GDPR Amendments

Principal Investigators (PIs) who have decided, on foot of legal / data protection advice, to submit an amendment to bring participant documentation for a currently approved study in line with GDPR 2016, and the Health Research Regulations 2018 are requested to submit using the following template letters, which also outline the process for submission.

GDPR amendment letter 1 - prospective participants

GDPR amendment letter 2 - previous participants

Receipt of research ethics committee approval is not, and should be not regarded as evidence of compliance with GDPR 2016 or the Health Research Regulations 2018.