Are you going to participate in research?
Here is everything you need to know.
What do you need to know when you take part in medical research?
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Sometimes a doctor or a researcher develops something to make people better.
This could be a medicine, or a treatment.
Next, they want to know if it works well.
And if it is safe to use.
That is why they test it with a group of people.
Sometimes it concerns a remedy for headaches.
But it can also be a treatment for stomach pain.
It could also involve an operation.
People take part in research because they choose to.
No one should tell you that you have to take part.
Some people who take part are ill.
They hope that the treatment that is being tested will help them get better.
Or they want doctors to learn more about their illness.
This can help others.
But people who are not ill also take part in research.
For example, to test new medicines.
Sometimes people get paid for taking part in research, but most of the time there is no payment.
Travel costs are usually reimbursed.
Research involving people is carefully controlled.
There are strict rules to follow.
Anyone wanting to carry out research must first make a plan.
This plan is submitted to a medical committee.
This is a group of people with a good understanding of many different illnesses and diseases.
It also includes people who know a lot about laws and regulations.
They check whether the plan follows all the rules.
They also check that it is safe for the participants.
The research can only start once the committee has approved it.
The committee that approves the plan is called an MREC.
This stands for Medical Research Ethics Committee.
The committee is usually attached to a hospital.
There is also another committee that checks whether the MRECs are doing their work properly.
This is the Central Committee on Research Involving Human Subjects (CCMO).
The CCMO also reviews certain research plans itself.
These are (research) studies with special considerations.
For example, if children are taking part.
Or people who are unable to make decisions for themselves.
For example, people with dementia.
You should only take part if you want to.
No one can tell you that you must take part.
The researcher must write down all the information for you.
This information explains everything about the research.
This is called the Information Sheet for Research Participants (IRP).
It explains what will happen and what you will need to do.
It also explains any potential risks and the measures in place to put things right.
Generally, you don’t have to decide straight away if you want to take part.
You should be given enough time to make your decision.
Read the information carefully at home, and think about it.
You can also talk about it with your family or your doctor.
You can ask the researcher any questions you have.
You can do this at any time.
Even when the research has already started.
You can also ask questions after the research has finished.
Sometimes there isn’t much time to think about whether or not you want to take part.
For example, if you are very unwell.
In that case, you may need to make a quick decision.
If you are certain that you want to take part, you will need to sign a form.
This is called a consent form.
By signing it, you confirm that you are taking part of your own free will.
Often, you will undergo an examination first to see if you are able to take part.
What you need to do as a participant is different for each research study.
Sometimes the researcher only measures your temperature or blood pressure.
Other times, you may have a blood test.
But the research could also involve an operation.
Or you may need to take a medicine.
For example, tablets or a drink.
If you take part, you must follow the instructions.
For example, you may be asked not to eat or drink before a test.
Or to take a medicine at the same time every day.
Or you may need to write down how you feel each day.
The research may not produce reliable results if you don’t follow the instructions.
If you don’t follow the instructions, the researcher may ask you to stop taking part.
You can stop taking part at any time.
You don’t have to give a reason.
However, it is important to talk to the researcher first.
You may not always be able to stop straight away.
If you are taking tablets, you may need to keep taking them for a while.
And reduce them gradually.
Sometimes the researcher may decide that you need to stop.
For example, if you experience side effects from the research procedure.
You may need to stop for a while and then restart.
Sometimes you may need to stop completely.
The researcher may still use information collected from you for the research study.
This also applies even if you stop taking part.
Taking part in research can involve some risk.
It is about finding new ways to treat people who are unwell.
It is not always possible to know exactly how a new treatment will affect you.
This means you may experience side effects.
The researcher must explain how large the risks are first.
You may be asked to do more than was originally agreed.
The researcher must tell you how likely it is that this may happen.
For example, you may need to attend more research visits.
Or the researcher may want to carry out more tests.
Or you may need to write down how you feel each day.
All of these things can be inconvenient.
During the research study, the researcher will record how everything is going.
They will write down what happens to you when you take a medicine.
Or how you feel after a treatment.
This report is subject to strict rules.
The researcher cannot share it freely with others.
And your name will not be included.
Instead of your name we will use a number.
This means that anyone reading the report will not know it is about you.
See also below: What you need to know about your data
You may be harmed as a result of taking part in the research.
You are insured for this.
See below for more information: What you need to know about insurance
Children are often not able to decide for themselves whether they want to take part in a research study.
However, taking part can still be beneficial.
Sometimes it may improve a child’s chance of getting better.
There are extra strict rules for research involving children.
They can only take part if there is no alternative.
For example, if a treatment for children cannot be tested in adults.
The risks should not be too high.
It should not be too burdensome for the child.
The people who care for the child must agree.
Usually, this means the parents.
They must give their consent by signing a form.
Children aged 12 and over must also sign themselves.
Children may not always be able to say what they think or feel.
Sometimes they may be too afraid to speak up.
That is why researchers must stop if they see that a child no longer wants to take part.
The researcher should ask the parents or carers how they can recognise when the child does not want to do something.
For example, if the child cries or is very anxious.
Or if they get angry or upset.
In that case, the child does not have to continue.
The people who care for the child can also decide at any time that their child should stop taking part in the research.
There are people who are unable to decide for themselves whether they want to take part in research.
They may find it hard to think clearly and may not understand a lot of things.
For example, people with dementia.
There are extra rules for research involving these individuals, similar to those for children.
They can only take part if there is no alternative.
The risks should not be too high.
It should not be too burdensome for them.
If an adult cannot decide for themselves, someone else must sign.
This is usually the husband or wife of the person who takes part in the research.
Sometimes it may be another carer.
People who are unable to make decisions for themselves may often also not be able to express what they feel.
The researcher should therefore ask carers how they can recognise when the person does not want to do something.
If they show in any way that they don’t want to take part, the researcher must stop immediately.
In that case, they do not have to continue.
Somebody who is unable to make decisions for themselves may also stop if the carers decide they should no longer take part.
They do not need to give a reason.
Do you have a complaint about how the research has been carried out?
It is usually best to discuss this first with the researcher.
Sometimes this may not be possible.
Or you may not want to do this.
You should therefore be able to raise your concern elsewhere.
The researcher must make this possible.
This information should be included in the information sheet.
You will receive the information sheet before the start of the research.
What you need to know about your data
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Everyone who takes part in the research receives a number.
The researcher records which data belongs to your number.
This includes your name, your age, and all other information about you.
The researcher keeps this information in a safe place.
This is usually a secure location at the clinic or hospital where the research is taking place.
The information sheet tells you where the researcher may store your data and for how long.
Very few people are allowed to see your data.
Who they are depends on the type of research.
This is also explained in the information sheet.
People working for the Health and Youth Care Inspectorate (IGJ) may always view the data.
They supervise whether the research is carried out properly and that everything is correct.
There are laws and rules for doing research.
And also for protecting your data.
The law that sets rules for researchers (in the Netherlands) is called the WMO.
This stands for Medical Research Involving Human Subjects Act (in Dutch: Wet medisch-wetenschappelijk onderzoek met mensen).
The rules for protecting and storing your data are set out in the GDPR.
This stands for General Data Protection Regulation.
All research studies are recorded.
They are included in a list.
Anyone can search this list.
It is called the Overview of Medical Research in the Netherlands (OMON).
Sometimes the researcher needs blood for the research study.
Or something else from your body.
For example, a small piece of your skin.
We call this bodily material.
The researcher may keep bodily material after the research has finished.
This is only allowed if you give your consent in writing.
There are rules about storing bodily material.
Where this is allowed and for how long.
Your data may sometimes be used for other research.
Or your bodily material.
There are rules for this.
It is only allowed with your consent.
And only for research related to the study you took part in.
Sometimes, the researcher may want to use your data outside the European Union (EU).
Outside the EU, the rules for research are different.
And the rules for using data and bodily material are also different.
But even outside the EU, no one should know that it’s your data being used in the research.
Or your bodily material.
The researcher must ensure that this is the case.
You may decide that you no longer want your data or bodily material to be used.
Even if you previously signed a consent form.
You can tell the researcher this.
They must then dispose of your bodily material.
And they may no longer use your data.
What you need to know about insurance
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Taking part in research may cause harm.
In other words, the research could have unwanted effects on your health.
Researchers must take out insurance for this.
Sometimes compensation is paid, but not always.
You don’t need to do anything about the insurance.
It is provided for you free of charge.
The insurance only covers harm caused by the research.
It must be harm that is caused directly.
Or within four years after the research.
You must report the harm within four years.
If you do not, the insurance company may not pay compensation.
There are other rules that may mean you do not receive compensation.
Before you take part, you will be given information.
This explains the risks involved.
It also explains what harm you might experience.
So, you are informed in advance about any possible risks.
If that expected harm occurs, it will not be covered.
However, if the harm is much worse than was expected or described, it may be covered.
Harm may also occur if you do not follow the researcher’s instructions.
In that case, you will also usually not receive compensation.
Unborn children can also be harmed during a medical research study.
This may involve a baby inside your womb or outside your body.
In research related to pregnancy, this harm is usually covered.
For example, if you took part in research involving pregnant women.
Or research involving the unborn baby inside your womb.
It may also involve research on an embryo outside your body.
An embryo is the early stage of a baby’s development.
In other situations, harm to an unborn baby is usually not covered.
For example, if you take part in a different type of research while you are pregnant.
Research that is not related to pregnancy or becoming pregnant.
In that case, you will usually not receive compensation for any harm to the baby.
This also applies if you did not know you were pregnant.
The amount paid by the insurance depends on the level of harm caused.
Serious harm leads to higher compensation than minor harm.
Details are included in Appendix E of the information sheet.
This also includes all the different amounts.
It also tells you where and how to report harm.
Sometimes, the research does not involve any risks to your health.
In that case, no insurance is taken out.
This is explained in the information sheet.