This article provides a brief introduction to some contemporary challenges found in the intersection of bioethics and international criminal law involving genetic privacy, organ trafficking, genetic engineering, and cloning. These challenges push us to re-evaluate the question of whether the international criminal law should hold corporations criminally liable. I argue that a minimalist and Strawsonian conception of corporate responsibility could be useful for deterring the wrongs outlined in first few sections and in answering compelling objections to corporate criminal liability.

The HIPAA Privacy Rule is notoriously weak because of its incomplete coverage, numerous exclusions and exemptions, and limited rights for individuals. The three areas in which it provides the most protection are fundraising, marketing, and research. Provisions of the 21st Century Cures Act, pending in Congress, and the Notice of Proposed Rulemaking to amend the federal research regulations, awaiting final regulatory action, would weaken the privacy protections for research. If these measures are adopted, the HIPAA Privacy Rule would have so (...) little value that it might not be worth the aggravation and burden. (shrink)

Like many other countries, South Korea has recognized the importance of biobanks as a tool for medical research and has engaged in two very important tasks to foster biobanking infrastructure: funding biobanks and setting up rules to protect the integrity of biobanks that share potentially sensitive personal information.

Clinical biobanks processing data of participants in the European Union fall under the scope of the General Data Protection Regulation, which among others includes requirements for consent. These requirements are further specified by the Article 29 Working Party —an EU advisory body currently known as the European Data Protection Board. Unfortunately, their guidance is cause for some confusion. While the GDPR allows participants to give broad consent for research when specific research purposes are still unknown, the WP29 guidelines suggest that (...) additional consent for specific uses should be obtained in addition to broad consent when this becomes applicable. This discrepancy elicits the question whether clinical biobanks can fail the requirement of consent if they obtain broad consent, but not a specific consent for each biomedical study. We analysed this discrepancy within the framework of contextual integrity, in order to describe the context-relative informational norms that govern information flows in clinical biobanks. However, our analysis demonstrates that there is no uniform set of norms that can be applied to all clinical biobanks. As such, neither the GDPR nor the WP29 guidance can act as a “one size fits all” approach to all clinical biobanks. Rather, differences between clinical biobanks—especially regarding the scientific aims and patient populations—make the case for context-relative norms that determine the appropriate type of consent. (shrink)

Although big-data research has met with multiple controversies in diverse fields, political and security implications of big data in life sciences have received less attention. This paper explores how threats and risks are anticipated and acted on in biobanking, which builds research repositories for biomedical samples and data. Focusing on the biggest harmonisation cluster of biomedical research in Europe, BBMRI-ERIC, the paper analyses different logics of risk in the anticipatory discourse on biobanking. Based on document analysis, interviews with ELSI experts, (...) and field research, three types of framing of risk are reconstructed: data security, privacy, and data misuse. The paper finds that these logics downplay the broader social and political context and reflects on the limits of the practices of anticipatory governance in biobanking. It argues that this regime of governance can make it difficult for biobanks to address possible future challenges, such as access to biomedical data by authorities, pressures for integrating biobank data with other type of personal data, or their use for profiling beyond medical purposes. To address potential controversies and societal implications related to the use of big data in health research and medicine, the paper suggests to expand the vocabulary and practices of anticipatory governance, in the biobanking community and beyond. (shrink)

A 2011 National Academies of Sciences report called for an “Information Commons” and a “Knowledge Network” to revolutionize biomedical research and clinical care. We interviewed 41 expert stakeholders to examine governance, access, data collection, and privacy in the context of a medical information commons. Stakeholders' attitudes about MICs align with the NAS vision of an Information Commons; however, differences of opinion regarding clinical use and access warrant further research to explore policy and technological solutions.