Participant Information Sheet and Consent - Children and Parents or Guardians - NEW FORMAT

133 Molesworth Street PO Box 5013 Wellington 6140 New Zealand

Participant Information Sheet - Parents or Guardians of Children under 16 years of age Long-term outcomes of myocarditis and pericarditis after Pfizer COVID-19 vaccination Formal Study title: Long-term outcomes of myocarditis and pericarditis after Pfizer-BioNTech COVID-19 vaccination in adults and children Sponsor: Medsafe, Ministry of Health Coordinating Investigator: Dr Tim Hanlon, National Immunisation Programme, Ministry of Health Contact: email c19myostudy@health.govt.nz or call 04 819 6800 Ethics committee reference 2022 FULL 11589 \ VOLUNTARY PARTICIPATION AND WITHDRAWAL FROM THIS STUDY Some children might be able to consent to take part in this study by themselves, and some children might need a parent to consent on their behalf. You may like to discuss the study and the contents of this participant information sheet with your child thoroughly. Whether or not your child wishes to take part in the study is their choice.

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If your child has a good understanding of the information provided in this participant information sheet about what the study involves, they might be able to consent to taking part in the study on their own. The researcher will talk to you and your child about this and will give them the opportunity to consent on their own if they are able to and would like to do this. They will still be able to ask you for help with answering any questions if they want to. The Child Consent Form is included at the end of this document for your child to read.

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Alternatively, if your child is not able to consent on their own, you will be asked to provide consent, and your child will be asked to provide assent. In this case you both need to agree to taking part in the study, but you will be asked questions on your child’s behalf.

They will still be able to help you answer some of the questions if they want to. The Parent/Guardian Consent Form and Child Assent Form are included at the end of this document for you and your child to read.

If you or your child do not want to take part in the study, you do not need to give a reason. If you and your child do want to take part and change your mind later, you can withdraw from the study

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by letting the research team know. If you decide to withdraw from the study your child’s original adverse event report submitted to the Centre for Adverse Reactions Monitoring (CARM) will remain in the Ministry of Health’s COVID-CARM database, but any data obtained in this study will be deleted. Choosing not to take part in the study or withdrawing from the study this will not disadvantage you or your child in any way and will not change the way their CARM report is used for routine safety monitoring.

WHAT IS THE PURPOSE OF THE STUDY? Myocarditis and pericarditis have been found to be rare side effects of the Pfizer COVID-19 vaccine. Myocarditis is inflammation of the heart muscle, while pericarditis is inflammation of the tissue forming a sac around the heart. When myocarditis and pericarditis happen at the same time, this is called myo-pericarditis. Based on information currently available, most people who develop myocarditis and/or pericarditis after vaccination recover well. However, more information is needed to better understand if there are any ongoing effects.

This study aims to describe the long-term health of people who develop myocarditis and/or pericarditis after their Pfizer COVID-19 vaccination. This study will allow us to better understand the safety of the Pfizer COVID-19 vaccine within Aotearoa New Zealand.

WHO CAN TAKE PART IN THE STUDY? People aged 12 years and over who have experienced myocarditis and/or pericarditis after their first or second dose of the Pfizer COVID-19 vaccine are being invited to take part in the study. At least 90 days must have passed since the myocarditis and/or pericarditis began before someone can take part.

WHAT WILL MY/MY CHILD’S PARTICIPATION IN THE STUDY INVOLVE? Participation in the study will involve a phone survey, which will take about 30 minutes to complete. You will be asked to answer questions on behalf of your child. You may wish to discuss with your child if they would like to take the survey with you or help you answer some of the questions. The survey will be carried out by registered nurses from the REACH AOTEAROA team of CBG Health Research Limited (CBG). CBG is a New Zealand company experienced in carrying out health surveys.

When you are first contacted by the nurse, they will tell you about the study and you and your child will have the chance to ask questions. You do not have to have to do the survey right away.

The nurse will talk with you and your child to find a time that works for you. If you or your child need more time to think about their participation, or to talk to whānau or friends about the study, the nurse can call back at another time.

If you would like to participate but would prefer not to do the survey over the phone, you can let the research team know by contacting us using the contact information in this letter, or by telling the nurse when they call you on the phone. There are other options available such as face-to-

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face or virtual (online) interviews. You can also let us know if you or your child have any specific cultural requirements or if you need an interpreter.

In the survey you will be asked about your child’s myocarditis and/or pericarditis diagnosis and symptoms, their current health, their medicines, and their relevant medical history. Some of the questions will relate to their mental health. The nurses are trained in asking these types of questions and will be able to give advice on support services you and your child can contact. You don’t have to answer every question in the survey.

To better understand your child’s myocarditis and/or pericarditis we will confirm when they had their COVID-19 vaccine(s) by checking their Ministry of Health COVID-19 vaccine record. This information will be linked with your survey answers.

If you agree (and if it is available), the nurse will access your child’s medical records from their GP or pharmacist to help answer some of the survey questions. They will only look at information that relates to the survey questions. This is optional and you don’t have to agree to it to participate in the survey.

If you and your child agree, we will ask their healthcare provider (such as their usual GP or nurse) for more information on their myocarditis and/or pericarditis. We will ask them about your child’s heart recovery, heart test results, heart medicines, and relevant medical history. You will be asked about this when you do the survey. This is optional and you don’t have to agree to it to participate in the survey. Your child’s medical records may also be used to help with getting this information, if you agree to it.

If you and your child agree, we will also link information about time they have spent in the hospital and prescriptions they have received since their myocarditis and/or pericarditis. We would also like to confirm the results of any COVID-19 tests they have had. You will be asked about this when you do the survey. This is optional and you don’t have to agree to it to participate in the survey.

WHAT WILL HAPPEN TO YOUR CHILD’S DATA? Security and Storage of Your Information: During this study CBG will record information about your child and your study participation. This includes survey answers provided by you and your child or their healthcare provider, as well as any relevant information from their medical records. Survey answers will be documented electronically by the nurse, and surveys will not be recorded. This information will be stored securely by CBG, who will provide this information to researchers within the National Immunisation Programme at the Ministry of Health. Any transfers of data will be done using secure methods.

Any other information about them that is collected as part of this study, including health information used for data linking, will be stored securely on Ministry of Health servers.

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Any information you and your child provide to CBG as part of this study will be deleted from their servers when the study ends. After the study ends your child’s information will be stored securely on Ministry of Health servers for at least 10 years from the time they become 16 years old, as required by the Health (Retention of Health Information) Regulations 1996. All storage will comply with local data security guidelines.

Identifiable information: Identifiable information is any data that could identify your child (e.g. their NHI number, name, date of birth, or address). Only the researchers within CBG and the National Immunisation Programme, and Medsafe, will have access to your child’s identifiable information.

Deidentified (Coded) Information: De-identified information is information about your child that cannot be linked back to them on its own (such as their age, gender, and myocarditis and/or pericarditis diagnosis).

To ensure your child’s personal information is kept confidential, information that identifies them will not be included in any report generated by the researchers. Instead, their data will be identified by a unique code. Any information about them collected as part of the study that is stored by the researchers within the National Immunisation Programme or Medsafe will be de-identified. A list linking their unique code with their name will be kept so that they can be identified by their coded data if needed. Only the researchers within the National Immunisation Programme and Medsafe will be able to re-identify you. This information will be stored securely on Ministry of Health servers.

The results of the study may be published or presented, but not in a form that would reasonably be expected to identify them.

Future Research Using Your De-Identified Information: Your child’s de-identified information provided in this study may be used for future research related to myocarditis and pericarditis after COVID-19 vaccination.

This future research may be conducted overseas. You and your child will not be told when future research is undertaken using their de-identified information. Their information may also be added to information from other similar studies, to form much larger sets of data.

You and your child will not get reports or other information about any future research that is done using their de-identified information. Their information may be used indefinitely for future research unless you withdraw your consent. However, it may be extremely difficult or impossible to access their information, or withdraw consent for its use, once their de-identified information has been shared for future research.

Other Future Research: During the survey you will be asked if you and your child would like to be contacted for future research studies related to myocarditis and pericarditis after COVID-19 vaccination. This is optional and you don’t have to agree to it. Saying yes will not commit you or your child from taking part in any further research; it just means we can contact you to ask.

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Risks: Significant effort will be made to protect your child’s privacy, however absolute confidentiality of your information cannot be guaranteed. Even with coded and anonymised information, there is no guarantee that your child cannot be identified. There is a very small risk of people accessing and misusing their information (e.g. making it harder for them to get or keep a job or health insurance). There is a possibility that the risk may increase in the future as people find new ways of tracing information.

Data-linking can produce a detailed picture of individuals. Data-linking increases the risk of identifying individuals and possibly others who may be in the same households, organisations, iwi or hapū. Some studies link information from multiple different sources (for example education records, tax records, and justice records). However, for this study we will only link relevant health information about your child which is stored by the Ministry of Health. This includes information about their COVID-19 vaccine(s), and with your consent some additional health information on hospitalisations, prescriptions, and COVID-19 tests. By linking only relevant health information, this reduces the risk of causing harm or being able to re-identify them.

This research includes basic information about your child’s ethnic group, age range, and sex. It is possible that this research could one day help people in the same groups as them. However, it is also possible that research findings could be used inappropriately to support negative stereotypes, stigmatize, or discriminate against members of the same groups as them.

Rights to Access Your Information: You and your child have the right to request access to their information. You also have the right to request that any information you disagree with is corrected. You also have the right to ask the researchers any questions about the usage of your child’s data. If you wish to do so please refer to the contact information in this letter.

Rights to Withdraw Your Information: You may withdraw your consent for the collection and use of your child’s information at any time, by informing the research team. If you or your child withdraw consent, their study participation will end, and the researchers will delete their data from their records. If you wish to do so please refer to the contact information in this letter.

You can request to have any information about your child, from this study, that is held by the Ministry of Health deleted at any time. However, we may not be able to remove their de-identified information from any analysis or reports that have already been done. This is because their deidentified information will have been grouped with answers from other study participants.

CAN I FIND OUT THE RESULTS OF THE STUDY? You will be asked by the nurse if you would like to be sent a copy of your own study results, and/or a summary of the overall study results once these are available, or you can let the research team know at any time. We also hope to publish the results of this study in a scientific journal

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WHO IS FUNDING THE STUDY? The study is being funded by the Ministry of Health.

WHO HAS APPROVED THE STUDY? This study has been approved by an independent group of people called a Health and Disability Ethics Committee (HDEC), who check that studies meet established ethical standards. The Northern B Health and Disability Ethics Committee has approved this study.

A Research Oversight Committee made up of experts and lay people has been set up to maintain oversight and provide support for this study. Their responsibilities include providing advice when needed, ensuring all aspects of the study proceed as approved by the HDEC, and that the objectives of the study are met.

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WHO DO I CONTACT FOR MORE INFORMATION? If you have any questions, concerns or complaints about the study at any stage, you can contact the research team for this study on: Phone: 04 819 6800 or 0800 478 783 Email: c19myostudy@health.govt.nz Website: health.govt.nz/MyocarditisStudy

If you want to talk to someone who isn’t involved with the study, you can contact an independent health and disability advocate on: Phone: Fax: Email: Website:

0800 555 050 0800 2 SUPPORT (0800 2787 7678) advocacy@advocacy.org.nz https://www.advocacy.org.nz/

You can also contact the health and disability ethics committee (HDEC) that approved this study on: Phone: Email:

0800 4 ETHIC hdecs@health.govt.nz

If you would like Māori or Pasifika health or cultural advice for this study, please contact the CBG REACH AOTEAROA team on: Phone: Email:

0800 478 783 info@cbg.co.nz

If you need health advice or advice on finding health services near you, please contact your usual healthcare provider in the first instance. You can also call Healthline for advice for free, 24 hours a day, 7 days a week, on: Phone: 0800 611 116 Website: www.healthline.govt.nz

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Assent Form for child (with parent consent) Long-term outcomes of myocarditis and pericarditis after Pfizer COVID-19 vaccination You may wish to discuss this letter with you parent or guardian to make sure you understand it.

Tēnā koe, You have been selected to take part in a research study. The Ministry of Health has been told of that you had myocarditis or pericarditis after your COVID-19 vaccination. This means that after your COVID-19 vaccination, your heart or the area surrounding your heart became swollen. We know this may have been upsetting and may have affected your day-to-day life, and so we would like to understand how you are feeling now. The study will help us understand how you and other people with similar experiences are feeling after these events.

To take part in this study, your parent/guardian will need to answer some questions about you.

The researcher asking the questions will be a nurse. You may want to be there when they do this, or help them answer some of the questions, but you do not need to be there if you do not want to. If you find any of the questions upsetting or would like to talk to someone after the study, the nurse will be able to tell you about some support services that might be able to help you. If you do not want us to ask your parent or guardian questions about you, we will not do this. This will not affect you in any way. If you do want to take part in the study, you can stop at any time. We would also like to talk with your doctor and ask them some questions about you and your heart if you and your parent/guardian are happy with this.

Make sure you talk about the survey with your parent. If you have any questions you and your parent/guardian can talk to the researchers before you decide if you want to take part in the study.

The nurse will go through this form with you.

By agreeing to take part in this study, you understand and agree to the following: •

I have read, or have had read to me in my first language, and I understand the information in this assent form.

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I know I can ask my parent or guardian or the researchers questions at any time.

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I understand what will happen during this study, and I have had time to think about what the study involves for me.

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I understand that taking part in this study is my choice and that I may change my mind about it.

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I understand that whatever I decide, my health care and legal rights will not be affected.

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Consent Form for parent/guardian (with child assent) Long-term outcomes of myocarditis and pericarditis after Pfizer COVID-19 vaccination You may request an interpreter to help you understand this form.

You may also discuss this form with your whānau, friends, or your child’s healthcare provider.

By agreeing to participate in this study, you understand and agree to the following: •

I have read, or have had read to me in my first language, and I understand the Participant Information Sheet.

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I have been given sufficient time to consider whether or not I want to participate in this study on behalf of my child.

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I know I can ask questions at any time and I can contact the researchers at any time if I want more information.

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I understand that taking part in this study is voluntary (my choice) and that I may withdraw my child from the study at any time without this affecting their medical care.

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I understand that information about my child’s COVID-19 vaccination(s) will be accessed for this study and linked to their survey answers.

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I understand that my child’s de-identified information from this study may be shared with other researchers doing similar research on myocarditis and pericarditis.

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I agree to an approved auditor appointed by the New Zealand Health and Disability Ethics Committees, or any relevant regulatory authority or their approved representative reviewing my child’s relevant medical records for the sole purpose of checking the accuracy of the information recorded for the study.

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I understand that my participation in this study is confidential and that no material, which could identify my child personally, will be used in any reports on this study.

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I know who to contact if I have any questions about the study in general.

If you take part in the study, you will also be asked if you consent to the following: •

I give permission for my child’s relevant medical records from their GP and pharmacist to be accessed for this study.

(optional)

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I agree to researchers accessing and linking information from my child’s health records relating to: o any time I have spent in the hospital since my myocarditis and/or pericarditis o any medicine prescriptions I have received since my myocarditis and/or pericarditis o the results of any COVID-19 tests I have had.

(optional)

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I agree to my child’s healthcare provider being contacted to complete a survey about their myocarditis and/or pericarditis

(optional)

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I agree to being contacted to be asked about participating in future studies about myocarditis and pericarditis that the Ministry of Health may want to do.

(optional)

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I would like to be sent a copy of my child’s study results and/or a lay summary of the study results once the study is finished.

(optional)

A nurse from CBG will read through this consent form with you. They will ask you if you consent to take part in this study on behalf of your child, and they will document your answer electronically. They will also read through the assent form with your child.

If you agree to take part in the study, the nurse will also ask you about the ‘optional’ statements. They will ask you if you consent to each option individually, and they will document your answers electronically. These are optional, and you and your child can still participate in the study if you don’t consent to these.

You can keep this form for your information. You do not need to sign or return this form.

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Consent Form for child (consenting on their own) Long-term outcomes of myocarditis and pericarditis after Pfizer COVID-19 vaccination You may request an interpreter to help you understand this form.

You may also discuss this form with your whānau, friends, or healthcare provider.

By agreeing to participate in this study, you consent to the following: •

I have read, or have had read to me in my first language, and I understand the Participant Information Sheet.

•

I have been given sufficient time to consider whether or not to participate in this study.

•

I know I can ask questions at any time and I can contact the researchers at any time if I want more information.

•

I understand that taking part in this study is voluntary (my choice) and that I may withdraw from the study at any time without this affecting my medical care.

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I understand that information about my COVID-19 vaccination(s) will be accessed for this study and linked to my survey answers.

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I understand that my de-identified information from this study may be shared with other researchers doing similar research on myocarditis and pericarditis.

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I agree to an approved auditor appointed by the New Zealand Health and Disability Ethics Committees, or any relevant regulatory authority or their approved representative reviewing my relevant medical records for the sole purpose of checking the accuracy of the information recorded for the study.

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I understand that my participation in this study is confidential and that no material, which could identify me personally, will be used in any reports on this study.

•

I know who to contact if I have any questions about the study in general.

If you take part in the study, you will also be asked if you consent to the following: •

I give permission for my relevant medical records from my GP and pharmacist to be accessed for this study.

(optional)

•

I agree to researchers accessing and linking information from my health records relating to:

(optional)

o o o

any time I have spent in the hospital since my myocarditis and/or pericarditis any medicine prescriptions I have received since my myocarditis and/or pericarditis the results of any COVID-19 tests I have had.

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I agree to my healthcare provider being contacted by the research team to complete a survey about my myocarditis and/or pericarditis.

(optional)

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I agree to being contacted to be asked about participating in future studies about myocarditis and pericarditis that the Ministry of Health may want to do.

(optional)

•

I would like to be sent a copy of my own study results and/or a lay summary of the study results once the study is finished.

(optional)

A nurse from CBG will read through this consent form with you. They will ask you if you consent to take part in this study, and they will document your answer electronically.

If you agree to take part in the study, the nurse dwill also ask you about the ‘optional’ statements. They will ask you if you consent to each option individually, and they will document your answers electronically. These are optional, and you can still participate in the study if you don’t consent to these.

You can keep this form for your information. You do not need to sign or return this form.

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