Clinical research

These are scientific studies involving human participants, with the goal of advancing medical or biological knowledge. They are prospective in nature and often involve long-term follow-up of patients (or healthy volunteers, outside oncology). There are three categories of RIPH, mainly differing in:

• The type of intervention required by the study (whether or not it alters usual patient care);
• The level of risk or burden for participants.

All clinical studies must:

• Be sponsored by an organization (sponsor) responsible for managing the study and ensuring compliance with ethical and scientific standards;
• Obtain approval from an independent ethics review board (called a “Comité de Protection des Personnes” in France);
• Be authorized by the French Data Protection Authority (CNIL) for the handling of personal health data, or follow a designated reference methodology.

Each study is led by a principal investigator, who is responsible for:

• Clearly informing potential participants about the study’s purpose, methodology, potential benefits, risks, and their rights (including the right to refuse or withdraw at any time);
• Collecting informed consent from each participant. Depending on the study’s category, this may require signed written consent or a simple non-objection.

Category 1 - Interventional research

Category 1 interventional studies involve procedures that carry a certain level of risk for participants and are not justified by their standard medical care. Previously referred to as biomedical research, this category primarily includes studies on medications, but may also involve surgical procedures or medical devices. Category 1 studies are subject to strict regulations and must receive approval from the French National Agency for the Safety of Medicines and Health Products (ANSM).

Category 2 – Interventional research with minimal risk and constraints

These studies may involve minimal-risk procedures or non-invasive interventions, as defined by official guidelines (for example, limited-volume blood samples). Medications or healthcare products may be used, but only within their standard conditions of use, and not as the main focus of the study. This category includes what used to be referred to as research on standard care practices. Participants face minimal additional burden or risk.

Category 3 – Non-interventional research

Despite their name, non-interventional studies (Category 3) may still include certain procedures or actions defined by regulatory decree. However, they are considered risk-free and do not alter the participants’ usual care. All procedures performed and products used are part of standard clinical practice. This category includes observational studies such as those evaluating treatment adherence, or monitoring drug safety after market approval.