On January 21, 2019, the 2018 revision of the Federal Policy for the Protection of Human Subjects (aka the “Common Rule”, found in 45 CFR 46) was implemented. Research that is sponsored or monitored by the United States Department of Health and Human Services (US DHHS – NIH, NCI, OHRP) is subject to this revised regulation, within the confines of existing Canadian regulations and laws.
Please note that the office will be closed due to the winter holidays as follows:
- Monday December 24th to Wednesday December 26th, 2018
- Tuesday January 1st, 2018
For urgent requests only, the after hours emergency line is 780-999-6792.
Effective October 29, 2018 the Health Research Ethics Board of Alberta (HREBA) will be enabling improved view access to cancer studies in the IRISS system for research administration personnel at the Northern Alberta Clinical Trials and Research Centre (NACTRC). NACTRC is a joint venture between the University of Alberta and Alberta Health Services and provides administrative and operational services for research involving Alberta Health Services in the greater Edmonton area.
View access for NACTRC will be enabled according to information provided by researchers within the HREBA – Cancer Committee applications on a study by study basis.
As of October 1, 2018 all open HREBA-CC paper files have been migrated to the IRISS system. Paper/e-mail submissions are no longer accepted as all ethics files are now being processed through IRISS. E-mail info@hreba.ca if you have any questions.
The Data Migration Project is coming to an end October 1, 2018, at which point HREBA-CC will process all ethics files through the IRISS system. Paper/e-mail submissions will no longer be accepted, and HREBA will not be able to help with the migration of any remaining paper files. For details see this memo.
For cancer studies reviewed by the HREBA Cancer Committee:
- HREBA Optional Research Consent Template – Updated May 2018
- Informed Consent Form Template for Participation in a Research Study: Non-Clinical Trial Research
For studies reviewed by the HREBA Community Health Committee:
There are new HREBA Reportable Events Forms which must be used as of 01 February 2018:
HREBA Local Adverse Events Report Form (V2 01 Feb 2018)
HREBA Non-Local Adverse Events Report Form (V2 01 Feb 2018)
HREBA Additional Reportable Events Form (V2 01 Feb 2018)
There is also a new HREBA Protocol Deviation Form (V2 01 Feb 2018).
The 2018 meeting dates and submission deadlines are available for all HREBA Committees.
2018 Cancer Committee Dates and Deadlines
2018 Clinical Trials Committee Dates and Deadlines
2018 Community Health Committee Dates and Deadlines
Please note that there are no exceptions to the submission deadlines.
If your study is industry funded, please submit a HREBA Billing Information Form_Nov 2017.
- If your study is currently not in IRISS, complete the form and mail it to HREBA.
- If your study is in IRISS, upload the completed form to the “REB Service(s) Fee” section.
A Reportable Events Module in IRISS is available for those who have studies reviewed by the Cancer or Clinical Trials Committees.
Guidance is available for those who need to know what events are significant enough to report.