Code E: Annex B - Licensing and consent flowchart

Consent

Consent is required unless:

•    it is obtained before 1 September 2006, (it is an 'existing holding')
or
•    it is from the living and is non-identifiable to the researcher and is for a specific project approved by a 'recognised' research ethics committee or is received from a HTA-licensed research tissue bank [RTB) with generic ethical approval from a 'recognised' research ethics committee

Licence

A licence is required unless:

•    it is for a specific project approved by a 'recognised' research ethics committee (or pending approval)
or
•    it is received from a HTA-licensed research tissue bank [RTB) with generic ethical approval from a 'recognised' research ethics committee
or
•    storage is 'incidental to transportation' 

or
•    there is no intention to use or store human cellular material for research, and the only holding of cellular material is temporary and forth e purpose of obtaining material which does not contain cells
 

Consent

Consent is required unless the material was obtained before 1 September 2006 (it is an 'existing holding')

Licence

A licence is required unless: 
•    it is more than 100 years old or
•    it is for a specific project approved by a 'recognised' research ethics committee (or pending approval)
or
•    it is received from a HTA-licensed research tissue bank (RTB) with generic ethical approval from a 'recognised' research ethics committee

or
•    there is no intention to use or store human cellular material for research, and the only holding of cellular material is temporary and for the purpose of obtaining material which does not contain cells
 

Please note:
•    Some RTBs require external researchers to obtain project-specific approval from a recognised research ethics committee.
•    RTBs need to be covered by a HTA licence because at least some of the tissue being stored is not for specific projects holding approvals from recognised research ethics committees.