Protecting Privacy of Pregnant and LGBTQ+ Research Participants.

This Viewpoint summarizes existing federal regulations aimed at protecting research data, describes the challenges of enforcing these regulations, and discusses how evolving privacy technologies could be used to reduce health disparities and advance health equity among pregnant and LGBTQ+ research participants.

Scientific research and product development in the United States to address injuries from a radiation public health emergency.

The USA has experienced one large-scale nuclear incident in its history. Lessons learned during the Three-Mile Island nuclear accident provided government planners with insight into property damage resulting from a low-level release of radiation, and an awareness concerning how to prepare for future occurrences. However, if there is an incident resulting from detonation of an improvised nuclear device or state-sponsored device/weapon, resulting casualties and the need for medical treatment could overwhelm the nation's public health system. After the Cold War ended, government investments in radiation preparedness declined; however, the attacks on 9/11 led to re-establishment of research programs to plan for the possibility of a nuclear incident. Funding began in earnest in 2004, to address unmet research needs for radiation biomarkers, devices and products to triage and treat potentially large numbers of injured civilians. There are many biodosimetry approaches and medical countermeasures (MCMs) under study and in advanced development, including those to address radiation-induced injuries to organ systems including bone marrow, the gastrointestinal (GI) tract, lungs, skin, vasculature and kidneys. Biomarkers of interest in determining level of radiation exposure and susceptibility of injury include cytogenetic changes, 'omics' technologies and other approaches. Four drugs have been approved by the US Food and Drug Administration (FDA) for the treatment of acute radiation syndrome (ARS), with other licensures being sought; however, there are still no cleared devices to identify radiation-exposed individuals in need of treatment. Although many breakthroughs have been made in the efforts to expand availability of medical products, there is still work to be done.

Ethical, legal and social implications of human genome studies in radiation research: a workshop report for studies on atomic bomb survivors at the Radiation Effects Research Foundation.

The Radiation Effects Research Foundation (RERF) is the primary organization in Japan dedicated to studying the health consequences of the Hiroshima and Nagasaki atomic bombings in World War II. In December 2020, RERF held a virtual international workshop on the ethical, legal and social implications (ELSI) of genome studies. In this workshop, the ELSI considerations of future human genome studies on radiation research including atomic bomb survivors and their families were discussed. Since genome sequencing (GS) is now practical and affordable, RERF now plans GS of parents/child trios to examine genetic effects of atomic bomb radiation. As such studies may engender some novel risks and benefits, ethics review and engagement with families (including consent) need to be considered. These include protection of individual privacy, use of samples from deceased prior participants, return of results to the participants, public sharing of genome data and advance science and social welfare. Specifically with regard to social welfare, the results of such studies may have implications for public and government decision-making regarding social benefits of victims and other important questions. Based on these broad-ranging discussions we have developed the following concepts to guide this work: "trust," "compromise" and "relationship building," inclusive of the concerned stakeholders, scientific aims and Japanese society at large. We conclude that in order to realize, establish and maintain these concepts, it is essential to put procedures into place to ensure the successful, consensus-based implementation of the RERF studies.

Developing a Database of Structural Racism-Related State Laws for Health Equity Research and Practice in the United States.

OBJECTIVES: Although US state laws shape population health and health equity, few studies have examined how state laws affect the health of marginalized racial/ethnic groups (eg, Black, Indigenous, and Latinx populations) and racial/ethnic health inequities. A team of public health researchers and legal scholars with expertise in racial equity used systematic policy surveillance methods to develop a comprehensive database of state laws that are explicitly or implicitly related to structural racism, with the goal of evaluating their effect on health outcomes among marginalized racial/ethnic groups. METHODS: Legal scholars used primary and secondary sources to identify state laws related to structural racism pertaining to 10 legal domains and developed a coding scheme that assigned a numeric code representing a mutually exclusive category for each salient feature of each law using a subset of randomly selected states. Legal scholars systematically applied this coding scheme to laws in all 50 US states and the District of Columbia from 2010 through 2013. RESULTS: We identified 843 state laws linked to structural racism. Most states had in place laws that disproportionately discriminate against marginalized racial/ethnic groups and had not enacted laws that prevent the unjust treatment of individuals from marginalized racial/ethnic populations from 2010 to 2013. CONCLUSIONS: By providing comprehensive, detailed data on structural racism-related state laws in all 50 states and the District of Columbia over time, our database will provide public health researchers, social scientists, policy makers, and advocates with rigorous evidence to assess states' racial equity climates and evaluate and address their effect on racial/ethnic health inequities in the United States.

Privacy and Security Issues with Mobile Health Research Applications.

This article examines the privacy and security issues associated with mobile application-mediated health research, concentrating in particular on research conducted or participated in by independent scientists, citizen scientists, and patient researchers. Building on other articles in this issue that examine state research laws and state data protection laws as possible sources of privacy and security protections for mobile research participants, this article focuses on the lack of application of federal standards to mobile application-mediated health research. As discussed in more detail below, the voluminous and diverse data collected by some independent scientists who use mobile applications to conduct health research may be at risk for unregulated privacy and security breaches, leading to dignitary, psychological, and economic harms for which participants have few legally enforceable rights or remedies under current federal law. Federal lawmakers may wish to consider enacting new legislation that would require otherwise unregulated health data holders to implement reasonable data privacy, security, and breach notification measures.

Exploring Solutions to Foster ATMP Development and Access to Patients in Europe.

There are several critical factors that have influenced the (un)success rate of advanced therapy medicinal products (ATMPs) over the first ten years since the EU Regulation 1394/2007 entered into force. This article provides an overview of the current regulatory scenario and outlines the outstanding challenges to be faced in order to further promote research and development of ATMPs and the issues to be considered in the perspective of a possible legislative reform.

Antiretroviral treatment, government policy and economy of HIV/AIDS in Brazil: is it time for HIV cure in the country?

Brazil is a low-and-middle income country (LMIC) that, despite having a large population and continental dimensions, has been able to successfully fight HIV/AIDS through a number of governmental and societal measures. These included an early response to the epidemic, the development of a universal and free public health system, incisive discussions with pharmaceutical companies to reduce antiretroviral (ARV) drug prices, investments towards the development of generic drugs and compulsory licensing of ARVs. Through such measures, Brazil is among the leading LMIC towards achieving the 90-90-90 UNAIDS goals in the years to come. In this review, we analyze Brazil's progress throughout the HIV/AIDS epidemic to achieve state-of-the-art ARV treatment and to reduce AIDS mortality in the country. The top-quality HIV/AIDS research in Brazil towards HIV prophylactic and functional cure, the next step towards the economic sustainability of the battle against HIV, is also discussed.

Research and development of mAb drugs in China: a look from policy perspectives.

Background: Monoclonal antibody (mAb) drugs are increasingly important for the pharmaceutical industry across the globe. In China, mAb drug developments face many challenges. Multiple policies have been implemented recently to reinforce support in various areas. This study aims to investigate the latest landscape of mAb drugs in China from policy perspectives encompassing R&D, clinical trials, marketing approval, and talent pools.Methods: Information about mAb drugs approved in the United States, the European Union, Japan, and China by 2017 and mAb-related policies in China were retrieved from government websites and third-party statistical databases for descriptive, statistical, and comparative analysis.Results and discussion: In China, 21 mAb drugs (10 locally-developed and 11 imported) have so far been approved. For the 11 imported mAb drugs in China, the median drug lag in the marketing approval was estimated at 87.1 months, compared with the U.S. (0 months), the EU (8.9 months), and Japan (43.4 months). However, as far as the dramatically changing innovation supporting system in China is concerned, emergence of new biopharmaceutical companies, transformation of the current drug companies and their shift to antibody therapy, and the pooling of high-level talent contribute to mAb development in China. The number of clinical trials and marketing applications and approvals involving mAb drugs is also growing. Favorable policies will continue to play a role in the sustainable development of mAb drugs in China.Conclusion: The research showed that the reform of multiple policies and incentives for attracting/retaining high-level talent has evidently been effective in addressing the drug lag of mAb drugs in China. In future development, China should actively monitor the global R&D outcomes and industrial development trends of mAb drugs and make the policy environment more attractive to enable more mAb drugs to be marketed in China as soon as possible.