Human Tissue Authority

The regulator for human tissue and organs

C2

C2 Information about the consent process is provided and in a variety of formats

32.  One major shortfall was found against standard C2 at an establishment. This was due to a combination of several minor shortfalls relating to deficiencies in the consent process and the information provided to donors. Information for donors, including the exclusion criteria, was not routinely being given in advance of consent being sought. Additionally, as this procedure had not been formalised or documented, an inconsistent approach amongst staff seeking consent, posed a risk that donors may not be suitably excluded from the research.  

33. A weakness in the traceability system was also identified at this establishment. Research staff could contact fellow staff members to provide repeat donations. Although a coding system had been adopted, research staff were able to break the code and approach specific members of staff to donate again.  This information was not explained to donors during the consent process and they were unaware that they may be approached again. 

Last updated on: 3 Aug 2016