Study Initiation and Management: Protocol amendments

Introduction

If amendments to the study are to be made once it has started, these may need to be reviewed by the ethics committee that originally reviewed the study. The NRES website has information on the amendments that need to be submitted for review (substantial amendments). The link is available in the 1st resource below. There is no requirement to notify the main REC of non-substantial amendments.

From the 1st September 2009, the NRES online application form can no longer be used to generate any new forms (including amendment forms). If you are still involved in an ongoing study that was originally approved on the NRES form then to submit amendments to existing studies you will need to create a minimal dataset in the Integrated Research Application System (see 2nd resource below).  Guidance for submitting amendments via IRAS for all review bodies is in the 3rd resource below.

Applicable regulatory bodies, such as the HFEA, may also wish to be notified of amendments to a project. A renewal of research licence application is required, this along with the guidance notes can be downloaded from the 4th resource below. Existing licence holders should liaise directly with the HFEA Regulation Department on renewals and evaluations. Contact details are available in the 5th resource below.

Funders may also wish to be notified of any changes that may impact the science as these may require further peer review; or if additional funds are requested.