IntegReview Ethical Review Board is an independent institutional review board (IRB) dedicated to providing unsurpassed ethical review services. The ethical principles employed by IntegReview that govern the conduct of human research are those identified in the Belmont Report; respect for persons, beneficence and justice.
An institutional review board (IRB), also known as an independent ethics committee (IEC) or ethical review board (ERB), is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans. In the United States, the Food and Drug Administration (FDA) and Department of Health and Human Services (specifically Office for Human Research Protections) regulations have empowered IRBs to approve, require modifications in planned research prior to approval, or disapprove research. IRBs are responsible for critical oversight functions for research conducted on human subjects that are scientific, ethical, and regulatory.
IntegReview complies with the regulations as defined in the United States Food and Drug Administration (FDA), Code of Federal Regulations, Title 21, Parts 50, 54, 56, 312 and 812, International Conference on Harmonisation (ICH) Guidelines for Good Clinical Practices, E6, the Department of Health and Human Services (DHHS) regulations as identified in the Code of Federal Regulations, Title 45, Part 46, other regulations as applicable, as well as local and state laws.
In November 2011, IntegReview established a Canadian Research Ethics Board (REB) to review research conducted in Canada in accordance with Health Canada’s Division 5, the TCPS 2 – 2nd Edition Tri-Council Policy Statement and the ICH Guidelines for Good Clinical Practice.
IntegReview offers IRB review of the following types of research:
- Phase I-IV biomedical research
- Medical device research
- Social and behavioral research
- Investigator-sponsored research
- Single investigator research
- Multiple investigator research
- Research conducted in academic and hospital settings
- Expedited review of research that qualifies, as identified in the Federal Register
- Expedited review of Investigators involved in multiple-investigator studies
- Projects that may be exempt from federal regulations
- Transnational (International) research
- Research conducted in Canada (Because of provincial restrictions, the IntegReview REB will not provide oversight for research in Alberta, Saskatchewan, Newfoundland and Labrador)
- Qualified delegated review (for research conducted in Canada)
IntegReview is comprised of six (6) committees that meet on a weekly basis, with one of the committees equipped to review research conducted in Canada. Unscheduled meetings may be planned to meet client needs. Each committee is comprised of highly knowledgeable, dedicated individuals with experience, training and expertise. Additional expertise is available from other consultants (scientific specialists) when required.
As an advocate for research participants, IntegReview is committed to protecting the rights and welfare of human subjects participating in research by:
- Striving to go above and beyond federal regulations
- Ensuring research is ethical and safe
- Providing education for all parties involved in research
IntegReview is committed to maintaining superior customer service without compromising ethical values by:
- Providing rapid, quality service
- Assisting clients with ethical compliance
- Demonstrating respect
- Offering flexibility
IntegReview is committed to meeting rigorous standards for quality and maintaining sound policies and procedures involved in the protection of human research participants. IntegReview has been awarded full accreditation of its human research protection program (HRPP) by the Accreditation of Human Research Protection Programs, Inc.® (AAHRPP), since June 2007. AAHRPP accreditation will expire on 9/17/2015.
Capabilities
- Turnaround of full board documents within two business days of Board review
- Turnaround of expedited documents within two business days of receipt of complete document submission
- Real-time delivery of documents to a password-protected, encrypted Internet web board (web portal)
- Secure, web-based system (iRB-Link) that allows direct submission of new study forms to IntegReview
- Weekly and as-needed meetings
- Revisions and maintenance of approved Informed Consent documents
- Informed Consent composition
- Document translation
- Competitive fees
- Quality assurance/Quality control
- Flexibility to meet client needs
- Pre-review and consultation, as requested
You may obtain answers to questions, express concerns, and convey suggestions regarding IntegReview’s Human Research Protection Program (HRPP) via e-mail to Robert Orozco, Director of Compliance or by dialing (512) 326-3001, extension 207.