色狗导航

Once you have signed the Ethics Review Form, it will be locked. A notification message will appear at the top of the screen to confirm this status.

• While the form is locked, no further changes can be made.
• However, you can still request the required signatures using the blue ‘Request Signature’ buttons.

Making Changes After Signing

If you need to make changes to the form select the ‘Unlock’ option at the top of the form.  If this option is not visible, select ‘More’ to view all available actions.

Unlocking the form will cancel any existing signatures or signature requests

You will then be able to update the form. Once your changes are complete, you must:

• Re-sign the form, and
• Re-send all signature requests

You cannot unlock a form once it has been submitted, unless it is returned to you for revisions.

If you need to make changes to a study that has already received a favourable decision, please refer to the Amendments Guidance.

Proposals for ethics review will be considered by the Ethics Review Sub-Committee. The level of review is dependent on the type of submission.

Studies must not be undertaken without confirmation of a favourable ethics review having been received by email. 

Further information is available below.

The Ethics Review Sub-Committee produces a series of Guidance Notes for Investigators, which are intended to help investigators plan for various aspects of their research.

The Guidance Notes are not intended to include an exhaustive list of factors that should be taken into account, but it is hoped they will encourage investigators to adopt best practice, and familiarise themselves with the appropriate legislation/regulatory frameworks.

Templates for supporting documents are available through LEON.  These include:

• Information Sheets
• Consent Forms
• Assent Forms

They are located in the under the Help tab at the top-right of the LEON Homepage.

You can give access to other investigators on your study by selecting ‘Share’ from the actions across the top.  You should add your collaborator’s email and then tick the appropriate boxes to indicate the level of access you want to give them. Then select ‘Share’.  Students must share their form with their project supervisor.  

NOTE:  You will not be able to share an application unless the investigator has activated their LEON account.  If the system says the account is not active you should ask the investigator to access the system, this will activate their account.

• You will not be able to share an application with external investigators as they will not have access to the system.
• Students can also share the form specifically with their academic supervisor by selecting ‘Roles’ on the left-hand side. This will give supervisors permission to make changes. 
• You can see who has been given access to the form by selecting the ‘Collaborators’ tab.  You can ‘edit’ their permissions or remove their access. To remove their access, ensure all the options are unticked and then save. 
• Those with permission to view the form can leave comments by selecting the speech bubbles.  Comments can be viewed by clicking the speech bubble or selecting 'comments' in the overview section.

Once the form is completed it should be signed to complete the submission process.  Student applicants should check with their supervisor that the form is completed appropriately before requesting signatures.

Applicant Signature

Once the form is completed the applicant should ‘sign’ the submission.  This will lock the form.

• Click on the ‘sign’ link to sign the form.

Request Signatures

Once the form has been signed the applicant should request the other signatures required.  These will be listed below the applicant’s signature.  Click on ‘request signature’ and enter the appropriate details.

The responsible investigator signature, if required, must be requested from the responsible investigator listed in the application.  For student projects this will be the project supervisor.

School signatory contact details are provided within the form as appropriate.

Declined Signatures

If your signature request is declined, you will be sent feedback explaining this decision.  

If you have been asked to make changes to your proposal before resubmitting signature requests, you will need to select 'unlock'.  This will allow you to amend the proposal.

Once you have updated the proposal you will need to SIGN it again and re-send ALL of the signature requests.

Submission

Once all of the signatures are granted the form will be submitted.  Applicants will receive an email confirming submission.

We recommend running a completeness check to ensure that the submission process has commenced.

You can check the status of the project in the 'overview' on the right-hand side.  This should say 'submission in progress' or 'submitted by applicant' if the form has submitted.  Once ethical clearance is issued the status will say 'favourable'.

If you receive an email notifying you that your signature has been requested please refer to the guidance below.  Further information is provided regarding the signature process.

Amendments are changes to studies that have already received a favourable decision from the Ethics Review Sub-Committee.  The type of amendment required will depend on the nature of the changes being made and the type of submission.  The guidance below will indicate which amendment type is required.  If you require further guidance contact LEON@lboro.ac.uk. 

Amendment requests must be submitted before changes are implemented, they cannot be approved retrospectively.