NIHR BioResource: Consent records

The NIHR Bioresource consists of several groups of participants: ~70k from the general population and blood donors (COMPARE, INTERVAL and STRIDES studies); ~19k with one of ~50 rare diseases (RD) including a ~5k pilot for GEL; ~30k with Inflammatory Bowel Disease (IBD) which include the members of Gut Reaction, the Health Data Research Hub for IBD; and ~20k with Anxiety or depression (GLAD study). It intends to extend recruitment in all areas, and to other rare and common disease groups, with a target of ~300k by 2022. The NIHR BioResource records consent details – form, version and date - from participants at many points of recontact. In addition, participants are empowered to contact the study direct to express their preferences. The primary use of consent records is as an exclusion when participants are invited to take part in experimental medicine studies. However consent is also factored in to the release of samples and data for sample-only and data-only studies. One implication, is that data releases have freezes that capture a snapshot of the current consent statuses. How the withdrawal process is managed, and implications for whether data can be removed rapidly from already published datasets is described in our Participant Privacy Notice, online at https://bioresource.nihr.ac.uk/privacy/