Your Right to Stop, and Questions to Take to the Team
Part of Pediatric Trials: Over time, and endings.
About 4 minutes. Free, in your language, no account needed.
This is general education about clinical research — not medical advice, and not a way to join a study. Talk to your own doctor about your situation.
This is the last lesson. It covers the most important right, and then the practical questions.
The right to stop
The WMA Declaration of Helsinki, in its October 2024 version, states at paragraph 26 that a potential participant must be informed of the right to refuse to take part, or to withdraw consent at any time, without reprisal.
ICH E11 states that in all cases pediatric participants should be made aware of their right to decline to participate or to withdraw from a study at any time.
Both of you hold this. You may withdraw the permission you gave. Your child may withdraw their assent. Neither of you has to give a reason.
Your child's care continues
This is the fear that stops families, so it should be said directly.
Stopping a study does not end your child's treatment and does not end their relationship with their care team. You return to the care your child would otherwise have received.
Nobody may treat your child differently, delay their care, or be cold to your family because you stopped. If that ever happened it would be a serious failing, and the ethics committee contact in your documents exists partly for that reason.
How to stop
Tell the team. Telling the research nurse or your child's doctor is enough to begin.
Two things are usually offered, and both may be accepted or declined:
- A safety conversation. Some treatments should not be stopped abruptly, or need something watched afterwards. That is medical information for your child's protection. If it starts to feel like persuasion, you may say so.
- Some final checks. A last visit or a follow-up contact to make sure your child is well.
Stopping is often not all or nothing. You may be able to stop the treatment but keep safety follow-up, stop extra research procedures but continue treatment, decline an optional part, or pause rather than stop. Ask what the options are.
Information already collected usually stays in the study, because removing it would distort results already produced. You can usually stop further collection.
Questions to take with you
About the study
- What is this study trying to find out, and why does it need children?
- What exactly would happen to my child, at each visit?
- Which parts might help my child, and which are only to gather information?
- What is known about the risks, and what is not yet known?
- What happens if we say no?
About my child's part
- How will this be explained to my child, and by whom?
- Is there an assent document, and may I see it?
- What happens if my child says no, or refuses a procedure?
- How will their agreement be revisited as they grow older?
- What will you do if my child is distressed?
About practical life
- How many visits, over how long, including follow-up?
- How many blood draws, and what is the limit?
- How many school days?
- What is reimbursed, how is it claimed, and how long does it take?
- Is there a play or child life specialist?
About safety and contact
- Who do we call, including at night and at weekends?
- Who is our main contact?
- How will the study team and my child's usual team communicate?
About afterwards
- What happens when the study ends?
- How long is follow-up, and can we stop it?
- What happens to my child's samples and data?
- Will we be told the results, and will there be a plain-language summary?
Three things always allowed
Taking time. You may take the documents home, read them slowly, and come back with questions.
Bringing someone. Another adult hears what you miss.
Asking again. "I did not follow that — can you explain it differently" is exactly the right thing to say. Explaining clearly is their job.
In short
- You may withdraw permission, and your child may withdraw assent, at any time, without reprisal and without a reason.
- Your child's care and their relationship with their team continue. Nobody may treat them differently.
- Telling the research nurse or doctor is enough, and stopping is often not all or nothing.
- Take written questions covering the study, your child's own part, practical life, safety contacts, and what happens afterwards.
- Taking time, bringing someone, and asking again are always allowed.