The Participant Relationship

Part of Sub-Investigator (SUBI) Training: Working With the Site Team.

About 2 minutes. Free, in your language, no account needed.

You may be their doctor and an investigator at once

That dual role is common and it carries a pressure the participant feels more than you do.

They may agree to things to please you, or fear that declining affects their care.

Separate the two roles out loud

Say which hat you are wearing. "This part is about the study, and it is completely separate from your treatment here" is worth repeating.

Protect the right to decline

Every visit, not just at consent. A participant can decline a procedure, miss a visit or stop entirely, and their care continues unchanged.

Participants who feel unable to say no stay in studies they want to leave, and their data suffers along with them.

Answer questions about their own results

Participants are entitled to information about their own health. Where the study blinds results, explain what can and cannot be shared and why.

"I cannot tell you which group you are in, and I can tell you your kidney function is stable" is usually both true and enough.

Do not oversell

Optimism from a clinician is heard as a prediction. A participant told the trial drug is "very promising" has been given an expectation the evidence does not support.

Notice burden

Extra visits, extra bloods, diaries, devices. Participants rarely complain and often quietly disengage.

Asking how they are finding it surfaces problems while they are still fixable.

Their account is clinical data

What they report about symptoms, adherence and side effects is data, not background. Record it as they said it.

Ending well matters

At the end of participation, tell them what happens next, how they hear results, and thank them. They gave time and accepted risk so a question could be answered.