An IRB is an independent committee that reviews, approves and monitors research involving human participants to protect their rights, safety and welfare. Outside the US the equivalent is usually called an ethics committee.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Institutional review board
noun · clinical research
An independent committee that reviews research involving human participants before it starts and throughout its conduct, to protect their rights and welfare.
Related terms
In short
Explained
Before a study can enrol, the IRB reviews whether the risks to participants are minimised and reasonable relative to anticipated benefits, whether selection is equitable, whether informed consent will be properly sought and documented, and whether there are adequate provisions for monitoring safety and protecting privacy. It looks at the protocol, the consent form and participant information, recruitment materials, and anything participants will see or complete, including questionnaires and diaries.
Once the study is running, the IRB must approve changes before they are implemented (except to remove an immediate hazard), receive reports of unanticipated problems, and carry out continuing review at intervals appropriate to the risk. Our IRB submission checklist lists the documents a typical initial submission needs.
ICH GCP uses "IRB/IEC" to cover both US institutional review boards and independent ethics committees elsewhere. In the UK they are research ethics committees; under the EU Clinical Trials Regulation, ethics review is part of the coordinated national assessment. The role is the same: independent protection of participants.
For multi-site studies in the US, NIH policy and the revised Common Rule generally require a single IRB of record for cooperative research, rather than separate review at every site, to reduce duplication.
Blank ePRO · patient questionnaires
Evening diary
Daily 18:00 to 24:00, Visit 1 to Visit 15
2. Did you take your study medication today?
○ Yes○ NoQuestion 3 shown only if No.
In Capture
IRBs need to review participant-facing materials. Capture exports blank eCRF and blank ePRO PDFs generated from the approved forms, including the phone layout of questionnaires with skip logic explained, versioned with an effective date. Consent templates cover common study types.
Pre-launch readiness
1 site activated
1 form not yet approved
Institutional review board.
They play the same role. IRB is the US term; elsewhere they are usually called independent or research ethics committees.
Under FDA regulations, at least five, with varied backgrounds, including at least one non-scientist and one member not affiliated with the institution.
Yes, before implementation, except where a change is needed to eliminate an immediate hazard to participants.
Blank eCRF and ePRO PDFs in one click. Free sandbox.