Health research projects can be complex challenges for those who undertake them and include substantial work that is not, in itself, a part of the scientific discipline. This work relates to the ever-evolving requirements of legislation, administration, and secure IT facilities, and the tasks can prove to be a significant barrier for researchers with inadequate access to research infrastructure and resources. Additionally, inappropriately applied study designs or statistical methods may result in studies which add little value to their field, but these issues may be avoidable if the necessary infrastructure and support is available. The aim of this paper is to describe the structure of a research support unit in the Region of Southern Denmark and how the unit has grown over time, followed by a discussion addressing challenges which may arise when building such research infrastructure.

This paper presents a descriptive case on the structure of the research support unit OPEN (Open Patient data Explorative Network). It outlines the establishment, growth, and challenges through semi-structured interviews with founders and users of OPEN, user experience surveys, internal and official documents, and internal database reports on projects that have used or are going to use OPEN’s facilities.

OPEN was established in 2008 to support researchers in collecting and storing data and biological material from research projects, and has since evolved and grown, providing support and infrastructure in nearly all aspects of the research process, and continuously adapting to meet the changing needs of the researchers. From 2008 to 2022, a total of 1814 health research projects have received support from OPEN, with 255 of these being admitted as new projects in 2022. User satisfaction surveys and interviews showed high levels of satisfaction in support and services, but also highlighted areas of infrastructure which can be developed further.

OPEN has experienced significant growth since it was founded, evolving into a one-stop shop for research support. A flexible framework and agile adaptation to user needs have been important factors in this expansion. The challenges and successes of this process may inspire others working with health administration and research infrastructure.

Behind each health research project and published scientific paper, there is a substantial amount of related work that, in itself, is not part of the scientific discipline. These derived tasks often relate to legislation and secure IT facilities for collecting, processing, analysing, and storing data, whether it is laboratory data, clinical data, or register data. This substantial work can often be a barrier to health care professionals who have highly relevant research ideas but little research infrastructure around them and inadequate knowledge about these aspects of the research process [1,2,3].

Researchers’ lack of in-depth knowledge about study methodology or statistics can also lead to waste in research, which is a well-documented problem [4,5,6]. Inappropriate study designs, incorrectly applied statistical methods, and poor reporting of results can result in research that remains unpublished or adds little value [4, 7, 8]. Many of these issues may be correctable through access to the necessary research infrastructure and expertise, including statisticians, methodologists, and specialists in research legislation and processes [7,8,9]. Support from health research specialists during a project could thus improve the quality of the research and increase health research capacity at both individual and group level [9, 10], and possibly reduce waste in research [1, 3, 11].

The major reform of the Danish public sector in 2007 [12] led to greater focus on conducting high-quality research in the hospital sector [12, 13]. At Odense University Hospital (OUH) in the Region of Southern Denmark, it was decided to strengthen the research profile at the hospital by establishing a research support unit—the Open Patient data Explorative Network, or OPEN [13]. The aim of the unit was two-fold. Firstly, to support the clinical researchers in collecting and storing the patient data and biological material from research projects, and secondly, to create new possibilities for collaboration with other Danish researchers and foreign researchers [13].

Since then, the facilities and services offered by OPEN have grown to cover nearly all aspects of the research process, and the unit now supports health researchers at hospitals throughout the Region of Southern Denmark. This success brings challenges too, however, such as ensuring continuity in funding and commitment from key stakeholders, ensuring the availability of a highly experienced staff with a wide range of expertise, and assessing the impact that the research support unit makes to health research in the Region.

There is no set definition of what constitutes “research support”, and it can take many forms, e.g. funding aid [14] or clinical research support in the form of protocol development or trial supervision [15]. This complexity of research support is recognised by the RM Roadmap project funded by the European Commission. In this project, which OPEN is participating in, a pan-European community of research management excellence is coming together over three years to define a roadmap for the profession [16].

It is likely that other health research environments could benefit from having the sort of research support that OPEN offers, but institutions may be uncertain of how to establish such services and the organisation required behind them.

The aim of this paper is to describe the structure of the OPEN research support unit in the Region of Southern Denmark and how its facilities and services have grown to cater for an array of needs of health researchers. We provide examples of the types of projects that OPEN supports as well as the options for collaboration with researchers in the hospitals and university. We present the results of user experience surveys, and discuss factors that have contributed to the success of the unit as well as challenges for the future.

This descriptive case on a research support unit draws on multiple data sources and methods - including author involvement, interviews, surveys, and internal systems, documents, and databases - to provide insights into the structure and growth of OPEN.

Author involvement

The authors of this paper have different roles in OPEN and varying levels of seniority. Two authors have a high level of seniority within OPEN and were closely involved in its development. One author has been with the OPEN research support unit since its establishment, and another has been employed at OPEN for ten years. They each contribute with knowledge of the development, organisational structures, and services/facilities of OPEN.

Interviews

For the purposes of this paper, semi-structured interviews were conducted with two of the founders of OPEN, Torben Barington and Kim Brixen (interview guide in supplemental material S1), and a focus group interview (interview guide in supplemental material S2) was held with two users of OPEN. This included a new user with limited experience of the research support unit, and a researcher who has been a long-time user of OPEN’s facilities. The participants for the focus group interview were found by approaching researchers with different levels of research experience from the hospitals in the region, who had all used some of OPENs services.

User experience surveys

In the fall of 2022, OPEN began measuring user experience and proactively asking users whether OPEN’s admission meeting met their expectations, to gauge user needs early in the research process and identify areas of improvement. The survey only relates to the initial process, admission meeting, and advice, so the results cannot be extended to all of OPEN’s facilities and services (The survey is included in supplementary material S3: Researcher satisfaction survey). The data included in this paper were collected from November 1 st, 2022 to October 31 st, 2023. In this period, 234 project admission meetings with 356 researchers were held, and all researchers received a questionnaire regarding their experience in that specific project admission meeting. Of those, 107 returned the questionnaire, resulting in a response rate of 30%. It was voluntary to respond to the questionnaire, and no reminders were sent to users who had not responded. It is possible for a researcher to have received and returned a questionnaire more than once if they attended multiple project admission meetings during the period.

Internal systems, documents, and databases

Factual data, such as the number of publications from OUH and projects admitted to the OPEN research support unit in the years since OPEN was established, were extracted from the University of Southern Denmark’s (SDU) research information management system, PURE (PUblication and REsearch), and OPEN’s internal administrative database system.

Also, we have examined the original documents relating to the decision regarding the establishment of OPEN, in particular the research strategy from 2007 [13] and documents following, e.g. minutes from the meetings of board of directors of OUH and the composition of and mandate to the steering committee of OPEN.

Furthermore, to illustrate the types of research that OPEN supports, we present three cases of research projects using OPEN’s facilities and services (Table 1).

The establishment of the OPEN research support unit was closely related to the national plan for specialised hospital services [13], in which the Danish Health Authority, in collaboration with medical associations and the five Danish Regions, granted the highly specialised health care functions among Danish hospitals following an application process. The aim of this national plan was to enhance quality through centralisation and continuity of care while ensuring efficient resource utilisation. Research activities were stipulated as a prerequisite for providing highly specialised services.

The timeline of OPEN’s organisational and facility milestones is shown in Fig. 1. OPEN was founded with a steering committee under a pre-existing hospital department in 2008, as support infrastructure for researchers at OUH, i.e. researchers affiliated with the Department of Clinical Research, SDU. Its mission was to support and strengthen health research locally.

Timeline of OPEN, depicting organisational and facility milestones. * Refers to infrastructure facilities (i.e. software, databases, servers etc.) available to the projects who receive support from OPEN. Each facility is described in supplementary materials S4: Descriptions of OPEN’s infrastructure facilities. ** Refers to in-person guidance, support, or advice from OPEN employees with expertise in the field. Depending on the extent of guidance needed (i.e. the number of hours), this may fall under the project’s free hours or the project can purchase additional hours of guidance. Large or extensive projects can buy the services of an OPEN employee for one or more days a week. Each guidance facility is described in supplementary materials S5: Descriptions of OPEN’s guidance and support services. *** As part of becoming an independent department in 2021, a formal research unit and research strategy was established. Prior to this, OPEN did not have its own research strategy as this was not a requirement

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In 2018, OPEN extended its services and facilities beyond OUH to serve researchers in the entire Region of Southern Denmark, which encompasses five hospitals, including OUH. This decision was based on the impact of OPEN on the amount and quality of research from OUH and the Department of Clinical Research at SDU. At the same time, OPEN embraced a vision to become the leading research support unit in Denmark. As the research support unit grew and the activity level increased, OPEN became an independent department under OUH in 2021. This expansion also required a formal research unit affiliated with SDU, and so the Research Unit OPEN was established (the organisational chart for OPEN is shown in supplementary figure 1: Organisational chart). Dedicated efforts were made to consolidate the existing pieces into a formal research unit and develop an independent research strategy, which came into effect in 2022. The researchers affiliated with Research Unit OPEN conduct independent research and collaborate with others on research initiatives in a broad range of fields, though primarily within epidemiology, statistics, and qualitative research. Since 2022, OPEN has thus been comprised of two parts – the OPEN research support unit and Research Unit OPEN. For clarity in this paper, OPEN refers to the OPEN research support unit unless otherwise specified.

The OPEN research support unit provides support to researchers and health research projects by offering a broad range of services and facilities. Facilities refer to research infrastructure, such as software, databases or servers, while services refer to in-person guidance, support, or advice researchers receive from OPEN employees. Since it was founded, OPEN has continuously adapted and expanded its portfolio to meet user requests, as reflected in the timeline (Fig. 1). Detailed descriptions of all facilities and services mentioned below are available in supplementary materials S4: Descriptions of OPEN’s infrastructure facilities and S5: Descriptions of OPEN’s guidance and support services.

The first facility offered by OPEN was a database for biological and clinical data, initially referred to as OPEN Projects. In 2011, an online digital randomisation tool was established, to facilitate the randomisation process in multi-site projects. In-depth guidance on research legislation and a more structured project registration followed in 2012, and Research Electronic Data Capture (REDCap) became available in 2013 [17, 18]. OPEN now offers REDCap for clinical research data entry, secure questionnaire distribution, and randomisation of patients. In 2016, a data analysis platform was established in the form of a secure server for data management and analysis. Several programs for data analysis are available on the platform, including STATA [19] and R [20] for analysing quantitative data, and NVivo [21] for analysing qualitative data. Additionally, files connected to specific studies (e.g. consent forms or diagnostic images) can be stored on the server. In 2021, OPEN launched the OPEN Register Database (RDB), a database that contains a selection of the nationwide health register data held by Statistics Denmark. The aim is to facilitate the utilisation of the Danish national health registers by the users of OPEN.

In 2015, an internal quality assurance system was established, as is required by law when assisting clinical trials on drugs and medical equipment. The system mainly consists of standard operating procedures (SOPs) aimed at ensuring that processes and IT infrastructures are secure and compliant with the legislation regulating health research and data protection. The quality system also ensures high quality and compliance with OPENs own standards for services delivered to the researchers.

OPEN provides guidance and advice in a range of methodological and scientific areas. Methodological guidance on register-based research and epidemiology was introduced in 2014, followed by the addition of statistical support in 2016 and qualitative research guidance in 2019.

In 2021, the Good Clinical Practice Unit of the Region of Southern Denmark was merged with OPEN. This unit offers guidance on clinical trials for drugs and medical equipment and monitors the trials in accordance with regulatory demands. A Clinical Trial Unit was established in early 2024, offering extended assistance for clinical trials at OUH.

Alongside the above activities, OPEN offers courses and workshops and has written guides and tutorials on various topics to assist researchers throughout their research processes.

No communication strategy regarding OPEN and its services has been formulated over the years. OPEN has reached out to possible users either by in person communication, such as giving presentations at relevant meetings, workshops, conferences, initiating bilateral meetings with possible users, or by written communication such as webpage of OPEN, the use of the local intranet of the hospitals in the region, mails to local heads of research and most recently the use of LinkedIn.

OPEN prioritizes ethical issues along with data privacy and security highly. No projects are granted access to OPEN’s facilities before they have been individually assessed for which approvals are necessary to conduct the project in accordance with the applicable legislation. Before data collection the necessary approvals for the processing of personal data have to be obtained by the project and sent to OPEN as documentation. All data is stored in OPEN’s systems in accordance with GDPR and the Danish Data Protection Act. Data access requires a personal password and user activities are logged, furthermore all project responsible researchers have to evaluate user access for their project every 6 months. All data platforms are hosted on secure servers in the Region of Southern Denmark and backed up continuously to avoid data loss. Standard Operating Procedures are in place for data restoration and for validation and testing when system updates are required. Additionally, OPEN employs staff who act as gatekeepers to ensure that users do not share or report data that could be personally identifiable from secure platforms that keep register data. If ethical or medical approval is required for the project in accordance with the Danish legislation, these are also obtained by the project and sent to OPEN as documentation prior to data collection on the participants. OPEN continuously advises the researchers on the need for data processing agreements, joint data controller agreements, material transfer agreements, data transfer approvals, ethical approvals, approvals for drug trials etc. OPEN offers to review consent forms and participant information, to ensure that they are understandable and in accordance with the legal requirements.

OPEN assists health researchers of various backgrounds and experience within the Region of Southern Denmark and the Department of Clinical Research, SDU. Thus, OPEN supports researchers at every career stage, from medical students to professors and clinical health professionals, and provides assistance for many types of health research projects. The largest category is projects headed by senior researchers (e.g. associate professors and professors) and clinicians (e.g. nurses, doctors, physiotherapists etc.) comprising 53% of projects admitted. PhD projects comprise 31% of the total project admission and on average, 71 PhD projects are admitted to OPEN each year in order to gain access to OPENs facilities and services. Students working on a master thesis constitute 13%, and post-doctoral researchers head approximately 4% of projects.

New projects are accepted through an initial admission meeting where the needs of the project are discussed. The main focus is on identifying relevant legal issues and assessing which of OPEN’s support facilities would be most beneficial for the project. OPEN rarely declines projects and does not set requirements regarding area of research, topics or methods, but if a project is very simple (e.g. selects data from very few patients with very few variables over a short duration of time), OPEN may suggest other data entry solutions outside its own facilities. OPEN’s only requirement for users is that their research leads to publications in scientific journals or is made public available in other ways, but it is not a requirement that OPEN or its employees are included as co-authors and OPEN follows the International Committee of Medical Journal Editors (ICMJE) recommendations for authorship [22]. OPEN must however be acknowledged in the publications from the projects.

From 2008 to 2022, a total of 1814 projects have used OPEN’s facilities, referred to here as being “admitted” to OPEN. Of these, 1360 were classified as active projects at the end of 2022 (Fig. 2). The projects have required OPEN’s services at different stages. Some projects have run over many years, while others are of shorter duration.

Total number of admitted, active and passive projects in OPEN per year* from 2008 to 2022. * End-of-year total in each category. Admitted: New projects admitted to OPEN between January 1st and December 31st that year. A project may only appear in this category for one year, and is moved to the ‘Active’ category for all subsequent years until it is marked as ‘Passive’. Active: All projects which do not have status ‘Admitted’ or ‘Passive’. There is no limit to how long a project may have the status ‘Active’ and the same project will therefore count towards the ‘Active’ category for multiple years. Passive: Non-active projects. Includes projects that have been withdrawn from OPEN, inactive projects (i.e. abandoned and any data deleted), and completed projects where data is no longer being stored. Once a project has been given status ‘Passive’ it counts towards that category for all subsequent years

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In 2022, 55% of the projects admitted to OPEN included subjects (both human and animal) located in the Region of Southern Denmark (Fig. 3). 10% of projects had study subjects located in more than one Danish region, 25% were national projects, and 6% of the projects included international study subjects. 4% of projects admitted to OPEN in 2022 could not be categorised according the geographical location of study subjects (either human or animal) as the projects did not include individualised data on a real study population, e.g. a theoretical methodology project applying statistical methods to a simulation dataset. The distribution of scientific collaborations (regional, national, or international) is not currently being registered. The opportunities for international cooperation was raised during an interview with Kim Brixen, one of the founders of OPEN, on July 4th 2023, who stated that “the internationalisation potential has not been utilised. …. OPEN has a point of development as a supporting unit. [Internationalisation] wasn’t part of the original thought though”.

Number of projects admitted in 2022 according to the geographical location of the study subjects*. *Study subjects may be either human or animal

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The ambition is that OPEN can offer all researchers the support they need to fulfil and increase their research activities. This requires providing competent guidance that supports high quality research. Therefore, OPEN is staffed by both generalists and specialists with diverse educational backgrounds, professional profiles, and research experience. There is an opportunity for combined employment at both the OPEN research support unit and Research Unit OPEN, allowing support unit staff to conduct their own research. This enables the employee to engage not only in consultancy work but also in research activities and scientific collaboration.

In relation to the expansion of services as seen in Fig. 1, the number of employees in OPEN has increased from three employees in 2008, to 12 in 2018, and 52 in 2023. Most are employed full-time in the research support unit, but some have part-time contracts, e.g. co-employment at SDU or at other hospital departments. Most of OPEN’s employees have worked there for more than 5 years, and 20% have been employed at OPEN for 10–15 years.

OPEN is a part of the Region of Southern Denmark and is therefore a public institution operating on a non-profit basis. OPEN receives an annual grant (financed by taxes) from the Region of Southern Denmark and the five hospital units in the region. The Region of Southern Denmark and the five hospital units are key partners of OPEN and they are directly involved in the decision-making process regarding new initiatives of substantial economic cost and increasing of the grant to OPEN, as this requires their support. Major initiatives or decisions regarding the development of OPEN is discussed and qualified by the steering committee in advance (supplementary figure S1: Organisational chart).

The grant from the Region of Southern Denmark and the five hospital units covers approximately two-thirds of the budget. The remainder of the budget is financed through user fees and other ad hoc external funds. OPEN strives to reach budget balance within each year, and in case of deficit OUH covers the margin. In 2023, the budget was approximately €3,9 million. In comparison, OPENs budget for the first year of operation was €0,13 million. The use of OPEN’s facilities is available to all researchers in the Region of Southern Denmark, and each project admitted to OPEN is granted 30 h of support distributed across all facilities and services free of charge. These 30 h refer to the time OPEN employees spend actively working on the project or offering guidance. Additional hours can be purchased at a not-for-profit price as needed, either as pay-as-you-go consultancy hours or a fixed consultancy, depending on the needs of the project and the users. In a fixed consultancy, a significant number of hours for in-depth work can be allocated to the project, and this is preferred in the case of complex or large-scale tasks. In such cases, a formal agreement is made regarding the period and the percentage of work time per week allocated to the project. This financing model allows for a large degree of flexibility in how researchers can use OPEN’s facilities and support options.

Table 1 presents three examples of projects that use OPEN as a research support unit. The projects vary in terms of study design, data types, and the extent to which they have incorporated OPEN’s facilities into their project workflows. The table also highlights three distinct approaches to collaboration and financing. One project remained within the 30 h of free support and guidance, making it a cost-free collaboration for the project (case 1). The second project (case 2) required additional hours of guidance and support that were procured as the project progressed, leading to a preferred pay-as-you-go consultancy model. The third project (case 3) chose to have an OPEN employee handle the full data management and analysis in each of the sub-studies and consequently established a fixed consultancy payment agreement.

OPEN began surveying user satisfaction on the initial contact in 2022 to identify areas of improvement and user needs, with results revealing a high level of user satisfaction. The survey had 107 respondents in the period November 2022 through October 2023, answering the question: ”To what extent did your project get the advice/support that you needed?” 61% answered to high extent, 38% to very high extent and 4% to some extent (Fig. 4a).

a-c User survey responses from 107 researchers* who participated in project admission meetings conducted between November 2022 and October 2023. * The same researcher may be included more than once if they attended multiple project admission meetings during the period

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Answering the question “How satisfied were you with the quality of counselling at the admission meeting?” The answers were mainly very satisfied or satisfied (94%), and the percentage of neither-nor, dissatisfied, or very dissatisfied amounted to 6% (Fig. 4b). When researchers were asked about the level of service, the vast majority (79%) of users reported they were very satisfied, and approximately one-fifth were satisfied (Fig. 4c).

Reflecting on the relationship between OPEN employees and the researchers, one of the founders commented: “Much has been done to ensure that there is no “customer perspective”. It must be a donation and a collaboration, not an exchange of goods” (Kim Brixen, July 4th 2023).

Additional comments from the user satisfaction survey and focus group interviews have noted that OPEN efficiently informs researchers about the relevant regulations and licenses that projects need to be aware of, and that OPEN “saves us, the researchers, a lot of time” (Focus group interview with Lars Folkestad and Jan Blaarkær, December 15th 2021). Furthermore, the minutes of the initial meeting are e-mailed to the SDU/hospital researchers afterwards, and this practice have been highlighted as a great service. When asked for suggestions for improvements, the users wished for a speedier process regarding the admission meeting and more extensive legal services.

The positive impression of OPEN’s level of service was also recognised in the focus group interview with two users of OPEN. These two users considered the service, quality of advice, and competence of staff at OPEN to be very satisfactory. They felt that they were greeted hospitably and that the service provided was adjusted to the level of experience of the user. When asked whether the use of OPEN helped to promote and strengthen health science research, the researchers agreed that using OPEN’s facilities had improved the quality of their research projects. They felt reassured that they were undertaking legally compliant research and following the relevant legislation: “You know that you are in compliance with the legislation, and you know that the tools you use are set up in a way that is reproducible and usable and understandable to others than those who designed the tool” (Focus group interview with Lars Folkestad and Jan Blaarkær, December 15th 2021).

In the interview, the users expressed satisfaction with the workflow in the OPEN research support unit and appreciated that OPEN refers users to other facilities outside the organisation if the request is outside of OPEN’s scope or area of expertise. Similar views were expressed in the comments from the user satisfaction survey.

The users in the interview had different levels of knowledge about OPEN, but both would prefer more information about the opportunities provided by OPEN’s facilities and services, as well as more visibility in the form of less online information and a more in-person information. The users agreed that knowledge of OPEN, and whether and when you include OPEN in research projects, depended on which hospital you work at in the Region of Southern Denmark. Providing services to all hospital units across the Region of Southern Denmark was also mentioned in the interview with one of OPEN’s founders, who stated that “It is a challenge to make the other hospitals feel that OPEN is theirs too” (Kim Brixen, July 4th 2023).

One of the users in the focus group interview referred to one of the original intentions for OPEN, i.e. namely to have an open source approach where data collected under the auspices of the OPEN research support unit would be made available to other health science researchers in the Region and thus be re-used. The user felt this intention has not been fully met and suggested that the opportunity to share and reuse data should be made clearer to researchers. Similar views were pointed out in the interviews with the founders of OPEN: “We have not promoted the idea of sharing data [collected through OPEN]. It took a few years to get the system working… It is something that we need to do more about. Means of action must be developed” (Focus group interview with Lars Folkestad and Jan Blaarkær, December 15th 2021).

The decision in 2007 by the Board of Directors at OUH to enhance research arising from the hospital and strengthen the research profile through greater funding has increased the number of professors and research units at the hospital. In 2012, OUH had 33 professors, and this number had increased to 119 in 2022 [23]. The hospital has also increased its financial support to PhD projects, and thus the number of PhD students has increased from 178 students in 2012 to 210 students in 2022 [23]. Publications from researchers at OUH have also increased in number, from 616 in 2009 to 1916 in 2022.

Since its establishment in 2008, the OPEN research support unit has continually developed new facilities and expanded its advisory capacity to meet the needs of clinical and health science researchers. OPEN began as a research infrastructure unit for one regional hospital but now supports health research conducted throughout the Region of Southern Denmark and has recently established its own research unit. This development reflects the growth in health research activity in the Region of Southern Denmark and the increased demands for registration and regulation in relation to clinical trials [24].

The growth of OPEN has occurred alongside increased research activity in the Region of Southern Denmark, evidenced by the increasing number of publications and researchers. It is uncertain how much of this growth is directly attributable to OPEN’s facilities and how much is attributable to services such as additional research funding, medical writing assistance, and other incentives which have also been introduced since 2007. However, the extensive increase in the use of OPEN’s facilities by researchers and the high levels of satisfaction reported by OPEN’s users who returned our satisfaction survey indicate that OPEN has contributed positively to the development of research in the region and possibly to reducing waste in research. To further assess the issue of waste in research, we currently in OPEN have a Ph.D. project that is dedicated to investigate the issue of waste in research at OUH. The purpose is to explore how Lean methodologies can increase research quality in clinical research by eliminating errors in the research processes. Results from this project are expected in 2025 [25].

Only a few scientific publications address experiences in establishing, structuring, and expanding research support units, making it pertinent for us to share our experiences [10, 15]. Based on literature search OPEN’s variety and flexibility of fee-free services compared to other research support units may appear to be unique, however, we do know of other northern European research support units which provide a not identical but somewhat similar broad range of services as OPEN supporting a variety of study types and designs [26,27,28,29]. They vary in respect to structure, facilities, and level of support but share a common aim of meeting the increasing demands in the research landscape. Generally, health research support services appear to be more common in the field of clinical trials, often as clinical trial units (CTUs) [10, 15, 30], though some may have a wider range of services, e.g. biobanks services or statistical advice [31,32,33].

Based on our findings the topic of health research support units is likely poorly reported in the literature, which might also reflect that research management is not yet fully defined as mentioned in the introduction section regarding the “RM Roadmap” project [16]. This project is working on defining research management across Europe and has created a working group specifically regarding research infrastructure as the definition of and services provided regarding research management is unclear.

While the structure established with OPEN might not be fully transferable and replicable to all other hospital research contexts, the actual services provided and the one-stop-shop approach could be relevant in many contexts. This being said we realise that the success of creating such an organisation also rests on dependable, foreseeable funding, organisation at hospital level and culture of cooperation between university and hospital.

An essential factor contributing to OPEN’s success is its experienced employees, who have a range of professional backgrounds and can provide support across the diverse aspects of health research projects. Many of OPEN’s employees have a background in research or are actively engaged in research themselves, while others have a technical or non-academic background. This professional variety fosters a collaborative and open environment that is free from rigid hierarchies, which greatly facilitates knowledge sharing and innovation for researchers seeking assistance. Centralisation of knowledge and expertise within an organisation such as OPEN may in some contexts be a cost-effective solution, as high-quality professional guidance allows researchers to focus on their core tasks. Users of OPEN consider the diversity of services to be an important characteristic, not only to remove obstacles in the research process but also to ensure that the research is conducted in accordance with current legislation.

OPEN’s close collaboration with the university yields numerous advantages. It enables employees to have joint positions in the two organisations and to have a dual role encompassing both operational and research activities. This synergy promotes efficient use of resources and expertise. SDU is also pivotal in promoting OPEN’s facilities to researchers.

One of the strengths of OPEN’s setup is the flexibility in adapting the levels of assistance to the researchers’ specific needs. As seen in Fig. 1, OPEN has continually expanded to offer more services and facilities, and most of these were developed in direct response to user needs. For this approach to be feasible, however, the researchers must be able to precisely define the task or issue they want assistance with, and then must supply the relevant data and information in the agreed-upon format and quality. Additionally, the researchers need to be available throughout the process to address any clarifications needed for task completion.

A part of OPENs success has been that the development of services in OPEN has been quite organic, based on the local needs of the researchers and targeted at known gaps and lacks within the research support services in the Region of Southern Denmark and SDU. The capability to adjust the services available to researchers fairly easily has made it possible to respond to the requirements of the researchers fast.

OPEN has continually expanded the facilities and services it offers and has formally established its own research unit in 2022. As OPEN was established as a novel service, there have so far been few struggles about what form the research support unit should take and what approaches should be used. OPEN is reliant on key decision-makers and financial contributors, particularly the Region of Southern Denmark and the OUH management. The issue of ownership of OPEN’s facilities and the level of commitment to its upkeep is one of the biggest challenges for the research support unit to overcome in the coming years. Amplifying the involvement of the OPEN steering committee will be crucial, along with introducing new initiatives for a strengthened local presence and enhancing communication strategies targeted at current users, potential new users and stakeholders, both locally, nationally, and internally. This as the informal feedback regarding OPENs performance from OPENs users to the financial contributors of OPEN is of great significance for the long-term support of OPEN.

OPEN continually strives to ensure that the services funded by our annual grant are available to all the projects requesting them. The current model, which includes a cap of 30 h, reflects this aim. It is our impression that this level meets the needs of most researchers; however, we have not formally assessed this. If the number of projects admitted to OPEN rises significantly in the coming years, it might be a challenge to increase the grant and it may be necessary to adjust the model to ensure continued support for all researchers in the region.

Due to the flexible scope of the tasks carried out by the OPEN research support unit and the absence of strict performance indicators, it has been essential to maintain a number of core employees who champion the vision, mission, and mind-set of the research support unit. These core employees have ensured the continual and coherent development of facilities and services, but the dependence on a small number of core employees has been, and still is, a significant risk factor for the sustainability of OPEN’s services.

A challenge stemming from OPEN’s extensive involvement in research projects lies in the difficulty researcher’s face when determining whether the nature of the services provided justifies granting co-authorship to OPEN employees. OPEN encourages adherence to the ICMJE recommendations [22], implying that tasks of an operational nature or those with limited scientific involvement do not merit co-authorship. While it is voluntary for the clinical and university researchers to use OPEN’s facilities and services, the extensive work that some OPEN employees contribute to projects should sometimes be reflected in authorship. Until now, such decisions have been made on an ad hoc basis, but there is a recognised need for more formal guidelines. Moving forward, OPEN expects to establish guidelines to systematically inform decisions regarding authorship.

The data presented and used in this paper have some limitations. First and foremost, it should be noted that all authors are affiliated with OPEN, which may influence the article. Only two people participated in the focus group interview, and their answers may have been influenced by the fact that it was OPEN employees who interviewed them. The authors recognize that this narrow qualitative data collection has a limited generalisability, and are therefore planning a more extensive qualitative study in the future. In addition, the response rate of the survey sent to OPEN’s users was low and only covering the initial phase of contact with OPEN. Survey participation is often non-random, and there is a possibility that the provided answers may not be fully representative of OPEN’s users. This could potentially lead to bias, resulting in more extreme views being emphasised. OPEN is currently developing a survey to address the continuous satisfaction level when using OPEN’s services. Moreover, data extracted from administrative systems that are developed for purposes other than this paper, only partially align with the desired format or quality for this study. Moreover, we lack data to assess whether OPEN users are representative of the broader research community, which should be considered when interpreting the findings, although OPEN is accessible to all career stages.

Among long-time OPEN employees, it has been observed that the complexity of the issues and projects for which researchers seek support has increased. Though we would have liked to explore whether this rise in complexity could be attributed to factors such as internationalisation and new study designs or if researchers have become more adept at using OPEN’s services for addressing complex problems, this was not possible using the available data. The internal databases from which the data was extracted were not developed for this purpose, and so the available data could not provide clarity on the issue of complexity. Moreover, due to the lack of performance indicators, it is challenging to document the direct effects of OPEN on research quality, quantity, and waste in research.

In the years to come, OPEN will have to intensify its efforts regarding using and re-using collected data and biological material. While the researchers collaborating with OPEN fully accept that data and biological material handled through OPEN may be (re-)used by other researchers, with the explicit consent of the original researchers, OPEN has yet to crack the code to encourage and, on a large scale, achieve the re-use of existing data for answering new research questions. This must be a key area of focus going forward, not only because it may make research more efficient but also as it presumably is the expectation of our patients and trial participants [34]. Succeeding in this respects an informal contract between researchers and participants, especially regarding participant willingness and cooperation, which is a prerequisite in research. Enablers to realizing the potential of the re-use of data will be factors such as strong leadership, using new technologies and algorithms, involvement of patients and relatives in the development and competence development of the involved partners.

As research projects become more complex, the need for new services and facilities arises [35]. Recently, a CTU has been established, and this service will be available to complex clinical trials as an add-on to OPEN’s other services which provide more practical and academic services.

With the increasing amount of detailed legislation on data and research, legal counselling is one of the services in the highest demand. In order to remain relevant to users, OPEN must strive to develop this area further in-house, and in collaboration with external partners.

The possibilities of expanding the services are vast, also when it comes to research support regarding AI, machine learning, the area of personalised medicine, and the use of genetic data. These areas and their possibilities are currently being explored to discern how to assist researchers in the future.

In all of these areas, OPEN must both align with the local needs of the researchers and the services provided in other parts of the Region of Southern Denmark and SDU. This is crucial, as other units in these major organisations may be developing (possibly competing) services that could overlap or partially meet the demand of the researchers. This is especially important since there is no set definition of what constitutes “research support”. Coordination and connectivity both internally and externally are critical when considering expanding to new services.

Developing a state-of-the-art research infrastructure is an odyssey, and much remains to be done. Some of the demands are mentioned above, but inspiration might also be found in other areas. With the advance of the ESG agenda (Environmental, Social, and corporate Governance), OPEN, in the long haul, might benefit from working systematically with these areas, e.g. the sustainability of IT facilities, the ethical impact of services, or unconscious bias in the guidance provided to researchers.

OPEN:

Open Patient data Explorative Network

OUH:

Odense University Hospital

SDU:

University of Southern Denmark

PURE:

PUblication and REsearch

REDCap:

Research Electronic Data Capture

RDB:

OPEN Register Database

SOPs:

Standard operating procedures

ICMJE:

International Committee of Medical Journal Editors

QUEST:

Quality, Ethics, Open Science, Translation

BIH:

Berlin Institute of Health at Charité

CTUs:

Clinical trial units

ESG:

Environmental, Social, and corporate Governance

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The authors thank Kim Brixen (former Chief Medical Officer at OUH) and Torben Barington (former head of OPEN) for their assistance in exploring the history of OPEN, from the earliest conception to present day.

We truly acknowledge the late Kim Brixen, whose passion, dedication, vision, and contributions played a significant role in the development, growth, and success of OPEN. He will be honoured and remembered with deep respect and gratitude. His legacy will remain a source of inspiration.

Moreover, the authors also thank Lars Folkestad and Jan Blaakær for providing insight on the experiences and perspectives of researchers using OPEN’s support services, and Signe Beck Titlestad for conducting the focus group interview. Furthermore, we thank Claire Gudex for constructive feedback during the writing process and Kasper Westphal Leth for assisting with the finalisation of the manuscript. Finally, our thanks to the staff and researchers at OPEN, the Department of Clinical Research, the Region of Southern Denmark, and all affiliated hospitals. OPEN would not have become the research support unit it is today without your unfailing support and commitment.

Open access funding provided by University of Southern Denmark.

This research received no external funding.

Conceptualisation, KHR and ASN; Methodology, All authors; Formal Analysis, JB, KHR, ASN, ERC; Investigation, All authors; Resources, All authors; Data Curation, All authors; Writing – Original Draft Preparation, All authors; Writing – Review & Editing, All authors; Visualisation, ERC; Supervision, All authors; Project Administration, All authors. All authors read and approved the final manuscript.

Correspondence to Anna Skat Nielsen.

This is an article describing the Danish support unit OPEN. The article and underlying data does not contain personal health data. In accordance with Danish legislation (Act on scientific ethical approval of health scientific research projects and health data scientific research projects, in Danish: “Bekendtgørelse af lov om videnskabsetisk behandling af sundhedsvidenskabelige forskningsprojekter og sundhedsdatavidenskabelige forskningsprojekter, LBK nr 1338 af 01/09/2020)” [36], no approval from any Scientific Ethics Committee is needed. Furthermore as this study is not a medical research project involving human subjects the Helsinki Declaration is not applicable to this study. Participants interviewed in this study has given a GDPR compliant consent.All participants in this study has been informed of the purpose of the study and consented to participate.

Not applicable.

All authors are affiliated with OPEN, but otherwise declare no competing interests.

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