Do you need an ethics committee opinion to use virtual reality?

Two answers circulate, and both are dangerous. One says "it is equipment, it is like buying an armchair, it needs nothing". The other says "it is technology with patients, it has to go to the ethics committee". Depending on the case either can be right, which is why the useful question is a different one.

The question that separates everything

Are you caring for a patient, or producing knowledge?

That line decides it, not the fact that technology is involved.

Care. Using a registered medical device, within its intended purpose, with a specific patient, because the team judges it does them good at that moment, is a clinical decision. The same kind as choosing to put music on, change the lighting or call the family. It does not, in itself, create a need for an ethics committee opinion.

Research. The moment there is a protocol, a knowledge objective and data collection beyond what care requires, the category has changed. That is ethics committee territory, under the framework for clinical investigation, which for medical devices has specific rules under the MDR (Regulation (EU) 2017/745) and, in Portugal, involves the competent ethics committee.

What crosses the line without anyone noticing

In practice almost nobody decides "let us do research". You slide into it. The most common triggers:

• deciding to publish. A conference poster is dissemination of knowledge. If the data came from patients, the ethics question appears, even if the collection was done with something else in mind;
• allocating patients to receive or not receive, in order to compare. That is study design, even when informal;
• applying scales that would not otherwise be applied, or applying them at moments defined by a protocol rather than by care;
• using outside the device's intended purpose;
• collecting data systematically on a purpose-built form, for later analysis.

None of these triggers is forbidden. They only change the process, and changing it after starting is where people get hurt.

The pilot trap

It is the most frequent case and worth stating plainly.

A department runs a pilot to decide whether to buy. It went well. Someone says: "this would make a paper." And then it emerges that the data was collected without a research framework, without consent for that purpose and without an opinion.

An opinion cannot be obtained retroactively for data already collected as though none were needed. Even retrospective use of routine data for publication usually requires an opinion from the institution's ethics committee and a lawful basis under the GDPR.

Prevention is cheap and takes five minutes: before the pilot starts, decide whether you will want to publish. If the answer is "maybe", treat it as research from the outset. It is far easier to hold an opinion you never use than to produce data you cannot use.

Consent is not the same thing

Two consents live on different planes and should not be confused:

• consent for the session: telling the patient what will happen, what they may feel and that they can stop at any moment. This always applies, and we have covered it separately;
• informed consent for research: specific, written, approved within the protocol.

Having the first does not remove the need for the second. And the second does not replace the first.

What the committee will ask

If you go that route the questions are predictable, and preparing them speeds everything up: what is the design, who are the participants and how are they selected, what data is collected and why, what risks exist and how are they mitigated, how is consent obtained and recorded, who has access to the data and for how long, and what happens if a participant withdraws.

Notice that almost all of them are about data and people, not about the technology. That is the most common preparation mistake: bringing a technical explanation of the equipment to a committee that wants to talk about participants.

What we do not do

We do not issue ethics opinions, and be wary of any supplier who tells you confidently that "you do not need one". We are not your institution's ethics committee, we do not know your protocol, and this is not legal advice. Whether your case is care or research is decided by the institution, and when in doubt by the committee itself, which usually answers a well-framed question quickly.

What we do is give you what it will ask about the system: what it logs, where the data sits, what leaves the institution, and the intended purpose in writing.

In short

• Caring is not researching, and that is what decides.
• Care within the intended purpose is a clinical decision.
• Publishing, allocating, applying scales by protocol or collecting data systematically changes the process.
• Decide before the pilot whether you will want to publish.
• When in doubt, ask the committee. It is cheaper than the alternative.