CMPath is working with key stakeholders; patient groups, funders, researchers, ethics committees, government bodies, to assess the feasibility of producing a nationally agreed, Health Research Authority (HRA) endorsed consent form for tissue donation.
In the UK, researchers must obtain written consent before securing tissue and data for biomedical research. However, there is little consensus between research ethics committees (RECs) on what makes a good consent form. Consent forms often vary in quality; they can be long and complicated, failing to communicate effectively to potential donors.
High-quality translational research often relies on tissue samples and is made possible because people are, in general, willing to donate tissue samples. Research by UseMyData and Independent Cancer Patients’ Voice show that concise consent forms which use simple language are preferred. If forms are too long and overcomplicated, donors do not read them properly. For researchers preparing consent forms and supporting materials such as Patient Information Sheets (PIS) for ethical approval can be time-consuming, and often various iterations are required to satisfy RECs, presenting a barrier to research.
CMPath aims to develop a generic consent form, which once agreed by all stakeholders, will be taken to the HRA to seek regulatory approval, to be implemented in the UK within the next 3-5 years.