The Health Research Ethics Board: Health Panel (REB 3) and Biomedical Panel (REB 4) are organized and operate in compliance with the TCPS2 (2014) Tri-Council Policy Statement: Ethical Conduct for Research Involving Human Participants, International Conference on Harmonization (ICH) E6, Good Clinical Practice (GCP), Part C Division 5 of the Canadian Food and Drug Regulations and the Canadian General Standards Board (CGSB 191.1 2013).
Where required, the Health Research Ethics Board complies with FDA regulations 21 CFR Parts 50 and 56, HHS regulations 45 CFR 46. The Health Research Ethics Board (Health Panel) and (Biomedical Panel) are registered with OHRP/FDA; the Health Panel IRB registration number is IRB00010106 and the Biomedical Panel IRB registration number is IRB00000927. The Federal Wide Assurance number for both Panels is FWA00000077.
HEALTH CANADA REB ATTESTATION
It is the Health Research Ethics Boards' policy not to sign individual Health Canada REB Attestation Forms. This letter serves as a substitute for this form, and is be taken into consideration along with any specific study approval that will be issued, as fulfilling the requirements set forth by Health Canada in regards to REB Attestation.
The Guidance for Clinical Trial Sponsors issued by Health Canada states that either the REB Attestation or similar documentation, meeting the requirements of Part C, Divisions 5 of the Food and Drug Regulations, is acceptable. To this end, the Health Research Ethics Board certifies that:
The membership of the Health Research Ethics Board complies with the membership requirements of Research Ethics Boards defined in Division 5 of the Food and Drug Regulations;
The Health Research Ethics Board carries out its functions in a manner consistent with Good Clinical Practices. Furthermore, members of the Health Research Ethics Board who are named as Investigators in research studies do not participate in discussions related to, nor vote on such studies when they are presented to the Committee.
USE OF ELECTRONIC SIGNATURES IN ARISE
ARISE (formerly called REMO) is compliant with US FDA 21 CFR Part 11 – Electronic Records. User entered usernames and passwords are sent to a campus-wide LDAP server for authentication over https. When user roles are assigned with ARISE, each role is evaluated based on the user’s valid relationships with the University which are provided by an Identity-Management System. ARISE uses a digital signature which means that the name of the signer is the name of the person who executed a particular action in ARISE. This is always printed in the History Log and, in the case of correspondence, in the letters themselves. The date and time when the signature was executed equals the data and time when the corresponding activity was executed, and the date and time are always indicated in the History Log. Finally, the ARISE system uses Secured Sockets Layer for communication over network with appropriate SOPs for controlling physical access to the servers.