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
- Medical Device
- Social and Behavioral
- Consumer Preference
- Observational / Registry
- Research conducted in academic and hospital settings
- Expedited review procedure for research that qualifies, as identified in the Federal Register
- Exempt projects
- Humanitarian Use Device (HUD)
- Global education and evaluation projects
- Stem Cell
Our clients include dedicated Sponsors, CROs, research clinics, institutions, hospitals, independent researchers, educators and evaluators.
We provide IRB review & oversight in the U.S., Latin America, Japan, and we collaborate with a Canadian-based IRB that conducts Canadian site reviews.