University of Tasmania, Australia

The title of the committee will be the Tasmanian Social Sciences Human Research Ethics Committee. The committee shall also be known as the Social Sciences HREC.

The Social Sciences HREC is a committee of the HREC (Tasmania) Network, which is constituted by joint agreement between the Department of Health and Human Services (DHHS) and the University of Tasmania (UTas) [the “Parties”]. The Social Sciences HREC has responsibility for the review of the following types of research projects:

ll research involving human participation that is conducted under the auspices of the University of Tasmania (eg for a University degree, a grant administered by the University, or for a planned publication or report where the author(s) will cite their role within the University) or that is conducted under the auspices of the Department of Health and Human Services. This may include commercial research and consultancy work if the researcher(s) will be using University of Tasmania equipment or resources, or will be covered by University of Tasmania indemnity/insurance for the work.

The following types of research that is undertaken under the auspices of the Department of Health and Human Services or the University of Tasmania is excluded from consideration by the Social Sciences HREC because it must be considered by the Tasmanian Health and Medical Human Research Ethics Committee;

a) Invasive physiological, clinical, and/or medical interventions,
b) Research involving the use of human tissue (including blood, reproductive and other tissues),
c) Human genetic research,
d) Research involving staff, patients or resources of any hospital in Tasmania (both Public and Private).
 
Some types of research involving humans may be exempt from ethical review if it is designated ‘negligible risk’ in accordance with the requirements of the National Statement on Ethical Conduct in Human Research 2007.

• 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;
• To consider whether the conduct foreshadowed in the research proposals that are approved is lawful;
• To maintain a record of all research received and reviewed, with decisions and conditions;
• To monitor the progress of research projects so as to be satisfied that they continue to conform with approved ethical standards;
• To establish and administer mechanisms for receiving and handling complaints or concerns about the conduct of an approved research or teaching project;
• To establish a mechanism for handling any breach of ethical guidelines
• To advise the participating intuitions regarding ethical approval for research and teaching projects
• To have the discretion to accept the findings of other fully constituted Australian HREC’s
• To report annually to the Australian Health Ethics Committee (AHEC) information relevant to its procedures
• To provide AHEC with access, upon request, to information in the Committee’s records, including the Research Management Database (RMDB)

The Social Sciences 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 Social Sciences 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:

• 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;
• 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;
• 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;
• At least one person who performs a pastoral care role in a community, for example, an Aboriginal elder or a minister of religion;
• 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
• 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 or send comment without apology or reasonable excuse. 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 directly to the Chair, through the pay system.

External members of the Committees who are not affiliated with 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 Social Sciences HREC meets monthly with the exception of the month of January. Meetings are held by teleconference between the Hobart and Launceston.

In accordance with the National Statement 5.1.18, the Social Sciences HREC administers an expedited review process for review of research that involves low risk to participants. A Minimal Risk form is used to help users determine the status of their application. Projects deemed to be Minimal Risk are considered by the Chair of the Social Sciences HREC, or by the Deputy Chair or Executive Officer in his/her absence.

The tracking of Minimal Risk applications is undertaken by the Ethics Officer Social Sciences and reported to the full Committee for ratification. The same conditions of annual reporting apply for Minimal Risk research as for any other research approved by the HREC. Where the Chair of the Social Sciences HREC considers that research may involve a departure from any of the ethical principles in the National Statement, the application must be considered by the full Committee and cannot be dealt with by expedited review.

The Social Sciences HREC receives and examines written applications for ethical approval for research involving human participation.
Agenda papers are distributed two weeks before each meeting.
The HREC considers each application and amendment and gives a final decision of

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

The Social Sciences HREC endeavours to reach decisions by general agreement.

The Social Sciences HREC have the authority to issue notification of approval to investigators prior to the HREC’s formal approval of the minutes of their meetings as the 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 Social Sciences HREC is undertaken by the Executive Officer under direction of the following persons:

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

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

•  Reporting

The Social Sciences 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 Social Sciences HREC reports annually to the Academic Senate of the University of Tasmania, the Secretary of the Department of Health & Human Services and any other key stakeholders.

Each month, the signed minutes of the Social Sciences 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.