2015 Modalities of consent

COREON session at WEON ‘Healthy Living’ 26 June 2015: Modalities of Consent
Marjanka Schmidt, Evert-Ben van Veen, Susanne Rebers, Bart van der Sloot

The COREON session at WEON 2015 was focused on the modalities of consent. This is a very timely subject in light of Europe’s General Data Protection Regulation (GDPR) discussions. The session included three presentations:

  1. Modalities of consent and their consequences – Evert-Ben van Veen
  2. A randomized controlled trial comparing consent procedures for the use of residual tissues: implications for patients, research, and clinical practice – Susanne Rebers, Alexander Brandenburg, Eric Vermeulen, Neil Aaronson, Flora van Leeuwen, Marjanka Schmidt
  3. Privacy as societal value – Bart van der Sloot

Consent can range from layered consent, to broad consent, to various opt-out mechanisms to no consent at all, as is the case in notifiable communicable diseases. Concentrating on data, mr. Evert-Ben van Veen discussed how the learning health care system is challenging the paradigm of informed consent. In the learning health system at start of data collection there are often no clear, well-defined questions (endpoints). Compared to intervention studies there is no physical harm. Medical confidentiality is not undermined by 'further use' of patient data for a learning health care system if certain safeguards are met. Importantly, informed consent does not work to protect against misuse of data in observational research, while fair use of data does protect. It is the responsibility of researchers to set up governance and data safety. Then we can sustain a solidarity-based learning health care system.

In the discussion about informed consent, there are several stake-holders, i.e. patients, researchers and clinicians. However, there is little evidence about the implications of the different consent procedures regarding use of residential tissue for research for patients, research, and clinical practice Dr. Rebers discussed the results of a randomized controlled trial, in which three consent procedures: opt-out (control group), written informed consent, and opt-out plus, an intermediate procedure in which an opt-out procedure is combined with active information provision to patients, were compared. Patients indicated to be most satisfied with the informed consent and opt-out plus procedures. Importantly, none of the patients in the opt-out arm, and just one patient in the opt-out plus arm, objected to the use of their tissue. However, in the informed consent arm, 39.1% did not return the consent form; not actively objecting, but nonetheless rendering their tissue non-accessible for research because explicit consent is lacking. This advocates against the introduction of informed consent for all secondary use of tissue.

Dr. Bart van der Sloot argued that we the current legal and social paradigms are no longer fit for today’s world of big data, and we need to creatively think about new views. In legal terms, privacy is currently primarily viewed as an individual right protecting individual values such as human dignity, individual autonomy and personal freedom. Current technological developments, known as Big Data, challenge these fundaments. First, many individuals are unaware that their data are gathered and processed by others, who have gathered information via, inter alia, secret surveillances activities, cookies, Google glasses or other means. As they are unaware of this fact, they will not claim their legal rights. But even if they would be aware, in the age of Big Data, data gathering and processing is so omnipresent that it will be undoable for individuals to assess every data processing activity and check whether their personal data are processed, whether this is done according to the applicable legal standards and if this is not the case, to file a court case. Importantly, many of the current data processing activities do not specifically affect individuals. There is a general shift from individual to group and societal interests. Focusing on consent-procedures for the (re-)use of, inter alia, DNA, body material and test results of specific patients is misguided. The protection of privacy should not be the right of an individual patient; it should be a duty of the doctor and the healthcare sector in general.

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