Study and approval types

• NHS Research Ethics Committee (REC) approval

  Work that involves the items above and which is classed as 'research' will most likely require NHS ethical review (often also called Research Ethics Committee or REC review). 

  There are two types of NHS ethics review - proportionate review and full review:

  • Proportionate review - the proportionate review service (PRS) provides an accelerated, proportionate review of research studies that raise no material ethical issues. Studies that have no material ethical issues have minimal risk, burden or intrusion for research participants. Researchers do not need to know if their study is suitable for proportionate review in advance. The Online Booking Service asks a number of questions to establish if an application should be booked for a Full or Proportionate Review meeting. Upon receipt, the REC Manager undertakes a thorough pre-screen of the application to gauge its PR suitability. 
  • Full review - any study not allocated to proportionate review will undergo a full review.

  There is no expedited review process for general research, however, there is for research relating to Covid-19. See the research involving the NHS and Covid-19 page for more information.

  The HRA have two decision-making tools to help you decide whether you need NHS ethics approval:

  • Is my study research?
  • Do I need NHS REC review?

  These tools are a good indicator of whether REC review is required but we advise that you always confirm this as sometimes a study not meeting these criteria can still require review. There is also a document describing the algorithm underpinning the 'Do I need NHS REC review?' tool which goes into more detail.

  These tools also only give an indication of whether an NHS REC review is required - you may still need a University ethics review or NHS R&D or information governance approvals.

  When might you not require an NHS REC review?

  Studies involving NHS or social care staff 

  Studies that only involve NHS or social care staff, and not patients or service users only require NHS REC review if the research raises ethical issues.

  Studies using data collected as a part of routine care or for research purposes

  You will need NHS ethics approval for research using this type of data unless:

  • the data has already been collected by a member of the patients' care team as part of routine care (without the intention that the data would be used for research) and individuals are not directly or indirectly identifiable to the researcher or any other parties involved with the research
  • the data you receive is completely anonymised and already in the public domain
  • the data you receive come under an existing ethics approval, such as a 'blanket' approval held by a data repository. 

  Data collected for a research purpose requires NHS ethics review even if collected by a member of the patients' care team or if the researcher will receive the data in anonymised form. If data are anonymised such studies will normally qualify for proportionate REC review.

  The sponsor or researcher can also choose to request an NHS REC review for a study if they have any concerns, for example, around ethical issues, consent, or identification of individuals, though this is normally expected to only be in exceptional circumstances.

  Studies involving social care

  Where the study will take place only in Scotland, NHS REC review is not required for research in the social care setting, unless:

  • the study involves adults unable to consent to themselves
  • the study involves NHS patients or a mix of NHS patients and social care users.

  Studies taking place elsewhere in the UK may require NHS REC review.

  Guidance and other approvals

  Seek guidance and confirmation from the relevant NHS boards' research and development department (or equivalent if social care). You can also obtain advice from an NHS REC or the University's Research Governance team.

  Although NHS REC review may not be required in some of these scenarios, you may still require NHS R&D, information governance or other approvals.

• Delegated NHS ethical approval: Data Safe Havens and tissue banks

  Sometimes research involving data or samples that would normally require NHS ethical approval can be covered by an existing blanket or delegated NHS approval. 

  This is mainly when data or samples are sourced from:

  • a tissue bank
  • a biorepository
  • a national clinical dataset
  • datasets managed by a data custodian.

  Some examples of these include the Edinburgh Brain and Tissue Bank, and some datasets held by Public Health Scotland's Electronic Data Research and Innovation Services (EDRIS) and the Health Information Centre (HIC) in Dundee. 

  In these cases, the organisation managing the data or samples has already obtained NHS ethics approvals and have established governance mechanisms and security controls such as access committees and safe electronic environments.

  See the data only research scenario for more information.

  If you think this may apply to your research it is important that you speak to these organisations early on in your research to establish what approvals are already in place and what else you will be required to obtain or submit. These may include the other approvals described on this page and specific training:

  • ethical approvals (NHS, University)
  • information governance approvals (Caldicott, PBPP)
  • human tissue approvals (HRA)
  • research and development approvals (NHS R&D, for data relating to specific health boards)
  • Good Clinical Practice training (see useful resources)
  • research data management, information governance or GDPR training (see useful resources).

• NHS Research and Development approval

  Studies involving NHS patients, staff or sites require NHS R&D approval, even if NHS ethics approval is not required. To obtain NHS R&D approval, you must apply via IRAS

  See the guidance on NHS research and Covid-19 and the critical role of R&D in deciding whether a study can commence.

• Information Governance approvals

  Studies involving the data of NHS patients or staff, plus some other groups, will often need data governance approvals. This can vary depending on the data source but may include:

  • Public Benefit and Privacy Panel (PBPP) - this panel reviews and approves research involving the use of patient data where individual consent is not sought and this includes data from more than one health board.
    
    
  • Caldicott Guardian - this body reviews and approves research involving the use of patient data where individual consent is not sought and this includes data from only one health board (contact the health board for details on their Caldicott Guardian and how to obtain approval).
    
    
  • Applications to access a data source - for access to data through a Safe Haven or where this is managed in some way will also require an application to the managing organisation. At St Andrews, this is often the Health Informatics Centre in Dundee or eDRIS in Edinburgh.

• Registration - service evaluations, audits and quality improvement

  Service evaluations, audit or quality improvement activities may need to be registered - you should contact the NHS board in question to check their requirements.

  NHS R&D can often assist in:

  • identifying the appropriate contact
  • confirming how your study should be categorised
  • whether any other processes must be followed or approvals obtained.

  So, seek confirmation from the NHS board's R&D team as to what steps you need to complete before commencing your work. Always keep copies of communications for your records.

  A project meeting the NHS's definitions of a service evaluation, improvement or audit may still meet the University's criteria for 'research involving humans' and so will still need University ethics approval. 

• NHS REC A approval - adults with incapacity

  Although this sits within the broad scope of NHS ethical review and approval, research involving adults with incapacity (sometimes referred to using the acronym AWI) requires special consideration and must be reviewed by a specific NHS Research Ethics Committee (NHS REC). In Scotland, this REC is called REC A.

• MODREC approval - research involving the MOD

  If you are planning research involving the Ministry of Defence (MOD) get in touch with Research Governance as soon as possible to discuss.

  Ethics review and approval for MOD-related research

  Obtaining ethics approvals for MOD-related research is similar to that for the NHS, as both rely on the guidance and frameworks of the HRA, except that applications are submitted to and reviewed by the MOD Research Ethics Committee (MODREC). Obtaining MOD approvals can take several months.

  Both MOD and NHS-related research requires a 'sponsor' i.e. an organisation which takes overall responsibility for the study and provides sponsor review and approval - this may be the University, MOD or another organisation depending on your role and project. 

  Due to the specific requirements for research involving MOD, it can be easier to obtain approvals if the research is funded or sponsored by the MOD or an associated body.

  There are some unique steps to submitting and obtaining MOD ethics approval:

  • Insurance requirements - the MOD operates a no-fault compensation scheme (NFCS) for participants in MOD approved research studies.
  • Participant documents - the MOD have template participant documents which they require researchers to use. These include references to the NFCS.
  • Security risk assessment - the MODREC application requires a security threat assessment to be completed.
  • Sign-off from an individual in a senior position - this is a specific rank or above if the research is sponsored by the MOD or an equivalent HERA grade if University-sponsored.
  • Submission of a sponsors checklist - this provides a record of the sponsors review.

  Before the application can be submitted to the MODREC, it must first undergo review and approval by the MOD's Scientific Assessment Committee (SAC) to ensure that the basis for and design of the study are robust. 

  You can find more information on MOD ethics approvals and requirements on the UK Government website.

  The guidance for preparing an NHS ethical review application will also be useful to help you understand the standards expected of an application and what a sponsorship review entails.

• Primary data collection

  Such as interviews, questionnaires, surveys, clinical assessments or tests

  Much of the research involving the NHS conducted at the University falls into this category - researchers collecting primary data from NHS patients or staff through methods such as interviews, focus groups, surveys or questionnaires. Sometimes this may be in combination with imaging, diagnostic tests, collection of biological samples or other assessments. 

  The approvals you will likely need, and which are obtained in the following order, are:

  • NHS ethics
  • University ethics
  • NHS R&D approval.

  An example of the process is available Swimlane diagram - primary data collection (PDF)

  There are several steps to obtaining these approvals but first:

  • speak to your NHS contacts or collaborators to ensure the study is feasible and can be supported
  • contact Research Governance to discuss your study.

  Then, start preparing your application:

  • Prepare a full set of application and study documents (see preparing your application)
    • IRAS application
    • study protocol
    • participant documents
    • interview schedules or questionnaires
    • testing, imaging or assessment protocols or schedules
    • any site-specific, University or procedure-related risk assessments
    • any other documents you will be referring to or relying upon in your study
    • you may also need to check whether there are any insurance considerations.

  Once you have prepared your application:

  • work with research governance as they conduct a sponsorship review - this can involve several revisions to your study documents after which the full document set must be re-checked. This can be quite a time-consuming process (see ).
  • work with Research Governance, RBDC and NHS R&D to determine if there are any arrangements or agreements.

  After the sponsorship review has been completed and you have been issued with a Sponsor's approval letter:

  • submit your IRAS application with all accompanying documents (see submitting your application)
  • complete the electronic sign off process 
  • book a REC time through the Central Booking Service
  • await REC review.

  Next - the NHS REC review:

  • make sure you are free to attend the REC review meeting if required. Students should ensure their supervisor can also attend. 
  • respond to any questions 
  • once you have an opinion, address any requests for revisions (see review outcomes)

  Once you have an NHS REC favourable opinion letter:

  • complete the cover sheet (and any other sections your SEC request) for the University ethical review application form and append your NHS ethics application documents and the approval letter (see applications which already have approval)
  • submit this to your School ethics committee for ratification and await approval
  • the IRAS submission process will also trigger notification to the NHS R&D department at your proposed sites and you must await their approval.

  Only once you have an NHS REC favourable opinion letter, a University SEC approval letter and confirmation from NHS R&D at each board involved in your study can you begin your research. 

• Data only studies

  Research which does not involve direct contact with participants

  Often researchers will collect data without direct contact with participants (i.e. recruiting and obtaining consent, collecting primary data), normally through data extractions from clinical systems or access to existing datasets.

  Data obtained without individual consent

  Where the research requires a large volume of data, such as from a large dataset or clinical systems, it is common that (due to the scale of the data) access is requested without seeking the consent of every individual whose data is held there.

  While consent in research is a key ethical principle, there are mechanisms in place for obtaining this type of data without individual consent if this is suitably justified and with appropriate safeguards.

  To protect participants, the public and ensure that access is appropriate, access to identifiable health or social care data without individuals' consent must be approved by an authorised body:

  • if the data is from a single NHS board - a Caldicott Guardian
  • if the data is from several NHS boards or from a national dataset - the Public Benefit and Privacy Panel (PBPP).

  If you will receive only anonymised data then these are not required. However, you should check with the NHS Board whether they have any other requirements. 

  Ethics approvals

  You will need NHS ethics approval for research using this type of data unless:

  • the data has already been collected by a member of the patients' care team as part of routine care (without the intention that the data would be used for research) and individuals are not directly or indirectly identifiable to the researcher and the data are being used to create a clinical or public health database (check the HRA guidance and you must speak to the relevant NHS board R&D contact)
  • the data you receive are completely anonymised and already in the public domain
  • the data you receive come under an existing ethics approval, such as a 'blanket' approval held by a data repository. 

  Data collected for a research purpose requires NHS ethics review even if collected by a member of the patients' care team or the researcher will receive the data in anonymised form. If data are anonymised such studies will qualify for proportionate REC review.

   

  The sponsor or researcher can also choose to request NHS REC review for a study if they have any concerns, for example, around ethics issues, consent or identification of individuals 

  Never assume that NHS ethics (or other) approval is in place or is not required - always confirm this with your data source and Research Governance.

  You will need University ethics approval, regardless of whether the data are anonymised or come under an existing NHS ethics approval.

  In what order to obtain approvals

  Obtaining approvals for these types of projects differs from other projects involving the NHS (where normally all NHS approvals are obtained first). This is because Caldicott Guardian and PBPP require evidence of NHS (if applicable) and University ethics approvals first before they will review your application. 

  So, you should obtain in this order:

  • NHS ethics (if needed)
  • University ethics approval
  • PBPP or Caldicott Guardian.

  An example of the process is available Swimlane diagram - data only (PDF)

  You must also check with your data source if you need to submit an access request application or similar, what their requirements are and when in the process this needs to be completed.

  When seeking ethical approval think ahead to your PBPP or Caldicott Guardian application - these are heavily focused on data management and data protection so review their application documents and discuss these aspects with your data source to ensure these are accounted for in your ethics applications. You can also speak to Research Data Management about developing a Data Management Plan.

  What you need to do to obtain approvals

  The process for obtaining NHS approval is covered in the previous scenario and under preparing an NHS ethics application. If you need NHS ethics, you should obtain approval and then:

  • complete the cover sheet of the University's ethical review application form
  • submit this along with all of your NHS application documents and approval letter to your School ethics committee
  • await your University ethics approval letter.

  Once you have these, prepare your Caldicott or PBPP application. You will need to:

  • carefully describe the reasons for your research and why your use of data without individual consent is justified
  • carefully describe every step of data extraction or collection, processing, analysis, storage and destruction
  • demonstrate consideration of data protection principles such as minimisation
  • demonstrate the ethics approvals you have already obtained.

  If your data source requests a Data Privacy Impact Assessment (DPIA), signed off by the University's Data Protection Officer, contact dataprot@st-andrews.ac.uk.

  Sponsorship of data-only studies 

  Where your study also requires NHS ethics, Research Governance will complete a full sponsorship review.

  If your study only requires University ethics and PBPP or Caldicott Guardian, Research Governance will provide guidance and advice and your SEC will provide ethics review. Data Protection will review and sign-off your PBPP or Caldicott Guardian application and documents. 

• Re-using data

  Previously collected as part of an NHS REC approved study

  To re-use identifiable data from a study which has, in the past, received NHS REC review and approval you need to review the consent given originally by participants:

  • Does the consent originally given by participants  allow for the data to be re-used or accessed outside of that study?

  For example, if yes, then you would expect to see explicit statements in the PIS and Consent Forms such as 'I agree to my data being used for future studies'. There may also be criteria or limitations such as the data only being available in anonymised form, to specific researchers or organisations, or for specific purposes or types of research.

  An example of the process is available Swimlane diagram - reusing data (PDF)

  Without consent

  If there is no consent for future use then it is highly unlikely that you would be able to re-use the data. 

  If consent wording is ambiguous you may need to seek legal advice.

  With consent

  If there is past consent which is appropriate for your purposes then it is likely you will still need to apply for NHS REC review, information governance approval, or both. This may be straightforward and only require proportionate review if your project is something like re-analysis of the existing data or where the data are in anonymised form.

  It may be more complicated if you intend to link the previously collected data to other data from different sources, including data about those same participants, or access the data in an identifiable form. 

• Service evaluations and audits

  Direct or indirect collection of data to evaluate or audit a service

  Service evaluations and audits (including quality improvement) are common non-research activities. These often involve collecting primary data directly from patients or staff or collecting clinical or administrative data around patient outcomes and key performance indicators.

  First, ensure if your study meets the definition of a service evaluation or audit:

  • check the HRA 'is it research?'' tool
  • review the University definition of research, service evaluation and audit
  • check with your target NHS board's R&D department

  If you are unsure, seek guidance. 

  NHS and University ethics

  If you have confirmed that your study is a service evaluation or audit, according to NHS definitions, then you do not need to seek NHS ethics approval. 

  However, your project may still meet the University’s definition of research involving humans and so will require University ethics approval.

  Information governance and project registration

  An NHS board may require that you demonstrate information governance compliance through completion of a form, Data Protection Impact Assessment (DPIA) or similar.

  Often non-research activities must be registered with the NHS board or approved by a specific committee.

  As boards’ structures, requirements, and policies vary (and these can also depend on the type of activity) it can be difficult to identify appropriate contacts and what is required. NHS R&D are a good place to start for advice.

   

  An example of the process is available Swimlane diagram - service evaluation and audit (PDF)

• General Practices

  Research involving data obtained from GP practices

  General practices have significant independence and autonomy. However, they are still bound by some aspects of NHS policy and operate within some of the governance frameworks. How NHS boards and GP practices operate and interact with each other varies. This can present challenges to researchers, particularly around determining what approvals or permissions are required. Speaking to the R&D department at the relevant NHS board is often a good first step to obtain guidance on what is required.

  Data that GPs generate, including that of patients, are controlled by each practice and they can decide whether this can be used for research. However, data held by GPs that has come to them from the wider NHS is jointly under the control of the GP practice and the local health board. 

  Working with GP practice data - permissions

  Permission is required from each GP practice to recruit patients, carry out study activities or access data at or from that practice. Depending on the requirements of the NHS board and the activity, you may also need NHS R&D or other approvals or to register the study with the board.  

  Working with GP practice data - ethics approvals

  Research involving GP practices that meets the NHS requirements for ethics approval require NHS ethics approval (see the other scenarios for what this entails).

  Research involving GP practices that meets the University’s definition of ‘research involving humans’ requires University ethics approval.

  Where both are required NHS ethics approval should be obtained first (see the Primary data collection scenario on this page).  

  Working with patient data from GP practices - information governance

  Each GP practice can act as Caldicott Guardian i.e. they decide whether a request to access identifiable patient data without individual patient consent is appropriate. Each practice may have its own form that researchers must complete to request access to data. Researchers may be asked to complete or obtain a Data Processing Impact Assessment or a Data Sharing Agreement.

  However, an NHS board may also have an information governance person or body which maintains oversight and may require that a researcher complete their processes either instead of or as well as GP practices.

  This, and to what extent the two interacts, can vary by board, practice, and where the data has originated from.

  Agreements and contracts

  When engaging in research with the NHS, in general, a formal agreement is often required between the University (RBDC) and any NHS board (R&D) involved. It is possible that when working with GP practices an agreement will be required between the University and each individual practice. 

  There is an example of the process Swimlane diagram - GP data (PDF)

• Industrial placements and honorary NHS contracts

  Projects conducted while on placement, for the purposes of an educational award

  Students may undertake work with the NHS as part of an industrial placement, 'independent research project', or similar. 

  If the activity meets any of the requirements for NHS or University ethics, information governance, R&D or other approvals then these continue to apply.

  Agreements are often put in place between the University and the NHS for such placements and students may be given an honorary NHS contract - this can sometimes be misconstrued as allowing unrestricted access to patients or their data. 

  This is not the case:

  • An honorary contract does not necessarily grant the same access or rights as an employment contract.
  • Contact with patients, their data or samples, by individuals outside of the patients’ direct care team and for purposes other than the care and treatment of that patient, will usually require local permissions.
  • This is true even if the person undertaking the activity were to be an NHS employee
  • Students on placements are still operating under the auspices of the University and so are bound by University policies such as Good Research Conduct and requirements around ethics review and thesis submission.

  You must seek advice from the NHS board's R&D team and Research Governance on whether any approvals are required before commencing your work. Always keep copies of these communications for your records.

• Studies outside of the UK

  If you are conducting a study outside of the UK which is clinical in nature, in a health or social care setting or similar you may need to obtain specific approvals depending on local requirements. Researchers should check with local collaborators and organisations to determine what is required for their study. 

  For this sort of research there are often requirements similar to those for research involving the NHS in the UK and the guidance on these pages may be useful to understand what is required in terms of study documentation (see preparing applications and study documents). 

  You may also need the University to act as Sponsor - this is very likely to be the case for a Clinical Trial and may be required for other types of study. The section on sponsor review will help you understand what is involved. 

  Contact researchgovernance@st-andrews.ac.uk to discuss your study.