Research, Innovation & Engagement Support

To maximise the chance of grant application success, researchers should develop their application in response to the funding call. Researchers should read all guidance associated with the call before starting their application. In addition, it is crucial to understand funders’ terms and conditions e.g., any restrictions, areas that are not supported by funding, since these can differ between funders, and failure to accommodate them could have a negative impact on delivery of the project. Researchers need to contact the Research Management Team for advice on funder-specific requirements. Details of funder-specific conditions can be found here: 

• NIHR
• UK Research and Innovation
• MRC
• CSO
• British Heart Foundation (BHF)
• Cancer Research UK
• The Royal Society
• Wellcome

The MVLS Centre of Excellence for Trials Collaboration (CETC) brings together specialist multidisciplinary expertise from across the University and the NHS to concentrate and enhance the design and delivery of internationally relevant and innovative trial research. The CETC Trial Application Prioritisation (TAP) committee will review funding proposals, and provide feedback from experts in e.g., design, methodology, analysis, and signpost to the teams that can help researchers to maximise their grant application success. Check the type of research that is in scope of CETC TAP review here. 

1. Complete and submit TAP application form. The researcher should aim to submit the application 12 weeks before the grant deadline. 

2. Receive initial feedback  and reccomendations within 7 days after the TAP Committee meeting.

There are other important areas that researchers must consider during the grant application preparation. 

Planning for impact 

Intellectual Property generation 

Pre-application due diligence - Trusted Research, Export controls etc 

Pre-application legal and contractual queries - The University of Glasgow Contracts Team will provide required advice 

Preparing a narrative CV 

The Research Data Management service can support the Data Management Planning including advice on funders’ requirements. 

Internal peer review can significantly improve the quality of funding applications, increasing the chance of success. The scope and depth of peer review is often driven by the scale of the research proposal. Expertise of research managers and academic colleagues can provide a different perspective that could help to improve and refine the research proposal. The peer review process is usually driven by the School policies.  

Detailed information on specific process is available at the Research Management Team website

Understanding the correct costing (Research Costing Principles) of a research project is critical to securing the required level of funding in support of a project’s research objectives. Navigating through critical costing principles can be complex. The Research Management Team can provide dedicated costing support to Principal Investigators across the College from the proposal stage through to final reporting.

NIHR guidance summarises items to consider when costing the project such as:

• Researchers and support staff time
• Patient and Public Involvement and Engagement
• Use of Research Facilities
• Use of IT services
• Equipment, services and consumables
• Partners cost
• Site cost
• Steering and Data Management Committee cost
• Responsible Data Sharing
• Research involving NHS resources (eg patients, facilities, staff etc) must have the associated NHS costs calculated too. This is usually done in collaboration with the lead NHS R&I/R&D team who will assist the investigator in the completion of the grant application form. It must be agreed by the NHS R&I/R&D team (Sponsor Research Co-ordinator, Innovation Co-ordinator, or Research Facilitator) before submitting to NHS R&I/R&D Finance for approval. In NHS GG&C, requests should be sent to the R&I grant email inbox: (ggc.randigrantapplications@ggc.scot.nhs.uk). After the R&I team allocates a reference number, the number will be forwarded to the Investigator for future reference and inclusion in all correspondence. Note that NHS GG&C R&I Finance requires at least 10 working days for review and sign off before the grant deadline or institutional approval deadline, whichever is earliest. In addition, the researcher must complete a Schedule of Events Cost Attribution Template (SoECAT). This document clarifies the appropriate attribution of site-level costs according to AcoRD principles. The tool will be usually completed at the research funding application stage and should also form part of the IRAS application document set for the projects in NHS and Social Care. The detailed information on how to complete the SoECAT is available at NIHR website. NHS R&I Coordinator will assist researcher with the SoECAT completion.

Patient and Public Involvement and Engagement (PPIE) is critical to designing research questions that matter to patients and the public and as such the health research must be designed in partnership with the people who will benefit from new developments. The PPIE group can provide a valuable lay perspective on projects for staff and students from the NHS and across the University of Glasgow. Available support combines access to lay perspectives on information content, study methods and research findings, with links to online resources that explain the basics of PPIE.

It’s important to establish the category of research project early in the process because it determines the approval/regulatory pathway that researchers must follow. Projects may be described as Research, Audit, Service Evaluation/Improvement/Development, Usual Practice or Health Surveillance.  There can be overlap between the different categories.

Guidance is available in the NHS Health Research Authority (HRA)’s Defining Research table and/or via the MRC/HRA’s online Decision Tool. 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:

• The University of Glasgow Research Regulation and Compliance Team 
• 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 Regulation and Compliance Office or the NHS GG&C Research & Innovation (R&I) Office.

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. The relevant regulations that must be followed are usually confirmed early in the approval process, but the requirements may differ depending on research project plan. CTIMPs, which are a certain type of drug trial, and Medical Device studies, are regulated by UK Legislation: CTIMPs, Medical Devices

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, researchers MUST seek clarification from the Research Regulation and Compliance Office at the earliest opportunity if they suspect that their research may fall within these categories

Generally, other 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:

• University of Glasgow Research Policies 
• NHS GG&C Standard Operating Procedures
• Declaration of Helsinki
• Good Clinical Practice

All research projects require a sponsor. A sponsor is an organisation or institution that takes on the responsibility for the initiation and management of a research project but is not necessarily the funder. University of Glasgow has a defined conditions when taking a sponsor responsibility. You can find detailed information on conditions of sponsorship for different type of research projects on the Research Regulation and Compliance Team website

Researchers must discuss their project needs with the NHS R&I/R&D team for all research projects involving the NHS; this may be NHS patients, their tissue or data, or studies involving NHS staff participating by virtue of their profession. The discussion should be held at the time of grant application and/or project planning to secure commitment for required resources and support.

NHS R&I/R&D management approval (obtained before project start) provides permission for a project to commence within the NHS. R&I approval ensures that the legal obligations are met, and it is issued following a formal review of the project by designated staff.

In addition, NHS R&I/R&D approval provides insurance/indemnity for research projects under the Clinical Negligence and Other Risks Indemnity Scheme (CNORIS) and is a condition of ethical favourable opinion. Detailed information about the approval process, including contact details of local Research Coordinators that can offer extensive support is available at the NHS GGC R&I website. 

The contact details of other Scottish Health Boards and R&D offices can be found here.

Trial/research project management and, when required, project monitoring are crucial elements of successful project delivery that must be considered at the time of project planning. The Glasgow Clinical Trial Unit (CTU) can offer complete Trial Management services including randomisation, data and project management, statistical and health economics expertise and safety monitoring. The NHS GG&C R&I team can be consulted for trial management and monitoring support (NHS GG&C R&I sponsored/co-sponsored trials). The CETC team can be contacted for startup support during the trial set-up phase until project-dedicated staff are in post.

Once the confirmation of a funding award is received, a number of activities must be completed before the research project can formally start.  Most of these are covered in the following sections but researchers must be aware of any funder-specific requirements, provide timely updates on trial development and respond promptly to funders requests. The researcher must work closely with the Research Management Team to ensure that the project is set up in all university systems. 

Trial registration on a publicly accessible database supports the principles of research transparency and result dissemination requirements.  It is considered good practice for all research and is a condition of a favourable ethics opinion for certain categories (unless a deferral of registration has been granted). Many publishers, including the International Committee of Medical Journal Editors (ICMJE), require registration as a pre-condition of publication.  Guidance on research registration can be found here. 

The following categories of research project require registration:

• Clinical Trial of an Investigational Medicinal Product (CTIMP) 
• Clinical Investigation or other study of a Medical Device (CIMD)
• Combined trial of an investigational medicinal product and an investigational medical device
• Any other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice
• Research tissue banks [UKCRC Tissue Directory]

Commonly used trial registries include:

• International Standard Randomised Controlled Trial Number (*ISRCTN) Registry 
• ClinicalTrials.gov 

*Note that trials submitted through IRAS combined review will be automatically submitted to ISRCTN for registration unless researchers advise of alternative registration arrangements.

Once project funding is secured, researchers must confirm the sponsor organisation before beginning the approval application process as Sponsor review and authorisation will be required for submission.

All research projects must have in place adequate insurance against potential harm to participants before starting. In some cases, specific elements of a research project mean that it is excluded from automatic cover under the University’s insurance policies and an additional premium may be required. Refer to the Insurance and Indemnity webpage for further information and contact the Research Regulation and Compliance Office for confirmation of adequate coverage if you are in any doubt.

It is important that all required contracts and agreements between all parties involved in the research project are in place before the project starts. This is to ensure that each party has clarity on its obligations and project expectations. The contracts and agreements also support protection and management of intellectual property. 

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 University of Glasgow Contracts Team  will advise on suitable types of contract, and will support contract set up, as well as contract review and amendment during the lifetime of the trial. Helpful information about setting up of specific contracts at the University of Glasgow e.g. Non-Disclosure Agreements or Material Transfer Agreements can be found here. 

A protocol is a document that describes the objectives, design, methodology, statistical considerations, and organisation of a research project. The protocol should describe all aspects of the research project including background and rationale and explain participant’s safety and safeguarding during and after the research project’s end. The protocol is one of the controlled documents, and any update must be reflected by a change of version number and date. 

The sponsor should specify who needs to sign the protocol. The protocol should be signed off by the Chief Investigator as a minimum, though other signatures may be required e.g., sponsor, trial statistician, etc. If Co – PIs are involved in multiple sites, they might sign the protocol as confirmation of its completeness and agreement to work to the current version. The funder should be informed of and approve any changes to a protocol.

The Health Research Authority (HRA) has produced essential protocol templates that are in line with regulatory requirements and the SPIRIT guidelines (Standard Protocol Items: Recommendations for Interventional Trials).

Contact CETC team if you need other protocol templates e.g. non CTIMP trials, protocol for other studies.  

The Integrated Research Application System (IRAS) is the system that allows researchers to apply for relevant permissions and approvals to conduct health and social care research in the UK. Review bodies using IRAS include:

• Administration of Radioactive Substances Advisory Committee (ARSAC)
• Confidentiality Advisory Group (CAG) [England and Wales]
• Gene Therapy Advisory Committee (GTAC)
• Health Research Authority (HRA) and Health and Care Research Wales (HCRW) for projects seeking HRA and HCRW Approval
• Medicines and Healthcare products Regulatory Agency (MHRA)
• NHS / HSC R&D offices
• NHS / HSC Research Ethics Committees
• His Majesty’s Prison and Probation Service (HMPPS)
• Social Care Research Ethics Committee

In the first instance, researchers must answer several introductory questions about their project, known as ‘Project Filter Questions’ that will lead the system to only enabled applicable questions, thereby producing a customised dataset, from which the relevant application forms will be populated. This avoids duplication of effort, with information being entered only once. Once all relevant fields are completed, the application forms are electronically authorised and submitted online.

The IRAS system offers a built-in E-Learning Module to help researchers navigate its  functions. There is also guidance (green icon) on specific questions within the system, as well as other sources of information to assist with completion. The Research Regulation and Compliance team also developped helpful IRAS Completion Guidance. 

Before the research project starts, all project documentation must be prepared, and relevant documents approved by the ethics committee and other applicable authorities.

The documentation might include:

Confirmation of sponsorship, signed protocol, Investigator’s brochure, privacy notice, participant information sheet(s) and consent form(s) and GP letter, other written participant information e.g. diary card(s), recruitment advertisement, risk assessment documentation, insurance certificate, pharmacy documentation including records for Investigational Medicinal Products(s) procurement and supply (e.g. shipping), laboratory accreditation(s) and normal values/ranges for laboratory/medical/technical tests/procedures, monitoring plan, case report forms (CRFs), statistician sign off, finalised clinical database, confirmation of safety data monitoring e.g. pharmacovigilance database, contracts & agreements, details of steering and data monitoring committees, standard operating procedures (SOPs), template logs including delegation logs, screening/enrolment logs, participant identification log, randomisation logs (where applicable), approvals from an ethics committee, NHS R&D/R&I management approval  or HRA/HCRW approval, Clinical Trial Authorisation, CVs and other evidence of relevant training (e.g. GCP/Regulation/protocol).

HRA link on participants documents for specific groups eg children, adults with incapacity etc: https://www.hra-decisiontools.org.uk/consent/index.html

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 research projects are exempt from ethical review; certain kinds of research projects using secondary data. The researcher must obtain confirmation of the exemption in case it is challenged in the future.

In most cases, the research will fall under the remit of an NHS Research Ethics Committee (REC) or a University Ethics Committee. The sponsor representative will advise student researchers who are unsure of the appropriate ethics committee.

NHS REC

Research involving NHS patients, their relatives/carers, information, or tissue will undergo ethical review by an NHS REC; for some other kinds of research, it is a requirement, e.g.  any research project involving adults without the 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 research projects 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. Contact information for all of the Scottish committees can be found here. However, NHS ethics committees operate online meetings now so, with the exception of Scotland A REC described above, there are no geographical restrictions when booking for review. An online application is made via the IRAS system and all the project documents will be automatically sent to the REC. 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. 

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 the College level and each of the four committees – MVLS, Science & Engineering, Social Sciences and Arts  provides guidance information and template documents for its  submission process.

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 the NHS REC review); it accepts applications at any time and there are no submission deadlines. Be aware that, although students can prepare the application, their Academic Supervisor must submit it online.

Watch this video on submissions to the MVLS ethics committee. https://youtu.be/2nIAbjgoxA4?si=8UbQlni36__wQaNj

Projects using NHS research sites need NHS Research & Development (R&D) or Research & Innovation (R&I) approval. As with an application for NHS ethical approval, the application for NHS R&D/R&I approval is done via the IRAS system. The researcher must be aware that there may be situations where IRAS is not used for ethical approval - for example when the project involves only NHS staff as participants - but an IRAS application is still required for NHS R&D/R&I management approval.

In broad terms, NHS R&I approval is given at the 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 are specified in the application.

Note: A research project delivered in multiple hospitals of one health board requires a single application for R&D/R&I management approval to the participating NHS board. This is known as a Single Centre study, although it might have multiple sites within the one health board.  Alternatively, if the project is delivered in hospitals in multiple health boards, the researcher must apply for NHS R&D/R&I management approval from each participating NHS board/Trust. This is referred to as a Multicentre study because it involves more than one health board or Trust.

An IRAS application form for NHS R&D/R&I management approval is needed regardless of whether the NHS location is a research site (research activity takes place at this location) or a Participant Identification Centre (PIC) , that may identify eligible patients and provide study information, but any research activity takes place outwith the NHS.

When the project is submitted for NHS R&D/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&D/R&I departments; thus, avoiding the researcher having to make multiple submissions to multiple different R&D/R&I offices. If the project 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&D/R&I approval.

The NHS R&I office in Glasgow is organised according to the research subject area. Certain categories of low-risk studies may be managed by the R&D Proportionate Review Team, regardless of subject area. This is distinct from REC Proportionate Review. The R&I contact will be confirmed early in the review process. Contact information for the other Scottish Health Boards, via the relevant Node is available here. 

UK Local Information Pack

Together with all the study documents, researcher must 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 former ‘Site Specific Information (SSI)’ form. Details of the Information Pack and the guidance 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: when there is one research site, or the study details are the same at each research site, there will be only one OID but if the activity is different between research sites, or different sites have different Principal Investigators, then you OID will be needed for each site.

In the first instance, the researcher completes 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 the initial IRAS submission. Thereafter, the researcher 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&D/R&I at the relevant site. 

So, while the researcher might have one outline OID that contains information applicable to all sites, there might be multiple localised OIDs, each one specific to a particular site or a particular set of activities. Additional information about Information Pack is also available here: 
Note: 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 will suffice.  If not, 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 the project involves both NHS sites and non-NHS sites, the researcher 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 a 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.

Each participating health board will issue its own R&D/R&I approval.  This is the final approval the researcher will receive for the research project. Once the approval is received from the first health board, the researcher can begin the project in that health board i.e., a researcher doesn’t need to wait for R&D/R&I approval from all participating health boards before starting.  As indicated in the  Research Passports section, NHS GG&C R&I approval for a study will be issued at the same time as the required Research Passport/s i.e., researcher will not receive one without the other.

Non-NHS locations

If the project 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, the researcher 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, the researcher must still have documented evidence of management approval for the research to proceed in that location.

Note that CTIMPs and Medical Device studies must include a non-NHS Site Assessment Form in the IRAS submission. 

This is applicable only to Clinical Trials of Investigational Medicinal Products (CTIMP) and for combined trials of an investigational medicinal products and investigational medical devices (IMP/Device trials).  

For both, the application for a Clinical Trial Authorisation is completed in IRAS along with submission for Research Ethics Committee (REC) approval.

Researchers can find the details on submission, review process and notification scheme here:  

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 conducted 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. UoG staff members should contact their College HR team for assistance; UoG students should contact the Research Regulation & Compliance team. Researchers wishing to work within the Imaging Centre of Excellence (ICE) Facility on the Queen Elizabeth University Hospital Campus should also contact the Research Regulation and Compliance Team for advice and support in proceeding with gaining access to the facility.

Once the confirmation that a Research Passport is needed is available, the researcher must complete the necessary paperwork:

Detailed information about Research Passports application process can be found here, including the application form in part 8.

• Applicants complete Sections 1-3 and 6 and their
• Academic Supervisor/Line Manager completes Section 4.
• The form should then be forwarded to the relevant University counter-signatory (UoG staff members to College HR and UoG students to the Research Regulation and Compliance Team  
• Advice will be given on which pre-engagement checks, if any, are needed. This will be dependent on the nature of the research activity but may include a criminal record and/or a health check. Additional forms that might be also completed are Research Passport Pre-employment Questionnaire processed by the Occupational Health Unit, Job Analysis Form completed by applicant's manager/supervisor, Disclosure Scotland.  

Research Passport questions

1) Will you have contact with patients/participants?     
If Yes,
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?

Short CV 

A template is available here.

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.

Applications are completed online. This includes payment information via the Disclosure Scotland payment portal. Payment by credit card is the most efficient method, either with a departmental credit card or claiming costs incurred back from research funds. Details of current charges can be found here.

Once  the payment reference number has been added to the application form, forward it to the relevant counter signatory 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 counter signatory 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 counter signatory 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 relevant counter signatory can advise.

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 either the Research Regulation & Compliance Office or College HR confirming the need for the check.  Submit all of your OH documents directly to OH, not to the RP counter signatory, who 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 Regulation & Compliance Office, and members of staff to College HR, for processing on behalf of the University before the application is submitted to the lead NHS R&I/R&D office. On receipt of the Research Passport application and supporting documents, the NHS team will process the application and issue either an Honorary Research Contract or a Letter of Access. NHS R&I/R&D will make this decision, depending on the nature of the 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’. NHS R&I/R&D will issue study management approval and a fully signed off Research Passport at the same time ie you won’t get one without the other.  
Once a Research Passport has been fully signed by the lead NHS R&I office and returned to you, it can be presented to R&I/R&D offices at other health boards and Trusts, should research access be needed elsewhere.

NHS to NHS proforma

Researchers who already have an NHS contract - either substantive or honorary – do not need a   Research Passport or any additional permission to conduct research within that NHS organisation, beyond approval of the study itself.  If, however, they wish to conduct research in an NHS organisation other than the one to which they’re contracted, they must complete a proforma titled ‘NHS to NHS confirmation of pre-engagement checks. The document can be found here and should be completed by either the  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, which will use it to issue a Letter of Access.

Clinical students

Students registered on a clinical course at the University of Glasgow and wishing to undertake research activity within the NHS won’t need a Research Passport if it is part of the clinical placement – pre-engagement checks will have been done before the course start.  The academic supervisor should contact the R&I department to discuss adding the student to the relevant study research team; they will be asked to provide confirmation that you will be supervised in the clinical setting. If the work falls outwith the curriculum, a Research Passport may be required (contact the Research Regulation & Compliance office for advice).  Note that other health boards’ requirements may differ so the relevant R&D office should be contacted for confirmation.

Sponsors have an obligation to monitor the progress of their trial. Ongoing data monitoring provides assurance that trial participants’ safety will be protected (e.g., a trial will be terminated if it presents an unreasonable and significant risk) and that the data gathered during a trial will be fit for purpose. Operational checks (e.g., on-site, remote, and centralized monitoring) and statistical surveillance can identify important data quality issues at a point at which corrective action is feasible.

All projects classified as clinical trials are required to establish a Trial Steering Committee (TSC). Guidelines for set up of TSC including a template for a TSC Charter can be found here.

In case where research involves particular risk factors, the formation of a Data Monitoring and Ethics Committee (DMEC) is needed. Detailed information on composition and remit of DMEC can be found here.

The essential project documents should be kept in a Project/Trial Master File (TMF). The file should be kept in a secure but accessible manner. A well-kept TMF can help with efficient trial management and can facilitate the reconstruction of the conduct of the research project during the audit/inspection process. The TMF should be held at the coordinating site (usually the Chief Investigator’s office or Coordinating Centre) and for multi-site trials, copies of relevant documents should be kept at each participating site in an Investigator Site File (ISF).  Most sponsors will provide guidance on the content and set up of the TMF/ISF based on their local policies/procedures. While the content of the file will reflect the nature of the project and will include documents relevant to the specific project design, researchers can consult guidance provided on the NIHR website.

Research projects that require ethical and NHS Greater Glasgow & Clyde (NHS GG&C) Board approval are required to have a study file. The recommended Research Study Site File Index can be found at the Glasgow Clinical Trials Unit websitehere.  This index may also be used for non-NHS GG&C sponsored studies if an index has not been supplied by the sponsor and the study team has obtained the sponsors approval. All studies conducted within NHS GG&C may be subject to research audit. 

The researcher must consider the need for any project supplies required for participants in the early project planning phase. While many supplies might not need specific management, it is important that supplies meet all quality requirements and are managed according to relevant guidelines and regulations. The researcher might need to secure availability of supplies with the different providers (e.g., some data collection devices might be managed and borrowed from different research facilities, laboratory supplies with adequate expiry dates might need to be secured by specific providers, etc.).

The management of investigational medicinal products usually requires specific expertise, and relevant organisations such as clinical trial pharmacy, clinical trial units or clinical research organisations must be consulted to ensure all regulatory and governance requirements are in place. In Glasgow, the Research Pharmacy team is embedded within the NHS R&I Management office. The NIHR provides detailed guidance on trial supplies relevant to CITMPS. 

When the project requires supplies or services that exceed the value  of £25k, the researcher must consult the Procurement process. 

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 research project 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 research project 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. 

STUDENTS: Academic Supervisors should NOT sign the Amendment Toolas Sponsor representative.

If the research project 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.  

Clinical trials are often subject to audit. The audits are usually part of the quality systems implemented by the sponsor organisation and research projects under the sponsorship or co-sponsorship of NHS GG&C R&I can be subject to audit. This applies also to sponsored and hosted non-CTIMP projects.

The details of the specific policy are available in the NHS GG&C R&I standard operating procedure GCP Audit of Research studies and systems supporting research  

Certain types of studies such as CTIMP, medical devices, or those involving human tissue may be subject to regulatory inspection.  

It is important to comply with the funder and other approval organisations’ reporting requirements. Researchers must clarify their reporting responsibilities at the time of project planning to ensure they remain compliant with the requirements.

Progress Report

It is recommended to start preparing this report in advance of the submission date to secure all the required documentation. Many funders require a finance report along with the report narrative. Contact the Research Management Team  to secure the finance report in time for progress report submission.

NHS Research Ethics Committee

One condition of NHS REC approval is submission of an Annual Progress Report to the committee which approved the research project for studies that are more than two years in duration, Research Tissue Banks or Research Databases. The report is due on the first anniversary of the Favourable Opinion (not study start) and every 12 months thereafter until research project 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.

GCP & Serious Breach reporting

Clinical Trials of Investigational Medicinal Products (CTIMPs) have a statutory requirement to report serious breaches of the clinical study protocol or Good Clinical Practice (GCP) to the MHRA within 7 days. In cases where a research project is sponsored or co-sponsored by an NHS health board, the researcher with responsibility for the conduct or quality of the trial must report these to the NHS R&D/R&I team immediately for resolution.

For non-CTIMP research, serious breaches of GCP or the protocol should be reported to the relevant ethics committee in accordance with the Research Ethics Committee Standard Operating Procedures.

Additional detailed information on reporting responsibilities are available at https://www.ct-toolkit.ac.uk/routemap/gcp-and-serious-breach-reporting/

On completion of the research project (this should be defined in the protocol), the relevant review bodies including the funder/s must be notified. In the case of NHS involvement, an End of Research project Notification form should be submitted to the REC and the Sponsor representative within 90 days of research project completion. The template form  along with the guidance on end of trial reporting to different organisations can be found here . As with Annual Progress Reports, REC will send reminders and failure to comply could result in ethical approval or sponsorship being revoked if it’s not received in a timely manner.

Each funder will determine the timeline for the Final Report delivery. In addition, a Final Summary Report should be submitted to the REC and the Sponsor representative within 12 months of research project completion. Studies reviewed by an NHS REC must use the online webform.

Researchers should include the plans for publication of their research in the protocol and project/budget plan. Funders will often require publication plans to be in place. In addition, the IRAS application form requires applicants to confirm how they intend to report and disseminate their results.

The common route to inform the research community of full trial methods and results is through publication in peer-reviewed scientific journals. Project/Trial information can be disseminated through trial registration, a summary of results, a final study report, sharing of deidentified individual participant data. The details about good reporting practice, including link to CONSORT guidelines developed to improve the reporting of randomised controlled trials are available here. 

It is good practice to give research participants the opportunity to access research findings too, bearing in mind that a scientific publication is unlikely to be suitable for a lay audience. Visit Public Engagement pages to find out more.  

It is important that researchers consider the need for archiving at the time of project planning including any cost involved. Researchers must plan their archiving in alignment with their funder/sponsor requirements and ensure that project funding provides the necessary resources. The required length of archiving might differ according to the nature of the project and its sponsor or funder. The MRC Good Research Practice Principles and Guidelines provide guidance on retention of basic research and population health and clinical studies. The NIHR clinical trials toolkit can also be consulted for the archiving requirements for Clinical Trials of Investigational Medicinal Products (CTIMPs). Projects conducted under the sponsorship or co-sponsorship of NHS boards will  be guided by the relevant standard operating procedures that must be consulted at the time of project planning.