Registration on the online ethics system

Your LSHTM / Novell login details will not work on this website.

New users must register on the system by clicking on the green 'New User' button - this will take you to a page where you will be required to enter your contact details.  

Once registered, you will receive an activation email to activate the account.

Once you are registered on the system, you can submit future applications by logging into system. If you forget your password, you can obtain this by visiting the website and clicking on ‘Forgot password’. NB: Please note that both the username and password are case-sensitive.

Please try to use Google Chrome or Firefox browsers to access the website.

Completing the application form

The system is set up so that you will not be able to submit your application until all the questions are answered and the documents which are requested are uploaded.

Steps to start a new application:· After you login, on the home page, you will see options to 'Create Project' in the left ‘Actions’ column.

· Please click on 'Create Project', enter the title of your project, and click on ‘Create’. This project will then be listed on the home page, please click on this - this will then take you to the navigation screen for the application form.

· The navigation screen consists of a list of all the sections of the application form for you to complete. You can click on particular sections to complete them in your preferred order.

· Alternatively, you may wish to progress by clicking on the ‘Previous’ and ‘Next’ arrows in the left ‘Actions’ column. To return to the navigation screen at any time, please click on 'Navigate' in the left ‘Actions’ column. If a question does not apply to your project, please state why it does not apply for the committee's reference.

· Please click on 'Save' in the left ‘Actions’ column, at regular intervals while completing the application.

· You can view all the documents that have been uploaded for the application by clicking on ‘Documents’ in the left ‘Actions’ column.

· You are not required to complete the form in one sitting. Please remember to logout at the end of each session. The ‘Logout’ button is located in the drop-down list at the top right of the headings bar underneath your name. When you return to complete your application, please login and click on the particular project name to return to the application form.   

- The 'Create Folder' option is available to you, if you wish to store future applications in separate folders. Please click on 'Create Folder', this will be listed in the Work Area in a grey box under 'Projects'. Please click on this grey box and then 'Create Project' within the folder. This will appear as a listing, please click on this and repeat the above steps.

-You can create a copy of a completed application form if required but the documents will require to be uploaded again. In the left column, please click on the 'Duplicate project' button - this will bring up a list of projects saved on the site. Please select the one you wish to copy and click on 'Duplicate'. The copy will appear in the Work Area as "project name duplicated".

-For MSc students, further guidance on completing the CARE form application is available in the project handbook.

Sharing forms
You can share application forms with other individuals so that they may also contribute.They must also register on the website.

Please follow the below steps:

• Once logged in, please select the relevant project and the relevant form (eg, amendment form) and then click on ‘Share’ in the left ‘Actions’ column.
  
• In the pop-up window, please enter the email addresses of the relevant people. If an error message is shown, please check - Individual users must register on the site for you to be able to add their email addresses.
  
  -In the corresponding drop-down list, please select the type of access level as required. 'Notifications' refer to alerts when a signature is received and from the committee regarding the status of the application.
  
• Please click on the ‘plus sign’ to add further names
  
• Please click on ‘Share’ to confirm.
  
• Individual users must register on the site to be able to login and view the shared application forms.
  
• To  remove access granted, please click on ‘Collaborators’ in the left ‘Actions’ column. Please click on ‘Cancel’ alongside the relevant names listed.

If you require further guidance there is an instructional video available on the ethics Intranet page on how to share forms on LEO: https://intra.lshtm.ac.uk/Research/Research-Governance/Ethics/LEO-help/index

· You can also transfer particular applications in full to other applicants if you wish. Please click on ‘Transfer’ in the left ‘Actions’ column and enter the required information. The applicant you have transferred a project to, is required to login into their account and accept the transfer.

For signatories: If the form is shared with you, you do not need to be sent a signature request to sign the form. You can sign it by visiting 'Section 13 - Signatures' (you can also access this by clicking on the 'Navigate' button) and then clicking the blue 'Sign' button in the relevant section. The signature is in the form of entering your login details for the LEO website. The applicant will be notified through the system that the form has been signed.

If you require further guidance on how to sign a form that has been shared with you, an instructional video is available here: https://intra.lshtm.ac.uk/Research/Research-Governance/Ethics/LEO-help/index

Submitting an application

Before a completed application can be submitted, it will require your signature. The signature is added in the form of re-entering the LEO login details.

Please note that if your application requires signatures from another person, eg. Supervisor, the system will ask you for the email address of the signatory in order to send a request for their signature.

The system can only send emails to registered users of the system.

If you receive an error message saying that the user does not exist in the system, please follow these steps:

Please email your chosen signatory outside the system, to register as a ‘New User’ on https://leo.lshtm.ac.uk for an account. New users can register on the system by clicking on the green 'New User' button - this will take them to a page where they will be required to enter their contact details.  

Once they register, they will receive an activation email to activate their account. Once they confirm to you that this has been done, you can send the signature request. They will be able to login and submit their signature on your application.

You will receive a notification to alert you when a signature has been received. Once all signatures are received, the form will automatically submit. You will see a message appear on the screen confirming that the application has been submitted. We will send you a formal acknowledgement when it is received by us.

For signatories: If you receive a signature request, these will be listed in the 'Signatures' box when you login. Please click on 'View Form' alongside the listing of the relevant applicant. You will be able to scroll through the application using the 'Previous' and 'Next' buttons or the 'Navigate' button where all the sections of the form are listed. You can expand the response box by click and dragging from the bottom right corner.  

When you are ready to sign, please click on the 'Sign' or 'Reject' buttons in the left column. The signature is in the form of entering your login details for the LEO website.  The applicant will be notified through the system that the form has been signed. 

If you require further guidance on how to sign a form after receiving a signature request, an instructional video is available here: https://intra.lshtm.ac.uk/Research/Research-Governance/Ethics/LEO-help/index

MSc Applications

Signature requests should be sent first to the individual who is supervising the project (this person may or may not be your personal tutor). In cases were there are 2 supervisors for a particular project, please only send a signature request to one supervisor. When you receive notification that they have signed, if applicable to your project, a signature request should be sent to the Chair, Animal Welfare and Ethics Board (AWERB), Faculty Safety Supervisor or DI for Human Tissue. This will be indicated to you on the form.

Then when you receive notification that the above have signed,a signature request should be sent to the Course Director (For DL courses - Project Module Organisers). Once you have received notification that the Course Director/Project Module Organiser has signed the form, provided you have received all other required signatures the form will automatically submit.

If the form is already shared with any of the above individuals, you are not required to send a signature request through the Leo website - you just need to communicate to them that the form is ready for their signature. Instructions for signing a shared form are as above.

Steps to submit an application: After all signatures have been received, your form will automatically submit. Once the application is submitted successfully, there will be a message on the screen confirming submission. (Please contact us asap if you experience any technical problems when submitting your form.)

Next Steps after an Application Has Been Submitted

After your application has been submitted to the committee, you will receive a confirmation email from the Ethics Administrator stating when you should receive feedback.

If you do not receive a confirmation email within 5 working days please follow up by emailing ethics@lshtm.ac.uk (staff) or MScethics@lshtm.ac.uk (students). 

Non - MSc Applications

Applications received by the end of the month will be reviewed by the 15th of the subsequent month (eg if submitted on 30 July, will be reviewed on 15 August). 

The committee reviews amendments twice monthly. Amendments received by the 15th of the month, will be reviewed by the 1st of the subsequent month. Amendments received by the end of the month, will be reviewed by the 15th of the subsequent month.

For the full list of meeting dates and submission deadlines please see the Intranet page here:

MSc Applications

Ethics approval will typically take 4 to 6 weeks from the date of submission, though this can be longer if the project is particularly complex.

Please note that we will be unable to accept applications submitted after 1 July. 

Steps to download a copy of the care form:  

Request for Clarification - Submitting Responses to Queries raised by the Committee

To respond to the Committees request for clarification you will need to make modifications to your submitted application. Once you login, please click on the project that you wish to send a response about:

• Click into any of the sections listed below in blue, then in the left ‘Actions’ column, please click on the ‘Unlock’ button. If there is no 'Unlock' button, the form is already unlocked for you - please proceed to make the below changes.
  
  
• On the form, please ensure that you select the correct box on Qn 2f (or Qn 2d for amendments) to indicate that you are responding to a request for clarification provided by the LSHTM Ethics Committee
  
  
• A covering letter listing the changes and requested clarification should be uploaded under Q2fi, which will unlock in response to you changing the answer to Q2f.
• Then proceed to upload any additional/ revised documentation in the relevant sections, where appropriate underlining or otherwise highlighting the changes you have made and giving revised version numbers and dates and make any further necessary changes to the application form. Any changes made to the form will be highlighted upon re-submission, for ease of reference of the committee.  
  
  
• Then obtain the relevant signatures again. The application will automatically re-submit ocne all signatures have been obtained.
  
  
• You will see a message appear on the screen confirming that the application has been re-submitted. We will send you a formal acknowledgement when it is received by us. 

If you do not receive an acknowledgement within 5 working days please follow up by emailing ethics@lshtm.ac.uk (staff) or MScethics@lshtm.ac.uk (students).

We are unable to specify a fixed turnaround time from the committee on your response. You will receive feedback response as soon as possible. If any delays are anticipated, we will inform you.

Insufficient Information (MSc only) - Submitting revised applications to the Committee 

To submit your revised application to the Committee you will need to make modifications to your application. Once you login, please click on the project that you wish to send a response about:

• Click into any of the sections listed below in blue, then in the left ‘Actions’ column, please click on the ‘Unlock’ button. If there is no 'Unlock' button, the form is already unlocked for you - please proceed to make the below changes.
• On the form, please ensure that you select the correct box on Qn 2f (or Qn 2d for amendments) to indicate that you are responding to the LSHTM Ethics Committee
• A covering letter listing the changes should be uploaded under Q2fi, which will unlock in response to you changing the answer to Q2f.
• Then proceed to upload any additional/ revised documentation in the relevant sections, where appropriate underlining or otherwise highlighting the changes you have made and giving revised version numbers and dates and make any further necessary changes to the application form. Any changes made to the form will be highlighted upon re-submission, for ease of reference of the committee.  
• Then obtain the relevant signatures. The application will re-submit upon receipt of all signatures.
• You will see a message appear on the screen confirming that the application has been re-submitted. We will send you a formal acknowledgement when it is received by us. 

If you do not receive an acknowledgement within 5 working days please follow up by emailing MScethics@lshtm.ac.uk. 

We are unable to specify a fixed turnaround time from the committee on your response. You will receive feedback response as soon as possible. If any delays are anticipated, we will inform you.

Submitting Amendments

To submit an amendment* where the original application was submitted prior to the use of LEO:

1. Go to https://leo.lshtm.ac.uk
2. Register for an account if you have not done so already.  This is not your LSHTM log-in
3. Click on “Create project”
4. Enter 'Project Title' and under ‘Main Form’ select ‘Minimum data set’ then click ‘Create’
   5. Please complete the form and click on ‘Submit’ in the left ‘Actions’ column. You will see a message appear on the screen confirming that the form has been submitted.
   
   

NB: Once this step has been completed for a study, you will not be required to repeat this step for submitting sub-forms for the study in future. 

6.Once this has been submitted, please proceed to click on the relevant project on the home page.
7. Then in the left ‘Actions’ column, please click on ‘Create a sub-form’ – a pop-up window will appear, in the drop-down list, please select ‘Amendment Form’, please click on ‘Create’
8. Please complete the 3 sections of the form, then sign and submit it.

You will see a message appear on the screen confirming that the form has been submitted. We will send you a formal acknowledgement when it is received by us.

For LSHTM London applicants: If you do not receive an acknowledgement within 5 working days please follow up by emailing ethics@lshtm.ac.uk (staff) or MScethics@lshtm.ac.uk (students).

For MRCG applicants: If you do not receive an acknowledgement please follow up by emailing ethics@mrc.gm

If you require further guidance on how to submit sub-forms when the original application was submitted via the Word versions, an instructional video is available here: https://intra.lshtm.ac.uk/Research/Research-Governance/Ethics/LEO-help/index

To submit an amendment where the original application was submitted on the online system, please follow these steps: 

Once you login, please click on the project that you wish to send an amendment for:

• In the left ‘Actions’ column, please click on ‘Create a sub-form’ – a pop-up window will appear, in the drop-down list, please select ‘Amendment Form’, please click on ‘Create’
• Please complete the 3 sections of the form and obtain all required signatures. The form will submit automatically once all signatures are obtained.
  
  You will see a message appear on the screen confirming that the application has been submitted. We will send you a formal acknowledgement when it is received by us.

If you do not receive an acknowledgement within 5 working days please follow up by emailing ethics@lshtm.ac.uk (staff) or MScethics@lshtm.ac.uk (students).

If you require further guidance on how to submit subforms when the original application was submitted via LEO, an instructional video is available here: https://intra.lshtm.ac.uk/Research/Research-Governance/Ethics/LEO-help/index

Submitting Annual reports, SUSAR, Protocol Violation and End of Study forms

To submit any of these reports where the original application was submitted via the word E2 document - please follow the below steps. Please select the relevant sub-form type: 'Annual Report Form' , 'SUSAR Form', 'Protocol Violation Form' or 'End of Study Form'.

1. Go to https://leo.lshtm.ac.uk
2. Register for an account if you have not done so already.  This is not your Novell log-in
3. Click on “Create project”
4. Enter 'project short title and under ‘Main Form’ select ‘Minimum data set’ then click ‘Create’
5. Please complete the form and then sign and submit.
   
   NB: Once this step has been completed for a study, you will not be required to repeat this step for submitting sub-forms for the study in future. 
   

6. Once this has been submitted, please click on the relevant project on the home page.

7. Then in the left ‘Actions’ column, please click on ‘Create a sub-form’ – a pop-up window will appear, in the drop-down list, please select the relevant sub-form type: 'Annual Report Form' , 'SUSAR Form', 'Protocol Violation Form' or 'End of Study Form', please click on ‘Create’
8.Please complete the sections of the form, and obtain all required signatures. The form will submit automatically once all signatures are obtained.

You will see a message appear on the screen confirming that the form has been submitted. We will send you a formal acknowledgement when it is received by us.

If you do not receive an acknowledgement within 5 working days please follow up by emailing ethics@lshtm.ac.uk (staff) or MScethics@lshtm.ac.uk (students).

If you require further guidance on how to submit sub-forms when the original application was submitted via the Word versions, an instructional video is available here: https://intra.lshtm.ac.uk/Research/Research-Governance/Ethics/LEO-help/index

To submit these reports where the original application was submitted on the online system, please follow these steps: 
Once you login, please click on the project that you wish to send a report for:

• In the left ‘Actions’ column, please click on ‘Create a sub-form’ – a pop-up window will appear, in the drop-down list, please select the relevant sub-form type: 'Annual Report Form' , 'SUSAR Form', 'Protocol Violation Form' or 'End of Study Form'. Then please click on ‘Create’
• Please complete the listed sections in the form, and obtain all required signatures. The form will submit automatically once all signatures are obtained.
  
  You will see a message appear on the screen confirming that the form has been submitted. We will send you a formal acknowledgement when it is received by us.

If you do not receive an acknowledgement within 5 working days please follow up by emailing ethics@lshtm.ac.uk (staff) or MScethics@lshtm.ac.uk (students).

If you require further guidance on how to submit sub-forms when the original application was submitted via LEO, an instructional video is available here: https://intra.lshtm.ac.uk/Research/Research-Governance/Ethics/LEO-help/index

Note: Please use the SUSAR Form to report any SUSARs and the Protocol Violation Form to report any violations/breaches of GCP or protocol. The SUSAR and Protocol Violation Forms should be completed promptly and submitted no later than 7 working days after the event. All other SAEs should be submitted via the Annual Report Form.   

Providing updates for SUSARs and protocol violations

To submit an update for a SUSAR or protocol violation, please follow these steps:  

Once you login, please click on the project that you wish to send a report for, then click on the original SUSAR form or Protocol Violation form located on the project tree :

• In the left ‘Actions’ column, please click on ‘Create a sub-form’ – a pop-up window will appear, in the drop-down list, please select the relevant sub-form type: 'SUSAR Update Form' or 'Protocol Violation Update Form'. Then please click on ‘Create’