Application challenges of the new EU Clinical Trials Regulation.

PURPOSE: The purpose of this paper is to discuss the challenges of the upcoming policy change in the field of clinical drug trials due to the shift from the Clinical Trials Directive 2001/20/EC to the new Clinical Trials Regulation 536/2014, adopted in 2014. Although it is expected that the new EU Clinical Trials Regulation will increase Europe's competitiveness in clinical research, the paper argues that some measures to assure protection of research subjects should be taken before the Regulation comes into application in 2018. METHODS: The methods used in this paper are comparative analysis of legal documents and related academic papers. RESULTS: The new Regulation serves as an efficient means to harmonize the clinical drug trial evaluation procedures across the EU. However, its application also raises potential challenges regarding interests and safety of research subjects: first, due to the possibility of skipping the assessment and balancing of benefits and risks from the scope of ethical review and limiting such a review to only Part II issues of the assessment report; second, due to direct applicability of the Regulation's rather vague and too general requirements for investigator's qualifications which does not allow the assessors (ethics committees and (or) competent authorities) to introduce higher qualification requirements for the investigators conducting high-risk clinical drug trials in the national legislation. CONCLUSIONS: There is an urgent need to raise awareness and facilitate debate on potential application challenges of the new Regulation.

Turning residual human biological materials into research collections: playing with consent.

This article focuses on three scenarios in which residual biological materials are turned into research collections during the procedure of procuring these materials for diagnostic, therapeutic or other non-research purposes. These three scenarios differ from each other primarily because they employ different models of consent: (a) precautionary consent, which may be secured during the collecting procedure; (b) the presumed consent model, which may be applied during the collection of materials; and (c) consent for research use of identifiable human biological materials, which may be skipped entirely. These scenarios offer additional sources of biological samples for research purposes and at the same time seem to offer even more flexibility in terms of stringency of consent as compared with the more traditional models of broad consent in prospective research collections and the waiver of consent in retrospective research. Our discussion leads us to think that precautionary consent is preferable to presumed consent and no consent when handling issues of consent in the use of residual human biological materials for research. However, such precautionary consent should not be construed as blanket, unrestricted consent for any future use.

Twenty years of human research ethics committees in the Baltic States.

Two decades have passed since the first attempts were made to establish systematic ethical review of human research in the Baltic States. Legally and institutionally much has changed. In this paper we provide an historical and structural overview of ethical review of human research and identify some problems related to the role of ethical review in establishing quality research environment in these countries. Problems connected to (a) public availability of information, (b) management of conflicts of interest, (c) REC composition and motivation of REC members, and (d) differing levels of stringency of ethical review for different types of studies, are identified. Recommendations are made to strengthen cooperation among the Baltic RECs.

Does the "new philosophy" in predictive, preventive and personalised medicine require new ethics?

This paper maps the ethical issues that arise in the context of personalised medicine. First, it highlights the ethical problems related to increased predictive power of modern diagnostic interventions. Such problems emerge because the ability to identify individuals or groups of individuals that can potentially benefit from a particular therapeutic intervention also raises a question of personal responsibility for health-related behaviour and lifestyle. The second major area of ethical concern is related to health prevention and distributive justice. The paper discusses the ethical challenges brought by the personalised medicine in the context of the Additional Protocol to the Convention on Human Rights and Biomedicine concerning Genetic Testing for Health Purposes. Finally, it notes that the issue of consent in the context of biobanks, the need to rethink the prevalent models of research designs and to communicate relevant findings to the donors of biological materials deserve further discussion.