Research is regulated to make sure it is conducted to a high professional and scientific standard.
Good Clinical Practice (GCP) is a set of international standards for designing, conducting, recording and reporting of clinical research. These standards are followed by all health professionals and ensure that people taking part are safe, and information is collected to the highest standard. GCP is the same anywhere in the world where clinical trials are run.
In Australia, several committees examine and approve a study before it begins. These committees confirm that a study is considered scientifically worthwhile and fair (ethical).
Topics on this page:
- Regulating committees
- Human research ethics committee
- Role of the National Health and Medical Research Council
- Research review committee – decides whether the study has social and scientific value, and if the way it is to be conducted will produce valid scientific results.
- Ethics review committee – 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 adequately 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.
For more information on how studies are conducted fairly, see Planning research.
Human research ethics committee
Once research has been approved by a research review committee, the human research ethics committee (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 committee 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 the study might impact on the participants’ quality of life.
Members of an ethics committee are always independent of the researchers. Committee members come from a variety of backgrounds, including medical, scientific, legal and religious professions, and the general community. There are usually at least eight core members covering a range of professional and personal experiences to reflect different points of view and provide balance.
Changes to research
Sometimes changes need to be made to the research, and these will need to be approved by the human research ethics committee.
- Before approval – The ethics committee 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. This is called an amendment. If there are any changes to the participant information, then participants already taking part in the study may need to sign a form to show that they have been informed of the changes (amendment) and still agree to be involved.
National Health and Medical Research Council
NHMRC’s mission is to build a healthy Australia.
It does this by developing health advice for the general community and health professionals, and funding research projects ranging from basic research through to clinical, public health and health services research.
NHMRC produces guidelines outlining ethical conduct in research. Ethics committees must follow these guidelines and report to NHMRC every year. You can download the National Statement on Ethical Conduct in Human Research (2007) (Updated March 2014) from nhmrc.gov.au/guidelines-publications/e72.