Filters

2021 - 20232

More filters

2022 - 20232
Reset filters

Settings

Subject: informed consent ×

Search Results

Now showing 1 - 2 of 2
  • Thumbnail Image
    Item
    Information Provision for Informed Consent Procedures in Psychological Research Under the General Data Protection Regulation: A Practical Guide
    (Thousand Oaks, CA : Sage Publishing, 2023) Hallinan, Dara; Boehm, Franziska; Külpmann, Annika Iris; Elson, Malte
    Psychological research often involves the collection and processing of personal data from human research participants. The European General Data Protection Regulation (GDPR) applies, as a rule, to psychological research conducted on personal data in the European Economic Area (EEA)—and even, in certain cases, to psychological research conducted on personal data outside the EEA. The GDPR elaborates requirements concerning the forms of information that should be communicated to research participants whenever personal data are collected directly from them. There is a general norm that informed consent should be obtained before psychological research involving the collection of personal data directly from research participants is conducted. The information required to be provided under the GDPR is normally communicated in the context of an informed consent procedure. There is reason to believe, however, that the information required by the GDPR may not always be provided. Our aim in this tutorial is thus to provide general practical guidance to psychological researchers allowing them to understand the forms of information that must be provided to research participants under the GDPR in informed consent procedures.
  • Thumbnail Image
    Item
    Data Sharing Under the General Data Protection Regulation: Time to Harmonize Law and Research Ethics?
    (Baltimore, Md. : Williams & Wilkins, 2021) Vlahou, Antonia; Hallinan, Dara; Apweiler, Rolf; Argiles, Angel; Beige, Joachim; Benigni, Ariela; Bischoff, Rainer; Black, Peter C.; Boehm, Franziska; Ceraline, Jocelyn; Chrousos, George P.; Delles, Christian; Evenepoel, Pieter; Fridolin, Ivo; Glorieux, Griet; van Gool, Alain J.; Heidegger, Isabel; Ioannidis, John P. A.; Jankowski, Joachim; Jankowski, Vera; Jeronimo, Carmen; Kamat, Ashish M.; Masereeuw, Rosalinde; Mayer, Gert; Mischak, Harald; Ortiz, Alberto; Remuzzi, Giuseppe; Rossing, Peter; Schanstra, Joost P.; Schmitz-Draeger, Bernd J.; Spasovski, Goce; Staessen, Jan A.; Stamatialis, Dimitrios; Stenvinkel, Peter; Wanner, Christoph; Williams, Stephen B.; Zannad, Faiez; Zoccali, Carmine; Vanholder, Raymond
    The General Data Protection Regulation (GDPR) became binding law in the European Union Member States in 2018, as a step toward harmonizing personal data protection legislation in the European Union. The Regulation governs almost all types of personal data processing, hence, also, those pertaining to biomedical research. The purpose of this article is to highlight the main practical issues related to data and biological sample sharing that biomedical researchers face regularly, and to specify how these are addressed in the context of GDPR, after consulting with ethics/legal experts. We identify areas in which clarifications of the GDPR are needed, particularly those related to consent requirements by study participants. Amendments should target the following: (1) restricting exceptions based on national laws and increasing harmonization, (2) confirming the concept of broad consent, and (3) defining a roadmap for secondary use of data. These changes will be achieved by acknowledged learned societies in the field taking the lead in preparing a document giving guidance for the optimal interpretation of the GDPR, which will be finalized following a period of commenting by a broad multistakeholder audience. In parallel, promoting engagement and education of the public in the relevant issues (such as different consent types or residual risk for re-identification), on both local/national and international levels, is considered critical for advancement. We hope that this article will open this broad discussion involving all major stakeholders, toward optimizing the GDPR and allowing a harmonized transnational research approach.