ABOUT US



ABOUT US

IRB Services meets the highest standards in both Canada and the United States. IRB Services parent company Chesapeake IRB is a US Company has been certified for 21 CFR Part 11 FDA Compliance. Health Canada has visited IRB Services facilities and the company is registered with a number of Provinces, allowing the organization to conduct reviews in more provinces and territories in Canada than any other IRB.

FDA/OHRP IORG Registration # IORG0000456

Please note: currently there is no official registry for research ethics boards in Canada, though IRB Services has official recognition on a provincial level and can conduct reviews in more provinces and territories in Canada than any other central IRB. All boards are federally registered in the United States with U.S. FDA/OHRP. IRB Services is a member of CAREB (Canadian Association of Research Ethics Boards), and PRIM&R (Public Responsibility in Medicine and Research). All ethics committees of IRB Services have been individually inspected and granted full accreditation by AAHRPP.

Background

Regulatory authorities in the United States and Canada require an Ethics Review of proposed clinical study programs before research can be carried out on human subjects.

CHALLENGES

Often qualified investigators, especially non-hospital or non-university based clinicians, have limited or difficult access to an Ethics Review Board. There are hospital based review boards but many have full review agendas near term, potentially resulting in lengthy review delays. Institutional Review Board Services - IRB Services (IRBS) was founded in 1993 in response to an industry demand to expedite Ethics Review of proposed clinical research in Canada, USA and elsewhere. IRB Services was founded with a mission to protect Human research participants, provide rapid turnaround times and conduct thorough ethical reviews that can withstand the scrutiny of regulatory bodies.

Confidentiality

IRB Services information systems are designed to keep all proprietary and sensitive information confidential and subject to applicable laws and regulatory guidelines.

Statement of Compliance / Attestation

The Institutional Review Boards (Independent Ethics Committees / Research Ethics Boards) of Institutional Review Board Services (IRBS) carries out its functions in accordance with good clinical practices (e.g., ICH GCP Guidelines) and Health Canada regulations and in compliance with FDA 21 CFR parts 50 and 56, DHHS 45 CFR part 46, and the Tri-Council Policy Statement for Ethical Conduct of Research Involving Humans, as appropriate to the research.

Institutional Review Board Services is registered with the FDA/OHRP # IORG0000456.Both boards of IRB Services are federally registered in the United States and have been individually inspected and accredited by AAHRPP. We have been successfully inspected by the U.S. FDA in 2012 without any findings.

The IRBs of IRB Services are registered with OHRP and U.S. FDA as follows:

  • ON IRB registration #IRB00000776
  • QC IRB registration #IRB00005290

Clients

The review boards of IRB Services review hundreds of protocols annually, sponsored by industry,government, and academia. Industry sponsors include many of the world's largest pharmaceutical, device or consumer product companies through to the smallest start-ups. Public sponsors include institutions such as the NIH, VA, CIHR. IRB Services conducts reviews for complex international studies. Some reviews have included American (U.S.) and Canadian multi-centre research, with investigators located in multiple provinces and states, with a Central IRB in Asia, and "oversight" IRBs located elsewhere to ensure compliance with U.S. FDA standards.

Conflict of Interest

IRB Services (IRBS) is a stand-alone entity not founded by or related to any SMO, CRO, investigator or manufacturer. Committee members are independent and compensated on a consulting basis, irrespective their determination regarding each study reviewed. Board members are completely independent of IRB Services and have no financial or other interest in IRB Services or its parent Company, Chesapeake IRB.

Reviews, not approvals - there is no guarantee that any research proposal will be approved if found not to meet standards. Furthermore, IRB Services (IRBS) is an independent company that does no contract research, or clinical research of its own and, it has no financial interest in the research projects it reviews. All reviews are strictly at arm’s length.

Limitations

The IRB of Institutional Review Board Services will review research involving human subjects or anonymous human tissue samples obtained from the federal government agencies or other organizations, so long as it conforms to generally accepted ethical precepts and will be conducted or sponsored by credible organizations that will operate in accordance with applicable local, national, and international laws and standards. IRB Services retains the right to refuse to accept research proposals for review at its sole discretion.

Research in the following categories is typically not accepted for review but may be accepted on a case-by-case basis, provided that it is in conformance with applicable legal, regulatory and ethical requirements and IRB Services standards:

  • Research that has been previously rejected by any other IRB/REB without complete correspondence regarding the previous review(s) and, if appropriate, adequate justification of why the research project should be considered as acceptable for review. IRB Services reserves the right to refuse to accept any application, even if such previous correspondence and justification are received. Should a research project previously rejected by another ethics committee be accepted for review, IRB Services in no way guarantees approval in whole or part, and has the right to disapprove the research on scientific, ethical or other grounds.

  • Some kinds of populations or other genetic research.

  • Gene alteration (including “gene therapy”) that involves human germline cells or human embryos is not ethically acceptable. Gene alteration for therapeutic purposes and involving human somatic cells may be considered for approval.

  • Research involving human embryonic stem cells provided that it is consistent with the applicable guidelines (for example, Canadian Institutes of Health Research Guidelines for Human Pluripotent Stem Cell Research or National Institutes of Health Guidelines for Human Stem Cell Research).

The following types of research are not accepted for review:

  • Research involving human cloning or use of fetal tissue

  • Research involving pregnant women, non-viable neonates, neonates of uncertain viability or fetuses (that is subject to 45 CFR 46 Subpart B)

  • Research involving prisoners (that is subject to 45 CFR 46 Subpart C)

  • Research in emergency settings conducted in the US and/or under a US IND (that is subject to 21 CFR 50.24 and 46.101(i)).

  • Research involving wards of the State or other agency, institution or entity (that is subject to 21 CFR 50 Subpart D 50.56 Wards, and 45CFR46.409 Wards)

  • Research involving the use of reproductive tissue (e.g., ova or sperm) that have been obtained through commercial transactions, including exchange for service.

  • Research involving the creation, or intention to create, hybrid individuals, human clones or chimeras (refer also to the Assisted Human Reproduction Act).