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General Information

What is research? expand

Human research is research conducted with or about people, or their data or tissue. It contributes enormously to the community. Much human research carries little risk and in Australia the vast majority of human research has been carried out in a safe and ethically responsible manner. For a listing of many clinical trials being conducted In Australia you can log onto the Australia New Zealand Clinical Trials Register.

How is research governed? expand

The National Statement on Ethical Conduct in Human Research 2007 (National Statement) provides guidelines for Researchers, Human Research Ethics Committees (HRECs) and others conducting ethical review of research, and also emphasises institutions’ responsibilities for the quality, safety and ethical acceptability of research that they sponsor or permit to be carried out under their auspices. In addition to the National Statement, the Australian Code for the Responsible Conduct of Research has an essential role in promoting good research governance. The Research Code sets down the broad principles of responsible and accountable research practice, and identifies the responsibilities of institutions and researchers in areas such as data and record management, publication of findings, authorship, conflict of interest, supervision of students and research trainees, and the handling of allegations of research misconduct.

Who approves research? expand

A judgment that a human research proposal meets the requirements of the National Statement must be made before research can begin. This is conducted by a HREC, like Bellberry who have established procedures for the ethical review of human research.

What are the Phases of a Clinical Trial?expand

Clinical trials are conducted in a series of steps, called phases – each phase is designed to answer a separate research question. Phase I: These studies involve the first administration of the medicine to humans. Medicines are usually given to small numbers of healthy volunteers, but sometimes to people affected by the disease the medicine is intended to treat. The purpose may be to determine the medicine’s safety, pharmacokinetics, pharmacological activity, side effects, preferred routes of administration, or appropriate doses (for later studies). The studies are usually undertaken in centres equipped for specialized monitoring and a high degree of surveillance. Phase II: These studies are typically the first trials of the medicine in people with the health condition for which the medicine is intended. The principal aim is to determine efficacy and safety and establish an appropriate dosing regimen. These studies are undertaken in a small number of closely supervised patients and conducted by researchers regarded as specialists in the health condition and its treatment. Phase III: These are undertaken if the Phase II studies indicate the medicine has potential benefits that outweigh any hazards. The studies involve greater numbers of patients with the health condition under study, and aim to determine whether the medicine confers clinical benefit in that health condition and whether the incidence and nature of adverse effects are acceptable. Phase IV: These studies are undertaken after the medicine has been approved for marketing for the treatment of a particular disease or for a particular indication. They may include studies to compare the medicine with a wider range of therapies, and may also further investigate the use of the medicine in the normal clinical setting of the disease (which may differ markedly from the conditions under which pre-marketing trials were conducted). Such studies also gather more comprehensive safety data, adding to the information known from the pre-marketing studies.

The role of a Human Research Ethics Committee (HREC)expand

A HREC’s primary role is to protect human research participants. The committee conducts an independent review of research studies to decide if they are ethical. In order to do this review a HREC has a composition of committee members as set out in the National Statement (Section 5.1.29 & 5.1.30). Members have a mix of backgrounds i.e. scientific, non scientific, legal, community representatives, pastoral care and a diversification of gender, age and ethnic and cultural background which assists in promoting a balanced review of the research. The National Statement is based on Values, being respect for human beings, research merit and integrity, justice and beneficence which help to shape the relationship between researcher and participant as one of trust, mutual responsibility and ethical equality. The Committees must be satisfied that the above values have been addressed and met and also considers the following main points:

  • Design and research conduct of the study. The ethics committee should consider the impact on the safety of the participants in the design of the study.
  • Recruitment of participants. The ethics committee should examine how participants are recruited and what recruitment and advertising material will be used and where it will be placed.
  • Protection of research participants. The ethics committee must look at how the study positively or negatively affects participants or their communities.
  • Informed consent. The ethics committee must decide if the consent forms and process are adequate.
  • Confidentiality. The ethics committee must ensure that the researchers have measures in place to protect the participants’ privacy.

The study is only approved and able to commence when all questions and issues have been satisfactorily answered.

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