2. The Office of Research Ethics September 10, 2012 MClSc Physical Therapy Student Orientation Office of Research Ethics

3. What We Do The Office of Research Ethics manages the approval and monitoring process for the use of humans in research at the University and its affiliated hospitals and research institutes. Presentation Title Here

4. Why We Exist To protect the research participants and make sure that they’re not exposed to any unnecessary harms, risks or discomforts. To protect the researchers and students carrying out the research. Presentation Title Here

5. Tri-Council Policy Statement 2 (TCPS2) TCPS2 is a guideline created by the Interagency Agency Panel on Research Ethics for the Tri-Council Agencies(CIHR, NSERC and SSHRC). To be eligible to receive and administer research funds from the Agencies, institutions must agree to comply with Agency policies, the TCPS2 being one of those policies. Researchers funded by the Agencies are expected to adhere to the TCPS2.

6. Is Ethics Approval Needed? All research involving humans conducted by faculty, staff or students at Western or its affiliated hospitals or research institutes must be reviewed by a University-sanctioned review board. At that point the board will decide if approval is needed, if this is in question. Presentation Title Here

7. Please remember… This includes ALL research. If you are not sure, please contact us and ask. You must obtain ethics approval BEFORE you begin your research. Retroactive approval will not be given under any circumstances. Presentation Title Here

8. Is Ethics Approval Needed? Yes… The following require ethics review by an REB before the research commences: (a) research involving living human participants; (b) research involving human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive materials and stem cells. This applies to materials derived from living and deceased individuals.

9. Is Ethics Approval Needed? No… Research that relies exclusively on publicly available information MAY NOT require REB review when: (a) the information is legally accessible to the public and appropriately protected by law; or (b) the information is publicly accessible and there is no reasonable expectation of privacy.

10. Publicly Available Info - Example The researcher wanted to record a speech by the Health Minister of Canada. This speech was to be given publicly and for all to hear. Therefore, based on the fact that this information was presented publicly, no ethics approval was needed. *Alternatively, the researcher also wanted to interview the Minister separately after, this is not public information and ethics approval and consent was needed.

11. Is Ethics Approval Needed? No… REB review MAY NOT be required for research involving the observation of people in public places where: (a) it does not involve any intervention staged by the researcher, or direct interaction with the individuals or groups; (b) individuals or groups targeted for observation have no reasonable expectation of privacy; and (c) any dissemination of research results does not allow identification of specific individuals.

12. Public Places - Example The researcher wanted to carry out observations in a public shopping mall in order to review the use of a certain guest service in that mall The shopping mall is a public place, she was not taking any video or audio recordings, was not going to identify the participants nor was she going to interact with them. Therefore, no ethics approval was needed. *Alternatively, a researcher wanted to go into a long-term care facility to observe – ethics approval WAS needed for this.

13. Is Ethics Approval Needed? No… Research that relies exclusively on secondary use of anonymous information MAY NOT require REB review when: It includes the use of anonymous information, or anonymous human biological materials, so long as the process of data linkage or recording or dissemination of results does not generate identifiable information.

14. Secondary Use - Example The researcher wanted to write a paper in which they would use an existing dataset maintained as a database to collect their information. Neither the PI nor the researcher were able to link the information from the database back to the person that the information was originally collected from. No linkage possible, completely de-identified and therefore no ethics approval needed.

15. Is Ethics Approval Needed? No… Research that is to be used for internal purposes only and will not be published MAY NOT require REB review when it is: Quality assurance and quality improvement studies, Program evaluation activities, Performance reviews or testing within normal educational requirements when used exclusively for assessment, management or improvement purposes, Course or program planning or development, Development of case studies for teaching purposes

16. Evaluation - Example The researcher wanted to assess / evaluate the performance of her organization by using feedback through focus groups, interviews and looking at billing records of this institution. This did not include any vulnerable populations and there were no known risks. Although ethics approval was not needed we still asked that she use our consent process to consent individuals being interviewed or participating in the focus group.

17. Research at another institution - Example A researcher wanted to do focus groups and surveys with all 3 rd year medical students at all medical schools across Ontario. Therefore, he had to first obtain ethics approval from Western as this is his home university and then he had to correspond with all other universities he wished to do his research at to ask what steps should be taken before he could start. This would be the same for anyone wishing to do research at Western that was not from this institution. They would also need Western approval to do research with Western staff, faculty or students.

18. Boards and Review Level Presentation Title Here

19. Boards and Review Levels HSREB Full Board Delegated 1 & 2 NMREB Delegated Sub-boards Department Here

20. Delegated Review Research that is deemed minimal risk or lower and does not use vulnerable participants, children or in some cases elderly. Minimal Risk: Research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in those aspects of their everyday life that relate to the research.

21. Delegated Review Level 1 Research which includes for example chart reviews, database or registry creation, analysis of tissue samples. Generally speaking research which does not involve participant contact.

22. Delegated Review Level 2 Research which includes contact with patients, participants in the form of focus groups, questionnaires, surveys, etc. Generally low risk patient / participant contact.

23. Deadlines The HSREB Full Board and Delegated Level 2 board have deadlines which must be adhered to. Please see our website for deadlines. The HSREB Delegated Level 1 board does not have deadlines. The protocols can be submitted at anytime and are reviewed within 2 weeks.

24. Ethics Review Process Submission of the Protocol and all necessary documentation by the deadline date. Pre-reviewed by the office. Reviewed by the board. Sent to the researcher for response. Response from the researcher. Approval. Department Here

25. ROMEO Our online, in-office database and protocol submission system. All protocols are now submitted via ROMEO. There are workshops offered or one-on-one training is also available. Please contact us if you would like assistance in obtaining your username and password.

26. Consent Process Presentation Title Here

27. The Consent Process The Consent Process should be thought of as a process, not just a letter and a form that the potential participants signs. The Letter of Information should not cause the potential participant to: –Feel overwhelmed by institutional approval –Fear loss of benefits, employment or educational status –Feel an obligation to participate –Believe there will be financial gain

28. The Consent Process This can happen in a number of ways: –Written Consent (Letter of Information + Consent to sign) –Explicit Consent (Letter of Information + Completion of Survey) –Explicit Verbal Consent (Telephone Script + Agree to Interview) You still need a Letter of Information or script for ALL of these forms of consent. Subjects must be told exactly what is going to happen to them (full disclosure)

29. Who We Are Department Here ROLENAMEPHONEEMAIL HSREB FULL BOARD Janice Sutherland86764 jsutherl@uwo.ca HSREB FULL BOARD Shantel Walcott87437 swalcot@uwo.ca HSREB Delegated & NMREB Grace Kelly84692 grace.kelly@uwo.ca Administrative Assistant Julie Pfeiffer86811 jpfeiff@uwo.ca Administrative Assistant Becky Ament84691 bament@uwo.ca

30. Where We Are We are located in suite 5150, Support Services Building, University of Western Ontario http://www.uwo.ca/research/ethics/ Presentation Title Here