Streamlining the Regulatory and Governance environment

Streamlining the R&G environment Presentation notes: The UKCRC Partners and stakeholders are committed to promoting a streamlined regulatory and governance environment that facilitates high quality clinical research whilst protecting the rights, dignity and safety of participants. The regulatory and governance environment for research is often presented as being inconsistent and overly bureaucratic, both in terms of administration and process as well as interpretation of regulations. The UKCRC Partners and stakeholders prioritise 6 key areas: Restructuring Health Service R&D Permissions:The UK Health Departments have introduced systems to ensure streamlined consistent approaches to R&D permission in each nation, furthermore they are committed to ensure that this systems are harmonised and that there will not be duplication of activities. Streamlining information requirements for permissions & approvals: the integrated research application system (IRAS): Before starting a research study it is often necessary to obtain a number of regulatory and permissions and approvals and this has until recently been achieved through the completion of many forms that often have overlapping information requirements. Under the UKCRC umbrella work is underway to address this through the introduction of an “Integrated Research Application System” (IRAS) which was launched for use in consultation in January 2008. A final version, incorporating feedback from users, is expected to be launched in summer 2008. Consistent approach to advice provision: The UKCRC has set up a Regulatory and Governance Advice Service that provides support for local advice providers through provision of consistent and authoritative advice on a range regulatory and governance issues. This service offers a route for resolution of complex queries (for example those involving more than one regulatory body) as well as online resources, including Q&As and toolkits and an online query submission function. Research Passport for Honorary Contracts: The Research Passport delivers honorary research contracts (where required) to those who have no contractual relationship with the NHS e.g. a scientist or psychologist employed by a University. It promotes consistent use of honorary research contracts by the NHS and clear guidance on their use. UK-wide Roll-out of the Research Passport began at the end of October 2007. Suite of model agreements:The roles and responsibilities of the parties undertaking a research study have to be agreed and documented before study start-up. This has in the past led to time-consuming and costly negotiations between sponsors and the site carrying out the research. Consequently, the UKCRC Partners and stakeholders have been working on a suite of model agreements that can be used off the shelf without protracted negotiation. Early engagement with regulatory change: Much of the regulatory change in the UK originates in Europe and so the UKCRC Partners and stakeholders have jointly developed a strategy that ensures that information about regulatory change is highlighted as early as possible so that it is possible to become involved earlier in the process. Further information: UKCRC regulatory and governance web pages: http://www.ukcrc.org/activities/regulation_and_governance Or contact the UKCRC secretariat at info@ukcrc.org, phone +44 (0)20 7670 5452.