Checklist

Ethics, consent & IRB readiness checklist

Interactive checklist to confirm consent language, IRB/ethics approvals, data privacy protections, special population safeguards, and ethical risk management before beginning studies involving people or sensitive data. Saves responses for audit trails and follow-up.

Interactive Tool

Ethics, consent & IRB readiness checklist

Use this checklist to confirm ethical and regulatory readiness before starting studies involving people or sensitive data. Save responses to create an audit trail, assign follow-up actions, and demonstrate due diligence to sponsors, IRBs, and regulators.

Include IRB/ethics committee reference numbers, regulatory notifications, and whether the study is exempt, expedited, or full review.
Has the protocol, consent forms, recruitment materials and supporting docs been submitted and acknowledged?
Enter the approval ID or 'Pending' if awaiting a decision.
Document pseudonymization, de-identification, access controls, and minimum necessary data elements.
Record links or locations of DPIA/PIA or note if not applicable.
Ensure purpose, risks, benefits, voluntary participation, withdrawal, data use, retention, sharing, and contact info are clear.
Select the intended sharing model and document retention schedule and responsible steward.
Includes foreseeable harms, mitigation measures, monitoring, incident reporting and escalation paths.
Summarize key protections, monitoring responsibilities, and planned audits.
Name and contact for ethical questions, IRB liaison, or Data Protection Officer.
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