The Journal of Law, Medicine and Ethics This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Conflict Resolution in the Clinical Setting: A Story Beyond Bioethics Mediation
Because ethics consults are often more about conflict than moral puzzlement, the skills of conflict resolution and communication facilitation are now deemed a core competency for ethics consultants. Those skills range beyond the traditional ambit of “bioethics mediation,” as illustrated here by a recent mediation regarding a difficult discharge. As conflict permeates healthcare, often spawning downstream ethical issues, conflict resolution services might be deemed a genre of preventive ethics suitably offered by ethics committees. If so, a strong distinction must be made. “Bioethics mediation” as historically defin...
Source: The Journal of Law, Medicine and Ethics - December 29, 2015 Category: Medical Law Authors: Haavi Morreim Tags: Independent Articles Source Type: research

Automatic Placement of Genomic Research Results in Medical Records: Do Researchers Have a Duty? Should Participants Have a Choice?
In genomics research, it is becoming common practice to return individualized primary and incidental findings to participants and several ongoing major studies have begun to automatically transfer these results to a participant's clinical medical record. This paper explores who should decide whether to place genomic research findings into a clinical medical record. Should participants make this decision, or does a researcher's duty to place this information in a medical record override the participant's autonomy? We argue that there are no clear ethical, legal, professional, or regulatory duties that mandate placement with...
Source: The Journal of Law, Medicine and Ethics - December 29, 2015 Category: Medical Law Authors: Anya E.R. Prince, John M. Conley, Arlene M. Davis, Gabriel Lázaro‐Muñoz, R. Jean Cadigan Tags: Independent Articles Source Type: research

Taiwan Regulation of Biobanks
This paper introduces legal framework and governance structure in relation to the management and development of biobanks in Taiwan. At first, we briefly describe Taiwan's population, political system and health care system. Secondly, this research introduces biobanking framework of Taiwan including 25 biobanks established with the approval of the Ministry of Health and Welfare. In those biobanks, “Taiwan Biobank” is the first and the largest government‐supported biobank which comprises population‐based cohort study and disease‐ oriented study. Since the collection of information, data, and biological specimen of ...
Source: The Journal of Law, Medicine and Ethics - December 29, 2015 Category: Medical Law Authors: Chien‐Te Fan, Tzu‐Hsun Hung, Chan‐Kun Yeh Tags: Symposium Articles Source Type: research

Spanish Regulation of Biobanks
The Spanish legal framework for the processing of samples and data with biomedical research purposes has sought to encourage scientific research, protect the right to freedom of research, and guarantee the interests of donors. The pillars of this legal framework are firstly, the duty to inform the donor in order to ensure that he or she is aware of the importance and the consequences of the donation; secondly, the control by ethics committees (RECs and External Ethics Committees of biobanks); and third, the supplementary application of the general rules on data protection. There are three different possibilities for proces...
Source: The Journal of Law, Medicine and Ethics - December 29, 2015 Category: Medical Law Authors: Pilar Nicolás Tags: Symposium Articles Source Type: research

Regulation of Biobanks in South Africa
The availability of biological samples and data is critical for the establishment of biobanks for health research purposes. Such availability should be ensured in accordance with relevant national legislation and ethical principles. In this article, we consider the extent to which the current legal and ethical regulatory frameworks in South Africa are capable of governing the use of stored biological samples in a manner that facilitates health research while at the same time protecting the interests of sample donors. These two attributes are essential for establishing biobanks in the country. Our evaluation of the framewor...
Source: The Journal of Law, Medicine and Ethics - December 29, 2015 Category: Medical Law Authors: Pamela Andanda, Sandra Govender Tags: Symposium Articles Source Type: research

Biobank/Genomic Research in Nigeria: Examining Relevant Privacy and Confidentiality Frameworks
Nigeria's commitment to genomic research and biobanking is beyond dispute. Proof, if there is need for one, is that the country is one of only six nations (others are Canada, China, Japan, the United Kingdom, and the United States) involved in the International HapMap Project. The HapMap Project is an innovative enterprise aimed at developing a haplotype map of the human genome, a tool that is helpful to studying the genetic basis of disease as well as the genetic or hereditary factors that contribute to variation in response to environmental factors, in susceptibility to infection, and in the effectiveness of, and adverse...
Source: The Journal of Law, Medicine and Ethics - December 29, 2015 Category: Medical Law Authors: Obiajulu Nnamuchi Tags: Symposium Articles Source Type: research

Genomic Databases and Biobanks in Israel
Large‐scale biobanks represents an important scientific and medical as well as a commercial opportunity. However, realizing these and other prospects requires social, legal, and regulatory conducive climate, as well as a capable scientific community and adequate infrastructure. Israel has been grappling with the appropriate approach to establishing such a repository, and debates over the governance, structure, finance, and mode of operation shed a bright light on the underlying social norms, civic engagement and scientific clout in steering a governmental response to pressing medical needs. The article presents the backd...
Source: The Journal of Law, Medicine and Ethics - December 29, 2015 Category: Medical Law Authors: Gil Siegal Tags: Symposium Articles Source Type: research

Regulation of Biobanks in France
The privacy of biobank research participants in France is protected by a combination of bioethics laws, research laws, and data protection laws. Although the law has attempted to facilitate research by creating an opt‐out regime for research with pre‐existing samples, other aspects of the law hinder research. The requirement for multiple consents throughout the process of biobank sample collection and use, the lack of acceptance of a broad consent for biobanking, and genetic exceptionalism in the law all complicate biobank research. With IRB approval, opt‐out consent may be used for genetic research using human tissu...
Source: The Journal of Law, Medicine and Ethics - December 29, 2015 Category: Medical Law Authors: Emmanuelle Rial‐Sebbag, Anna Pigeon Tags: Symposium Articles Source Type: research

Genomic Databases and Biobanks in Denmark
Biobanking in Denmark is regulated via patients' rights laws, data protection laws, and research ethics reviews. Danish law recognizes tissue samples as personal data for purposes of the data protection laws, meaning research with tissue samples may be subject to research ethics review, data protection laws, and patients' rights requirements depending on the circumstances of collection. However, research on information gained through whole genome sequencing is subject only to data protection laws, despite the similarity in the nature of the information. The regulatory framework treats biobank samples collected from patient...
Source: The Journal of Law, Medicine and Ethics - December 29, 2015 Category: Medical Law Authors: Mette Hartlev Tags: Symposium Articles Source Type: research

Privacy and Biobanking in China: A Case of Policy in Transition
Disease‐based biobanks have operated in hospitals and research institutes in China for decades, and China has recently embarked on a plan to establish further biobank networks with the aim of promoting data sharing among the existing biobanks. Although the Chinese Constitution has only recently begun to recognize individual privacy as a distinct and independent constitutional right, biobanking in China has been loosely regulated under a patchwork of sometimes overlapping laws (such as the Interim Measures for the Administration of Human Genetic Resources) and regulatory instruments, as well as and the policies of individ...
Source: The Journal of Law, Medicine and Ethics - December 29, 2015 Category: Medical Law Authors: Haidan Chen, Benny Chan, Yann Joly Tags: Symposium Articles Source Type: research

Biobanking and Privacy Law in Brazil
This article analyzes the current regulatory framework for biobanking, genomic research, and protection of privacy in Brazil. It is divided in four parts. The first describes the biobanking context in Brazil and its evolution in recent years. In the second, the entire regulatory framework on biobanking and genomic research is analyzed. The third part focuses on the critical evaluation of this regulatory framework, specifically on some major ethical dilemmas in biobanking. The fourth part describes the characteristics of the Brazilian biobanking and human research governance system, known as the CEP/CONEP system. Finally, t...
Source: The Journal of Law, Medicine and Ethics - December 29, 2015 Category: Medical Law Authors: Sueli Gandolfi Dallari, Felipe Angel Bocchi Castellaro, Iara Coelho Zito Guerriero Tags: Symposium Articles Source Type: research

Biobanking and Privacy Laws in Australia
Australian biobanks are largely autonomous and funded by local health care institutions, although some biobanks also receive funding from the National Health and Medical Research Council (NHMRC). There is no formal biobank legislation, but the NHMRC has developed biobanking guidelines. The regulation of biobanks is mainly through privacy laws and human research ethics committees. Australia is moving toward the use of broad consent for biobanking. International data sharing is permitted. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - December 29, 2015 Category: Medical Law Authors: Don Chalmers Tags: Symposium Articles Source Type: research

International Guidelines for Privacy in Genomic Biobanking (or the Unexpected Virtue of Pluralism)
This article reviews international privacy norms governing human genomic biobanks and databases, and how they address issues related to consent, secondary use, de‐ identification, access, security, and governance. A range of international instruments were identified, varying in substance — e.g., human rights, data protection, research ethics, biobanks, and genetics — and legal character. Some norms detail processes for broad consent, namely, that even where potential participants cannot consent to specific users and uses, they should be given clear information on access policies, procedures, and governance structures...
Source: The Journal of Law, Medicine and Ethics - December 29, 2015 Category: Medical Law Authors: Adrian Thorogood, Ma'n H. Zawati Tags: Symposium Articles Source Type: research

Biobanks, Data Sharing, and the Drive for a Global Privacy Governance Framework
Biobanks are a key emerging biomedical research infrastructure. They manifest the turn towards greater global sharing of genomic and health‐related data, which is considered by many to be an ethical and scientific imperative. Our collective interests lie in improving the health and welfare of individuals, communities, and populations; improving health and welfare requires access to, and use of, widely dispersed quality data. But sharing these individual and familial data requires in turn that due thought be given to the ethical and legal interests at stake. Most critically, data sharing must occur in an environment where...
Source: The Journal of Law, Medicine and Ethics - December 29, 2015 Category: Medical Law Authors: Edward S. Dove Tags: Symposium Articles Source Type: research

An Ethical and Legal Framework for Physicians as Surrogate Decision ‐Makers for Their Patients
In Western industrialized countries, it is well established that legally competent individuals may choose a surrogate healthcare decision‐maker to represent their interests should they lose the capacity to do so themselves. There are few limitations on who they may select to fulfill this function. However, many jurisdictions place restrictions on or prohibit the patient's attending physician or other provider involved with an individual's care to serve in this role. Several authors have previously suggested that respect for the autonomy of patients requires that there be few (if any) constraints on whomever they may appo...
Source: The Journal of Law, Medicine and Ethics - December 28, 2015 Category: Medical Law Authors: Philip M. Rosoff, Kelly M. Leong Tags: Independent Articles Source Type: research