Skip to content

CONSENT FORM FOR PARENT/GUARDIAN ON BEHALF OF CHILD PARTICIPANT

Ethics ID: Pro00XXXXXX Version Date: [INSERT DATE] Page 1 of 8

Title of Study: Cognitive Assessment Study (STUDY020)

Principal Investigator: Dr. Lawrence Richer Phone: [INSERT PHONE NUMBER]

Study Coordinator: Megna Lindsel Phone: [INSERT PHONE NUMBER]

Why is my child being asked to take part in this research study?

Your child is being asked to be in this research study because they have been diagnosed with Long COVID (also called Post-COVID-19 Condition). Long COVID can affect how children think, remember, and pay attention. We want to learn more about these effects so we can help children who have this condition.

This form contains information about the study. Before you read it, a member of the study team will explain the study to you in detail. You are free to ask questions if there is anything you do not understand. You will be given a copy of this form for your records.

What is the reason for doing the study?

Long COVID is a condition where symptoms continue for weeks or months after the initial COVID-19 infection. Some children with Long COVID have problems with thinking, memory, and concentration (also called "cognitive symptoms"). These problems can affect how well children do in school and in daily life.

The purpose of this study is to:

  • Understand how Long COVID affects thinking and memory in children
  • Track how these effects change over time
  • Test whether [STUDY DRUG - generic name] can help improve cognitive function in children with Long COVID
  • Learn more about which children are most affected and how we might help them

This study will enroll approximately [XX] children at this site, as part of a larger study with approximately [XX] children across [XX] sites in Canada.

[STUDY DRUG] is approved by Health Canada for [APPROVED USE]. In this study, we are testing whether it may also help children with cognitive symptoms from Long COVID. This use is considered experimental.

What will happen in the study?

Study Overview

If you agree to allow your child to take part, they will be in this study for approximately 18 months. During this time, your child will have approximately [XX] study visits. Each visit will take about [XX] hours.

Your child will be assigned at random (like flipping a coin) to one of two groups: - Group 1: Will receive [STUDY DRUG] - Group 2: Will receive a placebo (a pill that looks exactly like the study medicine but has no active medicine in it)

Your child will have a 1 in 2 (50%) chance of being in either group.

The study is double-blind, which means neither you, your child, nor the study doctor will know which treatment your child is getting. However, in case of an emergency, we can find out quickly.

Study Visits and Procedures

Screening Visit (Visit 1) - approximately [X] hours

At this visit, we will: - Review your child's medical history - Do a physical examination - Collect blood samples (about 2 teaspoons) to check your child's health - Have your child complete cognitive assessments (computer-based tests of memory, attention, and thinking) - If your child is female and able to become pregnant, a pregnancy test will be done

Baseline Visit (Visit 2) - approximately [X] hours

If your child qualifies for the study: - Your child will be randomly assigned to receive [STUDY DRUG] or placebo - Your child will receive the study medication with instructions on how to take it - Your child will complete cognitive assessments

Follow-up Visits (Visits 3-[X]) - approximately [X] hours each

These visits will occur at [SPECIFY SCHEDULE - e.g., Months 3, 6, 9, 12, 15, and 18]. At each visit: - We will ask about your child's health and any side effects - Your child will complete cognitive assessments - Blood samples will be collected at some visits (about 2 teaspoons each time) - Your child will receive more study medication

End of Study Visit - approximately [X] hours

At the final visit: - Your child will have a final physical examination - Final blood samples will be collected - Your child will complete cognitive assessments - We will discuss the study results with you when they are available

Cognitive Assessments

The cognitive assessments are computer-based tests that measure different aspects of thinking: - Attention tests: How well your child can focus and respond quickly - Memory tests: How well your child can remember information - Processing speed tests: How quickly your child can think and respond - Executive function tests: How well your child can plan and solve problems

These tests are like games on a computer or tablet. They are not painful and most children find them interesting. Each testing session takes approximately [XX] minutes.

Summary of Study Procedures

Visit Timing Physical Exam Blood Draw Cognitive Tests Study Drug
1 (Screening) Week 0 Yes Yes Yes No
2 (Baseline) Week [X] No No Yes Yes
3 Month [X] No Yes Yes Yes
[Continue as needed]
Final Month 18 Yes Yes Yes No

Optional Studies

The following studies are optional. For each optional study, you will be provided with a separate consent that describes the details, and which you will be required to sign if you wish to allow your child to participate. Your child can take part in the main study and not take part in these optional studies. If you decide not to allow them to take part in any or all of the optional studies, their care will not be affected.

  • Optional blood storage for future research: Extra blood samples may be stored for future research on Long COVID
  • Optional genetic testing: A sample may be used to study genes that might affect how children respond to treatment

What are the risks and discomforts?

Risks from Study Procedures

Blood draws: - Common (more than 50% of people): Brief pain, bruising at the needle site - Occasional (10-50% of people): Mild bleeding - Rare (less than 1% of people): Fainting, infection at the needle site

Cognitive assessments: - Your child may feel tired or frustrated during the computer tests - Some children find certain tests challenging, which may cause mild stress - Your child can take breaks at any time

Risks from [STUDY DRUG]

[INSERT DRUG-SPECIFIC RISKS HERE, grouped by frequency:]

Common side effects (more than 50% of people): - [List common side effects]

Occasional side effects (10-50% of people): - [List occasional side effects]

Rare side effects (less than 1% of people): - [List rare side effects]

Pregnancy Risk

If your child is female and able to become pregnant, she should not become pregnant while taking the study drug. The effects of [STUDY DRUG] on an unborn baby are not fully known. If your child is sexually active, she must use effective birth control during the study. Pregnancy tests will be done throughout the study.

Unknown Risks

There may be risks in this study that are currently not known. If we find out anything new during the course of this research which may change your willingness to allow your child to be in the study, we will tell you about these findings.

What are the benefits to my child?

There may or may not be direct benefit to your child from participating in this study. It is possible that the study drug may help improve your child's thinking and memory, but this is not guaranteed.

However, this study will help researchers learn more about how Long COVID affects children's thinking and whether [STUDY DRUG] might help. This information may help other children with Long COVID in the future.

What will we be asked to do while in the study?

While your child is in this study, you and your child will need to:

  • Attend all scheduled study visits
  • Give your child the study medication exactly as directed
  • Tell the study doctor about any health problems or side effects your child experiences
  • Tell the study doctor about any other medications your child is taking
  • Tell the study doctor if your child's contact information changes
  • If your child is female and able to become pregnant, use effective birth control and tell the study team immediately if she becomes or thinks she might be pregnant

What happens if my child is injured because of this research?

If your child becomes ill or injured as a result of being in this study, they will receive necessary medical treatment at no additional cost. By signing this consent form, you are not giving up any of your legal rights or releasing the investigator(s), institution(s), and/or sponsor(s) from their legal and professional responsibilities.

Do I have to agree for my child to take part in the study?

Being in this study is your choice. If you decide to allow your child to be in the study, you can change your mind and stop being in the study at any time, and it will in no way affect the care or treatment that your child is entitled to.

Can our participation in the study end early?

In addition to you being able to stop your child's participation at any time, the study doctor or the sponsor of the study may withdraw your child from this study if:

  • Your child does not attend study visits as scheduled
  • The study doctor feels it is in your child's best interest
  • Your child experiences side effects that make it unsafe to continue
  • Your child becomes pregnant
  • The study is stopped for any reason
  • The approval for the study is withdrawn

Are there other choices to being in this research study?

You do not have to allow your child to join the study in order to receive treatment. Your child's regular doctor can continue to monitor and treat their Long COVID symptoms. The study doctor will explain other treatment options to you in detail.

What will it cost to participate?

There is no cost to you or your child for taking part in this study. The study drug, cognitive assessments, and study-related tests will be provided at no charge.

Will we be paid to be in the research?

You will receive [AMOUNT] for each completed study visit to help cover the costs of travel and parking. If your child completes all study visits, you will receive a total of approximately [TOTAL AMOUNT] over the 18-month study period.

[OR: You will not receive payment for taking part in this study. However, reasonable travel and parking costs will be reimbursed.]

Privacy and Confidentiality

During this study, we will be collecting information (or "study data") about your child. We will use the data to help answer research questions and we will share (or "disclose") your child's information with others such as the study sponsor and other researchers. Your child's study data may also be shared with government departments involved in the approval of drugs for sale in a country. These departments are often called "regulatory authorities." An example of a regulatory authority is Health Canada.

Below we describe in more detail how your child's data will be collected, stored, used, and disclosed.

What data will we be collecting?

During this study, we will be collecting data about your child. Examples of the types of data we may collect about your child include: name, address, ethnic background, date of birth, age, health conditions, health history, medications, and results of tests or procedures that they may have had. We will only look for and collect the information that we need to do the research. We will get this information by asking you and/or your child questions and doing the tests outlined in this form. We will also look at their medical chart (paper or electronic) held by the study doctor or other doctors they have seen (such as their family doctor).

How will the study data be stored?

The study data we collect, which will include your child's name, will be securely stored by the study doctor during and after the study. We will also put a copy of this consent form in your child's clinical record, so that doctors you see in the future will know your child was in the study. In Canada, the law says we have to keep the study data stored for at least 25 years after the end of the study.

The study doctor will not release your child's name to anyone unless the law says that they have to.

How will the study data be used?

Your child's study data will be coded (with a number) so that it no longer contains their name, address, or anything else that could identify them. Only your study doctor will be able to link your child's coded study data to them. The coded study data will be sent to the Sponsor. This coded study data will be kept by the Sponsor in a secure manner and will be used now and in the future to:

  • Learn more about how [STUDY DRUG] works and how safe it is
  • Learn more about how Long COVID affects children's thinking
  • Learn more about how to treat Long COVID and similar conditions
  • Apply for approval to sell the study drug in Canada or other countries

This coded study data may also be shared with people who work with the Sponsor and with regulatory authorities. The Sponsor and/or the people they work with may be located outside of Canada, in countries that do not have the same privacy laws as in Canada. However, because nothing that is sent to the Sponsor will contain your child's name, no one who uses this information in the future will be able to know it came from them. The risk to your child's privacy, then, should be very small.

When the study is done, the Sponsor may place your child's coded study data into a secure database. The coded data may then be used to answer other research questions in the future. Only researchers who have the training and experience to do the research (also known as "qualified researchers") will be allowed to use the data. The data will be stored indefinitely for future research use.

Who will be able to look at my child's health data?

During research studies, it is important that the data we get is accurate. Therefore, your child's study data and original medical records may also be looked at by people from: the study sponsor, the University of Alberta auditors and members of the Research Ethics Board, Health Canada, and/or other foreign regulatory authorities.

By signing this consent form, you are saying it is okay for the study doctor/staff to collect, use, and disclose information from your child's medical records and their study data as described above.

If you would like to see the study data collected about your child, please ask the study doctor. You will be able to look at the study data about your child and you can ask for any mistakes to be corrected. The study doctor may not be able to show you your child's study data right away, and you may have to wait until the study is completed or another time in the future before you can see their study data.

If you leave the study, we will not collect new health information about your child, but we will need to keep the data that we have already collected.

What if I have questions?

If you have any questions about the research now or later, or if your child experiences any adverse effects, please contact:

Dr. Lawrence Richer (Principal Investigator) Phone: [INSERT PHONE NUMBER] 24-hour emergency: [INSERT EMERGENCY NUMBER]

Megna Lindsel (Study Coordinator) Phone: [INSERT PHONE NUMBER]

If you have any questions regarding your child's rights as a research participant, you may contact the University of Alberta Research Ethics Office at reoffice@ualberta.ca. This office is independent of the study investigators.

Funding and Conflict of Interest

This study is being sponsored by [NAME OF SPONSOR/FUNDING AGENCY]. The Institution and study doctor are receiving funding from the study sponsor to cover the costs of doing this study. You are entitled to request any details concerning this compensation from the Principal Investigator.

[If applicable: Dr. Lawrence Richer has no financial interest in the study drug or the sponsor company.]

How do I indicate my agreement to be in this study?

By signing below, you understand:

  • That you have read the above information and have had anything that you do not understand explained to you to your satisfaction
  • That your child will be taking part in a research study
  • That your child may freely leave the research study at any time
  • That you do not waive any legal rights by being in the study
  • That the legal and professional obligations of the investigators and involved institutions are not changed by taking part in this study

I agree to allow my child _______ to take part in this study. (CHILD'S NAME - please print)

I have the legal authority to give this consent.

Signature of Parent or Legal Guardian: _____

Printed Name: _____

Date: _____

I have explained this study to the parent/guardian. I have answered all questions to the best of my ability.

Signature of Person Obtaining Consent: _____

Printed Name: _____

Date: _____

Witness (if required)

Signature of Witness: _____

Printed Name: _____

Date: _____

A signed copy of this consent form has been given to you to keep for your records and reference.

Ethics ID: Pro00XXXXXX | Version Date: [INSERT DATE] | Page 8 of 8