Data is knowledge and innovation, ensuring scientific progress. 1 By coupling information from registries, researchers can obtain new knowledge of great value with regard to widespread medical conditions such as cardiovascular disease, cancer and depression. Complex legal issues in relation to further processing for research purposes. 5 (1) (b) & 89 (1) GDPR); if the data are not obtained directly from the individual, the GDPR also relaxes the normal transparency requirements. In effect in order to use personal data for research you need two bases; the legal basis (GDPR) and the ethical basis (informed consent). Vulnerable groups have been impacted disproportionately: even. If you are involved in any kind of scientific research, it is very likely that you are affected by the GDPR provisions. We provide some general pointers below to help demystify the GDPR and explain its impact. For example: the GDPR allows lawfully collected data (, if the data are not obtained directly from the individual, the GDPR also relaxes the normal transparency requirements. In this article, we look at the impact of the GDPR on scientific research based on a report prepared for the European Parliamentary Research Service. Oftentimes, it will not be the GDPR that restricts the sharing of health data, but rather the stricter and/or ill-adapted national rules that deviate from the GDPR. As noted in our recent blog post, they do not believe that data protection laws have been an impediment to “national approaches to sharing public health messages; of using the latest technology to facilitate safe and speedy consultations and diagnoses; and of creating linkages between public data systems to facilitate identification of the spread of the virus”. The GDPR provides for aresearch exemption in Article 89 GDPR, inter alia for scientific and research purposes. 1Where personal data are processed for scientific research purposes, this Regulation should also apply to that processing. 17(1)(c) and 17(3)(d) GDPR). Excessive burden on researchers, which could lead to delays in project development, Dynamic consent is not compatible with consent requirements under the GDPR, Pseudonymised data may trump epidemiologic research, Lack of clarity regarding the processing of children’s data, Bureaucratic burden and extra need for human, administrative and financial resources and data protection expertise, Lack of guidance or contradicting guidance issued by various supervisory authorities, especially in relation to best practices of anonymisation and pseudonymisation, Ambiguity regarding the applicable lawful grounds and the role of ‘public interest’, Specific provisions and challenges in certain areas of research, including genomic research, Need for specifying the appropriate measures and safeguards for data security. The GDPR aims to establish a uniform legal framework applicable to the processing of personal data across Europe, while allowing Member States to legislate differently with regard to specific matters. 2 On the basis of registries, research results can be enhanced, as they draw on a larger population. 20 11 Art. We are already used to working within a highly regulated environment, however, the GDPR will make us think differently about the data we hold. However, the GDPR also contains several provisions applicable exclusively to public health research.First, the GDPR encourages the member states to enact greater protections for the processing of sensitive data for health-related purposes. This had an effect on scientific research including clinical and translational research areas. One of those matters is the processing of personal data for scientific research purposes. the GDPR allows lawfully collected data (e.g., health care data) to be re-used for scientific research, without consent, provided appropriate safeguards are in place, such as key-coding (Art. This collecting and sharing of personal data often doesn’t stop at the borders of a country. The exemption under the GDPR relies largely on the same discretionary framework as in the 1995 Directive. How the General Data Protection Regulation changes the rules for scientific research The implementation of the General Data Protection Regulation (GDPR) raises a series of challenges for scientific research, in particular for research that is dependent on data. The EU General Data Protection Regulation (GDPR), along with the new UK Data Protection Act 2018, will govern the processing (holding or using) of personal data in the UK. The General Data Protection Regulation (GDPR) assigns to scientific research a special regime, but there have been few guidelines or comprehensive studies on … The new world economy relies on data-driven technologies and systems. 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In general, the GDPR is considered a further safeguard and enabler for scientific research mainly due to: Nonetheless, the GDPR provisions have been received with scepticism by research-associated stakeholders, mainly for the following reasons: Similar to scientific research, the GDPR is not a piece of legislation to be assessed independently of its intent, consequences and benefits concerning individuals and society at large. On the other hand, the GDPR also stresses the need for ethical and responsible research, that should provide the necessary safeguards for data subject’s rights and respect boundaries set out for specific circumstances. All Rights Reserved. Therefore, along with the set of carefully outlined data subjects' rights, the GDPR provides for a two-level framework to enable derogations from these rights when scientific research is concerned. Public health research is treated as a subset of scientific research under the GDPR (see Recital 159), and, therefore, the same exemptions and requirements apply. GDPR also establishes both general rules applying to any kind of personal data processing and specific rules applying to the processing of special categories of personal data such as health data. BBMRI-ERIC Webinar - ELSI The GDPR and Scientific Research. There is, however, a distinction between personal data and special categories of personal data . There are a number of aspects of the GDPR which are particularly challenging for life sciences businesses. For example, data sets consisting of “virus genetic sequence and other data related to the virus + age group of the patient (. Join our mailing lists to receive updates about our latest research and to hear about our free public events and exhibitions. There is a strong debate on whether the new General Data Protection Regulation (GDPR) constitutes an enabler or hindrance for scientific research. 14:45-15:45 (CET) – Complex Interactions: the GDPR, Data Protection and Research The GDPR provides safeguards and derogations relating to the processing of personal data for scientific research purposes. Information on the principles, requirements and definitions of the GDPR can be read here. The GDPR potentially affects the clinical and other scientific research activities of academic medical centers and other research organizations in the United States if the research involves Personal Data about individuals located in those countries regardless of the individuals’ citizenship status in the countries, but generally will not affect Personal Data collected from individuals then residing in the … COVID-19, Scientific Research and the GDPR – Some Basic Principles, Brexit Deal Keeps EU-UK Data Flows Open as Parties Pursue Mutual Adequacy, The EU’s Cybersecurity Strategy for the Next Decade, The European Union Agency for Cybersecurity Publishes a Draft Certification Scheme for Cloud Services, Twitter Fine: a View into the Consistency Mechanism, and “Constructive Awareness” of Breaches, It may be self-evident, but it is still worth noting, that the GDPR does, The GDPR does, however, apply to the personal data of any living individual, and those who are unfortunate enough to host the virus. In general, the GDPR is considered a further safeguard and enabler for scientific research mainly due to: High security standards ensuring public trust and reducing personal data breaches Increased cross-national harmonisation of data protection, enhancing cross-national research collaborations Article 42 GDPR Execution Act: where processing takes place solely for scientific or historical research purposes, or statistical purposes, the controller may declare articles 15, 16 and 18 of the GDPR inapplicable. Although the new regulations haven’t been designed specifically for research, we’ll need to make some changes to research practice. Data subjects will not have rights of access, rectification or … As scientists work around the clock to gain insights into the Corona virus and how to fight it, public and private-sector stakeholders are in discussions to promote the rapid exchange of scientific data. The GDPR offers sufficient tools to use health data for scientific research in the context of COVID-19. Even if the data sets contain personal data relating to patients, this does not mean that the data cannot be used or shared, and the GDPR contains numerous provisions allowing for this, especially where it involves scientific research. The General Data Protection Regulation (GDPR) and Data Protection Act 2018 came into force on 25 May 2018 in the UK. While the legal landscape is undoubtedly complex, data privacy regulators are aware of the critical need to exchange data to advance important research aims. Although the new regulations haven’t been designed specifically for research, we’ll need to make some minor changes to research … Conducting Research under the GDPR: Legal Bases June 2017 v.1.4 2 1. Therefore, it is important for universities that undertake research and process personal data for research purposes to be cognisant of these rights. European Citizens have a fundamental right to privacy and GDPR applies to any research that uses personal data. They often rely on processing personal data, and, in particular, sensitive or special personal data, whether for research, clinical trials, pharmacovigilance, or to programme machine learning in the operation of medical devices. New technological developments and globalisation have made it increasingly easier to collect and share personal data, also in scientific research. Whether you conduct clinical trials, biomedical research, publicly funded, commercial, social science, marketing or customer experience research, you should bear in mind that the GDPR also regulates this activity and prescribes adherence to specific principles and provisions. the GDPR provides that scientific research can be undertaken by both public and private entities, as is evidenced through the examples of scientific research: technological development and demonstration, fundamental research, applied research and privately funded research, as well as public health research. It recognises that any data can be useful for research, and that research can be a long-term endeavour – for example, the ICO say data can be stored for research indefinitely, where the controller has set out legitimate justification for such indefinite retention. The scope of the GDPR is broad. The GDPR and national data protection laws can, and often do, complicate the matter of sharing personal data, and health data in particular. At the same time, the framework limits the collection of sensitive data and its sharing across organizations and national borders. By Trix Mulder, LL.M. The safeguards include technical and organisational measures, data minimisation and pseudonymisation. During these discussions, the GDPR acronym inevitably rears its head and casts doubt over what is lawful. Appendix 42 Key GDPR provisions 42 . Based on these key findings and our experience in this field, we present the main benefits and challenges of the GDPR regarding research, before concluding with a GDPR preparedness plan for organisations involved in research. After the GDPR entered into force in 2016, ISC organised an influential seminar that mainly gathered experts, EU policy- and decision-makers, and representatives from research organisations, industry and advocacy groups. The GDPR makes provisions for processing personal data for research and archiving purposes as long as certain safeguards are in place. New transport systems such as micro-transit, motorbike taxis, e-scooters, bike sharing, cycle, Since its outbreak in Europe in February 2020, the COVID-19 pandemic has had an unprecedented impact on societies. As noted above, the scope of the notion of research under the GDPR is wide. If you would like to find out more about how we manage your personal information please see our privacy policy. Although the focus has been mainly on health research and data protection requirements, scientific research is broadly understood, including technological development and demonstration, fundamental research, applied research and privately funded research (Recital 159 GDPR). Missing, however, from the GDPR list of research-friendly provisions is an appreciation of the international dimensions of research and, consequently, a corresponding appropriate provision to enable scientific research data transfers across the globe. As medical data often involves special categories of personal data, there are some additional rules in place with regard to for instance security measures and consent. 21(6) GDPR); and. However, if the above information were to originate from an named hospital with on only one infected patient in this age group, the data could then be personal data, as re-attribution to the person would probably not require much effort. The Article 89 exemption can only be relied upon if the research cannot be done in a way that would not enable individuals to be identified and there are appropriate safeguards in place for the rights and freedoms of data. In research we hold personal data surrounding our participants and therefore need to be aware of data protection regulations when carrying out our day-to-day work. They explored possible implications of the GDPR on the operation of R&D and science, and on collaborative EU research. Tips for GDPR Compliant Scientific and Statistical Research 37 7. For more information please contact our team: Human genomics, human enhancement, artificial intelligence and robotics offer benefits for both individuals and society. You can find more information about the specifics of the legislation on the GDPR details for researchers page. Copyright © 2020, Covington & Burling LLP. Purpose of Paper The EU General Data Protection Regulation (GDPR) comes into effect in all EU Member States on 25 May 2018.1 This Paper provides EFAMRO and ESOMAR members with a framework to … Research Scenarios 39 8. GDPR was not designed to impede research and allows research certain privileges. Where patients cannot be informed individually (, an individual’s right to object to scientific research involving his/her data is restricted; the person in question would have to demonstrate cause for opposing it, and, in any case, the right does not apply where there are strong public interests that will be served  by the research (Art. Personal Data & Scientific Research. 89 GDPR Safeguards and derogations relating to processing for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes. Scientific research and the new General Data Protection Regulation (GDPR) Datum: 24 mei 2018: GDPR. Despite these derogations designed to promote research endeavors, the fact remains that the GDPR, in combination with national laws, is a very complex topic to navigate. It typically applies to data that has been pseudonymized or coded (, The GDPR does not apply to anonymous data, such aggregated data sets. Meanwhile, and in line with this thinking, the European Medicines Agency has called on researchers to pool research and collaborate to combat COVID-19. Research and GDPR [PDF 192.89KB] More details about ... scientific or historical research purposes or statistical purposes” (Article 89). an individual’s right to request erasure of their data is similarly restricted (Art. GDPR resources. Similar to Directive 95/46, the GDPR acknowledges the need for a facilitating regime for research. Repeatedly ranked as having one of the best privacy practices in the world, Covington combines exceptional substantive expertise with an unrivaled understanding of the IT industry, and of e-commerce and digital media business models in particular. This means that the derogations mentioned above may not always apply or may not apply in the same way across the EU. Among other things, the GDPR allows Member States to maintain stricter rules in the area of health data. The resources below will help you understand the new requirements as they relate to research. Implied recognition of broad consent (Recital 33 GDPR). This page provides information to researchers on how to comply with the requirements of the General Data Protection Regulation (GDPR) and the UK Data Protection Act (DPA), throughout all stages of conducting research. Last Tuesday, the EDPB published its Guidelines 03/2020 on the processing of data concerning health for the purpose of scientific research in the context of the COVID-19 outbreak. In January 2019, the European Data Protection Board (EDPB) adopted in its Opinion 3/2019 on the interplay between the Clinical Trials Regulation and the GDPR. It is important to consider which processing ground and … In order to trigger the GDPR research flexibilities and reap the benefits, the study suggests that organisations should design and implement the following measures: The GDPR does not intend to impede scientific research and data-driven products and services. Despite EU data protection laws having been in place for over two decades now, the boundary between personal data and anonymous data is often frustratingly unclear. The EU General Data Protection Regulation (GDPR), along with the new UK Data Protection Act, will govern the processing (holding or using) of personal data in the UK. The type of scientific research, therefore, is not a differentiator in the context of the GDPR. However, it is essential to consider the ethics and human, Jon Betts is the lead for public sector at Trilateral Research and has been developing the CESIUM application within Trilateral’s STRIAD cloud platform from concept, We are in a period of redesigning and reinvesting in urban transport systems in European cities. GDPR recital 33 notes that research must act in a manner that is ‘in keeping with recognized ethical standards for scientific research’, and the UCL REC and other ethical review boards will usually expect informed consent. Home > COVID-19 > COVID-19, Scientific Research and the GDPR – Some Basic Principles.

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