Ethical and regulatory considerations

Approvals

Ethical approval for AgeX was given in 2010 and again in 2016 by Ealing & West London (now Harrow) Research Ethics Committee (ref 10/H0710/9). Section 251 support for use of patient-identifiable data without consent and for access to medical records by those outside the healthcare team was approved by the National Information Governance Board Ethics & Confidentiality Committee and is reviewed annually by the Health Research Authority Confidentiality Advisory Group, CAG (ref ECC 1-04 (b)/2010, IRAS ID 29856).

The chief investigator will submit and, where necessary, obtain approval from the Sponsor, the research ethics committee, CAG and NHS England for all substantial amendments to the trial protocol.

Reporting

The chief investigator will submit once a year, or on request, a progress report to the Sponsor, CAG, NHS England, and funder (where required). In addition, an End of Study notification and final report will be submitted to the same parties and the REC and Health Research Authority.

Protocol deviations

A study related deviation is a departure from the ethically approved study protocol or other study document or process or any applicable regulatory requirements. Any deviations from the protocol will be documented in a protocol deviation form and filed in the study master file.

Serious breaches

A “serious breach” is a breach of the protocol that is likely to affect to a significant degree the safety or physical or mental integrity of the trial participants, or the scientific value of the research. If a serious breach is suspected the Sponsor must be contacted within one working day. In collaboration with the chief investigator, the serious breach will be reviewed by the Sponsor and, if appropriate, the Sponsor will report it to the approving research ethics committee and NHS England within seven calendar days.