Guidelines - Summary of Changes

Effective October 1, 2009

IMPORTANT CHANGES TO REB GUIDELINES

It is the responsibility of the Health Sciences Research Ethics Board to review protocols for biomedical and clinical research involving human participants to ensure compliance with regulations and guidelines from the Tri-Council, Health Canada, ICH:GCP, the U.S. Office for Human Research Protection and others.  As these regulations change and as technology progresses, the guidelines under which the HSREB operates often need updating.   At recent meetings of the University Council on Research Ethics revisions of several HSREB guidelines were approved.

WHAT'S NEW?

Guideline 2-G-015: has been revised with minor wording modifications to note that there are exclusions to the reporting of Protocol Deviations as permitted by Health Canada.

Guideline 2-G-028: regarding research protocols that may pose a risk to pregnancy, a foetus, or subsequent child. The guidelines have been consolidated and modified to provide consistency in approach.  Formerly noted in three separate guidelines, information and direction on this topic can now be found in one guideline.

Guideline 2-G-004, the guideline for Use of Magnetic Resonance Imaging has been modified significantly in its format, and suggested/required wording for information documentation and requirements for level of review.  The revised guideline was a collaborative effort and included input from researchers, staff and imaging experts.  If you are involved in the preparation of research protocols involving the use of MRI, please review the revised guideline.

Guideline 2-G-007, Categories of Initial Review have been revised.  Section 3.7 has been revised to include MRI of up to 8.0T in healthy adult participants at the Delegated level.  Section 1.0, the introduction to this guideline has also been revised to note that Delegated review does not imply a faster review, only that it is a review of minimal risk studies.  If the Delegated reviewers do not have the expertise to adequately review the protocol in question they may refer it to an ad hoc expert or to the full HSREB for review.

We are setting up an email distribution list so that we can send notices regarding guideline changes, process changes and clarifications directly to interested sites.  If you would like to be included in these emails, please advise Susan Underhill at sunderh2@uwo.ca with appropriate contact information.

As always, if you have questions or require clarification regarding research ethics issues, please do not hesitate to contact the Office of Research Ethics.