Importance of Institutional Review Boards
When you’re doing a clinical study that involves the use of human subjects, Institutional Review Boards, or IRBs, will be involved. IRBs are third party reviewers that assure protection of the rights and welfare of human subjects. MRIGlobal has a registered in-house IRB in compliance with all necessary regulations.
We can help navigate the entire process as FDA clearance consultants.
How does the FDA define an IRB?
FDA regulations define an IRB as a formally designated group intended to review and monitor biomedical research involving human subjects. An IRB has authority to approve, require modifications in, or disapprove research. The purpose of independent review boards is to assure steps are taken to protect human rights and welfare when they participate as subjects in the research.
How do IRBs work?
There is a group process to review research protocols and related materials, such as informed consent documents, to ensure the rights and welfare of the human subjects are protected.
Besides having an in-house IRB for this process, MRIGlobal staff are experienced in the types of research protocols and documents that will ensure the assure protection of the rights and welfare of human subjects and secure approval from the IRB.
Develop your diagnostic product or design your studies with MRIGlobal
We are here for all of your diagnostic needs. Our CLIA-certified high complexity labs can perform reference testing. We can serve as a beta site to give usability feedback on a device or software that’s being tested, and we can help with research and development. If you have a high-level idea, but lack the technical expertise, we can bring your idea to fruition. From the pre-submission before testing to executing the testing itself and beyond, we’re one of the most comprehensive research firms for FDA clearance.
Whether you’re submitting to the FDA or regulatory agencies around the world, we can support you. From the biggest names in diagnostics to startups, we’ll make sure the process doesn’t overwhelm and that your diagnostic is submitted for clearance.