Common Volunteer Questions
The best and most convenient way to register with us is to register your interest online,
call our recruitment team on 028 9081 8385 or send an email to volunteers@biokineticeurope.com.
It usually takes around 5 minutes, once registered we can give you details of studies that you are suitable for.
We advise all healthy volunteers to contact us every 6 – 8 weeks to keep up to date with our current studies. We cater to a wide range of areas within the pharmaceutical industry and recruit both healthy volunteers and patients with certain medical conditions to participate in studies. If your circumstances change, let us know so we can keep your details relevant and up to date.
All studies conducted at BioKinetic Europe are reviewed and approved by a Research Ethics Committee (REC) and the MHRA (UK Regulatory Body) before the study can begin. The REC is an independent body composed of medical and lay professionals who carefully review each trial solely with the safety of a volunteer in mind. The MHRA focus is primarily on the scientific merit of a study. BioKinetic Europe only conducts studies approved by both.
If you are taking part in a study for the first time you might feel a bit uncertain. Your screening (medical) appointment is a great opportunity to ask any questions you might have in relation to the study drug and to gain a better understanding of what is expected of you during your participation in the study. Some things you might want to consider before attending a screening appointment are;
An ICF is an Informed Consent Form and records the process of obtaining your consent to take part in the clinical trial. In addition, you will be supplied with detailed trial information (Volunteer Information Sheet) so that your decision to take part is an informed one.
Every person who fits the criteria for the study and who passes the medical examination, has an equal chance of being offered a study place. You can however increase your chances of passing the medical examination by following the preparation for your medical guidelines listed below.
You will be required to fast for a number of hours prior to the pre-study blood and urine sample. This means no food and drink, apart from water, for a number of hours before your appointment and until after your blood sample has been taken. (Fasting time is study specific and may increase depending on the protocol requirements).
Usually you cannot be on other medication, prescription or over-the-counter, apart from HRT or oral contraceptives, (the timeframe for this differs depending on the study) before your pre-study medical appointment and until you have completed the study. Again there may be study exceptions to this. If unsure you are always best to check with one of the doctors.
Strictly no alcohol before your pre-study medical appointment (the timeframe for this differs depending on the study).
No strenuous exercise (i.e. running, work-outs etc) before your pre-study medical appointment (this is dependent on the type of study we are carrying out at the time). Strenuous exercise can sometimes temporarily change your blood results which could mean you will not pass your medical. (This may vary depending on the study.)
A sample of urine will be taken at your pre-study medical appointment to test for drugs of abuse (e.g. cannabis, cocaine, amphetamines and opiates). Additional tests for smoking and alcohol will also be conducted. A positive result will exclude you from the study and may exclude you from taking part in further BioKinetic Europe studies.
No dental treatment requiring a local anaesthetic before your pre-study medical appointment and until you have completed the study (the timeframe for this differs depending on the study). No general anaesthetic is allowed during the 3 months before the start of the study. (This may vary depending on the study.)
No blood donations (to the Blood Transfusion Clinic) are allowed during the 3 months before the start of the study. This is for your own health and safety.
What is involved in a screening (pre-study medical) appointment?
The screening involves a free, confidential physical examination with one of our fully qualified medical professionals. You will also be asked questions on your medical history. Certain studies may also include blood and urine samples, and other diagnostic tests. These procedures and questions are carried out to ensure that you do not have any medical problems which would make it unsafe for you to participate. Results of all tests are confidential.
In order to allow for the informed consent (see FAQ What is Informed Consent?) and the required medical procedures, a screening session normally lasts around 2 hours but this time may increase depending on the procedures required for an individual study. During your screening appointment you will also have the opportunity to look around the clinic and see where you will stay, if an overnight stay is required for the study.
As a general rule you will not be paid for attending screening, as at this stage your suitability for study participation is being assessed.
You will need to bring the following things to screening with you:
ID – photographic ID is required. This must be a passport, driving licence or electoral card. Student IDs, bus passes and senior citizen cards will not be accepted and you will not be allowed to proceed with the medical if your ID is not an approved form.
Proof of your national insurance number – such as your national insurance card, a letter from the DHSS, a payslip or P45/60. This is a means of identifying you and to ensure that you are not over volunteering.
Doctor’s details – There will be a place on the form for you to provide your doctors contact details including the practice phone number.
Yes, as we generally get in touch with your GP once you have attended screening. This will be to inform them that you may be taking part and to discover if there is anything relevant in your medical history that may affect your ability to take part in a particular study. If you have recently registered with a new GP surgery they may not be in full possession of your medical notes, you should check with them before attending your screening appointment.
Each study is well thought out to ensure that all study procedures are carried out at precise times. When you are not required for study procedures you will have time to relax. To help you do this we provide games, books and magazines, along with daily newspapers. There is also Sky Television (with limited channels), a DVD player and internet access available in the clinic. Please note that internet access can be limited.
You need to bring enough comfortable clothes, towels and toiletries for the duration of your stay. You can also bring books, mobile phones, DVDs, games consoles, i-pods/mp3 players and laptops, however this is dependent on the type of study and all electrical equipment must be switched off during clinical procedures.
For the majority of studies food and medication are all prohibited in the clinic (apart from approved HRT and Oral Contraceptive pill). There are some studies where you are allowed to bring your regular medication, this must be given to a member of the clinic staff who can give it to you at the allocated time.
For studies that require you to stay in the clinic all food will be provided. At screening you will be provided with a menu. You should carefully review the menu to ensure that you are happy to eat all of the food provided.
Dress in comfortable clothing, as ECGs are usually a part of study procedures you may want to consider wearing loose fitted tops. Please note that it is usually recommended to bring pyjamas to the clinic to allow the attachment of equipment. Footwear must be worn at all times in the clinic, soft soled shoes are preferable.
BioKinetic Europe is in a prime location in the heart of Belfast city centre, therefore we recommend you leave your car at home and use public transport if you are staying overnight. BioKinetic Europe is based just a few minutes’ walk from both Great Victoria Street train station and the Europa bus station. A Metro service to the Greater Belfast Area is also available from the City Hall which is close by. You can find further details on all these services by following the link below:
www.translink.co.uk/
If public transport is not suitable for you there are a number of car parks in the immediate area.
Visitors are not allowed into the clinic however they may deliver clean clothing, personal care items or books etc. Telephones are available for both incoming and outgoing calls.
There is a minimum period of 90 days allowed between finishing one trial and starting another; you can screen for a new study within this timeframe but cannot be dosed. We contact other Clinical Research Organisations and use The Over-volunteering Prevention System (TOPS) to register your details and ensure you have not participated recently. It is important for your own safety that you are open and honest about previous study participation. Failure to disclose recent study participation will mean that you will not be permitted to take part in studies with us.
Below are some useful link the regulatory bodies associated with clinical trials:
http://www.mhra.gov.uk/index.htm
http://www.nres.npsa.nhs.uk/patients-and-the-public
If you have a question that isn't answered here, please feel free to get in touch with us at volunteers@biokineticeurope.com
BioKinetic Europe
14 Great Victoria Street, Belfast, BT2 7BA Northern Ireland
E: volunteers@biokineticeurope.com
Volunteer Hotline: +44 28 90 81 83 85
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