Changes in approved research studies may not be initiated without prior REB review and approval. The only exception to this rule is when a change is necessary to eliminate apparent immediate hazards to human participants.
Researchers must submit an Amendment Application Form through the Research Services Portal (see right) for both major and minor amendment.
Fees for ethical review, amendments, and annual renewals are ONLY charged in 'for-profit' studies, such as sponsored clinical trials.
Please contact us if you are unsure if your study is required to pay fees.
Please refer to our Research Ethics Review Fees for clarification.
Amendments to the study structure and documentation are classified as minor, major or no fee amendments. For-profit studies will be levied a fee of $500 per major amendment, and $250 for minor amendment.
Major Amendments – any change to the study design and documentation that impacts the assessment of potential risk to participants. The following are considered major amendments:
- must be reviewed at a full board meeting as they are funded or supported by the US Federal government or are subject to the regulations of the US Food and Drug administration (21 CFR Part 56 Subpart C, Section 56.110);
- addition of genetic testing, new genetic tests, or tissue banking where genetic testing may/or will be performed;
- addition of an open label extension phase following a randomized trial;
- change in drug dosing/duration of exposure;
- decrease in monitoring of participants;
- change in recruitment technique that may affect confidentiality or the perception of coercion;
- change in experimental procedure or study population, including changes that affect the selection, monitoring, or dismissal of a clinical trial participant;
- any amendment that requires notification of and/or approval from Health Canada;
- significant changes to or additional study documentation such as participant information sheets, consent forms, questionnaires, letters of invitation, letters to GPs or other clinicians, information sheets for relatives or carers;
- a change of sponsor(s) or sponsor’s legal representative;
- appointment of a new PI or key collaborator;
- a change to the insurance or indemnity arrangements for the study;
- temporary halt of a study to protect participants from harm, and the planned restart of a study following a temporary halt;
- increased enrolment over and above what was requested in original application;
- change to the definition of the end of the study (not just extending the duration);
- updated Investigator’s Brochure (IB) with change in possible risk to participant; and
- changes to research involving US Federal funding in the study.
Minor Amendments – any other change to the study documentation, including:
- updated IB with no change to risk to participant – does not include detailed summary of changes
- minor changes to protocol, study design or other documentation – clarifications that do not increase the risk to participants
- expanding recruitment to additional department or location within Island Health
- addition of or changes to the Co-Investigator(s);
- changes to contact details for the sponsor, PI, or other study staff member;
- changes in funding arrangements;
- changes in the logistical arrangements for storing or transporting samples;
- extension of the study beyond the period specific in the application form; and
- inclusion of new sites and investigators in a clinical trial of investigational medicinal product.
No Fee Amendments
- minor administrative changes to the protocol or other study documentation, e.g. correcting errors, updating contact points;
- updated IB with no change to risk to participant – includes detailed summary of changes from previous IB;
- changes to the research team at trial site(other than PI or Co-Investigator);
- other materials given to participants (bags, birthday cards, expense forms, coffee mugs, newsletters, dosing diary, etc.); and
- changes in the documentation used by the research team for recording study data.