Effective May 3, 2004, all applications for approval by the CAMH Research Ethics Board of protocols, amendments or renewals must be accompanied by evidence of successful completion of the Tri-Council Policy Statement (TCPS-2) tutorial which can be accessed through http://www.pre.ethics.gc.ca/eng/education/tutorial-didacticiel/ Researchers who have already completed the NIH course may also wish to take the new TCPS-2 course but this is not mandatory.
EACH member of the research team must complete the course and supply Research Ethics Office. of CAMH Research Ethics Office with a copy of their certificate of completion. This requirement applies independent of source of study funding, although applicants for NIH funds must, in addition, take the NIH course.
Investigators must fill out the CAMH "Final Report for the Research Ethics Board" form and provide it to the CAMH Research Ethics Office upon completion of each study approved by the CAMH REB. If the study has NOT been completed or terminated, and needs to be renewed, please fill out the CAMH Annual Renewal of Ethics Approval form.
If a study is to be conducted only with external grant funding, the protocol will not be reviewed until the investigator indicates that the funding application has been successful and funds have been awarded. Investigators are free to submit their protocols prior to notice of funding but they will not be reviewed until funding has been confirmed.
If your study will be externally funded, please submit three (3) copies of your contract OR grant, including the budget, with this protocol form.
If your study will be internally funded, please submit three (3) copies of the budget with this protocol form.
Investigators are reminded that it is THEIR responsibility to renew Research Ethics Board approval on a regular basis. Approvals are given for at most 12 months and must then be renewed. If a study has finished recruitment and data analysis has been completed then a Final Report Form must be completed. Please refer to link for forms.
Investigators are reminded that approvals from the Research Ethics Board (REB) for studies/amendments which involve application to Health Canada are conditional upon approval by Health Canada. Therefore the study/amendment cannot be initiated until both approval from the REB and Health Canada have been obtained.
Effective immediately,scientists who wish to conduct PET Studies which involve a Clinical Trials Application to Health Canada must first obtain a completed form from Irina Vitcu, PET Centre, prior to any REB submission. This rule applies to both new protocols and study amendments.
CONSENT FORM CLINIC:
Are you having trouble drafting a consent form for your research study?
Do you want to learn more about CAMH, Research Ethics Board consent requirements?
If so, please contact Susan Pilon (Susan.Pilon@camh.ca) to arrange to meet with her for consent form advice.
NEW: Additional consent form information. Please include in all consent forms the following information:
"As part of the Research Services Quality Assurance Program, this study may be monitored and/or audited by a member of the Quality Assurance Team. Your research records and CAMH records may be reviewed during which confidentiality will be maintained as per CAMH policies and extent permitted by law".
Please verify if your consent forms reflect recent changes in the phone extension of the REB Chair, Dr. Padraig Darby. The new extension is 36876.
NEW: REB Update: Reminder and Changes in REB Requirements for Advertising for Research Subjects.
Please refer to link for this information.
New: GCP Training
As an academic health science center, it is essential that CAMH and researcher and research personnel ensure that research is conducted in compliance with federal, provincial, local and institutional regulations in order to ensure the safety of research participants. Compliance with Good Clinical Practice (GCP), which currently is the only international standard for conducting research, is important in ensuring the validity and credibility of research data by encompassing the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of human subject research studies. GCP also provides assurance that the rights, safety, confidentiality and well-being of research participants are protected.
GCP training is a CAMH requirement and must be completed prior to REB submission. Please contact the Research Training Coordinator for more information regarding GCP training.
Kindly send GCP certificates directly to the Training Coordinator and not to Research Ethics Office.