Ethical approval

Full, informed consent is a legal requirement for clinical trials or studies involving human subjects. Within this category, assent forms are documents that pertain to people who are too young or are unable to provide knowing consent. It typically requires oversight/signature from a parent or guardian. Consent mechanisms must be fully GDPR compliant, involving a clear affirmative action (an opt-in), with a clearly communicated right to withdraw consent. Consent can be gathered through paper forms or electronically.

Transfer of biological samples

International transfer of biological samples can be logistically challenging due to a variety of factors including temperature, contamination etc. It is therefore often preferable for analysis to take place in the centre at which samples are taken. In the case of the MCDS-Therapy Project, in the event that samples were required for the development of clinical endpoint biomarkers, these were taken from UK sites only to limit extensive transfer.