Before any research studies can begin, the study protocol must be submitted to research ethics board (REB), also known as an ethical review board or institutional review board. This is a committee that has been formed to approve, monitor, and review biomedical and behavioural research regarding humans. Their job is to determine whether or not research should be done. The number one priority of an IRB is to protect participants from physical or psychological harm.
Offord Centre researchers submit their study protocols to either the McMaster University Research Ethics Board (MREB) or the Hamilton Integrated Researcher Ethics Board (HiREB). They ensure our research follows Canada’s Tri-Council Policy Statement on the Ethical Conduct for Research Involving Humans. If research is being conducted in other locations (for example, in partnership with another university), the study may require ethical approval from that location’s REB as well.
The steps involved in the ethical review process are:
- The Principal Investigator (PI) writes the research proposal for the study. It should include: a literature review (with references) to support a rationale for the study; an explicit statement of the study objective/hypothesis; methodology [subject selection with inclusion/exclusion criteria, sample size justification, procedure, description and copies of measures to be used, statement of statistical procedures to be applied to the data]; detailed budget; information and consent forms; and, if applicable, any participant recruitment material (newspaper ad, posters, etc.).
- The PI completes the ethics board application form. Copies of the applications and the research proposals are submitted to the board for review.
- The REB meets once a month to examine submissions. Each protocol submitted is reviewed according to the criteria set forth by the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans.
- The REB render their decision. The study can be approved, conditionally approved pending minor changes or modifications, or rejected. If changes are needed, the PI can then make the required changes to attain full approval.
- Once approved, the study can begin. It must proceed according to the protocol submitted to the REB; if, throughout the course of the study changes need to be made, amendments can be submitted to the REB.
- REB approvals are granted for 1 year. If studies last longer than this, they must be re-approved each year.