Resources

Medical devices are governed by a complex array of legislation, including international standards (ISO) and regulations specific to countries or economic-political unions. Key regulatory bodies and texts include the Medicines & Healthcare products Regulatory Agency (MHRA) in the United Kingdom, the Medical Device Regulation (MDR) for the European Union, and the Food and Drug Administration (FDA) in the United States. These regulations apply to both the clinical investigation and sale of medical devices, including neurotechnological devices. For the latest updates or current versions of these regulations, checking these resources regularly is strongly advised.

With the rapid advancements in neurotechnology, data protection has become the focus of new regulations, culminating in the Regulatory Horizons Council Report. The Information Commissioner's Office (ICO) publishes updates on neurodata regulations that extend beyond the EU's General Data Protection Regulation (GDPR), depending on the type of medical devices. More information can be found on the ICO website here .

Policies and guidelines are essential for building a framework for Patient and Public Involvement (PPI). Several public organizations have published policies such as:

- National Institute for Health and Care Excellence (NICE)

- National Health Service (NHS)

- National Institute for Health and Care Research (NIHR) including the NIHR People in Research initiative

- MHRA

- UK Research and Innovation (UKRI): he institution provides guidance on engaging the public with research as well as providing case studies featuring different methods for PPI integration. Each of the councils of UKRI undertakes its own approach to PPI. They also outline a set of key principles, benefits, evaluation criteria, and best practice examples of co-production in research in their Resource Hub

- Engineering and Physical Sciences Research Council (EPSRC): EPSRC’s Health Technologies Strategy features PPIE as one of the enablers which should be addressed by research. The institution highlights that involvement is particularly important for healthcare as human interactions with health technologies can be amongst the most personal, intimate, and invasive of all interactions with technology. Consequently, they advise researchers to use PPIE in their healthcare research. In fact, funding proposals for UKRI’s EPSRC are required to provide a PPIE and partnership working plan as part of their submission. EPSRC provides a list of considerations and resources which should be requested when crafting research proposals.

- The Medical Research Council (MRC): MRC commissioned a review of PPI in research in 2022 and has recently released a new public partnerships strategy for 2024-2027 indicating that applicants for MRC funding will need to explain how PPI could inform and improve their research. Prizes will be offered to incentivise public partnerships in research. As an immediate action, they funded several research projects dedicated to understanding effective approaches to increasing public involvement in biomedical and (non-clinical) health research.

- Health Research Authority (HRA): HRA aims to protect and promote the interests of patients and the public in health and social care research. It sees PPI as a key element that can enhance relevance and quality of research. They developed four principles for meaningful involvement of patients and the public in health and social care research. Additionally, HRA provides a coherent list of resources on PPI, including guidance on running studies and best practices. The organisation issues a Public Involvement Newsletter on a monthly basis and features an HRA Public Involvement Network which provides support in HRA staff recruitment and staff training. HRA also hosts live consultations to make policies more effective, improve quality, and learn about issues they may not have thought about. Furthermore, members of the public can volunteer to become lay members on various HRA committees (e.g., Research Ethics and Confidentiality Advisory Group) and directly influence health and social care research. Contact: public.involvement@hra.nhs.uk

- The UK Standards for Public Involvement: The UK Public Involvement Standards Development Partnership was established in 2016 and includes representatives from Scotland, Wales, Northern Ireland, and England, as well as independent experts. The UK-wide standards issued by the organisation are designed to improve the quality and consistency of public involvement in research by providing clarity on what good public involvement looks like and encouraging behaviours and approaches that form the bedrock of good public involvement. They were especially developed for researchers working in health and social care. Contact: PublicPartnerships@nihr.ac.uk

- Social Care Institute for Excellence (SCIE): SCIE is a not-for-profit independent charity whose objective is to drive improvements across children’s, families’, and adults’ health and social care. They offer co-production training, resources, and host a National Co-production Week to promote co-production, share best practices, and celebrate successes. The organisation developed a jigsaw model of co-production which provides guidance on key issues that effective co-production should address. Contact: Contact Form

- Public Health Agency: The Northern Ireland-based organisation responsible for the implementation of PPI policy developed a centralised and comprehensive set of resources on PPI – Engage Platform. The website features a list of involvement opportunities and details of the researchers to contact for inclusion. They also provide an extensive set of guides, standards, and tools available for researchers as well as a video introduction to PPI in research. Researchers and postgraduate students can also pursue a free PPI training module and earn a digital PPI badge from UCC upon successful completion. Contact: ppi.secretary@hscni.net

In addition to its extensive PPI guidelines, NICE publishes quality standards and advice for specific diseases. The section on neurological conditions may be particularly relevant.

Beyond the guidelines provided by public institutions, various charities and research centers offer disease-specific guidance and PPI support. These resources are invaluable for researchers and patients alike:
- NHIR Oxford Biomedical Research Center for researcher's specific PPI guide

- Parkinson's UK

- Joint Programme – Neurodegenerative Disease Research (JPND)

- Mental Health Research

- The Brain Tumor Charity

- James Lind Alliance (JLA) Priority Setting Partnerships Guidebook

- The UK Standards for Public Involvement

- Social Care Institute for Excellence (SCIE)

Support and training for the implementation of medical device regulations, ISO standards, or clinical trials are available through accredited institutions, including the British Standards Institution (BSI).

In addition to technical guidelines, organizations such as UNESCO often circulate ethics-centered articles, available in the ethics of neurotechnology section of their website. These publications can be good indicators of future legislation as they regularly issue recommendations.

Reengineering neurotechnology: placing patients first (TUM)

Patient engagement in research (Patient Engagement in Research Partners)

Digital technology and PPI (UCL)

Epilepsy Action: Your Guide to Commissioning in Epilepsy. Guide for ensuring med tech for epilepsy aligns with patient challenges and needs.

iBCI-CC (Implantable BCI Collaborative Community): Convenes stakeholders into working groups to solve challenges of BCI development and implementation.

Dana Frontiers (Dana Foundation): Grants for neuroscience researchers to engage with patient groups and other stakeholders.

The Brain Tumour Charity: Information on how to engage with their “Involvement Network” of brain tumour patients and carers.

International Neuromodulation Society: Information for patients on conditions and therapies written by leading researchers in the therapy.

McPin Foundation: Examples of opportunities for mental health patients to contribute their lived experiences to research.

Alzheimer’s society: Partners with researchers to involve people affected by Alzheimer’s and dementia by shaping research projects from the proposal stage to active project guidance and funding dementia-focused studies. Contact: ResearchPartnerships@alzheimers.org.uk

Parkinson's UK: Supports researchers working in Parkinson's disease to involve patients and the public in their work in a meaningful way. Contact: researchinvolvement@parkinsons.org.uk

COMET Initiative PPI Toolkit (University of Liverpool): Guide for researchers to plan PPI for their study.

PCORnet (National Patient-Centered Clinical Research Network): Examples of patient engagement in studies on obesity, aspirin use, and more; patient co-investigators.

Voice: Platform to arrange public working groups with specific types of people for free.

BMC CRN (Boston Medical Center Clinical Research Network): Provide services to support community engagement and rapid study activation.

DCRI (Duke Clinical Research Institute): Examples of initiatives where patients serve on steering committees and provide input on trial design and patient materials.

IAPO: Working with Partners and Stakeholders Toolkit (International Alliance of Patient Organisations).

EUPATI: Toolbox (European Patients’ Academy on Therapeutic Innovation). Toolkits and guidelines to support collaboration between patient organisations and pharmaceutical industry.

Versus Arthritis: Involving People with Arthritis – A Researcher’s Guide.

Arthritis Research UK: PPI – A Researcher’s Guide. Guides for basic science and clinical researchers to involve arthritis patients.

ABPI + National Voices: Working together delivering for patients (Association of the British Pharmaceutical Industry collaboration with National Voices). Guide for helping charities and pharmaceutical companies work together.

PPMD Strategy (Parent Project Muscular Dystrophy): Collection of notes and publications from PPMD on their PPI strategy and accomplishments.

EMA: Engagement Framework (European Medicines Agency). Methods for EMA’s engagement with patients, including patient experience data collection and patient communication methods.

EPF: The Added Value of Patient Organizations (European Patients Forum). Overview of European patient organisations including their roles in involving patients during research and development.

ASIF: Working with the Pharmaceutical Industry (Axial Spondyloarthritis International Federation). Advice for axial spondyloarthritis patient groups to partner with pharmaceutical companies.

MTG: Medical Technology Group. Provides forums for patient representatives to engage with med tech manufacturers.

Oxford Blood Group: A Thames Valley Network and Oxford hospitals patient involvement group for individuals with haematology conditions. Part of the NIHR Oxford Biomedical Research Centre. Contact: OxfordBloodGroup@ouh.nhs.uk

Think Local Act Personal: A national partnership of over 50 organisations setting examples in public engagement for social care and the public sector. The entity features a National Co-production Advisory Group (NCAG) which comprises people who access services, carers, and family members. Resources include a ladder of co-production which describes co-production steps, case studies, council support, and topic-relevant podcasts. Contact: Contact Form

National Voices: A coalition of over 200 health and social care charities in England. It aims to design health and care services with and around disabled people, people living with health conditions, and people affected by health inequalities. The organisation meaningfully involves people with lived experience in decision-making around health and care. They provide a vast range of services including advisory on strategic co-production, roundtables, and hosting engagement events. Contact: info@nationalvoices.org.uk

Cancer Research UK: Cancer Research UK features a Patient Involvement Network which is used to showcase current opportunities to actively involve in their work people affected by cancer. They also offer a Cancer Insights Panel which consists of people from all over the UK with a range of different backgrounds and lived experiences, including patients, carers, and loved ones. To support best practice in PPI, they shared their own Patient Involvement Toolkit with guidance, tips, and templates to plan, deliver, and evaluate PPI initiatives. Contact: involvement@cancer.org.uk

In the UK a significant proportion of clinical research will be delivered in several structures funded by the National Institute for Health and Care Research (NIHR) . Their website offers resources for clinical and non-clinical researchers in the UK to connect with PPI groups . It is also worth noting that many of the NIHR structures are arranged regionally, at different levels and with different aims. Given the relevance of NIHR structures for clinical research and their leading role on PPI development, it is worthwhile to familiarise yourself with the local structures:

- NIHR Clinical Research Networks (CRNs): CRNs tend to be the structures closer to clinical trial delivery. They will be staffed by people who know the local territory well. They can provide help with patient recruitment and design of patient-centred studies in broad range of regions and specialties. They can also be very useful for interface with GPs and other primary care structures. This will be revamped soon with the delivery of the NIHR Research Delivery Network.

- NIHR CRFs (Clinical Research Facilities): These provide research facilities attached to NHS hospitals across England, to support with practical aspects of clinical trial delivery.

- NIHR Biomedical Research Centres (BRCs): BRCs involving patients in early-stage translational research including via specialty-specific TRCs (Translational Research Collaborations). They are themed and location specific, changing every 5 years. BRCs can deliver lab-based and “basic” science projects, although you can always expect a direct link to patient benefit or NHS application.

- NIHR Research Support Services (RSSs): The NIHR Research Support Service consists of eight regional hubs (research groups and Clinical Trial Units partnerships), a Specialist Centre for Public Health, and a Specialist Centre for Social Care. These entities can provide advice on patient, public, service user, and community involvement and engagement, and are skilled in developing/co-producing innovative PPIE approaches in collaboration with researchers, patients, community organisations, and the public. They expect to be involved at the grant preparation stage, as early as possible, so they can contribute towards this. To receive support, researchers are requested to select one of the RSS entities and contact them directly, ideally several months before the funding application deadline.

NIHR People in Research: A dedicated website connecting the public and researchers to collaborate on public health, social care, and NHS research. Researchers can submit available public involvement opportunities free of charge and make them visible to interested individuals directly on the website. Opportunities can be classified according to 25 research topics (including neurological disorders), various types of involvement, locations, suitability for beginners, as well as the ability to select remote-only assignments. Each listing features direct contact to the research team, which the candidate can use to express their interest in the study.

NIHR Community Engagement Partnerships Funds: As part of the People in Research Initiative, the NIHR promotes partnerships between community groups, social enterprises, and charities, and health and social care researchers. These entities can partner with an NHS Body, NHS trust, or other NHS services provider in England and submit joint funding proposals of £50k - £150k over 6-18 months. Interested parties can utilise the People in Research website to find partners and submit proposals.

NIHR Research for the Future: A NIHR Clinical Research Network (CRN) led and NHS-supported campaign promoting public involvement in health and care research. Registration is open to everyone 18 or above and living in England. Alerts ensure members are advised about opportunities for involvement in research (e.g., research project development and design). PPIE services offered include public recruitment for co-production, steering committee selection, research barrier identification, and priority setting. They also share case studies, training materials, and other resources on the campaign.

Contact: research.future@nca.nhs.uk

Learning for Involvement: A collaborative website dedicated to learning and development for public involvement in health and social care research bringing together PPI information, training, and resources (guidance, videos, etc.) in one place. Users can upload training and resources as well as utilise the already present resources.

Co-Production Collective: An international community of diverse, often underrepresented individuals working together on co-producing health, wellbeing, and innovation research. The organisation provides learning resources, training, newsletters, workshops, keynotes, and monthly co-production meetings. The Collective can aid in facilitating co-production in research projects.

Contact: coproduction@ucl.ac.uk

James Lind Alliance (JLA): Facilitates Priority Setting Partnerships (PSPs) connecting clinicians, patients, and carers to indicate their research interests to health research funders and ensure the practicality of health research outcomes. JLA Advisers act as independent consultants who facilitate PSPs, but their funding and organising is the responsibility of a respective PSP. The organisation issued a Priority Setting Partnerships Guidebook.

Contact: jla@southampton.ac.uk

Health and Care Research Wales: A public involvement community register where Welsh citizens can register their interest to support health and social care research. Member involvement opportunities are listed on a dedicated page and categorised based on the level of involvement requirements and participation rewards. The platform features a list of involvement opportunities and an expression of interest form to join a study. Health and Care Research Wales Support and Delivery Service can help provide help in public involvement and engagement and listing of the opportunities on the platform.

Contact: healthandcareresearch@wales.nhs.uk

National Co-ordinating Centre for Public Engagement (NCCPE): NCCPE provides vast resources (tools, guides, case studies, newsletters, etc.) on promoting and supporting PPIE in higher education. The institute offers a Public Engagement Professionals network, academy trainings, accreditation, and consultancy services for higher education and knowledge institutions.

Contact: nccpe.enquiries@uwe.ac.uk

Health Innovation Network (HIN):HIN connects NHS academic, industry, third sector, and local organisations to collaborate on ensuring innovations, improvements, and best practices spread within NHS faster, thus quickly benefiting patients. Each of the 15 HINs provides a unique PPI approach adjusted to local circumstances, relationships, and organisational models. They also run The Patient and Public Involvement (PPI) Forum, a three-times-a-year event platform to share learnings and coordinate workings.

Contact: Contact Form

VOCAL:A Greater Manchester-based institution connecting the public with health researchers. The organisation provides support such as advice, training, consultancy, and mentoring to engage communities in health research studies. MRC commissioned Vocal to review public involvement in research with a special focus on non-clinical health and biomedical research. Together with MRC, Vocal developed a report on public involvement in research laying foundations for the development of a new MRC public involvement and engagement strategy.

Contact: info@wearevocal.org

Shaping Our Lives: A Community Interest Company which exists to promote the voices of different equality groups who use health and social care services and other services provided by the public and voluntary sectors. To ensure that services are efficient and meet the needs of the public, Shaping Our Lives provides various support including advice, training, workshops, lived experience user recruitment, evaluations, and resources to parties interested in involving service users in their research. They operate an Involvement Opportunities Board featuring non-paid engagement, involvement, co-production, and research opportunities for people who want to have a say and influence in health and social care. Researchers can request publishing their opportunities on the platform by submitting a dedicated form and mailing it to the organisation. Additionally, the society provides a list of paid functions on the Involvement Jobs Board.

Contact: hello@shapingourlives.org.uk

Public Health Agency:The Northern Ireland-based organisation responsible for the implementation of PPI policy developed a centralised and comprehensive set of resources on PPI – Engage Platform. The website features a list of involvement opportunities and details of the researchers to contact for inclusion. They also provide an extensive set of guides, standards, and tools available for researchers as well as a video introduction to PPI in research. Researchers and postgraduate students can also pursue a free PPI training module and earn a digital PPI badge from UCC upon successful completion.

Contact: ppi.secretary@hscni.net

PPI Network at Queen’s University Belfast: The network, established in 2020, aims to support PPI efforts undertaken by the university. It provides a repository of case studies, PPI-related sources from local, national, and international sources within the categories of co-production, guidance, ethics, collegiate shared resources, and payment categories. Additionally, the entity offers topical events and news on PPI theory and practice.

Contact: ppihub@qub.ac.uk

Co-production Works: A consultancy entity that supports public services organisations to engage in co-production with citizens, people who use services, and carers. They collaborate with researchers, artists, consultants, and filmmakers, and promise a one-stop solution to all co-production needs. Services include training, planning, delivery, and evaluation of co-production. Specifically for research projects, they can support recruitment of peer researchers, co-production advisory boards, research design and methodology, facilitation of focus groups, and one-to-one interviews, among others.

Contact: Contact Form

Marie Curie Research Centre at Cardiff University: Wales’s only dedicated palliative care research centre is actively including people affected by dying, death, and bereavement in the design and delivery of research projects. They developed the Public Involvement in Research Impact Toolkit (PIRIT) providing a free planning and tracking tool to support researchers in public involvement practice. The toolkit offers guidance on planning and integrating PPI in research, tracking contributions, and reporting their impact.

Contact: mariecurieppi@cardiff.ac.uk

Coalition for Personalised Care (C4PC):C4PC is a movement of people with lived experience of healthcare and their representative bodies, health providers, and commissioners. C4PC provides a co-production model developed in collaboration with the NHS which features five values and seven steps of successful co-production initiatives.

Contact: info@coalitionforpersonalisedcare.org.uk