Scientific Integrity

Decree no. 2021-1572 of December 3, 2021 concerns compliance with scientific integrity requirements by public establishments contributing to the public research service and foundations recognized as being of public utility whose main activity is public research.

It is available at https://www.legifrance.gouv.fr/loda/id/JORFTEXT000044411360/

This decree enshrines in law the principle that public establishments whose main activity is public research must follow in order to organize themselves to respect and ensure respect for the requirements of scientific integrity (SI).

It defines SI as the set of rules and values that must govern research activities to ensure that they are honest and scientifically rigorous.

It describes the responsibilities of public research establishments in terms of :

• IS training for staff and students,
• ensuring compliance with SI requirements,
• promoting open science,
• prevention, detection and investigation of IS breaches,
• the action to be taken and any sanctions associated with these breaches when they are proven.

Public research establishments are required to define a policy for the conservation, communication and re-use of raw research results and source codes, and must contribute to the appropriate infrastructures to meet these requirements.

They must ensure that their staff implement a data management plan for their research data.

Every two years, public research establishments send the Minister for Research and the Haut Conseil de l'évaluation de la recherche et de l'enseignement supérieur a report on the implementation of actions undertaken by the Scientific Integrity Referent (RIS) (reports of breaches of SI, reports received, distribution to the parties concerned of data and publications affected by breaches of SI, etc.) and on conflict of interest situations that have justified the removal of the RIS or the head of the establishment.

Scientific integrity (SI) concerns all research activities, whether publicly or privately funded. These include, but are not limited to :

• research design which, particularly when it comes to testing hypotheses, must not be biased in favor of a particular outcome.
• the conduct of research, which must be honest and rigorous, and comply with good laboratory practice and good clinical practice for biomedical research involving medicines for human use (but which are relevant and applicable to other clinical research).
• dissemination of research results, enabling them to be reproduced and their validity verified.
• respect for authorship rules that encourage intellectual and operational recognition of research contributors and are not based on hierarchical, administrative or financial aspects.

The SI extends to training activities, which are also concerned by deontology, in particular the supervision of doctoral students.

More broadly, the notion of scientific integrity extends to :

• the behavior of research professionals in their research, training and evaluation activities, both among themselves and in relation to individuals or institutions.
• the attitudes of researchers and teacher-researchers towards civil society.
• communication of research data, whether fundamental or clinical, particularly in the healthcare field.
• the transparency of research professionals' links of interest, enabling the analysis of potential conflicts of interest.

Decree no. 2021-1572 of December 3, 2021 requires public establishments contributing to the public research service and foundations recognized as being of public utility whose main activity is public research, to ensure compliance with the requirements of scientific integrity (SI) and the conservation of the raw results of scientific work carried out within them.

These establishments are responsible for:

• Raising awareness and train their staff and students in SI.
• Ensuring that the organization of their staff's work complies with SI requirements.
• Promoting the dissemination of open-access publications and the availability of methods and protocols, data and source code associated with research results, while encouraging the publication of negative results.
• Preventing and detecting breaches of SI.
• Investigating such breaches within a reasonable timeframe, according to transparent, formalized and fair procedures that respect the adversarial principle, and specify the general criteria for the admissibility of reports.
• Deciding on the action to be taken, including disciplinary action, in the event of proven breaches of SI requirements.
• Defining a policy for the conservation, communication and re-use of raw research results and source codes, and contribute to the appropriate infrastructure to meet these requirements.
• Ensuring that their staff implement a data management plan for their research.

L'Office Français de l’Intégrité Scientifique (OFIS) (https://www.hceres.fr/fr/ofis) participates in drawing up and implementing the national strategy for scientific integrity.

The institutions promote the fundamental principles of the SI enshrined in the European code of conduct for research integrity :

• Reliability in design, methodology, research analysis and use of resources.
• Honesty in developing, conducting, evaluating and disseminating research in a transparent, fair, complete and objective manner.
• Respect for colleagues, research participants, society, ecosystems, cultural heritage and the environment.
• Responsibility for research activities, from idea to publication, their management and organization, for training, supervision and mentoring, and for the broader implications of research.

An individual's ties of interest, whether positive or negative, are not limited to financial ties, but include all factors likely to influence his or her choices, resulting from his or her family life, emotional life, associative, political or trade union, philosophical or religious affiliations, intellectual or professional connivances that he or she may have established, his or her career path or expectations, and the hierarchies into which he or she fits.

Independence doesn't exist. Rather than being independent, an individual is expected to be impartial. This must be the position of everyone, RIS and the head of the institution included.

A conflict of interest is a situation in which a professional does not act, or may be suspected of not acting, in accordance with the interests he or she is socially expected to defend or care for, but in order to benefit other interests, either his or her own or those of a third party.

While it is up to the individual to declare his or her links of interest (particularly at the start of a presentation or course), it is primarily up to the person commissioning him or her (or receiving an article or scientific project) to determine whether or not these links constitute a conflict of interest with regard to the assignment requested or the documents submitted for evaluation.

Of course, an individual may freely choose to consider that his or her ties constitute a conflict and withdraw from a proposed mission. In this case, scientific integrity requires the individual to explain the reasons for his or her decision, which must be kept confidential.

The procedures for declaring links of interest are not uniform, and their form is often insufficient to enable a real assessment of potential conflicts of interest.

Scientific integrity requires an individual to specify all his or her links when asked for an assignment or the publication of research. Beyond the obvious declaration of financial support in all its forms, this may, for example, be :

• Tell the editor-in-chief of a journal requesting an article review about any links you may have with the authors of the article or with the work reported.
• To specify to the president of a jury requesting participation in the evaluation jury or the evaluation of a file with a view to financing or promoting a study, a student or a researcher, the negative or positive links one has with respect to the study, the candidate or the team to which he or she belongs.
• Report a personal relationship, family or otherwise, with a person working for a public or private institution with an interest in the case under review.

Once a tie has been correctly declared, i.e. a priori and explicitly, an individual cannot be suspected of a conflict of interest. It is the person who commissioned the work who can be criticized for failing to detect a conflict of interest in his or her declared links.

The diversity of links of interest and how to declare them has been the subject of recommendations targeted at the field of healthcare products and technologies: https://www.journal-therapie.org/articles/therapie/pdf/2012/04/th122076.pdf (en accès libre).

Conduct in research, like all conduct in society, is based on elementary notions that are supposed to have been passed down through education, but which are always worth remembering.

Honesty, transparency, reliability, benevolence and respect are the key elements of good conduct (and their antonyms, the hallmark of bad conduct) in research.

It is possible for conduct to be criticized, inappropriate or bad, or for errors to be unintentional. The benefit of the doubt must, first and foremost, be given to those who are under suspicion.

The misconduct of team leaders and mentors has been described on https://pubmed.ncbi.nlm.nih.gov/27115263/. They underline the importance of enabling the development of the people being mentored, and not the various interests of the mentor.

Research must be designed without seeking to promote an expected outcome.

Unexpected, "disappointing" results, or those that run counter to the researcher's hopes, should not be overlooked, as long as the methods used to obtain them are valid.

Good laboratory practice and good clinical practice must be respected. They are enshrined in law.

The European Code of Conduct for Research Integrity defines good practice in research:

• Reliability in design, methodology, research analysis and use of resources.
• Honesty in developing, conducting, evaluating and disseminating research in a transparent, fair, complete and objective manner.
• Respect for colleagues, research participants, society, ecosystems, cultural heritage and the environment.
• Responsibility for research activities, from idea to publication, their management and organization, for training, supervision and mentoring, and for the broader implications of research.

In case of doubt, any teacher-researcher or researcher should consult one of the university institutions responsible for guiding staff and students in matters of deontology, scientific integrity and ethics. See page : https://www.sorbonne-universite.fr/universite/nos-engagements/les-dispositifs-dintegrite-deontologie-et-ethique.

• Appointed by the head of the establishment (the dean of Sorbonne Université's Faculty of Health Sciences).
• Active or retired teacher-researcher or researcher who is not remunerated for this function, he is an ex-officio member of the Commission de Déontologie et de l'Intégrité Scientifique of the Sorbonne Université Faculty of Health Sciences.
• Accountable only to his manager, even though he doesn't depend on him.

Missions :

• Contribute to the establishment's scientific integrity policy.
• Raise awareness and train researchers and doctoral students in SI; organize measures to prevent and detect breaches of scientific integrity.
• Be available to answer any questions relating to SI (and sometimes even to research ethics).
• Investigate and inquire into reports of alleged SI breaches that the RIS may receive.
• Guarantee the confidentiality of the reporting procedure. The referent ensures that the adversarial principle is respected and that the procedure is transparent.
• Ensure that data and publications affected by a breach of scientific integrity are reported to the parties concerned.
• Report to the president or director of the establishment or foundation any internal systems or practices that do not offer sufficient guarantees.

The establishment provides the RIS with the resources it needs to carry out its tasks.

When the ICSR considers that he/she is not in a position to investigate a question or report independently, impartially or objectively, particularly when the question or report is likely to call into question the establishment's bodies, he/she will inform the head of the establishment and withdraw from the case.

If the case involves an inter-personnel conflict, the RIS may request the assistance of the Staff Ombudsman.

The RIS has no power of sanction.

He/she must establish the facts, if necessary using external experts, in order to draw up a report to be submitted to the head of the establishment, which may include recommendations.

RISs are listed on the Office Français de l'Intégrité Scientifique (OFIS) website: https://www.ofis-france.fr/"

Contact the RIS of the Sorbonne University Faculty of Health Sciences: christian.funck-brentano@sorbonne-universite.fr.