Research on human subjects must be reviewed by an independent committee before it begins. That committee is the Institutional Review Board, and its job is to protect the rights and welfare of participants. The IRB reviews the protocol, the consent form, and the recruitment materials. It assesses whether the risks are minimized, whether the benefits justify the risks, whether participant selection is fair, and whether informed consent will be properly obtained. It has the authority to approve, require modifications, or reject a study. It also monitors ongoing research and can suspend a study if problems arise.

IRBs are composed of at least five members with varied backgrounds, including at least one scientist, one non-scientist, and one person who is not affiliated with the institution. This mix ensures that studies are reviewed from both scientific and community perspectives. IRBs meet regularly and keep minutes of their deliberations. They operate under federal regulations in the US and equivalent rules in other countries. Researchers must report adverse events and protocol deviations to the IRB, and continuing review is required for most studies.

What the IRB evaluates:

• Risks. Are they minimized and reasonable in relation to benefits?
• Consent. Is it obtained properly and documented?
• Selection. Are participants chosen fairly?
• Privacy. Are data protected and confidentiality maintained?
• Vulnerable populations. Are extra protections in place for children, prisoners, and others?

IRB approval is not a one-time event. It is an ongoing relationship between the board and the research team.