Institute of Clinical Research and ABPI partnershi

A new UK scheme to introduce qualifications for clinical research staff will give Britain extra credibility in an increasingly competitive market for clinical trials research into new medicines. The new standards and qualifications will emerge from co-operation between two leading organisations, the Institute of Clinical Research (ICR) and the Association of the British Pharmaceutical Industry (ABPI), it was announced today. The standards would give British clinical research personnel additional standing and emphasise Britain’s status as a centre for quality research, because their ability to conduct research to the highest standard will be clearly identifiable from their ICR-ABPI qualifications. There is mounting pressure for formal qualifications in clinical research from within the industry and both the EU Clinical Trials Directive and the DoH Research Governance paper allude to ‘appropriately qualified’ personnel, yet clinical researchers are presently recruited by reputation alone. This leaves both employer and employee open to misrepresentation and misunderstanding of what their experience has entailed. By introducing an accredited scheme, the clinical research personnel will benefit from a portable qualification and the organisations that employ them have a clear indication of their aptitude. This will better enable employers to skills match staff to clinical research roles and will empower employees to control and direct their career path through continuous professional development. Also, the ICR will have a clear way of identifying the skills of its members, who will have accredited qualifications, and the ABPI can use the standards as a means to ensure best practice is achieved consistently by professionals employed in the industry. The ICR chairperson, Penny Maguire said, “The advantages of this alliance are manifold. Not only can we pool our resources and expertise, but we can ensure that the wishes of senior management in industry are compatible with the wishes of our members, such that measures to improve the quality and standards of ethical research also provide individuals with transferable evidence of their ability to do their job well.” The first accreditation phase is a set of modular units for clinical research associates working with clinical trial study sites, defining best practice and the criteria by which full competence in the role can be demonstrated. These competency standards have been submitted to the appropriate government body for approval and will be used as the basis for a recognised professional qualification in due course. Additionally, while the ABPI is UK focused, many of the organisations it represents have wider interests in Europe and further afield and the ICR is achieving its aim of increasing its membership in Europe. As both organisations have these strong international interests, there is scope for the standards to gain wider recognition and be adopted outside Britain.