Frequently Asked Questions (FAQs)

Ethics review is one of the keyways in which the University seeks to protect all stakeholders in its research projects, including both participants and researchers.  As such, the requirement for appropriate ethics review is part of the University’s Code of Practice for Research. For more information, see ‘Research Ethics - what do I need to do?’. 

Broadly speaking, a clinical study uses human participants or human data to evaluate biomedical or health-related outcomes. Clinical studies are considered to be observation based and includes; studies administrating questionnaires/interviews, studies limited to working with human tissue samples and/or data and physiology studies involving human volunteers. 

In contrast, a clinical trial involves an intervention whereby you are changing what the participant would do in their normal setting. These are aimed at evaluating a medical, surgical, behavioural, and/or dietary intervention. Clinical trials can often further sub-divided into a CTIMP and non-CTIMP. Whereby a CTIMP is a clinical trial of an Investigational Medicinal Product to determine its safety, efficacy, clinical effectiveness, or pharmacological or pharmacodynamic effects.

For more information see the UoB Clinical Research Definitions (Word - 92 KB), where you will also find the MHRA's algorithm to help you determine whether your clinical research projects is a CTIMP, non-CTIMP or study. 

Yes, if your clinical research project is to be / has been approved by the Health Research Authority (HRA) as per the UoB Principles of GCP for Clinical Research (Word - 84 KB). 

This includes studies that go through UoB REC but still require HRA approval. All other research projects (without HRA approval) do not require registration on a public database though it is good practice.

The reason for this is to help avoid waste through unnecessary duplication of research. Therefore, information about research projects (other than those for educational purposes) is to be made publicly available before it starts (unless a deferral is agreed by or on behalf of the research ethics committee). 

The Clinical Trials Oversight Committee at the University has developed some guidance on the different types of registries available for UoB sponsored projects (PDF - 218 KB).  Please contact researchgovernance@contacts.bham.ac.uk for further information. 

Currently, some projects submitted through IRAS are automatically registered on the ISRCTN Registry e.g. when Portfolio adapted (see the NIHR ISRCTN registration for more information) by the HRA.

Further information on project registration can also be found online:

• The HRA has guidance on Research registration and research project identifiers. 
• The HRA also produces guidance on Research Transparency.

Please contact researchgovernance@contacts.bham.ac.uk if you have any questions regarding project registration.

The university has insurance in place that provides cover for clinical trials in which the university participates, including those it sponsors. The term clinical trials is used here to refer to all types of clinical research projects i.e. studies and trials. Some exclusions apply to the university’s clinical-trials insurance cover, and these must be discussed with the Research Ethics, Governance and Integrity Team (REGI) prior to, or during, the sponsorship-review process.

The university’s insurance cover is renewed annually, at which time a new certificate is issued. For clinical research projects that fall under this standard clinical-trials insurance cover, the latest certificate can be downloaded from the intranet. See Clinical trials activities and Insurance Cover (PDF - 561 KB) for the latest certificate. For copies of previous certificates, please contact the REGI.

Where a project isn’t covered by the university’s standard clinical-trials insurance, the project-specific insurance certificate should be filed in the study/trial master file (S/TMF).

REGI

REGI stands for Research Ethics, Governance and Integrity Team. The team manages the University of Birmingham’s sponsorship of clinical research projects, in line with the principles of good practice set out in the UK Policy Framework for Health and Social Care Research. If you are interested in UoB sponsorship for a clinical research project, see Applying for University of Birmingham Sponsorship.

You should also contact the REGI if you have any queries regarding their other areas of responsibility, as listed below.

• Reporting: throughout the duration of the research, the REGI will monitor annual report submissions to the Research Ethics Committee (REC) and if applicable, to a competent authority such as the MHRA.
• Site agreement: the REGI is responsible for establishing agreements with participating sites.
• Insurance: the REGI ensures that research projects have appropriate insurance cover.

The REGI also facilitates the University’s research ethics processes for all staff and postgraduate student research projects. The team works with the University’s Humanities and Social Sciences (HASS) and Science, Technology, Engineering and Mathematics (STEM) research ethics committees to ensure that all research projects requiring University ethics review receive this as appropriate. For more information, see Research ethics – what do I need to do?

CRCT

CRCT stands for Clinical Research Compliance Team (CRCT). The CRCT helps to ensure clinical research projects, in particular clinical trials, are conducted in line with any applicable regulations, international standards, and the university’s own standards.

The CRCT develops and maintains the UoB Quality Management System (QMS), and supports researchers in developing their own documentation. The team also provides training and support to researchers, to help them to ensure that their clinical research projects comply with applicable regulations and standards.

The CRCT is responsible for carrying out compliance reviews across the university’s clinical research portfolio. The CRCT assesses a project’s compliance against applicable regulations and standards, using either the:

• sponsor support visit (SSV) programme
• audit programme.

For further detail about SSVs and audits, see the FAQ ‘What is the difference between an SSV and an audit?’

How does an NHS trust’s R&D department fit in?

R&D stands for research and development. If a clinical research project uses NHS premises, or involves NHS participants (staff or patients), researchers will need additional approval from the relevant NHS trust’s R&D department. This approval process is automatically included as part of the Health Research Authority (HRA) approval completed via the Integrated Research Application System (IRAS). However researchers are encouraged, at an early stage, to liaise directly with the relevant trust’s R&D department to ensure that the trust is able to facilitate the proposed research project. 

A Health and Safety Risk Assessment is required for all research prior to the research commencing. See Safety Services for more information.

In addition, for clinical research a separate project-specific risk assessment should be performed, which will include an assessment of the risks related to the research design and method, participant safety and reliability of the data/results.

Please see the UoB Project Oversight & Quality Management SOP (UoB-POS-SOP-001) (Word - 145 KB) for further details on carrying out a risk assessment. 

Within in the UoB Clinical Research QMS there are several tools you can use to help with the development of your essential documents. There are protocol templates for both CTIMPs and non-CTIMPs and studies (see also UoB Essential Document Development & Maintenance SOP (UoB-ESD-SOP-001) (Word – 401 KB)). These templates provide the structure for the protocol as well as instructional text throughout which provides an insight into what each section should include. Both of these templates are developed in line with the HRA requirements.

The Sponsor Review Tool (UoB-SPO-QCD-002) (Word - 330 KB) provides additional information on what should be included in each section of the protocol, as well as what information should be included in your Informed Consent Form, Participant Information Sheet and the IRAS form.

The HRA also have provided their own guidance and templates for the development of protocols, Informed Consent Forms and Participant Information Sheets.

In the CRCT we also provide a project set-up support service for researcher who require some additional support in the development of their study documents. This service is available to all researchers, but is perfect for PhD students or those setting up a clinical research project for the first time. For more information about project set-up support please contact us. 

Please also visit the clinical research e-Pathway that provides a roadmap to guide researchers during the lifetime of their research project including the setup of essential documents. 

A Sponsor Support Visit (SSV) is a facilitative visit to the investigator and research team. We will discuss and review your project, including key processes and documents such as the participant consent and enrolment, the collection and processing of study data and tissue sample management, as applicable. The visit allows us to share best practice between teams, as well as providing suggestions where areas of work might need further attention to ensure full adherence to applicable regulations and standards. SSVs usually look at one research project at a time and focuses on one of the following themes: Good Clinical Practice (GCP),  or Human Tissue across the whole project. 

Audits are used to assure adherence to our QMS which includes current legislation, standards and guidelines.  In some circumstances they may be used to assure adherence with other (local or external) QMSs. Any findings identified will need a response from the research team which must be in the form of a Corrective Action and Preventative Action (CAPA) plan.

Why have I been selected?

Currently both SSVs and audits are selected at random using a risk-based approach to identify potential clinical research projects

There are a variety of training courses and workshops by the CRCT available to support UoB staff and PhD students involved in research with participants. For example, an introduction to clinical research workshop, a delegation of duties training session and a workshop on conducting clinical research in a UoB laboratory. We always offer some online training via canvas that can be accessed all year round. Further information and links to this and other training can be found on our Training and Workshop page.

Good Clinical Practice (GCP) is a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical research that involve the participation of human volunteers. Compliance with GCP provides public assurance that the rights, safety and wellbeing of research participants are protected and that research data are reliable.

Do I need to be trained in it?

Staff members who are involved in the day-to-day (site) management of a CTIMP (e.g. Chief Investigator, Research Nurse, Trial Coordinator) are required to have completed the National Institute for Health Research (NIHR) GCP training online course. In addition, staff members have to ensure (and be able to evidence) they stay up to date with their knowledge of GCP and applicable regulations, for example through completing the NIHR GCP refresher courses every 3 years as per the UoB Clinical Research Quality Manual. 

Relevant material as defined by the Human Tissue Act is material, other than gametes, which consists of or includes human cells. This includes (but not limited to); bone marrow, faeces, platelets, saliva, teeth and urine. It does not include embryos outside the human body, or hair and nail from the body of a living person. See also the Human Tissue Authority (HTA) for a list of materials considered to be ‘relevant material’ under the Human Tissue Act 2004. 

Where UoB staff are involved in the handling, processing, receipt, storage or analysis of relevant material the following two laboratory specific UoB SOPs are applicable: 

• Laboratory Set-Up and Management (Word - 86 KB)
• Laboratory Facilities (Word - 122 KB)
• Sample Management (Word - 124 KB)

Please note: other UoB SOPs may be applicable to your research. If you are working with human samples as part of a clinical trial, you must also follow:

• Laboratory Analysis (Word - 83 KB)
• Reportable Issues (Word - 77 KB)

To access all the UoB SOPs and related documents, see the UoB Clinical Research QMS.

A Material Transfer Agreement (MTA) is a type of contract that covers the transfer of materials from one party to another. They can be used for all types of material, but in clinical research they are most commonly associated with the transfer of human biomaterials. A MTA will set out who is the owner of the material being provided and the permitted use of the materials in question for the other party. A MTA can be either “Outgoing” where the University is providing the materials or “Incoming” where we are receiving materials.

If you intend on transferring human biomaterial a MTA must be in place prior to samples being shipped to or from the University.

For trials and studies which have been approved by the Health Research Authority, material transfer may be covered by Appendix 3 of the Organisation Information Document (OID - formerly the Statement of Activities) – Material Transfer Provisions, which allows the Sponsor and participating organisations to agree to the transfer of human biomaterial (including relevant material as defined by the Human Tissue Act). For more information please see the OID guidance (PDF - 267KB). The material transfer may also be included in the Clinical Trial Agreement. However, if the transfer of human biomaterial is not covered by the either of these or the research is not being approved by the HRA, please contact UoB Contracts Team for support.

Good Manufacturing Practice (GMP) is a recognised standard for pharmaceutical manufacturing, processing, packing, release and holding ensuring medicinal products are consistently produced and controlled. The University of Birmingham has a GMP facility: the Medicines Manufacturing Facility (MMF) that  includes the Cell Therapy Suite (CTS), the Microbiome Treatment Centre (MTC) and the Healthcare Technologies Institute (HTI).