Full Board Review
This is the default that will apply unless there is sufficient justification for other levels of review. The HiREB uses proportionate review which determines if the research is greater than minimal risk (full Board review) or minimal risk (Delegated review).
Submissions are reviewed in the order of their arrival in the electronic eREB system. There are 2 submission deadlines per month, these being the second and last Tuesday of every month. Please see the www.www.hireb.ca website under Meetings & News for submission and meetings dates
Delegated Review
Studies that may qualify for delegated review:
- Are considered either minimal risk and non-invasive (e.g. retrospective chart reviews, non-intrusive questionnaires or surveys, non-invasive assessments, use of existing samples), or
- Involve only current standards of care, or
- Have had prior approval from the HiREB. Studies that have been approved by the HiREB or another REB are not considered for delegated review unless the relevant documentation (REB review letter, reply to any REB concerns and approval letter) is provided.
- The local principal investigator must include the justification for requesting delegated review. The decision of whether a study qualities for delegated review rests with the HiREB Chair.
Process
All applications receive in-depth review by two Board members and the Chair. Greater than minimal risk studies are presented, discussed, and evaluated at a full Board meeting. Minimal risk studies do not require approval by the full Board; instead, the outcome of their review is ratified at the next full
Board meeting.
The REB may vote to approve the application as submitted, to approve provisionally, with conditions, to defer a decision with recommendations for (usually major) changes, or to disapprove the application. Research may begin as soon as the local principal investigator receives a letter of authorization/final approval from the HiREB Chair indicating approval to proceed. Approval may be withdrawn (very rarely) by the Medical Advisory Committee, Board of Directors, or Joint Boards of Governors to whom all approvals are sent for review. A letter indicating the HiREB decision will be sent to the local principal investigator by the HiREB Chair, usually within one month of the submission deadline.
If the approval is conditional on modifications being made, research may not begin until these modifications have been verified and approved by the HiREB Chair and final approval has been provided.
All forms and correspondence submitted to the HiREB for review and/or approval from the REB must be signed by the Local Principal Investigator.
A Collaboration of
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