for studies involving human or animal tissues. This process can be time-consuming and requires thorough documentation to protect the welfare of subjects.
- Data Protection: Regulations like the General Data Protection Regulation (GDPR) enforce strict guidelines on the handling of personal data, including biological samples. Laboratories must implement robust data protection measures to comply with these regulations.
- Quality Standards: Laboratories must adhere to quality standards such as ISO 15189 for medical laboratories. These standards ensure the accuracy and reliability of histological tests but require significant resources to implement and maintain.
- Sample Transport and Handling: International and domestic regulations govern the transport and handling of biological samples. Compliance with these regulations, such as those outlined by the International Air Transport Association (IATA), is critical to prevent sample degradation and contamination.
