why is it important to be a volunteer?
Every new medicine must go through clinical trials. Without healthy and patient volunteers, no new medicines would be available to the community. Your participation today could lead to the availability of a life-saving medicine for somebody in the future. Every medicine that you have ever taken has been through similar testing somewhere in the world.
what are the risks?
All clinical research has some level of risk. In order to minimise the risks an evaluation of the research study is undertaken before it is approved to commence by an independent Human Research Ethics Committee (HREC). The HREC has a scientific sub-committee that reviews the science behind the new medicine, the effects seen in animal studies, the proposed doses to be administered and the design of the study. The HREC will also often seek further external expert reviews of particularly novel medicines. The HREC will also review and approve a Participant Informed Consent Form (PICF)). This is a non-technical description of the research study so that you can make an informed judgement as to whether to participate. You should review the PICF carefully. The PICF gives a detailed description about this investigational study, which the study doctor and/or his representative will discuss with you. Its purpose is to explain to you as openly and clearly as possible all the procedures involved in this study, before you decide whether or not to take part in it. Should you decide to participate in the study, you will be asked to sign this consent form, and a copy of the signed informed consent form will be given to you to keep. Every study is different in its risks, design and its duration. As a participant in a clinical research study you will be constantly monitored by qualified staff including doctors, nurses, pharmacists and allied health professionals.
what will happen during the screening process?
If you have expressed interest in a particular study, you will be telephone pre-screened by one of our recruitment staff. The telephone pre-screening will provide you with high level information about a particular study and you will be asked a number of general questions about your health, medical history and availability. If you appear to fit the general criteria (e.g. body weight, height, smoking status, medical history etc.) you may be invited to attend a screening visit. At or before the screening visit you will be supplied with a copy of the Patient Information Consent Form (PICF). Before agreeing to anticipate in this study, it is important that you read and understand the PICF which provides the explanation of the study and its procedures. The PICF describes the purpose, procedures, benefits, risks, and discomforts of the study. You should consider discussing your participation with family, friends or your local GP. For your own protection it is important that you reveal your entire medical history. Giving false, incomplete or misleading information concerning previous or present medical problems could be dangerous to your health. If you choose to participate, you have the right to withdraw from the study at any time. The study doctor and/or studyrepresentative will explain any difficult concepts or words included in the PICF and answer any questions you may have about this study. Once you have signed the consent form you will undergo physical examination, have some blood and urine tests and any study-specific screening tests. The screening tests may include tests for recreational drugs. The screening process will generally take 1–2 hours, it will then usually take one to two days to receive blood test results. If your results come back as suitable for the trial you may be offered a place in the trial. Not every participant who is screened will be suitable to be offered a place in a study. It is important that you understand that your participation in this trial is voluntary, as is the case with all research projects in Australia. If you do not wish to take part in the study, you are under no obligation to do so. If you decide to take part, but later change your mind, you are free to withdraw from the study at any stage. However, if you withdraw your consent, you will no longer be able to participate in the study. Your decision whether to take part or to withdraw will not affect your routine medical treatment or your
relationship with those treating you or your (present or future) relationship with The Centre for Clinical Studies.
what happens during a study?
Generally you will be admitted the day before a study starts. When you arrive you will undergo a number of tests, possibly including a full screen for recreational drugs and an alcohol breath test. If you are positive for recreational drugs or alcohol you will be excluded from the trial. In order to maintain a safe and secure environment your bag will be searched prior to admission to the clinical research centre. You will not be allowed to bring recreational drugs, alcohol, food or chocolate into the facility. You will be assigned a bed and provided with a locker for your belongings. On the morning the study commences you will be woken early. You will also probably have one or more cannulas inserted into your arm. A cannula is a small plastic tube that is kept in a vein in your arm for up to 24 hours during the time you are in the clinical research centre in order to take the multiple blood samples involved in this study. You will receive a dose of the new medicine and then have a series of tests performed – these may include an ECG (measurement of the heart), blood pressure, blood samples and other tests. Often these tests will be repeated at frequent intervals (e.g. every 5–10 minutes). All of the tests will be described in the informed consent form. You will have to remain in your bed for at least 4 hours after you have received medication. You will be advised by the study staff as to when you can leave your bed. Each study lasts for a different period of time – some participants will stay in the unit for 2 days, others may stay for 2 weeks – the duration of your stay will be described in the consent form.
what should I bring? You should bring your own toiletries and light clothes. You should wear enclosed footwear while in the unit. All of your meals will be provided throughout your stay. You are also encouraged to bring reading materials, ipods, lap-top computer etc. for your entertainment. Most beds have individual TVs, we also have an X-BOX, TV, DVD, internet terminals and a pool and air-hockey table.
what happens after you leave the facility?
Most studies will require you to come back a few days after you leave the facility. These ‘outpatient’ visits are important to ensure that you have not experienced any undesired effects after leaving the facility. On your final visit you will be reimbursed for your time and inconvenience (where applicable).
what are the house rules?
We have a number of ‘house rules’ that govern behaviour within the clinical research centre. These rules are put in place to protect the safety and privacy of you, the other participants and our staff. The house rules govern items such as visitor policy, general behaviour and safety procedures. You will be provided with a copy of these rules or they can be accessed on our website.
will it cost me anything?
All of your medical costs as part of the study will be paid for and you will not be charged for any tests. The sponsor of the trial will have agreed to provide compensation to you for any injury suffered as a result of your participation in the research project, in accordance with the Medicines Australia Guidelines for compensation for injury resulting from participating in a company-sponsored research project. A copy of the Medicines Australia Guidelines is available to you from the research staff on request. In the event that you suffer an injury as a result of participating in this research project, hospital care and treatment will be provided by the public health service at no extra cost to you.
do I get paid?
The Australian Health Ethics Committee recognises that it is ethically appropriate to reimburse participant expenses for taking part in research. In phase I studies we believe that it is appropriate to reimburse for time and inconvenience based on a schedule agreed by the Human Research Ethics Committee. The reimbursement is to cover the inconvenience of staying in the clinical research centre and your outpatient visits. A cheque will be given to you on your final post-study visit. Should you withdraw from the study before the final visit you will receive a partial payment according to the number of visits you have attended. Participant reimbursement compensates for your time, travel expenses, parking, and inconvenience. This reimbursement is not made for undergoing risk nor is it to compensate you for any loss of earnings as a result of your participation. For later phase studies, where there is the possibility for participants to derive health benefits from participation, reimbursement may be limited to travel expenses.
is my Doctor involved?
We encourage you to speak to your own Doctor about your interest in taking part in Clinical Trials. With your approval, we can correspond with your Doctor regarding studies that you may be interested in taking part in.
nucleus network is a not-for-profit organisation, where does the money go?
Nucleus Network currently reinvests profits in developing further clinical research capabilities within Australia. This includes providing subsidised training in clinical research across Australia, grant support to young researchers and development of new research facilities and laboratories.
