Organizations engaged in research involving humans are required to have proposed projects reviewed by a research ethics board (“REB”). Under the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (the “Policy”), an organization is responsible for establishing or appointing a REB to review the ethical acceptability of research involving humans which is conducted within its jurisdiction or under its auspices, including approving, rejecting, proposing modifications to or terminating any proposed or ongoing research.
There are many instances where organizations, due to their small size and/or limited resources, seek support for this function from other organizations that have established REBs. Under Article 6.1 of the Policy, organizations are permitted to appoint an external REB to act as its REB of Record provided that there is an official agreement between the parties.
Whether yours is the organization seeking to use the REB of another party as its REB of Record or is the organization that is willing to allow use of your REB by a third party, a formal contract – an REB of Record of Agreement – is required. When implementing an REB of Record Agreement, parties should turn their minds to certain key risk management considerations, including the following:
- the availability of REB time and resources;
- the willingness of REB volunteer members to assume additional responsibility;
- conflict of interest;
- allocation of risk and responsibility; and
If you are engaging in an REB of Record arrangement as user or provider, the Health Industry Group would be pleased to discuss available options and strategies and provide support in implementing your REB of Record Agreement.