Legal Q&A: What are „ethics votes“ and what is their legal force?

The BBMRI.at Legal Helpdesk Service – operated by legal experts from BBMRI.at partner UNIVIE– answers questions on legal and regulatory matters around biobanking and/or using biological samples and data. This service is offered to BBMRI.at partners to support them, as biobanking and research using biological samples and data (e.g. human, animal/veterinary, microbial, etc.) may raise legal questions. Answers provided by UNIVIE to legal questions are published in the BBMRI.at Knowledge Base.

QUESTION:

Legal Q&A: What are “ethics votes” and what is their legal force?

ANSWER:

1. Ethics Committees: Concept in European Union Law

An “Ethics Committee” (hereinafter: EC) – as defined by the European Union’s (hereinafter: EU) Clinical Trials Regulation^[1] (hereinafter: CTR) (and for the purposes of that Regulation) – is an “independent body established in a Member State in accordance with the law of that Member State and empowered to give opinions for the purposes of this Regulation, taking into account the views of laypersons, in particular patients or patients’ organisations”^[2]. An equivalent definition of an EC is provided in the Medical Devices Regulation^[3] (Article 2(56)).

Although conducting clinical trials, within the meaning of the CTR (as defined in Article 2(2)(2)), will likely not fall under the scope of activities of biobanks, the Regulation requires the favourable opinion of an EC as a precondition to undertake the research endeavours covered within the Regulation’s scope of application^[4].

This guides us to the conclusion that the current legal framework may occasionally make obtaining a positive ethical assessment a necessary step prior to conducting research. The expression “ethic votes” refers to the – often compulsory – positive opinion from an Ethics Committee required before pursuing certain types of scientific research projects, especially those involving humans or human substances. Outside of the clinical trials research scope, the EU’s framework does not always provide guidance on the legal force of ethical assessments. This means different EU Member States (hereinafter: MS) may have varying approaches to this: in some countries, conducting an EC review “[…] serves to advise the competent authorities which will decide whether the research can start”. In other countries, however, the EC “[…] conclusion will have legal force”^[5].

Research ECs may operate at an institutional (e.g. within a biobank or University) or national level. Their activities span from approval of research protocols prior to conducting research and/or reviewing research reports, at the end of the research project^[6], so national MSs’ law may require a multilevel intervention within research projects (and thus not restricted to a positive assessment of the research proposal, as required by Article 3(2)(a) of the CTD).

2. Ethics Committees in Austria

As mentioned above, ECs for research activities in Austria exist both at an institutional and national level. As put by the Austrian Federal Ministry of Education, Science and Research, “The awarding of funding is increasingly dependent on the existence of such bodies at the research institutions where the research will be conducted”[7]. Additionally, the “[…] great importance of these committees for the respective research institution […]” should be reflected in the fact that “[…] they should occupy as prominent and as independent a position as possible within the organization”. The Federal Ministry also recommends that universities “[…] regulate the establishment and duties of these committees by means of their statutes”. These statutes will typically inform on the nature of the EC’s decision: whether it is advisory or legally binding[8].

The existence of these ECs in certain institutions is required by law:

1. 30(1) of the Universities Act 2002[9] states that “The senate of every medical university or every university at which a faculty of medicine has been established shall appoint an ethics committee to assess clinical tests of drugs and medical products, the application of new medical methods and applied medical research involving human subjects” (authors’ translation);

1. 8c of the Federal Act on Hospitals and Sanatoriums[10] (KAKuG) requires that ECs are implemented in hospitals. ECs are tasked with the assessment of clinical trials of medicinal products and medical devices, the application of new medical methods and non-interventional studies, applied medical research, and the implementation of nursing research projects as well as the application of new care and treatment concepts and new care and treatment methods. The rules of procedure for each ECs are approved by the Landesregierung.

As for the nature of the decision of the ECs, there are some instances where consulting the EC is imposed by law. For example, the ECs established in accordance with § 30 of the Universities Act will have a role in sharing personal data pursuant to § 2f(7) of the Austrian Research Organisation Act (FOG)[11].

Additional resources that may be helpful

Legal:

1. Rules of Procedure of the Ethics Committee of the Medical University of Graz: https://www.medunigraz.at/frontend/user_upload/OEs/ethikkommission/pdf/Ethikkommission_Geschaeftsordnung.pdf (accessed: 14/11/2024);
2. World Medical Association’s Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects (last amended in October 2024);
3. Article 16 of the Council of Europe’s Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (Oviedo, 4.IV.1997). Austria is not a signatory-State of this Convention;
4. Chapter III (Articles 9 to 12) Council of Europe’s Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research (Strasbourg, 25.I.2005). Austria is not a signatory-State of this Protocol;

Other:

1. Materials from the BBMRI-ERIC Task Force Research Ethics Committees (TF REC);
2. The Medical University of Graz’s materials for ECs in Austria. Available at: Ethikkommissionen in Österreich (accessed: 14/11/2024).