Frequently Asked Questions

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 two weeks 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 two weeks 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. For a full list of the submission deadlines and meeting dates please see the ethics webpages: https://www.lshtm.ac.uk/research/research-governance-integrity/ethics/ethics-applications

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.

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 need 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 RGIO@lshtm.ac.uk. 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 RGIO@lshtm.ac.uk 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

My research is being conducted overseas (including remote research). Do I need to obtain local approval?

For studies conducted overseas it is essential that local ethics approval requirements are followed, including when research is conducted remotely, for example remote interviews. Local requirements vary so should be investigated, and an application submitted, if required, for each country in which the study is to be conducted. The process of ethical review for studies to be conducted overseas is not always straightforward. Collaborating with a local research organisation, or other relevant local experts, is good practice and they can often advise on local requirements for research. For students, your supervisor may be able to help you investigate whether any colleagues at LSHTM have conducted research in your country of interest, as they may be able to offer advice on which approvals are required. Alternatively, researchers can often contact the local Ministry of Health for advice. Where you believe local approval is not required, you must justify this in your application to the LSHTM ethics committee and describe any less formal permissions, invitations or local support being given for the study. For studies that are not being carried out in specific countries, and with no country focus, such as global online surveys, or where an advert for a research study is posted online and anyone can respond regardless of where they are based, it becomes impossible for researchers to know where their participants are based before they are recruited into the research. The committee recognise the difficulty of obtaining local approval when the researcher does not know where the participants are based, so for these types of ‘global’ projects where there is no other appropriate review body, LSHTM approval alone can be sufficient. It is the responsibility of the researcher to ensure that all required local approvals are in place before the start of the project.

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

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.

I have sent a signature request to the wrong person, how can this be cancelled?

1. Go to the signatures tab (not the signatures page) 2. Scroll down to signature requests and locate the request that needs to be cancelled. On the right under Action click the cancel button. An error message may appear, you can ignore this. 3. Go back to the Navigation tab (the one which shows all the blue links into different sections of the form). 4. Click on the Signatures section (section 15) 5. Go to the signature that needs to be requested and click the Request Signature button. 6. Enter the correct email into the pop-up and click ‘Request’

I/my supervisor/my course director has signed in the wrong place, how do I fix it?

Unlocking the form will reset the signatures and allow everyone to sign in the correct places. You can unlock the form by clicking the unlock button which should be visible on the left under Actions when you are in any of the question sections of the form. We also have an instructional video here if you have trouble: https://panopto.lshtm.ac.uk/Panopto/Pages/Viewer.aspx?id=63f48ad2-8255-459f-8ac8-ac1073c08d18

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 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.

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.

How do I submit an amendment application?

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 to submit. 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 to submit. 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?

Generally sub-studies are treated as new studies and therefore require a new application. For further guidance on whether a sub-study should be submitted as a new application vs an amendment, please see our guidance on the submission of sub-studies here: https://lshtm.sharepoint.com/Research/Research-Governance/Ethics/Pages/FAQs.aspx#Section9

How can I submit annual reports, adverse events or end of study forms on this system?

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. 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 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. 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. 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).

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 'View as PDF' button in the left Actions column. Then click on the blue 'View' button to view a pdf copy and download as required. The pdf copy can then 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 'View as PDF' 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 'View' button. 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

Where can I find information on the SCC and ethics procedure?

Information on the SCC and ethics procedure, including templates and meeting dates, can be found here: https://www.lshtm.ac.uk/research/units/mrc-gambia/scc-and-ethics-procedure

Is there guidance for the completion of the Leo form for Review of Project by SCC and Ethics Committees?

The MRCG Scientific Coordinating Committee (SCC) reviews the scientific content of a research project to be undertaken in The Gambia for the purpose: I. To judge that the project is scientifically feasible, has well-reasoned methodological process in answering the research questions II. To potentially advice improvement on approaches in the study to maximise the outcome and impact of the study III. To judge that the study environment is adequate and will facilitate timely recruitment of study patients and sample processes IV. To advice on potential ethical issues to address before the project is passed on to the MRCG/Gambia Government Ethics Committee. (Note that the Ethics Committee will not review any project if it is not approved by the SCC) 1. All research projects to be reviewed must be adequately explained in the Leo form following the systematic instructions in the form. (It has been observed that some important sections are incompletely described, making it difficult for the SCC to review the project). All sections are important, but we pick some important sections to help guide external applicants (Scientists and students outside the MRCG and LSHTM set up) to meet the description expectations. 2. Under Project Type, external applicants are not required to indicate any of the MRCG themes options (instead choose “other”) 3. Section 12: (scientific outline of the Project). You are required to give the details of the proposal that includes Scientific background (global and local situation), brief rationale or importance of the proposal (What is unique about your study) different from what is known. Then explain your study environment that will support your study. 4. Do NOT repeat what you wrote under 12 in the following 12b. Rather make a simple summary of your project proposal in a layman’s language (non-scientific explanation of what your proposal is about). This can be a paragraph or two that will avoid all scientific terms, attempting to explain your proposal to a lay person. 5. If your study has detailed protocols such as in Clinical trials (mandatory) or a full MSc or PhD proposal (optional), you can upload it as suggested in section 12b. 6. Section 13 & 13a require you to detail the importance of the study and this expands the brief rationale you mentioned in section 12. 7. Section 18 is the Method section and requires the detailed explanation of the procedures and study tools you would use to answer the objectives. This is an important section that should be systematically answered. One should first explain the various methods and tools you would use to generate data, study population, inclusion and exclusion criteria, measures of your primary outcomes and secondary outcomes (if applicable), and your data analyses plan. 8. The method section is followed section 20 and 20a to detail your sample size. 9. It is expected that supervisors of MSc and PhD students review the student’s input in the form and assist in correcting the details, making sure student do not complete the forms sloppily. Supervisors are also expected to sign the form before submission. It may be helpful if supervisors for MSc can attend the SCC presentation to witness the student presentation and his scientific understanding of the project. 10. Apart from the Leo form, an accompanying Information sheet for research consent from study participants are usually completed incorrectly, particularly for two areas: a) Under the section (Why is this study being done?). Imagine you are explaining to an uneducated participant you are recruiting and avoid any scientific explanation. Simply explain the importance of the study e.g., what the health condition is about and why you are interested to recruit him/her to help address your investigation and how this will help society at large b) The section (What does this study involve?). You state in simple terms for the understanding of the uneducated participant, how he/she is participating in the study (e.g., answering questions for how long? how these questions will be recorded and what will be done with them; Or providing samples and how much? What the tools are employed to get data from samples etc, where they will be processed and who are involved in the processing and data analyses, what happens to results that affects them etc. The position here is to ensure that participants understand why they are participating in your study.