HREC - Submitting your Application

• Review by the full HREC or Expedited review?
• Which HREC?
  • The Health & Medical HREC
  • The Social Sciences HREC
• What do you need to submit?
  • General applications
  • Clinical Trials
• When to submit your application
• Where to submit your application
• Fees
• Indemnity
• Local Health Disctrict Applications
• Monitoring and Reporting Requirements for Clinical Trials
  
   

 Review by the full HREC or Expedited review?

Research involving children, vulnerable groups, invasive procedures or a sensitive topic must be reviewed by a meeting of a full HREC. It currently takes approximately 6 weeks from date of submission for the review process to be complete.

Low risk research is normally reviewed by the Executive Committee of the HRECs. The Executive Committee meets weekly, and it currently takes approximately 3 weeks for this review process to be completed (to receive approval).

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 Which HREC?

Applications will be reviewed by the most appropriate Committee based on the area of research. Both Committees are constituted according to the National Statement on Ethical Conduct in Research Involving Human and accredited by the NH&MRC. This means that both Committees are able to review any application submitted, therefore applications which are on the border between the disciplines focused on by the two Committees will not be disadvantaged.

The Health & Medical HREC

This Committee primarily reviews:

• Clinical research (including clinical psychology research undertaken through Northfields clinic and clinical trials of drugs, surgical trials or trials of therapeutic goods)
• Research that has as its primary focus understanding of human physiological processes, the efficacy of medicines and human health,
• Research involving the administration of any substance or agent to participants (e.g. research involving administration of approved drugs, research involving alcohol or special diets or food supplements);
• Research involving the collection of body tissues or fluid samples (e. g. blood or urine samples);
• Physical procedures which involve risk of pain or discomfort for participants (including human movement research, research involving strenuous or repetitive exercise)

Committee Members

Meeting dates

 The Social Sciences HREC

This Committee primarily looks at research involving methods, practices and conceptual analysis familiar to the disciplines of the Humanities (including creative arts, history and English), Social Sciences (including commerce, economics, human geography, sociology, education and politics), or Behavioural Sciences (including marketing and psychology). Such research methods and practices include:

• Research to be analysed through the methods of the social sciences, humanities and behavioural science research
• Research involving focus groups or interviews
• Research involving access to private papers concerning public figures, political movements, historical events, artistic practice, educational policy, etc
• Interviews and surveys of community members about social practices and attitudes, public policies, marketing strategies, etc.
• Educational research.

Committee Members

Meeting Dates

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 What do you need to submit?

General Applications

Your application should include:

• The appropriate application form
  • For UOW staff or students, not involving NSW Public Health services or staff click here
  • For research involving NSW Public Health in any Local Health District click here
  • For clinical trials click here
• The Privacy addition if collecting/using health information
• Participant Information Sheet
• Consent Form
• Copies of questionnaires, interview questions, telephone scripts
• All advertising material
• Any approvals from other organisations that will be involved

How many copies?

For review by the full HREC submit 17 copies (plus original)

For review by the Executive Committee submit 1 copy (original) 

Applications to the full HREC must be signed by all investigators, their supervisors (if students) and the Head of Dept. They must be collated and submitted by the agenda deadline. Agenda deadlines are: 5pm for all full HREC meetings and 2pm every Wednesday for the weekly Executive HREC meetings.

 Clinical Trials

If you are conducting a Clinical Trial your application should include:

• Initial Application
• Privacy Addition
• Participant Information Sheet
• Consent Form
• Protocol
• Investigator's Brochure (x5)
• Advertising material
• Insurance Certificate (x1)
• Indemnity Forms link to HREC Review and Standard (3 of each)
• Study Budget
• CTN form (x1)
• Letter listing materials submitted and including details of who should be invoiced (x1)

How many copies?

17 copies of each item should be submitted, plus the original signed copy, unless specified otherwise. The materials should be collated into individual packages ready to be forwarded to the reviewers. Uncollated applications will not be accepted.

If the study involves the ISLHD a copy must also be submitted to the LHD (see below Where to submit your application').

A Site Specific Application (SSA) also needs to be completed for each site and submitted to the relevant Governance Officer for approval.

NHMRC position statement regarding CT monitoring

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 When to submit your application

Applications to the full HREC: Both HRECs meet monthly except in January. Check the meeting dates and agenda deadlines for the committee appropriate to your research. If you are uncertain call the Ethics Officer on 4221 3386.

Expedited Review: The Executive Committee meets weekly except in January. Applications can be submitted at any time and will be accepted for the weekly (Thursday) meeting if received by 2pm on the Wednesday.

 Where to submit your application

Applications should be sent to:

Human Research Ethics Officer
Research Services Office
Building 20
University of Wollongong
NSW 2522

If your research involves staff or patients of the ISLHD you need to forward a copy of the application together with a copy of the acknowledgement letter from the HREC to:

Professor Margaret Rose
Research Directorate
Wollongong Hospital
PMB 8808
South Coast Mail Centre 2521

 Fees

No fees are charged for the review of standard applications. The HREC charges fees for the review of clinical trials in accordance with NSW Dept of Health Policy. The details of who to invoice for the review should be included in the application.

The fees contribute to the cost of the administration of the HREC, defrayment of costs incurred by non-institutional Committee members in participating in the HREC, and towards the cost of training the members of the HREC.

The fees are:

* Amendments include any changes to the protocol excluding minor administrative changes.

^ Sub-studies will be reviewed and the fee determined on a case-by-case basis. The HREC may request that the sub-study be submitted as a new application and charge the full fee.

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 Indemnity

Applications for sponsored clinical trials should include Indemnity Forms for the study and for HREC review.

The Standard Indemnity Forms should be addressed to:

[name of site eg The Wollongong Hospital],
Illawarra Shoalhaven Local Health District 

As the HREC operates for the University of Wollongong and the ISLHD there should be two versions of the HREC Review Indemnity Forms, addressed to:

• The University of Wollongong of Northfields Avenue, Wollongong, NSW 2522, acting through the University of Wollongong and Illawarra Shoalhaven Local Health District Health and Medical HREC ; and
   
• Illawarra Shoalhaven Local Health District acting through the University of Wollongong and Illawarra Shoalhaven Local Health District Health and Medical HREC

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 Local Health District Applications

Which application form(s) should I complete?

All applications for ethical and scientific review and site authorisation of research taking place within the NSW public health system must be submitted through this Online Forms Website: https://ethicsform.org/Au/Help/Guidance.aspx

NSW Ministry of Health will only accept ethics applications completed on the NEAF or LNR form. The UOW ethics application form will not be accepted by any Local Health District.

National Ethics Application Form (NEAF)

Purpose of the NEAF

The purpose of the NEAF is to enable applicants to provide sufficient detail about the research project to allow a Human Research Ethics Committee (HREC) to make an informed decision about the ethical and scientific acceptability of the proposal.

When the NEAF should be used

The NEAF should be used for all applications for ethical and scientific review relating to research in which the risk to participants is more serious than discomfort, as described in the National Statement on Ethical Conduct in Human Research (2007).

 Other Information

All applications involving the clients of the LHD must include a researcher who is a staff member of the LHD.

Applications must be approved by the administration of the LHD, who review governance issues (eg resource availability) related to the applications. This is additional to the HREC review, which looks at applications for their compliance with relevant ethical and privacy guidelines and laws.

When you receive your acknowledgement letter from the HREC you should forward a copy of it with a copy of your application to:

Professor Margaret Rose
Research Directorate
Wollongong Hospital
PMB 8808
South Coast Mail Centre 2521

The HREC will forward copies of all correspondence it sends you to the LHD. When the LHD receives a notice of approval from the HREC, it finalises its review of the application and will notify you of the result.

Queries about the LHD review should be directed to Leigh Lees on 4253 4800. 

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>Monitoring and Reporting Requirements for Clinical Trials

Once you have obtained ethics approval you are required to submit a progress report annually and a final report on completion of your project. As evidence of continuing compliance, the Human Research Ethics Committee also requires that researchers immediately report:

·  proposed changes to the protocol including changes to investigators involved

·  serious or unexpected adverse effects on participants

·  unforseen events that might affect continued ethical acceptability of the project.

Our HREC follows the NHMRC position statement on Monitoring and reporting of safety for clinical trials involving therapeutic products