It also applies to the processing of personal data by a controller or processor not located in the EU when the data processing is related to: (a) Offering goods or services to participants in the EU, or (b) Monitoring of behaviour of participants within in the EU, as far as their behaviour takes place in the EU. [...] The elements related to data privacy that must be included in the participant information and consent form include: Identity and the contact information of the data controller (also referred as the sponsor for clinical trials) Contact information for the data protection officer (DPO) (generally the EU DPO will be listed, but the details for MCRI’s Privacy Officer may also need to be included). [...] An explanation as to the legal basis for the processing (e.g., whether the data is being processed based on consent and/or other legal bases set out under the GDPR) Informing participants of the existing of their Individual Data Subject Rights, and how they may be exercised: - The right to access the data - The right to object to processing - The right to erasure (i.e., The right to be ‘forgot. [...] Exemption - Individual Data Subject Rights The GDPR grants individuals new or improved rights in relation to their personal data, including: The right to access the data The right to object to processing The right to request that the data be deleted (i.e., The right to be ‘forgotten’) The right to request that the processing of the data be restricted; and The right to request the rectifi. [...] In a medical research project setting, should a participant request that their data be withdrawn from a project, the data collected up until that point may not be required to be deleted, even if the participant expressly states that it is his/her “right to be forgotten”, as deleting such information may seriously impact the integrity of the data or impair the achievement of the research purpose.
Authors
- Pages
- 7
- Published in
- Australia
