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Table of Contents
Table of Contents
Introductions
Introduction: Harmonizing Privacy Laws to Enable International Biobank Research
Mark A. Rothstein and Bartha Maria Knoppers - [PDF]

Biobanks of various types (e.g., public or private, single disorder or multiple disorder, open access or restricted access) have become an important part of modern biomedical research. Biobanks facilitate research on rare disorders, large-scale genomic analysis, and validation of promising findings using large cohorts, thereby promoting translational science and personalized medicine. An increasing number of biobanks are affiliated with or participate in international consortia to establish even larger repositories of biological specimens and health information.
Symposium Articles
Biobanks, Data Sharing, and the Drive for a Global Privacy Governance Framework
Edward S. Dove - [PDF]

Spurred by a confluence of factors, most notably the decreasing cost of high-throughput technologies and advances in information technologies, a number of population research initiatives have emerged in recent years. These include large-scale, internationally collaborative genomic projects (Table 1) and biobanks (Table 2), the latter of which can be defined as an organized collection of human biological material and associated data stored for one or more research purposes. Biobanks are a key emerging research infrastructure, and those established as prospective research resources comprising biospecimens and data from many participants are viewed as particularly promising drivers of biomedical progress. Such biobanks, particularly those publicly funded and set up to promote the public interest, have expanded across the globe in recent years.
International Guidelines for Privacy in Genomic Biobanking (or the Unexpected Virtue of Pluralism)
Adrian Thorogood and Ma'n H. Zawati - [PDF]

In an era of unrivalled sequencing, computation and networking capability, international sharing of genomic samples and data is becoming a modus operandi for modern medical research. Researchers are collaborating to establish large collections with global scale. Having never before set foot outside the cell, the molecules that shape us are being digitized and launched across the globe. Protecting individual privacy interests in this information is a central challenge of the genomic research era.
Biobanking and Privacy Laws in Australia
Don Chalmers - [PDF]

Australia is a multi-cultural society with a population of nearly 24 million. The Aboriginal heritage traces back some 40,000 years and continues to influence Australian culture as a whole. A large proportion of Australian citizens were of British descent or birth at the outset of the last century, but post-World War II there was significant immigration from other European nations, particularly from Greece and Italy. In the last decades, there has been a significant intake of migrants from Asia.
Biobanking and Privacy Law in Brazil
Sueli Gandolfi Dallari, Felipe Angel Bocchi Castellaro, and Iara Coelho Zito Guerriero - [PDF]

Recent scientific and technological developments have promoted the emergence of biobanks on a population scale. Although the storage of human biological material has taken place for a long time, it is only recently that biobanks have acquired a broader scientific significance, especially for genomic research. The increase in biobanks creates many ethical dilemmas, such as the protection of privacy, and creates the need for a new regulatory framework, which must enable the sustainable development of biobanks while also protecting the rights of research subjects and biobank participants.
Privacy and Biobanking in China: A Case of Policy in Transition
Haidan Chen, Benny Chan, and Yann Joly - [PDF]

With a population of over 1.3 billion, China is the most populous country in the world. It is facing an acute aging population problem, with a projected 440 million residents over age 60 and 101 million over age 80 by 2050. Furthermore, rapid industrialization and urbanization in China have resulted in serious air pollution and associated public health problems, including an increase in respiratory diseases and cancers. These and other demographic trends have generated concerns about the cost of health care and its impact on population health. In recent years, the Chinese government has invested heavily in the fields of translational research and biobanking with the hope that research in both fields can yield effective solutions to improve the public's health and quality of life. The establishment of national biobanks was identified as a major initiative needed for the biomedical industry in the 12th Five-Year National Development Plan of Strategic Emerging Industries promulgated by the State Council in 2012. In the meantime, the task of regulating data access and privacy has fallen on a number of government departments as well as on the biobanks themselves. This ensemble of regulators has, in recent years, released various normative instruments on the collection, handling, protection, and transfer of human genetic resources. Taken together, these policies form the data protection framework applied to biobanking initiatives in the People's Republic of China (PRC). This article presents a critical legal analysis of this framework with the aim of identifying areas that merit attention in future regulatory developments.
Genomic Databases and Biobanks in Denmark
Mette Hartlev - [PDF]

Denmark is a constitutional monarchy resting on the founding Constitution of 1849 and later amendments. The 179 members of parliament are democratically elected, and the government is formed on the basis of parliamentary principles. The queen functions as head of state without any power to intervene in legislative or executive matters. Greenland and the Faroe Islands are part of the kingdom, but self-governing. In total, the population is around 5.6 million. The country is divided into five regions and 98 municipalities. Members of both regional and municipal councils are democratically elected.
Regulation of Biobanks in France
Emmanuelle Rial-Sebbag and Anna Pigeon - [PDF]

France, a country with nearly 66 million inhabitants, contributed greatly to the construction of the European Union (EU) as one of the founder states. In 1957, the treaties establishing the European Economic Community (EEC) and the European Atomic Energy Community (Euratom) were signed by Belgium, France, Germany, Italy, Luxembourg, and the Netherlands in Rome. Today, they are referred to as the "Treaties of Rome." The French contribution to the EU has strongly influenced the political views on the development of Europe, notably pushing for a large contribution of member states to the decision making processes and to the orientation of the EU policies.
Biobank/Genomic Research in Nigeria: Examining Relevant Privacy and Confidentiality Frameworks
Obiajulu Nnamuchi - [PDF]

Health research raises profound concerns of an ethical and legal nature - concerns primarily centered on how to balance researchers' quest for scientific discovery against societal interest in protecting individuals whose participation makes the discovery possible. Particularly in a country such as Nigeria, which, not too long ago, suffered major abuse of research subjects (Pfizer's clinical trial of Trovafloxacin and resulting death of eleven children in 1996), deploying a robust ethicolegal regime capable of curbing excesses and protecting research participants whilst contemporaneously not frustrating scientific progress is not an easy task. This is even more critical in the context of novel scientific endeavors, such as biobanking and genomic research, particularly when a significant pool of potential donors are inadequately informed about the processes involved in their participation or the result.
Regulation of Biobanks in South Africa
Pamela Andanda and Sandra Govender - [PDF]

The ongoing efforts to establish biobanks in Africa envisage the availability of biological samples and data in accordance with relevant national legislation and ethical principles.1 Current literature has established that many African countries "do not have national legislation or guidelines on the use of stored biological samples" or if such guidelines are in place, then "disparities exist in relation to informed consent and export and import requirements." In this regard, this article considers the extent to which the available 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.
Spanish Regulation of Biobanks
Pilar Nicolas - [PDF]

Spain occupies an area of 504.645 km, and it has a population of 46.5 million people, out of which 4,538,503 are immigrants. Life expectancy is 82.5 years (85.5 for females and 79.5 for males). Its economy grew 1.4 % in 1014. Its current Constitution was enacted in 1978.3 It has been part of the European Union since 1986.
Taiwan Regulation of Biobanks
Chien-Te Fan, Tzu-Hsun Hung, and Chan-Kun Yeh - [PDF]

Taiwan is an island country situated in the northwest Pacific, close to the southeast of China. The land area is about 36,000 square kilometers. The population of Taiwan is about 23 million, and it consists of the majority Han ethnic groups (it can be further divided into Ho-lo, Hakka, and Mainlander) and dozens of minority groups who are collectively called "Formosan," an appellation for indigenous peoples in Taiwan. Formosans can be divided into Pingpu (plain-land indigenous peoples) and Gaoshan (mountain indigenous peoples) by their living area. In recent years, marriages between Taiwanese, Mainland Chinese, and Southeast Asians have increased significantly. Because of the genetic background of the Taiwanese people, it was thought to be highly beneficial for Taiwan to establish a biobank specifically designed for the Taiwanese population, as it would enable large-scale cohort studies to be carried out for common diseases occurring in Taiwan.
Independent Articles
Automatic Placement of Genomic Research Results in Medical Records: Do Researchers Have a Duty? Should Participants Have a Choice?
Anya E.R. Prince, John M. Conley, Arlene M. Davis, Gabriel Lazaro-Munoz, and R. Jean Cadigan - [PDF]

The growing practice of returning individual results to research participants has revealed a variety of interpretations of the multiple and sometimes conflicting duties that researchers may owe to participants. One particularly difficult question is the nature and extent of a researcher's duty to facilitate a participant's follow-up clinical care by placing research results in the participant's medical record. The question is especially difficult in the context of genomic research. Some recent genomic research studies - enrolling patients as participants - boldly address the question with protocols dictating that researchers place research results directly into study participants' existing medical records, without participant consent. Such privileging of researcher judgment over participant choice may be motivated by a desire to discharge a duty that researchers perceive themselves as owing to participants. However, the underlying ethical, professional, legal, and regulatory duties that would compel or justify this action have not been fully explored. This paper is not an argument for or against including genomic information in an individual's medical record. Our purpose, rather, is to explore the specific question of who should decide whether to place genomic information generated in a research setting in a participant's medical record.
Conflict Resolution in the Clinical Setting: A Story Beyond Bioethics Mediation
Haavi Morreim - [PDF]

Rarely do ethics consults focus on genuine moral puzzlement in which people collectively wonder what is the right thing to do. Far more often, consults are about conflict. Each side knows quite well what is "right." The problem is that the other side is too blind or stubborn to recognize it. And so the ethics consultant is called, perhaps in the hope that s/he will throw the weight of ethics toward one side and end the controversy so everyone can get on with other business.
An Ethical and Legal Framework for Physicians as Surrogate Decision-Makers for Their Patients
Philip M. Rosoff and Kelly M. Leong - [PDF]

Over the last century, and especially since the publication of the Belmont Report in 1978, respect for persons, as exemplified by respect for autonomous decision-making, has become a central tenet in the practice of medicine. The authority of cognitively competent adults to make their own healthcare decisions is enshrined in both law and practice in most advanced industrialized nations. The right to consent to or to refuse medical interventions is virtually absolute, but is contingent on the provision of materially relevant information about the benefits and burdens or risks of the proposed treatment as well as the freedom from coercion by others, especially healthcare personnel. This power also extends to the kinds, amounts and details of the proposed intervention, including the option to decline to hear anything, if one so chooses, assuming that this is a rational choice. This respect transfers to other competent individuals who are authorized as surrogates to decide for those who have temporarily or permanently lost the capacity to make their own healthcare decisions.
Regulating Tobacco Product Advertising and Promotions in the Retail Environment: A Roadmap for States and Localities
Tamara Lange, Michael Hoefges, and Kurt M. Ribisl - [PDF]

The evidence linking tobacco product advertising to adolescent smoking initiation and resulting longterm addiction, premature death, and disability is well established. Each link in the causal chain has been substantiated: children and adolescents are especially vulnerable to advertising; point-of-sale advertising comprises 92.1% of cigarette advertising and marketing expenditures by manufacturers and 71.3% of smokeless tobacco advertising; tobacco companies have targeted youth through advertising; advertising exposure causes adolescents to start and to continue smoking; among adults who become daily smokers, nearly all first use of cigarettes occurs by 18 years of age; adolescents who smoke are at high risk for long-term addiction because their brains are still developing; and long-term addiction results in the tremendous personal, social and financial costs of tobacco-related illnesses.
Currents in Contemporary Bioethics: Citizen Science on Your Smartphone: An ELSI Research Agenda
Mark A. Rothstein, John T. Wilbanks, and Kyle B. Brothers - [PDF]

Beginning in the 20th century, scientific research came to be dominated by a growing class of credentialed, professional scientists who overwhelmingly displaced the learned amateurs of an earlier time. By the end of the century, however, the exclusive realm of professional scientists conducting research was joined, to a degree, by "citizen scientists." The term originally encompassed non-professionals assisting professional scientists by contributing observations and measurements to ongoing research enterprises. These collaborations were especially common in the environmental sciences, where citizen scientists participated in counting wildlife and measuring environmental conditions. Later, patient groups began to play a more active role in supporting clinical trials and collecting health records from affected individuals.
Public's Health
Public Health and the Law: Legal Innovations to Advance a Culture of Health
James G. Hodge, Jr., Kim Weidenaar, Andy Baker-White, Leila Barraza, Brittney Crock Bauerly, Alicia Corbett, Corey Davis, Leslie T. Frey, Megan M. Griest, Colleen Healy, Jill Krueger, Kerri McGowan Lowrey, and William Tilburg - [PDF]

Since its inception in 2010, the Network for Public Health Law (Network) has aligned with federal, state, tribal, and local public health practitioners to assess how law can promote and protect the public's health. In 2013, Network authors illustrated major trends in public health laws and policies emanating from an internal assessment of thousands of requests for technical assistance nationally. More recently, the Robert Wood Johnson Foundation (RWJF) has invited the Network and other partners to consider new ideas and strategies toward building a "culture of health." Per Figure 1, RWJF's conception of a culture of health emphasizes key action areas essential to the promotion of health across all sectors and diverse populations.