College of Medical, Veterinary & Life Sciences

Research involving human participants, their data or their tissue must undergo ethical review to ensure that the participants’ health, well-being and rights are protected and upheld. This will always take precedence over any gain in scientific knowledge.

There are a handful of situations where studies are exempt from ethical review; certain kinds of data studies using secondary data, for example. If you think this applies to your study, you should get confirmation of the exemption, in case it is challenged in the future.

The sponsor representative for your study will confirm which ethics committee you should apply to. In most cases, this will be either an NHS Research Ethics Committee (REC) or a University Ethics Committee.

NHS REC

• Generally speaking, research involving NHS patients, their relatives/carers, information or tissue will undergo ethical review by an NHS REC; for some kinds of research it is a requirement, eg  any study involving adults without capacity to give their own consent (in Scotland, these MUST be reviewed by Scotland A REC, regardless of any NHS involvement), use of confidential patient data without consent or health-related research involving prisoners.  Note that studies involving only NHS staff as participants, by virtue of their professional role, will NOT undergo NHS REC review and should, instead, be submitted to a University ethics committee.
  
  The NHS Research Ethics Service across the UK follows a set of Standard Operating Procedures – the latest version can be found here – and contact information for all of the Scottish committees can be found here. An online application is made via the IRAS system and all your study documents will be automatically sent to the REC – see Section 4 for further information. Once an application is finalised and ready for submission, applicants use an online booking system, available 24 hours a day, 7 days a week, to book into an NHS REC meeting.
  
  Applicants and their Supervisors are invited to attend Full REC review meetings and, while this is not mandatory, it is encouraged, allowing discussion of the application and response to any queries ‘on the spot’.  Therefore, for logistical reasons, applicants often prefer to book into a local committee, although this is not a requirement and you may choose to book your study into a committee outwith the local area if they have earlier availability. The local West of Scotland Research Ethics Service comprises four committees; its webpages contain useful information on the submission, review and approval process, together with details of decision categories and timelines, committee meeting dates and contact information. Be aware that the submission deadline is usually 10 working days before a meeting date, to allow the committee time to review study paperwork.
  
  Some lower risk studies may be suitable for NHS REC Proportionate Review; you will be advised when you book a committee if this is applicable to your study. The submission process is the same, however, you may receive a decision slightly sooner than Full Committee review. Proportionate REC review is conducted remotely so there is no meeting to attend. Rather, you and your Supervisor will be asked to make yourself available by email or telephone over a number of specified days, in case clarification on any aspect of the application is needed. Studies that are suitable for PR REC review will, therefore, be booked into the next available committee, which could be anywhere in the UK.
  
  If, during the NHS REC review process, the committee asks you to make changes to any documents before it makes its final decision, these should be submitted to the Sponsor representative for review/authorisation, before they are submitted to the REC. Note that, you should only revise the IRAS application form at this stage if the REC specifically asks you to do so.
  
  Once the NHS REC has issued a Final Favourable Opinion, it is assumed that the study will commence within 12 months. Standard conditions of the approval will be provided and include submission of an Annual Progress Report – see Section 10 for further information.
  
  NHS REC approval will cover all the locations you have included in your application, regardless of type or location.
  
  

University Ethics Committee

• If your study is exempt from NHS REC approval, or has no NHS involvement, it will usually require University ethical approval instead so the relevant committee should be approached for confirmation. The University Ethics Committee is structured at College level and webpages for the four committees – MVLS, Science & Engineering, Social Sciences, Arts - can be accessed here. Each provides guidance information and template documents for submission to the respective committees.
  
  The MVLS committee reviews studies by correspondence, rather than in face-to-face meetings; as such, you won’t be invited to attend a meeting (unlike NHS REC review); it accepts applications at any time and there are no submission deadlines. Be aware that, although you can prepare the application, your Academic Supervisor must submit it online.
  
  If your study is being reviewed by a University of Glasgow ethics committee, it will be expected to comply with the University’s Data Protection processes. As such, it will require preparation of a Data Protection Impact Assessment (DPIA) and some studies will require a separate Privacy Notice, in addition to the Participant Information Sheet. Templates are provided via the College ethics committee webpages and the documents should be included in the submission.

Generally speaking, a research study will have one ethical opinion from a single committee. If your research study involves different participant groups, for example, a group of NHS patients recruited from a hospital AND a control group of healthy volunteers recruited at the University, you don’t split the groups and submit the patient activity to an NHS committee and the control group to a University committee. As long as both groups are part of the same study, contributing to answering the same research question, then the NHS portion of the study takes precedence and the complete study should be submitted to the NHS REC, which will review it in its entirety.

However, an exception to this is if the research activity is taking place overseas and, therefore, has ethical approval from a local committee in the overseas territory. On occasion, the local committee may require approval from a University ethics committee as well. Information on ethical review processes for research being conducted overseas can be found in the ‘Ethics procedures for University Colleges’ document available here and study-specific guidance can be sought from the relevant College ethics committee.

Finally, other research locations frequently utilised by University of Glasgow students include schools and the prison service. In both of these locations, in addition to ethical approval from either a University or an NHS ethics committee as appropriate, approval from an ‘in-house’ review process is also required. Details of the access arrangements for the Scottish Prison Service are available here and for Glasgow City Council Schools here. Processes for other prison and school locations may differ and appropriate requirements should be confirmed before proceeding.

In addition to ethical approval for your research study, you also need to ensure that you have permission from the organisation hosting the activity before proceeding.

NHS locations

In many cases, your study will include NHS research sites and, therefore, an application will be needed for NHS Research & Innovation (R&I) [formerly known as Research & Development (R&D)] management approval.

As with an application for NHS ethical approval, you apply for NHS R&I approval via the IRAS system – your answers to the Project Filter questions will enable the relevant questions. Be aware that there may be situations where you are not using IRAS to apply for ethical approval - for example, if your study involves only NHS staff as participants - but you need an IRAS application to apply for NHS R&I management approval. 

In broad terms, NHS R&I approval is given at health board level (this applies to Scotland; England & Wales are organised in Trusts; Northern Ireland, in Health & Social Care Trusts) and covers all of the NHS locations within it, that you have specified in your application. 

For example, if you want to conduct research interviews with patients at Glasgow Royal Infirmary (GRI) and at the Queen Elizabeth University Hospital (QEUH), you will make a single application to NHS GG&C R&I for management approval, which will cover both locations you have listed in the application.
This is referred to as a Single Centre study, as it involves one health board only, albeit with more than one location.

If, however, you also want to conduct interviews with patients from a hospital in a different health board, for example, Monklands Hospital in NHS Lanarkshire, then you will apply for NHS R&I approval from NHS GG&C AND from NHS Lanarkshire and you will receive an approval letter from each health board.
This is referred to as a Multicentre study because it involves more than one health board. 

You need to consider if the NHS location is a Research Site, where participant facing research activity takes place, or a Participant Identification Centre (PIC), which may identify eligible patients and provide study information, but any research activity takes place outwith the NHS. Further information can be found here.

Continuing the example above, you may ask clinicians at GRI and QEUH to identify patients who meet your eligibility criteria and to tell them about your study but, if the patients are interested in taking part, they contact you directly to arrange a research interview at the University. In this scenario, NHS GG&C would be acting as a PIC only.

An IRAS application form for NHS R&I approval is needed regardless of whether the NHS location is a research site or a PIC, or your study involves a combination of the two.

When you submit your study for NHS R&I approval, all the documents are automatically sent, via IRAS, to the NHS Research Scotland Permissions Co-ordinating Centre (NRSPCC) in Aberdeen, which will disseminate them to the relevant NHS R&I departments; thus, avoiding you having to make multiple submissions to multiple different R&I offices. 

If your study involves locations in any of the other home nations, NRSPCC will liaise with its equivalent body there to facilitate approval. Note that, in England & Wales, the approval issued will be known as HRA approval, rather than R&I approval.

The NHS R&I office in Glasgow is organised according to subject area.  Certain categories of low risk studies may be handled by the R&D Proportionate Review Team, regardless of subject area. Be aware that this is distinct from REC Proportionate Review; you cannot assume one from the other. Your R&I contact will be confirmed early in the review process. Contact information for the NHS GG&C R&I Office is available here and for the other Scottish Health Boards, here, via the relevant Node. 

UK Local Information Pack

Together with all your study documents, you need to submit a UK Local Information Pack, which contains the information that will allow each health board to assess the impact of the research and determine if it can be accommodated.  This replaces the ‘Site Specific Information (SSI)’ form, that you or your Supervisor may have used in the past. Details of the Pack and the process to be followed can be found here but, to summarise, it will include:

• a covering email, using the appropriate template: note that student studies usually have a non-commercial sponsor
• an Organisation Information Document, known as an OID: if you only have one research site, or the study details are exactly the same at each research site, you will only need one OID but if the activity is different between research sites, or different sites have different Principal Investigators, then you will need an OID for each one.

In the first instance, you complete only the questions marked with an asterisk (*) and, in this format, the document is known as the Outline OID. This should be forwarded to the sponsor representative for authorisation and then included in your initial IRAS submission. Thereafter, you will complete the remaining questions marked with a caret (^); this is known as a Localised OID (LOID) and will be authorised by a representative of R&I at the relevant site.

So, whereas you will have one outline OID that contains information applicable to all sites, you may have multiple localised OIDs, each one specific to a particular site or a particular set of activities.

Please note that NHS locations acting as PICs, rather than research sites, don’t require an OID. Instead, the appropriate model PIC agreement should be completed.

• a Schedule of Events (SoE) or Schedule of Events Cost Attribution Template (SoECAT): if the study is associated with a grant application that included NHS costings, it will already have a SoECAT, which can be used here.  Many student studies, however, do not, in which case a SoE must be completed, even if there is no funding going to the site for this research activity.
• a Delegation Log, only required for certain types of study.

If your study involves both NHS sites AND non-NHS sites, you should follow the above process for the NHS sites; generally speaking, no additional paperwork is required for non-NHS sites in this situation.

Information on this entire process, together with links to the various template documents, can be found here. Read the guidance carefully and note that, when acting as sponsor, both NHS GG&C and the University of Glasgow delegate the preparation of these documents, as well as their submission once authorised by the Sponsor, to the research team. Please note that, although the guidance indicates that an OID is not required if the Sponsor and the NHS organisation are the same, NHS GG&C DOES require an OID for UoG student studies that it sponsors.

Each participating health board will issue its own R&I approval and this is the final approval you will receive for your study. Once you have it, you can begin the study in that health board ie you don’t need to wait until you have R&I approval from all participating health boards before starting. As indicated in Section 6 Research Passports, NHS GG&C R&I approval for a study will be issued at the same time as the required Research Passport/s ie you won’t get one without the other.

Non-NHS locations

If your study also involves non-NHS sites, then appropriate management approval must be obtained before the study proceeds there. Details of these locations must be included in the IRAS form and, in most student studies, no additional paperwork will be required for the IRAS submission. However, you should contact the non-NHS organisation for guidance on its approval process and remember that, although it may be less formal than an IRAS application, you must still have documented evidence of management approval for the research to proceed in that location. CTIMPs and Medical Device studies must include a non-NHS Site Assessment Form in the IRAS submission, but this would be unlikely for a student study.

Once approvals are in place, if you want to make any changes to documents or procedures, however minor, you must contact the Sponsor representative in the first instance, unless a change is required for urgent safety reasons. It is the Sponsor’s responsibility to categorise the amendment as either Substantial or Non-substantial; common examples of both can be found here. The Sponsor representative will advise if the amendment requires approval or notification only before being initiated.

If the study has been subject to NHS REC and/or R&I approvals via an IRAS application, an Amendment Tool should be completed with details of the proposed change/s. The Tool, along with information and guidance on the Amendment process, can be found here. Don’t amend the original IRAS form, simply outline the proposed changes within the Amendment Tool. In addition, amend any affected study documents, remembering to track or highlight the changes and to update the version number/date, then forward all of these to the Sponsor representative for review and sign off. Once authorised by the Sponsor, the amendment can be submitted via the online IRAS submission function to REC and R&I, as appropriate.  As with the original application, your Academic Supervisor should NOT sign this form as Sponsor representative.

If the study did not include an initial IRAS application and was approved by a University ethics committee only, then the relevant committee should be contacted and its amendment process followed.