CM-Path Generic Consent Strategy Group
Following the Alder Hey retained organs scandal, written consent must be obtained from donors before securing tissue and data for biomedical research in the UK. However, there is often little consensus between research ethics committees (RECs) on what makes a good consent form, even though basic requirements for consent vary little between projects. Consequently, consent forms are often of variable quality, too long and complex, resulting in failure to communicate effectively to all potential donors.
Research involving human tissue is made possible because people are, in general, willing to donate tissue samples, with only a very small percentage of individuals refusing to do so. Indeed, high quality translational research frequently relies on this. Work done by groups such as UseMyData and Independent Cancer Patients Voice have demonstrated that individuals are generally content to donate tissues, but concise consent forms which use simple language are preferred; when too long and/or overcomplicated, in general donors do not read them properly. Furthermore, preparing consent forms and supporting materials such as Patient Information Sheets (PIS) for ethical approval is time consuming for researchers and often various iterations are required to satisfy RECs, presenting a barrier to research.
How to overcome this:
CM-Path proposes to work with key stakeholders; patient groups, funders, researchers, ethics committees, government bodies, to assess the feasibility of producing a nationally agreed, HRA-endorsed consent form for tissue donation.
Development of a consent form template which is agreed by all stakeholders. This will be lobbied at the highest level to initiate change, then taken to the HRA to seek regulatory approval, to be implemented in the UK within the next 3-5 years.
‘Evidence shows overwhelmingly that patients want to be part of moving research into their disease forwards. Making that research as easy as possible for health professionals to do, benefits us all. We welcome a simplified way for patients to provide consent for their tissue and data to be used for this research, and therefore improving patient outcomes.’