Ethics Review

Ethics appraisal is often treated as a formality. It is in fact a procedure with its own stages, its own experts and the power to reject an already-selected proposal.

Step one: your self-assessment

At submission you complete the ethics issues table across nine categories: human embryonic stem cells and embryos; humans as participants; human cells and tissues; personal data; animals; non-EU countries; environment, health and safety; artificial intelligence; other issues.

The temptation to answer "no" everywhere is strong, and this is the main mistake. All above-threshold proposals go through ethics screening, and undeclared issues surface anyway – but then as requirements before signature, and therefore as delay.

Step two: screening and assessment

Ethics screening happens during or soon after the scientific evaluation. It does not itself impose requirements, but it may oblige you to appoint an independent ethics adviser or board, and it flags proposals with serious or complex issues.

Ethics assessment is an in-depth analysis before signature. It covers proposals flagged as complex and, automatically, all involving human embryonic stem cells or embryos.

Four outcomes are possible: ethics clearance; conditional clearance with a list of requirements; a request for further information; and no clearance – meaning the proposal cannot be funded and is rejected, however high its scientific score.

Ethics requirements become obligations

Requirements due before signature usually mean updating the ethics section of the description of the action. Requirements due after the start are written into the grant agreement as ethics deliverables and placed in an automatically generated work package.

Plan time and a named person for them: these are contractual obligations, not aspirations.

During implementation

An ethics check is internal, run by the project or ethics officer. An ethics review is a detailed procedure with up to five external ethics experts and possible on-site visits. An ethics audit follows a substantial breach of ethical principles, research integrity or applicable law.

Consequences can reach amendment of the grant agreement and, in severe cases, reduction or termination of the grant.