Clinical research is regulated to make sure it is conducted to a high professional and scientific standard. In Australia, several committees examine and approve a clinical research study before it begins.
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The following committees confirm that a study is considered scientifically worthwhile and fair to the participants (ethical). They also check that the study meets any regulatory requirements set out in State and Commonwealth legislation.
- Research or scientific review committee – decides whether the study has social and scientific value, and if the way it is going to be conducted will produce valid scientific results. May be a subcommittee of a human research ethics committee.
- Human research ethics committee (HREC) – confirms that the interests of participants are protected and that researchers will run the study in a fair, honest and neutral (impartial) way. It ensures researchers won’t force people into participating, and that the risks of the research generally don’t outweigh the benefits.
- Research governance review – checks every site where the research will take place. This review is done by a research governance officer, who makes sure there are enough resources to carry out the proposed research and that the staff members involved are qualified. The governance officer authorises the research to begin at each site.
The study may also be monitored by outside agencies such as pharmaceutical companies, research institutions and auditors. These bodies ensure that the research is carried out properly.
Clinical research standards
All health professionals must follow a set of international standards for designing, conducting, recording and reporting clinical research called Good Clinical Practice (GCP). These standards ensure that people taking part are safe, their privacy is protected, information is collected to the highest standard, and results are reliable. GCP is the same anywhere in the world where clinical research is conducted.
Once a study has been approved by a research review committee, the HREC assesses the impact of the proposed research on participants, researchers and the general community. The impact is then weighed up against the benefits of conducting the research. The committee makes sure that the study will be carried out in a way that protects participants.
The HREC reviews a number of aspects of the study, including:
- the qualifications of the researchers conducting the study
- the way participants are recruited
- the quality of the participant information
- how risks to participants will be minimised
- how participants’ personal information will be used and stored
- how the study might impact on the participants’ quality of life.
Committee members are always independent of the researchers. They come from a variety of backgrounds, including medical, scientific, legal and religious professions, and the general community. To reflect different points of view and provide balance, the HREC will consist of at least eight core members with a range of experiences.
A research study cannot begin until it has received approval from the HREC and the governance office. For more information on how studies are conducted fairly, see Types of clinical trials.
Sometimes changes need to be made to the research:
- Before approval – The HREC may ask the research team to make changes to the proposed research before it can go ahead.
- After approval – Any changes that researchers want to make during the study must go through ethics approval again before the change can take place. For example, the researchers may want to expand the size of the study, or some safety information may have become available about the intervention. This is called an amendment.
If there are any changes to the participant information, participants already taking part in the study may need to sign a form to show that they have been told about the changes (amendment) and still agree be involved.
Therapeutic Goods Administration
The Therapeutic Goods Administration (TGA) is an Australian Government department that regulates all medicines sold in Australia. Any experimental drug used in a clinical trial must be registered with the TGA. For more on this, visit tga.gov.au.