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Human Research Ethics

POLICY NO: RES-2.3

DATE OF APPROVAL: 27 August 2004

AMENDMENTS:
Academic Board (AB2000/6/111) July 2000
Academic Board (AB2000/7) August 2000
Academic Board (AB2004/6) August 2004 
Deputy Vice Chancellor and Vice President: Research and Innovation (16 May 2006)
Academic Board (AB2008/2/28) 28 March 2008
Academic Board (AB2010/3/8.2) 28 May 2010

REFERENCE AUTHORITY: Deputy Vice Chancellor and Vice President (Research & Innovation)

CROSS-REFERENCES:
Australian Code for the Responsible Conduct of Research
National Statement on Ethical Conduct in Human Research
UniSA Framework for the Responsible Conduct of Research
Care and Use of Animals for Teaching and Research Purposes (RES 3) 
Australian code of practice for the care and use of animals for scientific purposes (PDF file 469kb)
Ionising Radiation Policy (HR 29)
Non-ionising Radiation Safety (HR 30)
Responsible Practice in Research (RES 1)
Biological Hazards and Genetically Modified Organisms (RES 4.3)

 


Preamble

This policy is intended to promote ethically good human research and is part of the University's broader research governance framework. The policy is based on the National Statement on Ethical Conduct in Human Research (2007) (National Statement) and Australian Code for the Responsible Conduct of Research (2007) (Australian Code).

Responsibility for the ethical design, review and conduct of human research is exercised at many levels. While the processes of ethical review are important, individual researchers and the University hold primary responsibility for ensuring that research is ethically acceptable.  

The University is responsible for ensuring that:

Researchers (and where applicable, Supervisors) are responsible for:

 

Policy

Research within the University involving human participants must be approved through the processes the University establishes for the ethical review of research. The University's Human Research Ethics Committee (UniSA HREC) is responsible for the management of the University's ethical review processes which are outlined in this policy. The University's HREC reports to the University's Academic Board through the Research Integrity, Accountability and Compliance Committee (RIACC). On a day to day basis, the Chair UniSA HREC reports to the Deputy Vice Chancellor and Vice President (Research and Innovation). The Chair UniSA HREC is authorised to approach the Vice Chancellor and President directly if he/she considers there is a potential conflict of interest.

 

Procedures

1.1 Risk

Research is ethically acceptable only when its potential benefits justify any risks (potential and/or actual) involved in the research. Potential harms in research include physical harms; psychological harms; devaluation of personal worth; social harms; economic harms, and legal harms. In designing a research project, researchers must identify, gauge, minimise and manage the risks involved in their project, particularly in relation to research participants.

Gauging risk involves taking into account the kinds of harm, discomfort or inconvenience that may occur; the likelihood of these occurring; and the severity of any harm that may occur. The greater the risks to participants in any research for which ethical approval is given, the more certain those approving it must be that the risks will be minimised and managed as well as possible, and that the participants clearly understand the risks they are assuming. Researchers are required to demonstrate to those who ethically review research projects that the potential benefits of the research justify any risks and how they will minimise and/or manage potential and/or actual risks.

1.2 Review

Research projects will be assessed by one of three levels of review, in which the level of review is determined by the ethical risk of the research.

  1. Negligible risk research describes research in which there is no foreseeable risk of harm or discomfort, and any foreseeable risk is no more than inconvenience. "Negligible risk" projects will be assessed within Expedited Ethical Review Level 1 (E1)
  2. Low risk research describes research in which the only foreseeable risk is one of discomfort. "low risk" projects will be assessed within Expedited Ethical Review Level 2 (E2)
  3. All other research is more than low risk and requires full ethics review by UniSA HREC (E3).

The level of ethical risk will be determined by the applicant's responses to questions in the online human research ethics application.

1.3 Expedited Review

Applications which qualify as E1 will be reviewed by the Chair or Deputy Chair of HREC.

Applications which qualify as E2 will be reviewed by a panel consisting of the Chair or Deputy Chair of HREC and relevant Research Ethics Advisor. The Chair (or Deputy Chair) may require other members of HREC and relevant Research Ethics Advisors to assist as necessary. The Chair (or Deputy Chair) may also seek external expert advice as required.

Applications which do not qualify for E1 or E2 review qualify as E3, and require full review by UniSA's HREC.

1.4 Exemptions

Exempt (as determined by the online ethics system)

Research is exempt from further review if the project involves the use of archived data only and the data collected is de-identified (data which does not contain personally identifiable information) and will not be reported beyond the University if it is:

Negligible (as determined by the online ethics system)

Research that is assessed as having 'negligible risk' does not require formal review if it is:

1.5 Course approvals

HREC may grant ethics approvals for courses in which a cohort of students undertake short duration research projects. Course approval applications will be subjected to the same process (including risk assessment) as other applications, and may be reviewed at E1, E2 or E3 depending on the level of risk.

Responsibility for submitting an application for course ethics approval and ensuring subsequent compliance with approval conditions normally lies with the course coordinator. In order to gain ethics approval for a specific course, the coordinator is required to follow the procedures as outlined in the ethics booklet entitled 'Course approvals'. At the conclusion of the course the coordinator is required to submit a completed course report form to the UniSA HREC through its Executive Officer.

1.6 Complaints process

Any complaints relating to research projects approved by UniSA's HREC or any complaints about UniSA HREC or decisions made by UniSA HREC should be directed to the Executive Officer of UniSA HREC, who will forward them to the Chair/ Deputy Chair. Depending on the nature and severity of the complaint, the Chair/Deputy Chair will either investigate the matter in consultation with the appropriate parties (chief investigator, supervisor, dean of research etc) or forward the complaint to the Deputy Vice Chancellor (Research and Innovation) for further investigation. Where a conflict of interest exists (potential or actual), the complaint will be either referred to one of the Deputy Chairs and/or the Deputy Vice Chancellor and Vice President (Research and Innovation). The Deputy Vice Chancellor and Vice President (Research and Innovation) will determine procedures by which the complaint is investigated.

2. Research Ethics Advisors

The University will appoint an appropriate number of Research Ethics Advisors (REAs) with relevant academic qualifications and research experience. REAs will be responsible for the promotion of ethical review across the Division in which the REA is based. The term of appointment will normally be two years.

A Research Ethics Advisor will assist in the promotion of ethical review through educating and communicating the principles of ethically conducted research at the local level and by:

3. UniSA Human Research Ethics Committee

3.1 Membership

The membership of UniSA's HREC conforms to the requirements of Section 5.1.29 "Composition of HRECs" National Statement on Ethical Conduct in Human Research. This membership is as follows:

a. a chairperson, with suitable experience, whose other responsibilities will not impair HREC's capacity to carry out its obligations;

b. a layman with no affiliation with the University and who does not currently engage in medical, scientific, legal or academic work;

c. a laywoman with no affiliation with the University and who does not currently engage in medical, scientific, legal or academic work;

d. a person with knowledge of, and current experience in, the professional care, counselling or treatment of people;

e. a person who performs a pastoral care role in a community;

f. a lawyer who is not engaged to advise the institution;

g. Two members with relevant research experience in the fields of health, medical sciences, allied health, pharmacy and/or nursing;

h. One member with relevant research experience in the field of education;

i. One member with relevant research experience in the field of psychology;

j. One member with relevant research experience in the social sciences and/or humanities;

k. an academic staff member who is Indigenous with research experience in Indigenous studies; and

l. a non-voting executive officer who is a professional staff member of the University of South Australia.

3.2 Appointment procedures

3.2.1 Nominations for positions (g) to (k) are to be made by Divisional Pro Vice Chancellors and submitted to the Executive Officer, Uni SA HREC who will forward nominations to the Chair, Academic Board for approval. Nominees will be selected by a method determined by the Divisional Executive. In making nominations, the Division is to specify the position involved. The Chair of Academic Board will forward these nominations to Academic Board with a recommendation as to appointments. Academic Board will then make the appointment to the position usually on the basis of the Chair of Academic Board's recommendation.

3.2.2 The Chair of HREC will be nominated by the Deputy Vice Chancellor (Research and Innovation) (after appropriate consultation) and may be either from among or external to the HREC members. Appointment to the position of chair is for a period of up to three years. Incumbents may be re-appointed.

3.2.3 Two Deputy Chairs will be appointed by the Deputy Vice-Chancellor and Vice President (Research and Innovation) in consultation with the Chair Uni SA HREC. Appointment to the position of Deputy Chair UniSA HREC is for a period of two years. Incumbents may be re-appointed.

3.2.4 There will be an alternate for each member of the committee, where the alternate satisfies the same membership criteria as the member. Appointment procedures for alternate members will be the same as for members. Deputy Chairs will act as alternates for the Chair as required.

3.2.5 Members are appointed to HREC for their expertise and not in a representational capacity. Appointment to all positions is for a period of two years.

3.2.6 Lay members of HREC will receive an honorarium, the amount being determined by the Deputy Vice Chancellor and Vice President (Research and Innovation).

3.3 Conflict of Interest

A conflict of interest in the context of research exists where:

Members of UniSA HREC and those whose advice it formally requests are required to disclose any actual or perceived conflicts of interest in research review this includes any:

Where a member of UniSA's HREC is involved in a project submitted to the Committee, then that member shall not take part in the assessment of that project.

3.4 Indemnification of members

The University shall indemnify individual members who serve on UniSA's HREC for any costs arising from legal action as a result of work that they undertake as a Committee member.

The University shall provide insurance protection for individual members who serve on UniSA's HREC for any costs arising as a result of work that they undertake as a Committee member.

3.5 Terms of Reference

(1) To protect the welfare and rights of participants in research.

(2) To consider ethical implications of all proposed research projects involving human participants submitted to it by staff and students of the University of South Australia and to determine whether or not they are acceptable on ethical grounds. These considerations will be based on the National Statement on Ethical Conduct in Human Research and other advice received from the NHMRC.

(3) To consider ethical implications of all proposed research projects involving human participants submitted to it by researchers not affiliated with University of South Australia and to determine whether or not they are acceptable on ethical grounds. These considerations will be based on the National Statement on Ethical Conduct in Human Research and other advice received from the NHMRC. Legal responsibility for research undertaken by researchers not affiliated with the University rests with those researchers and not the University of South Australia.

(4) To maintain a record of all proposed research projects in accordance with National Statement. The protocols of research proposals shall be preserved in the form in which they are approved including participant information sheets, consent forms or related correspondence.

(5) To monitor research projects which have been approved by UniSA's HREC.

(6) To respond to the NHMRC's Australian Health Ethics Committee as required.

(7) To develop and recommend policies and procedures to the University's Research Integrity, Accountability and Compliance Committee (RIACC) through the Deputy Vice Chancellor (Research & Innovation) (or at the discretion of the Chair to recommend directly to the Vice Chancellor on issues which may involve a potential conflict of interest for the Deputy Vice Chancellor (Research & Innovation) and report to RIACC concerning ethical issues in research involving human subjects conducted by, or under the supervision of, the staff or students of the University of South Australia.

(8) To report to RIACC on any relevant matters which may arise or may be referred to it.

(9) To consider any other matter relevant to human research ethics referred to it by members of the University community.

3.6 Specialist Advice

Additional expert advice will be sought from:

(a) a qualified medical practitioner if the member filling the category of a person with knowledge of, and current experience in, the professional care, counselling or treatment of people does not hold this qualification and;

(b) any other person or organisation as determined by HREC or the Chair/Deputy Chair HREC.

 

 

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