IRB Services | IRBS ETHICS REVIEW

ETHICS REVIEW

BACKGROUND

Regulatory authorities in the United States and Canada require Ethics Review before research can be carried out on human subjects. Often qualified investigators, especially non-hospital or non-university based clinicians, appear to have limited or difficult access to an Ethics Review Board. Alternatively, hospital based review boards may have full agendas, and the review process may be an extended one. As a result, the proposed research can be delayed, sometimes for months, while awaiting Ethics Review. Institutional Review Board Services (IRBS) was founded in 1993 in response to a perceived need for a mechanism to expedite Ethics Review of proposed clinical research in Canada and elsewhere. Quick turnaround times and reviews that can withstand the scrutiny of regulatory bodies are the core of the Company's mission.

GOVERNANCE

The Institutional Review Board (Independent Ethics Committee / Research Ethics Board) of Institutional Review Board Services is constituted and operated according to the rules and regulations as detailed in the Canadian Food & Drug Regulations, Division 5 (Clinical Trials), ICH GCP E6, the Canadian TCPS, U.S. CFR Title 21 Parts 50 and 56, and CFR Title 45 Part 46. Institutional Review Board Services also holds a Federal Wide Assurance with the US Office of Human Research Protections.

CLIENTS

The IRB reviews hundreds of protocols annually, sponsored by both industry and government. Industry sponsors include most of the world's most recognized brands. Public sponsors include the NIH, VA, CIHR. Reviews have been American and Canadian mult-centre research, with investigators located in most provinces and states, Asia as a Central IRB, and elsewhere as an "oversight" IRB to ensure compliance with FDA standards.

LIMITATIONS

The Ethics Review Board of Institutional Review Board Services limits itself to research on human subjects conducted or sponsored by credible organizations that will operate in accordance with applicable local, national, and international laws and standards. No research will normally be approved if previously rejected by any other IRB /REB unless in conformance with regulatory requirements and the IRB's standards. In general, research involving cloning, fetal tissue, gene transfer, some kinds of population or other genetic research and prisoners will not be accepted for review. The IRB will review anonymous tissue samples to be obtained from the NIH / NCI or other government agency, so long as it conforms to generally accepted ethical precepts.

CONFIDENTIALITY

Confidentiality of all proprietary information is assured, subject to applicable laws and regulatory guidelines.

CONFLICT OF INTEREST

Institutional Review Board Services is a stand-alone entity not founded by or related to any SMO, CRO, investigator or manufacturer. Committee members are compensated on a consulting basis, irrespective of an affirmative or negative opinion about any research proposal. None of the voting members holds any other financial or other vested interest in the company whatsoever for reviews, not approvals - there is no guarantee that any research proposal will be approved if found not to meet standards. Furthermore, as Institutional Review Board Services (IRBS) is an independent company that does no contract research, or conduct clinical research, nor is an offshoot of any company or entity that does, it has no financial interest in research projects it is asked to review - all reviews are strictly at arms length.