In early 2013, the Indian Central Drugs Standard Control Organisation, under supervision of the Health Secretary, introduced new rules governing the conduct of clinical trials involving human participants. Among other provisions, the rules require that sponsors of research compensate participants who are injured during the course of their research participation. The rules presumably were drafted to protect citizens from harm caused by biomedical research without unduly restricting access to the benefits that research can provide. While requiring compensation for injury is widely-acknowledged as a critical component of ensuring ethical conduct of human subjects research, in this case the legal restrictions do not match the ethical justifications that support a compensation requirement. To see this, it is important to examine the context in which the rules were written, the justifications for rules of this type, and what mechanisms are available to bring the effects of the rules into alignment with the norms their passage sought to promote.

Both researchers and clinicians are increasingly offering genomic testing for children and adolescents, a practice which parents have generally endorsed in numerous studies. By contrast, much less effort has been devoted to understanding what minors think about genetic and genomic testing. While a small number of investigators have shown that minors with or at risk for cancer generally concur with their parents and favor testing, other studies reveal that minors are less willing to participate in genomics research. Regardless, genetic and genomic testing of minors raises of host of potential legal questions. Key issues are: (1) To what extent can minors obtain genomic tests without involvement of parents or guardians? (2) To what extent can minors refuse genomic testing? and (3) To what extent can minors obtain their own results, keep their parents from getting access to them, and limit what their parents do with their genomic test results? While a number of authors have written about legal issues in genetic testing of minors, remarkably little has been written about the legal protections of minors’ choices about genomic analysis and return of results.

In the past two decades, courts and scholars have grappled with the appropriateness of pre-abortion disclosures mandated by the state. Statutes requiring physicians to recite a specific script, often detailing potential psychological “risks” of choosing to terminate a pregnancy, have proliferated nationwide over the past decade. Opponents of such laws have sometimes characterized the requirement of a procedurespecific disclosure as unnecessary and unique to the abortion context. In recent years, however, state legislatures supportive of abortion rights have legislated procedure-specific mandatory disclosures in the context of assisted reproduction and other health care procedures with reproductive health impacts.

The health care industry will be a large customer of big data while predictive analytics already underlie important health care and public health initiatives. Yet big data are not benign. For example, data brokers, the businesses that buy, process, and sell “big data” are performing an end-run around health data protection by creating data “proxies” outside of HIPAA-protected space. From 2012-14 various branches of the federal government published five major reports on privacy. All five were in favor of increased regulation of data brokers. However, their recommendations for legislative or regulatory intervention were quite diverse. This essay describes the various proposals and offers a critical synthesis.

Adopting international legal agreements for every global health challenge is not a good idea. Such an enterprise would require unprecedented political mobilization and resources that are impossible to sustain, and it would lead to further fragmentation in global health governance. International legalization also has its costs and trade-offs, including potentially devastating dark sides that we have tallied elsewhere.

Yet we believe that calls for an international legal agreement on antibiotic resistance (ABR) are important and that such an agreement is in fact much needed for the future of global health. We came to this conclusion based on a reasoned assessment of the facts before us — the potential benefits, costs, and trade-offs of an ABR legal agreement — and consideration of four criteria we previously proposed for prospectively evaluating proposals for new global health treaties.3 We came to this conclusion despite previously expressing concerns about adopting new international legal agreements on global health issues.

Research that recruits and surveys participants online is increasing, but is subject to fraud whereby study respondents — whether eligible or ineligible — participate multiple times. Online Internet research can provide investigators with large sample sizes and is cost efficient. Internet-based research also provides distance between the researchers and participants, allowing the participant to remain confidential and/or anonymous, and thus to respond to questions freely and honestly without worrying about the stigma associated with their answers. However, increasing and recurring instances of fraudulent activity among subjects raise challenges for researchers and Institutional Review Boards (IRBs). The distance from participants, and the potential anonymity and convenience of online research allow for individuals to participate easily more than once, skewing results and the overall quality of the data.

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.

The successes of the Human Genome Project and the continuing advances of DNA technology have ushered in a new era of genomic science. Investigators around the world are using genomic technologies to advance our fundamental understanding of biologic and physiologic mechanisms in humans and other species. The ability to sequence the entire human genome exponentially expands our ability to identify the contribution of genetic variation to disease risk and other phenotypic differences within the population. Information derived from this research has the potential to contribute to disease prevention, disease prediction, and personalized treatment. These scientific advances, however, raise several ethical, legal, and social challenges. Many of these challenges, including personal and societal benefits and risks, and privacy and confidentiality, are mirrored in the current professional and public debate about the perceived conflict between personal autonomy, privacy, and confidentiality, and the potential value of sharing genomic information within the family.

In spring 2013 the American College of Medical Genetics and Genomics (ACMG) Working Group on Incidental Findings in Clinical Exome and Genome Sequencing (hereafter “Working Group”) released a report of “Recommendations for Reporting of Incidental Findings in Clinical Exome and Genome Sequencing,” the culmination of a three-year long consensus project. The Working Group recommended that a number of incidental findings, which they define as “the results of a deliberate search for pathogenic or likely pathogenic alterations in genes that are not apparently relevant to a diagnostic indication for which the sequencing test was ordered,” be returned to clinicians (and patients) independent of patient preferences. The Working Group recognized that their recommendations may violate existing ethical norms, but believe this is justified by a fiduciary duty on the part of clinicians and laboratory personnel to prevent harm by warning patients about certain findings, a duty they claim “supersedes concerns about autonomy.”

Transparency and disclosure in the health care realm occupy a vital link between the delivery of medical services and patient autonomy. In her article, “Disclosure Two Ways,” Erin Bernstein skillfully explores this link in the context of abortion and assisted conception services, keenly observing the rise in mandatory disclosure laws in both arenas. Her thesis, as I understand it, is that laws that require enhanced disclosure above traditional informed consent thresholds can be understood as neutral tools in the name of patient protection, even — or perhaps especially — when their effect is to persuade a patient to forego the requested treatment. She combats the critique that pre-abortion required disclosures are sui generis, arguing against their uniqueness by analyzing them alongside a swell of mandated disclosure laws in the assisted reproductive technologies (ART) context.

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. 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.

This article assesses which policies for addressing antibiotic resistance (ABR) as part of a multi-pronged approach would benefit from legalization through an international legal agreement. Ten candidate policies were identified based on a review of existing literature, especially The Lancet Series on Antimicrobial Resistance (AMR), The Lancet Infectious Diseases Commission on AMR, and the World Health Organization (WHO) Global Action Plan for AMR. These policies were then grouped under the headings of access, conservation, and innovation.

Each of the ten policies were assessed using four criteria developed by Hoffman, Røttingen, and Frenk to help consider why their legalization may be helpful, necessary and/or justified. These criteria are: (1) the problem has a significant transnational dimension; (2) the goal justifies the coercive nature of law; (3) the outcome is likely to be beneficial; and (4) legalization represents the best commitment mechanism among competing alternatives.

For decades, health information has been collected and shared for health care delivery and public health purposes. While the “primary use” of patient data for providing direct health care services is the cornerstone of health care practice, health departments rely on data sharing for research and analysis to support disease prevention and health promotion in the population. As the U.S. health system undergoes a digital revolution, health information that was previously captured in paper form now can be captured electronically. Electronic health information (EHI) has transformed the efficiency, capacity, and functions of the U.S. health system. For this reason, there is increased attention to the “secondary use” of electronic patient data for public health uses, including disease reporting and investigation, syndromic surveillance, and patient-specific or population-level communications about health conditions and their associated risk factors. Secondary uses may also encompass clinical research, licensure, and payment for services.

The language of “protection” has been a dominate frame in the political discourse of the contemporary women’s movement, especially as it relates to reproductive health. Since the 1960s, and coming of age in the Women’s Health Movement, activists and advocates have fought for the protection of women’s rights and health, and against gender-based discrimination and restrictions to reproductive health services, such as abortion and contraception. In the case of women’s reproductive rights, the use of the “protective” frame has been a resonant and effective mobilizing discourse for quite a while. This paper investigates the use of this frame, by ideological opponents, during a recent California legislative session.

“Health in All Policies” (HiAP) is the latest manifestation of an ecological approach to public health enhancement — one that recognizes connections between health and other sectors, and that socioeconomic determinants of health are significant. HiAP is related to other holistic, prevention-oriented approaches to collective health, such as the use of Health Impact Assessments to evaluate the health externalities of pending government decisions. Yet HiAP is unique. It goes beyond evaluation of specific projects and policies, and embodies a distinct approach to cross-sectoral public health work.

More than a decade ago, Solomon Benatar and Peter Singer argued that “a new, proactive research ethics…must ultimately be concerned with reducing inequities in global health and achieving justice in health research and health care.” Towards this objective, a limited amount of recent scholarship has started to consider whether a theoretical basis exists for the position that international research should help promote global health equity and, if so, what the implications are for its conduct. Theories of justice from political philosophy establish obligations for parties in high-income countries to improve the health of parties in low- and middle-income countries (LMICs). These theories have been shown to provide grounds for the claim that international research should be conducted to advance justice in global health. What this means for research actors from high-income countries is the focus of a recently proposed ethical framework: “research for health justice.”

The nature and effectiveness of any international legal agreement is heavily shaped by the forum in which it is negotiated and implemented. This includes both the substantive content that global policymakers agree upon and the subsequent state compliance with those provisions. Forums differ in their institutional characteristics, thereby providing unique opportunities and costs for participating actors. Forums may have different mandates, capacities, cultures, members, and legal processes — all of which ultimately affect distributions of power and influence. These differences then shape how issues are framed, the content of agreements as they are negotiated, and the incentives states have to comply with any obligations.

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. It has been part of the European Union since 1986.

Spain is a social and democratic state subject to the rule of law. Liberty, justice, equality, and political pluralism are the highest values of the legal order of the rule of law. Spain is a constitutional monarchy with a parliamentary government. The legislative power rests upon two chambers: the Congress and Senate. The government exercises the executive powers and the regulatory powers. There have been six presidents since 1978 from all parties, socialist, centrist, and conservative. The judicial power rests upon the courts and tribunals established by law.

Should children ever have genetic testing for adultonset conditions? For the last two decades, there have been general recommendations from professional organizations that discourage such testing. Until recently, such testing was only plausible in the context of a family history of a Mendelian condition that might prompt the parents (or an adolescent) to request testing for the adult-onset condition present within the family. In this context there has been a gradual shift in the direction of suggesting parents should have greater discretion to obtain such testing after careful consideration of risks and benefits by the family and the health care provider.

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-ló, 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.