Trials4patients Richmond Pharmacology volunteer recruitment

Consent to cure

The research and development new treatments and cures open the possibility of enhancing the standard of living for millions of people worldwide. Volunteer involvement is a crucial part of this, but before participation is allowed each volunteer must provide the researchers with their signed consent. Why is informed consent so important?

"Pivotal to clinical trials is the participation of healthy volunteers and patients, and their safety is the priority of any trial. The informed consent of the volunteer is important in ensuring that each volunteer understands all the aspects of the trial and can therefore make an informed and educated decision regarding their participation." explained Dr Radivoj Arezina, Research Director at Richmond Pharmacology.

Clinical research is a highly regulated industry; each clinical study must comply with the EU Clinical Trials Directive (2001/20/EC) which is enforced in the United Kingdom by two governmental bodies, The Medicines and Healthcare products Regulatory Agency (MHRA) and by Approved Ethics Committees. It is the Clinical Trials Directive (2001/20/EC) which dictates that written consent from the volunteer is mandatory.

The Ethics Committee examines every component of the trial that affects the volunteers, to ensure they are fully informed to enable them to make a decision about participation. All written information given to the volunteer, including the consent form is reviewed for its accuracy and clarity.

Dr Radivoj Arezina

Dr Radivoj Arezina MD MSc (Research Director)

"In consenting, the volunteers are confirming that they understand all aspects of the study, including the study design and the medicine being researched, the volunteer must also be satisfied that our clinical staff have answered any further queries that might have arisen form the information provided. The data protection act which relates to volunteers' confidentiality and the appropriate storage of their data is also incorporated. We appreciate the principal aim of the informed consent is to protect the volunteer, by ensuring they are at all times fully informed," stated Dr Arezina.

At Richmond Pharmacology the volunteer's consent is required at two different stages of the clinical trial process,

  • Prior to the medical examination to determine their eligibility for trial participation, and
  • Prior to the start of the study once their eligibilty has been confirmed and they have been admitted into the unit.

This provides the volunteer with time to study the information for volunteers provided by the researchers, and gives them plenty of time and opportunity to discuss any queries they might have with the researchers' clinical or recruitment teams.

A common misconception that many potential volunteers have is, that once consent has been given the volunteer is no longer entitled to withdraw from a study. This is not the case, a volunteer's consent to participate can be withdrawn at any stage of the study without having to give a reason to the researcher.

"Participation of volunteers in any study is essential, and it is necessary that a pre-determined number of volunteers complete the study so that enough data is collected to produce a set of meaningful results. The data of any volunteer that withdraws consent is usually incomplete and can not be included into the final analysis. As a result another volunteer will have to replace the volunteer that has withdrawn and start from the beginning of the study. Ultimately this often leads to delays in completing the study and the medicine moving on to the next stages of research. The informed consent is therefore a representation of both the volunteers' and researchers' commitment to the development of the new medicine being studied." concluded Dr Arezina.

Richmond Pharmacology conduct clinical trials including healthy volunteers and patients to give sick people chance for a cure. If you would like further information on clinical trials, Richmond Pharmacology can be contacted free phone from the UK on 0800 0 27 37 47 or from outside the UK on 0800 00 27 37 47 or visit www.trials4japanese.co.uk.