Abstract
This paper explores some key discrepancies between two sets of normative requirements applicable to the research use of personal data and human biological materials: (a) the data protection regime which follows the application of the European Union General Data Protection Regulation (GDPR), and (b) the Declaration of Helsinki, CIOMS guidelines and other research ethics regulations. One source of this controversy is that the GDPR requires consent to process personal data to be clear, concise, specific and granular, freely given and revocable and therefore has challenged the concept of ‘broad consent’, which has been widely applied in the context of biobanking. Another source of controversy is the interplay between regulations of research ethics and protection of personal data related to the secondary use of personal data and biological materials. In this case, the GDPR ‘research condition’ provides an alternative to re-consent for the use of previously collected personal data and biological materials. Although the mentioned controversies have been raised in the legal literature, they have not been explicitly addressed from the research ethics perspective. Should consent be regarded as a priority legal basis for personal data processing in health data research? Can broad consent still be a suitable legal ground for biobanking? What should be the role of research ethics provisions that differ from the GDPR standards, and what should be the role and function of research ethics committees in the changing environment of health data research? These are the ongoing controversies to be explored in the paper.
Highlights
Informed consent remains a fundamental normative core of such well known legally non-binding global research ethics guidelines as the WMA Declaration of Helsinki (WMA (World Medical Association) 2013) and the Council for International Organizations of Medical Sciences (‘CIOMS’)
It should be noted that another alternative to re-consent based on the Article 9(2)(i) of the General Data Protection Regulation (GDPR), which allows exemptions from the explicit consent when “processing is necessary for reasons of public interest in the area of public health”, has recently been relevant due to the urgency of health data sharing in the context of research aimed at developing COVID-19 diagnostics, therapies and vaccines (Staunton 2021)
The GDPR has not been introduced as a research regulatory instrument (Slokenberga et al 2021), it has significantly shaped the conduct of scientific research in the EU in its attempt to harmonize two important but at the same time sometimes conflicting goals: first, giving European citizens more control over their personal data, and second, ensuring more flexibility in data processing in the context of research activities
Summary
Due to the mentioned difficulties in complying with the stringent GDPR concept of consent in health data research, the European Data Protection Board (EDPB) (EDPB 2019) and national bodies like Medical Research Council (MRC (Medical Research Council) 2020) and Health Research Authority in the UK (HRA (Health Research Authority) 2018), recommend choosing other legal bases for data processing than consent. The Article 29 Working Party provides an explanation of such a “stricter interpretation” of consent, which requires a continuous process of specification of consent by means of re-consenting for each subsequent step of the research project This interpretation seems to be in line with new interactive approaches, such as dynamic consent (Teare et al 2021). It has even been argued that incidental findings should not be seen as an unnecessary obstacle to biobanking, but rather as an incentive that could increase people’s motivation to donate their biological materials and data to biobanks (Lekstutiene et al 2021) All these attempts to find alternatives or to further develop the concept of broad consent show that there is a continuing discrepancy between its interpretations in the legal dogmatic and the broader academic literature
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