IATA — Safe Transport of Biological Specimens

Why IATA Matters for CRCs

The International Air Transport Association (IATA) establishes the standards for the safe transport of dangerous goods by air, including infectious substances and biological specimens. In clinical research, CRCs frequently ship blood, tissue, urine, and other biological samples from investigative sites to central laboratories — often across international borders.

Legal Requirements

Shipping biological substances by air is regulated by international law. Non-compliance can result in:

• Fines up to $500,000 per violation (in the US)
• Criminal prosecution
• Shipment rejection by carriers
• Danger to transport workers and the public
• Compromise of sample integrity

Classification of Biological Materials

• Category A (UN2814/UN2900): Infectious substances capable of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans or animals. Examples: Ebola virus cultures, active TB cultures. Rarely encountered in clinical research.
• Category B (UN3373): Biological substances that do not meet Category A criteria. This is the most common classification in clinical trials. Examples: routine blood samples, urine specimens, tissue biopsies from non-infectious conditions.
• Exempt Human Specimens: Specimens where the probability of containing pathogens is minimal. Examples: blood for cholesterol testing, glucose monitoring samples, drug screening specimens.
• Dry Ice (UN1845): Classified as a miscellaneous dangerous good (Class 9). Used to maintain specimen temperature during transport. Maximum 2.5 kg per package for passenger aircraft, 200 kg for cargo aircraft.