Any changes to the study protocol, investigator brochure, consent form, study instruments, recruitment materials, and/or funding must be detailed on an Amendment form.  Additionally, any changes to the LPI, PI, Co-investigator(s) and/or study coordinator must also be reported to the HiREB using an Amendment form.

If, in the investigator’s opinion, these changes could affect a participant’s willingness to participate, or adversely affect the risk/benefit ratio, an amended consent form must be submitted and further enrollment must be halted until the investigator has written approval to continue.  In some cases, re-consenting of all study participants may be necessary.


  • Advertisements (including social media) for recruitment purposes not submitted at the time of initial application must be approved by the HiREB prior to use.
  • Any changes in reimbursements or incentives must be approved prior to implementation.
  • Any planned inclusion/exclusion waivers or protocol deviations that are predicted should be submitted on an Amendment form.
  • Any inadvertent deviation/violation must be reported to the HiREB on the Protocol Deviation form

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