Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Mar;25(1):23-30.
doi: 10.1007/s11019-021-10060-1. Epub 2021 Nov 17.

Controversies between regulations of research ethics and protection of personal data: informed consent at a cross-road

Eugenijus Gefenas  1 , J Lekstutiene  2 , V Lukaseviciene  3 , M Hartlev  4 , M Mourby  5 , K Ó Cathaoir  4
Affiliations

Controversies between regulations of research ethics and protection of personal data: informed consent at a cross-road

Eugenijus Gefenas et al. Med Health Care Philos. 2022 Mar.

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.

Keywords: General data protection regulation; Informed consent; Research ethics; Research ethics committee.

PubMed Disclaimer

References

    1. Aitken M, de St. Jorre, J., Pagliari, C. , et al. Public responses to the sharing and linkage of health data for research purposes: A systematic review and thematic synthesis of qualitative studies. BMC Medical Ethics. 2016;17:73. doi: 10.1186/s12910-016-0153-x. - DOI - PMC - PubMed
    1. Article 29 Working Party. 2018. Guidelines on Consent under Regulation 2016/ 679’ WP 259 rev.1, as last revised 10 April 2018. https://ec.europa.eu/newsroom/article29/items/623051. Accessed June 7, 2021.
    1. Council for International Organizations of Medical Sciences (CIOMS). (2016). International ethical guidelines for health-related research involving humans (4th ed.). Geneva: CIOMS. https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf. Accessed June 7, 2021.
    1. Council of Europe. Recommendation CM/Rec (2016)6 of the Committee of Ministers to Member States on Research on Biological Materials of Human Origin. https://search.coe.int/cm/Pages/result_details.aspx?ObjectId=09000016806.... Accessed June 7, 2021.
    1. Dove ES, Chen J. Should consent for data processing be privileged in health research? A comparative legal analysis. International Data Privacy Law. 2020;10(2):117–131. doi: 10.1093/idpl/ipz023. - DOI

LinkOut - more resources