Research and ethics

The research approval process forms part of Scope’s research governance processes. The research approval process applies to any requests Scope receives to distribute information to assist with recruitment, including promoting research within Scope. The process ensures that the research to be conducted benefits Scope.

Researchers should factor in organisational and ethics approval early in project planning, including the Human Research Ethics Committee (HREC) submission and meeting dates.

Applications with less than three months between commencement and completion will not be accepted.

All research needs to undergo the two-stage review and approval process:

Step 1. Organisational approval (preliminary approval)

All research conducted at Scope must first be approved by management. Research may receive organisational approval if it aligns with Scope’s strategic direction and the Research Plan. Consideration will also be given to the resourcing required to support the research, the impact, risk, benefit, and the relevance of the research to Scope. Researchers who want to undertake research at Scope need to complete the Application to Conduct Research at Scope Form. The outcome will be communicated within three weeks of submission.

For more information about organisational approval, please email research@scopeaust.org.au.

Once organisational approval has been granted, an ethics application may be submitted (Step 2).

Step 2. Ethics approval (HREC approval)

All research conducted at Scope requires Scope HREC approval — even if it has been approved by another HREC. Applications must be submitted to the HREC Officer at hrec@scopeaust.org.au.

Organisational approval is a pre-requisite when applying to Scope’s HREC for review. Applications must be submitted to the HREC Officer as outlined in sections 1 and 3. Scope accepts applications on forms from other institutions, provided the institution has an HREC registered with the NHMRC. Scope also accepts applications using the Human Research Ethics Application (HREA). The Scope HREC Supplementary Form must also be submitted.

Researchers can expect to receive a response from the Committee for above-low risk applications within three weeks of scheduled meetings. All relevant documents referred to in the application (for example, recruitment materials, consent forms, surveys and observation forms) must be included. Incomplete or inadequate applications will not be considered.

Applications must be submitted as one single PDF file that includes all attachments (e.g., surveys, interview questions, other HREC approvals). Attachments should be clearly identified in the text and presented in the order in which they are mentioned in the application form. The Scope supplementary form should be last. Wherever possible, the PDF file should be “searchable”.

Researchers should use Scope’s approval and complaints clauses in all participant information and consent forms.

HREC Office ClosureSubmission dates must be adhered to and extensions are not permitted. Researchers may be invited to attend the meeting to discuss their application. Under no circumstances can research commence at Scope without written approval.

The HREC office will be closed from Monday 17th December 2018 through to Friday 11th January 2019, and will reopen on Monday 14th January 2019.

The review of submissions (i.e. applications, amendments, etc.) will not take place during the closure period; however adverse events, complaints and urgent issues will be addressed.

This Tip Sheet is provided to assist researchers to avoid delays in the HREC review and approval process. The Tip Sheet is based on common feedback provided to researchers by Scope’s HREC.

Research is defined by the National Health and Medical Research Council (NHMRC), the Australian Research Council, and Universities Australia as: “Original investigation undertaken to gain knowledge, understanding and insight.”

Low and negligible risk research

According to the National Statement on the Ethical Conduct in Human Research 2007 (updated March 2014), low risk research is defined as “research in which the only foreseeable risk is one of discomfort”.

Negligible risk “describes research in which there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience”.

Low risk research that does not involve the vulnerable groups outlined in Section 4 of the National Statement, and negligible risk research is reviewed by the HREC Chair or delegate. Scope accepts applications on forms from other institutions, the Human Research Ethics Application (HREA) and the Core Application Form.

Above low risk research

All research that is above low risk is reviewed by the full HREC.

Scope monitors research in accordance with the National Statement to ensure that research complies with the proposal that was approved by the HREC. Monitoring includes reporting and auditing.

Scope updates its forms for monitoring regularly. The most up-to-date version of all forms can be downloaded from this section and from section 8. Out of date or incorrect forms will not be accepted.

All reports must be submitted as one single PDF file that includes all attachments. Attachments should be identified and presented in the order in which they are mentioned. All reports should be submitted to the HREC Officer at hrec@scopeaust.org.au.

The outcome of any monitoring will be communicated within three weeks of submission.

Annual progress reports:

• Must be submitted every twelve months from the date of HREC approval
• Must be signed
• Complete the annual progress report

Final reports:

• Must be submitted within three months of the project completion date
• Should include copies of any publications listed in the report
• Complete the final report

Adverse events:

• Must be reported immediately
• Complete the Adverse events form

Request for Amendment:

• Any changes to approved research must be requested. For example, change in procedure or direction of the project, changes to research personnel, time extension, changes in the source or manner of recruitment and changes in the number of participants
• Minor amendments (such as change in sample size and change of timelines) will be reviewed by the HREC Chairperson
• All other amendments will be reviewed by the HREC
• Complete the Request for Amendment

Discontinuation of Research:

• Must be reported as soon as possible
• Complete the Discontinuation of research form

Audits:

• The self-audit must be completed and submitted with the annual progress report
• Complete the self-audit form

Scope’s HREC is registered as a Human Research Ethics Committee with the National Health and Medical Research Council:

HREC Identification Number: EC00428

Organisation Identification Number: ORG0554

As such, the Scope HREC is constituted and functions in accordance with the National Statement on Ethical Conduct in Human Research (2007; updated March 2014).

Committee members

Chairperson
Dr Philomena Horsley

Lay people
Mike Debinski
Amanda Tremellen

Person with knowledge of and current experience in the professional care, counselling or treatment of people
Brian Hardy
Cathy Lengyel

Someone in a pastoral care role
Rev Barry Fernley

Lawyer
Nic Cozens
Yvette Woodward

People with current knowledge of and current experience in the research that is relevant to the proposals to be considered
Dr Stella Koritsas (Deputy Chair)
Dr Anna Arstein-Kerslake
Associate Professor Jenny McGinley

People with lived experience
Shane Kelly
Jasmine Ozge

HREC TORs

• Adverse events
• Annual progress report
• Application to Conduct Research at Scope
• Core Application Form (CAF).
• Discontinuation of research
• Final report
• Human Research Ethics Application (HREA)
• Request for Amendment
• Self-audit

Complaints and other feedback should be submitted to the HREC Officer at hrec@scopeaust.org.au.

Complaints about the conduct of a specific research project or matters relating to HREC review will be investigated by the Chair and/or the CEO as appropriate and in accordance with Scope’s organisational processes.

Complaints relating to the rejection of an application by the HREC should be directed to the CEO via the HREC Officer.

• Guidelines approved under Section 95A of the Privacy Act 1988 (2014)
• Ethical Considerations in Quality Assurance and Evaluation Activities (March 2014)
• Australian Code for the Responsible Conduct of Research (2007)
• HREC TORs

HREC Officer: 03 9843 3000 or hrec@scopeaust.org.au

Dr Stella Koritsas, HREC Deputy Chair: 03 9843 3000 or skoritsas@scopeaust.org.au

Research Management: research@scopeaust.org.au