eREB User Manuals, Outlines and Quick Sheets
- Applicant Procedure Quick Sheet-Responding to HiREB – Provisional Approval/Deferral (March 10, 2022)
- Applicant Procedure Quick Sheet-Providing Requested Signatures (August 18, 2021)
- Applicant Procedure Quick Sheet-Login & Setup (August 17, 2021)
- Applicant Information Sheet – Folders (July 5, 2021)
- Applicant Procedure Quick Sheet – Centres (January 12, 2021)
- Confidentiality Agreement-Database, Chart Review, Tissue Applications (March 2, 2020)
- Naranjo Scale for LSAE (November 1, 2015)
- May 19, 2022: System Update: Release from Infonetica – click here for more details
- January 12, 2022: Updated “Centres” list – click here for more details
- October 15, 2021: System Update: Display Improvements – click here for more details
- July 23, 2021: System Error Notification: Auto Submit not working as expected–click here for more details
- July 7, 2021: Navigation changes for research teams – click here for more details
Researchers need to consider their in-person interactions with participants/patients, and are reminded to follow current institutional/public health policies for participant interactions.
As with previous waves, researchers will need to submit an amendment in order to transition to remote procedures (for example, virtual/remote participant interactions for consent and/or visits) if this is not already described in their current approved documents. This includes ensuring that materials are consistent with the Video Conferencing and Consent Guidelines. If you submit an amendment to address your changes given the current restrictions, please include the specific nature of the changes.
This should include:
• how you will inform the participants?
• what virtual platform you will use?
• informing the participants of the risks of that platform (see Video Conferencing and Consent Guidelines for example text)
Researchers may transition to remote visits immediately, prior to REB approval, if such a change is required to ensure the immediate safety of their participants, but this must then be reported via protocol deviation (and the amendment should be submitted to HiREB as soon as possible).
Amendments to HiREB for research protocols and documents are not required to address institutional screening requirements or vaccination policies. Inclusion/Exclusion criteria, screening scripts and tools, and data collection tools should not be impacted when researchers are solely following institutional policy.
Amendments are required if your study objectives newly require the collection of vaccination information as study data OR if your research as a whole must pivot to new methodology (e.g. remote vs in-person visits, remote consent, etc.).
Please note that these instructions relate only to HiREB submissions – institutional submissions and reviews may still apply. Please contact your research administration office for any questions about institutional requirements.
How do I manage privacy concerns when using video conferencing like Zoom?
Apps like Zoom, Webex, and MSTeams can be used, but privacy risks must be disclosed to participants in the consent. For Information, see 'Video Conferencing and Consent Guideline' in the 'Forms and Templates' tab on the hireb website
I have just obtained the last signature on my application. Is the application then automatically submitted in the eREB system?
YES! As of March 03, 2020 new forms have been published enabling the auto submission action. Once all signatures have been obtained the sytsem will automatically submit the application or sub form to the HiREB.
Signatures for persons that have access to personal health information are no longer required ?
As of March 03, 2020 the LPI no longer has to obtain signatures on the Retrospective Review of Medical Charts& Health Data application, Prospective Database Research application or the Human Tissue Research application. With the exception of the LPI you will need to have on file a completed Confidentiality Agreement-Study Member form for each person who will be reviewing/abstraction medical records/charts/health data or who will have access to this identifiable data. This form can be located on the hireb.ca website on the eREB page.
Can another individual sign the form if the LPI is away?
In general, exceptions may be made for LPIs who are on sick leave, maternity leave, sabbatical or deceased, but otherwise it is expected that the LPI would be able to sign the amendment form/approve the changes prior to submission.
If it is a paper study, or if the LPI is unable to access the eREB system unexpectedly, confirmation of the LPIs approval could be obtained via email and the email then attached to the submission signed by the Co-I. Otherwise the LPI should be signing prior to submission in the eREB system.
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Disclaimer: The Hamilton Integrated Research Ethics Board (HiREB) represents the institutions of Hamilton Health Sciences, St. Joseph’s Healthcare Hamilton, Research St. Joseph's-Hamilton, and the Faculty of Health Sciences at McMaster University and operates in compliance with and is constituted in accordance with the requirements of: The Tri-Council Policy Statement on Ethical Conduct of Research Involving Humans; The International Conference on Harmonization of Good Clinical Practices; Part C Division 5 of the Food and Drug Regulations of Health Canada, and the provisions of the Ontario Personal Health Information Protection Act 2004 and its applicable Regulations; For studies conducted at St. Joseph's Healthcare Hamilton, HiREB complies with the Health Ethics Guide of the Catholic Alliance of Canada