Large companies must increasingly satisfy not only the conditions of their formal licences, but also the concerns and expectations of host communities and broader society. This has led to the emergence, particularly in the minerals industry, of the notion of “social licence”, an interdiscursive term whose meaning is rarely interrogated. We use textual analysis to critically investigate the construction of social licence discourse in minerals companies’ sustainable development reports and at a recent industry conference. We find that the texts mystify (...) the nature of agency, and privilege processes that maintain existing power relations. Through their partial accommodation of heterogeneous discourses, the texts downplay tensions and conflicts. We conclude that there is a need to reconceptualise the nature of company–stakeholder relationships through a more collaborative, dialogic and reflexive process, avoiding the binary state implied by the term licence. (shrink)

As biobank research has become increasingly widespread within biomedical research, study-specific consent to each study, a model derived from research involving traditional interventions on human subjects, has for the sake of feasibility gradually given way to alternative consent models which do not require consent for every new study. Besides broad consent these models include tiered, dynamic, and meta-consent. However, critics have pointed out that it is normally not known at the time of enrolment in what ways samples deposited in a (...) biobank may be used in future research and that, for a consent to be informed, exactly this kind of knowledge is required. Therefore, there is an ongoing debate about the ethical acceptability of going for less than study-specific consent. In light of this debate we address the question of how to best protect participants against relevant risks and violations of autonomy. We apply the central aims of the informed consent process to the unique circumstances of biobank research where samples and data in many cases are stored for long periods of time and reused in subsequent studies. Thereby we are able to formulate a set of criteria focusing both on the risk of informational harm and the potential violation of participants’ values. We compare existing models of consent based on their ability to satisfy the criteria, and we find that the broad consent model offers the best level of protection for participants, although, it suffers from a few important deficiencies with regards to protection against participant value violations and long-term protection of autonomy, if it is applied without qualifications. For this reason, we propose modifications to the current broad consent model, in order to ensure that it provides protection of autonomy and participant values through strong ethical review and continuous communication. We conclude that a modified form of broad consent is ethically superior in biobank research, not only because it is most feasible but primarily because it offers the best available protection against the hazards facing research subjects in this form of research. (shrink)

Most babies born each year in the U.S. undergo mandatory newborn screening to detect serious medical conditions that can cause devastating effects if treatment is not initiated prior to the onset of symptoms. Not all of the blood collected from newborns is used during routine newborn screening, and many states retain the residual dried blood samples. DBS have a broad range of potential uses, from program evaluation to public health and biomedical research unrelated to newborn screening. State laws vary regarding (...) whether parental consent is required to use DBS for secondary research, but federal now requires parental consent for the use of DBS in federally funded research. (shrink)

Recent highly publicized privacy breaches in health care and genomics research have led many to question whether current standards of data protection are adequate. Improvements in de-identification techniques, combined with pervasive data sharing, have increased the likelihood that external parties can track individuals across multiple databases. This paper focuses on the communication of identifiability risks in the process of obtaining consent for donation and research. Most ethical discussions of identifiability risks have focused on the severity of the risk and how (...) it might be mitigated, and what precisely is at stake in pervasive data sharing. However, there has been little discussion of whether and how to communicate the risk to potential donors. We review the ethical arguments behind favoring different types of risk communication in the consent process, and outline how identifiability concerns can be incorporated into either a detailed or simplified method of communicating risks during the consent process. (shrink)

Proper procedures for informed consent are widely recognized as an ethical requirement for biomedical research involving human beings, in particular as a means to respect the autonomy and personal integrity of potential and actual research participants.

In lieu of an abstract, here is a brief excerpt of the content:Convention for Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Biomedicine: Convention on Human Rights and BiomedicineCouncil of EuropePreambleThe Member States of the Council of Europe, the other States and the European Community signatories hereto,Bearing in mind the Universal Declaration of Human Rights proclaimed by the General Assembly of the United Nations on 10 December 1948;Bearing in mind the (...) Convention for the Protection of Human Rights and Fundamental Freedoms of 4 November 1950;Bearing in mind the European Social Charter of 18 October 1961;Bearing in mind the International Covenant on Civil and Political Rights and the International Covenant on Economic, Social and Cultural Rights of 16 December 1966;Bearing in mind the Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data of 28 January 1981;Bearing also in mind the Convention on the Rights of the Child of 20 November 1989;Considering that the aim of the Council of Europe is the achievement of a greater unity between its members and that one of the methods by which that aim is to be pursued is the maintenance and further realisation of human rights and fundamental freedoms;Conscious of the accelerating developments in biology and medicine;Convinced of the need to respect the human being both as an individual and as a member of the human species and recognising the importance of ensuring the dignity of the human being; [End Page 277]Conscious that the misuse of biology and medicine may lead to acts endangering human dignity;Affirming that progress in biology and medicine should be used for the benefit of present and future generations;Stressing the need for international co-operation so that all humanity may enjoy the benefits of biology and medicine;Recognising the importance of promoting a public debate on the questions posed by the application of biology and medicine and the responses to be given thereto;Wishing to remind all members of society of their rights and responsibilities;Taking account of the work of the Parliamentary Assembly in this field, including Recommendation 1160 (1991) on the preparation of a Convention on bioethics;Resolving to take such measures as are necessary to safeguard human dignity and the fundamental rights and freedoms of the individual with regard to the application of biology and medicine;Have agreed as follows:Chapter IGeneral provisionsArticle 1. (Purpose and object)Parties to this Convention shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine.Each Party shall take in its internal law the necessary measures to give effect to the provisions of this Convention.Article 2. (Primacy of the human being)The interests and welfare of the human being shall prevail over the sole interest of society or science.Article 3. (Equitable access to health care)Parties, taking into account health needs and available resources, shall take appropriate measures with a view to providing, within their jurisdiction, equitable access to health care of appropriate quality. [End Page 278]Article 4. (Professional standards)Any intervention in the health field, including research, must be carried out in accordance with relevant professional obligations and standards.Chapter IIConsentArticle 5. (General rule)An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it.This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks.The person concerned may freely withdraw consent at any time.Article 6. (Protection of persons not able to consent)1. Subject to Articles 17 and 20 below, an intervention may only be carried out on a person who does not have the capacity to consent, for his or her direct benefit.2. Where, according to law, a minor does not have the capacity to consent to an intervention, the intervention may only be carried out with the authorisation of his or her representative or an authority or a person or... (shrink)