Ethics Submission Form

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Full Title *

Short Title/Acronym

SJGHC Ethics Ref

Are you the study PI?

YesNo

Your Name

Your Affiliation

Your Email Address *

Your Role

Nature of Submission *

New Study for ApprovalUpdate to Previously Approved Study

New Study for Approval

Level of Risk *

Higher RiskLow RiskMinimal RiskExpedited Review

Prospective Consent *

YesNo

Please check all that apply.

Will you be viewing identifiable medical records?

Will any identifiable data be transferred to external parties (i.e. outside SJGHC?)

YesNo

As per the Administrative Fee Schedule from the current SJGHC Research Handbook, a one-off fee is to be paid at the time of initial submission to the SJGHC HREC. Please enter details below for the SJGHC Ethics Office to issue a tax invoice for this fee.

Name of Australian-based Sponsor or CRO

Address of Australian-based Sponsor or CRO

Sponsor/CRO Contact Name

Sponsor/CRO Contact Email Address

Name of Private Consulting Rooms

SJG Site Associated with Private Consulting Rooms

SubiacoMurdochMidlandOther

Name of External Site/s

Where a study does not involve a SJGHC site in any research activity, SJGHC does not assume responsibility for the site-specific authorisation of the research. The SJGHC Human Research Ethics Committee will provide ethical oversight of the progress of the study only.

Ethical Issues

Waiver of Consent *

Please consult Section 2.3.9 and 2.3.10 of the National Statement

Section 95A Privacy Act *

Please consult "Determining whether S95A Guidelines Apply"

Assent from child or young person *

Please consult Section 4.2.6 of the National Statement

Opt Out Approach to Consent *

Please consult Section 2.3.5 and 2.3.6 of the National Statement

Delayed Consent *

Please consult Chapter 4.4 of the National Statement

Impaired Capacity to Consent *

Please consult Section 4.5.5 to 4.5.11 of National Statement

Consent given by substitute *

Please refer to the relevant state consent/guardianship laws where this study will be conducted, and contact the SJGHC Ethics Office

Involving Aboriginal or Torres Strait Islander Peoples *

Please consult this document for guidelines involving research with Aboriginal and Torres Strait Islander Peoples

How have you complied with the Guidelines for Ethical Conduct of Research about Aboriginal and Torres Strait Islander Peoples (2018)?

Which specialist HREC for research involving Aboriginal and Torres Strait Islander Peoples have you referred this study to?

Waiver of Consent

What patient-identifiable information will be accessed under the waiver of consent?

DataBiospecimensData and biospecimens

What records are you requesting access to?e.g. Medical records of all patients who received Treatment X at Hospital Y between Date A and Date B

What patient type of biospecimens are you requesting access to?e.g. Patients who received Treatment X at Hospital Y between Date A and Date B

Where is the data located?e.g. WebPAS, hospital medical files

Where are the biospecimens located?e.g. Australian Clinical Laboratories, SJG Subiaco Hospital

What data items do you want to collect?e.g. demographic data, pathological response

What biospecimens do you want to collect?e.g. FFPE tumour tissue blocks

Requesting access to collect data until?

Requesting access to biospecimens until?

Before deciding to waiver the requirement for consent to research, the HREC must be satisfied that the following requirements are met:

Study is "lower risk" i.e. the only foreseeable risk is one of discomfort

Benefits of study justify any risks of harm associated with not seeking consent

Impracticable to obtain consent (e.g. due to the quantity, age or accessibility of records)

No known or likely reason for thinking that participants would not have consented if they had been asked

Sufficient protection of their privacy

Adequate plan to protect the confidentiality of data

Plan to feed back study results to participants (where of significance to their welfare) e.g. website, news media

Possibility of commercial exploitation of derivatives of data/tissue will not deprive participants of any financial benefits to which they would be entitled

Waiver is not prohibited by state, federal or international law e.g. Privacy legislation, various legislation relating to participants with impaired capacity to provide informed consent for research where they receive treatment

Section 95A of Privacy Act

Australian Privacy Principles relevant to this submission

APP3: Collection of solicited personal information
(e.g. researcher to prospectively solicit and collect ‘additional’ personal information for inclusion in a record/publication)

APP6: Use or disclosure of personal information
(e.g. researcher to access personal information that already collected in medical records)

Other APP/s

What is the purpose of your research?

What considerations are involved in weighing the public interest in the proposed project against the public interest in the protection of privacy?

a) The proposed collection, use or disclosure of health information is necessary to the functions or activities of the organisation

YesNo

b) The research is relevant to public health or public safety

YesNo

c) The research is likely to contribute to:

The identification, prevention or treatment of illness, injury or disease

YesNo

Scientific understanding relating to public health or safety

YesNo

The protection of health of individuals and/or communities

YesNo

The improved delivery of health services

YesNo

Enhanced scientific understanding or knowledge

YesNo

Enhanced knowledge of issues within the fields of social science and the humanities relating to public health or safety

YesNo

d) The research will lead to benefits to individuals, to the category of persons to which they belong, or the wider community

YesNo

e) In particular, the research will lead to benefits for:

Children and young people

YesNo

Persons with intellectual or psychiatric disability

YesNo

Persons highly dependent on medical care

YesNo

Persons in dependent or unequal relationships

YesNo

Persons who are members of collectivities

YesNo

Aboriginal or Torres Strait Islander peoples

YesNo

Persons whose information relates to their mental or sexual health

YesNo

f) Scientific defects might arise if the research was designed differently

YesNo

g) There would be a cost if the research was not done (to the government, the public, the health care system etc.)

YesNo

h) The research is important to the public

YesNo

i) The data being sought are usually available to the public from the organisation that holds the data:

The way the research uses the data is consistent with the purpose for which the data was made public

YesNo

The research doesn't require alteration of the format of the data that would constitute a breach of APPs

YesNo

j) There is minimal risk of harm to an individual whose health information is to be collected, used or disclosed in the research, based on the information provided in proposals submitted under paragraph A.2.6, A.3.6, B.2.6, B.3.6 or C.2.6 of these guidelines

YesNo

k) The standards of conduct that are to be observed in the research, including:

The study design and the scientific credentials of those involved in conducting the study are appropriate

YesNo

If the study involves contact with participants, they will be treated with integrity and sensitivity, no intrusive questions will be asked

YesNo

Access to health information will be adequately restricted to appropriate personnel involved in conducting the research

YesNo

The procedures that are to be followed will ensure the health information is permanently de-identified before the publication of results

YesNo

At the completion of the research, all data-containing health information will be at least as secure as they were in the sources from which the data was obtained, including the date when the data will be destroyed or returned, in accordance with APP11

YesNo

Opt Out Approach to Consent

When it is feasible to contact some or all participants, but where the research is of such scale and significance that using explicit consent is neither practical nor feasible, an Opt Out approach to participant recruitment may be appropriate. The HREC must be satisfied that the following requirements are met to justify an opt-out consent:

Study is "lower risk" i.e. the only foreseeable risk is one of discomfort

Public interest in the research outweighs the public interest in the protection of privacy

Research is likely to be compromised if participation rate is not near 100% and requirement for explicit consent would compromise the recruitment rate

Reasonable attempts are made to provide all prospective participants with appropriate plain language information explaining nature of the information to be collected, purpose of collecting it, and the procedure to decline/opt out of participation or withdraw from the research

Reasonable time period is allowed between the provision of information to prospective participants and the use of their data so that an opportunity for them to decline to participate/opt out is provided before the research begins

A mechanism is provided for prospective participants to obtain further information and decline to participate/opt out

Data collected will be managed and maintained in accordance with relevant security standards

Governance process in place that delineates specific responsibility for the project and for the appropriate management of the data

Opt out approach is not prohibited by state, federal or international law e.g. participants with impaired capacity to provide informed consent for research where they receive treatment

Cognitive Impairment

People with a cognitive impairment include those with an intellectual disability or mental illness. The capacity of these people to consent to research and ability to participate will vary, so research should take into account the often "more than usual" vulnerability of these people and minimise potential forms of discomfort and stress.

As per the National Statement on Ethical Conduct in Human Research (NHMRC, 2023) “NS”, Chapter 4.5, the researcher should address the following in the study submission:

As per NS section 4.5, the study takes into account the specific nature of the impaired capacity: the person' condition, their medication or treatment, the complexity of the research and fluctuations in the condition i.e. if impaired capacity is transient

As per NS section 4.5.2, bearing in mind the participant's distinctive vulnerability, the risks of research are justified by the potential benefits of the research

As per NS section 4.5.10, study outlines the process of how it is proposed to determine the capacity of a person with a cognitive impairment, an intellectual disability or a mental illness to consent to the research

As per NS section 4.5.7, in seeking consent the study includes a process for discussion of any possibility that the person's capacity to consent or to participate in the research may vary or be lost altogether; what the person would wish to happen in such circumstances; and that the person's wishes would be followed unless changed circumstances would mean that acting in accordance with those wishes would be contrary to the person's best interests

As per NS section 4.5.6, in the case that impaired capacity is transient, when it is likely to be practicable to seek consent from the person

As per NS section 4.5.8, consent should be witnessed by a person who has the capacity to understand the merits, risks and procedures of the research, is independent of the research, knows the participant and is familiar with his/her condition

As per NS section 4.5.5, when the impaired capacity is NOT transient OR it is NOT practicable to seek consent, then consent should be sought from the participant's guardian, or person or organisation authorised by law

As per NS section 4.5.9, where consent has been given by a person authorised by law, the researchers should nevertheless explain to the participant, as far as possible, what the research is about and what participation involves

As per NS section 4.5.9, should the participant at anytime recover the capacity to consent, the researcher should offer him/her the opportunity to continue participation or withdraw

People Highly Dependent on Medical Care

People highly dependent on care may include those who are in intensive care (ICU)/neonatal ICU, emergency, palliative care, or are unconscious. Consent should be sought from people highly dependent on care wherever they are capable of giving consent and it is practicable to approach them. When the impaired capacity is NOT transient OR it is NOT practicable to seek delayed consent, then consent should be sought from the participant's guardian or person or organisation authorised by law.

When neither the potential participant not another on his/her behalf can consider the proposal and give consent, a HREC may, having taken account of relevant jurisdictional laws, approve a research project without prior consent if the following conditions are met:

Research does not constitute a clinical trial (in NSW, there is no legislative basis for delayed consent or waiver of consent for clinical trial on patients incapable of consenting)

There is no reason to believe that, were the participant or the participant's representative to be informed of the proposal, he/she would be unwilling to consent

The risks of harm are minimised

The research is not controversial

If the research is interventional, the research supports a reasonable possibility of benefit over standard care

If the research is interventional, any risk of the intervention to the participant is justified by its potential benefits to the participants

If the research is interventional, inclusion in the research is not contrary to the interests of the participant

As soon as reasonably possible, the participant and/or the participant's relatives and authorised representative should be informed of the participant's inclusion in the research and of the option to withdraw from it without any reduction in quality of care

Update to Previously Approved Study

What Committee will review this update? *

SRC (significant safety issues, IDMC and DSMB/safety reports, local SAE/SUSAR/USADEs, final reports, publications, presentations)HREC (all other updates)

SRC Update

If the type of update is not listed above, please select HREC as the committee that will review the update.

Please provide a brief summary of the proposed changes

Please give a reason for the proposed changes

Are there new safety risks that affect the ethical acceptability of the study? *

YesNo

What is the recommendation of the safety report?

HREC Update

If you are submitting a Final Report, please select the SRC as the Committee that will review the submission.

Please provide a brief summary of the proposed changes

Please give a reason for the proposed changes

Do the proposed changes raise any ethical issues?

YesNo

Do the proposed changes lead to any changed resource implications for the Participating Site?

YesNo

Please attach an amended PSOA.

What type of study personnel change are you submitting?

Change in Principal InvestigatorChange in Co-InvestigatorOther staffing changes

Please note: Only changes in Investigators require seperate notification to the Committee. Please submit all other staffing changes in the next Annual Report

Have you notified the Participating Site of this proposed update prior to submitting to the Committee for ethics approval?

YesNo

Please note: All proposed protocol amendments, extension requests and changes to study investigators must first be
discussed with the Participating Site before being submitted for ethics approval. Please contact the Participating Site prior to this submission

Please provide an amended fully executed PSOA or other evidence that the Participating Site is aware of the proposed update

New anticipated completion date for study

Reason why extension of approval is requested

Has an Annual Report been submitted for this study in the past year? *

YesNo

Please complete and submit an Annual Report by selecting "Annual Report" in the "Type of HREC Update" list above.

Please provide a reason for the study closure

Is a PICF Amendment required due to the Updated IB?

YesNo

Expiry date of Updated Insurance Certificate

Additional Site

Please attach the following documents to your submission:

Participating Site Operational Approval form for the new site (if SJGHC)
OR letter confirming governance approval for the new site (if external)
current CV and signed Declaration of Interest for the proposed Principal Investigator at the new site
signed Privacy Declaration if the PI is an external researcher

Local SAE/SUSAR/USADE

Type of Local Safety Event

Type of Study

Participating Site

Study Drug(s) and Dosage(s)

Study Device(s)

Study Intervention(s)

Event Term

Investigator(s)

Date of Event

# Report to SJGHC HREC

Participant ID

Participant Age

Gender

MaleFemale

Event Description and Management

Please describe what this event is related to *

Event Relationship to Study *

As per the SJGHC Research Handbook, unrelated Local SAEs are not required to be submitted to the SJGHC HREC.

Is this event a documented side effect? (i.e. specified in the study protocol)

YesNo

How often has this same event occurred to date in the present study?

In your opinion as a researcher conducting this clinical trial, are any amendments required to the Protocol and/or Participant Information and Consent Form?

YesNo

In your opinion as a researcher conducting this clinical trial, are there any implications for the continued conduct of the study?

YesNo

Serious Breach Report

Type of Breach

Type of Report

Date of Report

Stage of Report

Sponsor Name

CRO Name

Participating Site

Person/Organisation who committed Breach

Please ensure any Serious Breach that occurs at a SJGHC site or involves SJGHC participants or data
is also immediately recorded in Riskman as an incident.

For all local privacy/data breaches, please also escalate and complete mandatory notifications
as per SJGHC policy: GO GRC03 Privacy Data Breach and My Health Record Data Breach Framework and Response Plan.

Breach Details

What was the impact on participant safety?

What was the impact on participant rights?

What was the impact on the reliability and robustness of the data?

Action/s Taken

Comments from Review of Serious Breach by Participating Site

Annual/Interim Report

Final Report

Report Period From

Report Period To

Is this a registered study?

YesNo

Has the registry been updated with the final results of the study?

Does this study involve Western Australian sites and the recruitment of incapacitated adults using the Guardianship and Administration Amendment (Medical Research) Act 2020?

YesNo

How many incapacitated adults (research candidates) have been recruited into the study thus far with the prior consent of a research decision maker and/or HREC?

Has the researcher completed all paperwork and reports associated with recruitment of these research candidates, as per GAA Amendment (Medical Research) Act 2020 requirements?

YesNo

Site Name

Target Recruitment

Actual Recruitment

Screened

Withdrawn

Deceased

Completed

On Active Treatment

Follow Up

Lost to Follow Up

If applicable, what have been the reasons for participant withdrawal from the study?

Is this study conducted at other sites external to SJGHC?

YesNo

Total anticipated study recruitment

Total actual study recruitment to date

% of actual recruitment from SJGHC

If applicable, how did any delays impact on the study outcomes?

The study is currently

Approval Granted UntilAs per the ethics approval letter or extension date if approved by the SJGHC HREC

Expected Study Completion Date

As the study is now completed, please amend this form from an Annual Report (for HREC review) to a Final Report (for SRC review).

Describe the outcomes of the study so far, and the reason behind any delays

Have changes been made to the approved Protocol/Project Description, Participant Information and Consent Form (PICF) and/or the research personnel that have not previously been reported to the SJGHC HREC?

YesNo

Has the Protocol/Project Description most recently approved by the SJGHC HREC been complied with?

YesNo

Have all specific conditions of approval (as outlined in the original SJGHC ethics approval letter) been complied with?

YesNo

Briefly outline what action has been taken to ensure the complete and accurate recording and the safe storage and retention of data relating to this study

Briefly detail how privacy and confidentiality have been maintained

Briefly summarise the trends and significance of any Serious Adverse Events (SAEs) or unexpected outcomes in the conduct of the study. What actions have been taken in response to these?

What positive feedback has been received from participants?

What other feedback has been received from participants?

Have participants made specific complaints, raised concerns or offered suggestions about the consent process and/or consent documentation?

YesNo

The consent process may be explicit or implied, e.g. as with the completion of a study questionnaire, written or verbal, extended consent, unspecified consent such as generic consent for future research, substitute consent, delayed consent, opt out consent, etc.

Have any unanticipated ethical issues emerged in the course of the study?

YesNo

Have any potential researcher conflicts of interest (real or perceived) arisen in the conduct of the study that were not previously advised to the SJGHC HREC?

YesNo

Is the Insurance Certificate current for this study?

YesNoN/A

Please submit the current insurance certificate to the SJGHC HREC.

How many publications and/or presentations have arisen from this research?

Publications

Pending Publications

Presentations

Pending Presentations

Please forward the details of any pending publications to the SJGHC Ethics Office once they have been finalised.

Please forward the details of any pending presentations to the SJGHC Ethics Office once they have been finalised.

Publications

Please add details for all publications in the table below.

Full Reference

DOI

Publication Date

Recognition

Highly cited (>1 citation within 1 yr of publication)Selected for editorialResearch prize/Other peer recognition

Presentations

Please add details for all presentations in the table below.

Title

Date

Type

Conference Name

Conference Type

Results

Please provide a plain language summary of the main findings of the study

What type of translation do the study results have?

No TranslationEvidence for Status Quo (e.g. confirms efficacy of existing treatments or procedures)Recommends Change in Guidelines/Policy/System (i.e. recommends change in practice)New IP/Technology/Practice (e.g. new registered drug/device/licensed product)

What is the extent of the translation of the study?

No TranslationTranslation within SJGHC (i.e. study has resulted in change of practice within SJGHC)External Translation (i.e. study has resulted in wider change of practice beyond SJGHC)

If a study recommends change in practice it must have translation of results. Please amend your response.

Is this study connected to other research at SJGHC or a larger research program?

YesNo

Are there any further research opportunities to expand on this study?

YesNo

Have the study participants been informed of the findings of the study to date?

YesNo

Please attach a copy of the findings provided to study participants.

Expedited Review Checklist

"More than Low Risk" research which has previously been approved by an NHMRC Certified hospital-based HREC may be approved via an expedited review pathway if it meets the criteria specified below. The research will then be reviewed out of session or tabled directly at the next SJGHC HREC meeting for expedited review, depending on the timing of the submission.

Research is not investigator-initiated research

Research does not specifically involve pregnant women, children or device implants

Research is not a Phase I/II pharmaceutical clinical trial

Evidence of Peer/Scientific Review Process and support for the research (e.g. NHMRC grant sponsored research, investigational product licence, etc).

Documentation of at least one other NHMRC-Certified hospital-based HREC (please refer to list available here) or by the DOHWA HREC (in the case of WA Data Linkage Branch studies only)

NHMRC-Certified Hospital-Based HREC Name

Date Approved

Low Risk Checklist

More than Low Risk Checklist

Attachments

Please list all attached documents in the table below.

If your submission includes an amendment to a previously approved document (e.g. protocol, PICF) please ensure that you attach both a clean and tracked changes copy.

Document Title

Version

Date

File Upload

Browse

All documents must be in PDF format

Any further information for HREC/SRC consideration

Please ensure that site CEO, DMS and research office (if applicable) are copied in to this submission.

Please also ensure that the serious breach is entered into RiskMan.

Signature *

Draw signature|Type signatureClear

Date of Signature *

PI TItle *

PI First Name *

PI Last Name *

PI Email Address *

Contact Number

Postal Address Line 1

Postal Address Line 2

CC Receipt of Submission To

Please ensure that the Participating Site CEO/Director, Participating Site Research Office
and the CPI / any other SJG site investigators (if applicable) are copied in on this submission.

Submission Form Version 1.1 dated July 2025

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