Checklist

Research ethics & risk assessment checklist

Expanded operational ethics checklist with structured, savable items for consent, privacy, dual-use & biosafety, data sharing constraints, IRB readiness, and escalation. Use this interactive checklist to document readiness, capture notes, and flag items that require escalation before IRB submission or project start.

Interactive Tool

Research ethics & risk assessment checklist

This checklist helps teams assess ethical, safety, privacy, and regulatory readiness before starting or disseminating research. Work through each item, record brief notes where useful, and flag anything that needs escalation. Use the overall readiness rating and assessor notes to summarize next steps for IRB submission or leadership review.

Who completed this checklist?
Short name for the project under review.
If yes, ensure consent and IRB items are complete.
Signed templates, consent script, consent process, and record-keeping plan.
Assess whether consent language is plain-language, complete, and appropriate for participants.
If yes, document additional protections and approvals required.
Collect only the data needed for the research questions.
Describe method for removing or replacing identifiers.
e.g., hashing, tokenization, k-anonymity, redaction. Include residual re-identification risk if known.
Where will data be stored? Who has access? Encryption, backups, and privileged access controls.
Specify how long data will be kept and the disposal plan.
How and when will data be shared, if at all?
Agreements, NDAs, sponsor restrictions, export controls, or other limits on sharing or publication.
Does the work involve controlled technologies, reagents, or information requiring export review?
Could methods, reagents, data, or tools be repurposed to cause harm?
Briefly describe the risk and any mitigation ideas.
Select the biosafety level or select 'none' if not applicable.
If yes, provide escalation contacts below.
Who should be notified? e.g., biosafety officer, PI, ethics board, legal.
Are the protocol, consent forms, recruitment materials, and supporting documents prepared?
Attach or link required documents in your project system (attachments not collected here).
Includes who to notify, timelines, and recording requirements.
Financial or non-financial conflicts disclosed and management plan in place.
Describe payments, reimbursements, or incentives and how they are documented.
Plan for manuscripts, preprints, data release, and communications. Consider dual-use sensitivity and embargoes.
Use this to summarize whether the project is ready to proceed or needs further work.
1.0 10.0
Summarize outstanding risks, required edits, and who should follow up.
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