Human subjects protection review board

A human subjects protection review board is a committee that reviews, approves and monitors research involving human participants to ensure that their rights and welfare are protected. In the United States the statutory term is Institutional Review Board (IRB), governed by the Common Rule (45 CFR Part 46) and FDA regulations (21 CFR Parts 50 and 56); in Europe the equivalent bodies are ethics committees under the Clinical Trials Regulation and national law. Other jurisdictions use terms such as research ethics board (Canada) or human research ethics committee (Australia).

Whatever the name, the board assesses whether risks to participants are minimised and reasonable in relation to anticipated benefits, whether selection of participants is equitable, whether informed consent will be sought and documented appropriately, whether vulnerable populations such as incapacitated subjects and minors receive additional protections, and whether adequate provisions exist to protect privacy and maintain confidentiality of data.

For sponsors running multinational trials, the practical challenge is reconciling different boards' expectations on consent language, international data transfers, future use of samples and re-contact. A US central IRB will apply HIPAA authorisation requirements, while a French CPP will look for GDPR Art. 13 information and MR-001 compliance. Preparing a global consent template with country-specific data protection annexes, and aligning it with the DPIA, avoids inconsistent submissions and protocol deviations.