Human Research Ethics
Before conducting research that involves humans as participants, you must receive approval from the Human Research Ethics Committee. In conducting such research, all researchers must also read and abide by the Australian Code for the Responsible Conduct of Research.
Index
Submitting Applications
Guidelines and Forms
Reciprocal Approvals
Contact Details
Meeting Dates
Constitution
Common Problems
Sample Consent and Information Sheets
Additional Information
Useful Links
Frequently Asked Questions
Two-Tier System
Curtin operates a two-tier system for approving ethics applications.
- If your research poses a greater risk than participants would face in their normal daily routine, complete a Form A and submit to the Secretary, Human Research Ethics Committee(see Section 2 of the National Statement on Ethical Conduct in Human Research).
- Completed applications must be submitted 5 weeks before a scheduled meeting of the HREC. This is to allow time for a sub-committee to review applications and provide written advice to the full Committee. Please pay careful attention in particular, to the participant information sheets, consent forms and methods of recruitment. Please also ensure that you use clear, plain language throughout.
- If your research poses a low risk to participants, complete Form C. This should be signed by the Ethics Coordinator in your School or Faculty.
- What counts as low risk will vary between disciplines. For example, taking a blood sample is a low risk activity for medical doctors but not for people without medical training. Please talk to experienced researchers in your area or the Ethics Office about this.
Adverse Events
If an Adverse Event occurs in your research , stop gathering data, secure existing data, and where appropriate, make the research site safe and advise the Secretary immediately. This Flowchart explains the process.
Submitting Applications
Form A: Non-Minimal Risk
- If your research is likely to expose participants to more risk than they could expect on a normal day, then complete Form A. Risk takes many forms and includes such things as emotional upset, psychological distress, harm to reputation, and physical harm. If in doubt consult the Ethics Office or the National Statement Section 2.
- Application Process Flowchart and Guidelines.
- All applications are reviewed by sub-committee before being considered by the full Committee. Please allow adequate time usually 4-5 weeks for the review process. The full Committee meets monthly (see meeting dates). Please talk to the Secretary (contact details) if you have specific needs.
- Approval is granted for one year, but may be renewed annually using Form B a maximum of three times.
- Download Form A, complete and submit 3 hard copies (including original) to the Secretary.
- Please note: you may also submit your application electronically ( ethicsapplications@curtin.edu.au) but you application will only be processed when the 3 hard copies are received into the Ethics Office.
- If you plan to submit a copy of your application electronically this must be in pdf format (preferably as one document).
Form B: Renewing Approval or Changing Aspects of your Research
- Application for Renewal of Approval/Progress Report (Form B)
- Any changes to your research must be recorded in a Form B and submitted to the Secretary. Proposed changes must be approved by the Committee or the Executive Officer on behalf of the Committee before the changes can be implemented.
- The HREC also requires an annual report or advice that your research has finished or been stopped.
- A Form B must be submitted within one year of approval and each year following. An application for renewal may be made with a Form B three years running, after which a new application form (Form A), providing comprehensive details, must be submitted.
Form C: Low Risk
- If your research is likely to expose participants to no greater risk than they should expect on a normal day, complete Form C. This level of risk covers such things as simple observation, and administering short non-intrusive surveys.
- Guidelines for Form C Application
- Application Process Flowchart
- Download Form C, complete and submit to School or Faculty Ethics Coordinator.
Who may submit an application?
- Applications may be submitted by:
- a current member of Curtin Staff, who should be named as the Principal Investigator; or
- by the nominated representative of an organisation with which Curtin University of Technology has a current formal agreement. This formal agreement must define the approval, conduct and monitoring of research, who carries legal responsibility for it, and contain a schedule of associated costs.
- Low Risk (Form C) applications may be submitted by students, as well as those in the above categories.
Getting your application in on time
- Applications can be submitted at any time to the Secretary for review (two-tier process).
- Completed applications must be submitted 5 weeks before a scheduled meeting (see below for dates) of the HREC. This is to allow time for a sub-committee to review applications and provide written advice to the full Committee. Please pay careful attention in particular, to the participant information sheets, consent forms and methods of recruitment.
- Please also ensure that you use clear, plain language throughout. Applications are reviewed by sub-committee before being considered by the full Committee.
Getting an item on the Agenda
The agenda deadline is the Tuesday 14 days prior to the meeting date.
| Meeting Dates |
|---|
| Tuesday 1 April 2008 |
| Tuesday 6 May 2008 |
| Tuesday 3 June 2008 |
| Tuesday 1 July 2008 |
| Tuesday 5 August 2008 |
| Tuesday 2 September 2008 |
| Tuesday 7 October 2008 |
| Tuesday 4 November 2008 |
| Tuesday 2 December 2008 |
Guidelines
- Application Procedures and Guidelines for students and supervisors for all applications for Ethics Approval of Research Involving Humans
- Guidelines for a Two Tier Ethics Approval System and for research ethics coordinators (second tier) reporting to HREC (first tier)
- Ethics Checklist for students and staff to advise of the major types of ethical issues in your research (PDF version)
Application Forms
| Form A | Application for Ethical Approval of Research Involving Humans
|
Download Form A |
|---|---|---|
| Form B | Application for Renewal of Approval or Amendment Request
|
Download Form B |
| Form C | Application for Approval of Research with Low Risk (Ethical Requirements) | Download Form C |
| Guidelines for Form C Application (must be included when submitting Form C Application) | Download Guidelines |
Please note: you may also submit your application electronically ( ethicsapplications@curtin.edu.au) but you application will only be processed when the 3 hard copies are received into the Ethics Office. If you plan to submit a copy of your application electronically this must be in pdf format (preferably as one document).
Contact Details
All enquiries can be made to the Secretary, Human Research Ethics Committee:
The Secretary, HREC
Office of Research and Development
PO Box U1987
Perth WA 6845
Ph: +61 8 9266 2784
hrec@curtin.edu.au.
Note: Form C applications are submitted to the Ethics Coordinator in your School or Faculty. To find out who your coordinator is contact the Secretary.
Committee
The Human Research Ethics Committee is a panel of experts drawn from across the University. Under the National Statement on Ethical Conduct in Human Research there must be people from these Categories:
- A Chairperson who shall be the Deputy Vice-Chancellor (Research and Development) or their nominee;
- Two lay persons, one man and one woman, who are not associated with Curtin who are not currently involved in medical, scientific or legal work;
- At least one member who is a minister of religion, or a person who performs a similar role in a community, such as an Aboriginal elder;
- At least one member who is a lawyer;
- At least one member with knowledge of, and current experience in, the areas of research that are regularly considered by the HREC; At least one member with knowledge of, and current experience in, the professional care, counselling or treatment of people (e.g. medical practitioner, clinical psychologist, social worker, nurse, as appropriate);
At Curtin the identity of the Committee Members is confidential as they engage in blind peer reviews.
Additional Information
Curtin Staff or Students as Participants
- Researchers must receive separate permission from the Human Research Ethics Committee before getting access to staff or students' personal details with a view to inviting their participation in research.
- No surveys may be conducted in class time.
- No recruitment of participants is permitted in class time.
- The data collected should be anonymous.
- No staff member may recruit his/her own students as the power relation has a strong possibility of distorting consent and the data gathered.
- For Information on research involving staff and/or student participants consult the Survey Guidelines. Please note: these guidelines are currently under revision. Please submit your request to the Curtin Ethics Office.
Education Research
Education Departments in Australia are reviewing, or changing, their guidelines on research conducted in schools and TAFE Colleges. Please check with the Education Department in each state or territory before beginning any research in schools or TAFE Colleges. The guidelines for applications to conduct research in schools can be found on the Department of Education and Training website.
Databanks
If a databank is to be used as part of the research you must submit a (Form A) Application for Ethical Approval of Research Involving Humans
Reciprocal Approvals
Curtin has reciprocal approval processes in place to expedite research involving more than one institution. Curtin, following the new National Statement, is able to accept the decisions of properly constituted HRECs. Curtin HREC retains the right to subject any application to its usual review procedures.
The reciprocal approval process at Curtin
If you are a Curtin researcher (student or staff) and are planning to be involved in research that has been approved by a properly-constituted Human Research Ethics Committee at another institution you will need to have approval from the HREC before participating.
This process has been streamlined and you should do as follows:
- Download the latest version of the FORM A: Application for Ethical Approval of Research Involving Humans. (The latest version is required because the document is updated regularly);
- Complete Section 1, which requires details of the staff or students involved and a plain language statement describing the research;
- Append the original application as it was presented to the approving HREC, along with the approval letter from the approving HREC.
- Submit the application to the Secretary, Human Research Ethics Committee at least 5 weeks before the next meeting. The application is reviewed one member of the sub-committee. The application is then assessed at the next full meeting of the Curtin HREC.
Appeals Process
If you wish to appeal a decision of the HREC, please refer to the appeals process for guidelines, or contact the Secretary for details.
Useful Links
- If applying for a grant please refer to the Grants Office.
- Working with Children Check
- National
Health and Medical Research Council (NHMRC) Ethics Publications Webpage
- NHMRC Act (1992)
- National Statement on Ethical Conduct in Human Research
- Australian Code for the Responsible Conduct of Research Formerly the Joint NHMRC / AVCC Statement and Guidelines on Research Practice (1997) (Australian Government, National Health and Medical Research Council, Australian Research Council and Universities Australia, 2007)
- When does quality assurance in health care require independent ethical review? (2003)
- NHMRC Guidelines under Section 95 of the Privacy Act 1988
- Therapeutic Goods Administration (TGA)
- Clinical Trial
- Curtin Survey Guidelines (for Access to the University's Students and Staff)
