Two Duties of Care, One Person

Part of Research Nurse (RN) Training: Foundations for the Research Nurse.

About 3 minutes. Free, in your language, no account needed.

Why this matters

You owe a duty of care to the participant. You also owe a duty to the integrity of the trial. Most days these point the same way.

The days they do not are the days that matter, and they arrive without warning.

The two duties, stated plainly

The clinical duty. This participant, in front of you, deserves safe care. It does not pause because they signed a consent form.

The research duty. The trial must produce a truthful answer. Future patients depend on that answer being real. Data that was quietly tidied helps nobody.

Neither duty is optional and neither always wins.

When they pull apart

A participant is doing well and wants to skip a blood draw. Clinically, one skipped draw harms nobody. For the trial, a missing timepoint may make their whole PK profile unusable.

A participant reports mild nausea and asks you not to write it down, because they are afraid of being withdrawn. Clinically, you want their trust. For the trial, an unrecorded adverse event is a falsified safety record.

In both cases the answer is not to choose. It is to be honest with the participant about what you must do, and then to do it.

The rule that resolves most conflicts

Safety wins immediately. Integrity wins on the record.

If a participant needs urgent care, you give it, even if it breaks the protocol. Then you document the deviation fully and promptly.

You never solve a safety problem by breaking the record, and you never protect the record by withholding care. Those are the two failures, and they are both real.

In practice

A participant tells you they stopped taking the study drug four days ago because it upset their stomach, and asks you to keep it between you.

You cannot. And the way you say so matters.

You explain that you have to record it, that it is not a punishment, and that hiding it could make the drug look safer or more effective than it is for the next person. Most participants understand that. Very few want to distort a result that other patients will depend on.

What this looks like when it goes wrong

A nurse, wanting to protect a nervous participant, records a missed dose as taken. The participant stays in the study. The nurse feels she did a kindness.

The trial now believes that participant received a full course. If the drug fails, it will look less effective than it was. If it works, the dose will look lower than it truly needs to be.

One small kindness moved a number that will be used to treat strangers.

Key takeaways