Public participation is increasingly an aspect of policy development in many areas, and the governance of biomedical research is no exception. There are good reasons for this: biomedical research relies on public funding; it relies on biological samples and information from large numbers of patients and healthy individuals; and the outcomes of biomedical research are dramatically and irrevocably changing our society. There is thus arguably a democratic imperative for including public values in strategic decisions about the governance of biomedical research. (...) However, it is not immediately clear how this might best be achieved. While different approaches have been proposed and trialled, we focus here on the use of public deliberation as a mechanism to develop input for policy on biomedical research. We begin by explaining the rationale for conducting public deliberation in biomedical research. We focus, in particular, on the ELS (ethical, legal, social) aspects of human tissue biobanking. The last few years have seen the development of methods for conducting public deliberation on these issues in several jurisdictions, for the purpose of incorporating lay public voices in biobanking policy. We explain the theoretical foundation underlying the notion of deliberation, and outline the main lessons and capacities that have been developed in the area of conducting public deliberation on biobanks. We next provide an analysis of the theoretical and practical challenges that we feel still need to be addressed for the use of public deliberation to guide ethical norms and governance of biomedical research. We examine the issues of: (i) linking the outcomes of deliberation to tangible action; (ii) the mandate under which a deliberation is conducted; (iii) the relative weight that should be accorded to a public deliberative forum vs other relevant voices; (iv) evaluating the quality of deliberation; and (5) the problem of scalability of minipublics. (shrink)

In 2007, the Ethics and Governance Council of the UK Biobank commissioned a Report on ‘Concepts of Public Good and Pubic Interest in Access Policies’. This study considered the Biobank’s role as a ‘public good’ in respect to supporting and promoting health throughout society. However, the conditions under which access by third parties to UK Biobank are justified in the public interest have not been well considered. In this article, I propose to analyse the conditions that should allow such access. (...) My argument develops UK Biobank’s function as a ‘public good’ and in terms of its responsibilities as a public health institution; both to protect the rights of the participants and in having a role in reinforcing public goals. Although these two tasks may conflict, it is possible that resolute opposition to some third-party access demands—if properly justified in terms of a public interest—will be damaging to, rather than protective of, participants’ rights. To illustrate my argument, I consider the appropriate response to an extraordinary public emergency , such as a serious criminal investigation or disaster response, in terms of an ethical access policy. (shrink)

The empirical literature on the ethical, legal, and social implications of biobanking has almost entirely relied on the perspectives of those outside of biobanks, such as the general public, researchers, and specimen contributors. Little attention has been paid to the perspectives and practices of those who operate biobanks. We conducted a study of U.S. biobanks consisting of six in-depth case studies and a large online survey, which was developed from the case study results. The case studies included qualitative interviews with (...) a total of 24 personnel. Both interview and survey questions focused on how biobanks operate, and what policies and practices govern their relationships with specimen contributors and the researchers who use the specimens. Analysis revealed unexpected ethical dilemmas embedded in those policies and practices that highlight a need for practical planning. In this paper, we review three issues seldom explored in the ELSI literature: 1. the discrepancy between biobankers’ hope that the bank will exist “permanently” and the fact that funding is limited; 2. the lack of planning for what will happen to the specimens if the bank closes; and 3. the concern that once collected, specimens may be underutilized. These dilemmas are missing from current public representations of biobanks, which instead focus on the intrinsic value in storing specimens as essential to the advancement of translational research. We argue that attention to these issues is important for biobanking, and that greater transparency of these policies and practices will contribute to promoting public trust in biobanks. (shrink)

The above bit string encodes personal information about one of the authors of this essay. Of course, without rules to decode the bit string, it is impossible to say whether it is genetic information, weight, age, fingerprint, religion, etc. Layered on top of that technical decoding process is a social decoding process – how sensitive is this information? How useful is it to the government for various purposes? The objective of this paper is to offer some key lessons for the (...) regulation of genetic information collected by the state for law enforcement purposes. In the first part of the paper, we discuss two fundamental principles of informational privacy theory. Utilizing these, we then examine the statutory regimes that have emerged for the regulation of the information that the government collects in three different domains – fingerprints, department of motor vehicle records, and tax records. In the third and final part we use the results of our analysis as analogies for similar regulatory challenges in the regulation of genetic information collected for law enforcement purposes, and make some tentative recommendations. (shrink)

Sweden is probably one of the most secularized nations in the world. Therefore religious arguments tend to play a smaller role in the public bioethical debate than in most other countries. Issues such as abortion, stem-cell research, and therapeutic cloning have been far less controversial in Sweden than elsewhere. Instead, other issues have dominated recent bioethical debates in Sweden, in particular those concerning privacy and the control over biological information about individuals.

Paul Appelbaum and colleagues propose four models of informed consent to research that deploys whole genome sequencing and may generate incidental findings. They base their analysis on empirical data that suggests that research participants want to be offered incidental findings and on a normative consensus that researchers incur a duty to offer them. Their models will contribute to the heated policy debate about return of incidental findings. But in my view, they do not ask the foundational question, In the context (...) of genome sequencing, how much work can consent be asked to do? (shrink)

Though in existence for over thirty-five years, due to the increasing panoply of possible tests. Newborn screening programs are drawing public attention. Many jurisdictions have mandatory newborn screening programs for treatable disorders. Disorders are detected through tests on blood spots drawn from a newborn’s heel soon after birth and verified through a diagnostic test with follow-up. Unbeknownst to most parents, these blood spot cards are also stored thereafter. Indeed, while dried blood spots are primarily used for screening for health problems, (...) experience demonstrates that they can be made useful in various contexts unrelated to screening.Newborn dried blood spots have taken on a new life as a result of developments in genetics and the increasing ability of bioinformatics to link DNA information with clinical data. Additionally, storage and secondary uses have been documented to occur without parental consent. (shrink)

From antiquity to the present the ability of clinicians to assure confidentiality has been a cornerstone of practice. Though the expectations and emphases of the various ethical codes and laws concerning confidentiality have evolved over time, it has always been the practitioner’s responsibility to observe them. The use of computers for the generation and storing of individual medical records is a significant change from our current paper-based records. That change makes the security of records a technological problem generally outside the (...) realm of physician knowledge or control. Researchers and vendors first began developing electronic health records (EHRs) in the late 1960s to 1980s. “Peripherals” were .. (shrink)

As forensic techniques continue to improve, reports on the success of the police in using DNA analysis for solving past and present criminal cases are becoming an everyday occurrence in the media. There are two avenues by which police can collect and obtain access to DNA samples. The first is on the basis of legislation that allows the police to forcibly collec t samples in some situations. The second is through an access order granted by the court, which allows access (...) to samples from existing collections held by other parties. The purpose of this paper is to compare these two legal mechanisms that allow the police to acquire and access DNA samples. My concern is the increase in collection of DNA samples for genetic research, the moves to standardise data collection and the computerisation of medical records, may make research collections more attractive to the police. Are we are prepared for research collections to become an extension of the National DNA Database used for crime detection? In the USA a decision has been made that the police should not be allowed access to samples and information derived from ‘sensitive’ research. This article considers ‘the certificates of confidentiality’ that have been instigated by the National Institute of Health in the USA in order to prohibit such uses of research collections by the police. In this article I consider whether certificates of confidentiality should be used in the UK, as a way of providing greater protection to researchers and participants in research. (shrink)