Auckland Health Research Ethics Committee (AHREC)

Application Form vs 3.0

Introduction

A. When to use this form:

1. Complete this application form if you are a student and want to draft an application together with your supervisor prior to transferring the information into the Ethics RM form.

Questions marked with * are mandatory. Please do not delete any of the questions.

Please note, there is a shorter version of the form that could be used for audit of clinical data projects.

2. Prepare all the relevant documents:

The following documents are required:

o Study Protocol*o Scientific/Peer Review*o Principal Investigator CV*

The following documents may also be required, depending on the study type: Participant Information Sheet(s), Consent Form(s), Assent Form(s), Interview Schedule(s), Email Invitation(s), Questionnaire(s), Advertisements and Flyers, Support Letter(s), and any other study-related documents.

Refer to section H of this form for more information about requirements of the scientific review. See also Section 8.2 of the Applicants’ Manual.

3. Once the Word version application is finalised and associate documents have been prepared, an Ethics RM application can be created in two ways:

a. The academic supervisor can create the shell of the application and share the application with you. The academic supervisor or Principal Investigator (PI) can first create a ‘shell’ of the application (completing minimal details - project title and PI / supervisor name) and share the application with you for completion.

Once you have completed the application in Ethics RM, you must request your academic supervisor or PI to review and then submit the application for Academic Head sign-off.

b. You can create the application in Ethics RM, transfer ownership of the application to your academic supervisor / PI and request they share the application with you. You can initiate and complete the application form in Ethics RM noting your academic supervisor or PI as the Principal Investigator for the application.

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Once complete, you must then transfer ownership of the application to your academic supervisor or PI and request they share the application with you. (This is necessary because a student is not permitted to submit an application – the academic supervisor or PI is responsible for submission).

Please note: The research may not start until approval from AHREC has been obtained.

B. AHREC eligibility criteria:

If a research study is not eligible for review by an HDEC, approval must be obtained from either AHREC or UAHPEC.

AHREC reviews clinical/health research studies conducted by staff of the Auckland DHB and CM Health, (or other DHBs that might join AHREC), or studies by University of Auckland staff and students that fall under the definition of ‘clinical research’, and that are not in scope for HDEC review.

UAHPEC will no longer accept applications for clinical/health research studies or applications involving the use of human tissue in the research – these applications should seek AHREC approval.

University of Auckland Staff and students:All clinical/health research studies must be submitted to AHREC. The NIH definition of ‘clinical/health’ research is used.

C. Locality/Management approvals:

Locality approval for studies conducted at the Auckland DHB:

AHREC will provide locality/management approval for studies that involve Auckland DHB staff and patients (for low risk studies on behalf of the Auckland DHB Research Review Committee) for studies that fulfil the eligibility criteria for AHREC review and that DO NOT require the Auckland DHB Research Review Committee assessment.

Sign-off will be required at the end of this application form from a Clinical Director or a person/persons with authority in the area where the research will take place.  Please ensure that a discussion is started with this person(s) early in the application process and that they are registered with Ethics RM to prevent delaying the sign-off process. A Quick Reference Guide outlining the registration process of a person external to the University is available.

Locality approval for studies conducted at CM Health:

You are required to register your study directly with CM Health for locality approval. 

Auckland DHB and University of Auckland researchers will need to engage with a CM Health-based associate to represent them and access the online CM Health Research Registry on their behalf.  Your study will be processed through the CM Health locality approval process in parallel with the AHREC ethics approval process. 

D. Key contacts: 

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Support for Auckland DHB staff is available from the Manager, Auckland DHB Research Office at ResearchOffice@adhb.govt.nz (Tel 09 307 4949 ext 23854). 

Support for CM Health staff is available from the Research Coordinator, CM Health Research Office at researchoffice@middlemore.co.nz (Tel 021 574 928). 

Support for University of Auckland staff and students is available from the Ethics Administrator, Ethics and Integrity team, at ahrec@auckland.ac.nz (Tel 09 373 7599 ext 83711).

Section A: Applicants(Questions marked with an * are mandatory)

A.1 A1.1: Project Title:* Click here to enter text.

A1.2: Expanded Project Title (If required): Click here to enter text.

A1.3: DHB Project Number (If known): Click here to enter text.

A1.4: University of Auckland Funding Project Number: Click here to enter text.

A.2 Principal Investigator Contact details:*(or Supervisor for student research)

Name:* Click here to enter text.

Department:* Click here to enter text.

Faculty:* Click here to enter text.

Email:* Click here to enter text.

A.3 Alternative contact for communication if not via Principal Investigator:

Name: Click here to enter text.

Department: Click here to enter text.

Email: Click here to enter text.

A.4 Please select the organisation(s) / institution(s) you are affiliated with:*

☐ University of Auckland ☐ Auckland DHB ☐ CM Health

A.5 Please select the organisation / institution with responsibility for this project:*

☐ University of Auckland ☐ Auckland DHB ☐ CM Health

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A.6 Provide the name and contact details of a DHB contact person: Complete this question only if you are affiliated with the University

Name:* Click here to enter text.

Department:* Click here to enter text.

Email:* Click here to enter text.

A.7 Are there any other investigators involved in the project (add student researchers in questions A.8 or A.9)?

Name Email Affiliation Role in the projectClick here to enter text.

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A.8 Is this a student research project?*

☐ Yes ☐ No

A.9 Is this a summer studentship*?

☐ Yes ☐ No

A.10 If ‘Yes’ to A.8 or A.9, provide the Student Contact Details:*(duplicate the question if more than one student is involved in the project)

Name:* Click here to enter text.

Student ID:* Click here to enter text.

Department/School:* Click here to enter text.

Email:* Click here to enter text.

Degree/Qualification:* Click here to enter text.

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A.11 Does the research team include a DHB clinical supervisor?*

☐ Yes ☐ No If ‘No’: progress to question A.13

If ‘Yes’:A.11.a: Is the DHB Clinical supervisor the same as the PI named on this application?*☐ Yes ☐ No

If ‘Yes’: progress to A.11.b

If ‘No’: Progress to A.13

A.11.b: Please provide the name of the DHB Clinical Supervisor:*If you are the PI for this application, do not also add your name here.

Name:* Click here to enter text.

Department:* Click here to enter text.

Email:* Click here to enter text.

A.12 Summarise the Principal Investigator’s qualifications and experience relating to conducting studies of this nature (<200 words):* Click here to enter text.

Section B: Eligibility and Location

B.1 Indicate how this study meets the AHREC eligibility criteria and explain why it is not eligible for HDEC review:*Click here to enter text.

B.2 Please attach an HDEC Out of Scope letter (if applicable) to the eform

B.3 Where will the research take place?* Click here to enter text.

B.4 Does the study involve DHB patients or staff?* ☐ Yes ☐ No

B.5 If Yes in B.4, add which DHB(s):* ☐ Auckland DHB ☐ CM Health ☐ Other DHBs

For studies that require CM Health locality approval: Your study will be processed through the CM Health locality approval process in parallel with the AHREC ethics approval process. You are required to register your study directly with CM Health for the locality approval. Auckland DHB and University of Auckland researchers will need to engage with a CM Health-based associate to represent them and access the online CM Health Research Registry on their behalf. Queries can be directed to: researchoffice@middlemore.co.nz

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For studies that require Auckland DHB locality approval: Sign-off will be required at the end of this application form from a Clinical Director or a person/persons with authority in the area where the research will take place. Please ensure that a discussion is started with this person(s) early in the application process and that they are registered with Ethics RM to prevent delaying the sign-off process. A Quick Reference Guide outlining the registration process for a person external to the University is available.

If ‘Other DHBs’, list the other DHBs:*Click here to enter text.

Section C: Study Description

C.1 Prepare a study protocol to attach to the eform*

C.2 What is the principal question or hypothesis the study will address?*Click here to enter text.

C.3 Describe the scientific background of the study (<300 words):*Click here to enter text.

C.4 How will the study contribute to new knowledge and/or improve health outcomes?*Click here to enter text.

C.5 Provide a plain English summary of your study and the design used (<300 words):*Click here to enter text.

C.6 Provide a summary of the main ethical aspects of the study that you believe the study raises and provide a brief explanation of how these will be addressed or managed:*Click here to enter text.

C.7 Does your study include an audit of clinical data only?*☐ Yes ☐ No(If ‘Yes’, please complete the version of the form tailored to audits of clinical data)

C.8 Describe in detail what participants will have to do when taking part in the study:*Click here to enter text.

C.9 C.9.a: What are the inclusion and exclusion criteria for the study?*Click here to enter text.

C.9.b: How many participants do you intend to recruit?*Click here to enter text.

C.9.d.i: Does the research involve participation of adults?*

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☐ Yes ☐ No

If ‘Yes’, state the age(s) or age group(s) of the adult participants:*Click here to enter text.

C.9.d.ii: Does the research involve participation of children under sixteen years of age?*☐ Yes ☐ No

If ‘Yes’, state the age(s) or age group(s) of the child participants:*Click here to enter text.

C.9.d.iii: Does the research involve persons whose capacity to give informed consent (other than children) is compromised?*☐ Yes ☐ No

If ‘Yes’, explain:*Click here to enter text.

C.9.d.iv: Does the research involve participants who are in a dependent situation, such as people with a disability, residents of a hospital, nursing home or prison, or patients highly dependent on medical care?*☐ Yes ☐ No

If ‘Yes’, explain:*Click here to enter text.

C.9.d.v: Does the research involve persons who are vulnerable for some other reasons, such as older people, persons who have suffered abuse, persons who are not competent in English, or new immigrants?*☐ Yes ☐ No

If ‘Yes’, explain:*Click here to enter text.

C.9.e: How was the number of participants determined?*Click here to enter text.

C.9.f: Is a formal power calculation appropriate? If so, please provide details:*Click here to enter text.

C.10

Will any population groups be specifically targeted for inclusion in the study?*☐ Yes ☐ No

C.10.a: If ‘Yes’, indicate which groups:*Click here to enter text.

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C.10.b: Briefly describe how these populations have been or will be consulted:*Click here to enter text.

C.10.c: Briefly describe how the study may benefit these population groups:*Click here to enter text.

C.10.d: Describe any on-going involvement of the groups(s) consulted:*Click here to enter text.

C.10.e: Does the research raise any specific ethnic or cultural issues?*☐ Yes ☐ No If yes, explain:*Click here to enter text.

C.11

Has the study design been influenced by an organisation outside the University of Auckland/Auckland DHB/CM Health?*☐ Yes ☐ No If yes, explain:*Click here to enter text.

C.12

Provide the dates on which you plan to commence and conclude the study:*Planned commencement date: Click here to enter a date.Planned conclusion date: Click here to enter a date.

C.12.a: The standard length of AHREC approval is three years. Do you want to request a different length of approval?* ☐ Yes ☐ No

If ‘Yes’, please indicate the duration of approval you are requesting (in years):*Click here to enter text.

Please explain why this longer approval period is being requested:*Click here to enter text.

C.13

Describe any impact upon Auckland DHB or Counties Manukau DHB resources (e.g., use of staff time, premises, facilities, consumables) and, if no DHB budget is supplied, justify this:*Click here to enter text.

Section D: Responsiveness to Māori

D.1 WHAKAPAPA. Research should involve the development and maintenance of respectful relationships, engage Māori in decision making, and include clear, appropriate communication.

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Consultation and Engagement:

D.1: In what ways have you engaged with Māori organisations or communities in the planning stages of the research?*

☐ No consultation or engagementIf this is ticked, explain why no consultation or engagement with Māori organisations or communities was required:*Click here to enter text.

☐ Some consultation or engagement☐ Significant consultation or engagement D1.1: If ‘Some consultation or engagement’, select the consultation or engagement undertaken:*

☐ Māori reviewer☐ Peers/colleagues☐ Attended Māori responsiveness training in last two years [please provide evidence, i.e., certificate of attendance]☐ Attended Treaty of Waitangi training in last two years [please provide evidence, i.e. certificate of attendance]☐ Other

If ‘Other’, please provide details:*Click here to enter text.

D1.2: If ‘Significant consultation or engagement’, please detail with whom significant consultation or engagement were undertaken:*

☐ Whānau ☐ Hapū ☐ Iwi ☐ Mana whenua ☐ Other

If ‘Other’, please provide details:*Click here to enter text.

D.2 Please detail how study results will be disseminated to study participants and whānau:*

☐ Pānui/progress reports sent to participants and or whānau☐ Summary of results provided to participants and or whānau☐ Hui held with participants and whānau☐ Other

If ‘Other’, please provide details:*Click here to enter text.

D.3 Please detail how study results will be disseminated to key Māori stakeholders:*

☐ Pānui/progress reports sent to Māori DHB research committee ☐ Pānui/progress reports sent to other Māori organisations ☐ Journal article published – accessible to Māori

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☐ Presentations at hui and conferences ☐ Other

If ‘Other’, please provide details:*Click here to enter text.

D.4 Many Māori consider their blood and genetic material to be tapu. Participation in studies that involve the collection of tissue samples requires careful consideration. The collection of tissue samples for research purposes is recognised as a significant cultural issue.

D.4.a: Does this study involve the collection of tissue samples?*☐ Yes ☐ No (go to D5)

D.4.a.i: Please confirm that you have included a statement about the misuse of tissue in the PIS:*☐ Yes ☐ No

D.4.a.ii: Please confirm that separate consent forms are supplied for storage of samples for future unspecified use:*☐ Yes ☐ Not applicable (not part of this study)

D.4.a.iii: Please confirm that separate consent forms are supplied for use of samples for genetic or genomic analysis (e.g. biomarker sub-studies) :*☐ Yes ☐ Not applicable (not part of this study)

D.4.b: Māori view data derived from the tissue as the ‘shadow’ of the tissue.

Please explain how the data will be used and stored:*Click here to enter text.

D.5 TIKA. Researchers should have the appropriate skills and experience required to design research that contributes to equity and to Māori health development.

What is the expected level of involvement for Māori in your research project?*☐ Māori governance group ☐ Lead investigators ☐ Co-investigators☐ Research assistants ☐ As participants ☐ Co-ordinators☐ Expert advisors (tikanga, research) ☐ Other If ‘Other’, please provide details:*Click here to enter text.

D.6 The proportion of Māori participants in the study should reflect the proportion of Māori in the community with the health condition of interest.D.6.a: Please detail how participants are recruited for this study, and strategies to ensure appropriate recruitment of Māori:*Click here to enter text.

D.6.b: Please detail the total number of study participants in each locality:* Click here to enter text.

D.6.c: Please detail the total number of Māori participants expected:*Click here to enter text.

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D.6.d: Please detail the proportion of Māori participants expected:* Click here to enter text.

D.6.e: Please explain your calculations for the answers above, and provide the source of any data used:*Click here to enter text.

D.6.f: Will the study undertake an analysis of results by ethnicity?*☐ Yes ☐ No

Explain:*Click here to enter text.

D.6.g: If ‘Yes’ for D.6.f, please confirm that ethnicity data is collected, stored and handled using the standard ethnicity questions as recommended by the Ministry of Health:*☐ Yes ☐ No

If ‘No’, please explain:*Click here to enter text.

D.6.h: Might there be opportunities in future research projects to undertake an analysis of results by ethnicity?*☐ Yes ☐ No

Please explain:*Click here to enter text.

D.6.i: Have you or anyone in your team been involved in Māori-focused research?*☐ Yes ☐ No

Please describe:*Click here to enter text.

D.7 MANAAKITANGA Research should be conducted with respect for all persons involved and respect for their culture.

D.7.a: Please confirm that contact details for cultural support are provided in the participant information and consent form:*☐ Yes ☐ No

If ‘No’, please explain:*Click here to enter text. D.7.b: Please confirm that provision has been made for the participants’ whānau to be involved in the study:*☐ Yes ☐ No

If ‘Yes’, please explain:*Click here to enter text.

D.7.c: Please confirm that provision has been made for participants to undertake the study in te reo Māori if desired:*

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☐ Yes ☐ No

If ‘No’, please explain:*Click here to enter text.

D.7.d: Please confirm that provision has been made for appropriate tikanga Māori protocols to be carried out when required:*☐ Yes ☐ No

If ‘No’, please explain:*Click here to enter text.

D.7.e: Please describe how measures to ensure privacy and confidentiality are provided for participants and whānau:*Click here to enter text.

D.7.f: Describe any other provisions you have made in your study to ensure the cultural preferences of Māori have been considered:*Click here to enter text.

Please include copies of any support documents with this application.D.8 MANA Equity and distributive justice is at the core of mana. It relates to the potential

or realised risks, benefits and outcomes of the research.

D.8.a: Describe the process for obtaining consent from participants (and whānau):* Click here to enter text.

D.8.b: Will participants receive any payments, reimbursement of expenses or any other benefits or incentives for taking part in your study?*☐ Yes ☐ No ☐ Not applicable (not part of this study)

D.8.c: Have the cultural risks of the study been fully explained?*☐ Yes ☐ No ☐ Not applicable (not part of this study)

D.8.d: Please explain who will own the study results and why:*Click here to enter text.

D.8.e: Might your study contribute to improving health gains for Māori?* ☐ Yes ☐ No

Please provide an explanation for your response:*Click here to enter text.

D.8.f: Describe how this research can contribute to improving health literacy for Māori participants and whānau:*Click here to enter text.

Section E: Human Tissue

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E.1 The use of human tissue in New Zealand is regulated by the Human Tissue Act 2008 and the Code of Health and Disability Services Consumers’ Rights 1996.

Use of tissue in an identifiable form or without existing informed consent for use requires approval from HDEC, not AHREC.

HDEC may decline jurisdiction in the case of a masters or other student project, in which case AHREC will assess the proposal.

Will human tissue be collected and/or used in this study?*☐ Yes ☐ No (If ‘No’, move to section F)

E.2 What type(s) of human tissue will be collected and/or used in this study?*Click here to enter text.

E.3 Will your study involve:*☐ Human tissue collected from participants? Please answer E.7 and E.8☐ Existing stored human tissue samples? Please answer E.4, E.6 and E.7☐ Human tissue samples imported from outside New Zealand? Please answer

E.5 and E.7

E.4 Explain how and from where you will obtain these existing stored human tissue samples?*Click here to enter text.

E.5 Briefly explain why it is appropriate to use imported human tissue in your study:*Click here to enter text.

E.6 Explain if donors of existing stored human tissue samples used in your study will be identifiable by you or your research team?*☐ Yes ☐ No

E.7 Explain how human tissue samples will be stored during your study, and how the privacy of donors and participants will be protected:*Click here to enter text.

E.8 Explain if human tissue collected in New Zealand will be sent overseas as part of your study?*☐ Yes ☐ No

E.9 If ‘Yes’ for E.8, explain why it is necessary and appropriate that human tissue samples be sent overseas as part of this study:*Click here to enter text.

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E.10 Will the use of all human tissue in your study be in accordance with the informed consent (including consent to future unspecified research) that has been obtained from participants, donors of existing stored human tissue, or other persons entitled to give informed consent under the Human Tissue Act 2008?*☐ Yes ☐ No Explain:*Click here to enter text.

E.11 What tests or analyses will be carried out on the human tissue as part of the study?*Click here to enter text.

E.12 What will happen to the human tissue at the end of your study, or if participants withdraw consent for its use in this study?*

☐ Disposal☐ Return to donor, whānau, or family member☐ Return to current holder of existing stored human tissue (e.g., a tissue bank)☐ Transfer to another tissue bank☐ Storage by the research team for use in another study☐ Storage by the research team as part of a new tissue bank☐ Other

If ’Other’, please briefly explain:* Click here to enter text.

E.13 Might any aspect of your study produce findings that may be both unexpected and clinically significant for participants, donors of existing stored human tissue, or their families?*☐ Yes ☐ No

If ‘Yes’, what might these findings be, and how will participants, donors of existing stored human tissue, or their families be informed of them?*Click here to enter text.

Section F: Risks & Benefits

F.1 Describe any benefits the study may have for participants (<200 words):*Click here to enter text.

F.2 Describe any wider/other benefits of the study (<200 words):*Click here to enter text.

F.3 F.3.a: Is it possible the research will involve any risk of harm to the researchers?*☐ Yes ☐ No

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Explain:*Click here to enter text.

F.3.b: Is the research likely to cause any harm to the participants, such as physical pain beyond mild discomfort, embarrassment, psychological or spiritual harm?*☐ Yes ☐ No Explain and indicate this on the PIS:*Click here to enter text.

F.3.c: Does the research involve processes that are potentially disadvantageous to a person or group, such as the collection of information which may expose the person/group to discrimination?*☐ Yes ☐ No If ‘Yes’, explain and indicate this on the PIS:*Click here to enter text.

F.3.d: Does the research involve collection of information about illegal behaviour(s) which could place the researcher or participants at risk of criminal or civil liability or be damaging to their financial standing, employability, professional or personal relationships?*☐ Yes ☐ No If ‘Yes’, explain and indicate this on the PIS:*Click here to enter text.

F.3.e: Does the research involve participants who are being asked to comment on employers?*☐ Yes ☐ No If ‘Yes’, explain and indicate this on the PIS:*Click here to enter text.

F.3.f: Does the research involve matters of commercial sensitivity?*☐ Yes ☐ No If ‘Yes’, explain and indicate this on the PIS:* Click here to enter text.

F.3.g: Does the research involve University of Auckland or DHB staff or students where information of a personal nature may be collected and where participants may be identified?*☐ Yes ☐ No If ‘Yes’, explain and indicate this on the PIS:*Click here to enter text.

F.3.h Summarise all the risks associated with the study as outlined in the questions above:*(Do not describe procedures that will be undertaken as part of normal clinical care regardless of participation in your study, or the risks of such procedures. If research involves accessing individual health information without consent, consider risks of loss of privacy or confidentiality).

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Click here to enter text.

F.3.i: Does the research involve any intervention administered to the participant, such as drugs, medicine (other than in the course of standard medical procedure), placebo, environmental conditions, food/drink?*☐ Yes ☐ No

If ‘Yes’, please explain:*Click here to enter text.

F.3.j: Is the research considered a clinical trial?*☐ Yes ☐ No

If ‘Yes’, please explain:*Click here to enter text.

F.4 Will permission be required to access identifiable data?*☐ Yes ☐ No

Please explain:*Click here to enter text.

F.4.a: Who will have access to the identifiable data?*Click here to enter text.

F.4.b: Who will remove the identifiers from the data, and when this will be done?*Click here to enter text.

F.4.c: Will the identifiers be stored to enable future re-identification of individuals?*☐ Yes ☐ No

F.4.c.i: Will the identifiers be stored separately from the research data?*☐ Yes ☐ No

If ‘No’, explain:*Click here to enter text.

F.5 Will the study involve the administration of ionising radiation that is not needed for participants’ normal clinical management?*☐ Yes ☐ No

F.5.a: If ‘Yes’, describe the form(s) in which ionising radiation will be administered:*Click here to enter text.

F.5.b: If ‘Yes’, attach a statement from a medical physicist of the effective

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doses of radiation, together with an appraisal of their appropriateness and safety. *

F.5.c: Does the research involve processes that involve EEG, ECG, MRI, TMS, MRI, EMG, invasive or surface recordings?*☐ Yes ☐ No

If ‘Yes’, describe the form(s) in which ionising radiation will be administered:*Click here to enter text.

F.6 F.6.a: During the study, who will have access to health information used in the study?*Click here to enter text.

F.6.b: Explain how you will ensure the confidentiality of this health information during the study:*Click here to enter text.

F.7 F.7.a: Will the study involve interviews?*☐ Yes ☐ No If ‘Yes’, prepare the interview questions or discussion topics and attach to the eform.

F.7.b: Will your study involve focus groups?*☐ Yes ☐ No If ‘Yes’, prepare the focus group questions or discussion topics and attach to the eform.

F.7.c: Will your study involve the use of survey(s) or questionnaire(s)?*☐ Yes ☐ No

If ‘Yes’, provide title of questionnaire(s):*Click here to enter text.Prepare the survey(s) or questionnaire(s) and attach to the eform

F.7.d: If ‘Yes’, will the survey(s) or questionnaire(s) be anonymous?*☐ Yes ☐ No Please explain:*Click here to enter text.

F.8 F.8.a: In what form will the data from the study be stored after the study has finished?*☐ Identified ☐ Potentially identifiable ☐ Partially de-identified ☐ De-identified ☐ Anonymous ☐ Other If ‘Other’, provide more information:*Click here to enter text. The Health (Retention of Health Information) Regulations 1996 require that some

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health information be retained for a period of ten years.

F.8.b: For how long will information generated in this study be stored?*Click here to enter text.

F.9 Will the results of your study be published in a form that identifies (or could reasonably be expected to identify) individual participants?*☐ Yes ☐ No If ‘Yes’, add this to the PIS

F.10 Will the participants be audio-recorded, video-recorded or recorded by any other means?*☐ Yes ☐ No (go to F14)

If ‘Yes’, please provide more details:* Click here to enter text.

F.11 F.11.a: Will the recordings be transcribed?*☐ Yes ☐ No

If ‘Yes’, explain who will transcribe the recordings:* Click here to enter text.

F.11.a.i: Will participants be offered the opportunity to edit the transcript of the recording?*☐ Yes ☐ No If ‘Yes’, explain the process of providing the transcript and period allowed for editing:*Click here to enter text.

If ‘No’, explain why participants will not be offered an opportunity to review and edit their own transcripts:*Click here to enter text.

F.11.b: Will the recordings be translated?*☐ Yes ☐ No

If ‘Yes’, explain who will translate the recordings:*Click here to enter text.

F.11.b.i: If a person not part of the research team is going to transcribe or translate the recordings, will a confidentiality agreement be used?*☐ Yes ☐ No If ‘Yes’, attach the confidentiality agreement to the eform.

F.13 Will participants be offered their recordings or digital files of their recording (or a copy thereof)?*

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☐ Yes ☐ No

F.14 Will participants receive any payments, reimbursement of expenses or any similar benefits or incentives for taking part in the study?*☐ Yes ☐ No If ‘Yes’, describe these and explain why they are appropriate:*Click here to enter text.

F.15 F.15.a: Will the Principal Investigator or any Co-Investigator also be the usual health or disability support service provider for one or more participants in your study?*☐ Yes ☐ No

F.15.b: If ‘Yes’, briefly describe how the risk of a conflict of interest between the research and clinical roles of such investigators will be managed:*Click here to enter text.

F.15.c: Does the research involve any other conflict of interest or the appearance of a conflict of interest for the researcher?*☐ Yes ☐ No

F.15.d: Briefly describe the potential conflict(s) of interest and how it will be managed:*Click here to enter text.

F.16 Might the study adversely impact on the provision of health and disability services?*☐ Yes ☐ No If ‘Yes’, how will this possible impact be managed?*Click here to enter text.

F.17 Is this application related to one or more previous applications reviewed by an ethics committee?*☐ Yes ☐ No If ‘Yes’, explain the relationship, giving name of the reviewing ethics committee and the ethics reference number(s) of the previous application(s):*Click here to enter text.

F.18 Has an application for this study (or a substantially similar study) previously been declined by an ethics committee in New Zealand or overseas?*☐ Yes ☐ No

If ‘Yes’, explain:

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Click here to enter text.

Section G: Information & ConsentG.1 Explain how participants will be identified and recruited for this study:*

Click here to enter text.

G.2 Explain the process by which potential participants will be provided with information on the study, an opportunity to ask questions, and be asked to give their informed consent:*Click here to enter text.

G.3 Will you be using invitation or information documents during the consent process?*

If ‘Yes’, prepare recruitment, information and consent documents to attach in the eform

These may include a Participant Information Sheet, Consent Form, Assent Form, advertisement, email invitation, etc.Templates for a Participant Information Sheet and Consent Form are available from the AHREC web pages (link below). Additional templates are also available from the HDEC website at https://ethics.health.govt.nz/ . Please adjust these forms to comply with AHREC requirements as outlined in the AHREC Applicants’ Manual:https://www.auckland.ac.nz/en/about/research/re-ethics/auckland-health-research-committee.html

G.4 Will all participants in the study give their informed consent to participate?*☐ Yes ☐ No

If ‘No’, explain why it is appropriate that the study involve non-consenting participants:*(Not applicable to anonymous questionnaires)Click here to enter text.

Move to question G.6

G.4.a: If ‘Yes’: How will consent be obtained?*

G4.a.i: Written consent form?* ☐ Yes ☐ No

If ‘Yes’, explain storage provisions for the consent forms separately from the research data.*Click here to enter text.

If ‘No’, select the form of consent that will be used:*

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G4.a.ii: Oral consent ☐ Yes ☐ NoIf ‘Yes’, explain why this is appropriate and how a record of the consent will be kept:*Click here to enter text.

G4.a.iii: By submission of an anonymous questionnaire ☐ Yes ☐ No

G4.a.iv: Electronic check box ☐ Yes ☐ No

G4.a.v: Electronic consent form ☐ Yes ☐ NoIf ‘Yes’, explain the process of consent and how a record of the consent will be kept:*Click here to enter text.

G.5 Will you seek consent from participants to inform health practitioners with responsibility for their health care that they are taking part in your study?*☐ Yes ☐ No ☐ Not applicableIf ‘Yes’, ensure participants are informed in the PIS and give consent for their health practitioner to be informed via the CF.

G.6 Does your study involve deliberately withholding or concealing information from participants?*☐ Yes ☐ No

If ‘Yes’, provide more information and prepare a debriefing sheet to attach to the eform:*Click here to enter text.

G.7 Will you offer participants the opportunity to receive the results of the study?*☐ Yes ☐ No

G.7.a: If ‘Yes’, explain how you will provide a summary of the results to participants. Also indicate this on the PIS.*Click here to enter text.

G.7.b: If ‘No’, explain why you do not intend to provide a summary of the study results to participants:*Click here to enter text.

G.8 In which of the following forms will the results from the study be published or otherwise disseminated?*☐ Journal publication ☐ Conference presentation ☐ Thesis/dissertation☐ Other publications ☐ Hui ☐ OtherPublic meetingsIf ‘Other’, provide details:

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Section H: Science Review

H.1: Prepare a science review to attach to the eform application:*

1. For research supported by funding from competitive internal (DHB / University of Auckland) or external funding sources:

Proof of a peer-reviewed funding award will be sufficient.

2. For unfunded projects: Applicants are required to provide an independent science review. This should address the importance of the scientific question, the appropriateness of the methodology, study power, feasibility, the track record of the applicant(s), and a global assessment of the study’s scientific merit. Ensure the science review is signed, and preferable from someone external to the research team of this application.

3. For applications concerning student projects at or below masters level: The main supervisor may instead provide an explicit assessment of the research merit of the project, paying attention to the issues indicated above, but recognising that benefits for student learning may be part of the justification for a project and properly balanced against such things as scope and significance of health outcomes of the proposed research. For doctoral student projects, an independent science review (or competitive funding grant) is required. Ensure this review is signed by the supervisor.

NEAC: Areas of focus during peer review

Peer review can be tailored to deliver opinions on a variety of matters relating to a health and disability research proposal. In order to determine scientific validity, the following factors should specifically be determined and the person providing the scientific review must provide brief comments on each:

The relative merit of the research: A key consideration is whether the proposed work is important, worthwhile and justifiable. The research should address a health issue that is important for health and/or society. The aims, research questions and hypotheses will build on and address gaps in existing knowledge.

The design and methods: The quality of study design and methods should be reviewed to assess its robustness. This might include study methodology, a description of sample recruitment and characteristics (including number, gender and ethnicity where relevant) and proposed methods of data analysis. Indication of timelines for the research should be included.

The feasibility of the research: This includes assessing:o Whether the overall strategy, methodology and analyses are well reasoned and

appropriate to achieve the specific aims of the projecto Whether the research has the likelihood, on balance, of improving scientific

knowledge, concepts, technical capacity or methods in the research field, or of contributing to better treatments, services, health outcomes or preventive interventions

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o Whether the research will be achievable within the specified timeframe and the research team has the appropriate experience and expertise to undertake the research.

Section I: Funding

I.1 Will you receive funding for this project?*☐ Yes ☐ No

I.1.a: If ’Yes’, who will provide the funding?*Click here to enter text.

If applicable, please provide the study budget

I.1.b: If ‘Yes’, in which institution will the budget be held?*Click here to enter text.

I.1.c: If ‘Yes’, who will authorise expenditure from this budget?*Click here to enter text.

I.1.d: Does the PI, any Co-investigator, or any direct member of their families have any commercial interest or any financial relationship to the study sponsor or funder(s) that may influence his or her conduct in the study?*☐ Yes ☐ No

If ‘Yes’, please briefly describe the nature of this interest or relationship, and how the risk of a conflict of interest will be minimised and managed:*Click here to enter text.

I.1.e: Will the funder have the potential to influence the analysis or any resulting publication?* Click here to enter text.

I.1.f: Who will own the intellectual property rights to the study results?*Click here to enter text.

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