Ethical, legal, and social implications in research biobanking: A checklist for navigating complexity.

Biobanks' activity is based not only on securing the technology of collecting and storing human biospecimen, but also on preparing formal documentation that will enable its safe use for scientific research. In that context, the issue of informed consent, the reporting of incidental findings and the use of Transfer Agreements remain a vast challenge. This paper aims to offer first-hand tangible solutions on those issues in the context of collaborative and transnational biobanking research. It presents a four-step checklist aiming to facilitate researchers on their compliance with applicable legal and ethical guidelines, when designing their studies, when recruiting participants, when handling samples and data, and when communicating research results and incidental findings. Although the paper reflects the outcomes of the H2020 B3Africa project and examines the transfers from and to the EU as a case study, it presents a global checklist that can be used beyond the EU.

Legal & ethical compliance when sharing biospecimen.

When obtaining samples from biobanks, resolving ethical and legal concerns is a time-consuming task where researchers need to balance the needs of privacy, trust and scientific progress. The Biobanking and Biomolecular Resources Research Infrastructure-Large Prospective Cohorts project has resolved numerous such issues through intense communication between involved researchers and experts in its mission to unite large prospective study sets in Europe. To facilitate efficient communication, it is useful for nonexperts to have an at least basic understanding of the regulatory system for managing biological samples.Laws regulating research oversight are based on national law and normally share core principles founded on international charters. In interview studies among donors, chief concerns are privacy, efficient sample utilization and access to information generated from their samples. Despite a lack of clear evidence regarding which concern takes precedence, scientific as well as public discourse has largely focused on privacy concerns and the right of donors to control the usage of their samples.It is therefore important to proactively deal with ethical and legal issues to avoid complications that delay or prevent samples from being accessed. To help biobank professionals avoid making unnecessary mistakes, we have developed this basic primer covering the relationship between ethics and law, the concept of informed consent and considerations for returning findings to donors.

Oversight of EU medical data transfers - an administrative law perspective on cross-border biomedical research administration.

The notion of privacy has long had a central role in human rights law, not least in connection to health and medicine. International, regional and national bodies have enacted a number of binding and non-binding document for physicians and researchers to adhere to, in order to protect the autonomy, dignity and privacy of patients and research subjects. With the development of new technologies, the right to privacy has gained a new perspective; the right to protection of personal data within information and communication technologies. The right to data protection has been attributed an increasing importance within EU law. Accordingly, the use of health data in medical research in general and in biobank-related medical research in particular, has made data protection law highly relevant. In medical research involving biobanks, transferring human biological samples and/or individual health data is taking place on a daily basis. These transfers involve several oversight bodies, institutional review boards (IRBs), research ethics committees, or even data protection authorities. This article investigates the role of these national oversight bodies in the transfer of health data in cross-border research, from an EU law point of view. A special focus is laid on transfer of health data for research purposes from the EU to the US, in the light of the recently enacted EU-US Privacy Shield. The main question posed is how American oversight bodies for medical research can be expected to handle the increasingly strict EU requirements for the processing of health data in medical research review.