Frequently Asked Questions

Applications Timescales

By when do I have to submit my application for it to be reviewed next month?
The committee will meet virtually each month to review projects. Applications received by the end of the month will be reviewed on the 15th of the subsequent month (eg if submitted on 30 July, will be reviewed on 15 August). Applications received after the closing date will be reviewed the following month (eg if submitted on 1 August, will be reviewed 15 September). Responses from the ethics committee are usually sent out within a week of the meeting date, however this can occasionally take longer. Amendments The committee reviews amendments twice monthly. Applications received between the 1st and the 15th of the month will be reviewed on the 1st of the following month (eg if submitted between 1st and 15th July, will be reviewed on the 1st August). Applications received between the 16th and 31st of the month, will be reviewed on the 15th of the following month (eg if submitted between 16th and 31st July, will be reviewed on the 15th August). Responses from the ethics committee are usually sent out within a week of the meeting date, however this can occasionally take longer. MSc applications: For projects which do not require committee review/ ethical approval (this only applies to certain types of projects), a clearance letter will be issued within 1-2 weeks of submission. 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 2015. For a full list of the submission deadlines and meeting dates please see the ethics webpages: http://www.lshtm.ac.uk/research/researchgovernanceandintegrity/ethicscommittees/submissiondeadlines.html

Login Details / Access

My LSHTM/ Novell password is not working on this site?
New users are required to register on the system. Please click 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 will be able to login using the username and password you supplied at registration. *If you forget your password after registration, you can obtain this by visiting the website and clicking on ‘Forgot password’.
I have forgotten the password I set up at registration ?
If you forget your password after registration, you can obtain this by visiting the website and clicking on ‘Forgot password’. Your password will be sent to the email address that you use as the username on the website.
I am unable to login with my registered username and password ?
Please note that both the username and password are case-sensitive. Please take extra care when entering this information. If you continue to experience problems trying to log in, please contact us at ethics@lshtm.ac.uk (staff) or mscethics@lshtm.ac.uk (students).
I can't view the website properly/ certain features are not appearing?
Please use Google Chrome or Firefox to access the Leo website for optimum functionality. If you are using a Mac and experiencing any particular problems, please contact us at ethics@lshtm.ac.uk or mscethics@lshtm.ac.uk

Completing the application form

How do I start completing the application form?
• After registration, when 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. • When completing an application form, you will be able to progress to the ‘Previous’ and ‘Next’ sections by clicking on the relevant 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 specific question does not seem to apply for your project, please explain 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 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 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. For MSc students, further guidance can be found in the project handbooks.
Can I share the application form with others for them to contribute?
You can share application forms with other people in the team so that they may also contribute. Please follow the below steps: -Once logged in, please select the relevant project and relevant form (eg, amendment form) then click on ‘Share’ in the left ‘Actions’ column. Each individual form has to be shared. -In the pop-up window, please enter email addresses of the relevant people. If an error message is shown, please check that the person you are sharing the form with has an account on LEO - 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 either 'read-only' or 'full access' 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. Then click on ‘Cancel’ alongside the relevant names listed. An instructional video on how to share CARE forms is available from this link: https://panopto.lshtm.ac.uk/Panopto/Pages/Viewer.aspx?id=7b82b325-fc3b-4044-bceb-d220061e172e
Can I create a copy of a completed application form - as I need to submit an application for another project whose details are similar?
You can create a copy of a completed application form if required but contents are not transferred over and 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".
I'm planning an NHS Project. Is there anything I should know?
Any research being conducted within the NHS will require a sponsor. For clinical trials you will be asked to provide evidence of this under Q30e in the form of a sponsor letter. If you wish for LSHTM to be the sponsor of your trial/project please contact Naomi Tranter (naomi.tranter@lshtm.ac.uk) in the Research Governance and Integrity office. You will need to provide the study protocol, information sheets and consent forms and a PDF copy of the draft ethics application. Please allow 5 working days for sponsor review. Projects that have HRA approval may be eligible for fast-track review. For more information please see the Ethics webpage: http://www.lshtm.ac.uk/research/researchgovernanceandintegrity/ethicscommittees/submissiondeadlines.html
Do I need a Sponsor?
All clinical Trials and research conducted within the NHS require a sponsor. For clinical trials you will be asked to provide evidence of this under Q30e in the form of a sponsor letter. If you wish for LSHTM to be the sponsor of your trial/project please contact Naomi Tranter (naomi.tranter@lshtm.ac.uk) in the Research Governance and Integrity office. You will need to provide the study protocol, information sheets and consent forms and a PDF copy of the draft ethics application. Please allow 5 working days for sponsor review. for further information on sponsorship please see LSHTM SOP 002 on Sponsorship and Insurance: https://intra.lshtm.ac.uk/Research/Research-Governance/Standard-Operating-Procedures-(SOPs)/index
Is there any guidance on taking informed consent in research?
Guidance on informed consent can be found in the LSHTM SOP 005 on Informed consent for research: https://lshtm.sharepoint.com/Research/Research-Governance/Pages/standard-operating-procedures-(sops).aspx
LEO won't let me upload documents. How can this be resolved?
Occasionally while trying to upload documents an error message stating that the document cannot be uploaded because the file size is too large will appear. This normally occurs when LEO is being accessed via Internet Explorer. Changing the web browser to either Chrome (best) or Firefox usually resolves this issue. If you continue to have trouble after changing web browsers please contact either MScethics@lshtm.ac.uk or ethics@lshtm.ac.uk and help will be provided.
How do I unlock my application form?
The form will lock to all edits automatically upon signing/signature requests. To unlock the form: - Log into LEO - Click on the project - Click on any of the blue links to take you into a question section of the form - On the left under Actions, click the 'unlock' button (can be identified by the image of a padlock) Please be aware that unlocking the form will invalidate any signatures already on the form, and will recall any active signature requests. A form can only be unlocked before it has been submitted to the committee. If you have submitted the form, but now wish to make edits please contact ethics@lshtm.ac.uk (staff) or MScethics@lshtm.ac.uk (students) An instructional video on how to unlock a form can be found here: https://panopto.lshtm.ac.uk/Panopto/Pages/Viewer.aspx?id=63f48ad2-8255-459f-8ac8-ac1073c08d18

Signature Requests

Why is there an error when I try to send a signature request?
For error stating: 'You cannot request a signature from a collaborator' You do not need to send a signature request if you have already shared the form with the signatory (and thereby making them a 'collaborator'). (You can check this by clicking on the ‘Collaborators’ in the left ‘Actions’ column to see if their name is listed.) For error stating: 'User x does not exist on the system' The system can only send emails to registered users of the system. Please email your chosen signatory outside the system, to register as a ‘New User’ on http://leo.lshtm.ac.uk New users can register on the system by clicking on the green 'New User' button - this will take the user 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. Please ask them to inform you once this is completed so that you can send the signature request.
MSc applications - I have 2 supervisors, do I need to send signature requests to both?
Only one supervisor is required to sign off your care form application, you can decide who this will be in conjunction with your supervisors/ Course Director.
MSc applications - My supervisor is based at an external organisation, will I be able to send them a signature request?
Yes but they must register on the website if they have not done this already. Please email your chosen signatory outside the system, to register as a ‘New User’ on http://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 the user 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. They should inform you once this is completed so that you can send the signature request.
What happens after I have sent a signature request?
You will receive a notification to alert you when a signature has been received. Once all signatures are received, you will be required to submit the form. MSc Applications Signature requests should be sent first to the supervisor (one supervisor if there are 2 supervisors). Then 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 Designated Individual for human tissue. This will be indicated to you on the form. Then when you receive a 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, then you must proceed to submit the application. NB: If the form is already shared with either or both individuals, you do not require 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 shared forms are available elsewhere in the 'Help'/ 'FAQ' sections of this website. You must proceed to submit the form once all signatures have been received. This can be done by clicking on the 'Submit' button in the left 'Actions' column. 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.)
For signatories: Help with signing forms
Accessing the signature request: If the form is shared with you, you do not need to be sent a signature request to sign the form. You can access these forms by clicking on the 'Shared' box when you login. Please click on 'View Form' alongside the listing of the relevant applicant. 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. An instructional video on how to sign the form when it has been shared with you is available here: https://panopto.lshtm.ac.uk/Panopto/Pages/Viewer.aspx?id=4918d16e-5c95-4f52-afc4-98729d7df0d8 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. (If you choose to reject to sign the form, you will be provided a box to enter relevant comments for the information of the student) The applicant will be notified through the system that the form has been signed/ rejected. An instructional video on how to sign a form when you have received a signature request is available here: https://panopto.lshtm.ac.uk/Panopto/Pages/Viewer.aspx?id=afd8c998-84e9-47ff-b276-71aac48c1bd8
How do I know that my application has been submitted successfully?
Once the application is submitted successfully, there will be a message on the screen confirming submission. We will send you a formal acknowledgement of receipt for the application within 5 days. Please contact us if you have any queries regarding successful submission.

Submitting An Application

How do I submit my application?
From the 2nd October 2017 applications will submit automatically upon receipt of all required signatures.
What happens to my application after I have submitted it?
After your application has been submitted to the committee, you will receive a receipt confirmation email from the Ethics Administrator stating when you should receive feedback. 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). Amendment applications Applications received between the 1st and the 15th of the month will be reviewed on the 1st of the following month (eg if submitted between 1st and 15th July, will be reviewed on the 1st August). Applications received between the 16th and 31st of the month, will be reviewed on the 15th of the following month (eg if submitted between 16th and 31st July, will be reviewed by 15th August). MSc Applications For projects which do not require committee review/ ethical approval (this only applies to certain types of projects), a clearance letter will be issued within 1-2 weeks of submission. Ethics approval will typically take 4 to 6 weeks from the point of submission, though this can be longer if the project is particularly complex. Projects must not start until the student receives the ethics clearance or approval letter.
At what point should I follow up my application after submission?
After submitting your application by clicking the 'submit' button under Actions you should receive an email notification from the ethics administrator confirming receipt of your application and giving a estimated time for you to expect a response. If you have not received the confirmation email within 5 working days of submission please email ethics@lshtm.ac.uk (staff) or mscethics@lshtm.ac.uk (students) to follow up your application.
Can I withdraw my application after its been submitted?
If your form is submitted in error you can use the ‘Withdraw’ button located under Actions to withdraw your submission up until the point that the application has been validated. Once the application has been validated you will need to contact ethics@lshtm.ac.uk to have the application withdrawn.

Request for Clarification/Insufficient Information

How do I submit a response to the queries from the committee on my application?
The response is required to be submitted in the form of a revised copy of the application form through the ethics online applications website. -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). -Please ensure that you select the correct box on Qn 2f to indicate that you are responding to the LSHTM Ethics Committee. -A covering letter listing the changes and requested clarification should be uploaded under Q2fi (which will unlock upon 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 and re-submit the application by clicking on the ‘Submit’ button in the left ‘Actions’ column. -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. A template cover letter is available in LEO under 'Help' - 'Templates' An instructional video on how to respond to a request for clarification can be found here: https://panopto.lshtm.ac.uk/Panopto/Pages/Viewer.aspx?id=5e7b92d3-7345-47b0-af87-41df12f6fecd
Within how many days should I respond to the queries from the committee on my application?
There is no set time limit for sending through responses to the committee.
Within how many days will the committee give feedback on my response to their queries on my application? Do I need to wait until the next committee meeting?
You do not need to wait until the next committee meeting to hear back from the committee. We are unable to specify a fixed turnaround time from the committee on your response. You will receive feedback on your response as soon as possible. If any delays are anticipated, we will inform you. Please contact us with any specific queries.

Amendment Applications

How do I submit an amendment application?
To submit an amendment* where the original application was submitted via the word E2 document: (If you have already submitted sub-forms for this project in the past, please refer to the section on “To submit an amendment where the original application was submitted on the online system”): 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 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. NB: Once this step has been completed for the project, you will not require to repeat this step for submitting sub-forms for the project 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 ‘Amendment Form’, please click on ‘Create’ 8. Please complete the 3 sections of the form, then sign and submit it. 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, then sign and submit it. Instructional videos are available showing how to create sub-forms including amendments for project submitted both via the old paper form and the via LEO. When original application was submitted before LEO: https://panopto.lshtm.ac.uk/Panopto/Pages/Viewer.aspx?id=91f2bda7-5765-4b00-8a1f-602262d4e196 When original application was submitted via LEO: https://panopto.lshtm.ac.uk/Panopto/Pages/Viewer.aspx?id=0f19f693-9767-4e62-b4bc-22f0cca9af64
Can I share the application form with other members of my team for them to contribute?
You can share the amendment forms with other people in the team so that they may also contribute. Please follow the below steps: -Once logged in, please select the relevant project, then the relevant amendment form and then click on ‘Share’ in the left ‘Actions’ column. -In the pop-up window, please enter email addresses of the relevant people -In the corresponding drop-down list, please select either 'Read-only' or 'Full access' as required. -Please click on the ‘plus sign’ to add further names -Please click on ‘Share’ to confirm. -Individual users must also register on the site to be able to login and view the shared application forms. -To remove access granted, please click on the amendment form and then the ‘Collaborators’ button in the left ‘Actions’ column. Then click on ‘Cancel’ alongside the relevant names listed. An instructional video on sharing forms is available here: https://panopto.lshtm.ac.uk/Panopto/Pages/Viewer.aspx?id=7b82b325-fc3b-4044-bceb-d220061e172e
Can I submit my sub-study as an amendment?
No. Sub-studies are treated as new studies and therefore require a new application to be submitted.

Annual reports, adverse events&end of study forms

How can I submit annual reports, adverse events or end of study forms on this system?
To submit any of these reports where the original application was submitted via the word version E1 document - please follow the below steps: (If you have already submitted sub-forms for this project in the past, please refer to the section on “To submit these reports where the original application was submitted on the online system”): 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 Title' and 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. NB: Once this step has been completed for the project, you will not require to repeat this step for submitting sub-forms for the project 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 3 sections of the form, then sign and submit it by clicking on the 'Submit' button in the left 'Actions' column. 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. 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 form, please click on ‘Create’ -Please complete the listed sections in the form, then sign and submit it by clicking on the 'Submit' button in the left 'Actions' column. 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. An instructional videos on creating sub-forms are available here: Creating sub-forms when the original application was submitted before LEO: https://panopto.lshtm.ac.uk/Panopto/Pages/Viewer.aspx?id=91f2bda7-5765-4b00-8a1f-602262d4e196 Creating sub-forms when the original application was submitted via LEO: https://panopto.lshtm.ac.uk/Panopto/Pages/Viewer.aspx?id=0f19f693-9767-4e62-b4bc-22f0cca9af64 NB: Please use the SUSAR Form to report any SUSARs and the Protocol Violation Form to report any violations/breaches of GCP or protocol. The relevant form 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.
How can I submit an update for a SUSAR or protocol violation?
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’ Please complete the listed sections in the form, then sign and submit it by clicking on the 'Submit' button in the left 'Actions' column. 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).

Downloading a copy of completed form

How can I download a copy of my completed application form for my records?
Please login to the Leo account, click on the relevant project and then click on the 'Print' button in the left Actions column. Then click on the blue 'Print' button to view a pdf copy and download as required. You do not need to print a copy, the pdf copy can be saved onto your computer. An instructional video on creating PDF copies of the ethics form is available here: https://panopto.lshtm.ac.uk/Panopto/Pages/Viewer.aspx?id=16a6cbd7-5761-43c9-a035-8e145acdced1
How can I download an anonymised version of my completed care form?
You can download an anonymous version of the care form, without the details of yourself and your supervisor, as required for submission with your final project. (Students who submitted any 'Amendment' forms, should also provide these with their project reports as these form part of the approved care form applications) Please login to the Leo account, click on the relevant project and then click on the 'Print' button in the left Actions column. Then select the 'Redacted' option in the pop up window which appears on the screen and then click on the blue 'Print' button. Then click on the blue 'Print' button to view a pdf copy and download as required. You do not need to print the pdf copy, you can save it to your computer. An instructional video on creating PDF copies of your ethics form is available here: https://panopto.lshtm.ac.uk/Panopto/Pages/Viewer.aspx?id=16a6cbd7-5761-43c9-a035-8e145acdced1