Invited to health research: what should the information sheet explain?

If you are invited to health research, ask the team to identify its legal framework. These notes concern research involving human participants (RIPH) governed by French law; medicine trials and some medical device studies follow other rules.

In the information sheet, find the purpose, method and duration of the research. For interventional research, ask about expected benefits, demands, foreseeable risks, possible alternatives and the medical care planned if the study stops.

The form of agreement depends on the type of RIPH: written consent for some interventional research and express consent for research with minimal risks and demands. Non-interventional research cannot take place if you object. Ask which type is being proposed.

You can decline to participate or withdraw consent at any time, without liability or detriment because of that choice. Ask how to contact the team to communicate it and what follow-up arrangements are planned if your participation stops.

Withdrawing consent does not undo activities already performed or the use of data obtained on the basis of earlier consent. Ask about the rules for processing your data and the rights applicable to this research, rather than assuming automatic deletion.

The information sheet explains how to learn the overall results when the research ends. You also have a right to information about your health held by the team during or after the study. Keep the document and the team’s contact details to ask for these explanations.