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Integrated Research Application System (IRAS)

Collated Question-specific guidance for Project Filter

The following document collates all guidance for the questions in Project Filter.

Content

  1. Question Control 1 - The short title of the research
  2. Research or audit/service evaluation
  3. Question 2 - Clinical trials of investigational medicinal products
  4. Clinical investigations or other studies of medical devices
  5. Clinical trial of a drug/device combination
  6. Other clinical trials or clinical investigations
  7. Basic science study involving procedures with human participants
  8. Study administering questionnaires/interviews for quantitative or mixed
  9. Study involving qualitative methods only
  10. Study limited to working with human tissue samples and/or analysis of data
  11. Study limited to working with data
  12. Research tissue bank
  13. Research database
  14. Other research
  15. Question 2 - Clinical trials of investigational medicinal products
  16. Other research
  17. Commercial sponsorship or funding
  18. Clinical investigation for CE marking purposes
  19. Combined clinical investigation for CE marking purposes and clinical trial of an
  20. Post-market clinical study involving a change to standard care or randomisation
  21. Registry of a CE marked device in clinical use, involving no change to standard
  22. Performance evaluation of an In Vitro Diagnostic Device (PEIVDD)
  23. Clinical study of a non-CE marked device where commercialisation is intended
  24. Clinical study of a non-CE marked device where commercialisation is not intended
  25. Clinical study of CE marked device for an off-label indication
  26. Clinical study of CE marked device(s) for a labelled indication, involving a
  27. Clinical study of CE marked device(s) for a labelled indication, involving no
  28. Pre-clinical device development or performance testing
  29. Trials subject to advice from EAG/CHM
  30. Gene therapy medicinal products
  31. Question 2A - Ionising radiation
  32. You should answer “Yes” to this question if the research protocol includes any
  33. Question 2B - New human tissue samples (or other human biological samples)
  34. Question 2C - Existing human tissue samples (or other human biological samples)
  35. Question 2A - Ionising radiation
  36. You should answer “Yes” to this question if the research protocol includes any
  37. Research taking new human tissue samples
  38. Research involving surplus or existing samples identifiable to the researcher
  39. Research involving surplus or existing samples not identifiable to the
  40. Research involving identifiable data
  41. Research involving identifiable data
  42. Question 3 - Countries of the UK
  43. Lead R&D Office
  44. Countries of the UK
  45. Countries of the UK
  46. Question IRAS Form Guidance - IRAS Form
  47. Application for NHS/HSC management permission
  48. Question 4 - Application to the Social Care Research Ethics Committee
  49. Question 4 - Application to Research Ethics Committee
  50. Applying for clinical trial authorisation
  51. Application to MHRA Devices
  52. Application to Gene Therapy Advisory Committee
  53. Application to the Confidentiality Advisory Group (CAG)
  54. Question Application to NOMS - Select this option for projects taking place within the National Offender
  55. It is a requirement of the Medicines (Administration of Radioactive Substances)
  56. Form Print Guidance
  57. Question 4b1 - Research requiring approval/management permission for the NHS but not ethical
  58. Question 4b - Research requiring approval/management permission for the NHS but not ethical
  59. Question 5 - NHS or non-NHS site?
  60. What is NIHR CSP?
  61. The National Institute for Health Research (the NIHR) has put in place
  62. The Clinical Research Network (CRN) is part of the National Institute for Health
  63. Question 5c - The Clinical Research Network (CRN) is part of the National Institute for Health
  64. Question 6 - Children
  65. Question 7 - Adults unable to consent for themselves
  66. Question 8 - Prisoners
  67. Question 9 - Educational projects
  68. Research funded by the US Department of Health and Human Services
  69. Question 10 - Processing identifiable data without consent

The short title of the research

  • The program automatically uses this to create a "header" throughout the form. The applicant should include a version number as part of the short title to help the identification of documentation approved and the future monitoring of the application.

  • Use this title consistently in all information sheets and consent forms for research participants or others giving consent on their behalf. It must be sufficiently detailed to make clear to participants what the research is about. If acronyms are used the full title should explain them.

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Research or audit/service evaluation

Where a project is not classified as research, all potential applications in IRAS are disabled except those to the Confidentiality Advisory Group (CAG; see note below). Applications to other bodies are required only where a project is considered to be research.

The Research Governance Frameworks for Health and Social Care set out the responsibilities and standards that apply to work managed within the formal research context. For the purposes of Research Governance, 'research' means the attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods. Although some research projects include evaluation, where a project is considered to be solely audit or service/therapy evaluation, it will not be managed as research within the NHS or social care. Such projects do not require ethical review by a NHS or Social Care Research Ethics Committee or management permission through the NHS R&D office. There is no need to submit applications in IRAS either to the NHS REC or R&D office.

Differentiating research, audit and service evaluation

The Health Research Authority (HRA) has prepared some simple guidance for researchers in the form of a decision tool, which is available at http://www.hra.nhs.uk/resources/before-you-apply/is-it-research/ . The NHS R&D Forum has published more detailed guidance aimed primarily at NHS R&D offices, which is available at http://www.rdforum.nhs.uk/content/resources/#Deciding.

The decision tool is for use by applicants and R&D offices in assessing whether or not a project should be classified and managed as research. If in doubt, you may consult the Chair of your local NHS REC or your R&D office, or email the HRA Queries Line at hra.queries@nhs.net.

Additional guidance on the characteristics of research in the social care setting is available in the Research Governance Framework Resource Pack for social care available at http://www.hra.nhs.uk/resources/before-you-apply/non-nhs-recs/national-social-care-research-ethics-committee/ .

If after discussion the project is considered to be research, reply "Yes" to sieve question 1 and proceed with applications to a NHS REC and R&D office.

If the project is solely audit or service evaluation, or some other type of non-research activity such as case study, system/equipment testing or satisfaction survey, you should check with the NHS clinical governance office or local authority what other review arrangements or sources of advice apply to the project. For example, there may be standard guidelines on the conduct of clinical audit. The Caldicott Guardian of Local Authority Information Governance Lead will be a source of advice on the use of patient or service user data.

Confidentiality Advisory Group (CAG)

If you are conducting an audit, service evaluation or other non-research activity with a medical purpose and the project will involve use of identifiable patient data without explicit consent, you may need to apply for support under Section 251 of the NHS Act 2006. Please select CAG under Question 4 below in the sieve and continue with the application.

Please see http://www.hra.nhs.uk/about-the-hra/our-committees/section-251/ for further guidance.



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Clinical trials of investigational medicinal products

Select this option for medicinal trials falling within the scope of the EU Clinical Trials Directive and the Medicines for Human Use (Clinical Trials) Regulations 2004.

Medicinal products are substances or combinations of substances which either prevent or treat disease in human beings or are administered to human beings with a view to making a medical diagnosis or to restore, correct or modify physiological functions in humans.

A clinical trial is an investigation in human subjects which is intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more medicinal products, identify any adverse reactions or study the absorption, distribution, metabolism and excretion, with the object of ascertaining the safety and/or efficacy of those products. This definition includes pharmacokinetic studies.

Clinical studies involving only medical devices, food supplements or other non-medicinal therapies (such as surgical interventions) are not covered by the Directive. The Regulations do not apply to non-interventional trials. In such trials, no additional diagnostic or monitoring procedure should be applied.  Epidemiological methods should be used for the data analysis.

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for advising on the Regulations and requirements for clinical trial authorisation (CTA).  More detailed guidance is available at:

http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=723

Section 2 of the guidance links to an algorithm to help you decide whether or not your research is a clinical trial of an investigational medicinal product (CTIMP).

If you remain unsure after checking the algorithm, please contact the MHRA Clinical Trials Helpline for advice by writing to clintrialhelpline@mhra.gsi.gov.uk

It is a criminal offence to conduct a CTIMP anywhere in the UK without CTA from the MHRA.  This applies both to commercial and non-commercial research, and both to phase 1 drug development and later phase research.

Non-interventional trials of licensed medicines

Regulation 2 of the Clinical Trials Regulations defines a "non-interventional trial" as a study of one or more medicinal products with a marketing authorisation meeting all of the following conditions:

(a)               the products are prescribed in the usual manner in accordance with the terms of that authorisation

(b)               the assignment of any patient involved in the study to a particular therapeutic strategy is not decided in advance by a clinical trial protocol

(c)               the decision to prescribe a particular medicinal product is clearly separated from the decision to include the patient in the study

(d)               no diagnostic or monitoring procedures are applied to the patients included in the study, other than those which are ordinarily applied in the course of the particular therapeutic strategy in question

(e)               epidemiological methods are to be used for the analysis of the data arising from the study.

If your study is a non-interventional trial of a licensed medicine according to the Regulations, please select another option in Project Filter question {QNumber(Guid_Sieve_Q_2)}.  Where no additional research procedures are involved (e.g. questionnaires), the most appropriate category will usually be "Study limited to working with human tissue samples and/or data".  If the research will also involve questionnaires, please select "Study administering questionnaires/interviews for quantitative analysis, or using mixed quantitative/qualitative methodology".

Post-marketing surveillance by the pharmaceutical industry not involving any additional research procedures will generally fall within the classification of service/therapy evaluation rather than research.  Under NHS research governance arrangements, service/therapy evaluation does not require either ethical review or management permission from R&D offices.  For further guidance on differentiating between research, audit and service/therapy evaluation, please refer to the Health Research Authority (HRA) guidance, which is available at: http://www.hra.nhs.uk/resources/before-you-apply/is-it-research/





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Clinical investigations or other studies of medical devices

This option should be selected for any clinical investigation or other research study of a medical device.  Further questions will appear to identify the type of study and generate the appropriate version of the form.

Do not select this option where the research protocol involves use of a CE marked device within its intended purpose but is not designed to investigate the device itself.

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Clinical trial of a drug/device combination

Select this option only where the trial involves the use of both an investigational medicinal product and an investigational medical device (either a non-CE marked device or a device which has been modified or is being used for a purpose not covered by the CE mark).

In these circumstances, the trial would exceptionally require both:
  • Notice of No Objection under the Medical Devices Regulations 2002, and

  • Clinical trial authorisation under the Medicines for Human Use (Clinical Trials) Regulations 2004.

Applicants are advised to seek expert advice from either branch of MHRA on the regulatory requirements for combined drug/device trials.  Contact either of the following: Where MHRA advise that the trial will be regulated under only the Medicines or Devices Regulations, please untick the combined drug/device option and proceed as follows:
  • If regulated only as a medicinal trial, select "Clinical trial of an investigational medicinal product".

  • If regulated only as a devices investigation, select "Clinical investigation of a medical device".

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Other clinical trials or clinical investigations

This option should be selected for clinical research not involving investigational medicinal products or medical devices.

For example, this option would be appropriate for research involving:
  • Surgery

  • Radiotherapy

  • Imaging investigations

  • Mental health investigations or therapies

  • Physiological investigations

  • Trials of products not defined as medicines or medical devices (e.g. nutritional)

  • Complementary or alternative therapies

Medicinal research

If you are unsure whether your research is subject to the Medicines for Human Use (Clinical Trials) Regulations 2004, please consult the detailed guidance on the MHRA website at:

http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=723

Section 2 of the guidance links to an algorithm to help you decide whether or not your research is a clinical trial of an investigational medicinal product (CTIMP).  Specific advice may be sought by emailing clintrialhelpline@mhra.gsi.gov.uk.  If the research is a CTIMP, you must select the first option in answer to Question 2 on the project filter.

Devices research

If your research is a study of a medical device, please select the appropriate option on the Project Filter rather than "Other clinical trials or investigations".

Guidance on medical devices research is available in the document "Medical Devices Guidance for Applicants and RECs" at:

http://www.hra.nhs.uk/

Guidance on requirements for approval of clinical investigations by MHRA Devices is available on the MHRA website:

http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=194

For specific advice on devices research, please contact MHRA Devices (see contact details at the foot of the web page above).



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Basic science study involving procedures with human participants

This option may involve patients or healthy volunteers as participants, but the study does not affect any clinical care that the participant may be receiving. It is appropriate for scientific investigations involving procedures with participants that are additional to any clinical care, but not studying a novel clinical intervention or involving randomisation between treatment groups or any other change in existing clinical care.

For example, it would be suitable for studies involving:

  •  Imaging investigations (MRI, ultrasound etc)
  •  Physical examinations
  •  Physical tests
  • Computer tests
  •  Filming or photography
  •  Sample-taking.

Where the study involves taking samples but no other physical intervention or procedure, you may select either this option or "Research limited to use of tissue, other human biological samples and/or data". The set of questions generated in the application form(s) in IRAS will be the same in either case.

Where the study involves questionnaires and interviews but no physical interventions or procedures, it would be more appropriate to select the option "Research involving questionnaires or interviews for quantitative analysis or mixed quantitative/qualitative methodology".



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Study administering questionnaires/interviews for quantitative or mixed quantitative/qualitative analysis

Please select this option if your research:

  • Involves no clinical interventions or procedures (otherwise please select one of the clinical research categories);

  • Involves administering a questionnaire, or conducting interviews or focus groups with participants; and

  • Will use quantitative analysis, or a mix of quantitative and qualitative analysis methods.

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Study involving qualitative methods only

Please select this option if your research:
  • Involves no clinical interventions or procedures (otherwise please select one of the clinical research categories)

  • Involves no use of human tissue samples or other human biological materials

  • Will use only qualitative analysis methods.

If you select this option, questions in IRAS relating to statistical analysis will be disabled.

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Study limited to working with human tissue samples and/or analysis of data

Research in this category is based entirely on the analysis data and/or use of human tissue samples or other human biological material. It must involve no change to the normal clinical care or treatment of participants. There will be no participant contact or observation other than to collect samples and seek informed consent where appropriate.

This category applies to specific research projects using samples and/or data.  Where a favourable ethical opinion is given, this will apply for the duration of this project only.  To apply for ethical review of a licensed research tissue bank or a research database, please select the appropriate category.

If you select this option, supplementary questions will appear about the proposed use of data or human tissue samples in your study.  The version of the form applicable to your project will depend on your answers to these questions.  Tick all options that apply.

Research involving data collection through questionnaires or other intervention with participants should select another option.

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Study limited to working with data
Research in this category is based entirely on the use of data from patients, service users or other data subjects.  It must involve no change to the normal clinical care or treatment of participants.  There will be no participant contact or observation other than to seek informed consent where appropriate. 

This category applies to research involving data relating to the deceased, as well as to living data subjects.

This category applies to specific research projects using data to investigate specific research question(s) described in a protocol.  Where a favourable ethical opinion is given, this will apply for the duration of this project only. 

This category is suitable for specific projects which may be sourcing datasets from a research database for their study.  However, if you are a database manager and wish to apply for ethical review of the research database itself, including generic approval for the research programme supported by the database, please select the appropriate category within the Project Filter.

If you select this option, a supplementary question will appear about the identifiability of the data to be used in your study.  The version of the form applicable to your project will depend on your answer to this question.  A simpler version will apply where the research team will only have access to anonymised or effectively pseudonymised (coded) data. 

Research involving questionnaires, interviews, focus groups or other intervention with participants should select another option.



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Research tissue bank

Organisations responsible for the management of research tissue banks (RTB) anywhere in the UK may apply for ethical review of their arrangements for collection, storage, use and distribution of tissue.  A "research tissue bank" (or "biobank") is defined as:

A collection of human tissue or other biological material, which is stored for potential research use beyond the life of a specific project with ethical approval or for which ethical approval is pending.

Applications are not restricted to collections of human tissue within the definition of "relevant material" under the Human Tissue Act 2004.

If your research is a specific research project involving human tissue you should select another option on the Project Filter.

Licensing requirements

Under the Human Tissue Act, tissue banks in England, Wales and Northern Ireland storing relevant material for use in as yet unspecified research must obtain a licence from the Human Tissue Authority (HTA).

Applicants for ethical review of RTBs will be expected to provide the REC with a copy of the licence as a condition of ethical approval except where:

  • The RTB is established in Scotland

  • The biological material to be stored for use in research is outside the definition of "relevant material" under the Human Tissue Act, e.g. DNA, plasma, serum, cell lines.

  • Detailed guidance on licensing is available from the HTA at http://www.hta.gov.uk/licensing.cfm

Application for ethical review is voluntary

There is no formal requirement for tissue banks to obtain ethical approval under the Human Tissue Act or NHS research governance systems.  Applications for ethical review will therefore be made on a voluntary basis.

However, ethical approval for a bank may have benefits by facilitating programmes of research without a need for individual project-based ethical approval.   The RTB application form has an option for the applicant to seek generic ethical approval prospectively for a range of research to be carried out by the establishment responsible for the bank and/or by other researchers to whom tissue is released by the bank within the conditions of the ethical approval.  Such approval may be given for a period of up to 5 years and will be renewable.

Further guidance on RTB applications is available in the FAQs on the Human Tissue Act on the Health Research Authority (HRA) website at: http://www.hra.nhs.uk/resources/research-legislation-and-governance/questions-and-answers-the-human-tissue-act-2004/ 

Booking applications

Applications for ethical review of RTBs are booked for review via the Central Booking Service (CBS).  When speaking to booking staff it is helpful to begin by saying that the application is for a RTB rather than a specific project. 

For further guidance on applying for NHS REC review and booking, see: http://www.hra.nhs.uk/research-community/applying-for-approvals/research-ethics-committee/ and http://www.hra.nhs.uk/resources/applying-to-recs/.

Applications will normally be allocated to one of a panel of "flagged RECs", which have been assigned to review RTB applications and have received additional training. However, applicants may opt to apply to another committee within their geographical domain if they prefer.

NHS management permission

Under the Research Governance Framework (RGF), there is no requirement for NHS research permission for the establishment of research tissue banks in the NHS.  Applications to NHS R&D offices through IRAS are not required as all NHS organisations are expected to have included management review in the process of establishing the tissue bank and, where applicable, applying for licensing.

Research permission is also not required by collaborators at tissue collection centres (TCCs) who provide tissue samples or other biological material to a RTB under the terms of a supply agreement between the care organisation and the bank.  TCCs are not research sites for the purposes of the RGF.

RTB managers are advised to provide R&D offices at all TCCs with a copy of the REC application for information, together with a copy of the favourable opinion letter when available.  All TCCs should be listed in Part C of the REC application.

NHS researchers undertaking specific research projects using tissue/data supplied by a RTB must apply for permission to R&D offices at all organisations where the research is conducted, whether or not the bank has ethical approval.  Where the tissue/data is received in non-identifiable form and the research is covered by the terms of generic ethical approval for the RTB, no further REC application is required but the RTB should list the project in its annual report to the REC.



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Research database

Organisations responsible for the management of research databases anywhere in the UK may apply for ethical review of their arrangements for collection, storage and use of data, including arrangements of release of data to researchers.



A "research database" is defined as:

A collection of data, which is stored for potential research use beyond the life of a specific project with ethical approval or for which ethical approval is pending.

Application for ethical review is voluntary

There is no formal requirement for databases to apply for ethical review under NHS research governance systems, and ethical approval would only be required by legislation if processing identifiable data without consent.  Applications for ethical review will therefore normally be made on a voluntary basis.

However, ethical approval for a database may have benefits by facilitating programmes of research without a need for individual project-based ethical approval.   The database application form has an option for the applicant to seek generic ethical approval prospectively for a range of research to be carried out by the establishment responsible for the database and/or by other researchers to whom data is released within the conditions of the ethical approval.  Such approval may be given for a period of up to 5 years and will be renewable.

Booking applications

Applications for ethical review of research databases are booked for review via the Central Booking Service (CBS)  When speaking to staff it is helpful to begin by saying that the application is for a database rather than a specific project. 

For further guidance on applying for NHS REC review and booking, see: http://www.hra.nhs.uk/research-community/applying-for-approvals/research-ethics-committee/ and http://www.hra.nhs.uk/resources/applying-to-recs/ .

Applications will normally be allocated to one of a panel of "flagged RECs", which have been assigned to review database applications. However, applicants may opt to apply to another committee within their geographical domain if they prefer.

NHS management permission

Under the Research Governance Framework (RGF), there is no requirement for NHS research permission for the establishment of research databases in the NHS.  Applications to NHS R&D offices through IRAS are not required as all NHS organisations are expected to have included management review in the process of establishing the database.

Research permission is also not required by collaborators at data collection centres (DCCs) who provide data under the terms of a supply agreement between the organisation and the database.  DCCs are not research sites for the purposes of the RGF.

Database managers are advised to provide R&D offices at all DCCs with a copy of the REC application for information, together with a copy of the favourable opinion letter when available.  All DCCs should be listed in Part C of the REC application.

NHS researchers undertaking specific research projects using data supplied by a database must apply for permission to R&D offices at all organisations where the research is conducted, whether or not the database has ethical approval.  Where the data is received in non-identifiable form and the research is covered by the terms of generic ethical approval for the database, no further REC application is required but the database should list the project in its annual report to the REC.



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Other research

Select this option only if your research does not appear to fit any other category.

Selecting this option will generate a comprehensive version of the IRAS dataset, appropriate for example to an interventional clinical trial. You may wish to consider selecting another option to ensure that the dataset omits questions not relevant to your study. Further guidance on the types of study that are appropriate to each of the categories is available by clicking on the information buttons. If you require further advice, please contact the IRAS Queries Line at iras.queries@nhs.net





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Clinical trials of investigational medicinal products

Select this option for medicinal trials falling within the scope of the EU Clinical Trials Directive and the Medicines for Human Use (Clinical Trials) Regulations 2004.

Medicinal products are substances or combinations of substances which either prevent or treat disease in human beings or are administered to human beings with a view to making a medical diagnosis or to restore, correct or modify physiological functions in humans.

A clinical trial is an investigation in human subjects which is intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more medicinal products, identify any adverse reactions or study the absorption, distribution, metabolism and excretion, with the object of ascertaining the safety and/or efficacy of those products. This definition includes pharmacokinetic studies.

Clinical studies involving only medical devices, food supplements or other non-medicinal therapies (such as surgical interventions) are not covered by the Directive. The Regulations do not apply to non-interventional trials. In such trials, no additional diagnostic or monitoring procedure should be applied.  Epidemiological methods should be used for the data analysis.

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for advising on the Regulations and requirements for clinical trial authorisation (CTA).  More detailed guidance is available at:

http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=723

Section 2 of the guidance links to an algorithm to help you decide whether or not your research is a clinical trial of an investigational medicinal product (CTIMP).

If you remain unsure after checking the algorithm, please contact the MHRA Clinical Trials Helpline for advice by writing to clintrialhelpline@mhra.gsi.gov.uk

It is a criminal offence to conduct a CTIMP anywhere in the UK without CTA from the MHRA.  This applies both to commercial and non-commercial research, and both to phase 1 drug development and later phase research.

Non-interventional trials of licensed medicines

Regulation 2 of the Clinical Trials Regulations defines a "non-interventional trial" as a study of one or more medicinal products with a marketing authorisation meeting all of the following conditions:

(a)               the products are prescribed in the usual manner in accordance with the terms of that authorisation

(b)               the assignment of any patient involved in the study to a particular therapeutic strategy is not decided in advance by a clinical trial protocol

(c)               the decision to prescribe a particular medicinal product is clearly separated from the decision to include the patient in the study

(d)               no diagnostic or monitoring procedures are applied to the patients included in the study, other than those which are ordinarily applied in the course of the particular therapeutic strategy in question

(e)               epidemiological methods are to be used for the analysis of the data arising from the study.

If your study is a non-interventional trial of a licensed medicine according to the Regulations, please select another option in Project Filter question {QNumber(Guid_Sieve_Q_2)}.  Where no additional research procedures are involved (e.g. questionnaires), the most appropriate category will usually be "Study limited to working with human tissue samples and/or data".  If the research will also involve questionnaires, please select "Study administering questionnaires/interviews for quantitative analysis, or using mixed quantitative/qualitative methodology".

Post-marketing surveillance by the pharmaceutical industry not involving any additional research procedures will generally fall within the classification of service/therapy evaluation rather than research.  Under NHS research governance arrangements, service/therapy evaluation does not require either ethical review or management permission from R&D offices.  For further guidance on differentiating between research, audit and service/therapy evaluation, please refer to the Health Research Authority (HRA) guidance, which is available at: http://www.hra.nhs.uk/resources/before-you-apply/is-it-research/





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Other research

Select this option only if your research does not appear to fit any other category.

Selecting this option will generate a comprehensive version of the IRAS dataset, appropriate for example to an interventional clinical trial. You may wish to consider selecting another option to ensure that the dataset omits questions not relevant to your study. Further guidance on the types of study that are appropriate to each of the categories is available by clicking on the information buttons. If you require further advice, please contact the IRAS Queries Line at iras.queries@nhs.net





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Commercial sponsorship or funding

Answer YES if the study is sponsored or funded by the manufacturer of the device or by any other commercial company. This includes support for the study through provision of the device free of charge. It does not include arrangements to share the data from the study with the manufacturer.



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Clinical investigation for CE marking purposes

Select this option where the manufacturer is sponsoring or funding an investigation intended to provide clinical data to support CE marking of the device, or a change to existing CE marking. It may apply to any of the following:

  • A non-CE marked medical device;
  • A CE marked device which has been modified; or 
  • A CE marked device, which is being used outside its intended purpose.
  • If you select this option, IRAS will generate the forms required to notify the MHRA of the investigation and apply for a Notice of No Objection.

    The regulations on clinical investigations apply only to general medical devices and active implantable medical devices. For in-vitro diagnostic devices, select the specific option for performance evaluation of IVDDs.

    Further guidance is available on the Health Research Authority (HRA) website, in the document “Approval for Medical Devices Research” at: http://www.hra.nhs.uk/resources/before-you-apply/types-of-study/medical-devices-research-2/

    Detailed guidance on requirements for approval of clinical investigations by MHRA Devices is available on the MHRA website:

    http://www.mhra.gov.uk/Howweregulate/Devices/Clinicaltrials/index.htm

    For specific advice, please contact MHRA Devices (see contact details on the web page above).



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    Combined clinical investigation for CE marking purposes and clinical trial of an investigational medicinal product

    Select this option only where the trial involves the use of both an investigational medicinal product and an investigational medical device (either a non-CE marked device or a device which has been modified or is being used for a purpose not covered by the CE mark).

     In these circumstances, the trial would exceptionally require both:

    • Notice of No Objection under the Medical Devices Regulations 2002, and

    • Clinical trial authorisation under the Medicines for Human Use (Clinical Trials) Regulations 2004.

    Applicants are advised to seek expert advice from either branch of MHRA on the regulatory requirements for combined drug/device trials.  Contact either of the following:

    Where MHRA advise that the trial will be regulated under only the Medicines or Devices Regulations, please select another option as follows:

    • If regulated only as a medicinal trial, return to Question 2 of the Filter and select “Clinical trial of an investigational medicinal product”;

    • If regulated only as a devices investigation, select “Clinical investigation of a medical device for CE marking purposes”.



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    Post-market clinical study involving a change to standard care or randomisation between groups

    Select this option where the study involves:

    • CE marked device(s) which have not been modified and are being used in accordance with their intended purpose; and

    • Change to standard care for patients (at any site), or randomisation between groups.

    “Change to standard care” means that there could be a change to the patient’s treatment if they opt to take part in the study, compared to the treatment normally provided outside the study.

    Where use of the device is already part of current clinical practice at all participating sites, or is to be adopted as standard clinical practice prior to or alongside the start of the study, the option “Registry of a CE marked device in clinical use” may be selected instead.

    Selection of this option produces a version of the integrated dataset in Part A of IRAS appropriate to a clinical trial.  Part B Section 2 of IRAS will also be enabled to provide details of the device under study.  Depending on the procedures involved in the study, additional sections of Part B may be enabled.

     



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    Registry of a CE marked device in clinical use, involving no change to standard care or randomisation

    Select this option where the study involves:
    • CE marked device(s) which have not been modified and are being used in accordance with their intended purpose; and 
    • No change to standard care for patients (at any site), or randomisation between groups. 

    “Change to standard care” means that there could be a change to the patient’s treatment if they opt to take part in the study, compared to the treatment normally provided outside the study.

    This option is appropriate where use of the device is already part of standard clinical practice at all participating sites, or is to be adopted as standard clinical practice prior to or alongside the start of the study.

    Selection of this option produces a shorter version of the integrated dataset in Part A of IRAS. Part B Section 2 of IRAS will be enabled to provide details of the device under study. Depending on the procedures involved in the study, additional sections of Part B may be enabled.

    Post Market Surveillance – review requirements

    It is only necessary to apply for ethical review by a NHS REC and management permission for research from NHS R&D offices where a project is considered to be research.

    It is the sponsor’s responsibility to determine whether a project should be reviewed as research, in consultation with the host organisations for the project as necessary. Where advice is required, please seek advice initially from the R&D office at the lead site. Further advice may be sought from the Health Research Authority (HRA) Queries Line by emailing hra.queries@nhs.net, enclosing a summary of the protocol.

    Post Market Surveillance (PMS) studies of CE marked devices may be classified as service evaluation, not requiring ethical review or management permission from NHS R&D offices, where all the following criteria are met:
    (i) The product is used unmodified and within its intended purpose;
    (ii) The assignment of any patient involved in the study to a particular therapeutic strategy or diagnostic procedure is not decided in advance by a protocol but falls within current clinical practice;
    (iii) The decision to use the product is clearly separated from the decision to include the patient in the study;
    (iv) No diagnostic or monitoring procedures are applied to the patients included in the study, other than those which are ordinarily applied in the course of current clinical practice; and
    (v) Epidemiological methods are to be used for the analysis of the data arising from the study.

    If the study does not meet all of these criteria, it should be regarded as research. In particular, any case series study involving additional research procedures (e.g. scans, questionnaires) or additional clinical monitoring should be regarded as research and will require ethical review and R&D approval if conducted within the NHS.

    Further guidance is available in the document “Approval for Medical Devices Research” at: http://www.hra.nhs.uk/resources/before-you-apply/types-of-study/medical-devices-research-2/

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    Performance evaluation of an In Vitro Diagnostic Device (PEIVDD)

    This option should be selected for a performance evaluation of an in vitro diagnostic device (PEIVDD). This means a device intended by the manufacturer to be subject to one or more performance evaluation studies in laboratories for medical analyses or in other appropriate environments outside his own premises.

    PEIVDDs do not require a Notice of No Objection from the Competent Authority. Applicants are not required to apply to MHRA Devices using IRAS.

    However, notification is required under the In Vitro Diagnostic Devices Directive and the Medical Devices Regulations 2002. The MHRA must be provided with details of the manufacturer and the IVDDs being placed on the market using Registration Form RG3. Guidance is available on the MHRA website at:

    Selection of this option produces a version of the integrated dataset in Part A of IRAS appropriate to a clinical trial. Part B Section 2 of IRAS will also be enabled to provide details of the device under study. Depending on the procedures involved in the study, additional sections of Part B may be enabled.

    http://www.mhra.gov.uk/Howweregulate/Devices/InVitroDiagnosticMedicalDevicesDirective/index.htm

    Where PEIVDDs are conducted at NHS sites, ethical approval should be sought from a NHS Research Ethics Committee and permission obtained to conduct the research from relevant NHS R&D offices.

    Selection of this option produces a shorter version of the integrated dataset in Part A of IRAS. Part B Section 2 of IRAS will be enabled to provide details of the device under study. Depending on the procedures involved in the study, for example use of human tissue samples, additional sections of Part B may be enabled.



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    Clinical study of a non-CE marked device where commercialisation is intended

    This option should be selected where, although not commercially sponsored or funded, the study is intended to provide clinical data to support potential commercial development of the device.  Such studies are regulated under the Medical Devices Regulations and require a Notice of No Objection from the MHRA.

    For example, this option should be selected where a university or healthcare organisation has developed a novel device in-house and is collaborating with, or plans to collaborate with, a commercial company with the intention of manufacturing and marketing the product commercially.

    This option also applies where the study relates to an existing CE marked device, which has been modified or is being used outside its intended purpose, and the manufacturer intends to use clinical data from the study to support a change to CE marking.

    Selection of this option produces a version of the integrated dataset in Part A appropriate to a clinical trial.  Part B Section 2 of IRAS will also be enabled to provide details of the device under study.  Depending on the procedures involved in the study, additional sections of Part B may be enabled.

    If you select this option, IRAS will generate the forms required to notify the MHRA of a clinical investigation and apply for a Notice of No Objection.

    Further guidance is available in the document “Approval for Medical Devices Research” at:

    http://www.hra.nhs.uk/resources/before-you-apply/types-of-study/medical-devices-research-2/

    Detailed guidance on requirements for approval of clinical investigations by MHRA Devices is available on the MHRA website:

    http://www.mhra.gov.uk/Howweregulate/Devices/Clinicaltrials/index.htm

    For specific advice, please contact MHRA Devices (see contact details on the web page above).

     



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    Clinical study of a non-CE marked device where commercialisation is not intended

    This option should be selected for non-commercial clinical studies of novel devices, developed for use within a single entity, with no plans for commercial development of the product.

    For example, this option should be selected where a university or healthcare organisation has developed a novel device solely for its own use, and there is no intention to collaborate with a commercial company to market the product commercially.

    This option also applies where the study relates to an existing CE marked device, which has been modified by the host organisation, and there are no plans for the manufacturer to use clinical data from the study to support a change to CE marking of the product.

    Collaboration with another body in the design and manufacturing of the device does not exclude selection of this option, provided that it will be used within a single entity and commercialisation is not intended.

    Selection of this option produces a version of the integrated dataset in Part A appropriate to a clinical trial.

    Part B Section 2 of IRAS will also be enabled to provide details of the device under study, and includes a requirement for an additional declaration from the head of clinical engineering (or equivalent) at the institution.  In the absence of regulatory review by the MHRA, this declaration provides review bodies with assurance that the device has been manufactured and tested to comply with relevant quality standards, prior to clinical testing.

    Depending on the procedures involved in the study, additional sections of Part B may be enabled.

    Selection of this option does not generate the forms required to notify the MHRA of a clinical investigation and apply for a Notice of No Objection, as this is not required for a study of this type.

    Further guidance is available in the document “Approval for Medical Devices Research” at:

    http://www.hra.nhs.uk/resources/before-you-apply/types-of-study/medical-devices-research-2/

    Detailed guidance on requirements for approval of clinical investigations by MHRA Devices is available on the MHRA website:

    http://www.mhra.gov.uk/Howweregulate/Devices/Clinicaltrials/index.htm

    For specific advice, please contact MHRA Devices (see contact details on the web page above).  If after further consideration and consultation with MHRA it is established that notification of the MHRA is required, please select instead the option for a clinical study where commercialisation is intended.

     

     



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    Clinical study of CE marked device for an off-label indication

    This option should be selected for non-commercial studies of CE marked devices, where the product is being used outside the intended purpose specified in the CE mark but there are no plans for the manufacturer to use clinical data from the study to support a change to CE marking of the product.

    Selection of this option produces a version of the integrated dataset in Part A appropriate to a clinical trial.  Part B Section 2 of IRAS will also be enabled to provide details of the device under study.  Depending on the procedures involved in the study, additional sections of Part B may be enabled.

    Selection of this option does not generate the forms required to notify the MHRA of a clinical investigation and apply for a Notice of No Objection, as this is not required for a study of this type.

    Further guidance is available in the document “Approval for Medical Devices Research” at:

    http://www.hra.nhs.uk/resources/before-you-apply/types-of-study/medical-devices-research-2/

    Detailed guidance on requirements for approval of clinical investigations by MHRA Devices is available on the MHRA website:

    http://www.mhra.gov.uk/Howweregulate/Devices/Clinicaltrials/index.htm

    For specific advice on the regulation of devices, please contact MHRA Devices (see contact details on the web page above).

    If after further consideration and consultation with MHRA it is established that notification of the MHRA is required, please select instead the option for a clinical study where commercialisation is intended.

     



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    Clinical study of CE marked device(s) for a labelled indication, involving a change to standard care or randomisation between groups

    This option should be selected for non-commercial studies of CE marked devices, where the product has not been modified and is being used within the intended purpose specified in the CE mark, but the study involves a change to standard care or randomisation between groups.

    For example, this option would be appropriate for a clinician-led trial to compare the safety and efficacy of devices already on the market for the same indication.

    “Change to standard care” means that there could be a change to the patient’s treatment if they opt to take part in the study, compared to the treatment normally provided outside the study.

    Selection of this option will produce a version of the integrated dataset in Part A appropriate to a clinical trial.  Part B Section 2 of IRAS will also be enabled to provide details of the device under study.  Depending on the procedures involved in the study, additional sections of Part B may be enabled.

    Where use of the device is already part of current clinical practice at all participating sites, or is to be adopted as standard clinical practice prior to or alongside the start of the study, the option for a study in a labelled indication involving no change to standard care or randomisation between groups may be selected instead.  This would produce a shorter version of Part A.

    Further guidance is available in the document “Approval for Medical Devices Research” at:

    http://www.hra.nhs.uk/resources/before-you-apply/types-of-study/medical-devices-research-2/

    Detailed guidance on requirements for approval of clinical investigations by MHRA Devices is available on the MHRA website:

    http://www.mhra.gov.uk/Howweregulate/Devices/Clinicaltrials/index.htm

    Notification of the MHRA is not required for studies of CE marked devices for labelled indications

     



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    Clinical study of CE marked device(s) for a labelled indication, involving no change to standard care or randomisation between groups

    This option should be selected for non-commercial studies of CE marked devices, where the product has not been modified and is being used within the intended purpose specified in the CE mark, with no change to standard care of patients or randomisation between groups.

    For example, this option would be appropriate for a clinician-led case series study to evaluate clinical outcomes from a device already in use at all participating sites.

    “Change to standard care” means that there could be a change to the patient’s treatment if they opt to take part in the study, compared to the treatment normally provided outside the study.

    Selection of this option does not exclude additional research procedures as part of the protocol, e.g. additional scans, questionnaires, sample or data collection, provided that patient treatment is not altered.

    This option will produce a shorter version of the integrated dataset in Part A of IRAS.  Part B Section 2 of IRAS will be enabled to provide details of the device under study.  Depending on the procedures involved in the study, additional sections of Part B may be enabled.

    Further guidance is available in the document “Approval for Medical Devices Research” at:

    http://www.hra.nhs.uk/resources/before-you-apply/types-of-study/medical-devices-research-2/

    Detailed guidance on requirements for approval of clinical investigations by MHRA Devices is available on the MHRA website:

    http://www.mhra.gov.uk/Howweregulate/Devices/Clinicaltrials/index.htm

    Notification of the MHRA is not required for studies of CE marked devices for labelled indications.

     

     



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    Pre-clinical device development or performance testing

    Select this option where applications are required for non-clinical research undertaken as part of a device development programme, not involving use of the device in the course of patient care.

    It is recommended that researchers seek advice from their NHS R&D office on whether applications are required for research of this type.

    Ethical review by a REC is not required for bench research simply because it takes place on NHS premises or involves NHS facilities and resources.  However, ethical review could be required where a project involves, e.g. the collection of tissue samples from NHS patients or use of non-consented stored samples in testing a device.

    The R&D office can also advise on whether application is required for management permission to undertake research.  There may be instances where, although REC review is not required, R&D review is still needed to ensure appropriate use of NHS resources and minimisation of any risks to the organisation or the researchers themselves.

    Selection of this option will produce a significantly reduced version of the integrated dataset in Part A of IRAS, appropriate to a non-clinical study.

    Part B Section 2 of IRAS will be enabled to provide details of the device under study.  For this type of study, Part B Section 2 includes a requirement for an additional declaration from the head of clinical engineering (or equivalent) at the institution.  This is intended to provide review bodies with assurance that the device is being manufactured and tested in accordance with relevant quality standards.

    Depending on the procedures involved in the study, additional sections of Part B may be enabled, for example to provide information about the use of human tissue samples.



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    Trials subject to advice from EAG/CHM

    Introduction

    For certain types of clinical trial the MHRA will seek advice from the Expert Advisory Group on Clinical Trials (EAG) and the Commission on Human Medicine (CHM) before giving approval.

    Applicants should indicate in answer to Question 2a whether the proposed trial falls within the scope of the expert advice arrangements.

    Sponsors are requested to make contact with the Agency before making the application for Clinical Trial Authorisation (CTA) for such trials and to make available a data package allowing that advice to be obtained. The normal CTA application timeline will follow receipt of a valid application.

    Scope of the EAG/CHM arrangements

    The decision to refer applications for expert advice will be based on assessment of risk factors and the proposed mitigation strategy. Areas for consideration when determining risk factors include mode of action, nature of the target and the relevance of animal species and models.

    First in human (FIH) trials with novel compounds

    The arrangements apply to certain types of First in Human (FIH) trial with novel compounds, and to trials with integrin antagonists targeting leucocyte trafficking.

    Sponsors of all FIH trials should take account of the Guideline on Strategies to Identify and Mitigate Risks for First-in-Human Clinical Trials with Investigative Medicinal Products, issued by the Committee for Medicinal Products for Human Use in July 2007 at: http://www.emea.europa.eu/pdfs/human/swp/2836707enfin.pdf.

    MHRA may seek expert advice on FIH trials with novel compounds where:
    • where the mode of action involves a target that is connected to multiple signalling pathways (target with pleiotropic effects), e.g. leading to various psychological effects or targets that are ubiquitously expressed

    • acting (directly or indirectly) via a cascade system where there may be an amplification effect which might not be sufficiently controlled by a physiological feedback mechanism

    • acting (directly or indirectly) via the immune system with a target or mechanism of action which is novel or currently not well characterised

    • where there is novelty in the structure of the active substance, e.g. a new type of engineered structural format such as those with enhanced receptor interaction as compared with the parent compound

    • where the level of expression ad biological function of the target receptor may differ between healthy individuals and patients with the relevant disease

    • where there is insufficient available knowledge of the structure, tissue distribution, cell specificity, disease specificity, regulation, level of expression and biological function of the human target, including down-stream effects

    • acting via a possible or likely species specific mechanism or where animal data are unlikely to be predictive of activity in humans.

    Trials with integrin antagonists targeting leucocyte trafficking

    MHRA will seek expert advice from EAG/CHM in the case of trials with compounds which modulate leucocyte trafficking, except Phase 1 studies in subjects with no previous immunosuppression.
    1. The following applications will not routinely require referral:
      (a)   Compounds which modulate angiogenesis but no leucocyte trafficking nor have any cross-reactivity to integrins that modulate leucocyte trafficking
      (b)   Phase 1 healthy volunteer studies and patient studies in subjects with no previous immunosuppression using compounds which modulate leucocyte trafficking, provided that all the following conditions are met in the protocol:
      • A minimum of 3 months follow-up
      • Subject Alert Card
      • Neurological monitoring during the trial
      • MRI scanning where the patient population has a neurological condition (patient studies only)
      • PML Management Algorithm.
    2. Applications will require referral if they are:
      (a)   Phase 1 patient studies with compounds which modulate leucocyte trafficking
      (b)   Trials in previously immunosuppressed subjects or where subjects will receive concomitant immunosuppressant therapy
      (c)   All Phase 2 and 3 studies with compounds which modulate leucocyte trafficking
      (d)   Any application falling into (1) above where there is an area of concern.
    EAG/CHM procedures and required areas of discussion

    Guidance on procedures for seeking advice from EAG/CHM and applying for CTA have been published by the MHRA at: http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=986. The guidance includes a list of required areas of discussion by EAG/CHM and the contents of the data package to be submitted to MHRA.

    Implications for REC applications

    Applicants should indicate in answer to Question 2a whether the proposed trial falls within the scope of the EAG/CHM arrangements.

    If so, please explain the current status of the application for CTA in answer to Question A55 in IRAS. Further guidance is available from the information button next to this question. A copy of any relevant correspondence with MHRA should be enclosed with the REC application.

    The sponsor is responsible for ensuring that the main REC is kept informed about the progress of the CTA application and any changes made to the trial as a result of the expert advice from EAG/CHM. The REC should be fully informed about this either as part of the initial application or through further information provided in the course of the ethical review.

    Sequential or parallel processing?

    Sponsors may opt to apply either sequentially or in parallel to the MHRA and the REC.

    This decision may be influenced by a number of considerations. A sequential process may be preferable where, despite pre-submission advice from MHRA, factors such as the novelty of the compound including its mode of action and target, the relevance of animal models and the completeness of the data package available may result in protocol changes following EAG/CHM review. A sequential process would allow the ethics committee to receive the final version of the protocol and be fully informed about the outcome of the CTA application when undertaking its review.

    However, in other cases the sponsor may be confident that the protocol is unlikely to change and may wish to apply in parallel.

    Guidance for ethics committees Detailed guidance for ethics committees on the review of trials subject to EAG/CHM advice has been issued by NRES in an open letter dated 14 August 2007. A copy of this letter is available on the Health Research Authority (HRA) website at: http://www.hra.nhs.uk/documents/2013/10/expert-advisory-group-and-commission-on-human-medicine-process-letter-to-recs-chairs.pdf



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    Gene therapy medicinal products

    Gene therapy medicinal products are defined in Part IV of Directive 2003/63/EC (amending Directive 2001/83/EC) as follows:

    "... [a] gene therapy medicinal product means a product obtained through a set of manufacturing processes aimed at the transfer, to be performed either in vivo or ex vivo, of a prophylactic, diagnostic or therapeutic gene (i.e. a piece of nucleic acid), to human/animal cells and its subsequent expression in vivo. The gene transfer involves an expression system contained in a delivery system known as a vector, which can be of viral, as well as non-viral origin. The vector can also be included in a human or animal cell."


    For more information please refer to: http://www.hra.nhs.uk/resources/applying-to-recs/gene-therapy-advisory-committee-gtac/ .

    If you select Yes in answer to this question, the main application for ethical review must be submitted to GTAC.  Further guidance about applications is available next to the GTAC option in Question 4 of the Project Filter.



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    Ionising radiation

    You should answer “Yes” to this question if the research protocol includes any procedure involving exposure to diagnostic or therapeutic ionising radiation as defined in the Ionising Radiation (Medical Exposure) Regulations 2000 ("IRMER").

    For all studies where the answer to this question is “Yes”, Part B Section 3 of IRAS will be enabled. This section should be completed with input from a lead Medical Physics Expert (MPE) and lead Clinical Radiation Expert (CRE). Detailed guidance is available by clicking on the links in this section of IRAS.

    If the research involves (or might involve) ionising radiation at any stage, you should seek early advice from an MPE on completion of Part B Section 3 and compliance with IRMER.

    Procedures involving ionising radiation include:
    • Diagnostic X-rays, CT scans or DXA scans

    • Radiotherapy (including brachytherapy and therapy using unsealed sources)

    • Radionuclide imaging (including diagnostic imaging and in vitro measurements).

    Magnetic Resonance Imaging (MRI) or ultrasound investigations do not involve ionising radiation.

    You should answer "Yes" even where the exposures to be received under the protocol would be in accordance with normal clinical care outside the research setting.

    You should answer “Yes” where imaging investigations involving ionising radiation are required by the screening procedures for the study, for example where the protocol requires a diagnostic X-ray to confirm suitability for inclusion.

    However, you may answer "No" if the selection criteria include normal clinical exposures received outside the study but the study itself does not involve radiation exposure. This would apply where both the following criteria are met:
    • The exposures are authorised and undertaken in the course of normal clinical management, not for research purposes; and

    • The decision to authorise the exposures is clearly separated from the decision to include the participant in the research and is not decided in advance by the research protocol.

    For example, an epidemiological study of the long-term effects of radiotherapy might require that the participant had received radiotherapy of a particular type or within a particular period prior to inclusion in the research. The radiotherapy would have needed to comply with the provisions of IRMER relating to clinical exposures. However, it is not a research exposure for the purposes of IRMER and does not require approval as part of the ethical opinion.

    For studies involving administration of radioactive materials, ARSAC approval is required. For guidance on how and when to apply see http://www.arsac.org.uk

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    You should answer “Yes” to this question if the research protocol includes any procedure involving the administration of radioactive materials.

    For all studies where the answer to this question is “Yes”, the ARSAC Preliminary Research Assessment (PRA) form will be automatically generated as a project form. Note that the fields in this form are populated from the NHS REC form. If any fields are blank, please check your NHS REC form for completeness.

    Procedures involving the administration of radioactive materials include:
    • PET-CT

    • Nuclear Medicine Bone Scans

    • MUGA

    Diagnostic X-rays, CT scans and DXA do not involve the administration of radioactive materials.

    You should answer “Yes” even where the administration of radioactive materials to be received under protocol would be in accordance with normal clinical care outside the research setting.

    You should answer “Yes” where the procedures involving administration of radioactive materials are required by the screening procedures for the study, for example where the protocol requires a MUGA scan to confirm suitability for inclusion.

    However, you may answer "No" if the selection criteria include normal clinical exposures received outside the study but the study itself does not involve radiation exposure. This would apply where both the following criteria are met:
    • The exposures are authorised and undertaken in the course of normal clinical management, not for research purposes; and

    • The decision to authorise the exposures is clearly separated from the decision to include the participant in the research and is not decided in advance by the research protocol.

    For example, an epidemiological study of the long-term effects of 131I radioiodine treatment for thyrotoxicosis might require that the participant had received 131I radioiodine treatment prior to inclusion in the research. The 131I radioiodine treatment would have needed to comply with the provisions of IRMER relating to clinical exposures. However, it is not a research exposure for the purposes of IRMER and does not require approval as part of the ethical opinion.

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    New human tissue samples (or other human biological samples)

    Please answer Yes if the research will involve collecting samples prospectively from participants primarily for research purposes.

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    Existing human tissue samples (or other human biological samples)

    Please answer Yes if the research will involve the use of residual material left over from routine clinical or diagnostic procedures, or existing stored samples from an archived collection or tissue bank.

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    Ionising radiation

    You should answer “Yes” to this question if the research protocol includes any procedure involving exposure to diagnostic or therapeutic ionising radiation as defined in the Ionising Radiation (Medical Exposure) Regulations 2000 ("IRMER").

    For all studies where the answer to this question is “Yes”, Part B Section 3 of IRAS will be enabled. This section should be completed with input from a lead Medical Physics Expert (MPE) and lead Clinical Radiation Expert (CRE). Detailed guidance is available by clicking on the links in this section of IRAS.

    If the research involves (or might involve) ionising radiation at any stage, you should seek early advice from an MPE on completion of Part B Section 3 and compliance with IRMER.

    Procedures involving ionising radiation include:
    • Diagnostic X-rays, CT scans or DXA scans

    • Radiotherapy (including brachytherapy and therapy using unsealed sources)

    • Radionuclide imaging (including diagnostic imaging and in vitro measurements).

    Magnetic Resonance Imaging (MRI) or ultrasound investigations do not involve ionising radiation.

    You should answer "Yes" even where the exposures to be received under the protocol would be in accordance with normal clinical care outside the research setting.

    You should answer “Yes” where imaging investigations involving ionising radiation are required by the screening procedures for the study, for example where the protocol requires a diagnostic X-ray to confirm suitability for inclusion.

    However, you may answer "No" if the selection criteria include normal clinical exposures received outside the study but the study itself does not involve radiation exposure. This would apply where both the following criteria are met:
    • The exposures are authorised and undertaken in the course of normal clinical management, not for research purposes; and

    • The decision to authorise the exposures is clearly separated from the decision to include the participant in the research and is not decided in advance by the research protocol.

    For example, an epidemiological study of the long-term effects of radiotherapy might require that the participant had received radiotherapy of a particular type or within a particular period prior to inclusion in the research. The radiotherapy would have needed to comply with the provisions of IRMER relating to clinical exposures. However, it is not a research exposure for the purposes of IRMER and does not require approval as part of the ethical opinion.

    For studies involving administration of radioactive materials, ARSAC approval is required. For guidance on how and when to apply see http://www.arsac.org.uk

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    You should answer “Yes” to this question if the research protocol includes any procedure involving the administration of radioactive materials.

    For all studies where the answer to this question is “Yes”, the ARSAC Preliminary Research Assessment (PRA) form will be automatically generated as a project form. Note that the fields in this form are populated from the NHS REC form. If any fields are blank, please check your NHS REC form for completeness.

    Procedures involving the administration of radioactive materials include:
    • PET-CT

    • Nuclear Medicine Bone Scans

    • MUGA

    Diagnostic X-rays, CT scans and DXA do not involve the administration of radioactive materials.

    You should answer “Yes” even where the administration of radioactive materials to be received under protocol would be in accordance with normal clinical care outside the research setting.

    You should answer “Yes” where the procedures involving administration of radioactive materials are required by the screening procedures for the study, for example where the protocol requires a MUGA scan to confirm suitability for inclusion.

    However, you may answer "No" if the selection criteria include normal clinical exposures received outside the study but the study itself does not involve radiation exposure. This would apply where both the following criteria are met:
    • The exposures are authorised and undertaken in the course of normal clinical management, not for research purposes; and

    • The decision to authorise the exposures is clearly separated from the decision to include the participant in the research and is not decided in advance by the research protocol.

    For example, an epidemiological study of the long-term effects of 131I radioiodine treatment for thyrotoxicosis might require that the participant had received 131I radioiodine treatment prior to inclusion in the research. The 131I radioiodine treatment would have needed to comply with the provisions of IRMER relating to clinical exposures. However, it is not a research exposure for the purposes of IRMER and does not require approval as part of the ethical opinion.

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    Research taking new human tissue samples

    This option should be selected for research in which samples are collected prospectively from participants primarily for research purposes.

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    Research involving surplus or existing samples identifiable to the researcher

    Select this option for research using residual tissue left over from routine clinical or diagnostic procedures or using existing samples from an archived collection or tissue bank, where it is likely that the researcher will be able to identify the donors.



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    Research involving surplus or existing samples not identifiable to the researcher

    Select this option for research using residual tissue left over from routine clinical or diagnostic procedures using existing samples from an archived collection or tissue bank, where all the samples will be anonymised or pseudonymised and there is no possibility of the researcher being able to identify any donor.

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    Research involving identifiable data

    This option should be selected for research:
    • Using non-anonymised patient or service user data from databases or records

    • Observing treatment or care with no intervention.

    Research involving data collection through questionnaires or other intervention with participants should select another option.

    Answer No if your research will only use non-identifiable data, i.e. data that are "anonymised" or "pseudonymised" at the point of access by researchers.

    Anonymised data The Information Commissioners Office (ICO) refers to anonymised information as "information from which no individual can be identified". Refer to the ICO website for more information.

    "Pseudonymised data The ICO describes the process of pseudonymisation as distinguishing individuals in a dataset by using a unique identifier which does not reveal their "real world" identity.

    Tissue/data supplied by approved tissue banks and databases

    NHS researchers undertaking specific research projects using tissue/data supplied by a Research Tissue Bank or Research Database must still apply for permission to R&D offices at all organisations where the research is conducted, whether or not the bank/database has ethical approval.  Where the tissue/data is received in non-identifiable form and the research is covered by the terms of generic ethical approval, no further REC application is required but the bank/database should list the project in its annual report to the REC.



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    Research involving identifiable data

    This option should be selected for research:
    • Using non-anonymised patient or service user data from databases or records

    • Observing treatment or care with no intervention.

    Research involving data collection through questionnaires or other intervention with participants should select another option.

    Answer No if your research will only use non-identifiable data, i.e. data that are "anonymised" or "pseudonymised" at the point of access by researchers.

    Anonymised data The Information Commissioners Office (ICO) refers to anonymised information as "information from which no individual can be identified". Refer to the ICO website for more information.

    "Pseudonymised data The ICO describes the process of pseudonymisation as distinguishing individuals in a dataset by using a unique identifier which does not reveal their "real world" identity.

    Tissue/data supplied by approved tissue banks and databases

    NHS researchers undertaking specific research projects using tissue/data supplied by a Research Tissue Bank or Research Database must still apply for permission to R&D offices at all organisations where the research is conducted, whether or not the bank/database has ethical approval.  Where the tissue/data is received in non-identifiable form and the research is covered by the terms of generic ethical approval, no further REC application is required but the bank/database should list the project in its annual report to the REC.



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    Countries of the UK

    Please tick all the countries in the UK in which research sites will be located.

    A research site is defined as the single organisation responsible for conducting the research at a particular locality.

    The research site is not necessarily the location where research activities will actually take place. For example, in a research project by practice nurses from GP practices, interviews with participants may take place in the participant’s home, but the research site would be the GP practice, because the GP practice would be responsible for the research activity.

    Organisations where clinicians or clinical units refer potential participants to the research team for assessment and possible recruitment are not considered to be research sites.

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    Lead R&D Office

    The lead NHS R&D contact may be the R&D contact for:

    • The Chief Investigator''s employing NHS organisation
    • A partner NHS organisation of the university employing the Chief Investigator
    • A main NHS collaborator

    The lead R&D office should be contacted at the earliest possible stage to advise and support the research through the review process.

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    Countries of the UK

    • In Question 3 please indicate in which country the research tissue bank is physically located.

    • In Question 3a please tick all the countries where centres will be providing tissue and data to the research tissue bank.

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    Countries of the UK
    • In Question 3a please indicate in which country the research database is physically located.

    • In Question 3b please tick all the countries where centres will be providing data to the research database.

    Confidentiality Advisory Group (CAG)
    • If the database will be processing identifiable patient information relating to people in England and Wales without explicit consent, application may need to be made to the CAG for approval.

    • The remit of CAG covers data about patients living in or receiving care or treatment in England and Wales, whether it is processed in England and Wales or in other countries. Where CAG approves an exemption under Section 251 of the NHS Act 2006, this lifts the common law duty of confidentiality and provides protection to organisations in England and Wales owing that duty.

    • Detailed guidance about CAG applications is available next to the CAG option in Question 4.





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    IRAS Form

    What is the IRAS Form?
    From June 2017 all project-based research conducted in or through the NHS/HSC in England, Northern Ireland, Scotland and/or Wales use the ‘IRAS Form’ to seek: 

    • HRA Approval for research led from England.
    • NHS/HSC R&D Permission and NHS REC review (where required) for research led from Northern Ireland, Scotland or Wales.


    The IRAS Form should not be selected if your project is not conducted in or through the NHS/HSC. In these circumstances you should select the relevant alternative application form(s) at filter question 4. Please refer to the question specific guidance to assist your selection. 

    Where projects were created in IRAS prior to June 2017 and separate NHS R&D and/or NHS REC applications have been created then you should continue using these separate applications. You do not need to change your application form type to the IRAS Form. 

    Further information is set out below. 

     

    Research led from England: HRA Approval

    What is HRA Approval?
    HRA Approval is the process for the NHS in England that comprises a review by a NHS Research Ethics Committee (REC), where required, as well as an assessment of regulatory compliance and related matters undertaken by dedicated HRA staff. It replaces the need for NHS permission by each participating organisation in England. 

    Which studies should apply for HRA Approval?
    You should apply for HRA Approval if:

    • The lead NHS R&D Office for your project is in England; and
    •  Your research is described by any of the IRAS filter question 2 categories (except those for "Research Tissue Bank" and "Research Database").

    To apply for HRA Approval you should select the option for "IRAS Form" at project filter question 4. Before preparing and submitting your application please ensure that you refer to the guidance for applicants.

     

    Research led from Northern Ireland, Scotland or Wales: NHS/HSC Management Permission and Research Ethics Committee (REC) review, where appropriate

    Project-based research conducted in, or through, the NHS/HSC and led from Northern Ireland, Scotland or Wales use the IRAS Form to apply for:

    • NHS/HSC Management Permission
    • NHS/HSC Research Ethics Committee (REC) review, if required 

    As the IRAS Form combines the datasets for the above reviews the same single IRAS Form is submitted for both NHS/HSC management permission and ethical review.
    IMPORTANT: While a single IRAS Form is used, different routes of submission apply. Please refer to the E-submission/Submission tabs for the IRAS Form  
    More information about routes for seeking NHS/HSC management permission is provided at: https://www.myresearchproject.org.uk/help/hlpnhshscr.aspx

     

    Site-level information for participating NHS/HSC organisations
    This is dependent on the location of the participating site(s). Please refer to the guidance for more information.  

     

    Projects created prior to June 2017
    If you created your project in IRAS prior to June 2017 and used separate NHS REC and/or NHS R&D Form(s) then you should continue with these selections and not change to the IRAS Form.



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    Application for NHS/HSC management permission

    Researchers wishing to conduct research in the NHS (or Health and Social Care in Northern Ireland) must obtain NHS or HSC management permission (also referred to as R&D approval) for each NHS/HSC research site.

    Where the research site is a primary care site, e.g. GP practice, the host organisation is the Primary Care Trust (England), Health Board (Scotland), Local Health Board (Wales) or primary care site (Northern Ireland). For other NHS research sites the host organisation is the NHS Trust (England and Wales), Health Board (Scotland) or Health and Social Care Trust (Northern Ireland). Permission to conduct the research will be confirmed by the R&D office to the PI directly

    Chief Investigators are responsible for transferring SSI Forms to each Principal Investigator (PI) for completion. Each PI should also be provided with the R&D Form and the full set of documents in the R&D Form checklist.

    The process for applying for NHS/ HSC permission varies across the UK. The appropriate instructions for the CI are provided in the submission tab for the R&D Form, and the content of the tab is determined by the location of the lead R&D office as indicated in the project filter. The appropriate instructions for each PI are provided in the submission tab for the SSI Form, and the content of the tab is determined by the location of the lead R&D office selected by the CI and the location of the research site as indicated in the SSI Form.

    Where the research includes NHS sites in England and has a lead R&D office in England, please also review the guidance to question 5a of the project filter on whether you wish your R&D applications to be processed through the NIHR Co-ordinated System for gaining NHS Permission (NIHR CSP).

    Further guidance on applying for NHS/HSC management permission is available on the website of the NHS R&D Forum at http://www.rdforum.nhs.uk/. Contact details for R&D offices can be obtained via the links at http://www.rdforum.nhs.uk/content/useful-links/contact-details/ .



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    Application to the Social Care Research Ethics Committee

    The Research Ethics Committees (RECs) flagged for Social Care review adult social care research study proposals, intergenerational studies involving adults and children or families and some proposals for social science studies situated in the NHS. It generally expects to review the following types of study:

    1. Social care studies funded by Department of Health.
      • Research commissioned directly through the Policy Research Programme.
      • Information Centre (IC) studies (i.e. those to be designed by IC for implementation by Councils with Adult Social Services Responsibilities, who do not then individually need to seek additional review).
      • Studies commissioned by or through National Institute for Health Research (NIHR) School for Social Care Research.
      • Social care studies funded (in rare cases) through NIHR.
    2. Social care research that involves people lacking capacity in England and Wales and requires approval under the Mental Capacity Act 2005. The Social Care REC is recognised by the Secretary of State as an Appropriate Body for this purpose.
    3. Social care research involving sites in England and another United Kingdom country.
    4. "Own account" research undertaken by Councils with social services responsibilities, where the Chief Investigator and/or sponsor feels there are substantial ethical issues.
    5. Studies of integrated services (health and social care), provided that there is no clinical intervention involved.
    6. Studies taking place in NHS settings with patients or staff where the approach to data collection uses social science methods, provided that the research involves no change in treatment or clinical practice.
    7. Other social care studies not suitable for review by other NHS RECs, subject to the capacity of the Social Care REC. This could include service user-led research.
    8. Intergenerational studies in social care, where both adults and children, or families, are research participants.

    The RECs flagged for Social Care do not consider any research involving clinical interventions. Such research should be reviewed by another appropriate REC within the UK Health Departments' Research Ethics Service.

    Social Care applications are expected to fall into one of the categories below:
    • Basic science study involving procedures with human participants
    • Study administering questionnaires/interviews for quantitative analysis, or using mixed quantitative/qualitative methodology
    • Study involving qualitative methods only
    • Study limited to working with data (specific project only)
    • Research database

    Bookings are made with the Central Booking Service (CBS). Please see http://www.hra.nhs.uk/resources/applying-to-recs/nhs-rec-central-booking-service-cbs/ for more information. 



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    Application to Research Ethics Committee

    Detailed guidance on the requirements for ethical approval by Research Ethics Committees within the UK Health Departments’ Research Ethics Service is available on the Health Research Authority (HRA) website at: http://www.hra.nhs.uk/resources/before-you-apply/is-nhs-rec-review-required/

    On this web page you will find a detailed algorithm, designed to assist researchers, research sponsors and R&D offices in determining whether REC review is required, either under any applicable legislation or under the policy of the UK Health Departments.

    For guidance on applying to RECs please refer to:




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    Applying for clinical trial authorisation

    Clinical trial authorisation (CTA) from the licensing authority (acting by MHRA Medicines) is required for any clinical trial of an investigational medicinal product (CTIMP) to be conducted in the UK.

    Please refer to the QSG on the CTIMP option in Question 2 for guidance on how to determine whether your project is a CTIMP.

    Applications to MHRA may be made through IRAS. For further details see the guidance on applying to the MHRA on the Help page.

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    Application to MHRA Devices

    This option should be selected for a clinical investigation of a medical device undertaken by the manufacturer for CE marking purposes.  This will be either an investigation of a non-CE marked product, or an investigation of a CE marked product that has been modified or is to be used outside its intended purpose.  Notice of No Objection for such investigations must be obtained from MHRA Devices.  The forms required to apply to MHRA (PCA1, PCA2 and the sterilisation annex) can be generated from IRAS.

    MHRA approval is not always required in the case of:

    Medical devices manufactured "in-house" in a healthcare establishment

    Clinician led off-label use of a medical device.

    The need for MHRA approval will depend on the purpose of the investigation. Guidance on whether MHRA approval is required can be found on the MHRA website at:

    http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=194

    (See the information at the foot of the web page and in Bulletin 18, which is also available via the link above.)

    Where research involves in-house devices or clinician-led off-label use, applicants are advised to contact MHRA Devices to discuss the purpose of the investigation and determine whether MHRA approval is required.  Contact details for MHRA Devices are on the website (see link above).

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    Application to Gene Therapy Advisory Committee

    If your application is for ethical approval of a gene therapy clinical trial you must apply to the Gene Therapy Advisory Committee (GTAC).  GTAC is the UK national REC for gene therapy clinical research according to regulation 14(5) of The Medicines for Human Use (Clinical Trials) Regulations 2004.  This means that GTAC is the main REC for gene therapy clinical trials.

    If you select GTAC in Question 4, do not select the option to apply to another Research Ethics Committee.

    The option to apply to GTAC is only available where Question 2 indicates that the study is a clinical trial of an investigational medicinal product.

    Gene therapy medicinal products

    Gene therapy medicinal products are defined in Part IV of Directive 2003/63/EC (amending Directive 2001/83/EC) as follows:

    "...[a] gene therapy medicinal product means a product obtained through a set of manufacturing processes aimed at the transfer, to be performed either in vivo or ex vivo, of a prophylactic, diagnostic or therapeutic gene (i.e. a piece of nucleic acid), to human/animal cells and its subsequent expression in vivo. The gene transfer involves an expression system contained in a delivery system known as a vector, which can be of viral, as well as non-viral origin.  The vector can also be included in a human or animal cell."


    Applying to GTAC

    For guidance on applying to GTAC please refer to: http://www.hra.nhs.uk/resources/applying-to-recs/gene-therapy-advisory-committee-gtac/.

    The application form for GTAC in IRAS is identical to that for any other CTIMP submitted to a recognised REC.  There are however some differences in submission procedures:

    • There is an extended time period of 90 days for ethical approval.

    • Electronic submission of all documents is required.




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    Application to the Confidentiality Advisory Group (CAG)
    Introduction


    Section 251 of the NHS Act 2006 re-enacted Section 60 of the Health & Social Care Act 2001. These powers allow the Secretary of State for Health to make regulations to set aside the common law duty of confidentiality for medical purposes where it is not possible to use anonymised information and where seeking individual consent is not practicable. Approval of applications under Section 251 will only be considered where anonymised data will not suffice and consent is genuinely not practicable.

    The Health Research Authority (HRA) established the Confidentiality Advisory Group (CAG) to review applications and provide advice to the HRA in respect of this function. The HRA will also be able to make research decisions to set aside the common law duty of confidentiality under the Regulations on behalf of the Secretary of State, following advice from CAG.

    Applications receiving approval from the HRA under the resulting Regulations (Health Service (Control of Patient Information) Regulations 2002) are referred to as having obtained "Section 251 support". 

    For more information about CAG please refer to http://www.hra.nhs.uk/about-the-hra/our-committees/section-251/


    When should you apply to the CAG?

    You should apply to CAG if you need to access identifiable patient data relating to people living in, or receiving healthcare in, England and Wales without explicit consent, prior to the disclosure of confidential information. 

    For detailed guidance please refer to:
    Additional guidance and advice is available from the Confidentiality Advice Team. Contact details for this team are provided via the links above and on the IRAS Contact Us page. 

    Applications to CAG can be made simultaneously to applications made to the Research Ethics Committee (REC). 





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    Select this option for projects taking place within the National Offender Management Service (NOMS) that wish to undertake the project with Prisons or Probation Trusts. The NOMS approval process extends to research in Young Offenders’ Institutions (YOIs), but excludes research in Secure Training Centres, Secure Children’s Homes or with Youth Offending Teams – applications to conduct research in these areas should be directed to the Youth Justice Board.

    Further advice

    When submitting an application form to NOMS, the guidance must be followed. Please refer to: https://www.gov.uk/government/organisations/national-offender-management-service/about/research . For further advice, please contact the National Research Coordinator Committee at national.research@noms.gsi.gov.uk.

    Submission procedure

    The completed NOMS application form should be submitted electronically by sending as a file attachment to the National research Mailbox at the above email addresses. The PDF and XML versions should be sent. Hard copy is not required.

    Applications should be fully completed and the appropriate supporting documentation should be provided – the form should be accompanied by applicant CVs, any ethical submissions and approvals, and any questionnaires, consent forms etc that have already been devised. Incomplete applications are likely to delay the review process.

    All applications will be logged by the National Research Coordinator, and then reviewed by the appropriate persons (see https://www.gov.uk/government/organisations/national-offender-management-service/about/research ). If consideration by the full committee is required, the application must be submitted by the end of the month for the following month’s committee meeting (enabling views to be obtained prior to the mid-month meeting). All research applications will be reviewed against the following criteria:
    1. Are there sufficient links to NOMS’ priorities?
    2. What are the anticipated demands on resources (e.g. anticipated demands on staff time, office requirements, demands on data providers)
    3. Is there an overlap with other current / recent research?
    4. How appropriate and robust is the methodology to be applied?
    5. Are there any data protection / security issues?
    6. Are there any ethical considerations?
    7. What is the extent of the applicants’ research skills and experience?
    Researchers will be notified in writing of the decision. Successful applicants will be required, on completion of the project, to prepare a research summary for NOMS which (i) summaries the research aims and approach, (ii) highlights the key findings, and (iii) sets out the implications for NOMS decision-makers (approximately three pages; maximum of five pages). Successful applicants will also be required to submit a project review form (which covers lessons learnt and asks for ratings on key questions).

    If an application is declined, reasons will usually be provided. Consideration will be given to no more than one resubmission. When resubmitting an application, the reasons for the previous rejection should be fully addressed.

    Please also note that the decision to grant access to prison establishments or probation trusts (and the offenders and practitioners within these establishments/trusts) ultimately lies with the Governing Governor or Contract Manager of the establishment/trust concerned. With regard to applications from academic institutions, the lead researcher must be at postgraduate level or above. Due to the potential volume of applications from undergraduates it is impractical for NOMS to assist with these. The only exception to this is for students on placements, supervised by a member of NOMS.

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    It is a requirement of the Medicines (Administration of Radioactive Substances) Regulations 1978 that administrations of radioactive medicinal products to humans should be conducted under certificates issued by the Health Ministers. For research studies where radioactive medicinal products are used, a research certificate is usually required for an applicant at each of the sites participating in the study.

    The ARSAC Preliminary Research Assessment (PRA) form is automatically generated in IRAS when the project filter has been completed to indicate that the study involves the administration of radioactive materials. The ARSAC Preliminary Research Assessment (PRA) form may be submitted to the ARSAC Support Unit as soon as the application for ethical review has been submitted to the NHS REC.

    Applications to ARSAC for individual research certificates at each site may not be submitted until the Preliminary Research Assessment form has been submitted. However, the first certificate application may be submitted alongside the Preliminary Research Assessment form

    For further guidance, please visit http://www.arsac.org.uk or contact the ARSAC Support Unit.

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    Form Print Guidance

    Non-identifiable data may include sensitive data items. Please see the HES Extract Pack to see which items are identifiers and which are sensitive.

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    Research requiring approval/management permission for the NHS but not ethical review

    The following types of research project do not require application for ethical review but still require approval/management permission for the NHS, if they are undertaken in or through an NHS organisation:

    Projects limited to the use of samples/data samples provided by a Research Tissue Bank (RTB) with generic ethical approval from a REC, in accordance with the conditions of approval.

    Samples/data must be non-identifiable to the researcher at point of access, otherwise further ethical review of the project is required.

    Projects limited to the use of data provided by a Research Database with generic ethical approval from a REC, in accordance with the conditions of approval.

    Data must be non-identifiable to the researcher at point of access otherwise further ethical review of the project is required.

    Research involving previously collected, non-identifiable information

    Research limited to secondary use of information previously collected in the course of normal care (without an intention to use it for research at the time of collection) is generally excluded from REC review, provided that the patients or service users are not identifiable to the research team in carrying out the research. This exception also applies to research undertaken by staff within a care team using information previously collected in the course of care for their own patients or clients, provided that data is anonymised or pseudonymised in conducting the research.

    Research involving previously collected, non-identifiable tissue samples

    Research limited to use of previously collected, non-identifiable material consisting of or including cells in accordance with the terms of donor consent is generally excluded from REC review.

    However, REC review would be required if any of the following applied:

    (a) Consent for research has not been given, or the research is not within the terms of the consent

    (b) The samples will be held on premises in England, Wales or Northern Ireland without a licence from the Human Tissue Authority to store relevant material for scheduled purposes

    (c) The research also involves removal, storage or use of new samples from the living or the deceased

    (d) The research also involves use of identifiable information held with the samples.

    Research involving acellular material

    Research limited to acellular material (e.g. plasma, serum, DNA) extracted from tissue previously collected in the course of normal care is generally excluded from REC review, provided that the patients or service users are not identifiable to the research team in carrying out the research.

    This exception applies to research undertaken by staff within a care team using samples previously collected for clinical purposes from their own patients or clients, provided that the samples/data are anonymised or pseudonymised in conducting the research.

    However, REC review would be required if the research involved:

    (a) Collection of tissue samples from patients in order to extract acellular material for the research

    (b) Collection of information from patients

    (c) Use of previously collected information from which patients could be identified by the researchers

    (d) Analysis of DNA in material from the living, where consent for research is not in place from the person whose body manufactured the DNA

    Research involving the premises or facilities of care organisations

    REC review is not required for research involving use of or access to a care organisation's premises or facilities, provided that review is not required under any other applicable legal or policy requirement. For example, a Phase 1 clinical trial undertaken by a Contract Research Organisation on premises rented from a NHS Trust would legally require REC review under the Clinical Trials Regulations. But research undertaken by a university department on NHS premises, involving healthy volunteers not recruited as NHS patients and not subject to any legal requirements, would not require review by a REC within the UK Health Departments' Research Ethics Service and could be reviewed by the university's research ethics committee.

    Research involving staff as participants

    REC review is not normally required for research involving NHS or social care staff recruited as research participants by virtue of their professional role.

    Exceptionally, the Research Ethics Service may accept an application for review of research involving staff at the request of the sponsor, chief investigator or host organisation, where it agrees that the proposal raises material ethical issues. Agreement should be sought from the responsible operational manager for the REC centre prior to submission of the application. Requests should be sent by email, including a summary of the research proposal (maximum one page) and explanation of why the project raises significant issues which cannot be managed routinely in accordance with established guidelines and good practice, and requires ethical consideration and advice from a REC. Contact points for operational managers are provided on the Health Research Authority (HRA) website 

    Researchers in Higher Education Institutions (HEIs) are advised to check whether, under their institution's policy and internal arrangements, ethical review is required by their HEI research ethics committee.

    Please indicate in question {QNumber(Guid_Sieve_Q_4_B)} whether any of the above apply to your project. If not, please return to question {QNumber(Guid_Sieve_Q_4)} and select the option to apply for ethical review.



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    Research requiring approval/management permission for the NHS but not ethical review

    The following types of research project do not require application for ethical review but still require approval/management permission for the NHS, if they are undertaken in or through an NHS organisation:

    Projects limited to the use of samples/data samples provided by a Research Tissue Bank (RTB) with generic ethical approval from a REC, in accordance with the conditions of approval.

    Samples/data must be non-identifiable to the researcher at point of access, otherwise further ethical review of the project is required.

    Projects limited to the use of data provided by a Research Database with generic ethical approval from a REC, in accordance with the conditions of approval.

    Data must be non-identifiable to the researcher at point of access otherwise further ethical review of the project is required.

    Research involving previously collected, non-identifiable information

    Research limited to secondary use of information previously collected in the course of normal care (without an intention to use it for research at the time of collection) is generally excluded from REC review, provided that the patients or service users are not identifiable to the research team in carrying out the research. This exception also applies to research undertaken by staff within a care team using information previously collected in the course of care for their own patients or clients, provided that data is anonymised or pseudonymised in conducting the research.

    Research involving previously collected, non-identifiable tissue samples

    Research limited to use of previously collected, non-identifiable material consisting of or including cells in accordance with the terms of donor consent is generally excluded from REC review.

    However, REC review would be required if any of the following applied:

    (a) Consent for research has not been given, or the research is not within the terms of the consent

    (b) The samples will be held on premises in England, Wales or Northern Ireland without a licence from the Human Tissue Authority to store relevant material for scheduled purposes

    (c) The research also involves removal, storage or use of new samples from the living or the deceased

    (d) The research also involves use of identifiable information held with the samples.

    Research involving acellular material

    Research limited to acellular material (e.g. plasma, serum, DNA) extracted from tissue previously collected in the course of normal care is generally excluded from REC review, provided that the patients or service users are not identifiable to the research team in carrying out the research.

    This exception applies to research undertaken by staff within a care team using samples previously collected for clinical purposes from their own patients or clients, provided that the samples/data are anonymised or pseudonymised in conducting the research.

    However, REC review would be required if the research involved:

    (a) Collection of tissue samples from patients in order to extract acellular material for the research

    (b) Collection of information from patients

    (c) Use of previously collected information from which patients could be identified by the researchers

    (d) Analysis of DNA in material from the living, where consent for research is not in place from the person whose body manufactured the DNA

    Research involving the premises or facilities of care organisations

    REC review is not required for research involving use of or access to a care organisation's premises or facilities, provided that review is not required under any other applicable legal or policy requirement. For example, a Phase 1 clinical trial undertaken by a Contract Research Organisation on premises rented from a NHS Trust would legally require REC review under the Clinical Trials Regulations. But research undertaken by a university department on NHS premises, involving healthy volunteers not recruited as NHS patients and not subject to any legal requirements, would not require review by a REC within the UK Health Departments' Research Ethics Service and could be reviewed by the university's research ethics committee.

    Research involving staff as participants

    REC review is not normally required for research involving NHS or social care staff recruited as research participants by virtue of their professional role.

    Exceptionally, the Research Ethics Service may accept an application for review of research involving staff at the request of the sponsor, chief investigator or host organisation, where it agrees that the proposal raises material ethical issues. Agreement should be sought from the responsible operational manager for the REC centre prior to submission of the application. Requests should be sent by email, including a summary of the research proposal (maximum one page) and explanation of why the project raises significant issues which cannot be managed routinely in accordance with established guidelines and good practice, and requires ethical consideration and advice from a REC. Contact points for operational managers are provided on the Health Research Authority (HRA) website 

    Researchers in Higher Education Institutions (HEIs) are advised to check whether, under their institution's policy and internal arrangements, ethical review is required by their HEI research ethics committee.

    Please indicate in question {QNumber(Guid_Sieve_Q_4_B)} whether any of the above apply to your project. If not, please return to question {QNumber(Guid_Sieve_Q_4)} and select the option to apply for ethical review.



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    NHS or non-NHS site?

    A research site is defined as the single organisation responsible for conducting the research at a particular locality.

    NHS research sites would typically be:

    • A NHS Trust (in England or Wales)

    • A NHS Health Board (in Scotland)

    • A Health and Social Care Trust (in Northern Ireland)

    • A GP practice

    • A Strategic Health Authority in England (for public health, epidemiology or needs assessment studies)

    • A prison establishment in England or Wales.

    The research site is not necessarily the location where research activities will actually take place. For example, in a research project by practice nurses from GP practices, interviews with participants may take place in the participant’s home, but the research site would be the GP practice, because the GP practice would be responsible for the research activity.

    Organisations where clinicians or clinical units refer potential participants to the research team for assessment and possible recruitment are not considered to be research sites.

    NHS management permission (also termed "R&D approval") must be obtained for all NHS research sites.

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    What is NIHR CSP?

    The National Institute for Health Research (NIHR) Coordinated System for gaining NHS Permission (CSP) is a new system designed to support the application and approvals process for NHS permissions for NIHR Clinical Research Network Portfolio studies.

    Initially CSP will be available only to multi-site and single-site studies which are eligible for the NIHR Clinical Research Network Portfolio. This includes studies which are automatically eligible for the NIHR Clinical Research Network Portfolio, and those which are actively adopted into the NIHR Clinical Research Network Portfolio (including commercially sponsored studies).

    Is my study eligible for NIHR Clinical Research Network Portfolio?

    Please refer to the full eligibility criteria for details on the inclusion of studies in the NIHR Clinical Research Network Portfolio: http://www.crn.nihr.ac.uk/can-help/funders-academics/nihrcrn-portfolio/which-studies-are-eligible-for-clinical-research-network-support/  .

    How do I submit my study to CSP?

    If your study is potentially eligible for NIHR Clinical Research Network Portfolio, select Yes to question 5a, "Do you want your application to be processed through the NIHR Coordinated System for gaining NHS Permission?" to use CSP for obtaining NHS permissions for your study. You will be required to complete a short NIHR CSP Application Form, to provide basic details about your study to the NIHR Clinical Research Network Coordinating Centre.

    How will I know if my study has been registered with CSP?

    • For Non-commercially sponsored studies - The CSP Application Team at the NIHR Clinical Research Network Coordinating Centre will review your NIHR CSP Application Form to assess whether your study may be eligible for the NIHR Clinical Research Network Portfolio. You will be notified of the decision by email within 2 working days.

    • Commercially sponsored studies – The Industry team at the NIHR Clinical Research Network Coordinating Centre will review your NIHR CRN Portfolio Application Form to determine whether your study is already adopted by an NIHR Clinical Research Network. If not, the Industry team will contact the commercial sponsor to initiate the Industry Adoption process for the NIHR Clinical Research Network Portfolio. Queries about the eligibility of commercial research should be made to the NIHR industry team 0113 34 34 555 or email supportmystudy@nihr.ac.uk

    How is confidentiality maintained?

    NIHR CSP will replace existing application and approval processes for NHS permissions for NIHR Clinical Research Network Portfolio studies. All information and documentation submitted through IRAS to NIHR CSP will be held in the strictest confidence at all times and managed under a duty of confidence.

    If adoption of a commercially sponsored study is required, the NIHR Clinical Research Network Coordinating Centre will ensure that the UKCRN model Confidentiality Disclosure Agreement is in place before commencing the Industry feasibility and adoption process.


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    The National Institute for Health Research (the NIHR) has put in place infrastructure to support high quality research across the innovation pathway in England. Further details are available on the NIHR website at http://www.nihr.ac.uk/about-us/how-we-are-managed/our-structure/infrastructure/ . Some types of NIHR infrastructure funding cover the research costs of studies taking place within that infrastructure.

    If all the research costs and infrastructure costs (funding for the support and facilities needed to carry out research e.g. NHS Support costs) for this study are provided by a NIHR Biomedical Research Centre, NIHR Biomedical Research Unit, NIHR Collaboration for Leadership in Health Research and Care (CLAHRC), NIHR Patient Safety Translational Research Centre or a Diagnostic Evidence Co-operative in all study sites an application for NIHR Clinical Research Network (CRN) support should not be required. In this case please select 'yes' to this question. Please note by doing so you study will not be considered for NIHR CRN Support.

    If all of the research costs and infrastructure costs (funding for the support and facilities needed to carry out research e.g. NHS Support costs) for this study are not funded by a NIHR Biomedical Research Centre, NIHR Biomedical Research Unit, NIHR Collaboration for Leadership in Health Research and Care (CLAHRC), NIHR Patient Safety Translational Research Centre or a Diagnostic Evidence Co-operative in all study sites; your study may be eligible for consideration for NIHR Clinical Research Network support and inclusion in the NIHR Clinical Research Network (CRN) Portfolio. Please refer to the Eligibility Criteria for NIHR Clinical Research Network Support

    If you think the study meets the Eligibility Criteria, please select ‘no’ to IRAS Project Filter question 5a and ‘yes’ to IRAS Project Filter question 5b. Please refer also to the question specific guidance for IRAS Project Filter question 5b

    *If you wish to apply for NIHR CRN Support and inclusion in the NIHR CRN Portfolio you will be required to electronically submit a Portfolio Application Form (PAF) before you submit your other applications*



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    The Clinical Research Network (CRN) is part of the National Institute for Health Research (NIHR) and provides researchers with the practical support they need to make clinical studies happen in the NHS in England. This includes: helping researchers to set up clinical studies quickly and effectively; enhancing NHS resources, by funding the people and facilities needed to carry out research “on the ground", helping researchers to identify suitable NHS sites, and recruit patients to take part in research studies; supporting the life-sciences industry to deliver their research programmes; and advising researchers on how to make their study “work” in the NHS environment. More information regarding the CRN and the services it provides can be found at http://www.nihr.ac.uk/funding-and-support/study-support-service/

    Is my study eligible for NIHR Clinical Research Network Support and inclusion in the NIHR CRN Portfolio?

    Please refer to the Eligibility Criteria for NIHR Clinical Research Network Support.

    If you think your study may be eligible for NIHR Clinical Research Network Support, and you wish to apply, please select 'yes' to this question and complete and submit the Portfolio Application Form (PAF) ,which will then appear in the IRAS Project Forms menu associated with this study. Please submit the PAF before the other applications, including your application for HRA Approval (IRAS Form), as failing to do so may mean that you will be unable to access NIHR CRN Support for your study.

    Please note: If all the research costs and infrastructure costs (funding for the support and facilities needed to carry out research e.g. NHS Support costs) for this study are provided by a NIHR Biomedical Research Centre, NIHR Biomedical Research Unit, NIHR Collaboration for Leadership in Health Research and Care (CLAHRC), NIHR Patient Safety Translational Research Centre or a Diagnostic Evidence Co-operative in all study sites, an application for CRN support should not be required. Please refer to the question specific guidance for IRAS Project Filter question 5a.

    For Non-commercially sponsored studies - The Eligibility Team at the NIHR Clinical Research Network Coordinating Centre will review your NIHR CRN Portfolio Application Form (PAF) to assess whether your study may be eligible for consideration for Clinical Research Network support and inclusion in the NIHR Clinical Research Network Portfolio. You will be notified of the decision by email within two working days. Queries about the eligibility of non-commercial research should be made to: portfolio.applications@nihr.ac.uk 

    For Commercially sponsored studies – The NIHR Clinical Research Network Coordinating Centre will review your NIHR CRN Portfolio Application Form (PAF) to determine whether your study is already accepted by the NIHR Clinical Research Network.

    If not, they will contact the commercial sponsor to initiate the Industry application process for the NIHR Clinical Research Network Portfolio. Please note the IRAS application process is in addition to your commercial submission to the NIHR CRN Central Portfolio Management System, which you may have used to access the NIHR CRN feasibility services.

    Queries about the eligibility of commercial research should be made to the NIHR CRN on 0113 34 34 555 or email: supportmystudy@nihr.ac.uk



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    The Clinical Research Network (CRN) is part of the National Institute for Health Research and provides researchers with the practical support they need to make clinical studies happen in the NHS in England. This includes: helping researchers to set up clinical studies quickly and effectively; enhancing NHS resources, by providing access to the people and facilities needed to carry out research "on the ground", helping researchers to identify suitable NHS sites, and recruit patients to take part in research studies; supporting the life-sciences industry to deliver their research programmes; and advising researchers on how to make their study "work" in the NHS environment. More information regarding the CRN and the services it provides can be found at http://www.crn.nihr.ac.uk/

    Ticking "Yes" to this question means that your IRAS Form, grant award letter and/ or contract, and your protocol will be passed to the NIHR Clinical Research Network who will contact you regarding your application. Please see the information below for further details.

    Is my study eligible for NIHR Clinical Research Network Support and inclusion in the NIHR CRN Portfolio?

    Please refer to the Eligibility Criteria for NIHR Clinical Research Network Support

    Please note: If all the research costs and infrastructure costs are provided by an NIHR Biomedical Research Centre, NIHR Biomedical Research Unit, NIHR Collaboration for Leadership in Health Research and Care (CLAHRC), NIHR Patient Safety Translational Research Centre in all study sites in England an application for CRN support should not be required. 

    For Non-commercially sponsored studies - The Eligibility Team at the NIHR Clinical Research Network Coordinating Centre will assess whether your study may be eligible for consideration for Clinical Research Network support and inclusion in the NIHR Clinical Research Network Portfolio. You will be notified of the decision by email. Queries about the eligibility of non-commercial research should be made to: portfolio.applications@nihr.ac.uk 

    For Commercially sponsored studies – The NIHR Clinical Research Network Coordinating Centre will determine whether your study is already adopted by the NIHR Clinical Research Network. If not, they will contact the commercial sponsor to initiate the Industry Adoption process for the NIHR Clinical Research Network Portfolio. Please note the above process is in addition to the Industry Application Gateway application which you may have made to access feasibility services from the Clinical Research Network. Queries about the eligibility of commercial research should be made to the NIHR CRN on 0113 34 34 555 or email: supportmystudy@nihr.ac.uk



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    Children

    Please answer Yes if the research will include participants aged under 16, or use of their samples or data.

    You should still answer Yes if some or all of the participants will be able to consent for themselves under the Gillick principles.  Further guidance about this is available in Part B Section 7 of IRAS, which covers issues in the inclusion of children in research.

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    Adults unable to consent for themselves Please answer Yes if it is possible that the research could at any stage include adults (aged 16 or over) who are unable to consent for themselves due to physical or mental incapacity (including temporary incapacity).

    You should still answer Yes if participants will be able to give consent initially but you plan to undertake further research procedures on or in relation to such participants (including collection of new samples or data) following loss of capacity to consent during the study.  If participants would be withdrawn from the study following loss of capacity, you may answer No.  For guidance on retaining samples or data already collected at the point capacity is lost, please refer to the guidance on Question A35 in IRAS.

    Where research involves adults unable to consent for themselves, the application and approval requirements differ according to:

    • Whether your research is a clinical trial of an investigational medicinal product (CTIMP) or a non-CTIMP, and

    • In which countries of the UK the research sites will be located.

    Please indicate, in answer to the supplementary question, which countries you expect the research sites to be located in.

    Guidance

    Detailed guidance on ethical review of applications involving adults unable to consent for themselves is available on the Health Research Authority (HRA) website at:


    A summary of key points is below.

    Booking the ethics application

    Please refer the Health Research Authority (HRA) website for guidance on booking your application:
    http://www.hra.nhs.uk/resources/applying-to-recs/nhs-rec-where-to-book/

    When booking, please notify the team that the research may include adults unable to consent for themselves and indicate which UK countries are involved.

    The application will be allocated to review by a "flagged REC" (see below).   Applicants for research in England and Wales may indicate a preference for a particular flagged REC when booking the application.


    Flagged RECs

    The HRA has appointed a panel of flagged RECs to review all new research potentially including adults unable to consent for themselves.  The webpage listed above, which provides guidance on booking your application, also includes a link to the directory of RECs. 

    Where the research is a CTIMP, the application will be allocated to a committee which is both recognised by UKECA for review of CTIMPs and flagged for review of research involving adults unable to consent for themselves.

    Where the research is a CTIMP to be conducted at one or more sites in Scotland and the Chief Investigator is professionally based in Scotland, it must be reviewed by the Scotland A REC.

    Approval requirements (CTIMPs)

    The inclusion of adults unable to consent for themselves in any part of the UK is governed by the Medicines for Human Use (Clinical Trials) Regulations 2004.  The Mental Capacity Act 2005 has no application to CTIMPs.

    The ethical review must consider whether the trial is justified having regard to the conditions and principles specified in Part 5 of Schedule 1 to the Regulations.  These include provisions for informed consent to be given by the subject's legal representative.  A definition of "legal representative" for this purpose is given in Part 1 of Schedule 1.

    The Health Research Authority has issued an information paper on "Informed Consent in Clinical Trials of Investigational Medicinal Products", outlining the relevant provisions of Schedule 1.  This is available via the HRA website.  

    Applicants should give information about the inclusion of adults unable to consent in Part B Section 6 of the application form.

    Approval requirements (all other NHS and non-NHS research)

    Approval requirements for non-CTIMPs differ across the UK as follows:

    England and Wales:

    • In England and Wales, approval is required by an "appropriate body" under section 30 of the Mental Capacity Act 2005 (MCA) for any research, whether NHS or non-NHS research.

    • This approval must be given by a NHS REC in England or Wales, even where the research does not involve NHS patients.

    • For guidance on the research provisions of the MCA, see chapter 11 of the Code of Practice, available at http://www.opsi.gov.uk/acts/en2005/ukpgaen_20050009_en_cop.pdf

    Scotland:

    • In Scotland, approval is required under section 51 of the Adults with Incapacity (Scotland) Act 2000. This approval must be given by the Scotland A REC.

    Northern Ireland:

    • In Northern Ireland, there is no equivalent legislation.   Inclusion in research of adults unable to consent for themselves is governed by the common law.

    • Where the research will be taking place in Northern Ireland only, it should be reviewed by a Health and Social Care (HSC) REC in Northern Ireland.

    • Where the research will be taking place in another UK country as well, the research should be reviewed by a REC on the mainland in consultation with a HSC REC in Northern Ireland.

    The table below summarises the process for non-CTIMPs taking place in different UK countries.

    Countries where sites located

     

    Application process

    England and/or Wales only

     

    Apply to any flagged REC in England or Wales.

    Scotland only

     

    Apply to Scotland A REC.

    Northern Ireland only

     

    Apply to any HSC REC in Northern Ireland.

     

    England and Wales

    Apply to any flagged REC in England or Wales.

     

    England/Wales and Scotland

    Two applications should be made:

    1.      The England/Wales application should be made to a flagged REC in England or Wales.  

    2.      The Scotland application should be made to the Scotland A REC.

    Separate application forms should be submitted with separate REC reference numbers.  The application form can be duplicated to minimise form-filling.

     

    The applications will be reviewed separately having regard to the relevant legislation.  Any favourable opinion will apply only to England/Wales or Scotland respectively.   Different opinions may be given.

     

    England/Wales and Northern Ireland

    Apply to any flagged REC in England or Wales.

     

    Only one application is required.  The main REC will seek advice from a HSC REC on issues relating specifically to participants in Northern Ireland.   Any advice will be incorporated in the main review.

     

     

    Scotland and Northern Ireland

    Apply to Scotland A REC.

     

    Only one application is required.  The main REC will seek advice from a HSC REC on issues relating specifically to participants in Northern Ireland.   Any advice will be incorporated in the main review.

     

    England/Wales, Scotland and Northern Ireland

    Two applications should be made:

    1.  Application for England/Wales/Northern Ireland should be made to a flagged REC in England or Wales.

    2.  Application for Scotland should be made to the Scotland A REC.

    Separate application forms should be submitted with separate REC reference numbers.  The application form can be duplicated to minimise form-filling.

     

    The applications will be reviewed separately having regard to the relevant legislation.  Any favourable opinion will apply only to England/Wales/Northern Ireland or Scotland respectively.   Different opinions may be given.



     





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    Prisoners

    For this purpose, a prisoner or young offender is defined as any inmate of the prison systems of England and Wales, Scotland or Northern Ireland.  It does not include patients detained under the Mental Health Act at special hospitals or other psychiatric secure units, or juvenile offenders detained in local authority secure accommodation or secure training centres.

    The Offender Health Research Network (OHRN) publishes guidance on the various approvals and permissions required to conduct research involving prisoners in England and Wales, and may be able to assist with specific queries.  Further information is at http://www.ohrn.nhs.uk

    Except in Scotland, ethics applications involving prisoners should be booked with the Central Booking Service (CBS), which will arrange allocation to one of the RECs designated by NRES to review such research.  In Scotland the application may be made direct to the relevant REC if it is within a single domain; if it is multi-domain, it should be allocated through CBS.

    Health research involving prisoners or young offenders should relate directly to their health care and be of such a nature that it could only be conducted in this population.



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    Educational projects

    An educational project means any study undertaken for the purposes of obtaining an academic award, i.e. it is a required piece of assessed work in part fulfilment of the award. This includes doctoral research.

    Student research within the field of social care should ordinarily be reviewed by a University REC, rather than the Social Care REC. If such review is not available to the applicant, they are requested to contact the Social Care REC Manager at nrescommittee.social-care@nhs.net.

    If the project is undertaken as part of a PhD or other doctorate, answer Yes to Question 9a. If this is the case, the student should normally be named as the Chief Investigator.

    If the project is undertaken as part of an undergraduate or Masters level award, answer No to Question 9a. The student should complete the application, but should generally not be named as the Chief Investigator. Normally the student’s academic supervisor should be named as the Chief Investigator and should complete both the CI and supervisor declarations in Part D.

    Further guidance on student research is available on the Help page.



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    Research funded by the US Department of Health and Human Services

    Applicants for ethical review should note special arrangements for review of research with funding support from the US Department of Health and Human Services (DHHS).

    1. Applying to a REC with OHRP registration

    All such applications should be booked for review with the UK Health Departments' Research Ethics Service Central Booking Service (CBS) and allocated to a Research Ethics Committee (REC) which is flagged for this purpose (see section 3 below).

    All flagged RECs are registered with the US Office for Human Research Protections (OHRP) as an Institutional Review Board (IRB) / Independent Ethics Committee (IEC).

    CBS staff can also advise on booking with a REC that is flagged for the appropriate type of study (where applicable). For example, a clinical trial of an investigational medicinal product (CTIMP) with funding support from the DHHS must be reviewed by a committee that is both recognised to review the relevant type of CTIMP and registered with the OHRP.

    Where a DHHS-funded study is in a category that does not require review by a flagged REC by study type (e.g. a clinical trial not involving medicines or devices), it may be reviewed by any flagged REC for DHHS-funded research.

    2. Requirements for Federal Wide Assurance at research sites

    Each Trust or other host organisation participating in the study must have Federal Wide Assurance (FWA) in place with the OHRP. An FWA is a general commitment by the institution to comply, in the management and conduct of human participant research, with the DHHS Protection of Human Subjects regulations.

    Guidance on how to register for FWA at a non-US research site is available at: http://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/index.html

    Sponsors and Chief Investigators are strongly encouraged to make early contact with R&D offices at each planned research site to discuss preparations for the study. In order to obtain an FWA, the research institution must give details of the IRB/IEC(s) undertaking ethical review of DHHS-funded research to be conducted at the site. Therefore the FWA at each site must list the REC responsible for reviewing the current study and this REC must be registered with the OHRP.

    It is open to R&D offices to list all the RECs flagged as IRB Registered on their FWA. This can be done in advance of submitting the REC application and allocation to a particular REC for review, and may reduce start-up time.

    Trusts with an existing FWA may update their FWA at any time to include additional IRB/IECs. To update FWA, a revised version of the form should be submitted to OHRP.

    3. List of flagged RECs

    A listing of the NHS RECs in the UK flagged as IRBs is available via the HRA website at: http://www.hra.nhs.uk/news/rec/ by searching on 'IRB Registered'.

    Please use this search alongside selection of any other flags and/or committee types (e.g. RECs recognised to review CTIMPs in healthy volunteers) that are appropriate to your research to identify the RECs that could review your research.

    Where the type of research is not subject to flagging arrangements, any of the IRB Registered RECs listed may review the application.

    4. Further advice

    For further advice about the requirements of the DHHS or the process of registration for FWA, please contact the OHRP directly:http://www.hhs.gov/ohrp/about-ohrp/contact-us/index.html

    Details of registered IRBs and approved FWAs are available in the DHHS’s OHRP Database, which is available at: http://ohrp.cit.nih.gov/search/search.aspx?styp=bsc.

    For questions relating to the allocation of your REC application, please contact the Central Booking Service once you are ready to submit the application.



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    Processing identifiable data without consent If your project involves access to identifiable patient data relating to people living or receiving care and treatment in England and Wales without explicit consent, you may need to apply to Health Research Authority (HRA) for approval to process data without consent and an application should be made to the Confidentiality Advisory Group (CAG).

    For details of Section 251 of the NHS Act 2006 and supporting Health Service (Control of Patient Information) Regulations 2002, and how it regulates the control of identifiable patient data and how it may impact on your research, see http://www.hra.nhs.uk/about-the-hra/our-committees/section-251/. Further guidance is available from the information button next to the option on applying to CAG  in Question 4 of the Project Filter.

    An application for approval from HRA to process data without consent does not negate the need for a favourable opinion from a REC or approval/permission from the host organisation.



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    IRAS: Collated Question-Specific Guidance - Project Filter
    Updated 27/07/2017
    Version 14


     
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