eConsent regulations guide: what FDA, EMA and HHS expect

People searching for "eConsent regulations" usually expect a rulebook. There is not one. Regulators have taken the view that existing consent requirements are technology neutral and have issued Q&A guidance explaining how electronic tools can meet them. That is good news for flexibility and awkward for clarity: the answer to "is this eConsent flow acceptable" comes from several documents read together, plus the IRB or ethics committee that approves your process.

This guide sorts those documents into three groups: FDA, HHS and the EU. It is the regulatory companion to our product and drafting pages. For the technical side of signatures, read electronic signatures for clinical trials; for software selection, eConsent software for clinical trials; for writing the form, how to write an eConsent form. Everything below is a summary of public documents and secondary sources. Read the current primary texts and take advice before you rely on it.

FDA's informed consent rules in Part 50 set the elements of consent, require that consent be documented in a form signed and dated by the participant or legally authorized representative, and require that a copy go to the person signing. Part 56 requires IRB review. Part 11 sets conditions under which electronic records and electronic signatures are considered trustworthy and equivalent to paper. FDA and OHRP's Q&A on electronic informed consent, finalised in December 2016, brings these together for electronic tools. It states that Part 11 generally applies to electronic consent where Parts 50 and 56 apply, and that research outside those parts is generally outside Part 11 as well.

The Q&A is non-binding, but IRBs and sponsors use it as a reference. In outline, it encourages the following: the IRB reviews the electronic process and the content participants will see; the system lets participants ask questions and, where appropriate, talk to staff; the identity of the signer is verified by a method appropriate to the risk; the record of consent is retained with the signature and date; and the participant gets a copy in paper or electronic form. Treat these as summaries, since the guidance gives more detail and examples.

Two later FDA documents matter. The August 2023 final guidance on informed consent supersedes FDA's 1998 guide and restates what the IRB and investigator should see in the form, including compensation and undue influence. The October 2024 final Q&A on electronic systems, records and signatures replaced the 2007 guidance on computerised systems and addresses audit trails, data security and how Part 11 applies when digital health technologies or service providers are involved. Our 21 CFR Part 11 compliance checklist goes through the system controls in detail.

Research conducted or supported by HHS, including most NIH-funded work, falls under 45 CFR 46. The revised Common Rule, effective in 2019, requires consent to begin with a concise, focused presentation of the key information that helps a prospective participant decide, and it created a broad-consent pathway for storage and secondary use of identifiable information and biospecimens. Documentation requirements in 46.117 accept electronic formats. The practical effect for an eConsent flow is that the first screen or section should present the key information in a way that supports comprehension, not as a buried paragraph.

Many academic studies are both HHS-supported and subject to FDA rules, for example an NIH-funded trial of an investigational drug. The joint Q&A says to follow the regulation that gives greater protection where they differ. Your IRB will normally tell you which standard it applies; the IRB explainer and our IRB submission checklist describe what to prepare. For academic investigators, eConsent for academic clinical research covers typical set-ups.

The EU Clinical Trials Regulation 536/2014 sets out when and how informed consent is given in interventional trials of medicines, including principles for participants who cannot consent themselves and for minors. It applies directly in member states, but the practical acceptance of electronic or remote consent, identity verification and signatures varies by country and by ethics committee. In December 2022 the EMA, the Heads of Medicines Agencies and the European Commission published a recommendation paper on decentralised elements in clinical trials, which covers electronic informed consent and gives an overview of national provisions. It is non-binding and risk-proportionate in tone. Check whether it has been updated since.

Two other EU regimes matter. The GDPR governs personal data, and the consent to take part in a trial is distinct from consent as a GDPR legal basis; many trials rely on other legal bases for data processing and explain this in the information sheet. The EMA guideline on computerised systems and electronic data in clinical trials sets expectations for the system itself, including audit trails and access control; see our EMA computerised systems guideline guide and EU CTR clinical trial software. For the UK, which has its own rules, see the UK MHRA regulations guide.

Because the EU position depends on member state and ethics committee, the safest approach is to ask the ethics committee in each country whether it accepts your electronic process, and to document the answer in the submission. Remote patient consent for clinical trials and eConsent for decentralized clinical trials cover remote workflows.

Software does not make a consent process compliant on its own. The IRB or ethics committee must approve the process and content. The sponsor decides whether the system is suitable and validated for its use. The investigator remains responsible for ensuring that consent is informed and voluntary, which a screen cannot do. Capture provides the technical controls, and validated use is shared with the sponsor.

Also be careful with claims that go beyond the documents. This page does not say that FDA, EMA or any ethics committee has certified Capture, and no regulator certifies eConsent software in that way. If your study needs multilingual consent or specific re-consent workflows, confirm the current capability with the Capture team before you plan around it. This is general information, not legal advice.