NuGO Guideline 2

Informed consent

Content of the consent form for a nutrigenomics study

The signed consent form serves as a record of the information conveyed to the participant and documents the individual having agreed to participate in the study.

It should therefore either include or refer to the information sheet giving all information mentioned in Guideline 1 and also the following statements:

  • the research volunteer has read and understood the information sheet of the study
  • the research volunteer had enough time to read the information sheet and the opportunity was given to ask questions
  • the participation is voluntary
  • the research volunteer is free to withdraw consent at any time, without giving any reason, and without medical care or legal rights being affected
  • the research volunteer agrees to take part in the study

Where appropriate, the following aspects are recommended to be included in the signature form (optional):

  • the research volunteer understands his/her sample being used for genotype analyses
  • options to what extent the research volunteer wants to be informed about the test results (not applicable if it is not planned to disclose test results individually)
  • permission to use medical records or other sources of medical information (e.g. cancer registries)
  • interest in participation in further nutrigenomics studies