Sorbonne University Faculty of Medicine
The national meetings of the Deans of the Faculties of Medicine and Odontology have drafted an ethical and deontological charter to formalise and standardise their practices in this field. This Charter meets ethical requirements, particularly with regard to scientific and professional integrity, connected persons1, and social expectations. This text concerns the application of this charter by Sorbonne University’s Faculty of Medicine. The Faculty of Medicine bases all its activities on universal values honouring respect for human rights, dignity and solidarity. The faculty also shares the fundamental values of the University: upholding high standards, independence and humanism while promoting critical thinking and being open to society. The faculty complies with the laws and regulations in force in the country and, where there is no law or regulation, it is based on recommendations from national and/or international research, charters and bodies from the field of ethics. The faculty offers a public service in terms of its research, training, guidance and preparing their students for the world of work. Furthermore, its university hospital staff have a duty of care. It is essential that the academic and socio-economic sector, particularly the manufacturing sector, work together to achieve these objectives in training, research and care, in order that the students, society and patients can benefit from the best possible medical advancements. The concept of translational research, a continuum between basic and applied research, shows how important it is that these sectors work together. This dynamic, which is part of the faculty’s statutory objectives, must be carried out while respecting professional and scientific integrity, being transparent with regard to connected persons and while combatting influencing practices. In the context of education2, the faculty’s shared objective for common interest is to train future health professionals in caring for patients, managing public health issues and in respecting people’s dignity and protecting them. This is based on two areas, care and research. It is outlined in its educational policy that the protection of patients’ interests and the community must take precedence over all other factors. For this reason, medical training cannot be privatised for individual interests; it is a public health issue and this is non-negotiable. Students benefit from an institutional and academic framework that must guarantee this independence to them by providing them with a learning path provided by academics, in compliance with the principles of transparency, loyalty, impartiality and professional and scientific integrity, which these professionals undertake to uphold when they are employed. The pharmaceutical industry is often put at the forefront when it comes to conflicts of interest, when the cost factor of medical devices is as significant as it is. Subjects and industries related to health data and its analysis will be the main challenges for the future. Conflicts of interest do not summarise the ethical issues facing health faculties: professional and scientific integrity is also essential. Compliance with the undertakings of this Charter, which aims to promote ethical principles and principles relating to professional and scientific integrity, is necessary for the faculty’s operation and administration, as well as for its relations with partners in the socio-economic and public sectors, in particular hospitals, the liberal health sector and private actors. The faculty undertakes to abide by this Charter.
1) The faculty undertakes to uphold scientific integrity
The European Commission has made scientific and professional integrity to be one of its top priorities by raising the level of ethical and social responsibility requirements in teaching, research and health practices. The national ethics code for health professionals adopted by the faculty also emphasises the importance of health professionals respecting the principle of integrity. In addition, through its teaching and research objectives, the faculty undertakes to promote and respect the fundamental rights of those working in care and research, the regulations for protecting research participants, the proper use of health data and the conditions for access to and for using elements produced by the human body, in accordance with current legislation, all of which play a part in the concept of integrity. This is why the faculty undertakes to respect the proposals for the implementation of the national code of ethics for research professions, as outlined in the report by Prof. Pierre Corvol (29 June 2016). Some of these proposals are part of national policy or university policy, while others are specific to the faculty. Thus:
- Proposal 4 aims to “acquire a broader scientific culture, including an introduction to research ethics and scientific integrity”.
- Proposal 5 recommends to “ensure that all students have been made aware of the code of ethics and scientific integrity” for medicine schools. These proposals should be extended to all health professionals and students.
- Proposal 6 encourages interactive training (in a bottom-up style approach) where students who are trained in scientific integrity can help train the next generation
- Proposal 8 is to ensure that training is in place with regard to research ethics and integrity
- Proposals 9 and 10 encourage the faculty to have a code of ethics and scientific integrity by providing funding from the Agence Nationale de la Recherche (National Research Agency, like that of other national and European research agencies) subject to them having such a code and by asking the Haut Conseil de l’évaluation de la Recherche et de l’Enseignement Supérieur (High Council for the Evaluation of Research and Higher Education) to assess its implementation.
- Proposal 12 incites the faculty to “encourage the promotion and implementation of research on different ways to provide training on integrity and their impact, on epistemological questions on ethics, integrity and scientific responsibility, as well as the effect of this on society“.
The faculty undertakes to put measures in place that are likely to promote the fundamental and universal characteristics of scientific integrity and reproducibility, particularly being responsible when carrying out research, respecting they must:
- Provide a research protocol to be submitted in advance on an accessible site,
- Provide a statistical analysis of the results, which is to be carried out independently of the promoters and research actors,
- Provide a scientific report in accordance with the guidelines on the EQUATOR website (http://www.equator-network.org; CONSORT, ESTROBE, STARD, PRISMA, .),
- Provide the results, regardless of whether they are positive or negative, either in the form of a publication or by logging them in a logbook,
- Provide guaranteed access to the research data sources,
- Be transparent and open with regard to the research methods and results, thereby allowing the research to be verified and replicated.
The faculty undertakes to combat all breaches of scientific integrity (falsification and fabrication of data, stolen results and plagiarism, failure to respect the rights of research subjects such as their data rights or if they had not provided their consent, failure to comply with the regulatory obligations when researching humans or animals) and more generally against all “questionable research practices”. Plagiarism, creating de facto inequality, is damaging to the plagiarist, their institution, the scientific and/or academic community and the public, as the latter is liable for theft and misuse. In order to try and prevent plagiarism, the faculty undertakes to train their students and academics on the risk of plagiarism. The use of similarity detection software for theses and dissertations must be systematic. In the current regulatory context and in order to be as efficient as possible, the faculty should be supported by public authorities in acquiring and using such software. With regard to the role of the author of scientific articles or works, the faculty promotes and will ensure they comply with international regulations, particularly those of the International Committee of Medical Journal Editors (ICMJE, http://www.icmje.org/). The signature of a scientific article is recognising the ownership and intellectual value of a piece of work that has significantly contributed to the design or execution of the piece of work presented while fully respecting its integrity. The authorship of the scientific work must be attributed to those who meet the criteria of the ICMJE. Practices concerning so-called honorary authors (or “guest authors” because they did not participate in the research) and so-called ghost authors (e.g. an editor that was not credited or a student or member of staff that were knowingly omitted) should be prohibited, as this constitutes a breach of scientific integrity. The faculty condemns publishing the same data twice (self-plagiarism) except in special circumstances (different languages) and subject to the relevant journals providing their explicit consent and the readers being informed that this is the case. Editorial assistance from professionals who may be paid by a third party, such as a manufacturing company, may be sought for scientific publications, provided that this is made clear to readers and that the connected persons are explicitly mentioned in the publication. The publication of scientific works in so-called “predatory” journals is prohibited, as well as any form of editorial activity for these journals (https://www.councilscienceeditors.org/resource-library/editorial-policies/cse- policies/approved-by-the-cse-board-of-directors/predatory-deceptive- publishers-recommendations-caution/). Although editorial activities come under the freedom of academics, some of these activities may require authorisation in the event of the accumulation of additional activities because of the amount of time and remuneration they often require. With regard to the evaluation of research (peer-reviewed) but also for any other assignment where their expertise is required, academics must provide an impartial, quick and thorough evaluation, while respecting confidentiality, copyright and integrity. With regard to participation in research projects, scientific publications and communications, teaching activities and expertise, academics must openly state the connected persons that may have influenced their work, providing an exhaustive list. When communicating with the general public, lecturers must only talk about and publish works related to their professional expertise. As soon as they express an opinion (ideology, civic point of view or their political, cultural or religious stance), they must no longer express their view as a lecturer or as a member of staff of the said institution and they must state in what capacity they are expressing themselves. To monitor and support all the undertakings in this Charter, the faculty undertakes to appoint a scientific integrity point of contact and to set up an ethics committee for the faculty. This point of contact is a correspondent for the Office Français de l’Intégrité Scientifique [French Office for Scientific Integrity] and is there to support each university’s scientific point of contact. This point of contact is appointed by the faculty board3 on a joint proposal from the Dean of the Faculty and the Chairman of the Professional Conduct and Ethics Committee, they are to be an ex officio member of the Ethics Committee and they must not be dependent on the faculty authorities. They are part of the national and European networks of scientific integrity points of contact to compare their experiences in the field and to develop research practices.
2) The faculty is committed to ethics
The faculty undertakes to respect the code of ethics and integrity put forward by all the professional boards that created this code. Faculty staff must not use their prerogative to favour or harm a third party. They must not create or abuse a situation with a legal entity or individual that would lead to them not complying with the provisions of this Charter or to derogate from the texts and laws in force. For example, with regard to complying with the rules on managing connected persons and conflicts of interest, faculty staff must refrain from participating in debates and votes for making decisions on matters in which they have a personal, family or professional conflict of interest. To support this, a member of the Board of Doctors on the Research and Training Board and/or the ethics committee must be involved. The faculty is committed to training its students in ethics, with the professional boards’ support. It is recommended that this teaching is adapted based on what level the students are studying at and how much clinical responsibility they have, and therefore that this training is repeated throughout their studies. The faculty promotes gender equality, the fight against all forms of discrimination and disabled access. It undertakes to respect and ensure others respect national decisions on secularism that apply to both universities and partner health structures.
3) Ethical and professional training for responsible conduct
Compulsory courses on ethics and professional conduct are supported within the faculty in order to cover the points of this Charter, particularly:
- professional conduct and ethics, in collaboration with the relevant boards;
- the principles and rules of scientific integrity (including plagiarism and the regulations for scientific papers, declaring connected persons and managing conflicts of interest (as part of the principles of the American Medical Student Association’s Pharmfree Curriculum; https://www.amsa.org/wp-content/uploads/2015/03/ModelPharmFreeCurriculum.pdf);
- as well as more generally on the proper use of medical and scientific information, the manipulation of information and influencing practices, how to identify these practices and how to protect yourself from any risk of loss of independence. This training is provided again during the third cycle [year 7 onwards of medical studies] and it is adapted to the speciality taught and to students’ particular susceptibility because of their increasing responsibilities with regard to
Every year, the faculty provides ethics training to young teachers (Student Clinical Placement Coordinators, University Hospital Assistants) and new academics in the first months of them taking up their duties. Similar training is provided for teaching university and inter-university degrees and most National Council of Universities’ sub-sections now stipulate this as one of the prerequisites for training future academics. As part of the continuing professional development obligations, all teachers must also regularly receive the same training.
4) Transparency and declaration of connected persons
The declaration of connected persons is an important element of the policy for ensuring there are no conflicts of interest and for helping professionals whose jobs contribute to society [French “public life actors” – the mayor, head of public transport or responsible for construction] be more transparent. When called upon as experts, health professionals are already required to publicly disclose their connected persons through easily accessible national institutions. The faculty undertakes to make its connected persons of the members of its governance bodies (Research and Training Boards) and its committees that may have to deal with related subjects (committee for the accumulation of additional activities, ethics committee, teaching committee and research committee) available on its website. In addition, teachers must communicate their connected persons to students as a preamble to their teaching, whatever its nature (written, oral, online). The communication of connected persons before each class is an educational example of scientific integrity among students. Teachers must be neutral towards the company or institution that they have a relationship with.
5) Accumulation of additional activities
The Faculty has set up a committee to examine requests for the accumulation of additional activities, in accordance with the laws and regulations in force and following the recommendations of the National Conference of Deans of Faculties of Medicine, the National Conference of Deans of Faculties of Pharmacy, the National Conference of Deans of Faculties of Dentistry, the National Conference of Presidents of Institutional Medical Committees, University Hospitals and the National Conference of Director Generals of University Hospitals. As a reminder, this committee examines the agreement with the company or institution, with the applicant undertaking to ensure the work is produced independently, that it complies with social and tax obligations and, where applicable, to submit the agreement to the relevant professional board. The latter shall examine, where appropriate, the proportion of remuneration received in relation to the work provided. The time devoted to these authorised additional activities is capped in accordance with the rules in force. Authorisation to accumulate additional activities relates to all activities that give rise to authorised remuneration and unpaid activities carried out for a legal entity for profit. Authorisation is only given for one task and for a maximum period of one year, which can be renewed. Teachers are prohibited from any involvement in marketing/selling health products.
6) Benefits and gifts
Gifts funded by the industry are not permitted because, even if they are not expensive, they are likely to influence prescribers’ decisions, thereby directly affecting patients. Expenses (transport, accommodation, registration) to attend conferences, meetings and scientific congresses is an advantage that is authorised under certain conditions by law. This advantage must give rise to a declaration of their connected persons on their transparent site. Such compensation can only be accepted if it is subject to the faculty’s approval or if it follows a procedure preventing the company from selecting the recipients (payment of unrestricted funds). In the current absence of an appropriate source of institutional funding, neither hospital nor university, the expenses are considered to be an exception when a scientific paper is presented at certain scientific events and they are only covered for the author presenting the paper, or when participation in an event cannot be covered by research but it appears necessary for the teacher’s continuing professional development. In all cases, it is obligatory to provide a declaration of this funding to the faculty.
7) The faculty will ensure that external funding does not influence the independence of educational content
As a public institution whose purpose is to provide medical knowledge, the faculty must be transparent about the source of the funding it is likely to receive from manufacturers and other private bodies by publishing it on their website. The faculty will ensure that these bodies do not interfere with the independence of the educational content. Manufacturers are not permitted to provide financial support for initial or continuing vocational training (Continuing Professional Development or CPD), directly or through a subsidiary agency, with the exception of Fondations. The only exceptions to this rule are specific training schemes where the manufacturer is the only one to have some of the expertise (e.g. training about a specific device or piece of equipment) or those contributing to the guiding and preparing their students for the world of work in industrial sectors. In this case, a special dispensation must be issued by the Dean, after a favourable opinion from the Ethics Committee, and the training must be supervised by an academic with no link to the industry concerned. Direct funding to the faculty can be provided by manufacturers for research and educational purposes in accordance with several terms (apprenticeship tax, various forms of funding) that have been extended since the Law Pécresse. Such funding must not interfere with the faculty’s tasks and its obligation to educate and protect students from the influence of privately-owned bodies and must therefore receive a favourable opinion from the ethics committee. They must be approved by a vote from the Research and Training Board. As public institutions whose purpose is to provide medical knowledge, the faculty must be transparent about the source of the funding by ensuring that this information is available to the general public.
8) Good educational practices in relationships with health industries
Health products mentioned in teaching contexts must be referred to by their international non-proprietary names (INN) without mentioning any trade names or relaying marketing speeches, whatever the medium (written, oral, online). The same principles are applied to medical devices and referring to trademarks in general. They are also valid for exams, training and exam preparation, as well as for national exams. Faculty teaching, including continuing professional development, may not be provided by the manufacturer themself or their representatives, or by any other private for-profit organisation, other than by sharing experience on how that manufacturer runs their industry or by guiding and preparing students for the world of work in these industries. Dispensations are possible when only the manufacturer knows about the subject and this dispensation is then authorised by the Dean after consulting the ethics committee. Under no circumstances may educational materials distributed within faculties be written, distributed or funded by a manufacturer or any other private for-profit organisation. Students have the right to exercise a duty of confidentiality when they are in an influential position. They can express themselves freely on the conditions under which they are trained during hospital placements, without being reprimanded or penalised by their superiors. The elected students of the Research and Training Board may refer any situation to the Ethics Committee that they deem to be fitting. They may refer the matter to the ad hoc committees as soon as they become aware of such practices and their personal liability cannot be called into question in this context. Academics’ use of educational materials provided by manufacturers or any other private body, or the prior review of these materials by manufacturers or any other private body, is prohibited, including for external conferences.
9) Staff promotion and recruitment
Staff promotion and recruitment (teaching, research, administration and technical support) shall be based on fair and transparent criteria and methods, without discrimination or favouritism based on sex, age, socio-economic, ethnic, political, trade union or religious affiliation, while respecting the principles of scientific integrity. In the context of their academic recruitment, of both full and part-time staff, the faculty undertakes to not give priority to the quantitative aspects of research but to adopt a balanced quantitative/qualitative approach as well as a balanced research/educational approach. Assessment of scientific works should not be based solely on the impact factor of the journals but it should also focus on qualitative aspects (San Francisco Declaration on Research Assessment (DORA): http://www.ascb.org/wp-content/uploads/2017/07/sfdora.pdf). The SIGAPS or SIAPS point thresholds are only indicative of the minimum values required, which sometimes need to be adapted and put into context. These global quantitative variables do not allow individuals to be compared, especially when they come from different specialities. Any instance that has proven to fail to comply with the rules of scientific and professional integrity must be taken into account when assessing candidates and career paths.
10) Links with care partners
Compliance with the undertakings of this Charter is also necessary in the faculty’s relationships with its main partners and stakeholders in the world of health, particularly the hospital and the liberal health sector. Exposure to a risk of conflict of interests in healthcare sectors should not be underestimated. The principles of this Charter must be shared with health care institutions or places of care where teachers work and students are admitted. Faculties shall promote, together with partner institutions, procedures and recommendations to ensure quality teaching in practical placements, including ethical and practical quality, as well as a fair assessment of students during such placements. Placements should be assessed regularly. Marketing representatives from the pharmaceutical and health products industries (in the broad sense) are not permitted to meet university staff in areas of care or in the presence of students. Special dispensations may be issued for non-commercial purposes when only the manufacturer has the necessary expertise (e.g. of training about specific equipment or devices).
11) Commitment to training, listening and monitoring students
Student selection, guidance and assessment is based on fair criteria and methods. The faculty ensures fair access to learning resources and a fair approach to approval of teaching methods. As part of its teaching element, the faculty is committed to providing knowledge and skills to its students, which it owes to future patients and to the students they are training, who will be the health professionals in the future who are responsible for society’s patients. It is also committed to providing teaching quality and being kind to its students. Relationships between teachers, students and administrative and technical staff should be courteous and respectful, while respecting one another’s privacy. This also applies to inter-professional relationships, which are the basis for managing patients for the duration of their treatment.
12) Ethics Committee
An ethics committee is set up within the faculty in order to examine all issues relating to ethics and scientific and professional integrity, particularly any breaches of this charter. Any staff members or students may refer the matter to the ethics committee. The academics and president of this committee are elected. This committee includes members from outwith the faculty, including a student representative, a patient association representative, a representative for the Executive Director of the University Hospital and for the President of the Institutional Medical Committee of the University Hospital, and a member of the relevant board. Among the teaching members, there is at least one non-established teacher (Student Clinical Placement Coordinators, University Hospital Assistants). The scientific integrity point of contact is an ex officio member of the committee. The Ethics Commission prepares an annual report of its activities presented to the Research and Training Board and communicated to the Dean, who transmits it to the President of the University after consulting the Faculty Council.
13) Non compliance with the charter
This Charter is binding for all those within the faculty, regardless of their rank, status or where they are in the hierarchy. The faculty undertakes to refer any employee of the institution or student who has violated all or part of this Charter to the appropriate disciplinary authorities. The faculty undertakes to alert the supervisory authorities and the relevant professional boards in the event that it fails to comply with the points of the Charter that fall within the scope of a legislative or regulatory text. The faculty is committed to facilitating investigations on scientific and professional integrity, particularly those requested by scientific journals, learned societies and public institutions. These investigations must be carried out in accordance with the principle of the presumption of innocence, the rights of the defence and the protection of whistleblowers and copyright. The faculty is committed to implementing a global policy to combat reprehensible conduct: the process of receiving a complaint, the investigation process, the mediation system and handling plagiarism or fraud. It therefore undertakes to support or implement several processes including: retracting the publication, apologising, requesting disciplinary sanctions, issuing sanctions, reporting the issue to the relevant authorities and professional boards. In the face of a documented suspicion of improper conduct, academics and students are encouraged to approach the president of the ethics committee to determine whether or not an investigation should be conducted. The faculty undertakes that all its members will be informed about whistleblowers and the legislation in force. It undertakes to implement and promote these measures. The ethics committee is available to advise potential whistleblowers, including in situations that do not fall directly under the legal provisions. This Charter was adopted by the Research and Training Board on 20 December 2017.
- A link is a situation where partners have a common interest, in this case in developing health solutions. Without such a link, a partnership would not be possible. The link means that there is a mutual interest in working together on a scientific and intellectual project. A link of interest is therefore not only legitimate but also desirable for health progress. It is imperative to distinguish this concept from conflicts of interest. A conflict of interest arises from a situation where a public official has a personal interest that is likely to influence or appear to influence their impartiality and objectivity when carrying out their official duties. There is a “conflict of interest” when a person or an organisation is involved in multiple interests, whereby one of them could influence their motivation in acting on the others.
- The term teaching is associated with the three cycles of studies, as well as with continuing professional development.
- The term faculty council refers to the Research and Training Board as defined in the Education Code, as defined in Article L713-3.