Human Tissue Act (HTA) 2006
↓ Assess Your Current Situation ↓
You currently have Human Tissue as defined in UK law in your lab
or you know of old samples in your lab/fridges/freezers/slide boxes that are human tissue
…the research ethics approval period for use of those samples has ended
because Research Ethics Committee approval doesn’t last indefinitely
…the samples were collected after 1st September 2006
because there are some exceptions to tissue collected before September 2006
…to remain compliant with UK law, these are your choices;
Arrange for sensitive disposal of the Human Tissue that is no longer required for research,
Declare your samples (using this weblink) to the HTA team at Cambridge University Hospitals NHS Foundation Trust so that both the samples and the location can be added to the CUH Licence (under a named, responsible individual from your group). This will ensure that they are legally covered for storage in your lab/freezer under the HTA Licence number HTA12315 (or for material from the deceased HTA12318). This process allows you to store samples for a potential future ethically-approved project,
Arrange for the samples to be transferred to another institution that has an HTA licence, by use of a Material Transfer Agreement (link) , if that is within the original terms of patient consent.
Q. How should tissue be stored?
A. There are legal requirements concerning samples, storage equipment, and the way that consent and records are kept. Your samples will become part of the hospital collection that is reported to the HTA and is subject to regular audit. This link tells you how human tissue needs to be stored to comply with the HTA
One easy way to pre-empt this issue is to add ‘HTA issues’ as a standing agenda item to your lab meetings. Samples held within the Department of Medicine are not ‘automatically’ covered by the CUHNFT licence.
Q. Is there any quick, hassle-free online training in human tissue storage?
A. You and any member of your team handling human tissue should do this free online course explaining the Human Tissue Act from the MRC (relevant course is called Research and human tissue legislation – Updated) which doesn’t take long to do.
HTA FAQ (link)
Imported Human Tissue:
Disposal of Human Tissue SOP:
|Did you know that certain regulations may also apply to imported Human Tissue? It is always best to arrange for a Material Transfer Agreement to make sure that all the necessary steps have been taken.||A standard operating procedure (SOP) for the disposal of human tissue is now available if you would like to include it in your lab or share with your team.|