Recommendations for Creating Codes of Conduct for Processing Personal Data in Biobanking Based on the GDPR art.40.

Dorota Krekora-Zając,Jakub Pawlikowski,Błażej Marciniak

doi:10.3389/fgene.2021.711614

Dorota Krekora-Zając, Jakub Pawlikowski + Show 1 more

Open Access

https://doi.org/10.3389/fgene.2021.711614

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Abstract

Personal data protection has become a fundamental normative challenge for biobankers and scientists researching human biological samples and associated data. The General Data Protection Regulation (GDPR) harmonises the law on protecting personal data throughout Europe and allows developing codes of conduct for processing personal data based on GDPR art. 40. Codes of conduct are a soft law measure to create protective standards for data processing adapted to the specific area, among others, to biobanking of human biological material. Challenges in this area were noticed by the European Data Protection Supervisor on data protection and Biobanking and BioMolecular Resources Research Infrastructure–European Research Infrastructure Consortium (BBMRI.ERIC). They concern mainly the specification of the definitions of the GDPR and the determination of the appropriate legal basis for data processing, particularly for transferring data to other European countries. Recommendations indicated in the article, which are based on the GDPR, guidelines published by the authority and expert bodies, and our experiences regarding the creation of the Polish code of conduct, should help develop how a code of conduct for processing personal data in biobanks should be developed.

Highlights

The last few decades have seen a dynamic development of biobanks collecting human biological material and data that broaden knowledge about genetic, behavioural, and environmental determinants of many diseases, support the development of new biomarkers and drugs and improve medical care toward more personalised medicine (De Souza and Greenspan, 2013; Paskal et al, 2018; Malsagova et al, 2020)
Biobanks are defined as collections of human biological material and data (McNally and Cambon-Thomsen, 2005; OECD, 2009; Taipei, 2016), and data collecting, processing and sharing constitute a vital part of human biological material (HBM) biobanking for scientific research purposes (Molnár-Gábor and Korbel, 2020)
That seems why the General Data Protection Regulation (GDPR) developers predicted the possibility of further supplementing the regulation and the development of bottom-up and sector-based regulations of the codes of conduct based on GDPR art. 40

Summary

INTRODUCTION

The last few decades have seen a dynamic development of biobanks collecting human biological material and data that broaden knowledge about genetic, behavioural, and environmental determinants of many diseases, support the development of new biomarkers and drugs and improve medical care toward more personalised medicine (De Souza and Greenspan, 2013; Paskal et al, 2018; Malsagova et al, 2020). Exceptions can be stipulated in the national law concerning data processing for scientific research purposes by limiting the right of access The code provisions fulfil an essential role because the code describe exceptions acceptable by the national law and situations in which the laws are likely to prevent or hamper the implementation for specific scientific purposes An example of such exception the regulation of the Polish code of conduct on the right to rectification of the data included in the medical documentation can be given as an example. Groups. 4) Clear layout and understandable language. 5) Taking into consideration different guidelines on scientific research bioethics and ethics

DISCUSSION

CONCLUSION