The safety of clinical trial participants is of paramount importance to CRO companies. All clinical trials in Australia are regulated by laws and codes of conduct which were created to protect participants and the integrity of a clinical trial.
Before a clinical trial is approved, it needs to be thoroughly assessed by a Human Rights Ethics Committee which confirms that the research meets the guidelines of the National Statement on Ethical Conduct in Human Research. All trials follow a protocol which ensures that they are as safe as possible.
All participants of a clinical trial need to be informed about the objectives of the trial, what is expected of them, and any risks or discomforts that may be experienced during or after the trial. They are also reassured that their personal details will be kept confidential.
A risk is the possibility of pain or inconvenience occurring. An assessment of the risks associated with clinical trials includes:
- Identifying risks.
- The severity.
- How to minimize risks.
- Determining whether risks can be justified.
- Managing risks.
The professionals who assess the risks include:
- Researchers: Identify, minimize and manage risks.
- Institutions: Working with ethical committees to complete ethical review.
- Human Ethics Committee (HRECs): Reviewing research proposals and making judgements about potential risks and benefits of the clinical trial.
Ways of minimizing potential risks:
- Researchers have an obligation to minimize any risks to participants by assessing clinical trial aims, their importance and the ways they are achieved.
- A clinical trial is ethically acceptable only when the benefits justify the risks.
- If the level of risk is not justified by the benefits, the clinical trial process will need to be reassessed.
Ways of managing risks after they have been identified:
- Methods to deal effectively with any risks that may occur.
- A monitoring process is put in place.
- The bigger the risk, the more likely it is managed effectively.
It is crucial for every CRO company to follow strict guidelines and protocols and to understand the different needs of each participant. Viewing all research through an ‘ethical’ viewpoint rather than a ‘beneficial’ one will ensure that the wellbeing of every participant is kept at the forefront of every clinical trial.