participant info & consent dec 2003 - royal children's … · web viewthis document...

Standard Wordings for Participant Information and Consent Forms

Introduction

This document outlines standard wordings that you may find helpful to use in your Participant Information and Consent Form (PICF).

The RCH Human Research Ethics Committee has approved the wording for the below topics and, for this reason, the wording cannot be changed:

anaesthesia MRI scans radiation compensation for commercially-sponsored clinical trials.

The other standard wordings can be adapted as needed.

Note that:

Not all of the standard wordings in this document will be applicable to your research study. Please only use the standard wordings that are relevant to your research project.

Wording that appears as [italics in square brackets] should be edited according to your research protocol.

The wordings in this this document have been drafted for the Parent/Guardian PICF templates. If you wish to insert these wordings into the Participant PICF template you must edit each wording to ensure that you are referring to ‘you’ throughout the documents not ‘your child’.

PICF Standard Wordings of 20 v2018.2 (REG)

WHAT IS THE RESEARCH PROJECT ABOUT?

Registration status of a drug/device – For clinical drug/device studies only (select most appropriate sentence)

Medicines and medical devices have to be approved for use by the Therapeutic Goods Administration (TGA) Australia. [Name of drug/product] is approved in Australia to treat [condition]

Or

[Name of drug/product] is an experimental treatment. This means that it is not an approved treatment for [condition] in Australia or other parts of the world.

Or

[Name of drug] is approved in Australia to treat [other condition]. However, it is not approved to treat [condition]. Therefore, it is an experimental treatment for [condition]. This means it needs to be tested to see if it is a useful treatment for [condition].

Describing genetics and genetic research

Our bodies are made up of different types of cells. Inside these cells you find genes. Genes are passed down in families from parents to children. You get half your genes from your mother and half from your father. A gene is like a small microchip which contains all the information that makes us what we are, including our eye colour, blood type and whether we are born as a boy or a girl.

There are about 23,000 genes that make up a human being and genes are arranged along a chemical substance called DNA. Sometimes a gene contains a ‘spelling mistake’ that upsets the gene’s coded message. This mistake is also called a variation. This makes the gene not work properly and is known as a mutation or change.

Many health conditions or diseases are caused by a change in one or more genes. These conditions may be present at birth or may appear later in life.

Genetic research involves testing and studying genetic material, usually DNA. Genetic research is done for many reasons including:

finding out why some diseases run in families and how it is passed on from one generation to the next

working out the chance of a future baby having a genetic condition discovering more accurate ways of predicting disease in a group of people or where there is a

strong family history of a disease.

Describing cell lines

In this research project, we plan to establish a cell line. A cell line is formed when we take cells from the blood and grow them in the laboratory. We can keep the cells alive indefinitely. Creating a cell line allow us to produce a never-ending supply of cells for researchers to use. Cells lines are everlasting, which means they can be stored and used indefinitely by researchers.

Describing data linkage

Throughout our lives, information is collected about our health and health care. This information is collected by hospitals, health departments and other groups or organisations that provide health


services. The collection of this information is usually required by law and is securely stored by the service or agency that collects it.

Health research is very important as it looks at how health care is managed and how services are delivered and used. Data linkage is a way of connecting information held by different groups or services in a way that protects a person’s privacy. Being able to link data can be very useful in health research. It can provide a more accurate picture of the overall health and well-being of group of people. More recently health information has been linked to other areas, including education.

WHO IS FUNDING THIS RESEARCH PROJECT?

Funding - For standard studies only

This project is funded by [insert names of funding groups and/or departments and/or sponsors].

Funding - For clinical drug/device studies only

This study is being conducted by [insert sponsor name]. [insert sponsor name] is the sponsor of the study. The Royal Children’s Hospital is funded by the sponsor to run this study. All money paid by the sponsor to the hospital goes to pay the costs of equipment, tests and staff to run the study.

Or

This study is being conducted by [insert name of international sponsor] and sponsored in Australia by [insert local sponsor name]. The Royal Children’s Hospital is funded by the sponsor to run this study. All money paid by the sponsor to the hospital goes towards the costs of equipment, tests and staff to run the study.

Or

This study has been started by the Principal Investigator [insert name].

And, if applicable:

Your child will not be paid to take part in this research project. We will refund you for any [travel/parking costs] that you have when coming to the hospital for research study related visits.

WHY IS MY CHILD BEING ASKED TO TAKE PART?

We are asking your child to take part because [insert appropriate details eg they have (condition); they are aged (age range) etc]

WHAT DOES MY CHILD NEED TO DO IN THIS RESEARCH PROJECT?

Projects involving randomisation

RandomisationWe will put your child into one of two groups:

Group 1. Treatment group. In this group your child will be given [drug name/program sessions]

Group 2. No treatment group. In this group your child will be given [placebo drug/no treatment/standard treatment] [A placebo is a medication with no active ingredients. It looks like the real thing but is not.}


This will be done by chance, similar to tossing a coin, so your child has an equal chance of being in either group.

[For non-blinded studies insert – Neither you, your child or your doctor can choose which group your child is put in].

[For double-blinded studies insert – Neither you, your child nor your doctors will know which group your child is in. It is possible to find out which group your child is in if we need to].

Study Visit Table (example)

Study Visits

Procedures

Screening Visit Treatment Visits Follow-up

VisitUp to 2 weeks

before first dose

Visit 1 Visit 2 Visit 3 Visit 44 weeks after last

dose

Consent form XReview of

medications X X X X X X

Questionnaires X X X X XPhysical

examination X X X X X X

Vital signs X X X X X XBlood test 10ml 5ml 5ml 10ml

Urine collection X X XECG X X X

Visit Time (hours) 2 1 1 2 1 2

Projects involving pregnancy testing (select appropriate sentence and BOLD)

Pregnancy test

If your child is a girl who has reached puberty and is able to have children, she will have a [urine/blood] pregnancy test.

Girls must have a negative pregnancy test to be able to take part in this project.

Projects involving MRI Scans

MRI Scan

We would like your child to have a [xxx] MRI scan.

MRI is short for magnetic resonance imaging. The MRI scanner has a strong magnet. The magnetic attraction for some metal objects can pose a safety risk. It is important that metal objects are


removed and not taken into the scanner room. You must tell us if your child has metal implanted in their body, such as a pacemaker or metal pins after being involved in an accident.

The MRI scanner is a large machine that is shaped like a big tube and is open at both ends. It has a bed to lie on and a head rest. The bed moves into the magnetic cylinder so that the part of the body that is scanned is in the centre.

· Since the MRI machine is a big magnet, care must be taken not to take any metal into the scanner room. Before your child’s scan, we will ask you and your child to complete an MRI safety questionnaire. On the day of the MRI scan, one of the MRI technologists will go through the safety questionnaire again with you and your child.

· Before the scan your child will need to remove anything made of metal, for example jewellery, hair pins, watches etc. They may also need to remove make up, hair extensions or glitter as these items interfere with MRI pictures.

· We will ask your child to lie on the bed and we will make sure they are comfortable.· We will give your child some earphones because the scanner makes loud knocking noises

while the pictures are taken. Your child can watch a video or listen to music during the scan.· Your child needs to lie very still while the pictures are taken.· The scan will last [x] minutes.

Before the MRI scan your child can have a practice MRI (also called a “mock MRI”). This involves spending time with an educational play therapist so that your child can become familiar with the MRI scan procedure. They will lie inside a ‘pretend’ MRI scanner that makes the same noises. We can organise a mock MRI session if you and your child want one.

Projects involving blood sample collection and delayed consent

Due to the critical time nature of this project, we collected a [insert volume] blood sample for this study on your child’s arrival to [insert ward/department]. We have stored the sample until we are able to discuss the project with you and ask if you are interested in participating. As the sample was taken at the same time as other blood samples for your child’s medical care, any additional discomfit to your child has been minimal. If you decide not to participate in the study the research blood sample will be destroyed.

Test Samples – For clinical drug/device studies only

Participation in this study involves the collection of the following samples which will be used for research purposes:

blood saliva urine.

These samples will be stored, tested at, located, and kept for [insert details].

Projects involving audio-recording

We will make a digital audio-recording of the [interview/focus group] so we can concentrate on listening to what your child has to say rather than distract ourselves by taking notes.

After the [interview/focus group] we will transcribe the recording. This means we will make a full written copy of the recording.


Access to hospital medical records

In this project, we will collect and use information from your child’s hospital medical record for research purposes. The information we will collect includes: [list details].

Access to Newborn Screening Card for research purposes

When your child was born, they had a small blood sample collected to test for serious and treatable diseases. This sample was collected by pricking your baby’s heel and four blood spot samples were collected on a card. The newborn screening card was sent to the Victorian Clinical Genetic Services (VCGS) laboratory for testing. The blood spots remaining on the card after testing were stored by VCGS.

We would like your permission to access your child’s newborn screening card and use # of the remaining blood spots in this research project. VCGS will allow us to access your child’s newborn screening card if we have your consent as well as ethics approval for this research. VCGS makes sure they keep one complete blood spot in storage should it be needed for future medical reasons.

Please tick the appropriate box on the consent form to let us know if you consent to this or not.

Optional Consent – Data linkage

Optional Consent

We would like your permission to let us link to other databases to collect additional information that will help us to [insert details]. We will collect information about you from the following databases or organisations: [as examples

Births, Deaths and Marriages register NAPLAN Australian Early Development Index (AEDI)].

OR

We would like your permission to let us link to information collected by Medicare. The information we collect from Medicare will help us to [insert details]. So we are able to do this, we will ask you to complete a Medicare Australia Authority to release personal Medicare and PBS claims information to a third party form.

Optional Consent – Storage of blood sample for use in future research (extended consent)

Optional Consent

We would like you to consider letting us store any leftover blood samples collected as part of this study, for use in future ethically-approved research studies related to [condition/disease]. If you give your permission, we will store your child’s blood sample at the [institution name] for an indefinite period of time. The sample will be stored using a special ID number. Your child’s name will not be attached to the sample. We do not plan to contact you or your child if the sample is used in future research. Please tick the appropriate box on the consent form to let us know if you consent to this or not.


Optional Consent – Future research

Optional Consent

We would like you to consider letting us to send you information about new research projects that may be suitable for your child. The information we send will give you the full details about the project. It is your choice whether you agree to let your child take part in any future project or not. You are not obliged to take part in any future research you are sent information about.

Other treatment - For clinical drug/device studies only

Other treatmentIt is important to tell us about any treatments or medicines your child may be taking. This includes prescription medicines, over-the-counter medicines, vitamins or herbal medicines. If there are any changes to these, while they are in this study, you must let us know.

And, if applicable:

During the study, your child may not be able to take some or all of the medicines or treatments they usually take for their condition. We will tell you which treatments or medicines need to be stopped while your child is in the study.

Informing your GP - For clinical drug/device studies only

Informing your GP

We will tell your GP that your child is a participant in this study. It is helpful for your GP to know this should your child need to visit them during the study about a medical problem.

Or

You should tell your child’s GP that your child is taking part in this research study.

After the study ends - For clinical drug/device studies only

After the study endsAfter the study has ended, the study drug will not be available until it has been registered by the Therapeutic Goods Administration.

Or

After this study has ended, your child may be able to take part in an extension study to continue taking the study drug.

Withdrawal from study treatment - For clinical drug/device studies only

Withdrawal from study treatmentThis study may be stopped for a variety of reasons. We may need to take your child off the study treatment for the following reasons, such as if:

we believe that it is in their best interest


they have side effects from the treatment that are considered too severe your child becomes pregnant your child does not follow instructions or come to planned study visits the study treatment is shown not to be effective the treatment has been shown to work and does not need to be studied any further the sponsor stops the study unexpectedly.

New information may become available that might affect your decision to let your child stay in the study. If we learn any new information, we will talk to you about it.

WHAT ARE THE ALTERNATIVES TO TAKING PART?

For clinical drug/device studies only

The alternatives are for your child to get the standard medical care and treatment for their condition. This includes:

[include a brief description of treatment]

CAN MY CHILD WITHDRAW FROM THE PROJECT?

For clinical drug/device studies only

If you give your consent and change your mind, you can withdraw your child from the project. You do not need to tell us the reason why. However, please tell us if you plan to take your child out of the project so we can let you know if there are any health risks or special requirements linked to this. If your child leaves the study, we will use any information already collected unless you tell us not to.

For all other studies

If you give your consent and change your mind, you can withdraw your child from the project. You do not need to tell us the reason why. If your child leaves the project we will use any information already collected unless you tell us not to.

WHAT ARE THE POSSIBLE BENEFITS FOR MY CHILD AND OTHER PEOPLE IN THE FUTURE?

Individual benefits

There is no direct benefit to your child if they take part in this project.

Or

We cannot guarantee that your child will get any benefits from this project. However, there is a chance that your child will benefit from: [describe potential benefits].

Or

We are unable to say if this project will be of direct benefit to your child. However, by taking part in this project your child will be more closely monitored than is usual.


Benefits to others

This project will not directly benefit your child. However, we hope that the project will benefit other children with [describe condition] in the future. It could do this by [add details].

WHAT ARE THE POSSIBLE RISKS, SIDE-EFFECTS, DISCOMFORTS AND/OR INCONVENIENCES?

Side effects - For clinical drug/device studies only

Medical treatments often have side effects. Your child may have none, some or all of the side effects listed below. These side effects may be mild, moderate or severe. If your child has any of these side effects or you are worried about them, please talk to us. We will also be looking out for side effects.

There may be side effects that we do not expect or know about. Please tell us immediately if your child experiences any new or unusual symptoms.

Many side effects go away shortly after treatment ends. However, sometimes they can be serious, long lasting or permanent. If a severe side effect or reaction occurs, we may need to stop your child’s treatment.

If your child experiences any symptoms listed below, or if they feel unwell in any way or notice something different about their body, please call us straightaway. We will assess whether these symptoms are related to the study drug.

Side effects table - For clinical drug/device studies only

Very common Common Uncommon Rare Very rareaffects more than 1 in 10

patients

affects between 1 and 10 in every 100 patients

affects between 1 and 10 in every 1,000

patients

affects between 1 and 10 in

every 10,000 patients

affects between 1 and 10 in

every 100,000 patients

Emotional/Psychological distress

If your child becomes upset or unhappy due to taking part in this project, we can arrange for counselling or other suitable support. Any counselling or support will be provided by someone who is not part of the research team. You can delay or end your child’s participation in the project if they feel any distress.

Or

We have been careful to make sure the questions in the survey do not cause any distress. However, if your child is worried by any of the questions they do not need to answer them.

Or

We do not expect the survey to cause your child any anxiety or distress.

New information about risks


During the research project, we may find out new information about the risks and benefits of this project. If this happens, we will tell you the new information and how it may affect your child. The new information could mean your child is no longer able to take part in this research project. In all cases, we will offer your child all available care to suit their needs and medical condition.

If you decide that your child can continue in the study, you may be asked to sign an updated consent form.

Unexpected risks and/or side effects

There may be new or unexpected risks and/or side effects.

Blood test risks

Blood testsThere are no major risks associated with a blood test. It is possible your child may feel some discomfort during the test. They may feel a sting when the needle is put in their arm to take the blood. We can use a cream to numb the skin before the blood is taken. It is possible there may be some bruising, swelling or bleeding where the needle enters the skin. Some people can feel a little light-headed when blood is taken.

Reproductive risks (select most appropriate sentences and BOLD)

Reproductive risks

Because of the age-range of participants in this study, it is possible that your child may have started or gone through puberty. The following information is important if your child is able to become pregnant or father a baby:

It is important to be aware that the treatment in this study may affect an unborn baby.

The effects of the study drug on an unborn or newborn baby are not known. If your child is pregnant, she cannot take part in this study. Your child should not become pregnant or father a baby while in this study. Your child should not breastfeed a baby while in this study. We can advise whether your child needs to use contraception, what kind of

contraceptive methods to use, and how long to use them. Your child must agree not to take contraceptive pills because of possible effects of

the drug treatment. Your child must use some other form of contraception instead. We can give your child more information about preventing pregnancy. If your child becomes pregnant during the project, we need to be told immediately.

Genetic test risks (select most appropriate sentences)

Genetic tests

The genetic tests we are doing are for research purposes. We will look at your child’s genes for features relevant to the research project.

Genetic test results


We will not give you or your child the results of any genetic tests because it is not known how reliable the results are.

Or

We will not give you the results of any genetic tests. This is because at this stage, we do not know what the results mean and they would not change the way we care for your child.

Or

The genetic tests results will be available if you would like to know them. You can decide whether you want to be told the results. It is important that you read the information about genetic test risks carefully so you can make an informed decision. If you decide to get your child’s test results, genetic counsellors are available to help you through the process. This will be at no cost to you.

Genetic testing risks

Genetic testing can raise important issues. Although we do not expect many issues to arise, you should be aware of this. If something is found in the genetic testing, you may need to tell your child about this sometime in the future. Think carefully before agreeing to let your child participate.

It is important to understand that the results from genetic research may not show that a person has a particular condition or whether they will develop it. Results may only show that a person has an increased risk of developing a condition. Even then, there is no guarantee that a person will develop the condition.

We are only searching for genes that are related to [condition]. However, it is possible that we may find genes responsible for other genetic conditions that you do not know about. If we find that your child has any genetic condition that you do not know about, we will contact you to discuss the findings. We will also refer you to a genetic counsellor.

On rare occasions, we may find a change in your child’s genes that is unrelated to the research. We might not know if the change is important. However, if any changes are found, we will tell your doctor who will discuss this with you. If we do find an unusual gene change, your child’s health can be managed in the most appropriate way.

The genetic tests we do may tell us something about you or your wider family. Learning about the results from genetic research may affect you and your family emotionally. It could also interfere with family relationships. By chance, we may discover that parents and children or siblings may not be biologically related. Information regarding paternity or maternity will not be available.

Some people in your family might want to know about your child’s results and whether the result has implications for them. You get to decide whether you want to tell them about the test results.

If you decide to find out the results of your child’s genetic tests, this may have implications for them in the future. For example, they may need to tell third parties about these test results. These third parties could include insurance companies, employers, and financial or educational institutions.

Some people find it stressful to get information about their genetic make-up and future health. There is also the possibility that genetic information may be important in understanding the risks of having a child with [condition] in the future.


If you want to talk about any personal issues or need counselling as a result of your child’s participation in this study, we can refer you to an independent genetic counsellor. This will be free of charge. We are also available to discuss any concerns you may have.

We will keep test results private but we cannot guarantee complete confidentiality. Because some genetic conditions are very rare it may be possible to identify test results to the person who gave the sample.

MRI risks – do not edit the following wording

MRI risks

To date, there are no known long-term health risks related with MRI scans. The scans are considered a safe procedure when performed at a centre with appropriate guidelines, such as The Royal Children’s Hospital.

The MRI scanner has a strong magnet. The magnetic attraction for some metal objects can pose a safety risk. It is important that metal objects are removed and not taken into the scanner room. You must tell us if your child has metal implanted in their body, such as a pacemaker or metal pins after being involved in an accident.

While it is operating, the scanner is noisy. However, your child will wear earphones to protect their ears. The scanner is shaped like a long tube and may cause some people to feel cramped. Some people can feel anxious during the scan. If your child feels anxious we will stop the scan.

We are taking the scans for research purposes. They are not meant to be used to help diagnose, treat or manage your child’s medical condition.

After the MRI scan, a radiologist will look at the images for unusual features or unexpected findings. If the radiologist finds something that needs further examination, we will organise a referral to an appropriate medical doctor. The discovery of an unusual feature could have consequences for your child and may affect their ability to work in certain professions or get insurance cover. However, the discovery of an unusual feature may also help your child get beneficial treatment.

Please consider the pros and cons of discovering a health risk before deciding whether to let your child take part in this research project.

Anaesthesia risks

Anaesthesia risks

Anaesthesia is generally very safe but there are some risks associated with it. The most common problems of anaesthesia are feeling unwell or vomiting, bruising at the site of injections, sore throat or hoarse voice. Some children may have a fear of and become upset by the procedure. Most patients do not have these problems. If these problems do happen, they usually get better very quickly.

Anaesthesia can cause problems that are more serious where damage may be permanent, but this is rare. Damage to the teeth is less common in children than in adults. The risk of brain damage or death due to anaesthesia is very rare.

The risk of problems from anaesthesia increases for patients who are having more major surgery, those with medical problems and those that require difficult anaesthetic procedures. If you have any concerns about these issues, you should discuss this with the anaesthetist looking after your child.


Radiation risks

Note to researchers:Projects that include exposure to ionising radiation procedures that are additional to standard clinical care are reviewed by an approved medical physicist. The medical physicist calculates a radiation dosage and researchers will be given a recommended radiation risk statement that must be inserted into the PICF exactly as advised.

WHAT WILL BE DONE TO MAKE SURE MY CHILD’S INFORMATION IS CONFIDENTIAL?

Note to researchers:

Data format: use of the term ‘de-identified’ is to be avoided when describing how data will be stored as its meaning is ambiguous. The National Statement advises use of the following terms:

Identifiable: data will be stored with personal identifiers attached to it eg name, date of birth, UR number

Re-identifiable (coded): all personal identifiers will be removed and replaced with a code number which is linked to personal information to enable re-identification if necessary

Non-identifiable (anonymous): no personal identifiers or code numbers are attached to the data

Types of consent: Specific consent: use of data collected for this research project only

Extended consent: use of data collected for this research project and for use in future related research

Unspecified consent: use of data collected for this research and for use in any future research

Data retention: Health information collected whilst an individual is a child must be kept for 7 years after their 18th

birthday or for 15 years after the end of a clinical trial – whichever date is the later.

Participants aged less than 18 years: research information must be kept at least until the participant turns 25 years old.

Participants older than 18 years: research information must be kept for a minimum of 7 years.

Research information that is non-identifiable must be stored for 5 years following the last publication of the study.

Statement for identifiable data

In this study we will collect and use personal and health information about your child for research purposes. Any identifying information that we collect about your child will be treated as confidential. It will be used only in this project, unless we say otherwise. We can disclose the information only with your permission, except as required by law.

All information will be stored securely in the [department name] at [institution].

The following people may access information collected as part of this research project:

the research team involved with this project


The Royal Children’s Hospital Human Research Ethics Committee.

The information will be identifiable. This means that your child’s name and/or other personal details will stay on the information.

As the participants in this project are under 18 years old, information will be kept at least until the youngest participant turns 25 years old.

Or, if applicable:

As the participants in this project are over 18 years old, we will keep their information for at least seven years.

The following wording must be inserted:

You have the right to access and correct the information we collect and store about your child. This is in accordance with relevant Australian and/or Victorian privacy and other relevant laws. Please contact us if you would like to access this information.

And, if applicable:

At the end of the study, we may present the results at conferences. We may also publish the results in medical journals. This will be done in such a way that your child cannot be identified.

And, if applicable:

The results of this research will be used by [name of researcher], to get a [full name of degree] degree.

Statement for re-identifiable data for standard research

In this study we will collect and use personal and health information about your child for research purposes. Any identifying information will be treated as confidential. It will be used only in this project, unless we say otherwise. We can disclose the information only with your permission, except as required by law.



the research team involved with this project The Royal Children’s Hospital Human Research Ethics Committee

The stored information will be re-identifiable. This means that we will remove identifying information such as your child’s name and give the information a special code number. Only the research team can match your child’s name to their code number, if it is necessary to do so.

As the participants in this project are under 18 years old, we will keep their information at least until the youngest participant turns 25 years old.

Or, if applicable:





And, if applicable:


Statement for re-identifiable data for a clinical drug/device study



The information will be re-identifiable. This means that we will remove your child’s name and give the information a special code number. Only the research team can match your child’s name to their code number, if it is necessary to do so.

As the participants in this project are under 18 years old, we will keep their information at least until the youngest participant turns 25 years old. Alternatively, we will keep their information for at least 15 years after the study has closed – whichever date is latest.


The coded information from this study will be sent to [sponsor name, country]. [sponsor name] will make sure that any information it receives or discloses is kept as confidential as possible. [sponsor name] may request to review your child’s hospital medical record.


the research team involved with this project The Royal Children’s Hospital Human Research Ethics Committee.

These groups may need to inspect and/or copy your child’s research records for data analysis. They may also want to check that study procedures are followed correctly. Your child’s name and personal details will not be released unless required by law.

Some of the information collected as part of this research may be important for your child’s medical treatment and health. The following information will be placed in your child’s hospital medical record to help the people who care for him/her:

[insert relevant details eg. Blood test results]

Any [state sample type] sample collected as part of this study [insert details re use, storage and disposal of sample].


Your child’s sample may be sent to another laboratory for testing. Any samples sent from The Royal Children’s Hospital will be labelled with your child’s code number only. It will not be possible for the testing laboratory to identify your child’s sample. It is important to note that any samples sent overseas are not protected by Australian laws and regulations.


[Insert sponsor specific wording – ensure it is in plain English and may only be added if not covered by the above standard wording]

Statement for non-identifiable data

Any information we collect and use during this research project will be treated as confidential. Only the researchers involved with this project and The Royal Children’s Hospital Ethics Committee can have access to this information.


The information will be non-identifiable. This means that the information is anonymous and will not include any name or code number. No one, not even the research team, will be able to identify your child’s information.

We are required to keep information for at least five years following the last publication of the project.

At the end of the study, we may present the results at conferences. We may also publish the results in medical journals.

And, if applicable:


Statement for re-identifiable data plus collection of a biological sample




the research team involved with this project The Royal Children’s Hospital Human Research Ethics Committee.

The information will be re-identifiable. This means that we will remove your child’s name and give the information a special code number. Only the research team can match your child’s name to their code number, if it is necessary to do so.

As the participants in this project are under 18 years old, we will keep their information at least until the youngest participant turns 25 years old.


Or, if applicable:



Any [state sample type] sample collected as part of this project [insert details re use, storage and disposal of sample].

Your child’s sample may be sent to another laboratory for testing. Any samples sent from The Royal Children’s Hospital will be labelled with your child’s code number only. It will not be possible for the testing laboratory to identify your child’s sample. It is important to note that any samples sent overseas are not protected by Australian laws and regulations.


And, if applicable:


Statement for storage and use of sample/data in future research


When tissue banks or data banks are being set up, the PICF must describe the following details:

what sample/data is being kept for future research purposes

where the sample/data is being stored

what format the sample/data is stored (eg anonymous or coded. Explain that coded samples/data means that it can be re-identified)

what the sample/data will be used for eg for use in related research (extended consent) or for use in any type of research (unspecified consent)

how long the sample/data will be kept for

whether participants will be informed of future use of the sample/data

if participants will be given the results of any future research using the sample/data

if participants will be re-consented for the continuing use of their sample/data when they turn 18 years old

if a sample is being stored, will additional data be kept with the sample

if the sample/data is being sent overseas it must be stated that it will not be protected by Australian laws and regulations (statement should be bolded).

Statement about confidentiality in focus groups/group interviews


We will ask your child and others in the group not to talk to outside people about what was said in the interview. In other words, we will ask each group participant to keep what was said in the group private. However, you should know that we cannot stop participants from sharing things that should be confidential.

WILL WE BE INFORMED OF THE RESULTS WHEN THE RESEARCH PROJECT IS FINISHED?


The RCH HREC requires that study participants are sent a thank-you letter that includes a plain English summary of the study results.

We will send you a summary of the overall project results. The summary will be of the whole group of research study participants, not your child’s individual results.

WHAT HAPPENS IF MY CHILD IS INJURED DURING THE PROJECT?

If you suffer any injury or complication as a result of this research project, contact the study team as soon as possible. The study team will help to arrange appropriate medical treatment for you. If you are eligible for Medicare, you can get medical treatment as a public patient in an Australian public hospital. This is at no cost to you.

WILL MY CHILD BE ABLE TO CLAIM COMPENSATION IF INJURED?

For clinical drug/device trials only


All participants in Phase 1 & 2 studies must be given a copy of the Medicines Australia (MA) compensation guidelines. For all other clinical trials, the MA compensation guidelines should be made available on request.

Wording for Commercially Sponsored Phase 1 & Phase 2 Clinical Trials – MUST be used exactly as appears

There are two avenues that may be available to you for seeking compensation if your child suffers an injury as a result of their participation in this research project:

The pharmaceutical industry has set up a compensation process, with which the Sponsor [full name of Australian corporate sponsor], of this research project has agreed to comply. Details of the process and conditions are set out in the Medicines Australia Guidelines for Compensation for Injury Resulting from Participation in a Company-Sponsored Clinical Trial. In accordance with these Guidelines, the sponsor will determine whether to pay compensation to you, and if so, how much. The research staff will give you a copy of the Guidelines together with this Participant Information and Consent Form. If you have any questions about the Guidelines, please ask to speak to [Name of designated person, as follows:Phase One First-in-human trials – a “nominated person” in the department capable of explaining them.Other Phase One and Phase Two trials – Ethics Office contact, as for ‘complaints’].

You may be able to seek compensation through the courts.


Wording for all other Commercially Sponsored Clinical Trials – MUST be used exactly as appears

If your child suffers an injury due to this research project, there are two possible avenues of compensation that may be available to them:

The pharmaceutical industry has set up a compensation process, with which the Sponsor [full name of Australian corporate sponsor], of this research project has agreed to comply. Details of the process and conditions are set out in the Medicines Australia Guidelines for Compensation for Injury Resulting from Participation in a Company-Sponsored Clinical Trial. In accordance with these Guidelines, the sponsor will determine whether to pay compensation to you, and if so, how much. A copy of the Guidelines is available to you from the research staff on request. If you have any questions about the Guidelines, please contact [name of Ethics Office contact, as for ‘complaints’].

You may be able to seek compensation through the courts.

Wording for Investigator-Initiated Clinical Trials

By signing the consent form, you are not giving up any legal rights to seek to obtain compensation for injury.

WHO SHOULD I CONTACT FOR MORE INFORMATION?

If you would like more information about the project or if you need to speak to a member of the research team in an emergency please contact:

Name: <insert name>

Contact telephone: <insert contact phone number>

Email: <insert email>

You can contact the Director of Research Ethics & Governance at The Royal Children’s Hospital Melbourne if you:

• have any concerns or complaints about the project

• are worried about your rights as a research participant

• would like to speak to someone independent of the project.

The Director can be contacted by telephone on (03) 9345 5044.

CONSENT FORM

Note to researchers:If you are offering consent choices, the PICF must give detail about each optional consent under a sub-heading titled Optional Consent in ‘What do I need to do in this research project?’

I do I do not consent to my child being video-recorded.


I do I do not consent to my child being audio-recorded.

I do I do not consent to my child being photographed.

I do I do not consent to my child having an MRI scan.

I do I do not consent for the researchers to contact my child’s GP/family doctor.

I do I do not consent to the researchers accessing my child’s medical record.

I do I do not consent for the researchers to contact my child’s school teacher.

I do I do not consent to data linkage.

I do I do not consent to be contacted about future research projects that are related to this project.

I do I do not consent to the storage and use of my child’s information in future ethically-approved research projects related to this [project/disease/condition].

I do I do not consent to the storage of my child’s [blood/tissue] sample for use in future ethically approved research projects related to this [project/disease/condition].

I wish to be contacted before my child’s sample is used in future research .

I do I do not consent to the use of my child’s already stored [blood/tissue/Guthrie card] sample for this research project.

I do I do not consent to the collection of a [blood/saliva/cheek swab] sample for genetic testing.


participant info & consent dec 2003 - royal children's … · web viewthis document...

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