A Research Passport system is being rolled out across the UK as part of the continuing efforts by government, the pharmaceutical industry, academia and the National Health Service (NHS) to harmonise and streamline the administration of research involving NHS patients.
The Research Passport forms part of a wider Human Resources (HR) Good Practice Resource Pack for research in the NHS, which is available through the National Institute for Health Research (NIHR). The passport system was originally developed and piloted from 2004 in Greater Manchester, with the aim of saving time, money and effort when researchers not employed by the National Health Service, and who have no contractual relationship with the Service, want to work across a number of NHS organisations (e.g., conducting multicentre clinical trials).
Following a roll-out across the northwest of England in 2005, the UK Clinical Research Collaboration (UKCRC) took up further development of the Research Passport through the NHS R&D Forum, including pilots in London, Trent, Tayside, the South Coast, Staffordshire, Shropshire and North Wales between August 2006 and April 2007. In January 2006 the government said in its health research strategy document, Best Research for Best Health, that it would adopt the passport as one of a series of measures to unify and streamline research administration in the UK.
Implementation of the new system, which is expected to be completed next year, will be driven by the Departments of Health in England, Northern Ireland, Scotland and Wales, working closely with both the NHS and the university sector. The new Comprehensive Local Research Networks established by the NIHR will adopt the Research Passport as standard practice and develop working procedures with their local partners.
Usually non-NHS staff who want to carry out research in the NHS have to obtain an Honorary Research Contract (HRC). In the past, the UKCRC notes, there has been no clear UK-wide guidance on the situations in which HRCs are required and how they should be used. This led to been inconsistencies in the way different NHS organisations issued honorary contracts. Moreover, researchers looking to work across multiple NHS sites needed to get a new HRC from each host organisation, each of these involving several pre-engagement checks (e.g., Criminal Records Bureau, occupational health checks).
The Research Passport enables pre-engagement checks conducted by non-NHS employers to be shared with NHS organisations, removing the need for duplication, while providing a streamlined standard application system and ensuring consistent and appropriate use of HRCs. It has the added benefit of clarifying good HR practice around the use of pre-engagement checks for researchers who hold honorary clinical contracts or NHS substantive employment contracts, and who wish to conduct research across several NHS organisations, the UKCRC pointed out.
New publications on clinical trials
The UKCRC has also launched two new publications providing information for the public and patients about the different types of clinical trial carried out in the UK.
A leaflet, Clinical trials: what they are and what they’re not, answers some common questions about trials, such as whether they are safe and whether participants are just being used as ‘guinea pigs’. More detailed explanations on what clinical studies are, and how they are set up and run, are available in a booklet, Understanding Clinical Trials.
The publications, which were developed with the help of the Association of Medical Research Charities, accept that some patients will not want to take part in clinical trials, especially those lasting several years. Other patients, though, enjoy trials and feel they are contributing to medical advances, the UKCRC says.
The leaflet and booklet also acknowledge the safety issues raised by last year’s disastrous Phase I study with the TGN1412 monoclonal antibody at London’s Northwick Park Hospital, explaining that “this was an extremely rare event, which is one reason why it attracted such intense interest”, the UKCRC notes.
“Without trials, there is a risk that people could be given treatments which have no advantage, waste resources and might even be harmful,” the new booklet states. “Many treatments that are now in common use in health care were tested in clinical trials.”
Both publications may be downloaded from the UKCRC website at www.ukcrc.org/publications/informationbooklets.aspx.