What is considered Human Tissue under HBRA?
Note1: Cell-free samples are not considered human tissues.
Note2: HBM which has been substantially-manipulated but is individually-identifiable, is still considered to be "human tissue".
|Examples considered to be substantial manipulation||Examples not considered to be substantial manipulation|
|Culture expansion of cells* from tissues, cell lines created from tissues, formalinfixed paraffin-embedded tissue, enzymatic treatment to dissociate cell cell contact, breaking open to cells to recover subcellular components. |
*includes creation of induced pluripotent stem cells from primary cells.
|Cutting, grinding, shaping, centrifugation, sterilization, low-level irradiation, cell separation, concentration/purification, filtering, lyophilisation, freezing, cryopreservation, vitrification.|
Click here for more examples of substantial manipulation.
You may also refer to MOH's Decision Tool to determine if you fall under HBRA's Human Tissue Framework.