Ethics Home

1.1

The protection of the welfare and rights of participants in research.

1.2

Human Research Ethics Committee (HREC) is constituted and functions in accordance with the National Statement on Ethical Conduct in Human Research (2007).

2. Reporting

2.1

Eastern Health Quality and Risk Committee.

3. Function

3.1

Responsibilities

3.1

Review of all research proposals according to the values and principles of ethical conduct including research merit, integrity, justice, beneficence and respect.

3.2

Monitoring of all approved research projects until completion through audit activities and the review of adverse events, safety updates and annual reports.

3.3

Adherence to requirements stipulated by the National Health and Medical Research Council (NHMRC) in particular with reference to the National Statement on Ethical Conduct in Human Research (2007) and the Australian code for the responsible conduct of research (2007).

3.4

Fulfilment of ethical and legal responsibilities.

3.5

Meeting any obligations under hospital insurance policies.

3.6

Maintenance of records for all on-going research projects.

4.   Scope

4.1

A range of research projects are considered including:

• Drug trials
• Device trials
• Mental health projects
• Qualitative research
• Trials involving genetic testing
• Trials involving tissue and body fluid storage
• Projects where potential contentious issues are explored

4.2

Projects from the following organisations are considered:

• All Eastern Health campuses including Acute, subacute, community health and Mental Health Programs.
• External organisations and non-affiliated researchers applying to conduct research at Eastern Health.
• An Eastern Health employee will normally act as an associate researcher or contact person.

5. Membership

5.1

The minimum membership appointments will be as follows:

• Chairperson (1)
• Lay man (2)
• Lay woman (2)
• Persons experienced in professional care, counselling or treatment of people (3)
• Persons in pastoral care (2)
• Persons with current research experience (3)
• Lawyer (1)

5.2

Where possible membership will consist of equal numbers of men and women and at least one third of the members should be from outside of Eastern Health.

5.3

Members are required to declare any conflict of interest and will not be able to adjudicate on research projects in which they have personal involvement.

5.4

Members are recruited and appointed as individuals for their knowledge, qualities and experience by the Chair Person using open and transparent processes.

5.5

Members will be provided with a formal notice of appointment.

5.6

Members are encouraged to attend training programs in research ethics with appropriate funding assistance at least every 3 years.

5.7

Membership is voluntary and appointments will be reviewed every 3 years.

5.8

Membership will lapse where members are not in attendance for three consecutive meetings without leave.

5.9

The Chair person will be appointed by the Chief Executive Officer

6. Meetings

6.1

Frequency of meetings will be monthly from February to December.

6.2

An additional meeting may occur in January subject to Committee decision.

6.3

Agenda papers must be circulated to all members one week prior to the next scheduled meeting.

6.4

As far as possible the NHMRC minimum membership (eight) should be present at each meeting constituted as follows:

• Chairperson (1)
• Layman (1)
• Laywoman (1)
• Person experienced in professional care, counselling or treatment of people (1)
• Person in pastoral care role (1)
• Lawyer (1)
• Persons with current research experience (2)

6.5

Where there is less than full attendance of the minimum membership members will be provided with agenda papers and have the opportunity to provide comments on the ethical acceptability of the research projects.

6.6

Members who are unable to attend must contact the Research Office in order for a formal apology to be recorded.

7.   Decision Making

7.1

Decision is reached by general agreement and may not involve unanimity.

7.2

The Committee may at its discretion invite researchers to attend meetings for discussion of the proposed research.

8. Sub Committees

8.1

The purpose of the sub-committees is to:

• Manage the workload of the main Committee
• Ensure efficiency of the review process.

8.2

Members may be selected from an established pool with relevant expertise.

8.3

Sub-committees will meet prior to the Committee meeting.

8.4

Results of any review and action will be tabled and included in the meeting minutes.

8.5

Sub-committees may refer any matters to the main Committee as required.

8.6

The following agenda items may be reviewed:

• Serious adverse events and safety updates
• Annual reports
• Investigator brochures
• Quality assurance projects
• Low risk projects suitable for expedited review (formal ratification to be obtained at the main Committee meeting)
• Minor amendments
• Flyers and advertisements
• Notifications

9. Complaints

9.1

Complaints should be referred to the Chair person in the first instance.

9.2

The Chair person may involve the Committee in resolving the complaint.

9.3

The hospital’s complaint resolution process will be followed in the case of unresolved complaints.

10.   Fees

10.1

Fees are payable for research submissions according to the established fee schedule which is updated from time to time.

11.   References

11.1

The National Statement on Ethical Conduct in Human Research (2007).

11.2

The Australian code for the responsible conduct of research (2007).

12.   Review

12.1

Every three years or as required.