IRB Services is a service-driven organization striving for excellence in human research participant protection and committed to providing efficient customer-oriented services by:
- Maintaining an effective Human Research Protection Program to protect the rights and welfare of human participants in research reviewed under the auspices of our IRBs.
- Partnering with sponsors, CROs, institutions and researchers to promote scientifically and ethically sound research.
- Continuously evolving our processes to exceed customer expectations as well as applicable regulatory, legal, and ethical requirements.
- Being advocates, in the research community and with peers, regulators and the public, for the ongoing evolution of these standards.
We aim to cultivate a culture of conscience both within our organization and all organizations with which we interact.
Please click on the relevant link to download the document your require. Documents are a PDF version. To ensure maximum compatibility please have the current version of the Adobe® Acrobat. Should you have any questions regarding any of these forms please do not hesitate to contact us info@irbservices.com.
General Guidance: Investigator Reporting Requirements
The purpose of this guidance document is to provide instructions to investigators, contract research organizations (CROs) and sponsors about the investigator reporting obligations to the IRB.
General Guidance: Investigator Reporting Requirements
FDA Guidance for Industry
Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects
This guidance provides an overview of the responsibilities of a person who conducts a clinical investigation of a drug, biological product, or medical device (an investigator as defined in 21 CFR 312.3(b) and 21 CFR 812.3(i)). The goal of this guidance is to help investigators better meet their responsibilities with respect to protecting human subjects and ensuring the integrity of the data from clinical investigations. This guidance is intended to clarify for investigators and sponsors FDA’s expectations concerning the investigator’s responsibility (1) to supervise a clinical study in which some study tasks are delegated to employees or colleagues of the investigator or other third parties and (2) to protect the rights, safety, and welfare of study subjects.
2009_FDA guidance_Investigator Responsibilities.pdf
Health Canada's GCP Pre-inspection Package
Health Canada's pre-inspection package which will assist Canadian research sites in complying with Health Canada regulations and preparing for an inspection by the Health Product and Food Inspectorate.
GCP pre-inspection.v1_en.pdf
IRB Services is a service-driven organization striving for excellence in human research participant protection and committed to providing efficient customer-oriented services to research sponsors. Our goal is to partner with you and researchers to promote scientifically and ethically sound research. We aim to cultivate a culture of conscience both within our organization and all organizations with which we interact.
When working with IRB Services you can simply expect more.
- multiple Boards with frequent meetings
- rapid reporting of Board decisions
- e-submissions for sponsors and sites
- streamlined applications focused on essential information
- experienced and service oriented support staff
- dedicated teams for unique needs of various study phases:
- Phase I & Special Projects Team
- Phase II - IV Team
- Continuing Review Team
Sponsors / CROs
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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 - IRB 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 IRB Services (IRBS) 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 review boards of IRB Services review hundreds of protocols annually, sponsored by both industry and government, and academia. 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.
Confidentiality
Confidentiality of all proprietary information is assured, subject to applicable laws and regulatory guidelines.
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 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.
Reviews, not approvals - there is no guarantee that any research proposal will be approved if found not to meet standards. Furthermore, as IRB 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.
Limitations
The review boards of IRB Services (IRBS) will review research on human participants or research involving 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 (IRBS) 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 accepted on a case-by-case basis, provided that it is in conformance with applicable legal, regulatory and ethical requirements and IRBS 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. IRBS 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, IRBS 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 population 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 prisoners (as per 45 CFR 46 Subpart C).
- Research in emergency settings conducted in the US and/or under a US IND (as per 21 CFR 50.24 and 46.101(i)).
- Research involving wards of the State or other agency, institution or entity (as per 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).
