Governance, advice and ethics systems

The NIHR is working to simplify and streamline administrative and regulatory procedures governing research trials and studies. 

The key initiatives are: 

• Ensuring good governance through networks
  A national unit in the NIHR Clinical Research Network Coordinating Centre (NIHR CRN CC) coordinates R&D management.
  
  A key function of the NIHR Comprehensive Research Network (CRN) is excellent R&D management to deliver proper governance. It helps researchers deal with regulatory, governance and ethics procedures to consistently high standards, safeguarding the rights, safety, dignity and well-being of people who take part.
  
  The research-active NHS organisations in the CRN work together as a national research management and governance service, sharing common procedures and integrated R&D information systems.
  
  The national coordinating unit for research management and network became operational in April 2007. The NIHR CRN implemented the Comprehensive Local Research Networks (CLRNs) from 2007. 
  
  To improve the quality, speed and efficiency of research and research processes in the NHS, the NIHR is also facilitating the reconfiguration of NHS R&D offices within a national framework for research support services. This will harmonise and streamline the local processes for funded health research in the NHS and build consensus on a proportionate risk-based interpretation of policies and rules by NHS R&D offices.
  
  
• Integrated Research Application System (IRAS)
  IRAS is a single, integrated on-line application system, launched in January 2008, that streamlines the process for permissions and approvals to conduct health and social care research. Using IRAS, researchers can enter information about their study in one place. It is designed to save time and effort.  Applicants no longer duplicate information in separate application forms for each type of approval. The system has prompts and an e-learning module to help them get it right.
  
  The National Research Ethics Service developed IRAS with support from its partners including the NIHR. The Department of Health funds it. Further information is available on my research project website. 
  

• The NIHR Coordinated System for gaining NHS Permission (NIHR CSP)
  In 2008, the NIHR launched a procedure to streamline local NHS permission so that clinical research studies can be approved much more quickly. This includes a 'one stop shop' and shared information systems, reducing bureaucracy for studies intended for the NIHR Portfolio.
  
  The NIHR CSP is now the standard method of providing and checking information on studies for adoption for the NIHR Portfolio. Investigators apply through the Integrated Research Application System. IRAS now provides a single point of application for research regulation, approvals and local permission to start a study.
  
  From April 2009, NHS organisations have to use the NIHR CSP for NIHR portfolio studies if they are to qualify for NIHR clinical research network funding.
  
  Further information can be found on NIHR Clinical Research Network website.
  
  
• Research Passport
  The research passport unifies and simplifies administrative procedures to make it easier and faster to begin agreed research studies. It is a streamlined approach to issuing honorary research contracts for researchers who have no contractual arrangements with the NHS but who carry out research in the NHS that can affect patient care.
  
  We developed the Research in the NHS - Human Resource (HR) Good Practice Resource Pack, with extensive support from the NHS R&D Forum working with partners in the UK Clinical Research Collaboration (UKCRC). After piloting in September 2006, the Pack was made generally available in 2007. The pack will be revised from time to time.
  
  The Department of Health recommends the Research Passport to the NHS, Higher Education Institutions (HEIs) and other research employers working in partnership with the NIHR. The UKCRC Partners endorse the routine use of the Research Passport system.
  
  The resource pack provides guidance and good practice standards for the NHS and Higher Education, to achieve consistency in issuing and recognising NHS honorary research contracts. The Comprehensive Local Research Networks have adopted the Research Passport as standard practice.
  
  Research Passport: Research in NHS - HR Good Practice Resource Pack
  
  
• Regulatory and governance advice service
  The Regulatory and Governance Advice Service is a national advice service of front-line advisers in the CLRNs, linked to national experts on regulatory processes, approvals and permissions.
  
  We and our partners developed and piloted an Advice Service for regulatory and governance issues under the auspices of the UK Clinical Research Collaboration (UKCRC). The Advice Service was expanded in 2007 to cover the whole of the UK. In England, it works locally through the Comprehensive Local Research Networks.
  
  The Regulatory and Governance Advice Service handles complex queries and those involving more than one regulatory issue. It is developing authoritative, web-based resources, such as tool kits and a new online Q&A, to share good practice, promote consistency and provide support to local R&D. The future of the Service is under review in light of the government’s decision to create a Health Research Authority.

          Further information is available through the UKCRC.