Take away from 2019
In April, we launched the RA Watch, intending to face the ever increasing activity and complexity of the regulatory aspects concerning human research in Switzerland – to track changes anticipated and offer them to you as a digest. Indeed, the legislation is undergoing continual development to stay abreast of and adapt to the many societal, technological, political fluctuations and ensure that Switzerland remains competitive.
We have not been disappointed! This timely matter has kept us fully engaged, observing and analysing events. In 2019, we saw the publication of a series of documents on the evaluation of the Human Research Act (HRA) and its ordinances, which entered into force in 2014; recommendations to adapt the law were published at the end of the year and should be implemented through coming months or years. Additional considerations – linked to the disruptive opportunities brought by new methods and technologies and the potential availability of ever more sharable data – have led to the elaboration of new documents. To mention a few, there are guiding principles and recommendations for registries in human research, the version 2 of the national General Consent (GC), key documents for biobanks, and more. A specific category of products, the medical devices, has also been scrutinised and draft ordinances were published and opened for consultation.
Perspectives for 2020
We’re following many pertinent questions: How will human research be shaped in the year to come? How will Switzerland be affected, in concrete terms, by new European regulations, notably the EU General Data Protection Regulation EU 2016/679 (GDPR) and EU Clinical Trials Regulation EU 536/2014 (CTR)? How will the final legislation on medical devices look like?
Increased transparency (in particular, the publication of research results), open science, patient-centricity, larger numbers in patient recruitment, innovative trial designs, real-world clinical data and evidence, data governance, and the modernisation of institutional tools are all key themes that will keep regulators and the human research community on the edge of their seats this year. Let’s start the year with an update on the GC.
Stay tuned with us. We’ll keep you updated on all the trends, news, and twists and turns that this field will bring in 2020! Till then, take care of yourselves during this special time of coronavirus pandemic.
Prof. Dr. iur Dominique Sprumont, President of the CER-VD
06.10.2021Dear Regulatory Affairs Watch Editors*, First, I want to congratulate you for offering the research community useful information on the ethical, legal and regulatory framework of research involving human participants in Switzerland. This is an excellent initiative. I read with great interest the latest issue (Issue 3, March 2020). In principle, I cannot agree more with the promotion of the concept of a General Consent (GC) form for research. This is a useful tool to facilitate the conduct of research involving human participants, which improves patients’ participation and the public awareness about the importance of research. The pandemic of COVID-19 makes it even more important. Thus, I thank you for informing your readers about the status of GC form in Switzerland. There is only one missing element. The historical overview stops at the adoption of the UNIMED GC form in September 2018 and its approval in principle by swissethics in November 2018. Yet, at that moment, the model still raised important concerns, as expressed by the cantonal data protection authorities, several patients’ organizations and some RECs: lack of information on the consequences of anonymization, on the governance of research in the concerned institutions, on the participants’ right to have access to their data, etc. There was also the issue of incompetent adults and minors, vulnerable populations requesting a specific procedure including asking their consent when they (re)gain their legal capacity. Those critics were deemed serious enough for the SAMW to plan a meeting on January 2019 to address them with all stakeholders and finalize the document. Yet, this meeting was cancelled at the last minute, which stopped abruptly all attempts to solve the remaining objections. The UNIMED model promulgated in February 2019 still suffers from those unsolved questions with one important exception. In its announcement of February 22, 2019 concerning the GC form, swissethics specified: “Every institution that uses the GC is obliged to respect national and international norms and standards for the data banks (registries) and biobanks. In this way, the rights of donors who voluntarily participate in the research can be guaranteed”. Everyone would agree that only asking patients to sign the GC form without having the proper governance system in place is like driving a car without a license. Before using the GC form, the concerned institutions must assure that they have the capacities to conduct research in accordance with the Declaration of Taipei and applicable laws and regulation. UNIMED acknowledged the problem as it published on January 12, 2020, a Recommendations concerning the application of the General Consent. This document provides guidance on the issues of incompetent adults’ participation and obtaining the consent from their legal representatives, as well as specific aspects of governance. Yet, not targeting the patients and only available in English, it may have no or limited impact in improving the information of future research participants. Thus, even if the recommendations should be praised as a useful tool for researchers, it falls short of answering the remaining critical elements of the UNIMED model. If I share your optimism about the progress made in Switzerland to implement a GC form at the national level, more efforts are needed. First, there are still hospitals and research institutions that have not yet adopted an adequate governance system of research. For instance, there are hundreds of biobanks in Switzerland, but only 22 have so far obtained a label from Swiss Biobanking Platform (SBP) (11 Norma, 8 Vita and 3 Optima). Second, the current UNIMED model is not fully implemented in all hospitals, as illustrated in the latest issue of RA Watch. There are sound ethical and legal grounds, as well as varying local needs and practices to explain the diverging opinions on the GC form. Thus, the consensus around the UNIMED model remains in part only at the level of principles. As soon as the COVID-19 crisis will allow it, the time will come to invest in the governance of research at the institutional level and work on a new GC form free of its current weakness.
Answers (1)RA Watch Editors
06.10.2021*Note from the editors: Comment received in March 2020, revised 10 July 2020