SLaM/IoPPN R&D: guidance for submission of non-CTIMP amendments v2
This guidance is for researchers (including students) at the Institute of Psychiatry, Psychology &
Neuroscience (IoPPN) or South London and Maudsley NHS Foundation Trust who require
confirmation of sponsorship for an amendment to their research study, where the original
sponsorship was managed by the SLaM/IoPPN R&D office.
Amendments are changes made to a research study after a favourable ethical opinion has been
given. Amendments can be ‘substantial’ or ‘non-substantial’ depending of the nature of the
changes involved.
The Health Research Authority (HRA) oversees NHS ethics committees and a UK wide process for
handling amendment for NHS R&D. This includes guidance on what constitutes substantial and
non- substantial amendments, the amendment submission process as well as whether or not NHS
sites need to be notified of an amendment.
If the R&D approvals for your study were originally managed through NIHR CSP, please be aware
that as of 31 March 2016 amendments will be categorised by the HRA and will no longer be
submitted to NIHR CSP.
 Detailed guidance on amendments is on the HRA website: http://www.hra.nhs.uk/researchcommunity/during-your-research-project/amendments/
 Please also see the attached HRA leaflet ‘hraapproval-amendments’
Sponsorship
All amendments must be notified to the sponsor, and agreement from the study sponsor is required
before an amendment is submitted to ethics and/or R&D. In order that we can review your
amendment for sponsorship please email the following documents to us at slamioppn.research@kcl.ac.uk
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If the amendment is substantial:- Draft IRAS substantial amendment form and
new/amended documentation.
 If the amendment is non-substantial:- HRA non-substantial amendment form (available
from R&D office or http://www.hra.nhs.uk/resources/during-and-after-yourstudy/nhshsc-rd-notification-non-substantialminor-amendment-form/ and new/amended
documentation.
Please use the track change function to show where documents have been amended.
All amendments – please complete the amendment sponsor request form and return this to us
with the amendment documents. The amendment sponsor request form asks for information
on the following:
 Whether the amendment is substantial or non substantial
Please refer to the guidance in appendix A when categorizing your amendment and contact us
if you are unsure whether the amendment is substantial or non-substantial.
 If the original R&D approvals for your study were not managed through NIHR CSP, please
provide a list of the NHS trusts that have issued you with NHS R&D approval (we need
these to ensure that sites are notified of the amendment). If you are not sure whether your
original R&D approvals went through CSP contact the R&D office and we can look this up
for you. If the original R&D approvals were managed through NIHR CSP we will be able at
the moment to obtain details of the sites for you.
 Whether the cost of the amendment is covered under your existing funding, or whether
there is additional funding. For all new funding sources, please provide details and include
a copy of the funding confirmation with the amendment, for example an external funding
award letter, or email from the BRC or internal department. Where funds are held at the
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IoPPN please also forward the IoPPN cost code. We need this information to pass onto the
relevant grants office at IoPPN and SLaM and for our R&D reporting.
Whether the amendment affects the original end date of the study, and if so whether the
funder has been notified and issued a funding extension (if required).
If you have any questions about your funding or how the amendment will impact on the
funding conditions please contact your grant office directly for advice
Whether an annual progress report has been submitted to the REC within the last 12
months (as required by the NHS ethics service, and for our sponsor records). If not, please
include a completed annual progress report with your amendment documents when you
send them to us for review. Details are on the HRA website here:
http://www.hra.nhs.uk/research-community/during-your-research-project/progressreporting/
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If your amendment involves changes to PET scans (dosage or number of additional
scans), the NHS REC will need reauthorization from the medical physics experts.
When you send us the Notice of Substantial Amendment form, please make sure
that the reauthorised NHS REC form is included with your submission for us to
review and confirm sponsorship. You can request the signatures from the CI
and the sponsor after we confirm sponsorship.
When we receive your amendment in the R&D office we will acknowledge receipt and it will be
reviewed by a facilitator who will contact you if there are any changes required or if we need more
information.
Sponsor sign off for amendments
When the amendment is ready for submission we will arrange sponsor sign off for you. Once this
is in place and you have the sponsor and Chief Investigator signatures please do the following
(instructions will also be included in the sponsorship confirmation email):
Submission of amendment
 Email the amendment and documents in a zip file to the REC manager (contact details are
on your ethics approval letter, contact details for all NHS RECs can also be found on the
HRA website), and copy in the HRA hra.amendments@nhs.net
 Substantial amendments will be validated and then reviewed by REC subcommittee, or
occasionally a full committee. The outcome will be confirmed to you by formal letter within
35 days.
 Non-substantial amendments or any amendments that do not require NHS REC review
should be submitted by email to hra.amendments@nhs.net. using the HRA non-substantial
amendment form. Where a non-substantial amendment is to be notified to the REC for
information only (for example if the non-substantial amendment involves a change to the
protocol or any documents originally reviewed by the REC), copy the REC into the email to
the HRA.
Notifying sites of amendments and NHS R&D review
In terms of site approval and whether NHS sites are required to be notified of amendments, the
Health Research Authority (HRA) groups amendments into three different categories (A, B and C)
for the purpose of handling them in a manner appropriate to the amendment and who needs to
review it The categorization of your amendment will be confirmed by the HRA when you submit
the amendment for review. The classifications are as follows:
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Category A: the amendment affects all sites that will all need to review.
Category B: the amendment affects specific sites, these sites will need to review
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Category C: No sites need to review and you can implement the amendment as soon as
you have REC approval (if this is required for the amendment).
Where sites are required to review the amendment they have 35 days (or until REC
approves if this is after the 35 day date) to tell you they are not able to accommodate
amendment or to or ask for more time for review. You can then implement the amendment.
 Please see Appendix B for the HRA categorisations of amendments
When the HRA has categorised the amendment and sites need to be informed, please follow
the steps on the flowchart in the HRA leaflet ‘hraapproval-amendments’
The R&D office will support you with notifying sites
 Please check that you have the email contact details for the R&D offices of all sites involved.
An up to date contacts list is on the R&D forum website:
http://www.rdforum.nhs.uk/content/contact-details/
Please copy all correspondence to our R&D office email address slam-ioppn.research@kcl.ac.uk. As
the sponsoring R&D office we are responsible for ensuring that your amendments go through the
correct approvals process and are notified to sites appropriately, and that we keep a full record of
the amendment.
Please be aware that it is the Chief Investigator’s responsibility to ensure that sites and local PIs
have the correct up to date REC approved study documents. This is not provided by local R&D
offices.
Appendix A
Categorising amendments to research projects (non CTIMPS)
HRA definition of a substantial amendment: one that is likely to affect to a significant degree:
(a) the safety or physical or mental integrity of the subjects of the trial,
(b) the scientific value of the trial,
(c) the conduct or management of the trial, or
(d) the quality or safety of any investigational medicinal product used in the trial.
HRA guidance on whether an amendment is substantial:
‘In deciding whether an amendment is substantial, consideration needs to be given to whether the
proposed changes will affect the research “to a significant degree”. Particular account should be
taken of any implications for the safety or welfare of participants, and of any information that
participants might require to give informed consent to continue to participate in the research as
amended. It is recommended that where there is any doubt about the potential implications of the
amendment for participants, it should be treated as a substantial amendment and ethically
reviewed by the REC’
The following changes should normally be regarded as substantial:
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changes to the design or methodology of the study, or to background information affecting
its scientific value;
changes to the procedures undertaken by participants;
any change relating to the safety or physical or mental integrity of participants, or to the
risk/benefit assessment for the study;
significant changes to study documentation such as participant information sheets, consent
forms, questionnaires, letters of invitation, letters to GPs or other clinicians, information
sheets for relatives or carers;
a change of sponsor(s) or sponsor’s legal representative;
appointment of a new chief investigator;
a change to the insurance or indemnity arrangements for the study;
inclusion of a new trial site (not listed in the original application) in a CTIMP;
appointment of a new principal investigator at a trial site in a CTIMP;
temporary halt of a study to protect participants from harm, and the planned restart of a
study following a temporary halt;
a change to the definition of the end of the study;
any other significant change to the protocol or the terms of the REC application. -
Minor amendments: There will be changes to the details of research that have no significant
implications for participants or for the conduct, management or scientific value of the study and
can be regarded as non-substantial or minor amendments. Examples might be as follows:
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minor changes to the protocol or other study documentation, e.g. correcting errors,
updating contact points, minor clarifications;
updates of the investigator’s brochure (unless there is a change to the risk/benefit
assessment for the trial);
changes to the chief investigator’s research team
changes to the research team at particular trial sites (other than appointment of a new
principal investigator in a CTIMP);
changes in funding arrangements;
changes in the documentation used by the research team for recording study data;
changes in the logistical arrangements for storing or transporting samples;
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inclusion of new sites and investigators in studies other than CTIMPs;
extension of the study beyond the period specified in the application form.
Changes to contact details for the sponsor (or the sponsor’s representative), chief investigator or
other study staff are minor amendments but should be notified to the main REC for information.
Amendments requiring submission of a new application NRES SOPS v5.1
A new application should only be required where a proposed amendment would fundamentally
alter the nature of the research and the extent of the involvement of, or risk to, existing and/or
potential participants. Examples might be where the proposed amendment involves:
 A change in the primary purpose or objective of the research, such as introduction of
additional genetic studies;
 A substantial change in research methodology;
 Introduction of new classes of investigations or other interventions (rather than simply rescheduling or modifying those already approved);
 Recruitment of a new type of participant (especially if these would be regarded as being
from vulnerable groups);
 A proposed sub-study with a different Chief Investigator and/or an intention to publish the
results separately from the parent study.
Where an amendment involves the submission of a separate protocol, the REC should normally
require the submission of a new application.
Appendix B
HRA categorisation of amendments A,B and C
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.