Frequently asked questions
- Is my proposal research?
- What does a Research Protocol need to include?
- Who will lead the study?
- Who will Sponsor the study?
- What is the difference between a Sponsor and a Funder?
- Has the study been costed?
- How might I fund my study?
- What do I need to comply with? (Good Clinical Practice)
- What Applications and Approvals are needed for the study?
- Do I need NHS REC approval if I am planning on conducting research with NHS staff as participants?
- Do I need REC approval if I am planning on conducting research outside of the NHS; no NHS patients or staff but healthy volunteers as participants?
- Are there any additional approvals necessary for studies involving Investigational Medicinal Products?
- What is the Confidentiality Advisory Group (CAG)?
- The study involves a new device: is there anything additional I need to do?
- How do I manage data protection?
- What is the General Data Protection Regulation (GDPR)?
- What is a ‘research site’?
- What will I need to do if I intend to conduct my study entirely outside the UK?
The Health Research Authority (HRA) has published a decision making toolkit to determine whether a piece of work, a project or an investigation, is classified as research. HRA guidance document with definitions here:
Clinical Audits, Service Improvement Projects and Service Evaluations are not and do not require a submission to the Research Ethics Committee, Health Research Authority (HRA) or approval from the JRMO, however if conducted within Barts Health they will need to be registered with the Clinical Effectiveness Unit.
If you are unsure whether your work should be defined as research, audit, service evaluation or ‘other’, please contact the JRMO's research governance team.
The JRMO has protocol templates for researchers applying for sponsorship from either Barts Health NHS Trust or QMUL. The templates depend on the study type and we require researchers to complete them before we can receive your application and confirm sponsorship. The Protocol is only one document of your minimum application pack. For a copy of the appropriate template relevant for your study (MHRA Regulated studies, Interventional Studies or Research Studies), please find them attached to our SOPs. For further advice about how to complete the Protocol, please seek guidance from the JRMO's research governance 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' MyResearch website for more information.
- The Principal Investigator (PI) is the investigator responsible for the running of a research study 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 usually 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 both a member of a local research team at a site and also working as a Key Collaborator at a project-wide level). They could be grant co-applicants or protocol co-authors, expert peers or statisticians.
- Local Research Team 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. Further guidance about student projects can be found here.
Guidance and how to apply for sponsorship to BH or QMUL can be found here.
A Sponsor is the organisation that takes responsibility for the design, conduct and management of the research. The sponsor provides the indemnity and insurance for the study, protecting the research team and study participants from both negligent and non-negligent harm.
A Funder is the company, charity, research council or other organisation or group of people (e.g. crowd-funding) that provides finance, staff, equipment or resources to facilitate the research.
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 Costing and Contracting page for more information.
The JRMO’s Costing & Contracts team has an on-line costing tool that establishes how much your study will cost the institution and research team to deliver. All studies must be costed. If your proposed research involves significant costs and you intend to apply for external funding you should look into applying and securing funding as soon as possible. A range of funding opportunities is available, including project-specific grants, Research Councils or being awarded a sum of money from an interested third party such as a charity or other institution. More information can be found here.
For MHRA regulated studies (Clinical Trials of Investigational Medicinal Products (CTIMPs), Advanced Therapy Medicinal Products (ATMPs), non CE marked medical devices) that are sponsored by QMUL or BH, the CI and statistician must attend the JRMO Good Clinical Practice (GCP) training course before the JRMO will issue the Final Sponsorship greenlight.
Good Clinical Practice is mandatory for all CTIMPs and recognized as best practice in relation to all other clinical research.
For more information on this, including the internationally-accepted Principles of GCP see the NIHR guidance document here.
All research conducted within or involving NHS patients, staff, data, or facilities must comply with the UK Policy Framework for Health and Social Care Research 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)
- General Data Protection Regulation (GDPR)
- Health and Safety at Work Act
- International Air Transport Association (IATA)
Please seek advice from the research governance team if you are unsure of what is relevant to your study.
The regulatory bodies you need to apply to will vary depending on the type of study, participants involved and research sites.
All clinical research requires formal sponsorship before a study can progress to the HRA approval process. The JRMO research governance team 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 North Thames 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.
NHS REC review is not normally required for research involving NHS or social care staff recruited as research participants by virtue of their professional role. For more information see the HRA website and the HRA decision tool. Please note that although NHS Staff studies do not require NHS REC approval, they do require HRA Approval.
Do I need REC approval if I am planning on conducting research outside of the NHS; no NHS patients or staff but healthy volunteers as participants?
It is highly likely you will need approval from the appropriate ethics committee. If the research is being conducted as part of an educational qualification or employment with QMUL you should seek approval from the Queen Mary Ethics of Research Committee (QMERC) prior to commencing your research.
Are there any additional approvals necessary for studies involving Investigational Medicinal Products?
Yes. These include:
- 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
- If the study involves an 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.
The Confidentiality Advisory Group (CAG) receives and reviews applications from researchers who propose to access confidential patient information without consent. The CAG advises on whether there is sufficient justification for the HRA or the Secretary of State for Health to approve- any query regarding CAG can be sent to: HRA.CAG@nhs.net. 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 no 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) and any medical equipment (and associated documentation) that is intended for use on patients within BH intended for use in research 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 Malcolm Birch, Equipment Service Director at email@example.com
Collection and use of data:
As researchers working within BH, you must abide by the Data Protection Act 1998 (replaced by General Data Protection Regulation (GDPR) in May 2018) 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 (up to one month once the GDPR is in place). 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. For further details on data management please see SOPs 38a, 38b, and 11a.
The Data Protection act only applies to European Economic Area (EU plus Iceland, Lichtenstein and Norway). If your study requires you to send data outside EEA you must only transfer coded information and need to seek explicit informed consent from the data subject(s).
Storing Human Tissue
Our 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.
The EU’s GDPR will apply from 25th May 2018 and will replace all pre-existing provisions under the Data Protection Act 1998. It is intended to strengthen and unify data protection for all individuals within the EU. For more information on how this may impact your research please contact the JRMO research governance team and the HRA website.
A research site is defined as the single organisation responsible for conducting the research at a particular locality. The research site is not necessarily the location where research activities will actually take place. For example, an entire NHS Trust is a named site; e.g. Barts Health NHS Trust would be the named site, even if the only place it is happening is the Royal London Hospital for example. Similarly, in a research study conducted by practice nurses from GP practices, interviews with participants may take place in the participant's home, but the research site would be the GP practice. Research sites are organisations responsible for participant-related research procedures specified in the protocol - including recruitment and informed consent. Referral of a patient for assessment and possible recruitment is not part of the conduct of the study.
A ‘Participant Identification Centre (PIC)’ is not classified as a site; it is used to inform potential participants about a study (such as putting up a poster in a waiting room to advertise a study), on the basis of which the potential participants may choose to contact the researcher should they wish. There are no research activities taking place at a PIC.
Depending on the nature of the study, you may need sponsorship and/or REC approval. In addition to relevant UK approvals, the study must be approved in accordance with local Laws, Regulations and Guidelines. You will need to liaise with the international organisation you intend to name as a research site and request guidance from them as to the local requirements for research approvals.
Please note that the NHS (including Barts Health NHS Trust) is unable to sponsor any research that takes place outside of the UK, due to its status as a UK health body. However QMUL can consider sponsoring an international study, if appropriate. Please see the JRMO webpage on non-medical research for more information.