CORE management: The reality principle

Abstract

Responsible science is mandatory for every research institution. As economic challenges, fast evolving technologies and competitiveness impact drastically the scientific productivity and quality, institutions must take action. Research core facilities using animal models (CORE) are central in biomedical institutions. Therefore, building a strong CORE represents a priority for research organizations. More precisely, COREs must define their purpose, ensure proper long term resources and promote ethics and transparency. The heads of COREs play, as managers, a key role in the development and in the coordination of all activities. They deal with multiple challenges, such as divergent objectives, heavy workload and limited resources, exposing them to psychosocial risks, and might compromise their ability to react rationally to the pressure. The implementation of a culture of care and of social responsibility is essential for COREs and for their institutions. In this, the collaborative efforts between institutions’ officials, administrative staff and scientists allow the support of CORE decisions, the development of innovative tools and the promotion of a responsible science. Overall, the improvement of the CORE strategy and functioning results in increased scientific success rates for the institution, while reducing psychosocial risks for personnel.

As former managing director of an institutional research core facility using animal models, I have decided to share my views on the challenges and possible solutions.

‘What is wrong with my management?’ I asked myself while facing recurrent and what seemed to be unsolvable issues in the professional environment. Among those obstacles were the rapid turnover of highly specialized staff, the inadequate timing between research and administrative requirements and the shortage of resources to implement new regulatory policies. From this point on, as managing director of a core facility, I could accept my inner emotional state and initiated actions following the ‘reality principle’. Such a principle was developed by Freud in 1911 as a major concept in Psychology and Psychoanalysis. It refers to the ability of the individual (his/her ego) to react with rationality to a situation. It is opposed to the ‘pleasure principle’, in which the ego uses passion and emotion to act. Based on this ‘reality principle’, I analysed the external situation, listed all the tangles and elaborated concrete strategies to move forward and unlock the process with adequate solutions.

The goal of this article is to expose those challenges based on ground characterization and provide solutions, in order to help institutions’ officials, managers and scientists to build a functional and long lasting management system of research core facilities using animal models.

The purpose and organization of institutional research core facilities using animal models have evolved during the past decade. Newly built facilities are large and centralized multimodal resource centers which act as research core facilities combined with animal facilities. Both types of facilities are client oriented services for independent research groups, based on the use of shared resources: 1) research core facilities facilitate the development of scientific projects, thanks to shared laboratory staff, laboratory space, and technological tools, ¹ and 2) animal facilities are used to house and raise animals (from various species) with shared animal care staff, animal space and housing equipment. ² Throughout this article, such combined structure will be referred as ‘CORE’.

Particularly in biomedical research institutions, CORE facilities play a major role in research, by providing 1) housing and care to animals, 2) scientific and technical expertise to scientists, 3) innovative tools to answer scientific hypotheses, 4) animal and technical training to multiple users, and 5) legal compliance according to all regulatory policies related to animal use in research. Managing such an organization is complex as it requires identifying and implementing a variety of objectives that are not intrinsically linked. These objectives can be categorized within four key domains: scientific, technical, economic and ethics. The role of the manager, together with the administrative and CORE staff, is to build a functional model in which all four domains are integrated. Ultimately, the collaboration of the entire institution towards a full acceptance of all scientific, technical, economic and ethics objectives is mandatory for research quality and success.

The most demanding role for CORE managers is to deal with the existing divergent objectives, in order to create a successful CORE model. The execution of the scientific, technical, economic and ethics objectives are mandatory to allow the CORE to function and the institution to maintain its internal equilibrium. Multiple risks can emerge when institutions and COREs are not successful in setting up a solid strategic plan, integrating the four objectives. To prevent the risks, several solutions can be developed within institutions hosting large and multimodal resource centers using animals.

Science, the common ground

To address the scientific objective of the CORE, it is very beneficial for the manager to have experience with leading research projects. Indeed, when managers are former scientists, they have a clear understanding of all science related matters (funding, design, methods, publication, etc.) and a solid trust from the research groups. The credibility also originates from the international recognition by external peers (past publication track record) and from the internal recognition by group leaders that are CORE users (past and present existing network). ³ Concerning animal related research, the veterinary prospective is important and requires strong collaborative work with the designated veterinarian.

As scientific expert, the main tasks of managers are 1) to understand the scientific needs of research groups, 2) to be aware of new scientific discoveries and constant development of new technical tools, and 3) to provide expertise and guidance via consultancy. In parallel, the manager also could play a role in the scientific development of methods to answer questions from the community. The planning of a scientific CORE programme can be done in collaboration with research teams, to facilitate and accelerate the process. More deeply, it allows the establishment of a positive and creative interaction between the CORE and the research community.

Concerning biomedical research, both scientific and technical discoveries are evolving very fast, which increases the level of competitiveness between institutions and between COREs. The most relevant emerging risk for the research institution is linked to the lack of scientific competitiveness. For research groups and the institution, it induces a drop of visibility, thus reducing funding opportunities and interests from the scientific community and from economic partners. A refined allocation of the CORE resources is necessary to remain competitive. For its organization, the CORE must have access to internal and/or external research funding, to laboratory equipment, and to dedicated and well-trained laboratory staff. ¹ For example, the creation of CORE-dedicated competitive Research and Development calls from the institution can be particularly effective to support research development by the CORE and stimulate collaborative efforts with research teams. In addition, considering that the scientific and technical objectives are central to the daily life of the CORE, managers should be selected for their previous experience in supervising large and translational research projects, and should focus their time and effort on the scientific objective.

Because time is an important factor influencing the development of research projects, it should be considered in the equation at various levels, independently of the CORE functioning. Science is a fast-moving field that is confronted with increased administrative requirements. It is clear that the administrative burden refers to policies and laws enabling to act and trace processes; however, it is often based on long and complicated steps. As of yet, 1) managers and scientists are still dealing with multiple, sometimes redundant, documents to fill out, sign, submit and store, and 2) administrative services are often run with shortage of staff; both greatly slow down the process. In large research organizations, an effort should be made to develop electronic applications and totally abolish paper documents. Most importantly, institutions should recruit sufficient administrative staff to cover all needs of the CORE and scientific communities, especially within the departments of human resources, finance and grant office. In August 2019, the National Institute of Health published a complete report on measures to be taken to reduce the administrative burden for researchers using animals. With the help of the American Ministry of Agriculture and the Food and Drug Agency they have analysed redundancy of policies and listened to organizations and stakeholders. Within a two year time frame, they plan on providing guidance about federal standards, reinforcing agency coordination and generating new resources and training support. ⁴ Similar initiatives could be launched in Europe as well.

Infrastructure and technologies, the two pillars

To remain attractive and functional, facilities must provide research teams with proper infrastructure and equipment, so that experiments can be performed under optimal conditions. In the case of COREs, it is necessary to take into account both the experimenter’s and the animal’s needs, thus requiring the most adapted infrastructure and equipment for the project and housing of the identified species. The financial resources of the institution are key in the context of optimal infrastructure and equipment. Even though the cost analysis of animal research is complex and still debated, it is an important part of the institutional investment. ⁵ More precisely, infrastructure and equipment represent a large portion of the CORE indirect and direct costs, when considering both purchase and maintenance.^1,5 The manager must elaborate a clear and detailed investment plan to be validated by the institution’s officials, prior to the creation of the CORE. Once funds are available, the manager is the key person in the selection and implementation of new equipment. It is crucial to investigate the technical needs of the scientific community, and their level of expertise and autonomy regarding the use of the equipment. Summarizing the needs of a large community of research teams is a tedious task that requires anticipation, coordination and diplomacy. A detailed survey must be sent to all research groups prior to the creation of the CORE and must be renewed every two to five years in order to adapt to the fast-evolving scientific needs. The participation by all groups is essential to validate the choices and draw a complete picture. After generating the full list of tools required, the manager, in collaboration with company providers, must study the efficiency of the tool and its potential to be user friendly, in the context of multiple users going from beginner to expert knowledge. To complete the view on technical objectives, an important part of the manager’s duties is linked with 1) the writing of clear standard procedures and concise instruction manuals, as well as 2) the development of certified intensive training programmes adapted to users from beginner to expert levels. Indeed, the manager and the CORE staff must promote quality research by offering adequate theoretical and hands-on training programmes.

Risks related to technicality can emerge when equipment from research groups is integrated within the pool of equipment provided by the CORE. Even if several conditions can be defined for the use of such equipment, for example, elaborating a priority schedule, reducing the cost, et cetera, it is totally inefficient in the context of a CORE model within a large institution. Among concrete difficulties, there are changes related to the owning team itself (change of decision to share along the way, definitive departure from the institution, etc.) and the economic aspect related to the use of the equipment (owner not willing to pay to use his/her equipment). Thus, CORE should only provide equipment that has been purchased for common use. In the case of very particular needs from identified research groups, equipment should be purchased and supervised autonomously by the research group. Such conditions should be well defined in terms of duration, space and usage needed as it can interfere with the CORE functioning. Another risk related to equipment use is linked with the fast-evolving technologies and scientific questions. The process of renewing equipment regularly is often slowed down by funding availability as well as space availability. The pool of equipment can be divided into three categories: 1) standard and well-established tools to fit the maximum needs, which will be purchased initially and for long term use, 2) specific and innovative tools to be validated over time, which will be purchased every 2–5 years, and 3) CORE developed tools to be provided upon specific request. For example, CORE research space can be divided into three areas corresponding to the three categories of equipment, and can be distributed as follows: 70% of the space equipped with standard equipment and open to all users, 25% of the space equipped with innovative tools and open to expert users only, and 5% of the space equipped with tools under development and open to CORE staff only.

In many organizations, committees of scientific experts are created to support the execution of the CORE scientific and technical objectives. ¹ Members of such committees must be elected by the scientific community for a defined duration and must disclaim any conflict of interest. It is very important for members to be legitimated by the entire research community. In addition, by implementing a term appointment, it allows a turnover of ideas and the integration of new groups over time. The manager must be part of the scientific expert committee and be the spokesperson for dialogue with the institution’s officials.

Because both scientific and technical objectives directly serve research programmes developed within laboratories, such missions generate positive and collaborative efforts between CORE staff and research teams. Science is thus a common ground to be used to federate individuals of one institution towards the success of the CORE.

Economics, the sinews of war

The third objective to consider for an institutional CORE facility is the financial plan. ⁶ To function, the manager must elaborate a business plan together with the finance department. Large CORE facilities using animals are at high cost for institutions. Personnel and equipment costs are the two major direct costs to integrate into the business plan. Most of the large COREs are organized as fee for service facilities. This key feature requires research teams to accept to pay for the use of shared personnel and equipment, and to have a dedicated budget. In this context, interactions between group leaders and CORE managers tend to be complex and tense when they concern money and budget. To compensate, institutions may take the decision 1) to provide basic animal housing services only together with allocated space for research to be filled and supervised autonomously by research teams, 2) to cover most expenses and investments, thus allowing fees to be minimal for internal research teams, and 3) to open CORE facilities to external industrial partners, thus equilibrating the business plan with external incomes. ¹ In this scenario, the manager is in charge of calculating/implementing fee for service activity using benchmarks, providing key numbers for billing, and promoting the service inside and, especially, outside of the institution. Considering the competences and skills required to implement the economic objective, this responsibility should be given to a dedicated person. This CORE administrator, with deep knowledge of finance and accounting, could be shared between different CORE facilities within the institution. He/she would work in close collaboration with the CORE manager to 1) define priorities for budget expenditure and investment, and 2) validate the business plan.

Two institutional departments are clearly involved in the execution of the economic CORE model: the grant office and the transfer and technology department. The grant office is a key element for success in the execution of the CORE economic objective. First of all, information on CORE fees should be made accessible by the grant office to scientists so that they will be able to anticipate and integrate CORE fees within their proposals as a routine process. Second, the grant office should promote the integration of COREs as identified partners within research projects. Both actions would allow the research team and the CORE to acquire the necessary budget prior to starting the experiments and to clarify their respective duties and plan accordingly. This centralized mechanism increases efficiency in the grant application process and facilitates communication between all participants of the project. The transfer and technology department is essential to provide industrial partners to COREs. It also plays a key role in the development of promotional strategies of the CORE outside the institution. To promote CORE services adequately, this department must work in close collaboration with the manager to perfectly understand the strengths and limitations of the CORE. In addition, the transfer and technology department can support the development of new CORE services by anticipating and matching the needs of external partners. For visibility and attractiveness towards external partners, COREs can also integrate known networks of core facilities and engage into certification programmes, such as ISO9001 or AAALAC accreditation.

Importantly, the CORE economic objective is not always clearly stated, understood and accepted by the scientific community. Indeed, besides lack of institutional funds or general resources, the most relevant risk is the refusal of the economic model by the research groups. A large part of this refusal can be explained by a lack of understanding of the economic CORE models, including vision and costs. The institution’s officials, such as the administrative director, must take a clear and deep engagement in transparency and education towards scientists. A full acceptance of the economic CORE model will come with a clear understanding of the institution’s stakes. Neither the CORE administrator nor the CORE manager should be given the responsibility to explain and clarify the global economic strategy of the institution (for example, regarding the decision of the institution to cover or not cover CORE expenses for the elaboration of CORE fees).

Ethics, the social responsibility

Finally, in the research field using human subjects and animals, ethics objectives represent an important part of the CORE organization. In Europe, ethics guidelines related to the use of animals for scientific purposes are provided by the European Commission. The European directive released in 1986 and describing major requirements related to the care and use of animals in research was repealed in 2010 (European directive 2010/63/EU). The goal of the new directive was to strengthen regulatory policies, emphasize the role and responsibility of individuals implicated (from the study director to the animal caretaker) and reflect on the importance of the 3Rs principle for the replacement of animals, the reduction of their number, and the refinement of procedures.

Briefly, concerning the institution, it became mandatory to designate 1) a person in charge of the educational training programme to provide guidance on mandatory training opportunities, to compile all certificates and diploma, and 2) a person in charge of animal welfare for the creation of an animal welfare body to provide guidance on the 3Rs, to perform post-approval monitoring, and to ensure proper care of animals (enrichment, humane end points, etc.). Concerning the research teams, group leaders had to submit an animal protocol to be evaluated by an institutional body, such as an ethics committee, and approved by competent authorities, such as the Ministry of Research and Education in France; both roles are taken by the Institutional Animal Care and Use Committee in the United States. Concerning the CORE facility, it remained mandatory to obtain an authorization delivered by the Ministry of Agriculture (for most countries) and to designate a person in charge of controlled substances, as well as a person in charge of veterinary care (designated veterinarian). In Europe, national implementation of such changes took several years for most countries.

In France, for example, the European directive was translated to decrees in 2013, and institutions are still struggling with the full application of these decrees. For instance, many institutions have designated the veterinarian or the CORE manager for all regulatory and ethics matters. CORE managers in charge of compliance often act as spokespersons in front of the regulatory and ethics bodies, such as the legal inspectors from the Ministry of Agriculture or from the drug agency (ANSM). Because the execution of the ethics objective includes obtaining all authorizations to perform animal work and obtaining quality data, CORE managers and staff are asked to ensure compliance and integrity at all times. Like for the economic objectives, this mission within the CORE organization is complex and can be seen negatively by the research community. Oversight of research projects by CORE managers can in fact create conflicts and be detrimental for future interactions with research teams. Indeed, controlling compliance and thus solving non-compliance issues should not be part of the duties of the CORE manager. For example, CORE managers may have to revoke access to users upon successive non-compliances while helping the same team to design a new experiment. The positive and creative interaction promoted during scientific meetings and discussions is incompatible with the possible negative and punitive interaction implemented during legal and ethics audits. Thus, the creation of a dedicated compliance officer position is mandatory in this context. The competences required for the position are linked with veterinary care, ethics and legal understanding. The work should be done in collaboration with the legal department and with the institution’s officials. More precisely, the compliance officer should report directly to the director of the institution, who is legally liable in the case of disagreement and non-compliance. In addition, the role of the ethics committee is crucial to support the mission of the compliance officer. Because high quality research is expected by the research community, by the economic partners and by the public, it is important to strongly promote integrity and compliance within every institution. To achieve such standards, institutions may decide to initiate voluntary evaluation by external partners, such as AAALAC; the goal of such accreditation is to strengthen the animal welfare and compliance programme, and clearly improve research quality.

To insist again on the need to alleviate the administrative burden related to ethics and compliance matters, legal institutions requiring specific authorizations should develop electronic applications, coordinate their calendars and provide training to facilitate the process. ⁴ An amendment to the European directive 2010/63/EU was published in 2019 to emphasize the importance of reducing the administrative burden in the use of animals in research. The recommendation was to merge several formats of reporting to facilitate the process. Meanwhile, group leaders should better integrate the factor of time within their research planning. For example, tutorials could be presented to group leaders in order to explain the animal protocol review process, including timelines, calendars, and legal and administrative requirements.

In the field of research using human subjects and animals, ethics is associated with social responsibility. Indeed, social responsibility refers to the individual and collective engagement towards the benefit of others, and more globally towards our society. COREs and institutions should promote social responsibility in order to be understood and supported by the general public. A responsible science, the fourth R, corresponds to a transparent research respecting and benefiting all. One major risk related to social responsibility is the development of a possible gap between science and society. In eras during which scientific data are challenged by social media and individuals, and animal activism is rising, transparency and ‘culture of care’ are two concepts to valorise. Since 2019, increased transparency towards the public is another amendment added to the European directive 2010/63/EU. In addition, several countries are now participating in the transparency agreement programme launched by the European Animal Research Association. The implementation of a ‘culture of care’ is also fundamental at the CORE and institutional levels. Such strong and collective commitment towards animal welfare, compassion and excellence makes a real difference to prevent the risk and succeed. In conclusion, all players of an institution must accept their social responsibility and act accordingly.

Psychosocial risks, the major crisis

As mentioned in the introduction, the role of CORE managers is complex and recurrent and/or what seem to be unsolvable challenges can undermine their self-confidence. Among such challenges, there are incompatibilities of objectives (example: scientific versus economics), of duties (example: scientific collaboration versus compliance oversight) and of competences (example: scientific skills versus accounting skills). At some point, the CORE manager may wonder what is wrong with his/her management capabilities. Indeed, their ability to follow the reality principle and to move forward can be compromised. This reality principle refers to the individual ability to act according to the reality of the situation using rational thinking. During difficult times, the CORE manager may experience frustrations, negative emotions and a high level of stress and anxiety.

Adding up divergent objectives, heavy workload, limited resources, reduced trust from the public and highly demanding ‘clients’ and ‘legal authorities’, CORE managers are deeply exposed to psychosocial risks. These risks have increased drastically for managers in general, and unfortunately science is not spared. Assessment of such risk is thus of particular importance in the management of CORE facilities using animal models; although, consecutive studies from the European Agency for Safety and Health at Work showed that in the work environment, independently of company size, sector or country, there was a clear inability and inefficiency to assess and prevent psychosocial risks. This could be attributed to lack of awareness, lack of resources and lack of expertise/support. ⁷

To tackle this issue, institution’s officials, human resources and occupational health and safety departments should be educated on the risks, so that they can adapt their strategy. Their action plan to implement the ‘culture of care’ could include: 1) attributing the adequate resources, 2) clarifying and refining the missions of individuals, 3) communicating effectively on potential risks, 4) promoting and recognizing good practices, 5) conducting regular surveys and interviews of individuals at risk, and 6) elaborating a strong support programme. ⁸

In addition to animal welfare, the culture of care should indeed be integrated as a priority in every institution and for all individuals. It covers, for example, recruitment, professional development and recognition. The benefits of the culture of care are numerous and positive for the institution. In addition to the sense of pride of the employees, it allows individuals to engage a culture of care towards others and in particular towards animals.

At the level of CORE managers, several actions can be initiated to reduce and prevent psychosocial risks. They can become part of a professional network to confront other opinions, get advice and recognition, and share experience. They can also seek help from various bodies, such as 1) the ethics committee to share compliance responsibilities and develop clear and accepted local guidelines, 2) the administrative director to alert about the situation and required decisions to be taken, and 3) the occupational health and safety department to express the difficulties and request a complete physical and psychological health assessment.

In conclusion, institutions and COREs are key players in the development of a responsible and transparent science. All individuals are actors within their institutions, and thus must commit to the culture of care and to the concept of an individual and collective social responsibility towards the science, the animals and the public.