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Research Ethics and Governance
All research undertaken within the Sydney Local Health District is subject to review by ethics and/or safety committees. The role of these committees is to safeguard the welfare and rights of both research participants and researchers.
In Australia, all research studies involving human participants must adhere to the National Statement on Ethical Conduct in Research Involving Humans (2007, updated March 2018) (the National Statement). Projects (protocols) for every research study must be approved by an accredited Human Research Ethics Committee (HREC). The core membership of the HREC complies with the National Statement in that it includes a chairperson, a laywoman, a layman, a minister of religion, a lawyer, a medical scientist with research experience and a counsellor. Additional members represent the main areas of medical research at the hospital. The HREC meets each month and, over an average year, considers more than 400 new research proposals, as well as reviewing progress and compliance of all currently approved studies.
In undertaking an ethical assessment of a proposed project, the HREC considers a number of issues:
| Is the purpose of the study such that it will usefully advance medical/scientific knowledge? |
| Has it been designed so that a valid conclusion will be reached? |
| What procedures will study participants undergo? Are they unnecessarily painful, arduous, risky or time-consuming? |
| Are questionnaires phrased in such a way that they do not cause anxiety, distress or alarm to study participants? |
| Is any undue inducement being offered to encourage prospective study participants to take part? |
| Have the Participant Information Sheet and Consent Form been prepared in clear, concise, plain language giving full details of the procedures, risks and benefits which the study participant will face if he/she agrees to participate? |
| Have suitable arrangements been made to ensure that people of non-English speaking backgrounds also have the opportunity to take part in the study and to give informed consent to their participation? |
Animal Research
Research which will involve the use of vertebrate animals must be submitted to the Animal Welfare Committee (AWC). This committee meets monthly and its membership and procedures comply with the Australian Code for the Care and Use of Animals for Scientific Purposes (8th Edition 2013).
The AWC's primary objective is to ensure that animals used in medical research are treated with due care and consideration for their welfare. Research projects are assessed in the light of the procedures which the animals will undergo, and the pain and/or stress which this will entail. As animals cannot explain their response to different procedures, they must be treated in the same way as humans would be in similar situations. For example, animals are anaesthetised for surgical procedures and receive analgesia for pain relief.
The AWC also ensures that the number of animals used in a particular study is the minimum required to give a statistically valid conclusion, that studies are not needlessly repeated and that animals are not used if there is any possibility that the research could be done by another method.
The AWC regularly inspects the Animal Houses under its jurisdiction to satisfy itself that the animals are healthy and well cared for, that they are suitably caged and that the premises are clean and free from vermin.
Institutional Biosafety and Radiation Safety
Some research studies, which may or may not require the use of human or animal participants, may involve the use of dangerous chemicals, ionising radiation or the manipulation of genetic material. These studies are reviewed by the Institutional Biosafety Committee (IBC) and the Radiation Safety Officer.