Good Practices at Inserm

Good ethical practices and professional conduct in health research contribute not only to building open and responsible science, but also to preserving community trust in scientific activity. Inserm implements the means and structures that enable these good practices.

Science is a common good that serves the collective interest and is based on trust in its objectives, methods, and results. To preserve this trust, Inserm contributes to the continuous development of requirements in terms of health research ethics and professional conduct. It plays a particular role in bringing French research up to international standards of good ethical practice and professional conduct, where needed. Inserm defines and implements a resolute policy on multiple levels.

Facilitation of ethical reflection in Inserm’s fields of activity

The Inserm Ethics Committee facilitates consideration of the ethical questions raised by research. It may be consulted by all Inserm staff, by the Directorate General, or it may decide to debate an issue unilaterally.

The Inserm Ethics Committee addresses issues such as human embryo research, genome modification, links between gender and health research, research in resource-limited countries, and access to innovation. It comprises Theme-Based Think Tanks that evolve in line with the emerging issues.

Research integrity and professional ethics

Inserm’s Office for Research Integrity handles reports on and responds to queries regarding scientific integrity. It also proposes prevention policies, promotes good practice, and participates in relevant national and international initiatives.

Inserm also has a Professional Ethics Board which fulfils a triple mission, advising on good professional conduct, secular matters, and whistleblowing.

Protection of personal data

Inserm generates and processes large amounts of personal data, which are utilized with the utmost rigor in compliance with the GDPR and French Data Protection Act. The Data Protection Officer (DPO) uses a network of advisors and coordinates the Inserm GDPR compliance process in conjunction with the various players involved in producing and processing these data.

Transparency of clinical trials and other research

Inserm, by signing the Joint statement on public disclosure of results from clinical trials promoted by the World Health Organization, undertakes to disclose the results of the clinical trials it sponsors, as well as those of all of the other research projects for which it is responsible.

Ethical evaluation of research directly or indirectly involving human subjects

Inserm places at the disposal of its researchers (and those of other organizations) an Ethics Evaluation Committee (EEC) that complies with the standards of the Institutional Review Boards and is registered as such, capable of evaluating research projects that do not fall within the French legal framework of « research involving human subjects » but which include humans. The Institute encourages the systematic prior review of this type of research by compliant EECs.

Sharing research findings and data

Inserm supports the sharing of research findings, notably through open access to publications (Plan S).

The Institute also supports the sharing of research data, particularly « individual patient data » from clinical trials and other research, or collections made for biobanks. This sharing takes place in compliance with the rules of personal data protection and the rights of the parties concerned (according to the terms of the Joint statement on public disclosure of results from clinical trials).

Information and training in the rules of good practice

Inserm is actively involved in informing the public and in training its staff in the rules of good ethical practice and professional conduct.

The Ethics and Animal Models Office promotes and supports the dissemination of good practices in animal experimentation. It helps with the design and implementation of projects in which animals are used for scientific purposes. It promotes staff training, animal welfare considerations, and the principles of the 3Rs (Replacement, Reduction, and Refinement).

The Ethics and Animal Models Office also participates in providing information on the conditions of use of animal models in scientific research, for example through the following articles: