Participant Information Sheet and Consent Form Template

1. This tem late is to assist resear!hers in the develo ment of a Parti!i ant Information Sheet and Consent Form. It is im ortant that you ada t this tem late to suit the audien!e and nature of the resear!h.

2. The language used throughout the form should "e easily understanda"le. #se lo!al
and sim lified terms rather than s!ientifi! terminology and a""reviations. $e re!ommend that you refer to the Plain %nglish Cam aign. 3. #se a ro riate language for the target &e' (ealand audien!e. For e)am le* !onsider the different 'ays needed to !learly !ommuni!ate to !hildren as o osed to their arents* or to eo le 'ith e) ertise in the area of study as o osed to eo le 'ith no su!h e) ertise. +ave someone in your target audien!e read through your information sheet "efore it is su"mitted to +D%Cs. ,. It may "e ne!essary to draft more than one information sheet if you need to !ommuni!ate to arti!i ant grou s 'ith different needs -su!h as arents/!aregivers and !hildren. or if your ro/e!t involves different ty es of arti!i ation.

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Participant Information Sheet

Study title: Lo!ality: Lead investigator: [lay study title] %thi!s !ommittee ref.: Conta!t hone num"er:

Your letterhead

0ou are invited to ta1e art in a study on 2 x3. $hether or not you ta1e art is your !hoi!e. If you don4t 'ant to ta1e art* you don4t have to give a reason* and it 'on4t affe!t the !are you re!eive. If you do 'ant to ta1e art no'* "ut !hange your mind later* you !an ull out of the study at any time. This Parti!i ant Information Sheet 'ill hel you de!ide if you4d li1e to ta1e art. It sets out 'hy 'e are doing the study* 'hat your arti!i ation 'ould involve* 'hat the "enefits and ris1s to you might "e* and 'hat 'ould ha en after the study ends. $e 'ill go through this information 'ith you and ans'er any 5uestions you may have. 0ou do not have to de!ide today 'hether or not you 'ill arti!i ate in this study. 6efore you de!ide you may 'ant to tal1 a"out the study 'ith other eo le* su!h as family* 'h7nau* friends* or health!are roviders. Feel free to do this. If you agree to ta1e art in this study* you 'ill "e as1ed to sign the Consent Form on the last age of this do!ument. 0ou 'ill "e given a !o y of "oth the Parti!i ant Information Sheet and the Consent Form to 1ee . This do!ument is 2x3 ages long* in!luding the Consent Form. Please ma1e sure you have read and understood all the ages.

WHAT IS THE PURPOSE OF THE STUDY?

Briefly explain in plain English: the purpose of the study, including its expected contribution to knowledge and its benefits to communities how the study meets the best intervention and e uipoise standards the purpose and practical significance of the use of randomisation, blinding or placebo the nature and sources for funding for the study, the institutional affiliations of the investigator!s", and who can be contacted to answer uestions and how to contact them the study#s status, with a current approval from an ethics committee$

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WHAT WILL MY PARTICIPATIO

THE STUDY I !OL!E?

Briefly explain in plain English: why has the person been chosen to participate what will be done in the study, including how participation in it will differ from not being in the study the time involved in participation !eg, the number and duration of any visits to the research centre, and the expected finishing date of the study" and follow up if relevant the purpose and expected number of tests or uestionnaires to be performed during the study !explain the procedures that will be followed on a step%by%step basis"$ will health information be collected !either directly from the participant via uestionnaires or indirectly by accessing medical records"$ &nform the participants if the study involves uestions which may be sensitive or cause embarrassment$

WHAT ARE

THE POSSI"LE "E EFITS A D RIS#S OF THIS STUDY?

Briefly explain in plain English: foreseeable risks, side%effects and discomforts of study participation, including any risks to the health of a participant#s family member!s"$ 'escribe how these will be managed discuss need for contraception if necessary, what are the possible direct benefits of this study the extent of the investigator#s responsibility to ensure that care is provided to participants during the study

WHO PAYS

FOR THE STUDY?

Briefly explain in plain English: participant will not incur any costs what payments or other forms of reimbursement, if any, will be provided in recognition of participation

WHAT IF SOMETHI

$ $OES WRO $?

(uggested text: 9Commer!ially s onsored: intervention studies: If you 'ere in/ured as a result of treatment given as art of this study* 'hi!h is unli1ely* you %on&t "e eligi"le for !om ensation from ;CC. +o'ever* !om ensation 'ould "e availa"le from the study4s s onsor* 2)3* in line 'ith industry guidelines. $e !an give you a !o y of these guidelines if you 'ish. 0ou 'ould "e a"le to ta1e a!tion through the !ourts if you disagreed 'ith the amount of !om ensation rovided. If you have rivate health or life insuran!e* you may 'ish to !he!1 'ith your insurer that ta1ing art in this study 'on4t affe!t your !over.

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<ther studies: If you 'ere in/ured in this study* 'hi!h is unli1ely* you 'ould "e eligi"le for !om ensation from ;CC /ust as you 'ould "e if you 'ere in/ured in an a!!ident at 'or1 or at home. 0ou 'ill have to lodge a !laim 'ith ;CC* 'hi!h may ta1e some time to assess. If your !laim is a!!e ted* you 'ill re!eive funding to assist in your re!overy. If you have rivate health or life insuran!e* you may 'ish to !he!1 'ith your insurer that ta1ing art in this study 'on4t affe!t your !over.

WHAT ARE MY RI$HTS?

Briefly explain: the voluntary nature of participation, including that they are free to decline to participate, or to withdraw from the research at any practicable time, without experiencing any disadvantage that participants have the right to access information about them collected as part of the study that participants will be told of any new information about adverse or beneficial effects related to the study that becomes available during the study that may have an impact on their health what provision will be made for the privacy and confidentiality of individuals

WHAT HAPPE

S AFTER THE STUDY OR IF

I CHA

$E MY MI D?

Briefly explain: whether any study intervention will be available to participants after the study and, if so, under what conditions !including any cost to them" how study data will be stored and for how long, whether the data will be retained for possible future use, who will be responsible for their secure storage and how they will be destroyed whether any biological specimens collected during the research will be destroyed at its conclusion and, if not, details of their storage and possible future use how the study findings will be communicated on completion of the study, including to participants, and in what expected timeframe$

WHO DO I CO

TACT FOR MORE I FORMATIO

OR IF

I HA!E CO

CER S?

If you have any 5uestions* !on!erns or !om laints a"out the study at any stage* you !an !onta!t: )ame, position *elephone number Email

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If you 'ant to tal1 to someone 'ho isn4t involved 'ith the study* you !an !onta!t an inde endent health and disa"ility advo!ate on: Phone: Fa): %mail: For Eaori health su =>== ??? =?= =>== 8 S#PP<@T -=>== 8A>A ABA>. advo!a!yChd!.org.nD ort lease !onta!t :

)ame, position *elephone number Email 0ou !an also !onta!t the health and disa"ility ethi!s !ommittee -+D%C. that a study on: Phone: %mail: =>== , %T+ICS hde!sCmoh.govt.nD roved this

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Con'ent Form

Your letterhead

If (o) nee* an I TERPRETER+ p,ea'e te,, )'&f you are unable to provide interpreters for the study, please clearly state this in the +articipant &nformation (heet

P,ea'e tic. to in*icate (o) con'ent to the fo,,o%in/ !,dd or delete as appropriate" I have read* or have had read to me in my first language* and I understand the Parti!i ant Information Sheet. I have "een given suffi!ient time to !onsider 'hether or not to arti!i ate in this study. I have had the o ortunity to use a legal re resentative* 'hanau/ family su ort or a friend to hel me as1 5uestions and understand the study. I am satisfied 'ith the ans'ers I have "een given regarding the study and I have a !o y of this !onsent form and information sheet. I understand that ta1ing art in this study is voluntary -my !hoi!e. and that I may 'ithdra' from the study at any time 'ithout this affe!ting my medi!al !are. I !onsent to the resear!h staff !olle!ting and ro!essing my information* in!luding information a"out my health. If I de!ide to 'ithdra' from the study* I agree that the information !olle!ted a"out me u to the oint 'hen I 'ithdra' may !ontinue to "e ro!essed. I !onsent to my FP or !urrent rovider "eing informed a"out my arti!i ation in the study and of any signifi!ant a"normal results o"tained during the study. I understand that there may "e ris1s asso!iated 'ith the treatment in the event of myself or my artner "e!oming regnant. I underta1e to inform my artner of the ris1s and to ta1e res onsi"ility for the revention of regnan!y. I agree to my -ty e of tissue. sam les "eing sent overseas and I am a'are that these sam les 'ill "e dis osed of using esta"lished guidelines for dis!arding "iohaDard 'aste. I agree to an a roved auditor a ointed "y the &e' (ealand +ealth and Disa"ility %thi! Committees* or any relevant regulatory authority or their a roved re resentative revie'ing my relevant medi!al re!ords for the sole ur ose of !he!1ing the a!!ura!y of 0es 0es &o &o

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the information re!orded for the study. I understand that my arti!i ation in this study is !onfidential and that no material* 'hi!h !ould identify me ersonally* 'ill "e used in any re orts on this study. I understand the !om ensation rovisions in !ase of in/ury during the study. I 1no' 'ho to !onta!t if I have any 5uestions a"out the study in general. I understand my res onsi"ilities as a study arti!i ant. I 'ish to re!eive a summary of the results from the study. 0es &o

0es 0es 0es 0es

&o &o &o &o

Dec,aration 0( participant1 I here"y !onsent to ta1e art in this study.

Parti!i ant4s name: Signature: Date:

Dec,aration 0( mem0er of re'earch team1 I have given a ver"al e) lanation of the resear!h ro/e!t to the arti!i ant* and have ans'ered the arti!i ant4s 5uestions a"out it. I "elieve that the arti!i ant understands the study and has given informed !onsent to arti!i ate.

@esear!her4s name: Signature: Date:

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Participant Information Sheet and Consent Form Template for Optional Future Use of Tissue Samples
?. This tem late is to assist resear!hers in the develo ment of an o tional Parti!i ant Information Sheet and Consent Form for use of human tissue for future uns e!ified resear!h ur oses. It is im ortant that you ada t this tem late to suit the audien!e and nature of the study.

B. Please note that !onsent to the future uns e!ified use of a erson4s tissue sam les
must "e distin!t from !onsent to !olle!t the sam le and distin!t from !onsent to use the sam le in s e!ified resear!h. @efer to the Fuidelines for the #se of +uman Tissue for Future #ns e!ified @esear!h Pur oses.

A. The language used throughout the form should "e easily understanda"le. #se lo!al
and sim lified terms rather than s!ientifi! terminology and a""reviations. $e re!ommend that you refer to the Plain %nglish Cam aign.

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Optiona, Participant Information Sheet for the U'e of Ti'')e for F)t)re Un'pecifie* Re'earch
Study title: Lo!ality: Lead investigator: [lay study title] %thi!s !ommittee ref.: Conta!t hone num"er:

Your letterhead

0ou have already agreed to ta1e art in a resear!h study on 2x3. This arti!i ant information sheet tells you a"out an o tional su" study 'hi!h 'ill "e !ondu!ted in a small num"er of su"/e!ts already enrolled in the 2)3 main study. This information sheet and !onsent form is in addition to the main study !onsent form that you have already signed. $hether or not you ta1e art in this o tional su" study is your !hoi!e. If you don4t 'ant to ta1e art* you don4t have to give a reason* and it 'on4t affe!t the !are you re!eive or your arti!i ation in the main study. If you do 'ant to ta1e art no'* "ut !hange your mind later* you !an ull out of the study at any time. This Parti!i ant Information Sheet 'ill hel you de!ide if you4d li1e to ta1e art. It sets out 'hy 'e are doing the study* 'hat your arti!i ation 'ould involve* 'hat the "enefits and ris1s to you might "e* and 'hat 'ould ha en after the study ends. $e 'ill go through this information 'ith you and ans'er any 5uestions you may have. 0ou do not have to de!ide today 'hether or not you 'ill arti!i ate in this study. 6efore you de!ide you may 'ant to tal1 a"out the study 'ith other eo le* su!h as family* 'h7nau* friends* or health!are roviders. Feel free to do this. If you agree to ta1e art in this study* you 'ill "e as1ed to sign the Consent Form on the last age of this do!ument. 0ou 'ill "e given a !o y of "oth the Parti!i ant Information Sheet and the Consent Form to 1ee . This do!ument is 2x3 ages long* in!luding the Consent Form. Please ma1e sure you have read and understood all the ages.

WHAT IS THE PURPOSE OF THE STUDY?

Briefly explain: that you are seeking permission to store tissue samples for possible future use in either your own research or someone else-s research (clarify if samples will be used in commercial research) explain potential research possibilities and benefits !i$e$ if genetic research then explain what this is" but be clear if you cannot confirm exactly what types of research the samples will be used for

WHAT WILL MY PARTICIPATIO

Briefly explain:

THE STUDY I !OL!E?

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 why the person has been chosen to participate how participation will differ from non%participation !e$g$ if extra time or tests are involved" what type of tissue and.or genetic material will be collected, how much and via what procedure!s" if the donor#s identity and details will remain linked to the tissue samples or if they will be de%identified specify whether the donor may be contacted in the future regarding their sample and if information arising from future research will be made available to donors

WHAT HAPPE

S TO MY SAMPLES AFTER THEY HA!E "EE

COLLECTED?

Briefly explain: whether samples will be sent overseas and if so to what country!s" how samples will be stored and for how long how samples will be disposed of and if there are any cultural protocols in place for this acknowledge that all future unspecified research in )ew /ealand will be sub0ect to ethical review$ 1owever, when a tissue sample is sent overseas future research is likely to be considered by an overseas ethics committee without )ew /ealand representation acknowledge cultural issues that may arise with tissue donation

WHAT ARE

MY RI$HTS?

Briefly explain: the voluntary nature of participation, including that they are free to decline to participate without experiencing any disadvantage the donor will not own any intellectual property that may arise from any future research whether there is provision to withdraw consent and what the process for doing this is !i$e$ who to contact"$ 1owever, if consent is given for unidentified or de%linked use of tissue, the participant must be informed that they will not be able to withdraw their consent in the future what provisions will be made to protect the privacy and confidentiality of individuals, including any limitations compensation details

WHO DO I CO

TACT FOR MORE I FORMATIO

OR IF

I HA!E CO

CER S?

If you have any 5uestions* !on!erns or !om laints a"out the study at any stage* you !an !onta!t: )ame, position *elephone number Email

Lay study title: PIS/CF version no.: Dated:

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For Eaori health su

ort lease !onta!t :

)ame, position *elephone number Email If you 'ant to tal1 to someone 'ho isn4t involved 'ith the study* you !an !onta!t an inde endent health and disa"ility advo!ate on: Phone: Fa): %mail: =>== ??? =?= =>== 8 S#PP<@T -=>== 8A>A ABA>. advo!a!yChd!.org.nD roved this

0ou !an also !onta!t the health and disa"ility ethi!s !ommittee -+D%C. that a study on: Phone: %mail: =>== , %T+ICS hde!sCmoh.govt.nD

Lay study title: PIS/CF version no.: Dated:

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Optiona, Con'ent Form for the U'e of Ti'')e for F)t)re Un'pecifie* Re'earch

Your letterhead

If (o) nee* an I TERPRETER+ p,ea'e te,, )'&f you are unable to provide interpreters for the study, please clearly state this in the +articipant &nformation (heet

P,ea'e tic. to in*icate (o) con'ent to the fo,,o%in/ !,dd or delete as appropriate" I have read* or have had read to me in my first language* and I understand the Parti!i ant Information Sheet. I have "een given suffi!ient time to !onsider 'hether or not to arti!i ate in this study. I have had the o ortunity to use a legal re resentative* 'hanau/ family su ort or a friend to hel me as1 5uestions and understand the study. I am satisfied 'ith the ans'ers I have "een given regarding the study and I have a !o y of this !onsent form and information sheet. I understand that ta1ing art in this study is voluntary -my !hoi!e. I !onsent to the resear!h staff !olle!ting and ro!essing my information* in!luding information a"out my health. I agree to my tissue sam les "eing sent overseas I agree for my tissue sam les to "e stored and used in future resear!h "ut only on the same su"/e!t as the !urrent resear!h ro/e!t : 2give name of !urrent resear!h3 I agree for my tissue sam les to "e stored and used in future resear!h of any ty e 'hi!h has "een ro erly a roved I agree for my tissue sam les to "e stored and used in future resear!h e)!e t for resear!h a"out 2name ty e of resear!h3 I give ermission for my tissue sam les to "e stored indefinitely I 'ant my identity to "e 1e t 'ith my tissue sam le I 'ant my identity to "e removed from my tissue sam les and understand that in this !ase I 'ill not "e a"le to 'ithdra' my !onsent in the future I understand that I may 'ithdra' from the study at any time 0es &o 0es 0es &o &o

0es

&o

0es 0es 0es 0es 0es

&o &o &o &o &o

0es 0es 0es 0es

&o &o &o &o

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If I de!ide to 'ithdra' from the study* I agree that the information !olle!ted a"out me u to the oint 'hen I 'ithdra' may !ontinue to "e used. I 1no' 'ho to !onta!t if I have any 5uestions a"out the study in general.

0es

&o

0es

&o

Dec,aration 0( participant1 I here"y !onsent to ta1e art in this study.

Parti!i ant4s name: Signature: Date:

Dec,aration 0( mem0er of re'earch team1 I have given a ver"al e) lanation of the resear!h ro/e!t to the arti!i ant* and have ans'ered the arti!i ant4s 5uestions a"out it. I "elieve that the arti!i ant understands the study and has given informed !onsent to arti!i ate.

@esear!her4s name: Signature: Date:

Lay study title: PIS/CF version no.: Dated:

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