Research application submissions: Decision tool
Please use this decision tool to determine whether you should seek Research Governance and Regulation (RGR) approval prior to commencing your study.
If you remain unsure about whether you should seek RGR approval, please contact the RGR team who will be happy to advise you at: research.enquiries@gov.im
Section 1: Does my proposal qualify as research?
If you answer Yes to any to any of the following questions we would consider your project research and you should continue to Section 2.
If you answer No to all to all of the questions, you do not need to submit an application.
- Are the participants in your study randomised to different groups and any treatments, care or services allocated by randomisation?
- Does your study protocol demand changing treatment/care/services from accepted standards for any of the patients/service users involved?
(NB: Clinical audit and service evaluation examine how standard care is delivered; and by definition do not allocate treatment, care or service by randomisation according to protocol. In standard care, decisions around the treatment regime, care or service and how it will be administered are made jointly by the care professional and patient/service user. If patients/service users are to be randomised to treatments, care or services in your study you would answer yes)
- Is your study designed to produce generalisable or transferable findings?
(NB: Generalisable in this context means the findings can be reliably extrapolated from the study to a broader population of patients/service users and/or applied to settings or contexts other than those in which they were tested. Transferable in this context means the findings of a qualitative study can be assumed to be applicable to a similar context or setting. Most qualitative studies are not usually generalisable but can often be considered to be transferable.)
Section 2: Do I need to discuss my research proposal with Research Governance and Regulation and/or do they need to review my application?
If you answer Yes to any to any of the following questions, please submit an application to the RGR team.
If you answer No to all of the questions, you do not need to seek RGR approval.
- Will your research involve staff within Manx Care or linked providers?
- Will your research involve potential research participants identified in the context of, or in connection with, their past or present use of Manx Care or linked services, including participants recruited through these services as healthy controls?
- Will your research involve the collection, processing or use of information relating to any past or present users of Manx Care or linked services?
- Will your research involve potential research participants identified because of their status as relatives or carers of past or present users of Manx Care or linked services?
- Is your research a clinical trial?
- Will your research involve a medical device?
- Does your research involve exposure to any ionising radiation?
- Does your research involve the processing of disclosable protected information on the UK Register of the Human Fertilisation and Embryology Authority by researchers, without consent?
- Will your research involve the collection, storage or use of human tissue (i.e. any material consisting of or including human cells)?
- Will your research involve at any stage procedures (including use of tissue or information) involving adults who lack capacity to consent for themselves, including participants retained in study following the loss of capacity?
- Will your research relate to health and/or social care and involve offenders or those working within the Criminal justice system?
- Does your research involve xenotransplantation?
These questions have been adapted with kind permission from the UK Health Research Authority.
Application submission
Applications can be submitted via the online Integrated Ethics Portal (IEP).
You will need to create a new user account following the instructions on screen.
Once the application is validated by RGR, it is reviewed by the Isle of Man Research Ethics Committee (IOMREC).
Please see IOMREC page for meeting dates and further details.
Manx Care applications
All projects which involve Manx Care (either as sponsors, or use Manx Care resources) require sign off at line manager and Directorate level.
This ensures that each area is aware of the research happening in their Department.
They need to confirm that the capacity and capability is available, and that the research aligns with the strategic direction of the service area/Directorate.
You will need to enter your line manager’s email address as a required signature and they will be sent a link to authorise your application before you can submit.
In order to do so, your line manager will need to create an IEP account.
Reviewed: December 2022
