Who Is Who on the Team, and Who to Ask
Part of Pediatric Trials: Real life — school, routine and logistics.
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.
Knowing who does what makes it much easier to know who to ask, and saves a great deal of repeating yourself.
The people you are likely to meet
The principal investigator. The doctor with overall responsibility for the study at your hospital. In a pediatric study this is usually a pediatrician or pediatric specialist.
Sub-investigators. Other doctors on the team who can carry out study duties. You may see them more often.
The research nurse or study coordinator. Usually your main day-to-day contact. They arrange visits, explain what will happen, take measurements, and are often the first person you call when something is wrong.
Your child's usual doctors and nurses, who may or may not be the same people as the study team. If they are different, ask how they communicate with each other.
Play specialists and child life specialists. In many children's hospitals these are the people who prepare a child for a procedure, explain things in ways children understand, and reduce distress during it. If your hospital has one, they are worth asking for by name. Many families do not know they exist.
Phlebotomists experienced with children, pharmacists, radiographers, and laboratory staff.
Social workers, psychologists and family support workers, where they exist.
People you may not meet
The sponsor — the organization responsible for the study overall. You will not usually meet them.
The monitor — someone who visits to check the study is being run correctly and the records are accurate. They may look at your child's records for this purpose, and that should be explained during consent.
The ethics committee — the independent group that reviewed and oversees the study. Their contact details should be in your documents, and you may contact them directly with a concern.
The data monitoring committee — an independent group who look at the accumulating results while the study runs and can recommend that it be changed, paused or stopped.
Who to ask about what
- Appointments, forms, practical problems — the research nurse or coordinator.
- A symptom, or anything about your child's health — the study team's medical contact, using the instructions you were given. Use the emergency number if it is urgent.
- Preparing your child for a procedure, or distress during one — a play or child life specialist if there is one, otherwise the research nurse.
- Whether to take part, and what it means for your child's overall care — your child's own doctor.
- A concern about how your child is being treated — the principal investigator first; then the ethics committee or the hospital's patient advocacy service.
Two things to secure early
Contact details in writing, including who to call outside working hours, and what counts as urgent.
One named person you can go to first. Ask directly: who is our main contact? Having one name prevents a great deal of repeated explanation on difficult days.
And your child can ask too
Your child may ask questions directly, and should be able to. Some children will ask a nurse something they will not ask a parent, and some will ask a play specialist something they will not ask anyone else.
That is not going behind your back. It is your child using the process the way it was designed.
In short
- The principal investigator is responsible for the study at your hospital; the research nurse or coordinator is usually your day-to-day contact.
- Play or child life specialists prepare children for procedures and reduce distress. Ask whether your hospital has one.
- Sponsors, monitors, ethics committees and data monitoring committees work in the background, and you can contact the ethics committee directly.
- Secure contact details in writing, including out of hours, and one named person to go to first.
- Your child may ask questions directly, and that is the process working.