Human Tissue Authority

The regulator for human tissue and organs

Advice and learning

28.  Forty-one items of advice were provided against standard C1.

29.  Establishments should keep their approaches to completing consent forms under review. Variations in the approaches taken to completing consent forms were seen during inspections. This was because documented procedures did not contain comprehensive information about how consent should be recorded. The format in which donors are expected to complete consent forms should be described in procedures; for example, a donor may be required to tick or provide their initials against specific consent provisions to confirm their consent. 

30.  Consent forms and information sheets should contain comprehensive information to enable donors to make an informed decision about participating in research. Donors should be provided with information about; the types of samples to be donated; the frequency of donation and all anticipated research uses (including genetic research). Where samples are being prospectively collected for research involving DNA analysis, it should be made clear to the donor that their bodily material will be used for this purpose.

31. Researchers may purchase human tissue from tissue providers in order to conduct research. It is unusual to receive individual consent records in these instances. The HTA provided advice to establishments to formalise their supply arrangements to assure themselves that they receive human tissue for which the associated consent sufficiently covers the work they are undertaking. With this in mind, establishments may wish to review the template consent forms relied on by tissue suppliers. 

Last updated on: 3 Aug 2016