Welcome to the second episode of Cogitons Sciences, the podcast that deciphers science issues! Our guests Virginie Rage Andrieu, president of the National Conference of Personal Protection Committees, and Hervé Chneiweiss, president of the Inserm Ethics Committee, detail the functioning of medical research and its supervision.
How does the medical research sector work in France? Which bodies ensure that a form of ethics is respected? Should we set limits to research?
To answer these questions, Techniques de l’Ingénieur receives two guests. Virginie Rage Andrieu is the president of the National Conference of Committees for the Protection of Persons. She is also a member of the National Commission for Research Involving the Human Person at the Ministry of Health and she is also a lecturer in health law and pharmaceutical law. Hervé Chneiweiss is the Chairman of the Ethics Committee of Inserm (National Institute for Health and Medical Research). He is also president of the UNESCO International Bioethics Committee and works as a neurobiologist and neurologist.
Medical research, a supervised sector [1:45] – [14:08]
There are many steps between starting a research and marketing a drug or health product. For research on human beings to begin in France, it must be validated upstream by a Committee for the Protection of Persons (CPP). Ethical principles, such as respect for the human body, the processing of personal data, and the balance of benefits and risks reduced to a minimum, must be respected. The ANSM (National Agency for the Safety of Medicines and Health Products) must also give its approval. She will also be responsible for verifying that the validated protocols are respected in practice. [1:45].
Upstream of these questions, Inserm’s Ethics Committee may be called upon to examine the ethical questions raised by research. It is made up of experts in medicine, biology, but also in human sciences and philosophy. Working groups do not determine “What to think” but give “Food for thought” to researchers [9:23].
Is our research practice ethical? [14:08] – [27:43]
Much of medical research relies on clinical trials, but is it ethical to perform tests on humans? For Virginie Rage Andrieu, it is to imagine marketing drugs without prior tests that would not be ethical. Hervé Chneiweiss shares a revelation: “Man is not a mouse”. Thus, animal testing is not enough, we need proof of efficacy and safety, and that is why all tests are tightly supervised. [14:08].
From the point of view of the protection of private life, the data collected by the investigation centers are “pseudonymized” and the research promoters only receive codes. Participants in clinical trials are informed of their rights, can influence the processing of their data and can withdraw their consent at any time [20:23].
Hervé Chneiweiss acknowledges that France quickly set up consultative committees and laws to oversee research, which are constantly evolving. This is why from now on, the CPPs no longer evaluate the files dependent on their university, in order to limit the links of interest. [22.54].
Covid-19: urgent research [27:43] – [34.02]
From the start of the Covid-19 crisis, it was quickly decided not to alter the rigor of the assessment processes and therefore not to skip any steps. On the other hand, an acceleration of the processes was possible. Thus, the processing of files by the CPPs has been accelerated with direct dialogues between evaluators and research promoters. [27:43].
Hervé Chneiweiss thinks it is too early today to know if there were any ethical breaches during the crisis. On the other hand, he points to the lack of accessibility to the vaccine for many people, which is the major ethical question today. [32:10].
Should we limit the search? [34:02] – [41:01]
According to Hervé Chneiweiss and Virginie Rage Andrieu, research is already limited by many laws. However, an international consensus is more complex, even if there are laws at the European level. [34:02].
- CRISPR-Cas9 scissors – work by Emmanuelle Charpentier and Jennifer Doudna, 2020 Nobel Prize in Chemistry
- Huriet-Sérusclat Law (1988) relating to the protection of persons
- Oviedo Convention (signed in 1997)
- Charter of Fundamental Rights of the European Union (2000)
Resources to go further:
- Unnatural Selection documentary series
- Emmanuel Hirsch’s Treatise on Bioethics
Cogitons Sciences is a podcast produced by Techniques de l’Ingénieur. This episode was produced by Alexandra Vépierre, in collaboration with Intissar El Hajj Mohamed. The credits were produced by Pierre Ginon and the visual for the podcast was created by Camille Van Belle.