MINOR ASSENT FORM TEMPLATE

(Recommended for minor participants 7 – 11 years)

PARTICIPANT INFORMATION AND INFORMED ASSENT (7 – 11 YEARS)

[Name of Principal Investigator]:______

[Name of Organisation]:______

[Name ofSponsor]:______

[Name/Number of Project/Protocol and Version]:_____

Dear ______

We want to know if you want to take part in a research study. Research is how we try to learn answers to questions about new medicines like how well they work and if they are safe.

You have to give assent to take part in this study. When you give assent, it means that you understand what the study is about and agree to take part. You do not have to take part in this research study if you do not want to and no-one can force you to take part, not even your parents.

We have told your parents about this study and they agree that you may take part if you want to.

WHY IS THE STUDY BEING DONE

In this research study we want to see how well ______(specify study medicine) works and how safe it is. You are being asked to take part because the study doctor thinks that ______(specify study medicine) might help for your ______(specify condition).

WHAT WILL HAPPEN BEFORE THE STUDY STARTS

Screening visit

The doctor will tell you about the study and ask you and your parents some questions about your health and what medicines you are taking. You can ask as many questions as you want.

You will then have a health check or medical examination. During this medical examination we will do the following:

  • Measure how tall you are and how much you weigh
  • Examine your body
  • Ask you to wee in a cup
  • Take blood with a needle from a vein in your arm
  • Specify
  • Specify

Treatment / Other study visit

If the tests done at the screening visits show you can take part in this study, and if you still want to take part, we will ask you to come to the study doctor ____ times during the study. The study will last about _____months. At each visit you will be examined by your doctor and have the following tests done: (specify all invasive and non-invasive procedures)

  • Measure how tall you are and how much you weigh
  • Examine your body
  • Ask you to wee in a cup
  • Take blood with a needle from a vein in your arm

HOW DO I TAKE THE MEDICINE

The study medicine is in a tablet/liquid form. You have to swallow the medicine once a day after having breakfast.

WHAT DO I HAVE TO DO?

  • Please make sure that you do everything the study doctor or your parents ask you to do for this study
  • Tell the study doctor or your parents if you do not feel well or if you think the study medication is making you sick.
  • Taking part in this study if you are pregnant or breastfeeding can be very bad for the baby. If you are a girl and you think you may become pregnant please tell your study doctor and ask him to discuss birth control with you.

WILL ANYTHING BAD HAPPEN TO ME IF I TAKE THE STUDY MEDICINE

This medicine has been tested in grown-ups and did not have a lot of bad effects. Because this is the first time we are testing the medicine in children your age, we are not sure if there may be some bad effects that we do not know of.

Grown-ups who took this medicine, had some of the following bad effects:

  • Headache
  • Feeling sick to their stomach
  • Itchy skin
  • Tiredness

Please tell the study doctor or you parents immediately if anything happens to make you feel sick.

TAKING BLOOD

It may sting and bleed a bit when we take your blood. You may also feel dizzy. There is a small chance that you can get an infection but we will be very careful to make sure it does not happen.

WILL MY INFORMATION BE KEPT PRIVATE?

Yes. Only people that work for the company who is doing the study, the study doctor and people who work for the study doctor will be able to see your file with your information. Your name will not be in any documents that are printed about the study.

WILL MY PARENTS HAVE TO PAY THE STUDY DOCTOR?

No. Your parents do not have to pay for any of the tests or medications that you are getting as part of this research study. The study doctor will also give your parents some money to pay for petrol to get to the doctor and for food while you are waiting for the doctor to see you.

If you feel sick or something goes wrong while you are on the study, you will not have to pay for treatment to make you better.

DO I HAVE TO STAY IN THE STUDY?

No. You can stop taking part in the study any time you want to without giving a reason. Just tell your parents or study doctor and they will make sure that you get other treatment.

You might have to stop taking the study medication for different reasons, for example if it makes you feel very sick. The study doctor will explain what you should do if this happens.

Thank you for reading this information. If you still want to take part in the study, please circle the “Yes” or “No” below and sign your name on the Assent Form.

ASSENT FORM

Please circle the answer you agree with

  • Have you read or had someone read to you the Information Leaflet?
/ YES / NO
  • Has somebody explained the study to you?
/ YES / NO
  • Do you understand what the research study is about?
/ YES / NO
  • Have you asked all the questions you want?
/ YES / NO
  • Was all your questions answered in a way you understand?
/ YES / NO
  • Do you know it is ok if you want to stop taking part in the study at any time?
/ YES / NO
  • Do you want to take part in the research study?
/ YES / NO

If you answer any question ‘no’ or you do not want to take part, DO NOT sign your name

If you do want to take part, please write your name and today’s date on the lines.

______

NameDate

I attest that the minor participant named above had enough time to consider the information, had an opportunity to ask questions and voluntarily agreed to be in this study.

______

Printed Name of Person Explaining Consent

______

Signature of Person Explaining ConsentDate

______

Printed Name of Investigator

______

Signature of InvestigatorDate

I hereby verify that assent was obtained from the above minor participant. The participant has been informed about the risks and the benefits of the research, has been given the opportunity to ask questions and have them answered to the satisfaction of the participant and gave assent, without coercion or undue influence.

______

Printed Name of Witness

______

Signature of WitnessDate

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