Who Is Allowed to Know What

Part of Research Assistant (ASSIST) Training: Confidentiality and What You Do Not Say.

About 1 minutes. Free, in your language, no account needed.

Confidentiality here is stricter than you are used to

Participants give two separate things: their agreement to take part, and their agreement for their information to be used in a specified way. Both are limited to what they were told.

That means information cannot be shared just because someone asks, and not even because they work at the site.

Need to know is the test

The people who may see a participant's study information are the site staff involved in their care and the study, monitors and auditors checking the trial, and regulators. Everyone else, including colleagues on a different study, does not.

A relative is not automatically entitled either. Someone who drove a participant to their appointment may be told nothing about the visit without the participant's agreement.

The everyday risks

Screens left visible in a shared area. A conversation in a corridor. Paperwork face up on a desk. A participant's name said out loud in a full waiting room. A photo of a room with a consent form in shot.

None of these feel like breaches while they are happening, and all of them are.

If it goes wrong, say so

If information reaches someone it should not have, report it the same day. There are requirements about how quickly certain breaches must be handled, and the clock starts when somebody knows.

Hiding it removes any chance of limiting the harm, and the harm lands on a participant who trusted the site.