Regulatory support is available from the Research Governance Office and also from Regulatory Champions. The Research Governance Office is at hand to help with research involving human participants, human tissue and their data. However, if research involves developing medical devices, the TRI have funding available for regulatory advice to support this. We encourage researchers to get in touch with us at as early a stage as possible, to help eliminate the chance of costly regulatory re-development at a later stage.
The Research Governance Office can provide advice and support to staff and students wishing to conduct research involving human participants, their tissue or their data. The team provide guidance on:
- Sponsorship: the individual, company or organisation which takes responsibility for the initiation, management, and/or financing of a study
- Insurance/Indemnity: appropriate cover is required against potential harm to participants
- Ethics Applications and Amendments: ethical review is required for all research involving human participants
- Human Tissue: all relevant UK legislation which regulates research involving the use of human tissue must be complied with
- Data Protection: research generates data which must be handled in accordance with relevant information legislation
- Archiving: the process for timely archiving of essential research study documents once the study has been completed should be considered at the earliest opportunity
Working closely alongside colleagues in NHS Research & Innovation, the Research Governance team can help investigators ensure that they are aware of their responsibilities and that their research is conducted to the highest standard. Information on regulatory compliance for students is also available on the Student Project Regulatory Approval Roadmap.
For more information, please see the research governance webpages and contact Debra.Stuart@glasgow.ac.uk.
Medical Device Regulatory Support
General Medical Device and Diagnostic Regulatory Advice
Developing a medical device comes with complex regulatory requirements. Having the time and knowledge to navigate through these complexities is a significant barrier to innovation. To help with this, the TRI is providing access to support for researchers undertaking medical device projects to ensure regulatory compliance is followed from the outset, precluding the need for costly redevelopment / repetition of developmental work to the required regulatory standards. Regulatory guidance will be embodied in a Medical Device and Diagnostics Roadmap (development ongoing).
Bespoke Medical Device Regulatory Support
In addition to the generalised roadmap, tailored regulatory advice for translational projects that require more detailed and focused support is also available. Projects accepted for this support will receive 1-to-1 guidance from one of our regulatory consultants, who provides expert advice to correctly categorise prototype technologies, orientate them within the regulatory roadmap framework, and provide bespoke guidance on development strategies to ensure full compliance throughout the entire translational journey.
To apply for regulatory support, please contact Debra.Stuart@glasgow.ac.uk or Michaela.Petaroudi@glasgow.ac.uk and email@example.com for more information.
Translational Research Initiative Regulatory Support For Individial Projects
Through funding from the Wellcome Trust, the Translational Research Initiative (TRI) provides regulatory support for translational projects.
For short-term support, eligible projects can benefit from guidance in the monthly drop-in sessions to enable their transition towards clinical translation and commercialisation.
CLINICAL DROP-IN PROJECT SUPPORT SESSIONS
This new translational support scheme has been designed to help researchers access critical information and resources on key regulatory requirements of their clinically-translatable projects. This initiative aims to reduce barriers to clinical translation of innovative projects and ideas, by providing the tools and information that researchers require in order to progress their work towards clinical or commercial applications.
The service is open for applications by researchers throughout MVLS and aims to provide access to critical information and resources, through our regulatory consultant, to support their translational research. Researchers can submit queries on all aspects of the regulation of clinical device and therapeutics, in Europe or the UK, including MHRA submission requirements, appropriate documentation, timescales, fees etc.
Applicants are required to complete and submit a short application, Dr Michaela Petaroudi, along with their questions for the regulatory support consultant. Successful applicants will be invited to attend either a 30-minute 1-1 session with the consultant, where they will have the opportunity to discuss their queries and receive guidance on the regulatory aspects of their translational projects, or a 1-1 longer-term support (see section above), akin to our industry mentorship scheme. In case further, short-term support is needed, eligible researchers will be offered with the option to attend a follow-up session.
For any questions about this initiative, or to apply, please get in touch with the Translational Research Clinical Officer, Dr Michaela Petaroudi.