Privacy and confidentiality

Privacy of personal information and data protection

Personal information collected in the course of biomedical research must be considered confidential and protected accordingly. For this reason, the data should be stripped of identifiers, as much as possible and as soon as possible.

Data protection and privacy issues should be described in detail already in the application. If you collect private information (such as lifestyle data, drinking habits, health status, etc) you need to:



  1. Describe exactly what type of data will be collected. If personal data will be collected, justify the nature and degree of identifiability. State that only relevant data will be collected and this will not be more than needed for the research study.
  2. Explain how and where the data will be stored, as well as for how long and what will happen with the data after the completion of research?.
  3. Clarify whether the data will be fully anonymised (the process of anonymisation involves stripping the data of all identifiers, future identification is no longer possible) or only coded (the anonymisation can be made reversible, link to the data will be kept, future identification is possible). If the data will not be fully anonymised, explain why you cannot anonymise the data (e.g. you need to recontact the participants or do follow-up in case of long-term study). If the data will be coded, describe the coding system, and who will have access to the code.
  4. Explain how you will ensure the confidentiality of any information collected and how any link to the subject will be handled if not fully anonymized. Confirm that it cannot be tracked back to individuals unless essential for the study.
  5. Explain if any information could lead to stigmatization, depending on how it is collected.
  6. Indicate if you intend to archive the data and/or biological materials for further uses.
  7. Indicate if you intend to use the data for commercial purposes.
  8. Show how the participants’ right to know and right not to know any information collected about their health will be respected.