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Instructions for completing a Participant Information and Consent Form

This document is to assist researchers writing Participant Information and Consent Forms, or Parent/Guardian

Information and Consent Forms, also known as PICFs:

Go to the Research Ethics and Governance (REG) website to access the PICF template you need.

Please make sure you have downloaded the most up-to-date PICF template from the REG website. We

update our templates regularly.

Download the Example PICF from our website. This document gives you a clear idea of how the RCH ethics

committee wants you to write your own PICF. It uses plain language writing, including:

a friendly and professional tone, including lots of personal pronouns

the active voice

short sentences of 25 words or fewer

short paragraphs

relevant visual aids.

You should follow the RCH Communications Style Guide, available on our website. It gives useful tips on writing in plain language.

If you are using a parent/guardian PICF, refer to ‘your child’ throughout the document. If you are using a

participant PICF, refer to the participant as ‘you’.

Include the date and version number in the PICF. The date and version number should be the same on

page one, the footer and the consent page.

Complete each section of the PICF template. This should be done concisely, while giving the participants

enough information to enable them to provide informed consent.

Delete the optional consent tick box if it does not apply to your project.

Refer to the Standard Wordings document on the informed consent page of the REG website. You can

use the relevant sections from this document in your PICF. 1

HREC Project Number: <complete the ethics pre-submission form and then insert your HREC

number here> REG will advise you of this number after you have

completed and submitted the electronic pre-submission form

Short Name of Project: <insert short plain language title> This must be a short, plain language

title that participants can remember and refer to. For example, ‘Better

Sleep Project.

Full Name of Project: <insert full title of the project. If the participants do not need the full title,

delete this section>

Principal Researcher: <insert academic title, first name and surname, position> Only give

details of the principal investigator, not the whole team.

Version Number: <insert #> This must

match the version

number in the

footer and consent

form.

Version Date: <insert dd/mm/yyyy> This

must match the version

number in the footer and

consent form.

Thank you for taking the time to read this Parent/Guardian Information Statement and Consent Form. We

would like to invite your child to participate in a research project that is explained below.

This document is x pages long. Please make sure you have all the pages.

What is an Information and Consent Form?

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An Information and Consent Form tells you about the research project. It clearly explains exactly what the

research project will involve. This information is to help you decide whether or not you would like your child

to take part in the research. Please read it carefully.

Before you decide if you want your child to take part or not, you can ask us any questions you have about the

project. You may want to talk about the project with your family, friends or health care worker.

Taking part in the research is up to you

It is your choice whether or not your child can take part in the research. You do not have to agree if you do

not want to. If you decide you do not want your child to take part, it will not affect the treatment and care

your child gets at The Royal Children’s Hospital.

Signing the form

If you want your child to take part in the research, please sign the consent form at the end of this document.

By signing the form you are telling us that you:

understand what you have read

had a chance to ask questions and received satisfactory answers

consent to your child taking part in the project.

We will give you a copy of this form to keep.

1. What is the research project about?

Briefly describe the following aspects of your project in general and simple language. Keep your sentences to

25 words or fewer. Use one main idea per sentence. Target the information to the participants. Think about

what it is that they need to know. This could include information about:

the aims of the project. For example, how your project intends to fill the gap in knowledge.

why the project is important. For example, how it could contribute to care or education or research in the

future.

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the size or scope of the project. For example, how many participants will take part? How many hospitals

or countries are involved?

whether this is a pilot project or a follow-up project. If it is a pilot project, describe what this means.

Additional information for drug / device projects:

State the current registration status of each drug/device to be used in the research.

Distinguish between registration in Australia and overseas.

Where relevant, it should state that such use is experimental.

State whether or not the drug/device is registered for use in children.

Find relevant standard wording here .

Additional information for blood / tissue and genetics projects:

State if the project is using blood/tissue samples already taken and stored in the past, or if it involves the

collection of new samples.

If using already stored samples, state the original purpose of the collection of these.

If all you require is consent to use already stored samples, state this here.

2. Who is running the project?

The National Statement on Ethical Conduct in Human Research (2007) 2.2.6h requires that you state the

sources of funding for the research project.

The National Statement on Ethical Conduct in Human Research (2007) 2.2.6i requires that you declare any

financial or other relevant declarations of interest of researchers, sponsors or institutions.

Disclose any payments over and above costs.

Tell people who is involved in the project. For example, the RCH, other parties in Australia and elsewhere.

Find relevant standard wording here

3. Why is my child being asked to take part?

Briefly explain why their child has been invited to take part in the research. This may be because their child:

has a condition that is directly related to the research project

is part of a particular population group

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is of a particular age

has a particular relationship to another group in the project, for example, a sibling.

4. What does my child need to do in this research project?

Refer to the Example PICF on our website for how to set out this section.

Explain what participation in the project will involve. Set out this information in a logical, time sequential

order. This can include:

how long the participant will need to be in the research project

where the procedures will take place

the number of hospital visits, and how long each visit will take

state what type of procedures will take place as part of the project

tables, if the research involves multiple study visits with many different procedures

distinguishing between procedures that are part of standard clinical treatment and procedures are part of

the research project. It is only necessary to fully describe procedures that are outside of standard clinical

care. That is, procedure that are only happening because the participant is taking part in the research

project. You do not need to go into detail about procedures that the participant would get even if they

were not in the project

if you are planning to use the test results of standard clinical treatment as part of your research, clearly

state this

if you are accessing a hospital medical record to collect clinical information and use it for research

purposes, explain what information will be collected

If you will be using a questionnaire, state:

how long the questionnaire will take

the nature of the questions. Try to give an example of the type of questions you will ask, or the

themes within the questionnaire

the frequency of the questionnaires

how the questionnaire will be completed, for example, online or by post

explain if participants are to be randomised into groups. Explain the differences in participation for each

group

explain if participants need to keep a diary or fill in a chart

tell them if you will do an audio or video recording as part of the project

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if there are optional parts to the study, these should be clearly identified under a heading titled Optional

Consent. You need to tell participants what the optional consents involve.

Find relevant standard wording here

Additional information for drug-device, blood/tissue and genetics projects:

if the research involves a control group that is taking a placebo, state the placebo has no active medicine

in it

clearly state the procedures for how a drug or device is administered, taken or used

state the drug dosage

state if participants are able to continue using other medications or treatments while participating in the

project

if doing blood tests, state whether the participant will need to get any extra needles. State if more blood

is taken than is needed for standard testing. Write the amount in mls and also translate the amount into

teaspoons, noting that 5ml = 1 teaspoon. Explain how the blood will be taken and how often

if taking a tissue biopsy for research purposes, or taking more tissue than is required for standard testing

or treatment, explain how this will be done and by whom. Explain where and what is to be biopsied. For

example, ‘tiny samples of the lining of the small intestine’. Indicate the size or amount of tissue to be

taken. For example, ‘2-3 mm’. Also state how often sampling will occur

if samples are being taken, state if they are a mandatory or optional part of the project

if you are taking samples that are an optional part of the project, detail that consent is required by ticking

the appropriate box on the consent form.

Additional information for storage and future use of data and/or biological samples:

We recommend considering the possible future uses of the data/samples you are collecting.

It is best practice to offer participants options of what will happen to their data/samples. Some

participants may be happy to participate in a project, but may not want their data/sample stored for

future use. By providing participants with an option, you will still be able to recruit participants who

do not want their sample stored.

If you are requesting consent to store data/samples for use in future research, you should tell participants:

what sample/data is being kept for future research purposes

where the sample/data is being stored

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about privacy considerations. For example, will the sample/data be anonymous or coded. Explain

that a coded samples/data means that it can be re-identified

what the sample/data will be used for. For example, for use in related research or for use in any

type of research

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 the participant is under 18 and has not given consent, state that you will re-contact them when

they turn 18 to obtain their consent

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

if the sample/data may potentially be sent to institutions or laboratories outside the RCH/MRCI

if the sample/data is being sent overseas it must be stated that it will not be protected by

Australian laws and regulations. This statement must be in bold.

Projects involving MRI scans

Projects involving MRI Scans need to include an approved standard wording for this section.

Find relevant standard wording here

5. Can my child stop taking part in the project?

Your child can stop taking part in the project at any time. You just need to tell us so. 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.

If participants withdraw from the project, you must state whether you plan to keep and use information

already collected.

Find relevant standard wording here

6. What are the possible benefits for my child and other people in the future?

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Do not attempt to build up participant hope.

If there is no direct benefit to the participant, this should be made clear.

If it is difficult to predict whether taking part in the project will be of benefit, you can just say so.

Explain if your project provides benefits to the participant such as access to services/treatments that are

not otherwise freely available.

Reference to the potential benefit to future patients may be appropriate, but should not be exaggerated.

Explain how you will use the information that participants give you to help others in the future. For

example, to develop education programs for children, to prevent a condition, to promote health or to

improve the treatment or management of a particular condition.

Tailor information about these possible benefits to your project. Many people are happy to participate

when they know it will help others. Often, there is no direct benefit. However, the knowledge that is

gained from a project adds to what is known about a condition. This may result in in improvement in

future care.

Find relevant standard wording here

7. What are the possible risks, side-effects, discomforts and/or inconveniences?

Mention all possible known risks, side effects, discomforts and inconveniences of the research. You do not

need to state risks that are associated with procedures that are part of standard clinical care. Note that risks

can be both physical and psychological.

Explain how you will manage the risk. For example, that participants can contact you, that treatment can

be ceased, that you can refer a participant for follow up support with a counsellor.

Include a sentence stating that there may be unforeseen or unknown risks. Explain that if new

information about risks becomes known during the project, participants will be informed of this.

Explain the potential risks from blood tests, for example, bruising. Also state what you will be able to do to

treat or prevent this.

Include details about delayed side effects, especially if these can occur after leaving hospital.

If your project is of a highly sensitive nature, consider including a telephone contact number of an

appropriate agency. This is in the event that a person does not participate yet may be unsettled by the

invitation to participate.

Give some information on what you can do to minimise any discomfort of the procedures used. For

example:

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use of an anaesthetic cream to minimise the discomfort of a blood test

participant can choose where the assessment or interview can take place

experienced staff will be involved in particular aspects of the project to minimise anxiety.

Inconveniences might include the time taken for travel, extra visits or appointments, time off school or

work, or to fill in questionnaires or diaries.

Inconveniences may also include costs to the participant. For example, parking or public transport costs.

State if you are offering any reimbursement for these costs.

Find relevant standard wording here

Additional information for blood/tissue projects:

If there are cultural or religious sensitivities associated with use of the sample, state these.

Additional information for drug/device projects:

Give information about changes to existing therapies, if relevant

Give information about any tests or procedures the participant will need to have for research purposes

Quantify side effects as proportions eg one per cent or one in 100

Do not use < or > symbols

Include a side effect table and categorise side effects under heading such as common/uncommon/rare etc

List side effects in plain language. For example, refer to high blood pressure rather than hypertension

Information explaining side effects seen in animal studies does not need to be included if the drug has

been tested in humans and safety data is available

Include risks in relation to the use of ionising radiation, genetic testing etc, where appropriate

Risks related to conception, pregnancy and breastfeeding must be bolded.

State the circumstances and what will happen if the project finishes early.

Find relevant standard wording here

Additional information for genetics projects

Note that giving people information about their genetic make-up and future health may be distressing for

them.

Make it clear if you plan to disclose the results of any genetic tests or not. If you are not disclosing genetic

tests results, state why.

If you are able to disclose genetic tests results, state if it is optional to receive these.9

If you are disclosing genetic test results, explain if genetic counselling will be offered.

Explain if there is a risk that the genetic information given to participants may affect their ability to obtain

insurance or their education/employment opportunities in the future.

Mention if the genetic information you give to participants will give them information relevant for future

reproductive choices. For example, their chances of having children who are affected with a particular

genetic condition.

Explain if the genetic information you give to participants will also give information about other family

members. Discuss your policy in relation to disclosure to other family members

Mention if there is a possibility that the genetic analysis you perform could give other, unintended genetic

information as well. For example, information about non-paternity or non-maternity or non-relationship

to siblings or other disease susceptibility. Discuss your policy in relation to disclosure of these types of

information.

Find relevant standard wording here

Projects involving MRI scans:

Projects involving MRI Scans must include the approved standard wording for this section.

Find relevant standard wording here

Projects involving radiation:

If your project involves the use of ionising radiation, a medical physicist’s assessment must be completed.

Instructions on obtaining a medical physicist’s assessment is outlined in the Radiation Safety in Research

procedure on the RCH intranet.

Find relevant standard wording here

Projects involving anaesthesia:

Projects involving anaesthesia need to include an approved standard wording for this section.

Find relevant standard wording here

8. What will be done to make sure my child’s information is confidential?

Refer to the Standard Wordings document on our website for wording that you can insert into this section.

You should provide the participant with general information about plans for the confidential storage and

disposal of information. This could include information about:10

where the information will be kept

who will have access to the information

how the information will be stored. Electronic data needs to be password-protected and hard copy data,

including video or audio tapes, needs to be in locked storage

how long the information will be stored for. Note that HPP 4.2 prohibits a health service provider from

destroying or deleting health information about an adult until at least seven years after their last

attendance to the health service provider. Information collected whilst an individual is a child must be

kept until the individual turns 25. That is, seven years after they turn 18

what will happen to the information at the end of the storage period

the participant’s right to access, and request correction of, their information in accordance with relevant

privacy laws

how you plan to discuss or publish the results. For example, at conferences, in professional journals.

Explain that this will be done in a way that participants will not be identified

student researcher qualifications. If the project’s results are to be used for student researcher

qualification this should be stated.

Find relevant standard wording here

Additional information for blood/tissue and genetics projects

General information should be provided about your plans for the confidential storage and disposal of blood or

tissue or genetic samples. This could include information about:

where the samples will be stored. If the samples are being sent overseas, please put this statement in

bold. Also describe what laws or regulations will cover those samples

the length of time the samples will be kept

how the samples will be destroyed at the end of this period. If they are to be kept indefinitely, state this.

Also state whether the samples can be used after the life-span of the participant. Note that consent must

be sought for these options

who will have access to the samples

who will 'own' the samples

storage of the data or samples in a tissue bank. If a tissue bank is being used, this must be stated

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whether any future use of the samples will be overseen by an ethics committee.

Additional information for drug/device projects

You need to state:

that the Australian Therapeutic Goods Administration (TGA) has access to information

whether any other regulatory bodies that have access to this information

whether there will be commercial development of the research results.

9. Will we be informed of the results when the research project is finished?

The National Statement on Ethical Conduct in Human Research (2007) requires that you communicate the

project results to participants. In line with this, the RCH ethics committee expects that you send

participants a final letter. Refer to the REG website for an Example Final Letter and Final Letter Guidelines.

In the PICF you should state whether you will:

be making individual results available

publish a summary of the results. For example, on a website.

Find relevant standard wording here

Additional information for blood/tissue projects:

If you are storing tissue for future research purposes, you may be obtaining re-consent for research

purposes. If so, state that the distribution of results from these projects will be at the discretion of future

researchers.

If you are storing tissue for future research purposes, you may using this consent for those future research

purposes. If this is the case, state that results of any future research will not be made available to

participants.

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Additional information for genetics projects:

Will you be informing other family members about the results of the genetic information tests if the

results are relevant to them? If so, state this.

10. 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 child’s 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.

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Consent Form

HREC Project Number: <insert HREC number here>

Research Project Title: <insert short plain language title>

Version Number: <insert #> Version Date: <insert dd/mm/yyyy>

The following dot points should not be amended in any way:

I have read this information statement and I understand its contents.

I understand what my child and I have to do to be involved in this project.

I understand the risks my child could face because of their involvement in this project.

I voluntarily consent for my child to take part in this research project.

I have had an opportunity to ask questions about the project and I am satisfied with the answers I have

received.

I understand that this project has been approved by The Royal Children’s Hospital Melbourne Human

Research Ethics Committee. I understand that the project and any updates will be carried out in line with

the National Statement on Ethical Conduct in Human Research (2007).

I understand I will receive a copy of this Information Statement and Consent Form.

If you are offering optional consent for various procedures you will need to add appropriate optional tick

box as per the example below. Other optional consent tick boxes can be found in our standard wordings

Optional consent <Revise or delete if not applicable. If the project has optional consent options, these must

be explained in the body of the information and consent form>

I do I do not <eg I consent for my child’s tissue sample to be stored for use in future

ethically approved research related to <condition name>

I do I do not <eg I consent to be contacted about future research projects related to

<condition name>

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Child’s Name

Parent/Guardian Name Parent/Guardian Signature Date

Name of Witness to

Parent/Guardian’s Signature

Witness Signature Date

Declaration by researcher: I have explained the project to the parent/guardian who has signed above. I

believe that they understand the purpose, extent and possible risks of their child’s involvement in this project.

Research Team Member Name Research Team Member Signature Date

Note: All parties signing the consent form must date their own signature.

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