Audits and Service Evaluations do not require a submission to the Research Ethics Committee or approval from the JRMO, however if conducted within BH they will need to be registered with the Clinical Effectiveness Unit.
The HRA have a decision toolkit questionnaire to find out whether your project is research or not.
If you are unsure about whether your project is defined as research, audit, service evaluation or other, please contact the Research Support Unit (RSU).
What is the process?
A Research process flow-chart [PDF 307KB] is available to guide researchers through the process of conducting research.
The Research Team
The Chief Investigator (CI) is the person with overall responsibility for the Study. The HRA and IRAS have different definitions for CI role. Please check the HRA website and the IRAS pages for more information.
The Principal Investigator (PI) is the investigator responsible for the research study involves at any given research site. There is one PI per site, but in the case of a single-site study, the CI and the PI will normally be the same person.
Key Collaborators are any other investigators working on the study other than the CI, PI or local research team (unless they are based within a local research team at a site but also working as a Key Collaborator on a national level). They could be grant co-applicants or protocol co-authors, for example, expert peers or statisticians.
Local Research Team
These are members of the research team (other than the CI, PI or Key Collaborators) who take an active part in conducting the study, or administering any of the study procedures, at any given research site.
All research projects must have an identified sponsor. The sponsor organisation could be the CI’s employer, funder, a commercial company or an educational institution, depending on the nature of the study, purpose, scope and location.
The JRMO will normally identify the CI’s substantive employer as the sponsor. Where the study is an educational qualification, the university would be identified as sponsor.
Guidance and how to apply for sponsorship to BH or QMUL can be found here.
The JRMO will prepare a detailed project costing of the study for the relevant organisation, including appropriate charges to levy for the project, and advice on any precedents that
have been set with particular research sponsors. The formal costing document will be given to the PI.
Please see the Pre-Award pages for more information.
The organisations you apply to will vary depending on the type of study. All studies will need to use IRAS to create you application form.
All clinical research requires formal sponsorship before a study can progress to the HRA Approval process. The JRMO provides guidance on sponsorship applications before the process begins.
Health Research Authority
HRA Approval is the process that brings together the assessment of governance and legal compliance for the NHS in England. Working closely with the NIHR Clinical Research Network the JRMO will assess the capacity and capability of all sites to undertake research.
NHS Research Ethics Committee (REC)
All research studies involving human participants, human data or human tissue (with some exceptions) should receive an independent ethical review and approval from a recognised ethics committee prior to commencing.
To determine whether NHS REC approval is required, please use the HRA decision tool and further guidance here:
If you are still unsure how your project is defined, or whether it requires NHS REC review, please contact the RSU.
The REC must issue a final opinion within 60 days.
Additional for Studies involving Investigational medicinal products:
Medicines and Healthcare products Regulatory Agency (MHRA)
There is a legal requirement for researchers planning a clinical trial to apply to the Medicines and Healthcare products Regulatory Agency (MHRA) for a Clinical Trials Authorisation (CTA) before a trial starts (Medicines for Human Use (Clinical Trials) Regulations 2004).
The regulations apply to clinical trials where there is a medicine in any of the treatment or control arms of the study (including trials with healthy volunteers); and to trials attempting to generate information on the efficacy and / or safety of a medicine, including a standard treatment will also fall under the Regulations.
Trials of interventions such as surgery, where patients will be receiving medicines as part of standard treatment, do not come under the Regulations.
The MHRA part of this application is completed within IRAS but submitted to the MHRA via the Central European Submission platform [CESP]. Access to CESP will be given during the Sponsorship process by the GCP team.
The MHRA has produced a clinical trial algorithm to help you decide if you need to complete a CTA and how to apply.
If the trial is being funded and sponsored by a commercial company, it is likely the sponsor will submit the CTA on behalf of the Chief Investigator.
For trials that are sponsored by BH or QMUL the sponsor will delegate the responsibility for completing the CTA to the CI.
The MHRA must decide on your CTA form within 60 days.
There is a fee associated with this application.
Obtaining a EudraCT number
If your trial falls within the scope of the CT regulations you are required to register your project on the EudraCT database (developed by the European Medicines Agency) by obtaining a EudraCT number. This number becomes the main identifier for the trial and should be used on all correspondence with the MHRA, REC, and when reporting protocol amendments or serious adverse events.
To obtain this number you should go to the EMA website and click on the EudraCT section. Request a security code, which will be sent to you via e-mail. On receiving the code you can apply for the EudraCT number on the same website.
This email MUST be kept securely as your application to the MHRA will not be accepted without it.
The number received should be added to your CTA form and used and the unique identifier on all study documents
Additional for Studies involving MHRA regulated devices:
Medicines and Healthcare products Regulatory Agency (MHRA)
The MHRA part of this application is completed within IRAS but submitted on CD format to the MHRA. Details can be found on the MHRA website.
There is a fee associated with this application.
Confidentiality Advisory Group (CAG)
Applications to access confidential patient information without consent must go through the Confidentiality Advisory Group (CAG). It will advise on whether there is sufficient justification for the HRA or the Secretary of State for Health to approve. Application is via the IRAS system.
Letter of No Objection
If you are planning a project involving a medical device, you may need to obtain a Letter of No Objection from the MHRA. This is required for studies involving medical devices that are not CE-marked, or which will be modified or used outside of the parameters of the CE-marking and there is potential for the device to be commercialised or for its CE-marking to change following the study.
A letter of no objection can be obtained by completing the MHRA Devices form on IRAS and submitting it to the MHRA with supporting documentation.
The MHRA must assess study projects within 60 days
For more information on whether your medical device requires a letter of no objection please contact the GCP Team.
A letter of objection is not required for studies which only involve medical devices that are CE-marked, and are only being used within the parameters of the CE-marking.
Local Assessment of Equipment (including medical devices) used for research.
Any medical equipment (and associated documentation) that is intended for use on patients within BH must be assessed by Clinical Physics as soon as possible. Approval takes a few days.
For Trials involving medicinal products The Medicines for Human Use (Clinical Trials) Regulations 2004 is law with in the UK. All medical devices in the UK market must comply with device specific legislation, as governed by the Medical Devices Regulations 2002.
For more information please contact the Equipment Service Director, Malcolm Birch:
Collection and use of data:
As researchers working within BH, you must abide by the Data Protection Act 1998 and the Guide to data protection for researchers [PDF 143KB].
The Act defines personal data as any data that can be attributable to a living individual, and does not have to include name, address, and date of birth or gender. The CI is usually the named Data Custodian of the study.
Storage of data:
- Physical storage - should be kept in a locked filing cabinet, accessible only to the research team in a lockable room. Identifiable data will be transcribed and or anonymised and identifiers removed as soon as possible.
- Electronic Storage - including Cloud storage, IT programs and infrastructures, must be identified, risk assessed and validated where appropriate and kept in an encrypted format, accessible only to the research team via a password protected BH or QMUL computer.
Participants must know that any information kept on them because of their involvement with the trial will be kept securely.
The research findings of any study are to be stored at BH/QMUL Modern Records Facility, 9 Prescot Street, London E1.
Individual rights over data:
Under the Act individuals have a right to access any personal data that you have about them. Access must be given within 40 days of their request. The participant also has a right to request that you stop processing their data. If you receive such a request you must comply even if it means removing that person from the trial
There is no data protection act outside the EEA (EU + Iceland, Lichtenstein and Norway). Therefore, if your study requires you to send data outside EEA, you must only transfer coded information and seek explicit informed consent from the data subject(s).
How to store Human Tissue
The Human Tissue Resource Centre holds the licence for storage of human tissue for research that cover tissue banks operating within BH and QMUL, which authorise an establishment to continue its activities. This licence applies only to those groups which have registered with the HTRC as it is essential that the requirements of the Human Tissue Act are complied with.
Where studies are sponsored by QMUL or BH CTIMPs, the CI and lead team must attend the JRMO Good Clinical Practice training course before the JRMO will issue the Final Declaration of Sponsorship.
There are many regulations, frameworks and guidelines that can apply when conducting a research study involving humans.
Good Clinical Practice is mandatory for all CTIMPs and recognized as best practice in relation to all other clinical research.
The 13 principals of GCP are:
- Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).
- Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.
- The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.
- The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.
- Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
- A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favourable opinion.
- The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.
- Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).
- Freely given informed consent should be obtained from every subject prior to clinical trial participation.
- All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.
- The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).
- Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol.
- Systems with procedures that assure the quality of every aspect of the trial should be implemented.
The Declaration of Helsinki is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone document on human research ethics.
All research conducted within or involving NHS patients, staff, data, or facilities must comply with the Research Governance Framework (RGF) set out in the JRMO’s published Joint Research Policies. These outline the principles of good governance applying to all research.
Finally there are other regulations that may apply to your study:
- Ionising Radiation Medical Exposure Regulation (IRMER)
- Administration of Radioactive Substances Advisory Committee (ARSAC),
- Information Commissioners Office (ICO)
- Mental capacity Act
- Good Laboratory Practice (GLP)
- Good Manufacturing Practice (GMP)
- Health and safety at work Act,
- International Air Transport Association (IATA).
Please seek advice from the GCP team if you are unsure of what is relevant to your study.