Biobanking from an Ethical and Legal Patient Perspective

Last year the New York Times confirmed what the majority of people were already thinking in relation to terms and conditions. It was calculated that it would take 76 working days to familiarize yourself with all the digital privacy policies of your downloaded applications during a year and therefore how can someone possibly read them all. Therefore it is important in medical research that we prevent that consent is signed, but the actual content is not understood or not read at all when we ask patients to donate tissue or blood and share phenotypical data.

Put simply, saying that you have consent from the patient or donor to use their material is simply not good enough. The reality is that within GDPR consent is only one of 6 requirements for legally processing personal data. Other grounds in Europe include (GDPR.EU):

•          The performance of a contract
•          To necessary comply with legal obligation
•          Necessary to protect the vital interest of the patient/donor
•          Necessary for a task in the public interest
•          Necessary for legitimate interests of the controller of a third party

Researchers will still need to inform participants about what they are doing and obtain consent, as required in order to get ethical approval.

With the launch of GDPR in May 2018 some aspects of privacy and the position of patients were closely looked into by the biobank community. With specific focus to pseudonymization and anonymization; if data is anonymous it falls outside GDPR and should be helpful for biobanks, but where this is true, extreme caution is required.  Anonymity is by no means a fixed concept, and with datasets continually being linked and with technology developing, what is anonymous today will not necessarily be anonymous tomorrow.

Data-management solutions like Platform for Science can help; users can manage and track informed consent status, anonymize patient information and blind clinical relevant data. In combination with Thermo Scientific Matrix 2D barcoded tubes you can monitor both samples as data at every step of the process, including who was working on the material, if the proper training was received and the cold storage solutions used are calibrated. In addition, more and more discussions with regards to ‘incidental findings’ and disclosing information to participants might be beneficial, but it may also be harmful or even unwanted. This can only be done if there is some mechanism in place to re-identify the patient or donor.

Keeping the patient onboard and as informed as possible is a key aspect here for biobanks. They commit their time, input and in some cases material for research and have to understand what they commit to. Some years ago, the terms and conditions of some companies where longer then Shakespeare’s Hamlet and one had more words than Macbeth. Let’s not make it this complex for those that are supporting science to the benefit of a larger group of patients.

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