Extensions and amendments

Once you have received a favourable ethical opinion, if your project changes and no longer reflects that which you described in your original application; or if your project needs to be extended you must submit an amendment using ERAMS.

Extensions

A favourable ethical opinion is granted up to the expected end date of the project. If the project will not be completed by this date, an extension to a favourable ethical opinion must be sought by submitting an amendment through the ERAMS. This must be done in sufficient time for approval of the amendment to have been granted before the original favourable ethical opinion expires. A favourable opinion will only exceptionally be granted for more than three years. An amendment to extend the favourable opinion will then need to be submitted to extend the project beyond three years. A new application will be required if a project is to continue beyond six years. This is to ensure that the procedures and documentation comply with current best practice. The ERAMS reference numbers of previous applications should be provided at the start of the ‘Summary of the project’ section so that reviewers have full details of the project.

Amendments

You must always submit an amendment for any changes to a project which has already obtained favourable ethical opinion and a new application if a project is to continue beyond six years.

Substantial amendments:

• changes to the design or methodology of the study, or to background information likely to have a significant impact on its scientific value;
• changes to the procedures undertaken by participants;
• changes likely to have a significant impact on the safety or physical or mental integrity of participants, or to the risk/benefit assessment for the study;
• significant changes to study documentation such as participant information sheets, consent forms, questionnaires, letters of invitation, information sheets for relatives or carers;
  appointment of a new principal investigator;
• a change to the insurance or indemnity arrangements for the study;
• temporary halt of a study to protect participants from harm, and the planned restart of a study following a temporary halt;
• a change to the definition of the end of the study;
• any other significant change to the protocol or the terms of the original application for ethical approval.

Non-substantial amendments:

• minor changes to the protocol or other study documentation, e.g. correcting errors, updating contact points, minor clarifications;
• updates of the investigator’s brochure (unless there is a change to the risk/benefit assessment for the trial);
• changes to the principal investigator's research team;
• changes in funding arrangements;
• changes in the documentation used by the research team for recording study data;
• changes in the logistical arrangements for storing or transporting data/samples;
• inclusion of new sites and investigators in studies;
• extension of the study beyond the period specified in the application form.

If you are unsure of your amendment is substantial or non-substantial please contact the Research Governance Team for advice.