Governance, advice and ethics systems

The NIHR is working to simplify and streamline administrative and regulatory procedures governing research trials and studies. Implementation Plan 4.1a Bureaucracy Busting. Governance Advice and Ethics (PDF) describes how this is happening.

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.
  
  Implementation Plan 4.1b Bureaucracy Busting. Ensuring good governance through Networks (PDF)
  Implementation Plan 4.1g Bureaucracy Busting. NIHR Research Support Services (PDF)
  
  
• Integrated Research Application System (IRAS)
  IRAS is a single, integrated on-line application system. Launched in January 2008, it 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.
  
  Users and review bodies are encouraged to give feedback. The IRAS team is delivering the improvements they asked for. These are the main improvements so far:
  
• You can import and export data on Investigational Medicinal Products between EudraCT and IRAS for applications to MHRA Medicines.
• IRAS is the entry point for the NIHR Coordinated System for gaining NHS Permission (NIHR CSP).
• Version 2.0 of IRAS improved guidance and functionality, including electronic authorisations.
• Version 2.1 included the full EudraCT application form. This allows applications forms and xml files for authorisation of clinical trials of investigational medicinal products to be created from IRAS for submission to the MHRA.
• In April 2009 IRAS became the preferred method of application to the review bodies included in it.
• Version 2.3 (3 July 2009) included:
• the application form for the new Social Care Research Ethics Committee;
• a free, online e-learning module;
• Version 7 of EudraCT.
•  Version 2.4 (14 August 2009) includes the facility for creating Site-Specific Information Forms and managing amendments for studies that were submitted for REC review outside IRAS.
•  Changes to applications through the NIHR CSP
• Version 2.4.1 (21 Sept 2009) - change to question A4 in response to feedback.
• Version 2.5 (5 Oct 2009) includes
• MHRA Devices PCA2 Checklist Form has additional questions
•  Minor changes have been made to the ARSAC form.

The National Research Ethics Service developed IRAS with support from its partners including the NIHR. The Department of Health funds it. The IRAS team is preparing for an evaluation to inform future development.

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.
  
  Implementation Plan 4.1c Bureaucracy Busting. NIHR CSP (PDF)
  
  
• 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 (PDF), 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
  
  Implementation Plan 4.1d Bureaucracy Busting. Research Passport (PDF)
  
  
• 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.

          Further information is available through the UKCRC.

          Implementation Plan 4.1e Bureaucracy Busting. Regulatory and Governance Advice Service (PDF)