Pages

• About us
  • Board
    • Board Meetings
      • 2011
        • 1 December 2011
      • 2012
        • 11 January 2012
        • 22 March 2012
        • 25 October 2012
        • 30 July 2012
      • 2013
        • 05 December 2013
        • 20 May 2013
        • 22 January 2013
        • 23 July 2013
        • 24 June 2013
        • 29 October 2013
      • 2014
        • 07 July 2014
        • 12 May 2014
        • 16 June 2014
        • 22 January 2014
        • 24 September 2014
        • 26 February 2014
        • 26 March 2014
        • 26 November 2014
        • 29 October 2014
      • 2015
        • 15 April 2015
        • 16 September 2015
        • 18 February 2015
        • 18 November 2015
        • 20 May 2015
        • 21 January 2015
        • 21 October 2015
        • 22 July 2015
      • 2016
        • 08 August 2016
        • 13 April 2016
        • 16 November 2016
        • 17 February 2016
        • 20 January 2016
        • 20 July 2016
        • 20 May 2016
        • 21 September 2016
      • 2017
        • 12 April 2017
        • 17 May 2017
        • 22 February 2017
        • 25 January 2017
  • Governance
    • Accessibility
    • Equality and Diversity
    • Information Governance
      • Freedom of Information
        • How we make decisions
        • List and registers
        • Our policies and procedures
        • Our priorities and performance
        • Responses to previous Freedom of Information requests
        • The services we offer
        • What we spend and how we spend it
        • Who we are and what we do
      • Publication Scheme
    • Organisational transparency
    • Quality Assurance
  • Our committees and services
    • Gene Therapy Advisory Committee (GTAC)
    • HRA Approval
    • Integrated Research Application System (IRAS)
    • Our role in protecting participants
    • Research Ethics Committees (RECs)
    • Research Ethics Service (RES)
    • Section 251 and the Confidentiality Advisory Group (CAG)
      • CAG Advice and HRA/SofS Approval Decisions
        • Minutes of previous ECC meetings
        • Minutes of previous PIAG meetings
      • CAG members
      • What is Section 251?
    • The National Research and Ethics Advisors’ Panel (NREAP)
      • NREAP Guidance
      • NREAP Meetings
      • NREAP People
    • The Over-Volunteering Prevention System (TOPS)
  • Our consultations and calls
    • Closed consultations
      • Draft UK Policy Framework for Health and Social Care Research – for comment (closed)
      • Feedback on revised model Non-Commercial Agreement (mNCA) (Closed)
      • Guidance on participant information at the end of a study (closed)
      • NIHR call for simple and efficient trials (closed)
      • Protocol guidance and template for use in a Clinical Trial of an Investigational Medicinal Product (CTIMP) – for consultation in use (Closed)
      • Qualitative protocol guidance and template
      • Site specific information for NHS/ HSC sites – a call for comments
      • Transparency – Registration and reporting (closed)
    • UK Policy Framework for Health and Social Care Research – for consultation (closed)
  • Our partners
    • Four Nations Compatibility Programme
  • Our plans and projects
    • Collaboration and Development
    • HRA Approval
      • Amendments for the NHS in England for all studies
      • HRA Approval Programme – Listening to feedback
      • New NHS sites in England for all studies
      • Programme Governance
      • Student studies led from England
    • Replacing the Research Governance Framework
      • How we best support research in the NHS – Educational Research
      • Perception of risk in research
      • Risk in research: serious breach notifications and safety reporting
      • Social Care Scoping Exercise
      • What are the risks to research because of perceived risks of research?
    • Research Transparency
      • Older Transparency items
  • Our publications
    • Annual Report
    • Annual Reports for RECs in England
      • April 2011 – March 2012
        • East Midlands – Annual Reports
        • East of England – Annual Reports
        • London – Annual Reports
        • North East – Annual Reports
        • North West – Annual Reports
        • South Central – Annual Reports
        • South East Coast – Annual Reports
        • South West – Annual Reports
        • West Midlands – Annual Reports
        • Yorkshire & the Humber – Annual Reports
      • April 2012 – March 2013
        • East Midlands – Annual Reports 2012-13
        • East of England – Annual Reports 2012-13
        • London – Annual Reports 2012-13
        • North East – Annual Reports 2012-13
        • North West – Annual Reports 2012-13
        • South Central – Annual Reports 2012-13
        • South East Coast – Annual Reports 2012-13
        • South West – Annual Reports 2012-13
        • West Midlands – Annual Reports 2012-13
        • Yorkshire and the Humber – Annual Reports 2012-13
      • April 2013 – March 2014
        • East Midlands – Annual Reports 2013-14
        • East of England – Annual Reports 2013-14
        • London – Annual Reports 2013-2014
        • North East – Annual Reports 2013-2014
        • North West – Annual Reports 2013-2014
        • South Central – Annual Reports 2013-2014
        • South East Coast – Annual Reports 2013-2014
        • South West – Annual Reports 2013-2014
        • West Midlands – Annual Reports 2013-2014
        • Yorkshire and the Humber – Annual Reports 2013-2014
      • April 2014 – March 2015
        • East Midlands – Annual Reports 2014-15
        • East of England – Annual Reports 2014-15
        • London – Annual Reports 2014-2015
        • North East – Annual Reports 2014-2015
        • North West – Annual Reports 2014-2015
        • South East Coast – Annual Reports 2014-2015
        • South West – Annual Reports 2014-2015
        • Summary Reports for HRA Centres
        • West Midlands – Annual Reports 2014-2015
        • Yorkshire and the Humber – Annual Reports 2014-2015
      • April 2015 – March 2016
        • East Midlands – Annual Reports 2015-16
        • East of England – Annual Reports 2015-16
        • London – Annual Reports 2015-2016
        • North East – Annual Reports 2015-2016
        • North West – Annual Reports 2015-2016
        • South Central – Annual Reports 2015-2016
        • South East Coast – Annual Reports 2015-2016
        • South West – Annual Reports 2015-2016
        • Summary Reports for HRA Centres
        • West Midlands – Annual Reports 2015-2016
        • Yorkshire and the Humber – Annual Reports 2015-2016
    • Business Plan
    • HRA Latest
    • Year in Review
  • Who we are
    • Our strategic aims
    • Our values
• Call for good practice – info sheets (Closed)
• Call for good practice – participation (Closed)
• Change Management Project Board
• Committee Directory
• Confidentiality Advisory Group – Standard Operating Procedures
• Consent for simple trials (Closed)
• Contact Us
• Cookie policy
• Feedback
• Feedback on revised model Clinical Trial Agreement (mCTA) – England
• Former RECs
• HRA Approval Programme Staffing Project Board
• HRA Assessment Project Board
• HRA Board Expenses April 2014 – March 2015
• HRA Training
  • eLearning
  • Tools
  • Training days
    • Points of Care Trials
• Links for Reseach Committee
• NHS R&D resources
• NHS REC Proportionate Review Allocation System
• NHS Research Ethics Committee (REC) – submitting a response to provisional opinion
• NHS/HSC R&D – UK process for management of amendments
• Our performance
• Patient involvement strategy (Closed)
• Patients and the public
  • Contact the HRA public involvement team
  • How the HRA involves the public in its work
  • The HRA and public involvement in research
  • The research the HRA regulates and approves
  • Thinking about taking part or getting involved in research?
  • What patients and the public think about health research
    • HRA Sciencewise Public Dialogue project 2013
    • HRA Sciencewise Public Dialogue project 2014
• Pharmacy Assurance
• Public Dialogue Oversight Group
• Radiation Assurance
• REC Member Recruitment Policy
• Recruiting participants (Closed)
• Research Community
  • Applying for approvals
    • Administration of Radioactive Substances Advisory Committee (ARSAC)
    • Confidentiality Advisory Group (CAG): research and non-research applications
    • HRA Approval
    • Human Fertilisation & Embryology Authority (HFEA)
    • Human Tissue Authority (HTA) licence
    • Medicines and Healthcare products Regulatory Agency (MHRA) – Notice of No Objection (Medical Device Research)
    • Medicines and Healthcare products Regulatory Agency MHRA medicines – Clinical Trial Authorisation (CTIMPs)
    • National Offender Management Service (NOMS)
    • NHS management permission
    • Research Ethics Committee
  • Before you apply for approval
    • Access study support services
    • Define your study category
    • Determine whether your study is research
    • Determine which review body approvals are required
    • Funding
    • Participant information sheets and informed consent
    • Plan your sites
    • Planning and study design
    • Prepare other study documentation
    • Protocol
    • Research registration, research project identifiers and plans for dissemination of research findings
    • Roles and responsibilities
    • Seek advice and support
  • During your research project
    • Amendments
      • Completing setup of sites in England for applications made under pre-HRA approval systems
      • Definitions of substantial and non-substantial amendments
      • Preparing amendments
      • Which review bodies need to approve or be notified of which types of amendments
    • Preparing for the end of the study
    • Progress reports
    • Safety Information
  • End of study and beyond
    • Notifying the end of study
    • Participants at the end of study
    • Publication and dissemination
    • Use of tissue/ data after research
  • HRA Approval: the new process for the NHS in England
  • The review process
    • Confidentiality Advisory Group: review process
    • HRA Approval: review process
    • MHRA – Clinical Trial Authorisation
    • MHRA Devices (Notice of No Objection)
    • Navigating the review process
    • NHS Management Permission Review
    • NHS Research Ethics Committee (REC) review
• Research Ethics Committee Members
  • Guidance and policy for members: ethical review
  • Member feedback
  • REC Chairs and Vice Chairs: HRA policy and information
  • REC Members’ training
  • REC Membership: Applying to join a REC
  • Volunteer Members: HRA Policies
• Research Systems Project Board
• Resources
  • After you apply
    • Adding new sites to a study
    • Amendments
      • Substantial and non-substantial amendments
    • NHS Research Ethics Committee (REC) – Review Outcomes
    • Participant Identification Centres
  • Application Problem Solving
  • Applying for reviews
    • Applying for approvals: template documents
    • Integrated Research Application System (IRAS)
    • NHS / HSC R&D review or permission
    • Research summary
    • Scientific review of research
    • Site-Specific Assessment (SSA)
    • Study titles
  • Applying to RECs
    • Gene Therapy Advisory Committee (GTAC)
    • NHS Research Ethics Committee (REC) – Application Process Flowchart
    • NHS Research Ethics Committee (REC) – Directory
      • Mergers, closures and REC name changes
    • NHS Research Ethics Committee (REC) – Proportionate Review Service
    • NHS Research Ethics Committee (REC) – Where to Book
    • NHS Research Ethics Committee (REC) – Central Booking Service (CBS)
  • Before you apply
    • Clinical Research Networks
    • Clinical Study Design Considerations
    • Consent and participation
      • Adults unable to consent for themselves
      • Consent and participant information
    • Is it research?
    • Is NHS REC review required?
    • Non-NHS RECs
      • Higher education institution Research Ethics Committees
      • Ministry of Defence (MoD) Research Ethics Committee
    • Research funding
    • Research requiring NHS review but not ethical review
    • Roles and responsibilties
      • Chief Investigator
      • Principal Investigator
      • Researcher suitability and training
      • Sponsor
      • Sponsor’s legal representative
    • Types of ethical review
      • Ethical considerations in research
      • Ethical review for private and voluntary health care
      • Ethical review of Clinical Trials of Investigational Medicinal Products
      • Ethical review of investigations of Medical Devices
      • Ethical review of research in Independent Healthcare Establishments
      • Ethical review of research in nursing homes
      • Ethical review of research in residential care homes
      • Ethical review of research involving adults unable to Consent for Themselves
      • Ethical review of research involving exposure to ionising radiation
      • Ethical review of research involving human tissue
      • Ethical review of research involving practising midwives
      • Ethical review of research involving the HFEA register
      • Ethical review of research using confidential patient information
    • Types of study
      • Administration of radioactive substances
      • Clinical Trials of Investigational Medicinal Products (CTIMPs)
        • Clinical Trials of Investigational Medicinal Products (CTIMPS): EU Legislation
      • Ethical review of Social Care Research
      • Human Tissue
      • Ionising radiation
      • Medical Devices research
      • Phase 1 Trials
      • Questions and Answers – Medical Devices
      • Research Tissue Banks
      • Social Care Research
      • Student research
      • Study types
  • Confidentiality Advisory Group
    • Confidentiality Advisory Group (CAG) – annual review template
    • Confidentiality Advisory Group (CAG) – meeting dates
    • Confidentiality Advisory Group (CAG) – standard conditions of approval
    • Confidentiality Advisory Group (CAG) – amendment form
    • Confidentiality Advisory Group (CAG) – considerations and application guidance
    • Confidentiality Advisory Group (CAG) – Determining the need for a CAG application
    • Confidentiality Advisory Group (CAG) – form for non-research applications
    • Confidentiality Advisory Group (CAG) – frequently asked questions
    • Confidentiality Advisory Group (CAG) – precedent set criteria
    • Confidentiality Advisory Group (CAG) – Security review arrangements
  • Data legislation and information governance
    • Confidentiality, Privacy and Data Protection
    • Personal Data in Research
    • Research Databases
  • During and after your study
    • Care After Research
    • End of Study Notification – Clinical Trials of Investigational Medicinal Products (CTIMPs): EudraCT form
    • End of Study Notification – Studies other than Clinical Trials of Investigational Medicinal Products
    • NHS Research Ethics Committee (REC) – Annual Progress Report Forms
    • NHS Research Ethics Committee (REC) – CTIMP safety report form
    • NHS/HSC R&D – notification of non-substantial/minor amendment form
    • Progress and Safety Reporting
    • Transparency, registration and publication
  • HRA Approval: applicant guidance
    • HRA assessment criteria and standards
    • HRA Schedule of Events and Statement of Activities for HRA Approval
  • HRA Approval: Guidance for NHS organisations in England working collaboratively with sponsors/chief investigators
    • HRA Approval Portal
    • Illustrative examples of HRA Approval documentation
  • HRA Approval: Guidance for sponsors/chief investigators working collaboratively with NHS organisations in England
  • HRA Approval: Training Resources
  • HRA working in partnership
    • Memorandum of understanding – Human Tissue Authority / NRES
    • Memorandum of understanding – MHRA Medicine / NRES
    • Working between HFEA & CAG – HFEA registry data
  • NHS site set-up in England
  • Public involvement in research
  • Raising concerns about our services
    • Health Research Authority Complaints Policy
    • NHS Research Ethics Committee (REC) – Appeals
    • Raising concerns about a Research Ethics Committee (REC)
    • Raising concerns about the Health Research Authority
  • Regenerative Medicine
  • Research beyond UK
    • International Research
    • NHS Research Ethics Committee (REC) Review – International Research
  • Research legislation and governance
    • Four Nations and UKECA
      • 2013
      • 2014
      • 2015
      • 2016
      • 2017
    • Governance Arrangements for Research Ethics Committees (GAfREC)
    • Legal Requirements for Research Ethics Review
    • Questions and Answers – Mental Capacity Act 2005
    • Questions and Answers – The Human Tissue Act 2004
    • Research Governance Frameworks
    • Standard Operating Procedures
    • World Medical Association Declaration of Helsinki
• Risks in Research (Closed)
• Site map
• South Central – Annual Reports 2014-2015
• Sponsor Responsibilities (Closed)
• Terms and conditions
• Training Days
• Vacancies
• Expenses Policy