Remote Consent and Remote Visits

Part of ICH E6(R3) Annex 2 for Site Staff: Annex 2 and Decentralized Elements.

About 5 minutes. Free, in your language, no account needed.

Expert review pending. CRLN wrote this lesson against the ICH E6(R3) Annex 2 text adopted on 3 June 2026. It has not yet been reviewed by a subject matter expert. Always follow your protocol, your sponsor and your regulator.

Why this matters

When the participant is not in the room, the things you normally confirm by seeing them face to face have to be confirmed another way. Who is on the call? Did they understand? Who else will learn their address? Annex 2 sets out what to think about when consent and visits happen at a distance.

Consent can be remote

Annex 2 section 2.2 says the consent process may use varied approaches, such as text, images, videos and interactive tools, to give information and support understanding. The materials and the process should be tailored to the methods the trial uses. Section 2.2.1 says informed consent may be obtained remotely where appropriate. Section 3.2.6 says the protocol should describe the consent modalities, for example remote or in person.

Confirm identity by the method that was planned

When consent is obtained remotely, section 2.2.1 says the investigator should be assured of the identity of the participant, or of the legally acceptable representative. One example the Annex gives is checking an official identification document on a video call. Two things should be pre-specified: the verification method, and the measures that protect data privacy while it is done.

That means you should not improvise. If the plan says the participant shows ID on camera and you record the type of ID, then a photo of a driver's license sent by email is a different method. It may look reasonable, but nobody planned how that image would be protected. If the planned method cannot be used, stop and reschedule or offer another approved route.

Fit the method to the person

Section 2.2.2 asks teams to consider the characteristics of the trial population, for example people who are not familiar with computerized systems, and whether the consent method suits them. When computerized systems or remote consent are used, participants may be given the option of a paper or in-person process, to the extent feasible, if they prefer it.

For site staff, this is practical. If a participant struggles with an eConsent tablet and the IRB approved a paper version, offer it. Do not complete screens for them, and do not hurry them through at home overnight. If several participants struggle, tell the study team, because the consent plan may not fit the population.

Tell people who will see their information

Section 2.2.3 says the consent materials should describe what participant data will be collected, how they may be used and which parties will have access to personal information such as health records and home address. The Annex gives examples: activities at the participant's home or a local healthcare center, and data collected remotely through DHTs.

So if a home nursing vendor or a courier will need a participant's address, the consent materials should say so before that information is shared. A confidentiality clause in a vendor contract protects data after sharing. It does not replace telling participants.

Remote visits

A remote visit is still a trial visit. Annex 2 cares most about two things here.

Safety information must reach the investigator. Section 2.5 says safety information from home nursing, remote visits and DHTs should reach the investigator in a way that lets them make decisions about the participant's care. Section 3.9.1 asks the sponsor to make that information accessible in a timely manner. If a participant tells you about a symptom on a video call, that is safety information, whatever a wearable dashboard shows.

Remote data need security. Section 3.5.2 says remote data collection, including remote visits, DHTs and EHR extraction, needs special attention to data security, cybersecurity and privacy. Use only the approved platforms and channels. Personal messaging apps and personal email are not approved channels unless the study says they are.

Section 3.2.4 also asks sponsors to plan training and technical support for investigators, site staff and participants. If you have not been trained on a remote platform, ask before the first visit, not during it.

In practice

• Before the first remote consent, read the consent plan: how identity is checked, what is recorded, and what you do if the check fails.
• Keep the approved paper or in-person route ready for participants who prefer it.
• Check that the consent form names every party that will receive personal information, such as a nursing vendor.
• Treat anything a participant reports on a remote visit as safety information and route it to the investigator.

Key takeaways

• Remote consent is allowed where appropriate, using a pre-specified identity check with planned privacy safeguards (Annex 2, section 2.2.1).
• Offer paper or in-person consent, where feasible, to participants who prefer it (section 2.2.2).
• Consent materials say who will have access to personal information such as a home address (section 2.2.3).
• Safety information from remote visits and DHTs must reach the investigator in time to act (sections 2.5 and 3.9.1).