Research ethics at Université Paris-Saclay : Operations and issues

Research Article published on 20 June 2024 , Updated on 20 June 2024

An essential practice and a major pillar of quality research, ethics guarantees the proper operation of research and the protection of its subjects. The protection of study participants and their data, the integrity and transparency of scientific procedures and questioning the value of pursuing certain studies are among the broad spectrum of practices in ethical research. At Université Paris-Saclay, these ethical questions and best practices in research are examined with the support of a Research Ethics and Scientific Integrity Council (POLETHIS) and several laboratories.

(This article was originally published in L'Édition No. 23)

In June 2023, Université Paris-Saclay reestablished its Research Ethics and Scientific Integrity Council (POLETHIS) with the aim of continuing its efforts to ensure responsible and ethical research practices within the University. To achieve this, POLETHIS relies on a research ethics committee, monitoring tools and education on major ethical scientific issues. It also uses a network connecting the various research units and teams whose areas of expertise fall within the ethics and integrity of scientific research. Founded in 2017, since June 2023, POLETHIS has been chaired by Nathalie Guichard, professor in management sciences at the Sceaux Technical Institute (IUT) and a member of the Network, Innovation, Territories, Globalization laboratory (RITM - Univ. Paris-Saclay).

The University's Research Ethics Committee: missions and operations

Serving as a consultative tool for researchers at Université Paris-Saclay who must ensure good ethical practices in their studies, the University's research ethics committee is tasked with issuing advisory opinions (favourable, for modification, unfavourable or for referral to the institutional review board named CPP) on the research projects reviewed. "The primary purpose of the research ethics committee is to give an ethical opinion on the research protocols carried out in the Université Paris-Saclay laboratories," summarises Bernadette Martins, chair of the Université Paris-Saclay research ethics committee and head of the biomedical research administration cell at the French An essential practice and a major pillar of quality research, ethics guarantees the proper operation of research and the protection of its subjects. The protection of study participants and their data, the integrity and transparency of scientific procedures and questioning the value of pursuing certain studies are among the broad spectrum of practices in ethical research. At Université Paris-Saclay, these ethical questions and best practices in research are examined with the support of a Research Ethics and Scientific Integrity Council (POLETHIS) and several laboratories. Alternative Energies and Atomic Energy Commission (CEA) Paris-Saclay.

In France, since 2012, the Jardé law concerning research involving human subjects has governed the legal framework for ethical research practice, particularly in biology or medicine, facilitated by the institutional review boards. "However, many research themes do not fit the definition set by the Jardé law. Studies in sociology, psychology, sciences and techniques of physical and sports activities (STAPS), virtual reality, the food industry, and studies on retrospective medical data involving volunteers, do not fall under the jurisdiction of the institutional review boards and the Jardé law. This is why ethics committees have been set up in France, especially in universities," adds the committee's chair. The University's research ethics committee has three main missions: to ensure that the research project under review is risk-free for its participants, who have been informed of the project's procedures; to approve research prior to publication in a scientific journal; and to advise project leaders. "Virtually no human research can be published in a scientific journal without the approval of a research ethics committee," explains Ouriel Grynszpan, a member of the Interdisciplinary Laboratory for Digital Sciences (LISN - Univ. Paris-Saclay, National Centre for Scientific Research or CNRS, CentraleSupélec, National Institute for Research in Digital Science and Technology or Inria) and administrator of the University's research ethics committee. "In behavioural sciences, STAPS (physical and sports sciences and techniques), cognitive sciences, for studies on nutrition or education, an opinion is required. But this is not the case for all disciplines. In computer science, it depends on the journal. However the ethics committee's opinion is increasingly required: studies in computer science and concerning new technologies often involve tests with users."

Nevertheless, the vast majority of studies reviewed by the University's ethics committee do not pose significant risks to their participants: "We are still required to protect study participants, to check that there are no risks and that these individuals have received clear and concise information about the study in which they are taking part, and about their rights in relation to their data. Generally, we deal with research presenting very little risk, and which is less intrusive than that reviewed by the institutional review boards," describes Bernadette Martins. Comprising about thirty members, the Université Paris- Saclay research ethics committee meets monthly to review studies requiring its opinion. "A file is evaluated by two rapporteur members. On the day of the meeting, the two members discuss the project and raise ethical issues with the rest of the committee. Following this, we issue an opinion that we send to the project leaders for corrections. The aim is to give a favourable opinion on the projects reviewed," explains Bernadette Martins.

Observation as an ethical and epistemological investigation

Vincent Israël-Jost is a member of the Research in Ethics and Epistemology team at the Centre for Research in Epidemiology and Population Health (CESP - Univ. Paris-Saclay, Université Versailles -St- Quentin or UVSQ, French National Institute of Health and Medical Research or Inserm). He dedicates his time to analysing scientific practices, especially in the medical field, and their transformations. Within this team, the researcher studies the relationship to medical observations, a theme through which, after initial studies in mathematics, he ventured into research in ethics and epistemology - the critical study of science and scientific knowledge. "I started by studying mathemat ics, somewhat by default," he says. “I did a hospital internship, working on medical imaging, particularly of beating hearts. It was from this internship and the resulting dissertation that I began to develop a philosophical investigation of imaging."

Vincent Israël-Jost then completed two theses: one in mathematics applied to single-photon emission computed tomography (SPECT), and a second, a few years later, entitled "L'observation scientifique: aspects philosophiques et pratiques" (Scientific observation: philosophical and practical aspects). “In the philosophy of knowledge, observation is a very important category to explain how we produce knowledge about the world," explains the researcher. "And observation comes into play very quickly in this process: whether it concerns astronomy, biology, etc., at some point you have to look at something. Observation acts as a point of contact with the world. Theories can then be inferred from these observations. And traditionally observation is conceived as visual, And traditionally, observation is conceived as visual, placing directly us in the presence of phenomena. So what about instruments such as radio telescopes, magnetic resonance imaging (MRI) and others? There has been much debate about the status of instruments, with many refusing to see them as means of observation, since they are objects saturated with theories, from their design to their use and the interpretation of the images produced. From my hospital internship, I felt the need to understand the role played by the image reconstruction and visualisation tools related to medical imaging instruments in the development of knowledge."

In the course of his research, however, Vincent Israël-Jost has noted the ambivalence surrounding the use of images from medical instruments that have a composite dimension, being both reflections of nature and calculated, recreated from scratch by algorithms." What struck me was the mistrust of certain institutions, especially scientific journals, towards these algorithmically - processed images. When you look at the recommendations of leading journals like Nature, you are advised not to use image and data processing if at all possible, or only as minimally as possible. There is a real concern about distorting or embellishing data with these image processing tools, which are nonetheless massively used and essential for visualising phenomena. It was this tension that interested me," explains the researcher. In addition to observation, objectivity is another concept that Vincent Israël-Jost studies. "I think that science suffers a lot from a poor conceptualisation of objectivity," explains the researcher. "It's a word everyone knows, loaded with connotations linked to precision science, experimentation and high technology in the collective imagination."

However, in the practice of science, objectivity also means questioning possible biases, at every stage of the scientific process. "For example, research can be biased because the question addressed is ultimately not very intelligent or relevant. There are some striking examples of this, notably those identified by researchers in feminist epistemology. One study showed that women were inferior to men in mathematics. Methodologically, this is an impeccable, statistically significant study. The result is objective according to the common imagination. But there was in fact a huge lack of objectivity in this study. What was the initial impetus? What was the purpose of this study? Doesn't this result mentioned in the study deserve to be put into perspective in light of what we know about our society, where, for instance, young boys are encouraged from an early age to take an interest in science and mechanics, unlike young girls?"

Vaccination and Covid-19: a timely field for ethical reflection

Alongside his interests in observation and objectivity, Vincent Israël-Jost and his colleagues from the Research in Ethics and Epistemology team have been conducting studies on this extraordinary Covid-19 health crisis and, more generally, on vaccination, since the start of the pandemic. These studies have led to the publication of a book, "Éthique vaccinale - ce que nous a appris la crise sanitaire" (Vaccine ethics – what the health crisis has taught us), co-written with Paul-Loup Weil-Dubuc, also a researcher with the Research in Ethics and Epistemology team. The book aims to address a burning public health issue as broadly as possible. "My main concern was to avoid blind spots," confirms Vincent Israël-Jost. "It was essential that this book, which deals with vaccination, covered all the major topics, including vaccine prioritisation, vaccine hesitancy and the impact of lockdowns."

To write this book, the two researchers consulted specialists, both academics and non-academics, with the aim of building a foundation of knowledge on the subject. "We were looking for scientific clarification," explains Vincent Israël-Jost. "For example, the notion of mRNA vaccines or the concept of vaccine efficacy was unknown to us. So our first step was to turn to infectious disease experts, as well as doctors and individuals from the voluntary sector, to build our understanding around vaccines." The result of a truly collective effort, the book - some chapters of which were written by the aforementioned specialists - was published in 2023.

"In ethics, the devil is in the detail"

Further into the premises of the Research in Ethics and Epistemology team, Fabrice Gzil, associate professor at the Faculty of Medicine of Université Paris-Saclay, reflects on how he came to work in this team, as well as serving as co-director of the Espace éthique Île-de- France - a genuine space for debate, reflection and the development of a ethics culture. "I was a secondary school philosophy teacher. I had a passion for the history of philosophy, but I wanted these reflections and concepts to be used in answering questions posed nowadays by biologists and doctors," says Fabrice Gzil. "At the time, the first drugs for Alzheimer's disease, cholinesterase inhibitors, were being synthesized. Some studies suggested that these drugs might be more effective on a certain sub-population, from a genetic perspective. The question then was: should we genotype every patient who comes in for a consultation and catalogue their genetic heritage before prescribing this drug? For the doctors I met at the time, it was obvious that a philosopher should come and reflect on these issues with them."

Since then, Fabrice Gzil has worked with biologists, doctors and nursing staff interested in Alzheimer's disease and, more generally, in ageing. "I wore a lab coat and attended biological experiments, but also consultations and routine care work. I followed the diagnostic testing sessions. I went to meet patients in their homes, or in nursing homes (Établissement d'hébergement pour personnes âgées dépendantes, EHPAD). I wanted to be immersed in the day-to-day, ‘practical’ life of this disease. My study focused on the issue of respecting autonomy when it’s weakened by illness," summarises the researcher. For around fifteen years, since his thesis defence in 2007, Fabrice Gzil has set out to study the research epistemology associated with this pathology and the many difficult ethical questions it raises. He closely monitored the many professions associated with the disease.

"My work has a lot consisted of going into the field in order to understand the specific nature of the different professions dealing with Alzheimer's disease. We know that 23 different professions work with patients and their families. There are nursing assistants, geriatricians, neurologists, but also notaries and legal representatives in charge of protective measures (guardianship, trusteeship). There are also occupational therapists, speech therapists and psychomotor specialists who can intervene as needed. I immersed myself in the problems that each profession encounters," explains Fabrice Gzil. He was in particular interested in the legal issues surrounding Alzheimer's disease. "The issues differ depending on the profession. Judges must determine whether a sick person needs legal protection. Notaries, for their part, must ensure that the person is still capable of carrying out a notarial act (such as a will or donation) with the necessary discernment. In medicine, it is often said that to be valid, consent must be enlightened, i.e. informed. My work with notaries has shown me how difficult it is to determine whether consent is free, i.e. not coerced. We need to be sure that the person, who is cognitively fragile, is not under the control of a third party who is exerting what we call undue influence over them."

For one year, Fabrice Gzil talked to notaries and carried out a survey among them. As a result of this work, and in collaboration with the Superior Council of Notaries (Conseil supérieur du notariat), he published a twenty-page brochure explaining to the notarial profession how to spot cognitive disorders in an person, and how to determine whether they have an impact on the ability to make decisions or whether the person is a victim of undue influence. "This work was presented at the Congress of Notaries of France (Congrès des notaires de France) in 2020 and is now part of their heritage and their way of thinking. So this involves ethics but also, through objects like this brochure, means those ethics are applied. Working alongside notaries, geriatricians and all the other professions involved in Alzheimer's disease, we have developed concepts and ideas that have enriched ethical and philosophical thinking. It's through this immersion, by 'rubbing shoulders' with all these realities, that ethical and philosophical concepts are reinvented," summarises Fabrice Gzil.

As part of the Global Citizens Assembly on Genome Editing programme, organised by the United Nations (UN), Espace éthique Île-de-France has held a series of citizen debates on genome editing and its applications in various disciplines (agriculture, health, etc.). Fabrice Gzil and his colleagues used this opportunity to invite students from secondary schools in the Île-de-France region to take part in the debates. "We provided students with a documentation pack and organised meetings with genome experts to prepare presentations. We put together comprehensible summaries covering advances in genome editing, the key figures in this field, the types of problems that genome editing could solve, etc. Even though our aim was to educate, we were careful not to over-simplify the presentations. Because in ethics, the devil is in the detail. This enabled us to stimulate debate, teaching secondary school students how to debate democratically and critically, to listen to and learn from each other," shares the researcher. The students then participated in creating a map of controversies on the subject, representing the issues raised during the debates. According to Fabrice Gzil, this exercise was particularly interesting because it gave voice to a population that is often overlooked in public spaces: "Genome editing may have an impact on future generations. Yet younger generations are not always involved in bioethics debates. These meetings are a way of imparting debate skills to future citizens, and gathering their views on these complex issues," he concludes.

References