1. LEO: LSHTM Ethics Online Patricia Henley Quality & Governance Manager Research Governance & Integrity Office London School of Hygiene & Tropical Medicine

2. What is LEO? LSHTM Ethics Online Online ethics application system Used for staff and students at LSHTM – Merges staff application with MSc student CARE form Application: https://leo.lshtm.ac.ukhttps://leo.lshtm.ac.uk

3. MSc Ethics Committee Chair: Dr Cicely Marston Currently 11 members, across all faculties – Applications are assigned to 1 or 2 members representing the committee Workload of MSc ethics committee for 2014-2015: – Number of projects submitted for review: 611 128 unfavourable that required a new submission – Number of projects not requiring ethics review: 257 But still require completion and submission of CARE form! – Number of projects invalidated prior to review: 71

4. Ethical review All studies involving humans, their tissue and/or their data MUST have favourable ethical opinion BEFORE starting project. This includes: – Secondary data analyses – Studies using previously collected tissue – Questionnaires – Interviews and focus groups “casual chats” count as interviews!

5. Timelines Last date accepted by MSc ethics cmte: 1 July 2016 – If applications submitted after this date, you will likely not have time to start project, analyse results, and write up thesis for Sept deadline. Review takes 4-6 weeks (approx) You are required to have ethics approval in place before applying for travel award Consider whether you will also need local ethical approval as well

6. Logging in for the first time Click new user Does NOT use your standard LSHTM/ University of London log- in, but you can use your normal/LSHTM email and set password to be the same as for Moodle/email Help, FAQs, contact

7. Registration Note: Case-sensitive Will be your log- in for system

8. Logging in https://leo.lshtm.ac.uk Enter address and password EXACTLY as you registered

9. Work Area System messages appear here. Should also receive emails from “ERM” or “Infonetica” Archive of all projects Help, FAQs and contacts Current forms

10. Getting started Click on create project

11. Title and Form 1. Enter title, can be amended once in the form 2. Select “LSHTM Ethics Application & CARE form”

12. Navigation screen Title of project Sections to complete Greyed out means not applicable Click to get started Share allows collaboration on form with two users working on it at the same time. Print generates a pdf that can be saved locally. Can also print redacted Reference number Status of application

13. Sharing the form

14. Sharing To share application with others.

15. Sharing with Others

16. Recipient view Click to see what has been shared

17. Recipient view Click to viewOr reject

18. Completing the form

19. The “smart” form part 1

20. The “smart” form part 2 Answering yes will activate further questions Click next or previous or navigate to move through form Auto-saves BUT if haven’t worked on system >20min, will be locked out.

21. 2f: Original v Request for clarification First submission Responding to the cmte’s request for clarification

22. Applicant details

23. Filter questions For MScs: do not require ethical approval from LSHTM BUT still submitted as per other types of studies Some questions have help boxes Post-its to communicate

24. Post-its Click on the post-it

25. Post-its Type in comment, click +. Whoever is shared form can view

26. Post-its

28. Example: Secondary Data Analysis

29. Project Filter Includes for modelling projects unless fully from public domain

30. Outline To upload documents. Not all mandatory

31. Methods

32. Experience MSc: Upload own CV only. Ethics committee needs to assess your suitability for the project in terms of education training and experience Provides valuable information for ethics committee to determine appropriateness of study, eg RCT studies or working with children

33. Confidentiality & Data

34. Funding

35. Local Approval for 2 o data

36. Local Approval for 1 o data

37. Data Sources, IP & Permissions

38. Risk

39. Submitting the form

40. Signatures Students: 1.You sign 2.You can click “request signature from your supervisor” OR ask them to sign directly, if shared 3.Request signature from supervisor Course Director/Project Module Organiser 4.Request from others as required. *Signatories need to have an account. Make sure before requesting*

41. Submission When you are satisfied the form is complete and signatures have been received, click on submit. This will bring up a completion checker.

42. Completion Checker Clicking on link will bring you back to the question

43. Last Step 2. Click on submit to send in final (complete and signed) form to LSHTM Ethics Committee. Notification will be sent to applicant.

44. Reminder

45. Next steps You will receive an email notification regarding validation / invalidation of project Project will be reviewed by MSc ethics committee, or If no ethics review required, letter stating this will be emailed to you

46. Ethics committee response Three possible responses: – Favourable opinion: The committee has approved the project. There may be conditions attached to the approval eg the LSHTM ethics approval is contingent on receiving local ethical approval prior to starting the project – Request for clarification: The committee would like you to amend a few items. You must respond to the committee before they issue a favourable opinion – Unfavourable opinion: The committee has rejected the study and will provide reasons.

47. Queries and Help Contact: MScethics@lshtm.ac.ukMScethics@lshtm.ac.uk Telephone: 020 7927 2221 LSHTM ethics webpage −http://www.lshtm.ac.uk/research/researchgovernanceandintegrity/et hicscommittees/http://www.lshtm.ac.uk/research/researchgovernanceandintegrity/et hicscommittees/ How-to LEO videos −https://intra.lshtm.ac.uk/Research/Research-Governance/Ethics/LEO- help/indexhttps://intra.lshtm.ac.uk/Research/Research-Governance/Ethics/LEO- help/index Good Research Practice −http://www.lshtm.ac.uk/research/about/guidelines_on_good_researc h_practice.pdfhttp://www.lshtm.ac.uk/research/about/guidelines_on_good_researc h_practice.pdf

48. Questions?