Rights and verification · high severity
Privacy and human subject protections are built into the plan
Real-world data is still data about people. Consent, a waiver, ethics review and the privacy basis are part of whether the evidence can be used, not a compliance afterthought.
The check
Does the outline say how consent, ethics review and privacy law are handled for the data used?
What the outline has to carry
- privacy
- consent or ethics review
A check is met only when every element above is present. One element on its own is a partly evidenced check, not a pass.
What resolves it
Name the ethics body and its approval or waiver, the consent basis for each cohort, the de-identification or anonymisation applied, and the lawful basis under the privacy law that governs each site.
The source sentence
Privacy and human subject protections have to be built into those plans all across the way.FDA Watch, 40:34 to 41:24
The quotation is short and is used to show the sentence the rule is read from. The rule itself is our statement, not the speaker's words.
The legal basis
The held frameworks that bear on this check, with the control each one contributes. The link opens the framework page so the reader can check the source.
Ethics review and informed consent
An independent ethics body reviews the study, and consent is obtained and documented before participation.
International · Read the framework
Lawfulness of processing
Processing rests on a named lawful basis, and research processing is tied to the basis the sponsor actually relies on.
European Union · Read the framework
Lawfulness of processing
Processing rests on a named lawful basis, and the basis is recorded before the processing begins.
United Kingdom · Read the framework
General requirements for consent
Consent is voluntary and based on sufficient information and adequate understanding of the research and its implications.
Australia · Read the framework
Try it on your outline. The free check applies this rule and quotes the line it read.