Volunteer FAQ's

Frequently asked questions

What kind of medication will I have to take?  CRO’s help the world’s leading pharmaceutical companies develop existing and potential new medicines.  Studies are undertaken with different types of medicines, for example, pain killers, antidepressants, laxatives, medications for anxiety etc, some of the products are licensed (i.e. on the market, but maybe not in the UK), others being introduced into man for the first time.

Will I be told everything that is involved in the study?  When you ask to take part in a study, you will be invited to attend a meeting at which the study will be explained in detail.   You should ask any questions you might have.  If you don’t get an answer, don’t do the study.

Can I drink alcohol?  Usually not for 24 to 48 hours before each session of a study, and whilst on a study.  You may be allowed alcohol between sessions, but this will be outlined in the protocol and discussed at the pre-study information session.  Some studies may actually involve drinking alcohol!

What happens at a pre-study medical?  You meet a doctor or nurse first who will answer any questions you may have.  You should then be asked to sign a consent form to give your permission to take part in the study and any required procedures.  The doctor or nurse will then ask you about your medical history and give you a thorough medical examination.  You will then have certain procedures performed, usually urine and blood samples, blood pressure, height and weight and ECG (Electrocardiogram – a heart activity tracing).  Each study is different, so there may be additional tests to the above, which may require additional visits and procedures at the information session.

Why do we have to eat at set times?  Each person on the same study must eat at the same time so that consistent results regarding absorption of the drug from your “stomach” are obtained.  The timepoints are set by the pharmaceutical company sponsor and must be adhered to.

Will the insertion of the small plastic tube into my vein through which you draw blood hurt?  The insertion of the cannula should not hurt.  A local anaesthetic is given to the area before the cannula is inserted into the vein.

What short or long-term side effects might there be?  No long-term side-effects should be expected.  The common short-term side-effects are transient feelings of sickness, headaches, drowsiness and possibly a slight change in blood-pressure (feeling faint).  Any expected side-effects will be explained at the pre-study information session.  Usually, any side-effects are short-lived and will have disappeared prior to your post-study medical.

Are all studies reviewed by an Ethics Committee and who are they?  All study protocols should be reviewed by an Ethics Committee and the Committee should be entirely independent from the CRO for whom you are doing the study.  Ask this at the pre-study information session.  The Committee is responsible for ensuring that your safety has been thoroughly considered, that the information provided to you is fair, balanced and accurate and that your rights as a volunteer are maintained.  The Committee should consist of technical people (including doctors and pharmacists) and non-technical people such as lawyers and teachers.  The mixture of technical and non-technical people means that both scientific and medical information is thoroughly reviewed and that the information is put in clear, non-technical terms for potential volunteers.  The Ethics Committee also reviews all volunteer advertising material.

Will taking part in the study have any effect on an application for health or life insurance?  There is no evidence that anyone has been refused cover because of participation in a clinical trial.  Different insurance companies have different rules and should you have concerns you should discuss this with your insurer.

When can I do my next study?  Usually 3 months after the post-study medical, although this can be more or less depending on the rules of the next study you wish to take part in.

Do CROs have a financial interest/share in the companies (sponsors) developing medications?  The CRO should have no financial interest in sponsors, other than the fees charged for conducting the study, and these are independent of the scientific outcome.