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 details contact LEON@lboro.ac.uk for guidance. 

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

Before submitting minor amendments, you must update the form if necessary to access the latest version of the form.  If you see the link below at the top of the form, please select ‘update’. 

CHANGES NOT REQUIRING SUBMISSION OF AMENDMENT:

• Spelling corrections
• Formatting changes
• Removal of measures or questionnaires
• Changes to wording for clarification which do not change the study design
• Minor changes to questionnaires or interview questions which are still within the scope of the original submission.
• Minor changes to the participants which are still within the scope of the original submission e.g. from Loughborough University students to students from any University.
• Minor changes to the number of participants which do not change the study design.
• Minor changes to documents e.g. from in-person to online consent form.
• Change of location within the UK which does not increase the risks.
• Confirmation of insurance
• Changes to start date
• Removal of investigators
• Removal or reduction of incentive
• Changes to risk assessments

CHECKLISTS (nothing raised in Section A or B of original submission)

Minor amendments are only required to add investigators or extend the end date.  Documents should be updated with new details, but it is not necessary to upload a copy.

If changes to questions or measures are beyond the scope of the original submission a new Ethics Review Form should be submitted.  Questions which are within the scope of the initial submission do not require submission, see above.

Changes that would alter the responses to Section A or B are considered substantial.  Investigators must submit a new Ethics Review Form.

ENHANCED OR CHECKLIST+ (issues raised in Section A or B of original submission)

Minor amendments (see below for submission details)

• Changes which would alter the responses to Section B of the initial submission
• Extensions to the end date submitted before they have expired (see above).
• Change of responsible investigator/project supervisor (add as investigator)
• Addition of investigators
• Change to study design which does not increase risk to participants.
• Reduction or minor increase to frequency or duration of exercise/physical activity undertaken
• Reduction or minor increase in number, frequency or volume of bodily samples collected
• Change of country where these do not increase the risks e.g. change to a country with the same risk profile.
• Changes to participant groups which does not increase the risk to participants.
• Inclusion or increase to incentive
• Changing type of measure e.g. changing from interviews to focus groups where this is still in line with the initial submission.

Substantial amendments (see below for submission details)

• Changes which would alter the responses to Section A of the initial submission
• Changes to study design which increase risks to participants.
• Substantial increase to frequency or duration of exercise/physical activity undertaken, including addition of maximal activity.
• Change to type of exercise/physical activity undertaken
• Substantial increase in number, frequency or volume of bodily samples collected
• Change of location or country where this increases the risks e.g. to include travel to a country classed as high risk.
• Changes to participant groups to include vulnerable participants or increase the risk to participants.
• Changes to consent processes e.g. from opt-in to opt-out

[NOTE: For Generic Protocol amendments use the Generic Protocol Amendment Form.]

SUBSTANTIAL AMENDMENTS

For Substantial Amendments please contact the administrators at LEON@lboro.ac.uk explaining the nature of the changes.  The original Ethics Review Form will be unlocked by the administrators so that it can be updated.  Once updated the revised form should be submitted by requesting the relevant signatures.  School signatures will be required for substantial changes.  Substantial amendments are considered as new proposals and will follow the appropriate review process.

MINOR AMENDMENTS

For Minor Amendments you should submit the Minor Amendment Form through LEON.  Details are given below.

1. CREATE AMENDMENT FORM:

From your Work Area in LEON you should select the title of the project that you need to change. 

• Select ‘Create Sub-form’ and select ‘Amendment (MINOR)’ from the drop-down list.

2. COMPLETE THE AMENDMENT FORM:

Add details of your amendment request to the amendment form.

• Part One of the form ‘Study Details’ will be prepopulated from the original submission – please use this to ensure that you have selected the correct study to amend.
• Part Two of the form should be completed to indicate the requested amendments.
• Select the type of amendment and complete the relevant details.
• Attach any relevant updated documents. Tick ‘changes to study documents’ to open the relevant section of the form.

3. SIGN AMENDMENT:

Once completed the form should be signed by the responsible investigator.  If the responsible investigator is completing the amendment form, then select ‘sign’.  If you are not the responsible investigator then select ‘request’ and add the responsible investigators email address.  For students the form must be signed by your project supervisor.

Studies which involve changes to the collection of Human Tissue Act Relevant material will also require approval from the relevant Schools.  You should also send a signature request to the relevant HTA contact from the list provided.

4. SUBMISSION:

Once the relevant signatures are obtained the form will automatically be submitted.  You will receive confirmation of submission by email.  A decision will be sent to you by the Sub-Committee regarding the amendment once it has been reviewed.

5. REVISIONS

If you need to make changes to an amendment form that has been returned to you, please select the form by clicking on ‘project’ on the top left.  You can then see amendments associated with the project.  You should update the form as requested and then resubmit.

6. VIEW AMENDMENTS:

To view amendments to studies, you should select the study from your Work Area and then select ‘project’ on the top left.  This will take you to the ‘Project Tree’ which lists previous amendments. 

• You can view details by clicking on the amendment in the list.