What is involved in being a member of the Volunteer Panel?
Once you have successfully completed the screening process, you may become a member of the panel. Once on the panel, you will be sent the dates of forthcoming paid clinical trials, for which you may be eligible. You will need to send the form back in the pre-paid envelope, to indicate whether or not you are available to do the study. This reply slip also gives you the opportunity to inform us of any change of your personal contact details and the best time to call you. You may also phone or email to speed up the process. If you do not hear from us immediately after sending back your reply slip, it is because we are processing all of the responses.
Are there any risks involved in being on the Volunteer Panel?
If you decide to participate in a drug trial, you will have to attend a 'Consent Talk' that is given by the doctor who is involved in the study. The details of all procedures will be explained and you will be informed of any risks. This will be supported by written information. The decision to participate is taken by you; therefore you should not feel obliged to take part. If you choose to take part, you will need a screening medical to ensure that you are in good health and a suitable candidate for that particular paid medical trial. If you have recently undertaken a medical study, you must reveal this to the medical staff. It could be dangerous to your health if you participate in more than one drug trial at any one time or if you do not leave a long enough gap between studies. You could be exposed to substances that interact with each other.
How much time would I have to give to the paid medical trial?
Medical trials are varied in terms of the time and commitment required. It is fair to say that most of our studies run over office hours. With some particular drug trials you may be required to stay overnight at the unit, or longer.
How many paid clinical trials am I able to do a year?
You are limited to either 3 or 4 medical trials a year depending on the stage of development of the study drug.
What information do you need from me to check the National Clinical Trials Database?
In order to check the clinical trials database, we need you to provide us with your National Insurance number (if you are a UK citizen), and some form of photo identification. This might be your passport (which we must see if you are not a UK citizen), or if you cannot provide your passport, your driving licence. We need to see photographic ID to verify your identity. It is important to emphasise that neither your name nor any other personal information is entered into the clinical trials database. The only information entered into the clinical trials database is:-
- your national insurance number or passport number; and
- the date of your last dose of study medication
We need your permission to record your National Insurance number (or Passport number), and to submit that information to the clinical trials database. We also require your permission to hold the information within your medical notes, in secure conditions, so that we can check the database when you return to do future paid clinical trials. If you decide not to give your permission for us to submit this information you will not be able to participate in drug trials with GSK. You may also find that most other commercial research organisations and pharmaceutical units access this database, and will request similar information and permission from you. If you are in agreement please sign Form C.
What will you do with this information if I grant permission?
We will submit your National Insurance number (or passport number) to the clinical trials database, in order to check whether you are being considered for other paid medical trials. If you participate in a medical trial, the last date you received any study medication will be entered into the database. If an enquiry to the database indicates that you may be, or have been, recently participating in other drug trials, we will call other research units (or they may call us) to check this information. The only times we will submit your information to the database are either when you are screened prior to undertaking a study, or prior to your taking study medicine. If you withdraw from a study before you receive any medication, the clinical trials database will show that you did not receive any medication.
Who will see my medical information?
All your personal information will be treated as confidential, that is, any information that identifies you by name, will be held and processed under secure conditions. Access to that information will be limited to authorised personnel working at the unit and possibly to representatives of regulatory authorities. You must agree to these persons having access to your personal information for inspection and audit purposes only.
Is my participation in clinical trials voluntary?
Participation in paid clinical trials is entirely voluntary. Joining the panel does not oblige you to take part in a drug trial. You are able to withdraw from the Volunteer Panel at any time.
What happens if I am unsuitable for the Volunteer Panel?
Unfortunately we cannot accept everyone who applies to join the panel as there are a number of reasons why some people are unsuitable. Some reasons are medical; others may be related to work, lifestyle or social matters. If you are unsuccessful in your application we will inform you as soon as possible. However your information will be retained for 3 years in the event that our panel requirements alter in the future.
Who decides whether I am accepted on to the Panel?
The final responsibility for deciding whether you can join the panel rests with the clinical team. The clinical team also reserves the right to subsequently remove you from the Volunteer Panel if they consider it to be appropriate.
What happens at the consent talk?
Within approx. 28 days of the start of each study you will attend a consent talk where you will be given all the information and details about what to expect should you take part in the paid medical trial. Please feel free to ask as many questions as you like during this talk and you will also be given the opportunity to ask questions in private if required. If you do not wish to sign your consent form at that point, you are free to take this information away with you whilst you consider whether or not to take part. You can take as long as you would like to consider whether you definitely wish to participate in the drug trial.
How safe is it?
Paid clinical trials are carried out under the strict supervision of fully qualified doctors, nurses and other health professionals. All trials are run in accordance with European legislation and must first be approved a Research Ethics Committee and if a new medicine is involved by the MHRA (Medicines and Healthcare Products Regulatory Agency). Before every paid medical trial you are given information about the study to read through in detail and are able to spend as much time as required with one of the Research Doctors discussing all the details and potential risks of the drug trial. This process is called informed consent and must be completed before any study procedures are able to take place. After the formal consenting session with the doctor you will be able to take the information home to discuss with friends, family and maybe even your GP. A consent form does not need to be signed until you feel that you have enough information to make the decision to take part, and even once the form is signed you are able to withdraw from a medical trial at any time. Before you can take part in a paid clinical trial, we take great care to ensure that you are suitable to do so. You will be screened against the approved study protocol and are required to undergo a thorough medical examination, which includes taking blood samples for a variety of tests, as well as tracing your heart (ECG) and measuring your blood pressure. We will also contact your GP to check that there are no medical conditions in your history that might affect your participation, and we routinely make checks to ensure that previous drug trials you may have completed at another site will not affect your participation in a medical trial at GSK. Find out more about the specifics of the medical examination.
Will I be paid for taking part?
By participating in a healthy volunteer study, it is not anticipated that you will receive any therapeutic benefit from taking part and it is therefore considered ethical and appropriate that you should be paid for your time and inconvenience. The amount of payment you will receive for each drug trial will vary and is calculated based on the amount of time that you have to devote to the study, the number of visits and also the amount of inconvenience anticipated during the medical trial. An Independent Research Ethics Committee will have approved all the payments that we make to volunteers for trial participation. Study payments are made at the end of the drug trial after your final visit and are made by cheque, which will be made out in your name.
What happens when taking part in a paid medical trial?
This will vary according to the medical trial but you will always be told in detail what to expect, when you are invited for a consent talk - well before the start of the study. Once the clinical aspects of the study have occurred, then you will have some time to yourself. To pass the time, there are various sources of entertainment we have available, but we would also advise you to bring things in with you to occupy yourself for example, any studying, books or writing materials.