1. 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 Lancaster 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.
2. How long does it take to set a study up?
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 officer will advise to ensure your study is processed as quickly as possible.
3. What are ethics committees?
NHS Research Ethics Committees (RECs) exist to provide a safeguard for the rights, safety, dignity and wellbeing 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 LU will be Sponsoring your research project, you will need to submit your study to one of the relevant Faculty Research Ethics Committees. The Faculty Research Ethics Committees were 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 LU students or staff. The Faculty Research Ethics Committee will determine whether or not the research proposal conforms to general ethical principles and standards.
4. 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.
5. What is a Clinical Trial of an Investigational Medicinal Product?
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.
6. What is an investigational medicinal product?
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.
7. Will LU or UHMBT act as legal representative for my study?
LU or UHBMT may be able to act as legal representative for your study. An outline of the roles of a sponsor’s legal representative can be found at the HRA website. Please contact the JRO sponsorship team to discuss.
8. What is 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
9. Do I need a letter of access or honorary research contract?
If you are planning to undertake research at UHMBT 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.
10. Who can I approach if I require a contract to be put in place?
If you think you require a contract to be put in place for your research project, please contact the team on: firstname.lastname@example.org
11. 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. The IRAS 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. For more details contact: email@example.com
12. Is there someone I can speak to about Intellectual Property?
For further information please contact: firstname.lastname@example.org
13. What is the difference between pseudonymised 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.