University of Tasmania, Australia

The title of the committee will be the Tasmanian Health and Medical Human Research Ethics Committee. The committee shall also be known as the Health and Medical HREC.

The Health and Medical HREC is a committee of the HREC (Tasmania) Network, which is constituted by joint agreement between the Department of Health and Human Service (DHHS) and the University of Tasmania (UTas) [the “Parties”]. The Health and Medical HREC has responsibility for the review of all research projects and clinical trials involving human participation that are undertaken under the auspices of the Department of Health and Human Services or the University of Tasmania that involve the following:

1. Invasive physiological clinical, and/or medical interventions;
2. Research involving the use of human tissue (including blood, reproductive and other tissues);
3. Human genetic research and;
4. Research involving staff, patients or resources of any hospital in Tasmania (both Public and Private).

All other research involving human participants undertaken under the auspices of the Department of Health and Human Services or the University of Tasmania will be considered by the Tasmanian Social Science Human Research Ethics Committee unless it is designated ‘negligible risk’ in accordance with the requirements of the National Statement on Ethical Conduct in Human Research 2007.

1. To consider the ethical implications of all proposed research projects and clinical trials which involve or impact upon humans and approve only those projects which conform to the National Statement on Ethical Conduct in Human Research 2007;
2. To give formal approval to clinical trials and use of unregistered therapeutic goods as required under government and other regulations e.g. the Clinical Trial Exemption (CTX), Clinical Trial Notification (CTN) and Authorised Prescriber schemes;
3. To consider whether the conduct foreshadowed in the research proposals that are approved is lawful;
4. To maintain a record of all research received and reviewed, with decisions and conditions;
5. To monitor the progress of research projects so as to be satisfied that they continue to conform with approved ethical standards;
6. To establish and administer mechanisms for receiving and handling complaints or concerns about the conduct of an approved research or teaching project;
7. To establish a mechanism for handling any breach of ethical guidelines;
8. To advise the participating intuitions regarding ethical approval for research and teaching projects;
9. To have the discretion to accept the findings of other fully constituted Australian Human Research Ethics Committees, registered with the NHMRC;
10. To report annually to the Australian Health Ethics Committee (AHEC) information relevant to its procedures;
11. To provide AHEC with access, upon request, to information in the Committee’s records, including the Research Management Database (RMDB).

The Health and Medical HREC is an independent decision making body and its decisions are not subject to ratification by either the Department of Health and Human Services or the University of Tasmania.

The membership of the Health and Medical HREC is in accordance with the requirements of the National Statement on Ethical Conduct in Human Research 2007. The minimum membership is eight, and as far as possible, there should be equal numbers of men and women and at least one third of members should be not affiliated with either the Department of Health and Human Services or the University of Tasmania. There should also be members from both the North and the South of Tasmania.

The minimum membership of the committee is:

1. A chairperson, with suitable experience, whose other responsibilities will not impair the HREC’s capacity to carry out its obligations under the National Statement on Ethical Conduct in Human Research 2007;
2. At least two lay people, one man and one woman, who have no affiliation with the institution and do not currently engage in medical, scientific, legal or academic work;
3. At least one person with knowledge of, and current experience in, the professional care, counselling or treatment of people; for example a nurse or allied health professional;
4. At least one person who performs a pastoral care role in a community, for example, an Aboriginal elder or a minister of religion;
5. At least one lawyer, where possible one who is not engaged to advise either the Department of Health and Human Services or the University of Tasmania;
6. At least two people with current research experience that is relevant to research proposals to be considered at the meetings they attend.

No member may be appointed in more than one of the categories listed above.

The quorum for meetings of the Committees shall be members from all categories as stated above.

As required by the National Statement, where there is less than full attendance at a meeting, the Chair must be satisfied, before a decision is reached, that the minimum membership listed above have received all papers and have had an opportunity to contribute their views and that these have been recorded and considered.

Selection of members must follow an open and accountable procedure, as set out in the HREC (Tas) Network Policy and Procedures document. All appointments require the joint agreement of the Parties.

All new members undergo an induction process, usually a half day workshop run by the Executive Officer, though members may be sent an induction package to work through at their own convenience if attendance at the induction workshop is not possible.

Each member will be appointed for a two-year term and may nominate to extend the appointment for a further two years. The maximum term of membership is six years.

Membership will lapse if a member fails to attend three consecutive meetings without apology or reasonable excuse or fails to send comment prior to the meeting. Membership will also lapse if members fail to attend at least four meetings in a calendar year. In this instance the Chair shall notify Network Administration and the Executive Officer will notify the member in writing accordingly and take action to fill the position as required.

The Category (a) member (Chair) receives an annual payment at the discretion of the parties which is paid either as reimbursement of costs incurred as part of the role, such as printing, broadband costs, travel and accommodation or paid directly to the Chair through the pay system.

External members of the Committees who are not affiliated with the UTas or DHHS are paid a meeting fee as determined by the Secretary of DHHS and the Pro Vice Chancellor (Research) UTas. This fee is at the discretion of the parties and is intended to cover reimbursement of travel, parking and extraneous costs associated with attending meetings and other business associated with their membership of the Committees. There is otherwise no remuneration to members.

The Health and Medical HREC meets monthly, with the exception of the month of December. Meetings are held by teleconference between the Hobart and Launceston.

The Health and Medical HREC receives and examines written applications for ethical approval for research involving human participation.

Agenda papers are distributed four weeks before each meeting, and a second set of ‘tabled papers’ are sent to members two weeks before each meeting. The tabled papers comprise of applications which have been endorsed by that months meeting of the Scientific Research Advisory Committee.

The HREC considers each application and amendment and gives a final decision of

1. Approved
   1. Back to Executive Officer – HREC (Tas) Network – The committee grant the Executive Officer power to approve minor amendments to the application.
   2. Back to Chair – The committee grants the Chair power to approve the application if researcher response to committee concerns is adequate.
   3. Back to Committee – The researchers must respond to the HREC’s concerns and the application must be considered again by the full HREC meeting.
2. Approval pending researcher’s response to HREC comments. There are three levels to this decision:
3. Not Approved

The Health and Medical HREC endeavours to reach decisions by general agreement.

The Health and Medical HREC have the authority to issue notification of approval to investigators prior to the Human Research Ethics Committee’s formal approval of the minutes of their meetings. This is because minutes are circulated to members, via email, within a few days of the meetings and members will confirm at this point informally that they are a true and accurate record of the decisions. This is to prevent an unnecessary delay of one month before researchers can have approval to begin their project.

The Committees shall, as a condition of approval of each protocol, require that project supervisors immediately report to the respective Committee anything which might warrant review of ethical approval of the protocol, including serious or unexpected adverse effects on participants, proposed variations to the approved protocol, and any unforeseen events that might affect the continued ethical acceptability of the project.

The Committees have the discretion to suspend or withdraw approval for any project which no longer complies with the approved research protocol or where the research ceases to be ethically acceptable.

Administration of the Health and Medical HREC is undertaken by the Executive Officer under direction of the:

1. The Pro-Vice Chancellor (Research) & the Chief Medical Officer of the Department of Health and Human Services;
2. Chair of the Health and Medical HREC;
3. Members of the Committees; and
4. Direct supervisor (Manager, Research Services).

Administrative tasks such as agenda preparation, data entry and recordkeeping are undertaken by the Ethics Officer Health and Medical HREC, under the supervision of the Executive Officer.

The Health and Medical HREC reports annually, in the form of the required report to the Australian Health Ethics Committee under the National Health & Medical Research Council on their composition, membership, and activities.

The Health and Medical HREC reports annually to the Academic Senate of the University of Tasmania, Department of Health & Human Services and any participating institutions.

Each month, the signed minutes of the Health and Medical HREC are circulated to designated persons in the Office of the Pro Vice Chancellor (Research) at University of Tasmania, and the Office of the Chief Medical Officer, Department of Health and Human Services.