Research Ethics Western University Non-Medical Research Ethics Board Tri-Council Policy Statement 2 Grace Kelly Ethics Officer

Non-Medical Research Ethics Board Please note that the following slides and the information contained on these slides ONLY apply to the Non- Medical Research Ethics Board. If you wish to learn more about the Health Sciences Research Ethics Board please attend my sessions on the HSREB which are scheduled for later this week.

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.

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

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. If you are doing research with humans and are unsure of whether or not ethics is required, please contact our office first.

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.

When is Ethics Approval NOT Required? Chapter 2 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

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.

Which Research Ethics Board to Use? Chapter 6 Western University has two main Research Ethics Boards. The board being discussed today is the Non-Medical Research Ethics Board (NMREB). This main board is divided further, based on the level of risk indicated in the protocol. –NMREB Full Board, Delegated Board, Sub-REBs

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.

Sub-REBs and Delegated Review Chapter 6 The REB delegates research ethics review to an individual or individuals. Delegates are selected from among the REB membership with the exception of the ethics review of student course-based research. This can be delegated to the department, faculty or equivalent level (Sub-REBs).

Sub-REBs Chapter 6 Therefore, if your project is eligible for Delegated Review and you belong to one of these faculties, you should submit to the Sub-REB –Psychology –Education / Music –Political Sciences –Faculty of Information and Media Studies –Law –Ivey –Arts and Humanities

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 document 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

The Consent Process Chapter 3 Subjects must be told exactly what is going to happen to them (full disclosure) Subjects must agree to participate –Letter of Information –Consent Form –Assent Form

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.

Protocol Submissions & Review Process The Office of Research Ethics sets deadlines for each of its major boards NMREB Full Board – Deadlines Delegated – No deadlines

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

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

Question & Answer Period Thank you! We are always here to help. If you have any questions please contact Grace Kelly at ext or or Julie Pfeiffer at ext or