Statement of Compliance
Sterling Institutional Review Board (IRB) is duly constituted, has written procedures for initial and continuing review of clinical trials, prepares written minutes of convened meetings, and retains records pertaining to the review and approval process.
Sterling IRB is organized and operates in compliance with the U.S. Department of Health and Human Services regulations 45 CFR Part 46, the U.S. Food and Drug Administration regulations as described in 21 CFR Parts 50 and 56, and adheres to the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines. Sterling IRB is registered with OHRP/FDA; our IRB registration number is IRB00001790, parent organization number is IORG0001354.
Where applicable, Sterling IRB complies with Part C Division 5 of the Canadian Food and Drug Regulations and the Tri-Council Policy Statement.
Since 2010, Sterling IRB has been fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
Sterling Institutional Review Board’s primary responsibility is to protect the privacy, safety, and welfare of the human subject participating in research.
Health Canada REB Attestation
It is Sterling IRB’s policy not to sign individual REB attestation forms for Health Canada regulated research. The Health Canada Guidance for Clinical Trial Sponsors states that REBs may develop similar documentation that meets the requirements of Part C, Division 5, of the Food and Drug Regulations. Consistent with this guidance, the attestation below, in conjunction with any specific approval issued by Sterling IRB, will serve as the research ethics board attestation in lieu of the form provided by Health Canada.
In respect of the identified clinical trial, I certify, as a representative of the Sterling IRB North American panel that:
- The membership of the Sterling IRB North American panel complies with the membership requirements for REBs defined in Part C, Division 5, of the Food and Drug Regulations;
- The Sterling IRB North American panel carries out its functions in a manner consistent with Good Clinical Practices; and
- The Sterling IRB North American panel has reviewed and approved the clinical trial protocol and informed consent form for the trial. The approval and the views of the Sterling IRB North American panel have been documented in writing.