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We have revised our guidance on the regulation of bone marrow and peripheral blood stem cells (PBSC) donations where the donor is an adult lacking capacity or child without competence to consent.
This form needs to be completed where the assistance of a translator has been required by the Independent Assessor (IA) for the interview. The translator should not be known to either the donor or recipient. It is acceptable for telephone translators to be used.
IAs submit reports using the HTA Portal. This is a secure system which is data protected. The system allows IAs to write their reports electronically, upload supporting documents and save them before submitting them online to the HTA.
The Human Tissue Act 2004 (HT Act) provides the legal framework for bone marrow and peripheral blood stem cell (PBSC) donation in England, Wales and Northern Ireland.
This guidance provides information to potential donors, recipients and those setting up websites that aim to bring these people together on how the system works in the UK and issues to consider.
Accredited Assessors submit their reports using the HTA’s online submission system. This is a secure system which is data protected.
Under the Human Tissue Act 2004, any potential donation of a solid organ or part organ for transplantation must be assessed by an Independent Assessor (IA) and a report submitted to the HTA for consideration.
Following the transposition of the European Union Tissues and Cells Directives into UK law via the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended), the HTA (as a risk based regulator) focused on directing its resources to ensuring that those activities that...