Question
To ask Her Majesty’s Government, further to the Written Answers by Lord Triesman on 12 November 2007 (WA1–2) and by Lord Prior of Brampton on 24 March 2016 (HL7011), which of the successive lay summaries for research licence R0152 asserted a "need to derive stem-cell lines which are genetically similar to the recipient so they will not be rejected"; when the single embryonic stem cell (ESC) line produced in compliance with current standards and each of the other ESC lines were banked at the UK Stem Cell Bank; whether any of the aforementioned ESC lines were derived following any form of nuclear transfer or pronuclear transfer; if not, why the Human Fertilisation and Embryology Authority (HFEA) continued to permit the use of nuclear transfer under this licence when the originally stated objective remains unmet almost 12 years after the relevant licence was initially granted; what specific measures have been taken to strengthen the scrutiny of research applications at both the review of progress and renewal stages as recommended under "Key actions for HFEA" in the summary of the "Post Hwang Meeting" on 1 March 2006 that was published on the HFEA website; and how post-licensing scrutiny had been similarly strengthened as also recommended in the same document.
Answer
The Human Fertilisation and Embryology Authority (HFEA) has advised that the "need to derive stem-cell lines which are genetically similar to the recipient so they will not be rejected" was last referred to in the lay summary submitted in an application for the renewal of a research licence in 2008. As stated in the response to the Noble Lord on 24 March (HL7011), one stem cell line from the research project R0152 is in preparation for depositing with the UK Stem Cell bank.
HFEA licences do not specify time limits in which research objectives must be met and objectives can be up-dated or amended subject to approval by the Licence Committee. Progress of the research is taken into consideration at the renewal of a licence. Upon renewal, the centreâs progress report is sent to the peer reviewer who considers key questions around the necessity of the research.
The HFEAâs scrutiny of research has evolved considerably over the last 10 years. Its current system involves scrutiny of the application by a team of inspectors; scrutiny by an external, independent peer reviewer; and scrutiny by the HFEAâs Licence Committee.
In order to further support researchers, the HFEAâs Code of Practice includes a Guidance Note (22) specific to research and training and each centre has a nominated inspector through which post licencing scrutiny takes place. The McCracken report in 2013 did not highlight any concerns with the systems put in place by the HFEA to approve research.