Storage of anatomical specimens Public display of relevant material from deceased persons. a relevant material is to be stored for a number of purposes” a scheduled “scheduled purposes are defined as the activities relating to the removal, storage and use of human organs and other tissue that require consent. A list of scheduled purposes is provided in Table 3 overleaf (taken from HTA Code of Practice 1 Consent). – Table 3 Consent requirements under the Human Tissue Act for scheduled – purposes Roles and responsibilities under a Human Tissue Act licence The HTA prescribe that three key roles are required under The Act. These are: Licence Holder (LH) Designated Individual (DI) Persons Designate (PD) These roles and the associated responsibilities as summarised in Figure 6 and explained in full in the Human Tissue Act Standard Operating Procedure 2 (HTA-SOP-2). Although the PD role imposes no legal responsibility, it is a licence requirement that the Designated Individual has documented evidence of the PD’s acceptance of the PD role. The individuals assigned roles on the Newcastle University research HTA licence are set out in section 6.3. Figure 6 - Roles and responsibilities required under a HTA research licence Licensing exemptions A number of exemptions exist in which a HTA licence is not required to store a relevant material. Exemptions include: If the material is to be rendered acellular (i.e. cells removed, or disrupted) or transported to another establishment within 7 days If the material is to be stored for diagnostic or other purposes
Storage of anatomical specimens Public display of relevant material from deceased persons. a relevant material is to be stored for a number of “scheduled purposes” a scheduled purposes are defined as the activities relating to the removal, storage and use of human organs and other tissue that require consent. A list of scheduled purposes is provided in Table 3 overleaf (taken from HTA Code of Practice 1 – Consent). Table 3 – Consent requirements under the Human Tissue Act for scheduled purposes Roles and responsibilities under a Human Tissue Act licence The HTA prescribe that three key roles are required under The Act. These are: Licence Holder (LH) Designated Individual (DI) Persons Designate (PD) These roles and the associated responsibilities as summarised in Figure 6 and explained in full in the Human Tissue Act Standard Operating Procedure 2 (HTA-SOP-2). Although the PD role imposes no legal responsibility, it is a licence requirement that the Designated Individual has documented evidence of the PD’s acceptance of the PD role. The individuals assigned roles on the Newcastle University research HTA licence are set out in section 6.3. Figure 6 - Roles and responsibilities required under a HTA research licence Licensing exemptions A number of exemptions exist in which a HTA licence is not required to store a relevant material. Exemptions include: If the material is to be rendered acellular (i.e. cells removed, or disrupted) or transported to another establishment within 7 days If the material is to be stored for diagnostic or other purposes
Quality-Manual_Human-Tissue-Act_Research-HTA-QUAL-E03-Final.docx