Improving Research Inclusion: learning from NIHR and Research Council funded studies in England

Research Inclusion, Design, Participatory, Ethics, Equity, Learning, Marginalised-Excluded, Improve Policy/Practice ALL Metrics - Views Downloads How to cite this article Bhui K, Mooney R, Stepney M et al. Improving Research Inclusion: learning from NIHR and Research Council funded studies in England [version 1; peer review: 2 approved with reservations, 1 not approved]. NIHR Open Res 2025, 5:102 (https://doi.org/10.3310/nihropenres.14116.1) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente Select a format first ▬ ✚ Review [version 1; peer review: 2 approved with reservations, 1 not approved] Kamaldeep Bhui https://orcid.org/0000-0002-9205-2144 1-5, Roisin Mooney1,2,4, Melissa Stepney https://orcid.org/0000-0001-8743-9443 1,2, [...] Kanwal Mand https://orcid.org/0009-0006-7558-3222 6, Megan Kirk https://orcid.org/0000-0002-2069-2177 2,7, Erin Lawrence https://orcid.org/0009-0001-8311-4948 5, Anna Lavis6,8Kamaldeep Bhui https://orcid.org/0000-0002-9205-2144 1-5, Roisin Mooney1,2,4, [...] Melissa Stepney https://orcid.org/0000-0001-8743-9443 1,2, Kanwal Mand https://orcid.org/0009-0006-7558-3222 6, Megan Kirk https://orcid.org/0000-0002-2069-2177 2,7, Erin Lawrence https://orcid.org/0009-0001-8311-4948 5, Anna Lavis6,8 PUBLISHED 16 Oct 2025 Author details Author details 1 Psychiatry, University of Oxford, Oxford, England, UK 2 NIHR Oxford Health Biomedical Research Centre, Oxford, England, UK 3 University of Oxford Wadham College, Oxford, England, UK 4 World Psychiatric Association Collaborating Centre, Oxford, England, UK 5 Centre for Psychiatry and Mental Health, Wolfson Institute of Population Health, Queen Mary University of London, London, England, UK 6 Dept of Applied Health Sciences, University of Birmingham, Birmingham, England, UK 7 Nuffield Dept of Primary Care Health Sciences, University of Oxford, Oxford, England, UK 8 Institute for Mental Health, University of Birmingham, Oxford, England, UK 2 NIHR Oxford Health Biomedical Research Centre, Oxford, England, UK 3 University of Oxford Wadham College, Oxford, England, UK 4 World Psychiatric Association Collaborating Centre, Oxford, England, UK 5 Centre for Psychiatry and Mental Health, Wolfson Institute of Population Health, Queen Mary University of London, London, England, UK 6 Dept of Applied Health Sciences, University of Birmingham, Birmingham, England, UK 7 Nuffield Dept of Primary Care Health Sciences, University of Oxford, Oxford, England, UK 8 Institute for Mental Health, University of Birmingham, Oxford, England, UK Kamaldeep Bhui Roles: Conceptualization, Data Curation, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Conceptualization, Data Curation, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Roisin Mooney Roles: Funding Acquisition, Investigation, Project Administration, Resources, Supervision, Writing – Review & Editing Roles: Funding Acquisition, Investigation, Project Administration, Resources, Supervision, Writing – Review & Editing Melissa Stepney Roles: Conceptualization, Investigation, Methodology, Project Administration, Writing – Review & Editing Roles: Conceptualization, Investigation, Methodology, Project Administration, Writing – Review & Editing Kanwal Mand Roles: Conceptualization, Data Curation, Investigation, Methodology, Project Administration, Writing – Review & Editing Roles: Conceptualization, Data Curation, Investigation, Methodology, Project Administration, Writing – Review & Editing Megan Kirk Roles: Conceptualization, Data Curation, Investigation, Methodology, Supervision, Writing – Review & Editing Roles: Conceptualization, Data Curation, Investigation, Methodology, Supervision, Writing – Review & Editing Erin Lawrence Roles: Data Curation, Formal Analysis, Methodology, Project Administration, Writing – Review & Editing Roles: Data Curation, Formal Analysis, Methodology, Project Administration, Writing – Review & Editing Anna Lavis Roles: Conceptualization, Funding Acquisition, Methodology, Project Administration, Supervision, Writing – Review & Editing Roles: Conceptualization, Funding Acquisition, Methodology, Project Administration, Supervision, Writing – Review & Editing OPEN PEER REVIEW REVIEWER STATUS Research Inclusion (RI) seeks to improve the inclusion of marginalised groups with significant health care needs in research. Research programmes are known to under-recruit those with multiple health problems, facing health inequalities, and living in precarious social situations where their identity can be a source of stigma and discrimination 1 . RI strategies are likely to vary by the health conditions under scrutiny, research designs, the type and timing of data collection, venues for data collection, and the nature and complexity of interventions. There is little practical information for researchers on how do to this. In this paper, we set out a synthesis of lessons learnt from a range of research programmes in England. These include studies of adolescents living with adverse childhood experiences in complex intersectional positions of vulnerability; studies of ethnicity and multimorbidity including psychosis; and research to improve public and patient involvement with ultra marginalised adolescents. The research projects sought to ensure representation and participation by people with lived experience, and from the most marginalised groups facing multiple forms of vulnerability. We conclude that inclusion strategies must evolve within the research programmes; balance power and improve trust through co-design and participatory methods; build community partnerships and networks of trusted organisations before during and after the research; adapt research infrastructures that may act as barriers, alongside ensuring culturally responsive designs to tackle epistemic injustices, and secure necessary resources 2 . Research studies should be explicit on which marginalised groups they aim to recruit, anticipate flexibility to involve other unknown complex groups, set out procedures for participation and retention, reporting successes and failures, and generate recommendations for future studies. We place our learning in the context of published literature and propose a research inclusion checklist for future refinement. Research is important as it informs the development and adoption of new care and treatments. However, many people are not included in research. This occurs if their complex health problems and social situations prevent them from following the procedures by which people are recruited into research; they may have more immediate social and health care needs, or their complex conditions may be the basis of exclusion if researchers are studying a single condition. People likely to be excluded include older people, younger people those with multiple health problems and frailty if there are not sufficient resources to support them into research; and then there may be concerns about how to undertake research safely, for example, if people have experienced traumatic events and the research might make them feel distressed or unsafe. People from marginalised groups, by age, sex, sexuality, ethnicity, neurodiversity, socio-economic status and poverty, and place; therefore, these groups end up being excluded from research so that advances in care and treatment are not informed by their views. Given the are already most likely to face disadvantage and poor care and access, this makes their situation worse, as they do not benefit from advances. In this paper, we look at these issues through the lens of four research projects that are underway or nearing completion, and we summarise these lessons we learnt in practice, for how to improve research inclusion. The studies sought to learn about and provide support to young people (12-24) with adverse childhood experiences (The ATTUNE study), adults with multiple chronic conditions including a psychosis (Co-Pics and a PhD study in East London recruiting a similar group), and work from Leeds and Falmouth with ultra marginalised young people to understand what think of participating in research and what gets in the way. The studies were each fully funded, through bodies like United Kingdom Research Innovations through the Medical Research Council and various funding streams from the Nation Institute of Health Research. In this paper, we do not set out the full methods of each of the studies as these are reported elsewhere, rather, we try to set out the learning on how we had to adapt our approach and what worked well and what did not. This information is often not included in the main research paper. Although there is a lot of guidance, very little gives the practical information we discovered. We summarise it here and link it to research, where the approach appears be close to or similar to our discoveries. We also explain the challenges in doing such work, especially for universities and funders and researchers who find changing their procedures challenging. Research Inclusion, Design, Participatory, Ethics, Equity, Learning, Marginalised-Excluded, Improve Policy/Practice Corresponding Author(s) Kamaldeep Bhui ([email protected]) Grant information: This paper was inspired by research inclusion strategies developed in the design and delivery of the following research projects: ATTUNE funded by UKRI programme on Adolescent Mental Health and the Developing Mind (MR/W002183/1), Co-Pics NIHR Health and Social Care Delivery and Research Panel (NIHR151887), London Interdisciplinary Social Science Doctoral Training Partnership (LISS-DTP) PhD Studentship (grant number ES/P000703/1) ; Oxford Health NIHR BRC’s Developmental and Preventing multimorbidity themes. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Copyright: © 2025 Bhui K et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Bhui K, Mooney R, Stepney M et al. Improving Research Inclusion: learning from NIHR and Research Council funded studies in England [version 1; peer review: 2 approved with reservations, 1 not approved]. NIHR Open Res 2025, 5:102 (https://doi.org/10.3310/nihropenres.14116.1) First published: 16 Oct 2025, 5:102 (https://doi.org/10.3310/nihropenres.14116.1) Latest published: 14 May 2026, 5:102 (https://doi.org/10.3310/nihropenres.14116.2) The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. There is a newer version of this article available. of this article available. Research Inclusion (RI) ensures that research addresses today’s challenges with effective partnerships, sufficient resources, and a diverse range of people both leading and included in research3. RI reduces the potential for neglecting representation in research and combats perpetuating or worsening health inequalities3. Diverse perspectives must be represented by age, sex, gender, ethnicity, neurodiversity, and disability to improve scientific rigour and critical reflection on research questions and designs. Involving diverse participants and different disciplinary perspectives can help to innovate by challenging assumptions and paradigms and refocusing the scope of inquiry to areas of importance to the public and patients. This makes the research more generalisable, for example, to global majority populations (over 80% of the world’s population). The emphasis on protected characteristics (in British legislation) is valuable. The Equality Act (2010) specifies age, disability, gender reassignment, marriage and civil partnerships, pregnancy and maternity, race, sex and sexual orientation as protected characteristics. NIHR (National Institute of Health Research) is the biggest funder of health and social care research in UK and has mandated research inclusion; NIHR also asks for attention to socioeconomic status and inequalities, caring responsibilities, intersectional vulnerabilities, geographical location, and access to health and social care. Many standard categories used in research inclusion strategies (e.g. ethnicity) neglect heterogeneity within the categories, and risk obscuring more complex intersectional positions and identities. Consequently, routine data or surveys that do not critically consider these categories cannot deliver generalisable findings. Vulnerabilities to poor health can reflect interactions between multiple markers of social position, for example, social class, tribe, caste, or geographical location, migration or asylum status. These intersections need intentional inclusive approaches4. Health inequalities are more often encountered among disadvantaged groups5, the very groups that are under-represented in research that then informs practice and policy, which is only suitable for groups able to participate in research5,6. As a result, emerging innovations will not serve them well and will not be taken up, requiring further studies, expense, and later adaptation of interventions and policies. Although many funders and research institutions advocate for research inclusion, there are many practical details that are rarely specified. In this context, this analysis synthesises the learning from several research projects and initiatives to improve methods of Research Inclusion and Patient and Public Involvement (PPI). These studies include research by the Mental Health in Development and Preventing Multimorbidity Themes of the NIHR funded Oxford Health Biomedical Research Collaborative, seeking to improve inclusion for ultra-marginalised adolescents in Cornwall, Birmingham, and Leeds; and for recruiting people with severe depression into a trial of ketogenic diets, respectively; an NIHR funded study sought to recruit people with at least two or more multiple long-term conditions and psychosis (Co-Pics)7 in several urban and semi-rural areas in England; an ESRC funded doctoral student project recruited people with psychosis and physical multimorbidity in East London, building on the methods of Co-Pics; finally we include learning from a UKRI funded programme on the use of creative arts methods for understanding and responding to adverse childhood experiences (ATTUNE), recruiting young people aged 12–24 in several rural, urban and coastal venues8. Each of the study designs and cohorts are or will be separately reported (as cited). We present here an overview of RI approaches and considerations that we discovered and iteratively addressed before and during the studies (see Summary of RI Challenges). These observations were derived through deliberations within our research teams, our advisory boards, our PPI groups, and in the research design. Most studies included early participatory or creative elements, such as photovoice, or multi-modal arts work, or narrative methods, in the design (ATTUNE, Co-Pics). These are known to enable greater participation by those less able to use verbal methods, or where conventional research designs might be off putting or felt as traumatic. A relational recruitment procedure1 involved working closely with local research teams and trusted community partners (ATTUNE, Co-Pics, NIHR Oxford Health BRC). The emergent lessons (see RI Checklist) were derived from the experiences of the researchers, peer researchers, and community partners, NHS research infrastructures and NHS Trusts, during the time they were recruiting participants from diverse and marginalised positions. The recommendations may assist research organisations, NHS teams, charities, and local communities to build appropriately agile research infrastructure and skills. In this paper we summarised the learning from these four projects, rather than report fully the PPI arrangements of each project. In brief, in ATTUNE young people and lived experience expertise participated in the funding application and design, and in the delivery of each component, including deliberations on ethics, and in the interpretation and writing up of results. In Co-Pics and the related PhD project (both still being written up) on multiple long term conditions including psychosis, people with lived experience reviewed and contributed to and were involved in the application, in the data collection, interpretation, and writing up. In the NIHR BRC themes on Preventing Multimorbidity (in which Co-Pics is adopted) and the Developmental Theme, we have worked with lived experience experts with the relevant experiences and conditions to inform how we should undertake research; in these studies we had to devise the engagement and involvement plans after making contact with potential participants, showing flexibility and local and group specific adjustments in our approach. Again, people with lived experience were and will be involved in interpretation, for the NIHR BRC Developmental Theme. For this paper, we did not establish a separate PPI group, although we did share a summary of the paper and our main proposals (the checklist) with a panel of 5 young people, asking them to rank our proposals in priority. The studies were mostly following an experience based co design methodology, so mostly were not trials. The co-designed interventions are being or will be evaluated in the future. Where we outcome measures in ATTUNE, which were recommended by the funder to promote comparison across studies, but were also reviewed and critiqued by young people’s panels, to inform selection and modification and presentation. The conduct of research is often shrouded in technical terminology, either reflecting specific methodological paradigms or disciplinary framings of the problem that the researchers seek to solve. Esoteric or technical language is sometimes necessary, linked to theory to help us advance science, but such language can act as a barrier to inclusion9. For example, on interrogating concepts like personality disorder, or disease or illness, or ethnic group, agreeing an accessible vocabulary and explanations of causation often reveals conceptual confusion or obscured ambiguity amongst scholars. Such questioning helps improve the precision of the language used and exposes traditions and conveniences that must be revised. These negotiations ensure partnerships are grounded in shared concepts from inception, and that there is agreement on how words that carry power are to be used. Linked to language, once research is completed, the findings should also be accessible to the public, in a range of appropriate visual, audio, and sensory formats. For example, arts installations and exhibitions are an excellent vehicle for sharing research findings and for influencing practice and policy. RI seeks to democratise knowledge and shows what research is being done for public accountability; RI also challenges the language, framing, specific methods, objectives, and design; thus greater involvement of those who would not usually participate in research can bring benefits to them10. In our work with marginalised groups and with professionals delivering health and social care, it is always surprising how little of the research evidence is known. Therefore, assumptions of what is known or not before co-design and participatory methods should be challenged. Providing evidence summaries early in the process, again in multiple modalities, can help balance power to optimise trust and communication. The design, delivery, knowledge mobilisation strategies, and impact pathways should be informed and shaped by the beneficiaries so that research is relevant, ethical, and more likely to be impactful. Only through dialogue, with participants and intended beneficiaries through specified collaborative processes, will knowledge production address epistemic injustices and public and participants will come to trust the research process and later findings11. This should be in partnership with those expected to implement research findings in practice and policy. Participatory RI can identify research questions of importance to the public and patients, alongside refining or challenging those proposed by funders and professionals. However, an equally important function is to critique or to deprioritise questions or procedures that might reinforce stigma and prejudice, or indeed, halt research interests that are too far removed from patient experience. Such critique can prevent wasting resources on unhelpful approaches. This shift to find solutions during the research requires time to explore and progress, and may be viewed as demanding and costly, yet additional resources (time and funds) should be anticipated in the research design2. Implementing RI can be felt as disruptive of conventional research pipelines, but necessary to shift power away from research teams towards the beneficiaries. We found a re-think was often required in response to poor recruitment progress; pauses and perceived disruptions offered valuable opportunities to review research designs and underlying philosophical and conceptual confusions and assumptions. Lived experience perspectives often help uncover these assumptions. In our approach to inclusive research practice, we made use of participatory methods, emphasising co-design and collaboration with the intended beneficiaries from inception12. However, participatory methods are seldom used or reported13. Co-designed and collaborative research contrasts with traditional approaches, where funding priorities and study designs are often determined by governments, think tanks, charities, and learned societies and researchers. These usually also lock in a particular design, rather than respond to the ongoing and newly discovered needs of potential participants to ensure inclusion. Another benefit of co-design and participatory methods is that those expected to implement findings and wider public stakeholders become more informed of what matters to the intended beneficiaries, and what really is at stake for them. This prepares them to champion the implementation of research and anticipate which local regulatory and governance procedures need activation. Research inclusion often raises ethical questions and dilemmas when designing and delivering research. Adopting an inclusive research approach means upholding an ethical responsibility to ensure justice and fairness in research, where all groups have an opportunity to benefit from advancements in science, rather than a privileged subset. Globally, ethical dumping (the practice of researchers from high-income countries conducting unethical or exploitative practices in lower income countries) and helicopter research (not considering the impact on the community once the research is concluded) are being challenged and must be rigorously avoided and managed14. One way to combat ethical violations is to ensure research processes to recruit participants and deliver research are developed with and subject to critique by intended beneficiaries. Oversight committees will need to be attentive to potential dilemmas. Including ethical dimensions in all programmes helps to intentionally deliberate upon unanticipated dilemmas and see these as opportunities to learn. For example, in ATTUNE, we designed participatory methods involving multiple modalities of creative arts and communications (verbal, audio, video, sensory) and different approaches to co-design; this was time consuming and required thoughtful and sensitive engagement with the intended beneficiaries throughout. These approaches may be challenged if they are less familiar to funders, researchers and ethics committees15. Therefore, an important task is to explain and upskill such committees; this is additional work researchers must anticipate and undertake. In addition, the costs of more participatory and paced progress must be met. There are many examples of how research needs to be adapted to respond to ethical questions. For example, adequate support is required for people to enter research, especially if they are frail, vulnerable, or have experienced lifetime adversity and unfavourable socio-economic conditions; this requires more time to assess what kind of support is needed and to build trust; participants will need more support than is usual during and after the research. It is relatively easy, in our experience, for such groups to be systematically excluded by tight inclusion criteria or when the research infrastructure and teams do not have capacity to provide the necessary support. Judgements about suitability may carry inherent prejudices about people’s desire and ability to participate, often compounded by poor communication of the research aims and what participation involves. People who are experiencing poverty, mobility issues, as well as multiple health conditions require more time in travelling and entering and leaving research, and resources (for example, taxis may be required rather than public transport). There may be child-care needs to permit participation, and these too need resources and time. People with carer responsibilities will need support during the research process, especially if they are managing multiple social challenges like paying fuel bills, living in rural or distant areas, and if they need to prioritise immediate health and welfare appointments over research (theirs and the cared for person’s). Young people in care or living in precarity may struggle with lengthy consent procedures16; they may also not wish to discuss research participation with parents or carers. Whilst researchers and regulators insist on assurances of uniform informed consent processes and of confidentiality, should young people living in precarity with chaotic and unconventional circumstances be excluded, risking neglect of their significant health, welfare, and social care needs? If they have troubled and chaotic lives, they may not be able to participate in tightly scheduled research, or in a consistent manner; research should not assume levels of literacy or ability to express experiences verbally; for example, many struggle to complete questionnaires that require significant periods of concentration, and ones which ask about deficits and traumas such as maltreatment that may be distressing and difficult to recall. Again, the ethical dilemma is that such young people may be excluded, so procedures and practices and ethical conventions may need to be revised. Who will take responsibility in this instance? Social care and local authorities are often responsible for safeguarding protocols and protections. Their participation in research is a priority in the UK currently, yet this requires a larger infrastructure for social care research. The use of incentives in research is often questioned, yet for participants from poorer sections of society with multiple responsibilities and few assets, remuneration should reflect the time burden, and the emotional and cognitive demands involved in recruitment and participation, and practical issues (travel costs and time). Providing cash incentives may help, but can also compromise welfare and benefits, if the rules of welfare receipt specify limits to additional sources of income. Remuneration should also take account of time away from work, carer roles, and childcare costs. There are other examples of ethical challenges: young people may choose social media communications, or digital methods, which are often not deemed to be adequately secure and not favourably viewed by ethics committees or sponsors. Yet, if this is their preferred form of communication, it may improve representation, in part through building trust and a more convenient form of easy communication. One of our studies used social media recruitment achieving 300 participants in a few months (NIHR Oxford Health BRC; whereas for other studies (ATTUNE) this was deemed too risky and not supported. Consequentially, greater flexibility is required in ethics and sponsor procedures; greater (time) investment is needed for research teams to understand participants’ lives and how to adapt the pre-specified research infrastructure as a study proceeds. Testing out different methods might also be included in future research designs. The structural barriers that prevent use of health and social services, can be replicated in research. Innovative models can relocate research processes into community venues, ones that are more familiar to and trusted by participants; however, this means improving the infrastructure for research in the community in recognised safe spaces such as schools, charities, museums and art galleries17. Governance and assurance policies can become constraining and prohibitive, reinforcing structures of disadvantage. Therefore, we advocate for all research organisations and employers to review their policies and practices, on an ongoing basis, and perhaps even by each study, whilst evolving new procedures and practices. Watchful attention to potential for improvement should be welcomed, rather than seen to challenge or violate protocols and standard operating procedures. Advisory Boards and Data Monitoring and Ethics Committees are part of the current expected governance infrastructure in the UK; we found that raising the challenges and issues outlined at these committees can lead to productive opportunities to re-imagine inclusive research practice as studies proceed. Practically, revising procedures will require ethical re-review which can delay studies if the governance processes are themselves not sufficiently well resourced to reflect the demands of inclusive research. Patient and Public Involvement (PPI) is a widely accepted practice in health research, usually with appropriate representation on advisory boards, in research teams, and amongst participants. Resourcing PPI well, commensurate with objectives, can protect against tokenistic inclusion, and extractive and exploitative forms of PPI. Building trust takes time and researchers need to guard against potential for exploiting knowledge rich communities. Despite the advancements in PPI frameworks, there remain areas of improvement especially regarding impact on the emerging evidence base. Many PPI panels consist of members with similar health conditions and from similar social contexts without much consideration of intersecting vulnerabilities (e.g., race/ethnicity, sex, gender, neurodiversity, sexual orientation, socioeconomic status, disability) that shape health outcomes16,18–20. PPI needs to be adapted to facilitate inclusion of those located at the intersections of multiple disadvantages related to identities and socio-economic position. However, this usually ends up being undertaken on little resource and may be seen as unethical and unfair and ultimately fails to recruit intended participants. Furthermore, funder agencies may resist the additional expense, even if the proposals are fairer and appropriately challenge historically ineffective or exclusionary processes. We found that researchers should avoid rigid orthodoxies in PPI and EDI. They should build in additional thinking and time to consider the most marginalised in their localities and reflect on their own awareness and agility in grasping and overcoming knowledge gaps as a core task. Sometimes the pressure of preparing and launching a new research project against a strict timeline and working through all the contractual, ethical, workforce, and administrative stages can generate strain in the research team even if they have good intentions to make an impact. This needs care of the research team, especially if lived experience is prominent as this can be emotionally and cognitively demanding and place additional stress on teams. Building in reflective debriefs, and careful use of holidays and health days, alongside flexible working, and supports where required can be helpful. Indeed, research teams also often carry many undisclosed experiences of poor mental and physical health, and so the content of the research may be found to be distressing and emotionally challenging. A good research culture should be able to accommodate discussion of such issues, for example, by agreeing from inception a values framework, and reflective discussion. External facilitation can help team dynamics also. We recommend all members of the research team, irrespective of discipline, undertake research inclusion training, using and testing the participatory methods; for example, we’ve made good use of the approach recommended in living labs and learning labs. These ensure embodied and experiential learning rather than intellectual knowledge. To improve RI, we compiled a checklist as a set of standards derived from our work on various research projects. Our desire is these standards are adopted, but different types of research may require tailored refinement (e.g. cultural adaptation of psychological interventions or developing randomised controlled trials). Involving patients and lived experience experts is now common, but there are so many approaches and methods, that we propose these should always be co-designed specifically for each research project by those participating in that project and potential beneficiaries. The strategies we adopted and put forward evolved in partnership with project specific PPI panels, peer researchers, and community partners. We shared a summary of this paper and checklist with five young people through a survey. We did this to reduce burden to them of soliciting their views, recognising the paper is written as guidance for researchers rather than lived experience experts. We asked this group to rank our recommendations. We only present percentages ranking each statement as 1st or 2nd; see Checklist). This paper has set out learning from several research projects funded by different research commissioners. Our findings are aligned with research studies of mental illnesses21 as well as other health conditions21 We hope the paper will support research teams in research inclusion. Specifically, research teams including peer researchers will need to evolve a shared understanding of concepts and vocabularies and then pre-design research inclusion approaches, building in flexibility, lived experience perspectives, and participatory co-design methods. We hope to test and iterate the checklist of common challenges and mitigations to produce a standardised reporting framework. We welcome dialogue and collaboration to refine our recommendations for different types of research and different populations. This article did not require data assembly and formal analysis, rather a summary of our learning. No data are associated with this article. • Fear of research as a potential source of harm or as an extension of state authority into the everyday lives of people • Over surveillance and over researched communities can feel exhausted, exploited, and not see the benefit of their participation personally or for the public • A lack of trust given the historical record and legacy of scientific racism • Not understanding what research is, for example, it’s not always about experimentation or medication trials nor of interventions, and such portrayal may attract some people with altruistic intentions; yet these may also deter some who are aware of the historical harms inflicted upon marginalised groups over the years. • Wanting to retain control and not enter a series of processes and procedures which may nor may not be beneficial, but in which coercion or authority might be enacted. • Wanting to protect oneself from demands on limited time and resources (emotional, cognitive, and financial) as the reality for many is that they make ends meet on a day-to-day basis; they are already under immense strain and face daily fatigue. The cognitive and emotional demands of research may be one step too far. • For people living in precarity, facing multiple disadvantages; or experiencing poverty, violence, trauma, and discrimination, asked to give time and energy to research when they are not receiving adequate health or social care need can feel unjust. Furthermore, social support or therapeutic support may be more urgent than the research task. What are the ethical parameters in which researchers operate when they see these common dilemmas? • For some at the intersections of multiple sources of disadvantage, well-intended research processes can be felt as traumatic and compound fears and worries about participation. For example, autistic people who may also be gender diverse, and/or from a racial minority, might need more thoughtful and compassionate approaches– researchers will need to learn about identity-sensitive and trauma informed approaches22. For example, information must be delivered at the right pace, in the right form, and from a trusted source, clarifying vocabularies and listening to preferences during the process. • Cultural and spiritual beliefs, illness perceptions, literacy levels, and linguistic isolation might become barriers if researchers do not anticipate and address these issues in good time and optimise, adapt and test proposed measures and procedures. Resources should be included to address translation and interpretation, especially in mental health care where complex experiences are not easily translated and even validated measures have differing screening and performance properties. In our experience, consistency of interpreters, and translations reflecting common parlance rather than refined highly sophisticated translations are important. This means translators need to be versed in the conceptual and. philosophical dilemmas. • Protocol driven research to be completed against a schedule to a defined structure does not work in favour of research inclusion; such structured or standardised approaches make sense, but if they are too inflexible (funders, ethics committees, sponsors, research recruitment and delivery staff) they will perpetuate exclusion from research. Protocols are necessary, yet parameters of responsive flexibility should be included, rather than later changed being perceived as a protocol violation. • Miscommunications or failed expectations may be invalidating and compound preconceived fears and worries and undermine trust in a study. Careful design and preparation and involving a community panel can help prepare the tone and vocabulary through which people can be sensitively approached and involved and supported in and out of research. • Operate a relational approach and build trust through partners and key lived experience experts and peer researchers with appropriate skills and experiences; these are skills are valued and exceptional and should be recognised and rewarded as such (80%). • Ensure enough time and flexibility to accommodate unexpected needs and co-design of solutions (60%). • Ensure adequate resources and challenge extractive or exploitative processes, ensuring remuneration but also support into and before, during and after the research (20%). • Preliminary ethnography, for example, and meetings including all groups to learn about each other, and the diverse perspectives (without assumptions) can be invaluable (20%). • Ask for help: talk to communities of reference, to those groups you seek to work with, and take the time to respectfully engage and interact in a thoughtful and considerate manner (20%). • Incorporate reflexivity amongst researchers and lived-experience members to critically evaluate biases, assumptions and potential impact on the research programme as whole. Self-awareness and building trust to receive and act on participant feedback (e.g., critical friends) should be prioritised. • RI means discovery during the research, discovery of the right venues and ways to recruit, and sensitively clarifying the identities and beliefs of potential participants. • Adopt a trauma-informed research approach that recognises the prevalence and impact of discrimination and trauma when working with underrepresented groups; prioritise emotional and actual safety, trust, transparency, cultural humility and cultural safety. • Research teams must ensure they are adequately prepared, aware, willing to learn, and can adapt their processes and procedures where required; ethical committees and sponsors and commissioners of research must also recognise this additional demand and cost. Indeed, we need more research on these issues and what additional resources and skills are required. • Interdisciplinarity is invaluable as a form of challenge to assumptions and silos of disciplinary paradigms, but it does require additional time for people to know each other and avoid unhelpful group dynamics. • As you do the work, evolve better methods, practices, design, and see challenges as sources of interest and refinement rather than a frustration. • Agree procedures for resolving disputes, conflict, disagreements, and align this with project values and policies (e.g. for remuneration, authorship, etc). • We usually return to lived experience experts (who may not agree themselves) to help us identify what matters, and how to resolve disagreements; yet we also find the quality of the conversations and scholarship is enhanced by involving people with complex intersectional locations and identities; such an approach must involve a flatter power structure and moves towards shared starting points and agreed vocabularies. EDI toolkit: https://arc-nenc.nihr.ac.uk/virtual-college/equality-diversity-and-inclusion-edi-toolkit/ Centre for Ethnic Health Research Toolkit for Increasing the Participation of Black, Asian and Minority Ethnic Communities: https://arc-em.nihr.ac.uk/arc-store-resources/increasing-participation-black-asian-and-minority-ethnic-groups-health-and Heath inequalities impact assessment toolkit: https://forequity.uk/hiat/ How to incorporate Equality, Diversity and Inclusion (EDI) in Patient and Public Involvement (PPI) NIHRTV https://www.youtube.com/watch?v=j0cmoPLYW5c Bristol, North Somerset, and South Gloucestershire Trauma-Informed Practice Framework: https://bristolsafeguarding.org/media/dlhebkrr/bnssg-trauma-informed-practice-framework-2024.pdf Trauma-Informed Social Research: A Practical Guide: https://www.tnlcommunityfund.org.uk/media/insights/documents/Trauma-informed-social-research-A-practical-guide-2021.pdf?mtime=20220711144114&focal=none#:~:text=At%20the%20centre%20of%20trauma,%2C%20collaboration%2C%20choice%20and%20voice. We thank the respective funders, although our recommendations and findings are not endorsed or influenced by the funders. Faculty Opinions recommendedReferences - 1. Bradway M, Perestelo-Perez L, Torres-Castano A, et al.: Making "inclusion" more than a buzzword: a critical interpretive synthesis of literature about recruiting seldom-heard groups in health research. PLoS One. 2025; 20(6): e0318466. PubMed Abstract | Publisher Full Text | Free Full Text - 2. Flaskerud JH, Nyamathi AM: Attaining gender and ethnic diversity in health intervention research: cultural responsiveness versus resource provision. ANS Adv Nurs Sci. 2000; 22(4): 1–15. PubMed Abstract | Publisher Full Text - 3. Fisher OJ, Fearnshaw D, Watson NJ, et al.: Promoting equality, diversity and inclusion in research and funding: reflections from a digital manufacturing research network. Res Integr Peer Rev. 2024; 9(1): 5. PubMed Abstract | Publisher Full Text | Free Full Text - 4. 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PubMed Abstract | Publisher Full Text | Free Full Text Author details Author details 1 Psychiatry, University of Oxford, Oxford, England, UK 2 NIHR Oxford Health Biomedical Research Centre, Oxford, England, UK 3 University of Oxford Wadham College, Oxford, England, UK 4 World Psychiatric Association Collaborating Centre, Oxford, England, UK 5 Centre for Psychiatry and Mental Health, Wolfson Institute of Population Health, Queen Mary University of London, London, England, UK 6 Dept of Applied Health Sciences, University of Birmingham, Birmingham, England, UK 7 Nuffield Dept of Primary Care Health Sciences, University of Oxford, Oxford, England, UK 8 Institute for Mental Health, University of Birmingham, Oxford, England, UK 2 NIHR Oxford Health Biomedical Research Centre, Oxford, England, UK 3 University of Oxford Wadham College, Oxford, England, UK 4 World Psychiatric Association Collaborating Centre, Oxford, England, UK 5 Centre for Psychiatry and Mental Health, Wolfson Institute of Population Health, Queen Mary University of London, London, England, UK 6 Dept of Applied Health Sciences, University of Birmingham, Birmingham, England, UK 7 Nuffield Dept of Primary Care Health Sciences, University of Oxford, Oxford, England, UK 8 Institute for Mental Health, University of Birmingham, Oxford, England, UK Kamaldeep Bhui Roles: Conceptualization, Data Curation, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Conceptualization, Data Curation, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Roisin Mooney Roles: Funding Acquisition, Investigation, Project Administration, Resources, Supervision, Writing – Review & Editing Roles: Funding Acquisition, Investigation, Project Administration, Resources, Supervision, Writing – Review & Editing Melissa Stepney Roles: Conceptualization, Investigation, Methodology, Project Administration, Writing – Review & Editing Roles: Conceptualization, Investigation, Methodology, Project Administration, Writing – Review & Editing Kanwal Mand Roles: Conceptualization, Data Curation, Investigation, Methodology, Project Administration, Writing – Review & Editing Roles: Conceptualization, Data Curation, Investigation, Methodology, Project Administration, Writing – Review & Editing Megan Kirk Roles: Conceptualization, Data Curation, Investigation, Methodology, Supervision, Writing – Review & Editing Roles: Conceptualization, Data Curation, Investigation, Methodology, Supervision, Writing – Review & Editing Erin Lawrence Roles: Data Curation, Formal Analysis, Methodology, Project Administration, Writing – Review & Editing Roles: Data Curation, Formal Analysis, Methodology, Project Administration, Writing – Review & Editing Anna Lavis Roles: Conceptualization, Funding Acquisition, Methodology, Project Administration, Supervision, Writing – Review & Editing Roles: Conceptualization, Funding Acquisition, Methodology, Project Administration, Supervision, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information This paper was inspired by research inclusion strategies developed in the design and delivery of the following research projects: ATTUNE funded by UKRI programme on Adolescent Mental Health and the Developing Mind (MR/W002183/1), Co-Pics NIHR Health and Social Care Delivery and Research Panel (NIHR151887), London Interdisciplinary Social Science Doctoral Training Partnership (LISS-DTP) PhD Studentship (grant number ES/P000703/1) ; Oxford Health NIHR BRC’s Developmental and Preventing multimorbidity themes. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Article Versions (2) Copyright © 2025 Bhui K et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. metrics VIEWS $counts.viewCount downloads Citations CITE how to cite this article Bhui K, Mooney R, Stepney M et al. Improving Research Inclusion: learning from NIHR and Research Council funded studies in England [version 1; peer review: 2 approved with reservations, 1 not approved]. NIHR Open Res 2025, 5:102 (https://doi.org/10.3310/nihropenres.14116.1) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. track receive updates on this article Track an article to receive email alerts on any updates to this article. Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions Version 1 VERSION 1 PUBLISHED 16 Oct 2025 Views 0 How to cite this report: Mukwezwa-Tapera R. Reviewer Report For: Improving Research Inclusion: learning from NIHR and Research Council funded studies in England [version 1; peer review: 2 approved with reservations, 1 not approved]. NIHR Open Res 2025, 5:102 (https://doi.org/10.3310/nihropenres.15352.r38841) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/5-102/v1#referee-response-38841 https://openresearch.nihr.ac.uk/articles/5-102/v1#referee-response-38841 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Reviewer Report 28 Jan 2026 Rachel Mukwezwa-Tapera, The University of Auckland, Auckland, Auckland, New Zealand Approved with Reservations VIEWS 0 Thank you for the opportunity to review this very important and timely piece of work that fills a real practice gap in research inclusion, particularly with disadvantaged and ultra-marginalised communities. This paper focuses on what is actually taking place on ... Continue reading I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close Thank you for the opportunity to review this very important and timely piece of work that fills a real practice gap in research inclusion, particularly with disadvantaged and ultra-marginalised communities. This paper focuses on what is actually taking place on the ground, taking into consideration time, trust-building, flexibility, text negotiations, infrastructure barriers, and relational work. This practical systems-level view of inclusion is a major strength that is rarely articulated. The framing of inclusion as a power-and-trust issue is another important aspect highlighted. The checklist provided turns abstract inclusion principles into operational guidance. Even though it's still evolving, it gives research teams something concrete to work with. The insights are valuable, ethically grounded and highly relevant for researchers and funders as well. However, the paper currently reads more like an insightful reflection than a clearly defined synthesis or analytical piece. Strengthening methodological transparency, conceptual clarity, and structure would significantly enhance its contribution and credibility. Definition of RI - An in-depth definition of Research Inclusion (RI), and what it specifically means to the authors in the context of this paper, is not fully clear. Inclusion appears to refer not only to who participates in research but also to who shapes research, whose knowledge counts, and how research processes are adapted to reduce structural and relational barriers. A clearer definition of inclusion would help distinguish between representation, participation, co-design, and institutional change. The authors state that there is little ‘practical information’ on RI, while this is true, perhaps positioning RI in relation to other literature (e.g. participatory/community-based research, co-production/co-creation, trauma-informed research, critical/decolonial/Indigenous methodologies, etc.) would clarify what is distinctive here, avoid the impression of conceptual isolation and strengthen theoretical grounding. Inclusion and equity - Inclusion is closely tied to equity, but the mechanism is not explicitly unpacked. Equity requires adapting research design, resources, and procedures so that those with greater barriers can participate meaningfully. Highlighting how RI contributes to equity by adapting research design, resources and other aspects could be an essential addition. The dimensions of genuine inclusion are implied but not clearly articulated. How do we ensure RI is not consultative or tokenistic? How do we ensure RI addresses epistemic injustice, rebalances power in decision making, improves trust and relevance, and shapes ethical and practical adaptations? It might be helpful to present the core domains thematically and use examples from the studies where possible. (e.g. research team culture, working with lived experience, resources, ethics, trust/power, language and knowledge). Inclusion in research dissemination is not fully explored. If RI is about whose knowledge is valued and who benefits from research, then inclusion should also extend to accessible formats for information sharing, community-based dissemination, and other channels other than academic publication. RI and PPI – there appears to be an overlap between these two; however, there is little conceptual clarification. Is RI about who participates in research? Is PPI about involvement in research design and governance? Is RI and extension or reframing of inclusive PPI? Ethics – The ethics section is excellent and an enjoyable read that raises unresolved governance questions. Where are the boundaries of acceptable flexibility, and who sets them? Who assumes responsibility when deviating from standard protocol? Were any proposed adaptations rejected by ethics bodies (if yes, why?). Including reflections on governance realities would further strengthen this section. Synthesis of the lessons learnt – The process by which this process was done was not sufficiently explained. How were insights gathered from the different studies? Was there any structured reflection, documentation, or analytic process? How were the differing views/perspectives of researchers or partners handled? A brief description of the process undertaken to generate and synthesise learning would strengthen trust in the conclusions. The studies that this paper is based on are quite different; however, the learning is presented as largely universal. Did inclusion challenges/opportunities differ by context/study? Were some recommendations specific to certain designs? Acknowledging both differences and similarities across the studies would make the guidance in this paper more credible and nuanced. What did not work? – Including examples of failed approaches, tensions within teams, missteps with communities, unresolved dilemmas, trade-offs and other messy realities would strongly align with the paper’s reflective aim. Language accessibility – the authors note that language can be exclusionary, and if the article is to have broader accessibility (beyond academic circles) and RI alignment, some of the academic phrasing used requires detailed explanation (e.g., terms such as epistemic injustice, procedural justice, intersectional vulnerabilities, helicopter research, reflexivity). This creates a tension between argument and form. Limits of generalisation – Are the lessons primarily relevant to UK NIHR contexts? How applicable are they to tightly regulated trials? What resource assumptions underlie the recommendations provided? If working with communities with different cultures, languages, and religions, how do you ensure RI and manage conflicts? Implications – what are the implications of RI for researchers, funders, ethics committees, and institutions? The checklist is an amazing tool; however, it is not clear how the items were generated. Were these the only items generated, or were there others? If there were others, detail how and why they didn’t make it to the final checklist. Why were only 5 young people consulted for the ranking? Was that the response you were looking for, or was it lower than expected? Would the intersecting attributes of the people involved in the research affect how the ranking is done? What does the ranking represent (priority, feasibility, importance, etc)? Do teams get to rank as they see fit for their situations? If not, the ranking on the checklist might be misleading in my view, as different teams and contexts are likely to have very different requirements; e.g., ensuring adequate resources might be a higher priority for some research teams with an ongoing/strong relationship with their communities. Providing clarity on the checklist's development process and the intended future testing could be helpful to readers. Thanks again for the opportunity to read your work. I hope you will find my input useful. All the best. Definition of RI - An in-depth definition of Research Inclusion (RI), and what it specifically means to the authors in the context of this paper, is not fully clear. Inclusion appears to refer not only to who participates in research but also to who shapes research, whose knowledge counts, and how research processes are adapted to reduce structural and relational barriers. A clearer definition of inclusion would help distinguish between representation, participation, co-design, and institutional change. The authors state that there is little ‘practical information’ on RI, while this is true, perhaps positioning RI in relation to other literature (e.g. participatory/community-based research, co-production/co-creation, trauma-informed research, critical/decolonial/Indigenous methodologies, etc.) would clarify what is distinctive here, avoid the impression of conceptual isolation and strengthen theoretical grounding. Inclusion and equity - Inclusion is closely tied to equity, but the mechanism is not explicitly unpacked. Equity requires adapting research design, resources, and procedures so that those with greater barriers can participate meaningfully. Highlighting how RI contributes to equity by adapting research design, resources and other aspects could be an essential addition. The dimensions of genuine inclusion are implied but not clearly articulated. How do we ensure RI is not consultative or tokenistic? How do we ensure RI addresses epistemic injustice, rebalances power in decision making, improves trust and relevance, and shapes ethical and practical adaptations? It might be helpful to present the core domains thematically and use examples from the studies where possible. (e.g. research team culture, working with lived experience, resources, ethics, trust/power, language and knowledge). Inclusion in research dissemination is not fully explored. If RI is about whose knowledge is valued and who benefits from research, then inclusion should also extend to accessible formats for information sharing, community-based dissemination, and other channels other than academic publication. RI and PPI – there appears to be an overlap between these two; however, there is little conceptual clarification. Is RI about who participates in research? Is PPI about involvement in research design and governance? Is RI and extension or reframing of inclusive PPI? Ethics – The ethics section is excellent and an enjoyable read that raises unresolved governance questions. Where are the boundaries of acceptable flexibility, and who sets them? Who assumes responsibility when deviating from standard protocol? Were any proposed adaptations rejected by ethics bodies (if yes, why?). Including reflections on governance realities would further strengthen this section. Synthesis of the lessons learnt – The process by which this process was done was not sufficiently explained. How were insights gathered from the different studies? Was there any structured reflection, documentation, or analytic process? How were the differing views/perspectives of researchers or partners handled? A brief description of the process undertaken to generate and synthesise learning would strengthen trust in the conclusions. The studies that this paper is based on are quite different; however, the learning is presented as largely universal. Did inclusion challenges/opportunities differ by context/study? Were some recommendations specific to certain designs? Acknowledging both differences and similarities across the studies would make the guidance in this paper more credible and nuanced. What did not work? – Including examples of failed approaches, tensions within teams, missteps with communities, unresolved dilemmas, trade-offs and other messy realities would strongly align with the paper’s reflective aim. Language accessibility – the authors note that language can be exclusionary, and if the article is to have broader accessibility (beyond academic circles) and RI alignment, some of the academic phrasing used requires detailed explanation (e.g., terms such as epistemic injustice, procedural justice, intersectional vulnerabilities, helicopter research, reflexivity). This creates a tension between argument and form. Limits of generalisation – Are the lessons primarily relevant to UK NIHR contexts? How applicable are they to tightly regulated trials? What resource assumptions underlie the recommendations provided? If working with communities with different cultures, languages, and religions, how do you ensure RI and manage conflicts? Implications – what are the implications of RI for researchers, funders, ethics committees, and institutions? The checklist is an amazing tool; however, it is not clear how the items were generated. Were these the only items generated, or were there others? If there were others, detail how and why they didn’t make it to the final checklist. Why were only 5 young people consulted for the ranking? Was that the response you were looking for, or was it lower than expected? Would the intersecting attributes of the people involved in the research affect how the ranking is done? What does the ranking represent (priority, feasibility, importance, etc)? Do teams get to rank as they see fit for their situations? If not, the ranking on the checklist might be misleading in my view, as different teams and contexts are likely to have very different requirements; e.g., ensuring adequate resources might be a higher priority for some research teams with an ongoing/strong relationship with their communities. Providing clarity on the checklist's development process and the intended future testing could be helpful to readers. Thanks again for the opportunity to read your work. I hope you will find my input useful. All the best. - Is the topic of the review discussed comprehensively in the context of the current literature? Partly - Are all factual statements correct and adequately supported by citations? Partly - Is the review written in accessible language? Partly - Are the conclusions drawn appropriate in the context of the current research literature? Partly Competing Interests: No competing interests were disclosed. Reviewer Expertise: Inclusive Research. Indigenous Theories and Methodologies. Decolonial Approaches. Research Approaches with diverse communities. CITE HOW TO CITE THIS REPORT Mukwezwa-Tapera R. Reviewer Report For: Improving Research Inclusion: learning from NIHR and Research Council funded studies in England [version 1; peer review: 2 approved with reservations, 1 not approved]. NIHR Open Res 2025, 5:102 (https://doi.org/10.3310/nihropenres.15352.r38841) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/5-102/v1#referee-response-38841 https://openresearch.nihr.ac.uk/articles/5-102/v1#referee-response-38841 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. Views 0 How to cite this report: Gidlow C. Reviewer Report For: Improving Research Inclusion: learning from NIHR and Research Council funded studies in England [version 1; peer review: 2 approved with reservations, 1 not approved]. NIHR Open Res 2025, 5:102 (https://doi.org/10.3310/nihropenres.15352.r38341) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/5-102/v1#referee-response-38341 https://openresearch.nihr.ac.uk/articles/5-102/v1#referee-response-38341 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Reviewer Report 10 Jan 2026 Approved with Reservations VIEWS 0 The authors present an insightful and helpful reflection on research inclusion (RI) by drawing on experiences from four funded studies that worked with often marginalised groups. It is a very accessible article and identifies some important messages for researchers, ethics ... Continue reading 2. Karran E, Cashin A, Barker T, Boyd M, et al.: Using PROGRESS-plus to identify current approaches to the collection and reporting of equity-relevant data: a scoping review. Journal of Clinical Epidemiology. 2023; 163: 70-78 Publisher Full Text 3. J, Kavanagh S, Oliver: Reflections on developing and using PROGRESS-Plus. https://www.researchgate.net/publication/285979865_Reflections_on_developing_and_using_PROGRESS-Plus. 2008. I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close The authors present an insightful and helpful reflection on research inclusion (RI) by drawing on experiences from four funded studies that worked with often marginalised groups. It is a very accessible article and identifies some important messages for researchers, ethics committees, funders, and commissioners. I very much like the recommendations and checklist. 1. Type of article. It would be helpful to be explicit about what type of article this is. In the Abstract it is described as a ‘synthesis of lessons learned’ and in the Background, as ‘an overview of RI approaches and considerations that we discovered and iteratively addressed before and during the studies… observations were derived through deliberations within our research teams, our advisory boards, our PPI groups, and in the research design.’ It has the feel of a commentary based on the collective experiences, rather than a synthesis, as there is no information about the methods through which the experiences were brought together/synthesised to generate the key learning points (aside from the panel of 5 young people to rank the checklist items). My suggestion would be to increase the clarity on what sort of article this is and if possible, add more detail on how these experiences were collated. 2. Plain English summary. Ironically, given the topic of the paper, this is the weakest part. There is some content that is too academic in tone/language, some sentences that are poorly written, and there are some errors. A thorough proofread and input from a public member are recommended. 3. More detail on PPIE in four studies (p4). I understand that the purpose is not to present the approaches used in the four underpinning studies, but a table or similar that summarised the PPIE methods used in each would be helpful to show some specific examples and demonstrate the range. 4. In the background, it might be helpful to also point readers towards the extensive literature and guidance around reporting of subgroups for equity. E.g., Hollands, G. J.; South, E.; Shemilt, I.; Oliver, S.; Thomas, J.; Sowden, A. J., Methods used to conceptualize dimensions of health equity impacts of public health interventions in systematic reviews. Journal of Clinical Epidemiology 2024, 169, 111312. (Ref 1) Karran, E. L.; Cashin, A. G.; Barker, T.; Boyd, M. A.; Chiarotto, A.; Dewidar, O.; Mohabir, V.; Petkovic, J.; Sharma, S.; Tejani, S.; Tugwell, P.; Moseley, G. L., Using PROGRESS-plus to identify current approaches to the collection and reporting of equity-relevant data: a scoping review. Journal of Clinical Epidemiology 2023, 163, 70-78. (Ref 2) Kavanaugh, J.; Oliver, S.; Lorenc, T., Reflections on developing and using PROGRESS-Plus Equity Update. Equity Update: Cochrane Health Equity Methods Group 2008, 2, (2), 1-3. (Ref 3) Discussion/analysis. Page 8 – one potential recommendation, which I do not think I saw explicitly (apologies if I missed it), is to work with intermediary organisations that specialise in working with the target group. Researchers are often not well placed or equipped to identify, approach, recruit or perhaps speak with some individuals. Building in time and resource to partner with those organisations, perhaps paying for their staff time to recruit, facilitate data collection, etc. can be critical to reach groups and ensure that their voices are heard. 1. Type of article. It would be helpful to be explicit about what type of article this is. In the Abstract it is described as a ‘synthesis of lessons learned’ and in the Background, as ‘an overview of RI approaches and considerations that we discovered and iteratively addressed before and during the studies… observations were derived through deliberations within our research teams, our advisory boards, our PPI groups, and in the research design.’ It has the feel of a commentary based on the collective experiences, rather than a synthesis, as there is no information about the methods through which the experiences were brought together/synthesised to generate the key learning points (aside from the panel of 5 young people to rank the checklist items). My suggestion would be to increase the clarity on what sort of article this is and if possible, add more detail on how these experiences were collated. 2. Plain English summary. Ironically, given the topic of the paper, this is the weakest part. There is some content that is too academic in tone/language, some sentences that are poorly written, and there are some errors. A thorough proofread and input from a public member are recommended. 3. More detail on PPIE in four studies (p4). I understand that the purpose is not to present the approaches used in the four underpinning studies, but a table or similar that summarised the PPIE methods used in each would be helpful to show some specific examples and demonstrate the range. 4. In the background, it might be helpful to also point readers towards the extensive literature and guidance around reporting of subgroups for equity. E.g., Hollands, G. J.; South, E.; Shemilt, I.; Oliver, S.; Thomas, J.; Sowden, A. J., Methods used to conceptualize dimensions of health equity impacts of public health interventions in systematic reviews. Journal of Clinical Epidemiology 2024, 169, 111312. (Ref 1) Karran, E. L.; Cashin, A. G.; Barker, T.; Boyd, M. A.; Chiarotto, A.; Dewidar, O.; Mohabir, V.; Petkovic, J.; Sharma, S.; Tejani, S.; Tugwell, P.; Moseley, G. L., Using PROGRESS-plus to identify current approaches to the collection and reporting of equity-relevant data: a scoping review. Journal of Clinical Epidemiology 2023, 163, 70-78. (Ref 2) Kavanaugh, J.; Oliver, S.; Lorenc, T., Reflections on developing and using PROGRESS-Plus Equity Update. Equity Update: Cochrane Health Equity Methods Group 2008, 2, (2), 1-3. (Ref 3) Discussion/analysis. - Under the first two subheadings, an example or two from the underpinning studies would help to illustrate the suggestions; i.e., how you achieved these in a specific context. - Page 5 – when discussing the benefits of co-design that brings together the designers/deliverers and intended recipients of an intervention/public. Would another potential benefit be breaking down barriers and potentially unhelpful perceptions, and allowing stakeholders to become used to working with and hearing from the target group, which all serves to address the power imbalance? - Page 6 – ethical issues. I agree with everything written here. Current traditional processes are well-intentioned but often inappropriate in the types of settings you are working in. The recommendations do refer to ethics (under ‘Protocol drive research…’) but I wonder if this warrants its own bullet point to make a very specific and targeted point that researchers can use when making the case to ethics committees for flexible and proportionate approaches to working with some groups. Page 8 – one potential recommendation, which I do not think I saw explicitly (apologies if I missed it), is to work with intermediary organisations that specialise in working with the target group. Researchers are often not well placed or equipped to identify, approach, recruit or perhaps speak with some individuals. Building in time and resource to partner with those organisations, perhaps paying for their staff time to recruit, facilitate data collection, etc. can be critical to reach groups and ensure that their voices are heard. - Is the topic of the review discussed comprehensively in the context of the current literature? Yes - Are all factual statements correct and adequately supported by citations? Yes - Is the review written in accessible language? Yes - Are the conclusions drawn appropriate in the context of the current research literature? Yes

1. Hollands G, South E, Shemilt I, Oliver S, et al.: Methods used to conceptualize dimensions of health equity impacts of public health interventions in systematic reviews. Journal of Clinical Epidemiology. 2024; 169. Publisher Full Text2. Karran E, Cashin A, Barker T, Boyd M, et al.: Using PROGRESS-plus to identify current approaches to the collection and reporting of equity-relevant data: a scoping review. Journal of Clinical Epidemiology. 2023; 163: 70-78 Publisher Full Text 3. J, Kavanagh S, Oliver: Reflections on developing and using PROGRESS-Plus. https://www.researchgate.net/publication/285979865_Reflections_on_developing_and_using_PROGRESS-Plus. 2008. Competing Interests: No competing interests were disclosed. Reviewer Expertise: Health inequalities, multiple disadvantage CITE HOW TO CITE THIS REPORT Gidlow C. Reviewer Report For: Improving Research Inclusion: learning from NIHR and Research Council funded studies in England [version 1; peer review: 2 approved with reservations, 1 not approved]. NIHR Open Res 2025, 5:102 (https://doi.org/10.3310/nihropenres.15352.r38341) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/5-102/v1#referee-response-38341 https://openresearch.nihr.ac.uk/articles/5-102/v1#referee-response-38341 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. Views 0 How to cite this report: Kara H. Reviewer Report For: Improving Research Inclusion: learning from NIHR and Research Council funded studies in England [version 1; peer review: 2 approved with reservations, 1 not approved]. NIHR Open Res 2025, 5:102 (https://doi.org/10.3310/nihropenres.15352.r37861) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/5-102/v1#referee-response-37861 https://openresearch.nihr.ac.uk/articles/5-102/v1#referee-response-37861 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Reviewer Report 23 Dec 2025 Helen Kara, We Research It Ltd, Uttoxeter, UK Not Approved VIEWS 0 The article sets out to make recommendations for research inclusion based on learning from the recruitment phases of four PPI projects. Research inclusion itself is laudable, as is sharing learning at the earliest possible stage. However, I think there is ... Continue reading I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above. Close The article sets out to make recommendations for research inclusion based on learning from the recruitment phases of four PPI projects. Research inclusion itself is laudable, as is sharing learning at the earliest possible stage. However, I think there is more to be done to make this article truly beneficial. The authors assert that there is little practical information for researchers on how to do research inclusion. Under this specific term, they are correct. However, there are sizeable bodies of literature on approaches that are very closely related: participatory methods of various kinds, community-based research, co-production, co-creation, trauma-informed research, and so on – including their use in health settings and/or to investigate health-related topics. Many of these sources include practical information on how to implement the approaches they describe. These may well chime with the suggestions made in the article. I recommend that the authors familiarize themselves with these literatures and situate their work accordingly. What does research inclusion in health settings have in common with these other approaches? Are there specific features of research inclusion in health settings that make it different from related approaches? Here are some suggested starting points: https://www.annfammed.org/content/8/3/256.short https://journals.lww.com/EDHE/abstract/2001/14020/Community_based_Participatory_Research__Policy.6.aspx https://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.2001403 https://www.tandfonline.com/doi/abs/10.1080/14719037.2014.881539 https://www.tandfonline.com/doi/abs/10.1080/14780887.2022.2107967 As far as I can tell, all factual statements are correct; they certainly seem to be, but I have no way of checking because many are not supported by citations. The article is quite lightly referenced, which isn’t necessarily a problem, but if (as the peer review report form suggests) NIHR Open Research policy is for all factual statements to be adequately supported by citations, I do not think the authors have complied. That said, it is clear that some of the points they make are derived from the experiences of people involved in participant recruitment, so citations, as such, would not be appropriate for those points. However, the article jumps from ‘background’ to ‘discussion and analysis’ without any explanation of what happened in between. I take the point that the authors don’t want to give a full report of all the PPI arrangements, and I don’t think such a report is necessary. But they could report on how they gathered and analyzed data from people’s experiences, with some systematically selected illustrative quotes, which would help readers understand how the authors arrived at the conclusions they have drawn. Some of the language used is accessible. There is a plain language summary, which is helpful, though it is not very well written. There are several over-long sentences. The Plain English Campaign recommends 20 words as a general maximum sentence length and 25 words as an absolute maximum. This sentence is 50 words long: “This occurs if their complex health problems and social situations prevent them from following the procedures by which people are recruited into research; they may have more immediate social and health care needs, or their complex conditions may be the basis of exclusion if researchers are studying a single condition.” And it is not very clear what this sentence means. The summary could be a lot plainer and clearer without being dumbed down. Also, there are a number of grammatical errors and typos which need to be fixed, such as “…the Nation Institute of Health Research” (actually the National Institute for Health and Care Research, when written out in full). I would recommend consulting the Plain English Campaign’s website for guidance. I would also recommend reading a final draft of the summary aloud, to help identify any further changes that need to be made. In the body of the article, the authors acknowledge that “Esoteric or technical language… can act as a barrier to inclusion,” but they use such language regularly. Is it only researchers, or at least those who can follow technical research language, who get to find out how to improve research inclusion? Because that seems quite exclusive and therefore contradictory. Also, NIHR’s Open Research is intended to “enable others to build upon new ideas right away, wherever and whoever they are.” This suggests that materials on the platform need to be written in such a way that they could be used by research participants and the general public as well as academics and medical professionals. This article is not currently written in such a way, but it could be – and, in my view, it should be. In terms of the conclusions, I have chosen ‘partly’ as it’s difficult to tell whether the conclusions are appropriate in the context of the current research literature. This is because – as outlined above – so little of the relevant literature has been cited. I think the current version forms the basis of a useful article. I hope this review will help the authors. I am required to decide whether I think this article is scientifically valid. I don't think that is an appropriate criterion for this article. My actual view is that the article is good as far as it goes, but it doesn't go far enough, and it needs to be written better. This is a qualitative judgement not a scientific judgement. The authors assert that there is little practical information for researchers on how to do research inclusion. Under this specific term, they are correct. However, there are sizeable bodies of literature on approaches that are very closely related: participatory methods of various kinds, community-based research, co-production, co-creation, trauma-informed research, and so on – including their use in health settings and/or to investigate health-related topics. Many of these sources include practical information on how to implement the approaches they describe. These may well chime with the suggestions made in the article. I recommend that the authors familiarize themselves with these literatures and situate their work accordingly. What does research inclusion in health settings have in common with these other approaches? Are there specific features of research inclusion in health settings that make it different from related approaches? Here are some suggested starting points: https://www.annfammed.org/content/8/3/256.short https://journals.lww.com/EDHE/abstract/2001/14020/Community_based_Participatory_Research__Policy.6.aspx https://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.2001403 https://www.tandfonline.com/doi/abs/10.1080/14719037.2014.881539 https://www.tandfonline.com/doi/abs/10.1080/14780887.2022.2107967 As far as I can tell, all factual statements are correct; they certainly seem to be, but I have no way of checking because many are not supported by citations. The article is quite lightly referenced, which isn’t necessarily a problem, but if (as the peer review report form suggests) NIHR Open Research policy is for all factual statements to be adequately supported by citations, I do not think the authors have complied. That said, it is clear that some of the points they make are derived from the experiences of people involved in participant recruitment, so citations, as such, would not be appropriate for those points. However, the article jumps from ‘background’ to ‘discussion and analysis’ without any explanation of what happened in between. I take the point that the authors don’t want to give a full report of all the PPI arrangements, and I don’t think such a report is necessary. But they could report on how they gathered and analyzed data from people’s experiences, with some systematically selected illustrative quotes, which would help readers understand how the authors arrived at the conclusions they have drawn. Some of the language used is accessible. There is a plain language summary, which is helpful, though it is not very well written. There are several over-long sentences. The Plain English Campaign recommends 20 words as a general maximum sentence length and 25 words as an absolute maximum. This sentence is 50 words long: “This occurs if their complex health problems and social situations prevent them from following the procedures by which people are recruited into research; they may have more immediate social and health care needs, or their complex conditions may be the basis of exclusion if researchers are studying a single condition.” And it is not very clear what this sentence means. The summary could be a lot plainer and clearer without being dumbed down. Also, there are a number of grammatical errors and typos which need to be fixed, such as “…the Nation Institute of Health Research” (actually the National Institute for Health and Care Research, when written out in full). I would recommend consulting the Plain English Campaign’s website for guidance. I would also recommend reading a final draft of the summary aloud, to help identify any further changes that need to be made. In the body of the article, the authors acknowledge that “Esoteric or technical language… can act as a barrier to inclusion,” but they use such language regularly. Is it only researchers, or at least those who can follow technical research language, who get to find out how to improve research inclusion? Because that seems quite exclusive and therefore contradictory. Also, NIHR’s Open Research is intended to “enable others to build upon new ideas right away, wherever and whoever they are.” This suggests that materials on the platform need to be written in such a way that they could be used by research participants and the general public as well as academics and medical professionals. This article is not currently written in such a way, but it could be – and, in my view, it should be. In terms of the conclusions, I have chosen ‘partly’ as it’s difficult to tell whether the conclusions are appropriate in the context of the current research literature. This is because – as outlined above – so little of the relevant literature has been cited. I think the current version forms the basis of a useful article. I hope this review will help the authors. I am required to decide whether I think this article is scientifically valid. I don't think that is an appropriate criterion for this article. My actual view is that the article is good as far as it goes, but it doesn't go far enough, and it needs to be written better. This is a qualitative judgement not a scientific judgement. - Is the topic of the review discussed comprehensively in the context of the current literature? No - Are all factual statements correct and adequately supported by citations? Partly - Is the review written in accessible language? Partly - Are the conclusions drawn appropriate in the context of the current research literature? Partly Competing Interests: No competing interests were disclosed. Reviewer Expertise: Creative research methods including participatory/co-produced/co-created/trauma-informed etc. Research ethics. Health and social care. CITE HOW TO CITE THIS REPORT Kara H. Reviewer Report For: Improving Research Inclusion: learning from NIHR and Research Council funded studies in England [version 1; peer review: 2 approved with reservations, 1 not approved]. NIHR Open Res 2025, 5:102 (https://doi.org/10.3310/nihropenres.15352.r37861) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/5-102/v1#referee-response-37861 https://openresearch.nihr.ac.uk/articles/5-102/v1#referee-response-37861 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. Alongside their report, reviewers assign a status to the article: - Approved - Approved with reservations - Not approved | Invited Reviewers | ||| |---|---|---|---| | 1 | 2 | 3 | | | Version 2 (revision) 14 May 26 | ||| | Version 1 16 Oct 25 | read | read | read | Sign up for content alerts You are now signed up to receive this alert Alongside their report, reviewers assign a status to the article: Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions Provide sufficient details of any financial or non-financial competing interests to enable users to assess whether your comments might lead a reasonable person to question your impartiality. 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