Studienübergreifende Harmonisierung datenschutzrechtlicher und ethischer Gesichtspunkte in Patientenunterlagen: Eine Praxisanalyse

ZusammenfassungIm Rahmen des Deutschen Zentrums für Herz-Kreislauf-Forschung e. V. (DZHK) wurden die klinische Forschungsplattform des DZHK für die Erhebung von standardisierten Daten und Bioproben aus DZHK-finanzierten klinischen Studien sowie ein Antrags- und Zugangsprozess unter Einbeziehung eines Use and Access Komitees für weitere medizinische Forschungsprojekte aufgebaut.Die Sammlung dieser Forschungsressourcen erfolgt auf Basis eines DZHK-weit harmonisierten Broad Consent. Entsprechend ergänzte Patienteninformations- und Einwilligungsunterlagen der DZHK-Studien wurden seit 2013 bereits von über 50 Ethikkommissionen deutschlandweit positiv begutachtet. Inhalte von 43 Ethikvoten aus den Jahren 2017 und 2018 wurden ausgewertet sowie eine Ist-Analyse (Q4/2019) der Anzahl beteiligter Studienzentren und der Anzahl verwalteter Einwilligungsversionen durchgeführt.Die Auswertungen spiegeln die erhöhten Herausforderungen wider, die sich seit verbindlich werden der EU-Datenschutzgrundverordnung (EU-DSGVO) im Mai 2018 ergaben. Durch Forderungen und Änderungswünsche einzelner Ethikkommissionen werden derzeit (Q4/2019) 75 unterschiedliche, die Daten- und Biomaterialsammlung betreffende Patienteninformations- und Einwilligungsunterlagen für 19 klinische Studien verwaltet.Trotz eines, im Verhältnis zur Anzahl der teilnehmenden Studien und Studienzentren, hohen Harmonisierungsgrades bestehen aufgrund von Forderungen aus den Ethikvoten deutliche Unterschiede in den Formulierungen der DZHK-Patientenunterlagen, die u. a. kritische Aspekte wie Speicherzeitbegrenzung, Widerruf und Weitergabe von Daten für die Forschung betreffen. Der Artikel soll die Schwierigkeiten, mit denen wir und andere übergreifende Forschungsverbünde im Alltagsbetrieb bei Ethikeinreichungen konfrontiert werden, strukturiert darlegen und den Umgang des DZHK e. V. damit beschreiben um Wünsche für eine zukünftige Vorgehensweise zu formulieren.

Data protection-compliant broad consent for secondary use of health care data and human biosamples for (bio)medical research: towards a new German national standard

Background: The secondary use of deidentified but not anonymized patient data is a promising approach for enabling precision medicine and learning health care systems. In most national jurisdictions (e.g., in Europe and North America), this type of secondary use requires patient consent. While various ethical, legal, and technical analyses have stressed the opportunities and challenges for different types of consent over the past decade, no country has yet established a national consent standard accepted by the relevant authorities.Methods: A working group of the national Medical Informatics Initiative in Germany conducted a requirements analysis and developed a GDPR-compliant broad consent standard involving all relevant stakeholder groups and authorities.Results: This paper presents the broad consent text together with a guidance document on mandatory safeguards for broad consent implementation. The mandatory safeguards comprise i) independent review of individual research projects, ii) organizational measures to protect patients from involuntary disclosure of protected information, and iii) comprehensive information for patients and public transparency. This paper further describes the key issues discussed with the relevant authorities, especially the position on additional or alternative consent approaches such as dynamic consent.Discussion: Both the resulting broad consent text and the national consensus process are relevant for similar activities internationally. A key challenge of aligning consent documents with the various stakeholders was explaining and justifying the decision to use broad consent and the decision against using alternative models such as dynamic consent. Public transparency for all secondary use projects and their results emerged as a key factor in this justification. While currently largely limited to academic medicine in Germany, the first steps for extending this broad consent approach to wider areas of application, including smaller institutions and medical practices, are currently under consideration.

Trust and Trade-Offs in Sharing Data for Precision Medicine: A National Survey of Singapore

Background: Precision medicine (PM) programs typically use broad consent. This approach requires maintenance of the social license and public trust. The ultimate success of PM programs will thus likely be contingent upon understanding public expectations about data sharing and establishing appropriate governance structures. There is a lack of data on public attitudes towards PM in Asia. Methods: The aim of the research was to measure the priorities and preferences of Singaporeans for sharing health-related data for PM. We used adaptive choice-based conjoint analysis (ACBC) with four attributes: uses, users, data sensitivity and consent. We recruited a representative sample of n = 1000 respondents for an in-person household survey. Results: Of the 1000 respondents, 52% were female and majority were in the age range of 40–59 years (40%), followed by 21–39 years (33%) and 60 years and above (27%). A total of 64% were generally willing to share de-identified health data for IRB-approved research without re-consent for each study. Government agencies and public institutions were the most trusted users of data. The importance of the four attributes on respondents’ willingness to share data were: users (39.5%), uses (28.5%), data sensitivity (19.5%), consent (12.6%). Most respondents found it acceptable for government agencies and hospitals to use de-identified data for health research with broad consent. Our sample was consistent with official government data on the target population with 52% being female and majority in the age range of 40–59 years (40%), followed by 21–39 years (33%) and 60 years and above (27%). Conclusions: While a significant body of prior research focuses on preferences for consent, our conjoint analysis found consent was the least important attribute for sharing data. Our findings suggest the social license for PM data sharing in Singapore currently supports linking health and genomic data, sharing with public institutions for health research and quality improvement; but does not support sharing with private health insurers or for private commercial use.

Knowledge, perceptions and attitude of Egyptian physicians towards biobanking issues

Objectives Collection and storage of biospecimens and data for biobanking raise many ethical concerns. Stakeholders’ opinions about these ethical issues are important since they can help in the development of ethical guidelines to govern biobanking activities. Physicians are among the important stakeholders since they contact potential participants and could be biobank users. The goal of this study is to evaluate the perceptions and attitude of Egyptian physicians towards ethical issues in biobanking. Methods A cross-sectional online survey was designed and distributed with the target group between November 2019 and January 2020. Results The questionnaire was completed by 223 physicians. While 65.5% reported hearing the term "Biobanking" before, 45.7% knew that there are biobanks in Egypt. Participants had a general positive attitude towards the value of biobanks in research. About 73% agreed that biobanks can share biospecimens with international research organizations, but only 42.6% supported collaboration with pharmaceutical companies, and 44% agreed to the use of user fees by biobanks. About 48% supported the use of broad consent in biobanks, and 73.1% believed that donors of biospecimens should be informed about results of research performed on their biospecimens. Conclusion Although many Egyptian physicians heard about biobanking, they had limited knowledge about the existence of biobanks in Egypt. They had concerns about commercialization, use of broad consent and user fees. A knowledge gap exists among these stakeholders, which should be covered by different educational activities. Community discussions should start to reach consensus about the issues of commercialization and return of research results.

Guidance for ensuring fair and ethical broad consent for future use. A scoping review protocol.

Introduction: Broad consent for future use is the reuse of data and/or samples collected by a study by researchers who may not be affiliated with the original study team for purposes that may differ from the objectives of the original study. Sharing participant-level data and samples collected from research participants facilitates reuse and transparency and can accelerate drug or vaccine development, research findings, and translation. Data reuse and synthesis help prevent unnecessary research, thereby respecting research participants time and efforts and building their trust in the research process. Despite these myriad benefits, data and sample sharing represent a significant investment of time for the team that collected the data or samples, and may present additional risks for research participants, including that of re-identifiability and incidental findings, or for the source community. This scoping review will summarize existing guidance on broad consent for future use and highlight evidence gaps related to the ethical, equitable implementation of broad consent for future use. Methods and analysis: We will apply the Arskey and O’Malley scoping review methodology and best practice as outlined in the Joanna Briggs scoping review guidelines. The research questions have been identified through a literature review and consultation with subject-matter experts. The systematic search will be conducted in three databases using a tailored search strategy. We will search the reference lists of included articles or related systematic reviews for additional citations. The title-abstract and full text screening and charting the data will be conducted independently by two reviewers. Discrepancies will be resolved by a third reviewer. Results will be summarized in narrative form. Ethics and dissemination: This scoping review summarizes findings from existing publications and grey literature rather than primary data and, as such, does not require ethics review. Findings will be disseminated through an open access publication and webinar.

Context-Relative Norms Determine the Appropriate Type of Consent in Clinical Biobanks: Towards a Potential Solution for the Discrepancy between the General Data Protection Regulation and the European Data Protection Board on Requirements for Consent

Clinical biobanks processing data of participants in the European Union (EU) fall under the scope of the General Data Protection Regulation (GDPR), which among others includes requirements for consent. These requirements are further specified by the Article 29 Working Party (WP29)—an EU advisory body currently known as the European Data Protection Board (EDPB). Unfortunately, their guidance is cause for some confusion. While the GDPR allows participants to give broad consent for research when specific research purposes are still unknown, the WP29 guidelines suggest that additional consent for specific uses should be obtained in addition to broad consent when this becomes applicable. This discrepancy elicits the question whether clinical biobanks can fail the requirement of consent if they obtain broad consent, but not a specific consent for each biomedical study. We analysed this discrepancy within the framework of contextual integrity, in order to describe the context-relative informational norms that govern information flows in clinical biobanks. However, our analysis demonstrates that there is no uniform set of norms that can be applied to all clinical biobanks. As such, neither the GDPR nor the WP29 guidance can act as a “one size fits all” approach to all clinical biobanks. Rather, differences between clinical biobanks—especially regarding the scientific aims and patient populations—make the case for context-relative norms that determine the appropriate type of consent.