Amendments

Amendments are changes made to the research after review body(ies) approval has been given. General guidance on amendments during your study is provided in the Research Community and Resources areas of this website.

NHS/HSC R&D – UK process for management of amendments

[Please note: the references to the term ‘NHS’ in the following guidance encompasses the NHS in England and Wales, NHS Scotland and the Health and Social Care System of Northern Ireland.]

Introduction

This new (November 2014) approach for the management of amendments relates to changes made to a research study after NHS Research and Development (R&D) permission is granted (note: amendments made to a study prior to NHS R&D permission* being granted should be handled as part of the permission application process). These amendments may be ‘substantial’ or ‘non-substantial’, which is determined by the sponsor of the research study.

All amendments to a research study are expected to be implemented in a timely manner unless any regulatory authorisation/approval body does not give their approval or NHS/ HSC organisation objects to their implementation.

The management of amendments can represent a significant workload for NHS R&D offices and researchers. The Health Research Authority (HRA), National Institute for Health Research (NIHR) and Devolved Administrations have agreed to streamline the management of amendments by introducing a system of R&D categorisation of amendment. This categorisation will ensure that amendments are handled in a manner that is appropriate to the scale of the amendment and the potential risks to, and the liability of the organisation implementing the amendment.

This page outlines the guiding principles that are intended to underpin the new approach for managing amendments by NHS R&D offices across the UK. This guidance has been produced by the UK Wide NHS Permissions Compatibility Group, and endorsed by the following partners:

• Health Research Authority, England
• National Institute for Health Research (NIHR) , England
• Health & Social Care Research & Development (HSC R&D), Northern Ireland
• Chief Scientist Office (CSO), Scotland
• National Institute for Social Care and Health Research (NISCHR), Wales

Principles

1. The new approach for management of amendments for NHS R&D offices will apply to all multi-site studies being conducted in the UK. For single-site studies, processes for managing amendments may vary slightly in different nations – please refer to lead nation coordinating function for advice..
2. Urgent safety measures are not covered by this new approach – urgent safety measures should be notified to all participating organisations on receipt to ensure the participants’ safety.
3. It is expected that all substantial amendments will be submitted on the relevant notification template that can be accessed from IRAS, and sent in accordance with the instructions in IRAS, or in the case of notifications relating only to non-substantial/minor amendments using the Word document template.
4. This new approach changes the handling of amendments to ‘presumed implementation’ following regulatory approval, unless an objection to the amendment is raised by an NHS organisation within a reasonable time. For studies within the scope of this new approach, Chief Investigator (CI)/Sponsors can presume permission for implementation of an amendment after 35 days (subject to other regulatory approvals being in place), unless the NHS organisation raises an objection within this period.
5. To support the efficient management of amendments, the new approach introduces a system of categorisation to allow a proportionate process to be applied.
6. Those organisations responsible for categorisation will do so in a timely manner, and share the decision with all appropriate parties (CI/Sponsor, relevant NHS organisations, national coordinating functions). This decision will also indicate the date on which ‘presumed implementation’ of the amendment can occur.
7. NHS organisations considering the amendment are expected to do so in a timely manner.
   (a)  Where an amendment is accepted within the 35 day period, it is considered good practice for a letter to be issued to the CI/Sponsor to confirm continuing permission (subject to other regulatory approvals)
   (b) Once the 35 day period elapses, the CI/Sponsor may assume continuing permission (subject to other regulatory approvals)
8. The CI/Sponsor remains responsible for ensuring that amendments and any supporting documentation are passed to the local Principal Investigators (PIs) and their research team.

Categorisation of Amendments

Amendments have been grouped into three different categories for the purpose of handling them in a manner appropriate to the amendment.
NHS organisations should ensure the principle of these categorisations and the relevant processing of amendments is reflected in their SOPs as the MHRA will expect to see processing following the organisational SOP when conducting an inspection.

• Category A – Amendment to a research study that ALL participating NHS organisations are expected to consider
  This category includes any amendment to a research study that has implications for, or affects, ALL participating NHS organisations hosting the research study.
  All participating NHS organisations will be informed of, and have access to the amendment.
  All participating NHS organisations are expected to consider the amendment to determine whether they are able to continue NHS research permission.

•  Category B – Amendment to a research study that only those participating NHS organisations affected by the amendment are expected to consider
  This category includes any amendment to a research study that has implications for, or affects, SPECIFIC participating NHS organisations hosting the research study.
  Only those participating NHS organisations affected by the amendment will be informed of the amendment.  However, all participating NHS organisations will have access to the amendment through the relevant national co ordinating function.
  Only those participating NHS organisations affected by the amendment are expected to consider the amendment to determine whether they are able to continue NHS research permission.Note: Where the amendment is the addition of a new research site, the submission of a SSI application for a new research site should proceed through the NHS permission process appropriate to the addition of a new site in accordance with the requirements of the nation where the new research site is to be added.

 

• Category C – Amendment to a research study that participating NHS organisations are not expected to consider
  This category includes any amendment to a research study that has no implications that require management or oversight by the participating NHS organisations hosting the research study.
  All participating NHS organisations will have access to the amendment.
  Participating NHS organisations are NOT expected to consider the amendment or give continued permission for these amendments.
  There may be amendments of a confidential nature that the Sponsor is required to submit to the MHRA.  Such amendments will have no implications for, or affect, the participating NHS organisations hosting the research study.  Therefore these amendments will not be notified to the NHS organisations.

Guidance for submitting amendments

Please refer to:

• General guidance on amendments
• Guidance for submitting amendments after NHS/HSC R&D permission
• Leaflet on new UK process (v1.1, November 2014; pdf)

* From 1 April 2016 all permission for research in the NHS in England is managed through HRA Approval. Please refer to guidance for more information.

 

< Page last updated 23 March 2016 >