research ethics western university & university of windsor grace kelly ethics officer...
TRANSCRIPT
Research Ethics
Western University & University of Windsor
Grace Kelly
Ethics Officer
Today’s Agenda
•When is ethics approval required?
•Where are you required to submit?
•Which Research Ethics Board to use?
•Protocol submissions and Review Process
•Question and Answer Period
Research Ethics Workshop
When is Ethics Approval Required?
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 please contact our office first.
When is Ethics Approval Required?
The following require ethics review and approval 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 Required?
Quality assurance and quality improvement studies, program evaluation activities, and performance reviews, or testing within normal educational requirements when used exclusively for assessment, management or improvement purposes, do not constitute research for the purposes of this policy, and do not fall within the scope of REB review.
Where are you required to submit?
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 Windsor campus or one of the Windsor hospitals you may also need to obtain ethics from that institution. Please contact the institution for confirmation, based on your particular project.
Where are you required to submit?
When obtaining ethics it is generally best to receive ethics approval from your home institution first (i.e. if you are a Western University student, from Western University first).
As mentioned above, once you have received approval from Western you should contact the institution where the research will be carried out to ask if additional approval is needed and what level of approval is needed based on your particular project.
Which Research Ethics Board to Use?
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 Level 1, Delegated Level 2
Delegated Review
Any 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.
Delegated Review
Delegated Review Level 1
Research which includes for example chart reviews, database or registry creation, analysis of tissue samples.
Research which does not involve participant contact.
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.
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 1 – No deadlines
Delegated Level 2 – Deadlines the same as HSREB Full Board
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 by 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 519-661-2111 ext. 84692 or [email protected]
or
Julie Pfeiffer at 519-661-2111 ext. 86811 or [email protected]
