Research participation

Clinical trials are scientific studies that test new medications, procedures, devices and behavioural therapies on human volunteers. This is to assess for effectiveness and safety. It is a way to find out whether a new intervention works, is safe and potentially better than existing treatments. 

There are two types of trials - interventional and observational. 

Interventional clinical trials assign participants to different treatment groups and compare outcomes. Observational clinical trials observe participants but do not influence their treatments, focusing instead on what happens in different situations. 

Generally there will be two groups of participants.

One group will be given the trial medicine or device (treatment group). The other group will be treated with current treatment of 'placebo' (control group). 

These two groups are then monitored to gather information about the progress of their illness and to check for any new symptoms or side effects. After the information is assessed, doctors can see which group had the better outcome and discuss benefits and risks of the new treatment. 

There is no guarantee that being in a clinical trial will be of benefit, and there may be risks involved. Lots of effort goes into trying to control risks to your well-being and known possible risks must be explained in a written document that will be given to you. 

If new risks are learned during the trial, this information must be shared as well. If you decide to be a part of the trial you can stop participating at any time. As part of the decision-making process, you will be given a chance to discuss the potential risks and benefits with a study doctor. You should make a decision only after you fully understand the study and have had a chance to talk to your family and friends.

Remember that participation in any research is completely voluntary. Before you make a decision, you will be provided with a full explanation of the clinical trial, both verbally and in writing. Please carefully consider all the information before deciding to participate. If you have any further queries, ask as many questions as needed.

The explanation of the trial or study will include the following:

• information about the trial medication or device and the testing that has been done.
• any possible risks and benefits of the new treatment
• type, frequency and risks of any required medical tests or procedures
• how participation in the study differs from the care you would receive outside of the trial
• any alternative treatment options and any treatments that you will not be able to have while you are in the trial.

A doctor, commonly referred to as the Principal Investigator (PI) usually leads each clinical trial and most device trials.  The clinical trial team includes doctors, nurses, pharmacists and other health care professionals. This team is accountable for conduct of the whole trial. 

The Human Research Ethics Committee (HREC) needs to ensure that all clinical trials are ethically and scientifically reviewed. This committee group comprises of doctors, nurses, researchers, lawyers, ministers of religion, and members of the public. 

• To help improve knowledge about a disease
• To help develop a potential treatment for a medical condition
• To help other people impacted by the disease in the future
• Potential access to a drug not yet available to the general public
• Access to the medical professionals from the trial team such as a medical specialists
• Clinical trial related care, monitoring, medical tests and assessments in addition to your usual care

Once the medication reaches the clinical trial, the side effects would have already been extensively tested.  However, not all side effects can be known until the medication is used in humans and there may be unforeseen or unknown additional side effects. It is hard to predict in advance whether side effects might occur but even if they do, appropriate care will be given to participants. 

When ready, the results will be made available to doctors and these may be published in relevant medical journals and publications. Participants can request the results from the Principal Investigator.

Every clinical trial is conducted in accordance with the SA Health Privacy Policy. Your information remains confidential and will not be shared in any publication of the results. Your consent to share your information with any other organisation is obtained before information is released.

• You will only be asked to take part in a research project that is appropriate for you
   
• Participation in a research project is completely voluntary
   
• Your treatment will not be affected if you decide not to take part in a research project
   
• You will receive full information about the project
   
• You may change your mind and withdraw from a research project at any stage without your care being affected
   
• You are assured that your dignity, rights, safety, confidentiality and well-being will always be respected