2. Research Ethics Western University Health Sciences Research Ethics Board Tri-Council Policy Statement 2 Grace Kelly Ethics Officer grace.kelly@uwo.ca www.uwo.ca/research/ethics

3. Upcoming Educational Sessions Letter of Information and Consent Process Forms – Initial submission + Post Approval Forms Surveys and Online Research Teachers’ Research with their own Students ROMEO and electronic submissions

4. 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.

5. Today’s Agenda When is ethics approval required? (Chapter 2) Which Research Ethics Board to use? Where are you required to submit? (Chapter 6) The Consent Process (Chapter 3) Protocol submissions and Review Process Question and Answer Period

6. When is Ethics Approval Required? Chapter 2 ALL research involving human participants is subject to ethics review by an REB, even if approval may not be needed. Therefore, if you are doing research with humans and are unsure of whether or not ethics is required, please contact our office first.

7. When is Ethics Approval Required? Chapter 2 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.

8. When is Ethics Approval NOT Required? Chapter 2 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.

9. Publicly Available Information - 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.

10. When is Ethics Approval NOT Required? Chapter 2 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.

11. 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.

12. When is Ethics Approval NOT Required? Chapter 2 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.

13. 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.

14. When is Ethics Approval NOT Required? Chapter 2 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

15. 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.

16. Where are you required to submit? Chapter 6 All Western University students, staff and faculty must obtain research ethics approval from Western University to do any research at any location. If you are doing research at Western and at another location you may also need to obtain ethics from that institution. Please contact the institution for confirmation, based on your particular project.

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. Which Research Ethics Board to Use? Chapter 6 Western University has two main Research Ethics Boards. The board being discussed today is the Health Sciences Research Ethics Board (HSREB). This main board is divided further, based on the level of risk indicated in the protocol. –HSREB Full Board, Delegated Board Level 2, Delegated Board Level 1.

19. Delegated Review Chapter 6 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.

20. 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.

21. 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.

22. The Consent Process Chapter 3 Letter of Information 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

23. The Consent Process Chapter 3 Obtaining Consent 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)

24. Protocol Submissions & Review Process The Office of Research Ethics sets deadlines for each of its major boards http://www.uwo.ca/research/ethics/deadlines.html HSREB Full Board – Deadlines Delegated Level 2 – Deadlines Delegated Level 1 – No Deadlines

25. Protocol Submission & Review Process Timelines HSREB Delegated Level 1 –Protocols can be submitted at anytime –Reviewed within 2 weeks of being submitted –Recommendations sent out within 5 days of review HSREB Delegated Level 2 –Protocols are submitted on the deadline date –Reviewed at the meeting date indicated online –Recommendations sent out within 5 days of review

26. Protocol Submission & Review Process Forms The REB provides initial review and approval to a research project and the REB and the ORE provide ongoing post-approval review to research revision, etc. We are currently in the process of going electronic with our submissions - ROMEO

27. Question & Answer Period Thank you! We are always here to help. If you have any questions please contact Grace Kelly at 519-661-2111 ext. 84692 or grace.kelly@uwo.ca grace.kelly@uwo.ca or Julie Pfeiffer at 519-661-2111 ext. 86811 or jpfeiff@uwo.ca jpfeiff@uwo.ca