About IntegReview IRB
IntegReview IRB is an independent institutional review board that provides ethical review to approve, and conduct periodic review of biomedical, medical device, social, educational and behavioral research involving human subjects in the United States, Latin America, Japan and may collaborate with a Canadian-based IRB that conducts Canadian site reviews.
Integreview IRB is dedicated to providing unsurpassed ethical review services. The ethical principles employed by IntegReview IRB that govern the conduct of human research are those identified in the Belmont Report: respect for persons, beneficence and justice.
IntegReview is also known as an independent ethics committee (IEC) or ethical review board (ERB).
The Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) 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 IRB complies with the regulations as defined in the United States Food and Drug Administration (FDA), Code of Federal Regulations, Title 21, Parts 11, 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, Title 34, Parts 98 and 99, other federal agencies and regulations as applicable, as well as local and state laws.
IntegReview offers IRB review of the following types of research
IntegReview IRB has five (5) Boards that meet daily and can meet ad-hoc for unscheduled meetings (as needed). We review many therapeutic area and fields of research, including but limited to:
- Medical Device
- Consumer Preference
- Observational / Registry
- Research conducted in academic and hospital settings
- Expedited review procedure for research that qualifies, as identified in the Federal Register
- Humanitarian Use Device (HUD)
- Dietary Supplement
- Exempt projects
Our clients include dedicated Sponsors, CROs, research clinics, institutions, hospitals, independent researchers, educators and evaluators.
We can provide oversight in the United States and certain countries in Latin America. The following Latin American countries require local IRB/IEC review; therefore, IntegReview is unable to review research in Argentina, Brazil, Chile, Columbia, Mexico, Paraguay, Peru and Uruguay.
IntegReview can provide review of Canadian research sites / investigators.
IntegReview IRB also provides the following services:
- Board Member Consultancy (Pre-Review)
- Informed Consent Development
- PI Database - Site identification services, as requested
- Document rush requests