What does a HTA 2004 licence mean to our customers?
Human Tissue Act 2004 (HT Act) came fully into force on 1 September 2006.
The aim of the act was to provide a legal framework regulating the removal, storage, use and disposal of human tissue from the living and the removal, storage, and use of tissue from the deceased. It introduced regulation of activities like post-mortem examinations, and the storage of human material for education, training, and research. It is intended to achieve a balance between the rights and expectations of individuals and families, and broader considerations, such as the importance of research, education, training, pathology,
and public health surveillance to the population.
The Human Tissue Authority (HTA) is the governing body created to regulate activities that come under the HT Act.
At Cryoniss, we are compliant with:
- Human Tissue Authority and the HTA Codes of Practice A & E
- The Medicines for Human Use (Clinical Trials) Regulations 2004
- EMA reflection paper for laboratories carrying out clinical analysis
As such, this enables Cryoniss to store HT Act relevant human material for the purposes of research. This means that our customers do not need to hold a HTA licence themselves, which reduces their need for significant regulatory and quality management oversight, including annual licencing fees. We can do all of that for them. Equally, when clinical studies have been completed, samples collected can continue to be stored under our licence, ensuring they can still be of benefit to future research.
Alongside our legal obligations to comply with these regulations, as scientists we also have a moral and ethical duty to these patients who have donated these samples for research, via a process which at times can be invasive. At Cryoniss, understanding that patients come first is a core value of our business, and why all our processes and procedures have been developed to ensure samples are maintained to the highest standard throughout the cold chain.
During our onboarding process, we work closely with our customers to ensure that all legal, ethical and moral requirements are adhered to during the lifetime of the samples we store, including complete chain-of-custody tracking and management of consent. For tailored approaches, we implement a quality agreement, so all parties are clear on their responsibilities, ensuring ongoing compliance with both the regulatory authorities, and also with that of the patient.