F-2010-00165 - Verifying consent for research
11 August 2010
Summary of request
The Authority was asked how it ascertains that consent for the purposes of licensed research has been obtained and about the the linking of data on the use of patient material in research with evidence that consent for that research had been specifically obtained.
HFEA response
It is a condition of every licence issued by the HFEA that the conditions of Schedule 3 to the HFE Act 1990 (as amended) are complied with, including the requirement that, before giving consent, people providing gametes used to create embryos that are used in research are given such information as is proper. Guidance on information to be provided to research donors and obtaining their consent is provided in section 22 of the HFEA Code of Practice. This includes the expectation that people giving consent will be given a full description of the research project, its aims and how any individual donation will impact on the overall project. They should also be given an opportunity to ask any questions and to place any conditions on their consent to limit or control the use of their material in the context of a research project. The HFEA's remit does not extend to the use of eggs and sperm in research (i.e. where these are not used to create embryos) since these are not licensable activities under the HFEA Act 1990 (as amended).
Although the HFEA does not hold information on individual patient consent, compliance with Schedule 3 to the HFE Act 1990 requires that consent to the use of gametes to create embryos that may be used in research is given in writing. During an HFEA inspection visit to research centres, Persons Responsible are required to provide evidence that such consent has been obtained and this is reviewed by HFEA inspectors.
Page last updated: 09 August 2012