Study Initiation and Management: Protocol amendments

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Introduction

If amendments are made to a study once it has started, these may need to be reviewed by the ethics committee and other review bodies who originally reviewed the study. The HRA and IRAS websites have information on amendments that need to be submitted for review (see resources 1 and 2 below). Studies with HRA Approval are expected to notify both substantial and non-substantial amendments (3rd resource). There is no requirement to notify NHS RECs of non-substantial amendments.

Review may also be required by other bodies such as the MHRA or NHS R&D. Full details and guidance on submitting amendments to these review bodies can be found in the 2nd resource below.

Other applicable regulatory bodies, such as the HFEA, may also wish to be notified of amendments to a study as either a licence variation or licence renewal may be required. You can find details on varying or renewing a research licence in Direction 0008 on the HFEA's Clinic Portal (4th resource below).

If your study is covered by an HTA licence then the Designated Individual (DI) for that licence may wish to be informed of any substantial amendments. The method by which this is done will depend on local processes so researchers should contact the DI directly for information.

Funders may also wish to be notified of any changes that may impact upon the science of a study as these may require further peer review and potentially additional funds.

Resources