1. SLHD Ethics Review Committee (RPAH Zone)
The core membership of the SLHD Ethics Review Committee (RPAH Zone) [the Ethics Review Committee, ERC] 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 nurse. Additional members represent the main areas of medical research at the hospital.
In addition, the Ethics Review Committee is a lead human research ethics committee (HREC) under the NSW Department of Health's Model for Single Ethical & Scientific Review of Multi-Centre Research. As such, it is able to review applications for multi-centre research being undertaken in NSW/QLD/VIC/SA/ACT public health organisations. It has also satisfactorily demonstrated compliance with the National Certification Scheme criteria for multi-centre ethical review processes under the NHMRC’s Harmonisation of Multi-centre Ethical Review (HoMER).
The ERC meets eleven times per year and, over an average year, considers more than 300 new applications as well as reviewing the progress and compliance of all currently approved studies.
Types of research
Research considered by the ERC includes:
- Clinical research (all disciplines, including dentistry)
- Clinical trials (drugs, devices)
- Basic biomedical research
- Nursing and allied health research
- Mental health research
- Public health and epidemiological research
- Health services research
- Psychological and behavioural research
- Social science research
- Research using qualitative methods (questionnaires, focus groups, etc).
- Research studies or systematic collection of information involving any of the following also require ethical approval:
- access to medical records
- electronic databases
- use of archived tissue samples
- use of tissues collected at post-mortem
- disease registries
- tissue / DNA banks
- assisted reproductive technology
- research conducted via the Internet.
- Special requirements and/or guidelines apply to studies involving:
- ionising radiation
- hazardous chemicals
- assisted reproductive technology
- gene therapy
- Aboriginal & Torres Strait Islander people
- people who are not competent to give informed consent
In undertaking an ethical assessment of a proposed study, the ERC considers a number of issues: Is the purpose of the study such that it could usefully advance medical/scientific knowledge? Has it been designed so that a valid conclusion can be reached? What procedures will participants undergo? Are they unnecessarily painful, arduous, risky or time-consuming? Are questionnaires phrased in such a way that they do not cause anxiety or alarm to participants? Is any undue inducement being offered to encourage people to participate? Have the Information for Participants and the Participant Consent Form been prepared in clear, concise, plain language giving full details of the procedures, risks and benefits which the participant would 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?
2. Clinical Trials Sub-committee
Research studies which involve the clinical trial of drugs or devices are assessed by the Clinical Trials Sub-committee of the ERC. This Sub-committee has the responsibility for reviewing all aspects of the proposed study (including scientific rationale, study design, toxicology, pharmacology and previous clinical experience) to ensure that the expected benefits to participants outweigh the possible side effects. The Sub-committee then forwards the protocol, together with its advice and recommendations, to the ERC for its further consideration.
Members of the Sub-committee have expertise in a wide range of disciplines relevant to clinical trials. If necessary, the Sub-committee can request evaluation by independent (internal or external) assessors. The Sub-committee also meets eleven times per year.
3. Expedited review
The Ethics Review Committee has procedures for conducting expedited review in certain circumstances, if there are legitimate reasons for urgent consideration of an application.
"Research" or "Quality Assurance"? There is sometimes uncertainty as to how a project should be classified, and hence whether or not it requires ethical approval. The Ethics Review Committee does not regard classification per se as a relevant criterion. Regardless of whether a project is considered to be "research" or "quality assurance", it requires ethical consideration if:
- it involves a direct approach to patients or staff;
- consent is to be sought;
- medical or electronic records of groups of patients are to be accessed;
- identifying information is to be collected;
- personally or culturally sensitive information is to be collected;
- individuals (or groups) could be disadvantaged as a result of participation;
- information collected could have ethical, legal or commercial implications;
- the results might be submitted for publication.
- Examples of projects that do not require ethical approval are:
- laboratory QA programmes where no identifying information is recorded;
- anonymous patient satisfaction questionnaires;
- statistical summaries of hospital activities
4. Animal Welfare Committee
Research which will involve the use of vertebrate animals as subjects must be submitted to the Animal Welfare Committee (AWC). This committee meets monthly, and its membership and procedures comply with the Australian Code of Practice for the Care and Use of Animals for Scientific Purposes which are issued jointly by the National Health and Medical Research Council (NHMRC), the CSIRO and the Australian Agricultural Council.
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.
Every month the AWC 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.
5. Ethics of Clinical Practice Sub-Committee
This Sub-committee considers primarily policy issues in areas relevant to clinical practice. Issues can be referred from:
- SLHD Ethics Review Committee
- Hospital administration
- Medical Board
- Other committees (e.g. Patient Care Committee, Drug Committee, Quality Assurance Committee, Infection Control Committee, Data Security Committee, etc.)
- Any individual associated with SLHD.
The issues which the Sub-committee is available to review include:
- Assisted reproductive technologies (IVF, surrogacy, donor insemination, etc.)
- Care of the terminally ill
- Not-for-resuscitation policies
- Withdrawal of life-support
- Pregnancy termination
- Consent for post-mortem examinations & use of tissues
- Innovative therapies (see below for full details)
- Resource allocation
- Ethical issues in postgraduate teaching
- Relationship between health care professionals and the pharmaceutical industry
- Innovative therapies
Most proposals for the introduction of new techniques and the use of approved / listed devices in new settings are considered by the Ethics of Clinical Practice Sub-committee once support in principle has been obtained at facility level. See the SLHD Policy Directive SLHN_PD2011_005 "New Interventional Procedures: The Safe Introduction of New Interventional Procedures and Clinical Innovations into Clinical Practice".
Where the new intervention has any commercial involvement, a standard protocol and / or a patient outcomes register, or where the device has not been approved / listed for use in Australia, consideration by the Clinical Trials Sub-committee and the Ethics Review Committee will be required as an alternative pathway, ie Study protocol / Registry > Clinical Trials Sub-committee / Ethics Review Committee > notification to the Therapeutic Goods Administration (TGA) under the CTN Scheme.
Implementation of a new intervention on the basis of individual patient need using an unapproved device > application via the Ethics Review Committee to the TGA under the SAS or for the clinician to become an Authorised Prescriber of the product.
The Sub-committee's Terms of Reference and membership are available on this website.The Sub-committee meets monthly, and reports via the SLHD Ethics Review Committee. Meetings are relatively informal. Relevant individuals are often invited to attend meetings to discuss issues or provide expert advice to the Sub-committee.
6. Institutional Biosafety Committee (IBC)