Harmonising the human biobanking consent process: an Irish experience

Biobanks are repositories of human biological samples and data. They are an important component of clinical research in many disease areas and often represent the first step toward innovative treatments. For biobanks to operate, researchers need human participants to give their samples and associated health data. In Ireland, research participants must provide their freely given informed consent for their samples and data to be taken and used for research purposes. Biobank staff are responsible for communicating the relevant information to participants prior to obtaining their consent, and this communication process is supported by the Participant Information Leaflets and Informed Consent Form (PI/ICFs). PILs/ICFs should be concise, intelligible, and contain relevant information. While not a substitute for layperson and research staff discussions, PILs and ICFs ensure that a layperson has enough information to make an informed choice to participate or not. However, PILs/ICFs are often lengthy, contain technical language and can be complicated and onerous for a layperson to read. The introduction of the General Data Protection Regulation and the related Irish Health Research Regulation presented additional challenges to the Irish biobank community. In May 2019, the National Biobanking Working Group (NBWG) was established in Ireland. It consists of members from diverse research backgrounds located in universities, hospitals and research centres across Ireland and a public/patient partner. The NBWG aimed to develop a suite of resources for health research biobanks via robust and meaningful patient engagement, which are accessible, General Data Protection Regulation/Health Research Regulation-compliant and could be used nationally, including a PIL/ICF template. This open letter describes the process whereby this national biobank PIL/ICF template was produced. The development of this template included review by the Patient Voice in Cancer Research, led by Professor Amanda McCann at University College Dublin and the Health Research Data Protection Network.

Reconciling fragmented sectors of health research regulation: toward an ecosystem of processual regulation

The delivery of good outcomes from human health research is entirely dependent on the proper functioning of the attendant regulatory systems. This article focuses on the processes of regulation themselves, and how these might be better understood, so that regulators and other stakeholders have a strong normative basis upon which to pursue the regulatory objective of achieving outcomes with maximum social value. The argument is made that the concept of ‘processual regulation’—which promotes a whole systems approach to regulation—can assist greatly in the design, implementation, and review of human health research. This moves beyond the current often-fragmented approach to regulation towards a joined-up, reflective, and responsive system that has fitness-for-purpose at its core.

Legal and ethical regulation of genetic research

The paper deals with the problems of genetic research regulation stemming from the peculiarities of this area of knowledge where research is practically inseparable from patient treatment, and cognitive practices are connected with the development and implementation of new devices, methodologies, and technologies to a much greater extent than in other areas of human activity. The issues of genetic research regulation are analyzed in the context of the concept suggested by Helga Nowotny and Giuseppe Testa distinguishing three human technologies of standardization through which control over the development of knowledge about genes is exercised. These three technologies are law, governance and bioethics, and the efficiency of their interaction is declared a necessary and sufficient condition for the successful development of molecular genetic sciences. The paper examines all the three technologies one by one, identifies the specifics and difficulties of their implementation in present-day Russian science, and assesses the genetic research prospects assuming the implementation of the aforementioned technologies. Particular attention is paid to institutionalization of ethics committees as an element of the genetic research regulation system. Substantiation is provided for the thesis that ethical committees should act as an institution combining rulemaking, management, and expert functions rather than as a structure capable of performing advisory and recommendatory functions only. The ability of the Russian society and state to withstand the grand challenges of our time is associated with the success in solving this problem.