The Human Biomedical Research Act, recently passed in Parliament, is a complex piece of legislation that will have a significant impact on the way human biomedical research is conducted. The law includes new, criminally enforceable requirements for consent, documentation, IRB organization and administration as well as researcher, IRB and research institution responsibilities. (The law also contains requirements for tissue research, but this workshop will focus on the non-tissue provisions of the law). While the law is not yet in force and detailed regulations pursuant to the Act have yet to be promulgated, it is important for researchers, IRB members and institution administrators to understand the basics of the law and begin exploring how they may have to adapt.
For this workshop, we will focus on three aspects of the Act:
The scope of the Act: ‘Human biomedical research’ is carefully defined within the act, but some confusions may arise. We will discuss and help clarify what sort of research will be regulated under the act.
Consent requirements: The Act lays out a detailed set of requirements for the consent process, including the information to be conveyed and conditions under which consent may be waived. We will survey these requirements and look carefully at how they can be implemented.
New responsibilities: Researchers, IRBs and research institutions all have specific responsibilities delineated under the Act, including procedures to be followed, reports to the Ministry of Health, and accountability for the ethical conduct of biomedical research. We will explain those responsibilities and explore strategies for ensuring that they are met.
Each of the three topics will be introduced to attendees by our staff, followed by interactive discussion among breakout groups of cases that will help flesh out the intricacies of each topic. The workshop will then reconvene to synthesize what groups had discussed, clarify confusions that may have emerged, and draw lessons for broader practice.
Registration is free and open, but spaces are limited to 80 attendees, so sign up early to guarantee a place.