IRB (institutional review board)

An institutional review board (IRB) is the committee that reviews research involving human subjects and has the authority to approve it, require changes, or disapprove it.

How it works in a university-industry collaboration

Under the federal Common Rule, an IRB reviews the human-subjects research the policy covers, with the authority "to approve, require modifications in (to secure approval), or disapprove" it (45 CFR 46.109). Studies that need review by the full board are, with some exceptions, reviewed again at intervals that match their risk, at least once a year. FDA has its own IRB rules for the clinical investigations it regulates, and they apply to company sponsors too (21 CFR 56).

If a company-funded project involves people, such as a user study, clinical samples, or survey data, the university's IRB usually reviews the university's part. Approval has to be in place before that work starts, and it has to stay current. Projects stall when nobody owns the renewal date, so name an owner at the kickoff meeting.

Translation Box: IRB

On the academic side: the university's own committee, and a routine step for any human-subjects work, with its own forms, timelines, and check-ins.

On the industry side: called an ethics committee in many countries, and for clinical work a sponsor may use an independent IRB. The company's question is usually when the work can start, which depends on the approval date.

What Helikon does with it

On the Helikon platform, a project records whether IRB approval is needed, when it was approved and when it expires, and the approval letter itself, attached from the project's files.