Study Plan & Design
The first step is to decide what it is you want to find out – what question do you want your project to answer? - and then think about how you might go about doing that. Discuss all of this with your Academic Supervisor, they’ll guide you on appropriate methodology and what’s practical/feasible in the subject area you want to study and the time you have available.
1 PROJECT CATEGORY
Before you go any further, you need to establish the category of study you’ve designed. It’s important to do this early in the process because it determines the approval/regulatory pathway that you need to follow.
Projects may be described as Research, Clinical Audit, Service Evaluation or Usual Practice.
Guidance on the characteristics of each of these can be found in the NHS Health Research Authority (HRA)’s Defining Research table.
In addition, an online Decision Tool has been developed by the Medical Research Council (MRC) and the HRA to help categorise your project. There can be overlap between the different categories and it’s not always obvious which applies so, in the event of any uncertainty, confirmation should always be sought by sending a project summary to any of the following, who can assist you:
- University of Glasgow Research Governance
- NHS Greater Glasgow & Clyde (GG&C) Research & Innovation (R&I)
- NHS West of Scotland Research Ethics Service
In NHS GG&C, specialist support and advice for projects categorised as Audit or Service Evaluation can be sought from the health board’s Clinical Governance Support Unit (access via the NHS GG&C webpages); such projects will NOT be handled by either the University’s Research Governance Office or the NHS Research & Innovation (R&I) Office.
The remainder of the guidance contained within the Roadmap will apply to RESEARCH projects only.
Types of research study
Research studies come in many different forms, ranging from the most highly regulated Clinical Trials of Investigational Medicinal Products (CTIMPs) and studies involving Medical Devices through to projects involving analysis of data or tissue samples only, with no participant contact; as well as everything in between.
The relevant regulations that must be followed will be confirmed for you early in the approval process but be aware that the requirements may differ depending on what you have planned.
- CTIMPs, which are a certain type of drug trial, and Medical Device studies, are regulated by UK Legislation:
These types of research are not usually suitable for educational student projects but particularly with the increasing use of software applications (apps) for the management of healthcare, there can be ambiguity. Therefore, you MUST seek clarification from the Research Governance Office at the earliest opportunity if you suspect that your study may fall within these categories.
- Other research studies
Generally, research studies that are not CTIMPs or Medical Device trials, are subject to the UK Policy Framework for Health and Social Care Research. This document outlines the principles of good practice that should be applied when managing and/or conducting research with patients, service users and the public in health and social care research.
Other sources of guidance for the standards that are expected in the conduct of health research include:
All NHS-related studies must have a Sponsor. This term refers to the individual, company or organisation that takes responsibility for the initiation, management and/or financing of a study. While it can be an individual, given the legal implications, it’s usually an organisation that is the Sponsor, with a nominated individual acting as Sponsor representative. Please note, your Supervisor CANNOT be Sponsor representative.
Often, University of Glasgow students will want to undertake research involving our closest collaborating health board, NHS Greater Glasgow and Clyde (GG&C). We have some very specific arrangements in Glasgow because of the way the two organisations work together - generally speaking, if you are a University of Glasgow student and your research study involves any part of the NHS, then NHS GG&C will Sponsor. However, there are some exceptions to this, for example, if you are also an employee of a different health board or trust, in which case you should approach your employer to discuss sponsorship in the first instance. Under specific circumstances, the University may Sponsor research studies.
Generally speaking, student studies will have a single sponsor. Only specific kinds of drug trials known as CTIMPs (Clinical Trials of Investigational Medicinal Products) are co-sponsored in Glasgow, so this is not usually applicable to student studies.
Sponsorship has implications for how the project will be insured so it’s important to get confirmation early in the planning stages of your project, which organisation will take on the role. Contact the MVLS Research Governance Office or NHS GG&C R&I at this point by sending a summary of your study proposal, making it clear that you are UoG student. This will allow them to confirm which organisation will act as Sponsor. This decision will also have implications for the way in which you prepare your study documents to ensure compliance with the General Data Protection Regulation. NHS GG&C as Sponsor will ask you to embed specific information regarding the way in which data are handled, in the body of your Participant Information Sheet (you will be provided with the text), whereas the University of Glasgow, as Sponsor, will direct you to its Data Protection processes and the possible use of a separate Privacy Notice document.
As well as the role of Sponsor, you should discuss other roles within the study team with your Supervisor.
- This is the person designated as taking on overall responsibility within the team of researchers for the design, conduct and reporting of the study.
Until recently, doctoral students were able to take on this role but this is generally no longer the case, unless the student is also an experienced care practitioner undertaking an educational qualification for continuing professional development, or doctoral-level study while employed by a health and social care provider or university, or a researcher undertaking doctoral-level study in receipt of a fellowship.
In most cases, therefore, the Academic Supervisor will take on this role and should familiarise themselves with the responsibilities they are taking on. These are listed in the Declaration section of the IRAS form they will authorise (see Section 4 for more information).
- This is generally the person that takes on responsibility for the day-to-day running of a research study. This can often be the student, at any level of study, as long as they are appropriately qualified or experienced to take on the various tasks. Be aware that you may be asked to provide evidence of training and competency for specific procedures and activity.
Having established who will take on what role, the next step is to think about the documents that you will need to conduct your chosen study methodology. Not every study will need all of the same kind of documents, but the most common ones include a protocol (this is a mandatory document for an IRAS submission), participant information sheet, consent form, letter or email of invitation, GP letter, advert/poster, questionnaires/interview schedules etc. Your Supervisor will advise you on which documents your specific methodology will need. Templates are available from a number of different sources (see below):
A research protocol is a mandatory document for an IRAS submission and should describe your study in its entirety. If the protocol templates provided here don’t match precisely with your study plans, you can always use elements from each to create a bespoke version but you are unlikely to need to start completely from scratch. Work with your academic supervisor to ensure that all the relevant information is included, such as the background to your research; the methodology you will use; if applicable, the type of participants you plan on recruiting; how you will analyse the data you collect; and how you plan on reporting your findings. Other elements that should also be included but can sometimes be overlooked at this early stage include a data management plan, including any future data sharing, data retention and archiving arrangements as well as how you will address any data protection considerations – further information on both of these topics is available online and your Sponsor representative will also provide guidance on any requirements.
Before a study begins and before any research activity takes place, including approaching people to discuss being involved, all of the relevant approvals and permissions must be in place. You don’t want to get to the end of your study, only to discover that something was missing and jeopardise your degree. Most studies, especially those that involve the NHS, will need multiple different approvals; your Sponsor representative will advise you on those your study needs.
The following are the most common for student research studies:
- If your study involves humans, their data or their tissue, then you should assume that it will need ethical approval, unless your Sponsor representative, or an Ethics committee representative, confirms otherwise (there are a handful of exceptions discussed later). Ethical approval provides assurance that the rights, safety, dignity and well-being of participants are protected. Depending on the nature of your research, this may be issued by an NHS Research Ethics Committee or a University Ethics Committee. You may also need to consider applying for additional ethical approval, for example, if your proposed research will take place in schools, prisons or overseas. See Section 7 Ethics Approval for more information.
- As well as approval confirming that your research is ethically sound, you must make sure that you have permission from the organisation/s that will host your research. This may require an application for NHS management approval and/or permission from a non-NHS organisation, depending on the nature and location of your research. See Section 8 Management approval for more information.
- You may also need to consider other approvals; for example, if you want to access identifiable patient data without consent, you will need permission from the relevant health board’s Caldicott Guardian; the NHS Scotland Public Benefit and Privacy Panel, if more than one Scottish health board is involved; the Confidentiality Advisory Group, in England and Wales or the corresponding equivalent in Northern Ireland; or the relevant individual in a non-NHS organisation. Your Sponsor representative will advise you if this is needed for your study.
Examples of other processes that may also need to be followed before student research studies begin include:
- Registration on a publicly accessible database is a legal requirement and a condition of NHS Research Ethics Approval for certain types of research trials. If required, your Sponsor will advise you on its policy.
- Those who wish to conduct research within the NHS, but who have no contractual arrangement with any NHS Health Board or Trust may need a Research Passport in order to gain permission to access the NHS for research purposes. This is the process that uses standardised documentation, provides a single set of pre-engagement checks and can be presented to all relevant NHS organisations across the UK. See Section 6 Research Passports for more information.
- Other agreements that may be required before your study can proceed include Data or Material Transfer Agreements, if you are proposing transferring data or tissue to an external organisation. In a small number of cases, student research studies may generate Intellectual Property for the University, in which case it may be referred to the IP Team within the Central Research Office.
The Integrated Research Application System (IRAS) is the system that allows you to apply for relevant permissions and approvals to conduct most health and social care research in the UK. Once information has been completed, it is used to generate a number of different application forms for multiple committees, thus avoiding duplication of effort. It is an electronic system and forms are completed and submitted online.
In the first instance, you will be asked a number of introductory questions about your study, known as ‘Project Filter Questions’. Based on the answers you give, the system will filter the information and generate only the relevant application forms, which will be applicable to the kind of research study you want to conduct. So, if you find yourself being asked questions that don’t seem to make sense or be applicable to your study, for example, if you’re being asked to describe the consent process for recruiting paediatric patients but your study doesn’t include children, or you’re asked for information about levels of ionising radiation exposure but your study doesn’t involve X-rays, then go back to the Project Filter questions and make sure that you’ve answered them all correctly.
The IRAS applications most commonly used by students are for NHS Research Ethics approval or NHS R&I (formerly known as Research & Development [R&D]) Management approval, if the research is taking place in Scotland; in England or Wales, this will instead be a single approval known as NHS Health Research Authority (HRA) approval.
If your research study does not involve the NHS, you may not need to submit an IRAS form and may follow other approval processes instead. Your Sponsor representative will advise you.
If you do need to make an application via IRAS and you are not familiar with the system, you are strongly encouraged to work through its built-in E-Learning Module; this will hopefully help you avoid the common pitfalls. Guidance on specific questions is also available throughout the IRAS system itself (click on the green icon). Further information on the practicalities of using the system, as well as answers to common questions and troubleshooting information, will be available here shortly.
Once you’ve drafted your study documents, your Academic Supervisor must review and approve them before you send them for sponsor review and the next stage of the process:
- if you are submitting to a University ethics committee only and do NOT need an IRAS application then a formal sponsor may not be required. However, you should contact the Research Governance Office for confirmation.
- if your study needs an IRAS application of any kind then it, and ALL of the associated study documents, must be reviewed and authorised by the Sponsor representative before submission. The IRAS form will also need to be authorised by your Academic Supervisor and the study’s Chief Investigator. Often, these roles will be undertaken by the same person – the IRAS system does not recognise this and they will need to authorise the form twice.
Student research studies, like all others, must have adequate insurance against potential harm to participants in place before starting. In some cases, specific elements of a research study mean that it is excluded from automatic cover under the University’s insurance policies and an additional premium may be required. Please, therefore, refer to the Insurance and Indemnity webpage and contact the Research Governance Office for confirmation of adequate coverage, if you are in any doubt.
6 RESEARCH PASSPORT
The Research Passport system is the process by which researchers, who have no contractual arrangement with the NHS, either substantive or honorary, gain permission to access NHS patients, staff, facilities or data. The system standardises the process across the UK and provides assurance to NHS Health Boards and Trusts that appropriate pre-engagement checks have been carried out before either an Honorary Research Contract or a Letter of Access is issued.
Advice on whether or not a Research Passport is required must be obtained from the Research Governance Office before applying. Thereafter, student Research Passport applications will be administered by the Research Governance Office; University staff Research Passport applications by the relevant College HR department.
If you will be working within the Imaging Centre of Excellence (ICE) Facility on the Queen Elizabeth University Hospital Campus, please contact Dr Debra Stuart, Head of Research Governance, directly for advice and support in proceeding with gaining access to the facility.
Once you have confirmation that a Research Passport is needed, complete the necessary paperwork:
a) Research Passport application form
Further information about Research Passports can be found here, including the application form in part 8. Students complete Sections 1-3 and 6 and your Academic Supervisor completes Section 4. The form should then be forwarded to the University counter-signatory. For student applications, this will be the Research Governance Office.
You will be advised which pre-engagement checks, if any, are needed. This will be dependent on the nature of your research activity but may include a criminal record and/or a health check. The Research Governance Office will advise which checks you need by using your answers to the following questions:
Research Passport questions
1) Will you have contact with patients/participants?
a) will this contact be direct (ie in the same room as them) or indirect (eg telephone contact)?
b) what age will the patients/participants be? ie will any of them be aged less than 18 years?
c) what, specifically, will you do with the patients/participants?
d) where will this take place?
e) will you provide health care, or will your activity have a direct bearing on the quality of care?
2) If the answer to 1) is No, will you work with patient tissue or organs in NHS facilities or with NHS data (anonymised or identifiable)?
3) Are you currently a member of the PVG scheme for Adults OR Children?
4) Will you be working with the Imaging Centre of Excellence (ICE) facility on the Queen Elizabeth University Hospital Campus?
b) Short CV
A template is available here.
c) Disclosure Scotland certificate
Criminal record checks are conducted in Scotland by Disclosure Scotland. There are different levels, depending on the nature of your activity – Basic, Standard, Enhanced and membership of the Protecting Vulnerable Groups (PVG) Scheme. You will be advised which level you need, if any, by the Research Governance Office.
Paper application forms are available. However, it is recommended that the forms are completed online; this includes payment information via the Disclosure Scotland payment portal. We do not have invoicing arrangements with Disclosure Scotland so payment must be made by credit card. Speak to your Academic Supervisor about how this will be handled – your department may have a departmental credit card, for example, or you may claim the cost back from research funds. Details of current charges can be found here.
Once you have added the payment reference number to the application form, forward it to the Research Governance Office, who will need to confirm your identity before countersigning the application form on behalf of the University. You will be asked to provide three official documents, including one with a photograph, confirming your name, date of birth and current address (ie where you are living just now/your term-time address). Each document doesn’t need to contain all three pieces of information but, between them, they should confirm your details.
Once your ID has been confirmed, the countersignatory will sign the form and send it to Disclosure Scotland. You will receive a copy of your certificate, by post, usually within 2-3 weeks. For all levels except Basic, the countersignatory will usually also receive a copy.
Be aware that Basic, Standard and Enhanced Disclosure certificates have no expiry date but most organisations will accept a Disclosure Certificate from the previous 12 months.
Membership of the PVG scheme, however, is an active process – once you join the scheme, you remain a member until you remove yourself from it so, if anything appears on your criminal record in the future, organisations associated with your membership as ‘Interested Parties’ will be notified. You, therefore, must keep your membership details up-to-date and notify Disclosure Scotland of any changes, such as a change of address or name. If you have previously joined the PVG scheme for a different purpose, for example, you might be a volunteer for a charity, but you need PVG scheme membership for a Research Passport application for research activity as part of your course, then you need to apply to have the University added to your membership as an Interested Party by completing an ‘Existing PVG Scheme Member Application Form’. You, therefore, need to keep hold of your original PVG Scheme Number because you’ll need it for this new application. The Research Governance Office can advise.
d) Occupational Health certificate
If you will have direct contact with patients, you will be advised that you need a health check as part of your Research Passport application. You should apply to the University’s Occupational Health (OH) Unit for clearance; alternatively, OH certificates from other appropriately accredited units may be acceptable. Details of the application process, cost and the information that OH requires, can be found here. To avoid unnecessary delays when you submit, use the OH paperwork checklist to ensure that you include all the necessary information with your submission; this includes an email from the Research Governance Office confirming the need for the check. Submit all of your OH documents directly to OH, not to the Research Governance Office, which should not see your personal information. You should simply forward on the OH certificate, once you have received it from OH by email.
Students should send the completed Research Passport form, together with the relevant supporting documents to the Research Governance Office for processing on behalf of the University. If your lead NHS R&I office is in NHS GG&C, we will forward to the documents directly to them, once they’ve been processed by the University. If not, they will be returned to you, to submit them to the relevant health board. On receipt of your Research Passport application and supporting documents, the NHS team will process your application and issue you with either an Honorary Research Contract, or a Letter of Access. R&I will make this decision, depending on the nature of your activity.
Please note that a Research Passport must be linked to either an existing research study or one which has, at least, started the approval process and is ‘in the system’. If yours is a new project, NHS GG&C R&I will issue study management approval and your Research Passport at the same time ie you won’t get one without the other.
Once your Research Passport has been fully signed by the lead NHS R&I office and returned to you, you can present it to R&I/R&D offices at other health boards and Trusts, should you need research access there.
NHS to NHS proforma
Some University of Glasgow students also have an NHS contract - either substantive or honorary. If this applies to you, you won’t need a Research Passport or any additional permission to conduct research within that NHS organisation, beyond approval of the study itself.
If, however, you want to conduct research in an NHS organisation other than the one to which you’re contracted, you need to complete a proforma titled ‘NHS to NHS confirmation of pre-engagement checks’. The document can be found here and should be completed by either your employing NHS HR department or, in the case of clinical academics, the University’s HR team. It can then be presented to R&I/R&D offices at other health boards/Trusts.
If you are registered as a student on a clinical course at the University of Glasgow and you wish to undertake research activity within NHS GG&C, you don’t need a Research Passport – you will have had pre-engagement checks done before your course started. Your supervisor should contact the R&I department to discuss adding you to the relevant study research team; they will be asked to provide confirmation that you will be supervised in the clinical setting. Other health boards’ requirements may differ so they should be contacted for confirmation.
7 ETHICS APPROVAL
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.
- 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.
8 MANAGEMENT APPROVAL
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.
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.
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.
Before starting your research study, you should review all the study paperwork, ensuring that all the necessary approvals are in place and all of the relevant documents are stored in the Site File (a Participating Site File Index template can be found here). Remember that, during your study’s lifetime, it may be selected by the Sponsor for audit so the Site File should be maintained and updated throughout, as required, and should be ‘audit-ready’ at all times.
Only once all relevant approvals are in place can the study begin. In studies involving the NHS, R&I management approval is the final approval you will receive and, once you have this, you can begin your study.
What if something goes wrong during the study?
Inevitably, in the course of conducting a research study, things sometimes don’t go to plan and what you intended to happen, doesn’t. This may be a ‘non-compliance’ with the activity you had outlined in your study protocol or a ‘serious breach’ of more general research standards, by which you must abide, for example, the principles of Good Clinical Practice. You may become aware of such situations yourself or they may be identified by others, for example, if your study is being audited by the Sponsor. It could range from a minor administrative error that has no consequences on participant safety or data integrity all the way up to a critical incident that could put participants at immediate risk. The latter would be unusual in a student study; however, it’s important that you are aware of them and your obligations, should they occur.
The important thing, if a non-compliance or serious breach come to light, is not to ignore it or try to cover it up; rather, it should be appropriately reported, handled and documented. How you do this and the process you need to follow will depend on the nature and seriousness of the event and its consequences.
On becoming aware of a potential non-compliance or serious breach in your study, you must inform your Supervisor and Sponsor representative in the first instance.
Governance will ask for a summary of the situation, assess its seriousness, escalate it, if necessary, to relevant colleagues within the sponsor organisation and advise on any Corrective and Preventative Actions required. If NHS GG&C is your Sponsor, it will follow its Standard Operating Procedures for handling both of these situations; other sponsor organisations should be contacted for details of their processes.
Any breach or suspected breach involving personal data, or an accident or misuse of personal data must be reported immediately to the University’s Data Protection Office and your Academic Supervisor and Sponsor representative informed.
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.
10 ANNUAL PROGRESS REPORT
One condition of NHS REC approval is submission of an Annual Progress Report to the committee which approved the study. The report is due on the first anniversary of the Favourable Opinion (not study start) and every 12 months thereafter until study completion. The template document can be accessed here and the Report should be submitted to the REC and the Sponsor representative. REC will send reminders if these are not submitted in a timely manner and persistent failure to do so could result in ethical approval or sponsorship being revoked, so put a note in your diary to avoid this happening.
11 END OF STUDY NOTIFICATION
On completion of the study (this should be defined in the protocol), the relevant review bodies must be notified. In the case of NHS involvement, an End of Study Notification form should be submitted to the REC and the Sponsor representative within 90 days of study completion. The template form can be found here. As with the Annual Progress Reports, REC will send reminders. Failure to comply could result in ethical approval or sponsorship being revoked if it’s not received in due course so put a note in your diary to avoid this happening.
12 FINAL STUDY REPORT
Within 12 months of study completion, a Final Summary Report should be submitted to the REC and the Sponsor representative. There is no template for this but guidance on the information that should be included can be found here. Often, this can be in the form of an abstract, a dissertation/ thesis chapter or a publication.
Once you’ve submitted all of the necessary reports to all of the relevant approving bodies, all that remains is for you to follow the plans you incorporated into your protocol regarding any future data sharing, data retention and archiving.
You can now consider your research study completed. Well done!