Updated September 2025
General changes throughout
- correction of typographical errors and other minor errors
- changed the primary format of the document from pdf to a webpage which necessitated other changes
- replacement of footnotes with embedded links to other resources as appropriate
- tables replaced with listed information
- updated links to external resources as required
- created a new appendix for footnotes
1.1 IRAS application completed correctly
- clarified that tissue left over from other research studies can be used in a new research study that wants to use existing human biological samples
3.1 Protocol Assessment
- clarified that samples may be retained for up to 12 months after the end of the study for the purpose of data verification
4.3 Financial arrangements assessed
- clarified that evidence of the iCT submission to CPMS should be provided in the IRAS application pack
5.1 Assessment of Information Governance, Data Protection Compliance and Data Security
- section title changed from ‘Compliance with Data Protection law and data security issued assessed’ to clarify that it this section applies to wider information governance as well
- simplified the language throughout this section
- general changes to structure, format and presentation throughout the section
- correction of typographical errors and other minor errors
- introduced additional sub-section headers and added sub-section numbers to each header
- added a new section-specific contents box
- moved the study wide considerations from the end of the section to the beginning
- 5.1.6 – updated section to reflect updated guidance on who can access patient data and what circumstances they can do so
- 5.1.11 – added new information to describe the difference between a UK representative and a UK legal representative
- 5.1.12 – added new information to describe the role of a data protection officer
- 5.1.14 – moved information about transparency requirements to create a new section-specific appendix (Appendix 1)
- 5.1.15 - moved information about data subject rights and appropriate additional safeguards to create a new section-specific appendix (Appendix 2)
- 5.1.15.4 – added new information to explain why consent should not be used as the legal basis for processing personal data under UK GDPR in a research study
- 5.1.16.1 – moved information about the Chapter V conditions for international transfer of personal data to create a new sub-section specific appendix (Appendix 3)
5.2 CTIMPS Arrangements for compliance with the Clinical Trials Regulations assessed
- clarified that children aged 16 or older are presumed to be able to give consent on their own behalf, rather than needing to be older than 16
5.3 Compliance with national legislation regarding Adults unable to consent for themselves in a non-CTIMP
- clarified the different requirements for an ‘Appropriate body’ in Northern Ireland compared to England and Wales
- updated the sub-section header from ‘Provision of advice/consent from consultees/Legal representatives’ to ‘Provision of advice from consultees and receiving consent from Legal representatives’ to clarify that consultees give advice but legal representatives can give consent
- clarified that in England and Wales where capacity (not consent) is likely to be lost during the course of research, the sponsor should explain what monitoring arrangements will be put in place
- clarified that in England and Wales where capacity (not consent) is lost during the course of research and the sponsor wants to conduct further activities constituting ‘intrusive research’ on that participant then approval from a recognised REC and advice from a consultee should be sought
- clarified that in Northern Ireland where capacity is likely to be lost during the course of research, the sponsor should explain what monitoring arrangements will be put in place
- clarified that in Northern Ireland where capacity is lost during the course of research and the sponsor wants to conduct further activities constituting ‘intrusive research’ on that participant then approval from an appropriate body and advice from a consultee should be sought
- added new information about when a participant loses capacity in Northern Ireland but consent has been given prior to the loss of capacity for use of previously collected samples and data
- added new information about the requirement for consultee advice when the potential for losing capacity was discussed during the initial research consent process with the participant
5.4 Compliance with national legislation regarding Human Tissue
- clarified that tissue can be stored for up to maximum of 7 days without a HTA license in England, Wales and Northern Ireland for research purposes
5.5 Compliance with any other applicable laws or regulations
- deleted duplicative study wide considerations
6.2 CTIMPS – Clinical Trial Authorisation (CTA) letter received
- removed mention of applications being made on EudraCT forms
Updated November 2021 or before
General changes throughout
- updated further guidance links
- additional minor textual changes to improve readability and provide additional context and guidance
- clearer distinction between study wide considerations as opposed to introductory and contextual guidance in each area of assessment
Section A (Areas of review HRA assessment which are additional to the UK study wide governance criteria
- section A moved to the end of the document and retitled ‘Additional areas of review for the purposes of HRA/HCRW Approval’. Amended to reflect changes in expectations following adoption of these checks by Wales, and to reflect the position agreed with the MHRA in respect to Principal Investigator oversight
1.1 IRAS application completed correctly
- amended to reflect current policy positions regarding student research, as expressed here and to add further clarity regarding the position agreed with the MHRA in respect to participating site types
2.1 Participant information / consent documents and consent process
- general updates to reflect policy expectations regarding the common law duty of confidentiality and the information that should be provided to study participants
- addition of detailed requirements regarding child participants, the nature of consent (in line with ICO position), in respect to the management of Potential ‘health-related findings’ and the use of Electronic Consent methods (in line with the Joint HRA/MHRA statement)
3.1 Protocol assessment
- additional clarification regarding the need for the protocol to provide instructions to participating NHS/HSC organisations to enable them to deliver the research, including regarding the definition of the end of the study
4.1 Allocation of responsibilities and rights are agreed and documented
- updates to reflect changes in the availability of, and expectations regarding the use of, model agreements
- updates to reflect the contractual requirements of GDPR
4.2 Insurance / indemnity arrangements assessed
- updates to insurance expectations in line with the UK Policy Framework for Health and Social Care Research, in particular in respect to management and design
- changes to insurance expectations as these relate to primary care following disestablishment of PCTs and equipment indemnity following changes in expectations relating to the Master indemnity agreement
4.3 Financial arrangements assessed
- no additional significant changes
5.1 Compliance with Data Protection law and data security issues assessed
- additional criteria with respect to situations where a study requires the installation of specific software on NHS systems, or the utilisation of hardware additional to standard NHS equipment
- redrafted to include requirements of Data Protection Act 2018 and GDPR and to more clearly express the requirements of the Common Law duty of confidentiality
5.2 CTIMPs – Arrangements for compliance with the Clinical Trials Regulations assessed
- redrafting to more clearly describe expectations regarding the conduct and management of the CTIMP at participating NHS/HSC organisations
- additional criteria in relation to the inclusion of minors in a CTIMP and in relation to incapacitated adults
- additional information provided regarding HRA Pharmacy Technical Assurance
5.3 Compliance with national legislation regarding Adults unable to consent for themselves in a non-CTIMP
- additional section added to separate the requirements more clearly in relation to Adults unable to consent for themselves in a non-CTIMP in line with relevant legislation and policy guidance, and reflecting the differences in legislation between the four nations, including the Mental Capacity Act (NI) 2016
5.4 Compliance with national legislation regarding Human Tissue
- additional section added to separate the requirements more clearly in relation to compliance with national legislation regarding Human Tissue in line with relevant legislation and policy guidance and reflecting the differences in legislation between the four nations
5.5 Compliance with any other applicable laws or regulations
- deletion of criteria in relation to Adults unable to consent for themselves and Human Tissue
- updated criteria in relation to the requirements of the Welsh Language Act 1993
- additional criteria in relation to The Ionising Radiation (Medical Exposure) Regulations 2017 and the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018 including the Radiation Technical Assurance programme
6.1 NHS Research Ethics Committee favourable opinion received for applicable studies
- no additional significant changes
6.2 CTIMPs – Clinical Trial Authorisation (CTA) letter received
- no additional significant changes
6.3 Devices – MHRA Notice of no objection received
- amended to reflect changes in medical device regulations for MHRA assessment in Great Britain (England, Wales and Scotland) differ from those applicable to Northern Ireland. The Northern Ireland Protocol requires Northern Ireland to continue to align with EU rules for devices after 1 January 2021. Therefore, the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR) will apply in Northern Ireland from 26 May 2021, and 26 May 2022 respectively, in line with the EU’s implementation timeline
6.4 Other regulatory approvals and authorisations received
- redrafting of requirements when accessing patient information without consent
- updated criteria in relation to access to Criminal Offenders
- additional criteria in relation to Genetically Modified Organisms (GMOs)