The research participant's informed consent form does not have a uniform, standard form. In addition to the elements necessary to participate in the study, the form should also give the study participant the opportunity to express a declaration of will regarding the use of scientific results and his or her personal data in the future.

In addition to obtaining the participant's consent to participate in the study and the future use of scientific data, a separate issue is obtaining consent to the processing of personal data.

For consent to be considered adequate under the GDPR, it must be given freely, consciously, specifically and with an unambiguous indication that the individual wishes his or her data to be processed.

The GDPR defines such consent as "specific" and it is important to understand what this means in practice.

The specificity of consent means that the person from whom the data is collected, or more precisely the "data subject", understands what is being collected and how it will be used. The data subject must have choice and control over what he or she decides to provide to the researcher and for what purpose. Therefore, consent cannot be presumed or implied from a declaration of will with other content.

Consent must be related to one or more specific purposes, which must then be sufficiently explained.

At the time of data collection, the purpose of processing personal data for future scientific research often cannot be fully identified. Therefore, data subjects should be able to consent to certain areas of research or elements of research projects, provided that the intended purpose allows for this, provided that the research complies with recognized ethical standards for research.

If consent is to legitimize the processing of special categories of personal data, information to the data subject must clearly refer to this.

Pursuant to Art. 9 GDPR, the processing of special category personal data is prohibited. Unless the data subject:

  • has given informed consent to the processing of this personal data for one or more specific purposes, and
  • processing is necessary for the purposes of scientific research, provided that appropriate technical and organizational safeguards are taken to ensure compliance with the principle of data minimization and pseudonymization.

As in the case of consent to the use of personal data, the purpose of using scientific data in the future can also be specified in detail.

Information obtained in connection with a medical experiment or screening test may be used for scientific purposes without the consent of the participant in a way that prevents his/her identification.

It should also be remembered that for consent to be expressed correctly, the informed consent form should be personally signed and dated before the person who is to participate in the study actually starts participating in it or, in the case of a minor, by his or her legal representative.

Failure to properly address consent issues may limit the ability to publish results, use and share data in the future.