- How long does it take to set up a study?
The JRO will aim to process all studies as quickly as possible. The length of time to review a study will depend on the complexity of the study and the completeness of the documents provided. The coordinator or sponsor advisor assigned to your study will provide the required templates and advise to ensure your study is processed as quickly as possible. The coordinator or advisor will also ask about your expected time lines and will advise on how best to meet these.
- Is my study research?
Some projects may not meet the definition of research, and therefore would not require review by an ethics committee or the Joint Research Office. To determine whether your study is classified as research, you should use the Health Research Authority online tool on the HRA website.
- What are ethics committees?
NHS Research Ethics Committees (RECs) exist to provide a safeguard for the rights, safety, dignity and well-being of research participants. RECs review the research proposals submitted to them and provide an opinion about whether or not the research is ethical. RECs are completely independent of research Sponsors, funders and researchers. Unless explicitly stated, all research involving NHS patients should be submitted to an NHS Research Ethics Committee. If you are unsure whether your study will come under the remit of an NHS REC, you should use the Health Research Authority online tool.
If your study does not involve NHS patients and UCL will be Sponsoring your research project, you will need to submit your study to the UCL Research Ethics Committee. The UCL Research Ethics Committee was created to review all research proposals involving living human participants and the collection and/or study of data derived from living human participants undertaken by UCL students or staff. The UCL Research Ethics Committee will determine whether or not the research proposal conforms to general ethical principles and standards.
- What is a Clinical Trial of an Investigational Medicinal Product (CTIMP)?
A CTIMP is an investigation which is undertaken to determine the efficacy or safety of a medicine in human subjects; as defined by the Medicines for Human Use (Clinical Trials) Regulations 2004.
- What is an investigational medicinal product (IMP)?
An investigational medicinal product is any medicinal product which is being tested within a trial or any product, including placebo, used as a reference in a clinical trial. This includes products with a marketing authorisation where the product is:
- used in a different form from the marketing authorisation;
- used for an indication not included in the summary of product characteristics for that product or
- used to gain further information about the product as authorised in the clinical trial authorisation.
- What is a Medical Device?
The term ‘medical device’ is defined as any instrument, apparatus, appliance, software, implant, reagent, material, or other article used in medical practice. This includes devices used alone or in combination with software necessary for:
- Diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease;
- Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability;
- Investigation, replacement or modification of the anatomy or of a physiological or pathological process or state or
- Providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
- If your study meets the definition of a CTIMP or Medical Device trial requiring MHRA approval, who do you contact?
If you are planning a CTIMP or Regulated Device Trials which you would like UCL to sponsor and you have either a substantive or honorary contract with UCL, the first step is email CTIMPS@ucl.ac.uk.
You are strongly advised to contact the JRO at CTIMPS@ucl.ac.uk as early as possible and a minimum of 8 weeks before submitting any grant application, to allow sufficient time for the team to help you develop your trial costing.
When you have made contact with the JRO, we will send you a straightforward First Contact Questionnaire and request your draft protocol. We will set up a meeting with you to get an understanding of your trial and the resource requirements.
- What is an ATMP?
An advanced therapy medicinal product (ATMP) is a medicinal product which is either:
- a gene therapy medicinal product
- a somatic cell therapy medicinal product
- a tissue engineered product
- How do I fill out an Integrated Research Application System (IRAS) form?
If UCL is sponsoring your study, we recommend you refer to our IRAS guide in the first instance. IRAS has very helpful tips for answering questions – these can be found by clicking on the green ‘i’ icon next to each question.
- What is a peer review?
A peer review is the process of submitting your proposed work (protocol) to an expert (or experts) in the same field to examine and provide feedback on the proposed research idea.
A peer review would generally focus upon:
- The relative merit of the research
- The design and methods
- The feasibility of the research
- The presentation of the application
- Scientific validity
More information on the peer review process for UCL/UCLH Sponsored studies can be found in Standard Operating Procedure for Peer Review for Studies Sponsored by UCL and UCLH.
- What format should my protocol take?
Depending on your study type, the UCL/UCLH JRO has 4 different protocol templates that researchers can use:
- Medical Device Trials
- All other interventional trials
- Non-interventional trials
It is mandatory to use the CTIMP, ATIMP and Medical Device Trial templates. It is not mandatory to use the interventional and non-interventional trial templates, but it is strongly encouraged as it helps to ensure that all regulatory aspects are covered and provides clear guidelines for the researcher and research teams.
- Will UCL or UCLH act as legal representative for my study?
UCL or UCLH may be able to act as legal representative for your study, particularly if the sponsor on based outside the UK. An outline of the roles of a sponsors legal representative can be found at the HRA website. Please contact the JRO sponsorship teams to discuss.
- Do I need a Letter of Access or Honorary Research Contract?
If you are planning to undertake research at UCLH but do not have an employment contract with the trust, you will need to obtain a LoA or HRC (depending on the type of research activity). More information on how to apply for this can be found on the NIHR website. Contact the JRO on uclh.jro-communications.nhs.net for further information. For more information please see the Research Passports page.
- Will someone at the Joint Research Office sign my grant application on behalf of the organisation?
Yes – if the Chief Investigator is based at UCL or UCLH. We encourage grant applications to be submitted to us as far in advance as possible, in order for us to confirm that all costs associated with the study have been considered. Please check the signatories required. For Sponsor representative signatures, the signatory is likely to be the Director or Deputy Director of Research Support. For NHS finance signatures, the signatory is likely to be the JRO Head of Finance.
- I am a student - why does my study need costing?
Costs are incurred in many different types of projects, including some carried out by students. Therefore the Joint Research Office may carry out a costing review to ensure that all study costs are adequately covered, and that no cost is incurred by the trust.
- Who can I contact to discuss costing of research studies?
At the Joint Research Office (JRO) we have a finance team skilled in costing research projects and making sure everything you need is included in your grant or application. Contact the Costing Team by email: R&D.Finance@uclh.nhs.uk.
- Where can I find the costing templates for NHS studies?
- What do you mean by financial management?
Financial issues don’t end once you have the funding is in place. Keeping your grant monies in good order is important for the success, not only of your project, but for the future success of your grant applications. Delivering your project on time and to budget is a sign of a well planned and executed project. We provide financial management including invoicing and financial monitoring of your study. Contact R&D.Finance@uclh.nhs.uk.
- Who can I approach if I require a contract to be put in place?
Contracts and agreements relating to NHS permissions or Sponsorship will be coordinated by the assigned JRO Coordinator working on the review or processing of your study or by emailing the JRO on firstname.lastname@example.org . Enquiries can also be directed to the Contracts and Legal Affairs Manager at the JRO. Details can be found under management team on our Contact Us pages.
- How do I submit a substantial amendment?
A substantial amendment form can be generated on the Integrated Research Application System (IRAS), and must be signed electronically by the Chief Investigator and the Sponsor Representative. If your study is on the National Institute for Health Research Portfolio, this form (and supporting documents) can then be submitted electronically through IRAS and will automatically be forwarded to R&D offices. However, IRAS cannot submit amendments to the NHS Research Ethics Committee – this needs to be done separately via email. Refer to the Studies in Progress section of this website for further details.
- Is there someone at the Joint Research Office I can speak to about Intellectual Property?
Yes. We have two routes for gaining such support. Commercial Intellectual Property queries will be supported by the JRO/UCLB Senior Business Manager. IP relating to specific research projects (sponsorship) can be sent to the JRO Contracts and Legal Affairs Manager. Details can be found under management team on our Contact Us pages.
- Does GDPR affect my research study?
For more information on GDPR please see the Regulatory Approvals page.
- Where UCL are the Sponsor, to what extent is it acceptable to share data externally?
Any transfer of data to another person or entity should be subject to the framework of an agreement which will vary depending on the nature of the data and parties involved. It is best to in touch with a member of the R & D team and understand your data sharing rights in advance of the project discussion.
- What is the difference between pseudonomised data and anonymised data?
Pseudonomised data is considered Personal data which has a key allowing the re-identification of Data Subjects. Anonymised data cannot be reverse engineered to re-identify individual Data Subjects. In research, it is encouraged when possible to anonymise data at the earliest opportunity thereby placing it outside of stricter laws and lowering both individual and institutional risk.
- What should you do if you think your study or project will result in a novel invention or any other form of Intellectual property right?
In the first instance it is advised that you contact the Contracts & Legal Affairs Manager at JRO who will advise you on the next steps based on the study/ project details.