Non-Medical Research Ethics Board Western University Non-Medical Research Ethics Board Reporting of Events Grace Kelly Ethics Officer grace.kelly@uwo.ca www.uwo.ca/research/ethics

Events to be Reported Protocol Changes All changes made to an approved document must be submitted to our office for review and approval BEFORE the change occurs. The new documents cannot be used until the approval has been received by your office.

Events to be Reported Deviations In the case where the change to the protocol was not provided to us before the change occurred (e.g. you have exceeded the number of study participants) then a Deviation must be submitted. Once submitted the board will decide whether or not the study data collected (outside of approval) can be used.

Events to be Reported Adverse Events All adverse events must be submitted to our office in a timely manner. Examples of adverse events include harm to a research participant during the study, death, illness (related to the research).

Events to be Reported Abuse or Neglect Anyone who has reasonable grounds to suspect a child is or may be in need of protection must promptly report the suspicion to the CAS.

How to Report Abuse or Neglect Should be reported for any child under the age of 16 immediately. The person who witnessed or heard of the abuse or neglect must be the person to file the report to CAS. Abuse / neglect must be reported even if the information is otherwise confidential. If the matter is urgent and you cannot connect with CAS, contact your local police.

Local CAS Number The Children's Aid Society of London & Middlesex http://www.caslondon.on.ca/contact-us 1680 Oxford Street East P.O. Box 7010 London ON, N5Y 5R8 Telephone: 519 455 9000 Facsimile: 519 455 4355 Toll Free: 1 888 661 6167 Email: info@caslondon.on.ca Office hours are 8:30am - 4:30pm Monday to Friday. For emergency service after regular office hours, contact 519 858 5998.

Reporting Abuse to our Office After the abuse / neglect has been reported to the CAS please file a report with our office. The report should contain the following information: The study title The study number The PI name The date the incident occurred What the incident was  Who was present at the time of the incident How this was reported to the Office of Research Ethics (initially) and the time frame How this was reported to the Children's Aid Society (and the time frame)

Resources Child Abuse Guidelines for Reporting Child Abuse and Neglect from the Ontario Ministry of Children and Youth Services  http://www.children.gov.on.ca/htdocs/English/topics/childrensaid/reportingabuse/abuseandneglect/abuseandneglect.aspx

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 Alternatively please contact our help desk at 519-661-3036