Research policy and consent

Research Policy and Consent

The aim of this study is to test whether researchers/innovators are able to classify a medical device according to the EU medical device regulation using the Oxford Global Guidance software program. It will also identify if there are any questions that are not used when classifying a medical device using the Oxford Global Guidance software tool.

The value of answering the above research questions is to ensure that the Oxford Global Guidance tool can be applied across users when classifying medical devices. This tool will save researchers / innovators time on their medical device journey.

We appreciate your interest in using Oxford Global Guidance. You have been invited to participate as you are 18 years or older working in the area of medical devices, including: Academic researchers, clinicians, science students, innovators, start ups, SME's, research council, research services and tech transfer support. Please read through these terms before agreeing to participate by pressing the 'get started button' on the landing page. You may ask any questions before taking part by contacting the researcher (details below).

Dr. Rita Hendricusdottir and Professor Jeroen Bergmann in the Department of Engineering Science at the University of Oxford are investigating whether researchers / innovators are able to classify a medical device according to the EU medical device regulation using the Oxford Global Guidance software program. It will also identify if there are any questions that are not used when classifying a medical device using the Oxford Global Guidance software tool.

Please follow the questions using your device description. It should take about 30 minutes. No background knowledge is required.

How will your data be used?

Your answers will be completely anonymous, and we will use all reasonable endeavours to keep them confidential.

Your data will be stored in a password-protected database and may be used in academic publications. Your IP address will not be stored for research purposes. Research data will be stored for a minimum of three years after publication or public release.

Who will have access to your data?

Responsible members of the University of Oxford and funders may be given access to data for monitoring and/or audit of the study to ensure we are complying with guidelines, or as otherwise required by law.

This tool is developed by Dr Rita Hendricusdottir. The principal researcher is Professor Jeroen Bergmann who is attached to the Department of Engineering Science at the University of Oxford. This project has been reviewed by, and received ethics clearance through, the University of Oxford Central University Research Ethics Committee R63968/RE001.

What if there is a problem?

If you have a concern about any aspect of this project, please speak to Dr. Rita Hendricusdottir (rita.hendricusdottir@eng.ox.ac.uk). The researchers will aim to acknowledge your concern within 10 working days and give you an indication of how they intend to deal with it. If you remain unhappy or wish to make a formal complaint, please contact the relevant Chair of the Research Ethics Committee at the University of Oxford: Chair, Medical Sciences Inter-Divisional Research Ethics Committee; Email: ethics@medsci.ox.ac.uk; Address: Research Services, University of Oxford, Wellington Square, Oxford OX1 2JD. The Chair will seek to resolve the matter in a reasonably expeditious manner.

By clicking "Get started" on the landing page you agree to the information above and agree to participate with the understanding that the data you submit will be processed accordingly.