What an Ethics Committee Can Require
A companion reading on the ethics-committee lens — written for the sponsors, CROs and study teams who prepare the submission
REGULATORY OPERATIONSPrepare the device and consent evidence before the submission: a committee's remit reaches further into a DHT study than most teams plan for.
Consent is the committee's center of gravity, but usability, device suitability and safeguards for vulnerable participants sit inside the approval criteria — and in the US the IRB makes the SR / NSR determination. A question becomes enforceable once written into a condition of approval; hold the evidence at filing.
Each perimeter carries a predictable question and the evidence for it
| Perimeter | Typical committee question | Evidence a prepared submission holds |
|---|---|---|
| Consent | "Is eConsent valid and informed, including remote?" | Approved materials, version control, re-consent plan, signature route |
| Human factors | "Can the real population use it safely?" | Usability / use-safety evidence for the actual users |
| Device suitability | "Is the device fit for its role — is this significant-risk?" | Suitability assessment; the SR / NSR determination (21 CFR 812.66) |
| Data integrity | "Does device-side integrity protect rights?" | Device-side integrity evidence supporting rights and safety |
Four things a DHT study should expect to be asked to evidence
Suitability, usability and protection of participant data are inside the approval criteria; device-side audit trail and time source are primarily a GCP matter a committee may reach via rights and safety.
The eConsent content and process, including the remote elements, are reviewed and approved before use and on amendment. Identity and comprehension must be designed in, not assumed.
Additional safeguards are an explicit approval criterion, not a courtesy; assent and representative-consent arrangements are reviewed with the rest of the consent materials.
An expectation voiced in a meeting requires nothing; a condition of approval, required modification or national decision does — enforceable through continuing review and suspension.
Six questions to answer before the committee asks them
- 1Make eConsent valid, informed and identity-bound — including remote elements, version control and a re-consent plan.
- 2Confirm the signature route under national law in each country — qualified, advanced or case by case — incl. for a legal representative.
- 3Evidence that the real population can use it safely — usability and use-safety results for the actual users, harder for vulnerable groups.
- 4Assess and record device suitability — a suitability assessment tying role to conditions, plus device-side integrity evidence.
- 5Settle the SR / NSR determination early — in the US, the IRB's call under 21 CFR 812.66 decides whether an IDE is needed first.
- 6Document vulnerable-population provisions — assent, representation and usability provisions, per Stakeholder Edition S14.
21 CFR 56.109, 56.111, 56.113 · 21 CFR 812.66, 812.2(b)(1)(ii), 812.30(a) · 21 CFR 50 subpart D · Regulation (EU) 536/2014 Arts 31–32 · ICH E6(R3) s.1, s.2.8 · FDA/OHRP eConsent Q&A (2016) · HMA/EC/EMA DCT paper v02
© qointa 2026 – Public – Uncontrolled when printed · Not legal advice; this summary does not classify any device.
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