Terms of Reference

This page provides information about the Terms of Reference for the Department of Health Human Research Ethics Committee.

Page last updated: 23 February 2017

Charter

  1. The Department of Health (the Department), in exercise of its commitment to the conduct of human research according to the highest ethical and scientific standards, has established the Department of Health Human Research Ethics Committee (the Committee).
  2. The Department may consider and implement changes to the structure and operations of the Committee including dissolution, streamlining, re-configuration and establishment as deemed appropriate from time to time, provided that any changes do not compromise the capacity of the Committee to meet all relevant standards and procedures.
  3. The Committee will act in accordance with the Terms of Reference (Word 44 KB) as amended from time to time.

Scope of Responsibility


  1. The Committee provides ethical assessment of non-biomedical human research proposals that:
    • are funded by the Department; or
    • require access to, or linkage of, departmental data collections; or
    • are initiated or conducted, either wholly or in part, by departmental staff;
    and either
    • have not been considered by another Human Research Ethics Committee; or
    • have been referred to the Committee by a data custodian or by a senior executive of the Department.
  2. Persons undertaking research that meet these criteria must obtain ethics approval.
  3. Ethics approval from the Committee does not guarantee access to, or release of, departmental data. The Committee is not responsible for the release of departmental data. This is the responsibility of the appropriate departmental data custodian.

Roles


  1. The Committee's roles are to:
    • ensure that the design and conduct of any human research that it reviews within the scope of its responsibilities conforms with the current version of the National Statement on Ethical Conduct in Human Research 2007 (National Statement) and other relevant national codes of human research ethics such as the Australian Code for the Responsible Conduct of Research;
    • ensure that participants in any human research that the Committee reviews and approves are accorded the respect that is due to them and, in particular, that their welfare, privacy and confidentiality are protected;
    • promote ethical standards in human research and in information privacy, in research proposals referred to it, and within the Department, by providing unbiased guidance to researchers; and
    • facilitate and foster ethical human research that is of benefit to Australian communities through efficient and effective review processes.

Functions


  1. In fulfilling these roles, the Committee will:
    • review all human research proposals that are within the Committee’s scope of responsibilities and make a determination as to whether or not they are acceptable on ethical grounds and meet the requirements of the National Statement;
    • ensure that it is sufficiently informed on all aspects of a research project, including its scientific and statistical validity, before deciding whether a proposal is both acceptable on ethical grounds and conforms with the National Statement;
    • advise the Department and applicants whether or not reviewed research projects are acceptable on ethical grounds and have or have not been approved and provide reasons, linked to the National Statement, for those decisions;
    • consider issues referred by the Department and, where appropriate, provide advice to the Department on policy issues with ethical implications;
    • determine, in relation to each reviewed and approved research project, that there will be mechanisms to monitor the conduct of the research, that the frequency and type of those mechanisms reflect the degree of risk to participants and ensure ongoing compliance with the National Statement and any other relevant guidelines; and
    • maintain a record of all research projects received and reviewed, so that the following information is readily accessible:
      • name/s of all organisation/s and institution/s involved in the project;
      • title of the project;
      • project identification number/s;
      • name/s of principal researcher/s and their qualifications, along with the name of the contact officer/s;
      • correspondence between the Committee and the researcher about the review;
      • acceptance or rejection of any changes to the proposal;
      • proposed date of completion of the proposal;
      • formal advice of final ethical approval or non-approval, with date;
      • terms and conditions, if any, of approval of any proposal;
      • date and duration of the approval;
      • correspondence between the Department and the National Health and Medical Research Council (NHMRC) on matters which fall within the Committee’s terms of reference.
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