Information about volunteering for a clinical research trial

Many studies involve both men and women but some will have restrictions depending on the type of medicine being tested. Women who take part will have to avoid becoming pregnant during the study.

Some clinical studies need healthy volunteers. However, most of our studies need people with a specific medical condition such as asthma or Type 2 diabetes.

Your initial contact will be by telephone with one of our staff. If you think you are interested in taking part we will send you written information about the study treatment and the tests that will be performed. You will be invited to the clinic for some screening tests to make sure it is safe for you to take part and to check that you are suitable.A doctor and study researcher will ask you questions about your health and any medicines you are taking and will explain the study to you.  You will be asked to sign an Informed Consent form before any tests take place to show that you understand what is involved. If you wish to continue and qualify for the study you will be asked to return to the clinic at specific times for treatment and tests. You might only be given medicine to take when you are at the clinic or you might be given medicine to take when you are at home. You might also be asked to record information about your health while you are away from the clinic. This is often done using electronic devices provided to you for the study.

Some studies are very short and you might only need to come to the clinic a few times over 4 to six weeks. Other studies may go on for 6-12 months or even several years. The time that you spend at the clinic may also vary - you might only need to come in for a short while (30-60 mins) or you might need to stay all day or possibly overnight. This will be clearly explained to you before the start of the study.

Your health will be monitored while you are on the trial so you might find out more information about your health and medical condition. You may also receive advice about how to best manage your condition. The medicines or treatments you receive might make you feel better, although we cannot guarantee this. Some participants will receive a placebo instead of the new treatment. You might receive a new treatment that is not available to the general public. Even if your health doesn't improve, the information we get from the study might lead to new medicines being developed.

Most of our trials are 'placebo-controlled' so you might not recieve any active treatment. If you do receive active treatment it might make you feel better, but it might not.  There is also a risk that your condition might get worse. However, your health will be carefully monitored throughout the study. If your condition deteriorates, it is likely you will be taken off the trial and other treatment instituted.

There are always some risks - both from the medicines that you might take and the tests that are perfomed. Some of the medicines we test are still at the very early stages of development and not much information is known about them. You may have side effects which are mild or possibly unpleasant or serious. Other medicines might have been on the market for years and they are well understood, but there may still be the risk of new side effects. However, your safety is our highest priority at all times and you will be carefully monitored by trained staff. If the study doctor thinks that it is not a good idea for you to take part or continue in the study you will be withdrawn and referred to either your GP or a specialist centre for further medical care.

Your involvement is entirely voluntary (your choice). You can decide not to take part or you can agree to take part and then change your mind at any time, for any reason. If you start a study and then change your mind, you can withdraw from the study - but we would ask you to come to the clinic for a final visit so that we can check your health and make sure you are getting the right treatments for your condition.

P3 Research staff and people who monitor the study for the sponsor company. We also like to notify your GP - so that we can make sure that it is safe for you to take part - but we will ask for your permission first. Nobody else will know unless you choose to tell them and all information that we collect about you during the study will be kept confidential.

Yes. The study information is confidential but you are quite welcome to discuss the study with your friends, family/whanau and GP to help you decide whether to take place or not. You should also be aware that your employer or insurance company might ask whether you have ever had certain tests - if you've had these tests as part of a clinical trial you may be obliged to tell them and this might affect your employment or insurance status.

You will not have to pay for any of the medicines or tests that you receive during the study. If you are currently receiving a benefit we recommend you check with your benefit provider (e.g. WINZ) to make sure your payments won't be affected by taking part in the study.

For most studies you will not get paid for taking part but all study related expenses, such as travelling costs, will be re-imbursed. Some studies involving long term visits to the clinic may provide a payment in recognition of your time and inconvenience.

If you are injured as a result of taking part in a study you must notify the study doctor immediately. Clinical trials that are being perfomed for a pharmaceutical company are not covered by ACC but sponsor companies are required to provide adequate insurance. You are unlikely to receive any compensation if an injury is caused by you or if you do not follow the study doctor's instructions.

Some studies have no restrictions but some might ask you to make a few changes whilst you are taking part. This might include avoiding alcohol, caffeine and certain foods, restricting exercise at certain times, fasting overnight and witholding some medicines for a while. Some studies might also have birth control requirements. You will also need to visit the clinic at specific times, so you should think carefully about your ability to do so before you agree to take part in a study. If you take any recreational drugs, such as cannabis, you will not be able to take part in one of our studies. The requirements will be clearly explained to you before you agree to participate.

Your personal information, such as your name, address and contact details will be kept by P3 Research and will remain confidential. We will ask for your permission to keep your personal information in a database so that we can contact you later if you are interested in taking part in more trials. You can decline this request if you choose. Your study results, such as blood tests or the results of other assessments will be sent to the sponsor company for analysis. Once the company compares your results with those of everybody else on the study, they will be able to determine if the treatment is effective and if any changes need to be made in future studies. The Sponsor company will not be given your name and will not be able to link your results back to you. The results of the study may be presented at scientific meetings, or may be published in scientific journals such as The Lancet or The New England Journal of Medicine. Your name will not appear in any presentation or publication. The study results may ultimately be sent to regulatory authorities around the world as part of a marketing application for a new or updated treatment.

Before any study can be performed it has to be approved by an independent Ethics Committe. This Committee includes doctors, researchers, consumer representatives and may also include lawyers, statisticians and pharmacists. They are completely independent to P3 Research and the sponsor company and it is their job to make sure that all studies are being performed in an ethical manner and not putting patients at unnecessary risk. They will not approve any study that they are not happy with. For all new medicines or medicines that are being used in a new way, the study must also be approved by the Ministry of Health. In addition to these independent checks all studies will be thoroughly reviewed by P3 Research's experienced medical staff and, if the study is being sponsored by a pharmaceutical company, it will also have been designed and reviewed by their medical and research staff. Despite all these checks it is important to remember that all studies carry some risk and there is always the possibility of unexpected side effects.