Search

This article is devoted to the analysis of the genomic research legal regulation in the Russian Federation and the USA. In the United States, in addition to the legislation great importance is attached to medical and scientific institutions self-regulation, and such information is usually open. It is concluded that in Russia, despite the presence of both state and non-state scientific institutions engaged in genomic research, the mechanism of self-regulation as a whole is fragmented. It is also noted that Russia and the United States have specific legal regulation of these relations, which is reflected in the text of the article. For example, in the United States, unlike Russia, most organizations conducting genomic research, including genomic testing, are non-governmental. Currently, the general trend in the legal regulation of genomic research in Russia and the USA is the active development of normative legal regulation. Moreover, a significant difference in the approaches of these countries is the active role of the US states in the development of regional legal regulation on these issues. Despite the fact that Russia is a federal state, the subjects of the Russian Federation are significantly limited in the genomic research legal regulation possibilities. This is largely due to both legal and political reasons that were given in this article. In the United States, a number of statutes have been adopted at the state level that regulate genomic research in such aspects as health insurance, confidential of personal information, the prohibition of discrimination, screening of newborns, and certain types of clinical and scientific research. It should be noted that the genomic research regulation in the United States is not integrated into a single national consolidated act, which is a feature of this legal system. A comparative legal study of the fundamentals of legal regulation and self-regulation of genomic research in Russia and the USA made it possible to understand the specifics of regulation of these issues in different legal systems. The positive regulatory experience in conducting genomic research in the United States can be used to improve the regulatory framework of the Russian Federation in this area.

A core aspect of the entrepreneurial hospital is the mobilisation of the means of care beyond care itself. In previous work, we showed how the entrepreneurial hospital uses its unique access to patient populations, whose health needs make them available, in order to facilitate research into therapeutic, diagnostic, or service delivery innovation. It ‘entrepreneurialises’ care, we argued, to meet research needs. What may be less obvious in this process, however, is that research, too, is entrepreneurialised to meet care needs. That is, the entrepreneurial hospital not only constitutes its patient populations and care infrastructure as distinctive assets that serve its entrepreneurial aims, but also positions its entrepreneurial aims as a decisive element in the service of care. This article develops the concept of the entrepreneurial hospital to help theorise biobanking. It foregrounds the views of biobankers – drawing from our ethnographic research and especially our interviews with key-informants (2008-2009) who work in some relation to biobanking in a Canadian province – thereby providing a window onto an important, yet under-examined, set of rationales motivating the entrepreneurial integration of care and research through biobanks.

This paper explores enactments of participation in two Swiss biobanking configurations, a cohort biobank and a general biobank. It sheds light on the role of Personalized Health endeavours, in which biobanks play a crucial role. In order to contribute to the understanding of the role of participation in biomedical research dynamics, the analysis focuses on the processes of co-production of identity and biobanks (Tupasela et al. 2015). It documents the overlaps between the population – providers of biological samples – and the public, the collective who is expected to give its opinion on issues raised by the reconfiguration of the research/healthcare interface. It shows that modalities of participation impact the potential scientific value derived from the biobank’s population, but also that the reconfiguration of the research/healthcare interface at the core of biobanking contributes to the current blooming of discourses and practices of participation. It argues that the forms of collective identity shaped through participation as population and/or public, exceed formal strategies of participatory governance and may play an even more important role in the shaping of biobanking configurations.

Chronic non-specific contamination of the reproductive tract in animals is a major issue during early postpartum, natural coitus, or artificial insemination. Uterine infection is one of the major concerns reducing fertility, production loss, and early culling of the animals. Therefore, the aim of this study was to identify any novel bacterium if present in the uterine environment of Bubalus bubalis causing infections. A strictly anaerobic bacterial strain designated as Paraclostridium bifermentans GBRC was isolated and characterized. Bacterium was found to be Gram positive moderate rod with motility. The optimum growth was observed at 40 ± 2 °C. The pathogenic characteristics of the GBRC strain, such as hemolysis, gelatin hydrolysis, and the production of volatile sulfur compounds, were similar to those seen in the epithelial layer invading pathogenic strains. Assembled genome size was 3.6 MB, with 78 contigs, and a G + C content of 28.10%. Furthermore, the whole genome sequence analysis confirmed the presence of genes encoding virulence factors and provided genomic insights on adaptation of the strain in the uterine environment. Based on the phenotypic and genetic differences with phylogenetic relatives, strain GBRC is proposed to represent a first reported species of the genus Paraclostridium with potential pathogenic character, from the buffalo uterine environment. This study analysis of the GBRC strain serves as a key reference point for the investigation of potential pathogenic strains that may cause endometritis and metritis in bovine.

The COVID-19 pandemic has taken a substantial human, social and economic toll globally, but its impact on Black/African Americans, Latinx, and American Indian/Alaska Native communities in the U.S. is unconscionable. As the U.S. continues to combat the current COVID-19 cycle and prepares for future pandemics, it will be critical to learn from and rectify past and contemporary wrongs. Drawing on experiences in genomic research and intersecting areas in medical ethics, health disparities, and human rights, this article considers three key COVID-19-related issues: research to identify remedies; testing, contact tracing and surveillance; and lingering health needs and disability. It provides a pathway for the future: community engagement to develop culturally-sensitive responses to the myriad genomic/bioethical dilemmas that arise, and the establishment of a Truth and Reconciliation Commission to transition the country from its contemporary state of segregation in healthcare and health outcomes into an equitable and prosperous society for all. [ABSTRACT FROM AUTHOR]

Realisation of the value and the commercialisation potential of data is gaining exponential momentum. The combination of historical data exploitations and the use of technologies that allow for the triangulation of data results in the collection, storage, and processing of massive amounts of data require diligent data management, including adherence to privacy and other laws, both nationally and internationally. The intrinsic value of scientific data, especially in genomics, becomes apparent when data are shared, often in collaboration with international partners, and compiled into big data sets that are subsequently used for benefit, including commercial benefit. The purpose of this article is to explore the commercialisation of data in South Africa against the backdrop of the legal framework governing the protection of personal information, confidentiality and privacy, with a specific focus on genetic and genomic information. Related issues, such as the collection and sharing of data, ownership of data and challenges about informed consent are also considered. After a brief evaluation of the African regulatory landscape relating to the protection of personal information, the article concludes with a few recommendations aimed at improving the status quo and sensitising the South African public as to the value of their data and personal information, as well as the potential uses and abuses to which their personal information may be subjected. [ABSTRACT FROM AUTHOR]

Findings from recent studies show that the relationship developed with the particular researcher asking for broad consent plays an important role in the participant's willingness to give consent. Interviews and focus groups were conducted in order to present a description and analysis of meetings in which broad consent took place and to examine the role of recruiters in the patients' decision-making and in building trust in the Lausanne University Hospital Institutional Biobank (BIL). Our findings suggest that patient broad consent to biobanking is strongly related to its setting. BIL recruiters' were aware of their role as ambassadors of the BIL and their responsibility towards patients. Patient interviewees were sensitive to the quality of the information delivered, the timing of the consent request and the recruiters' attitudes and behaviours, including the presence of the white coat. Participating in the BIL also seemed to reinforce the patient's self-esteem and perceived efficacy, particularly since they are themselves ill and inactive when requested to participate. Recruiters and participants report that participation may be motivated by fundamental (existential) goals. Organisational factors also affected recruiters' activity and the broad consent procedure raising several ethical issues. This qualitative study suggests that biobanking based on information-based models of decision-making might need to be re-evaluated in order to improve broad consent. Our findings have implications for the practice of broad consent and patient autonomy, as well as for the recruiters' role and training. [ABSTRACT FROM AUTHOR]

Background: The recent expansion of genomic biobank research in the Arab region in the Middle East North Africa has raised complex ethical and regulatory issues. However, there is a lack of studies regarding the views of Arab researchers involved in such research. We aimed to assess the perceptions and attitudes of Arab researchers regarding these issues in biobank research. Methods: We developed a questionnaire to assess the perceptions and attitudes regarding genetic research of researchers from Egypt, Sudan, Morocco, and Jordan. The questionnaire requested demographic data, perceptions, and attitudes regarding the collection, storage, and use of biospecimens and data, the use of broad consent, data security, data sharing, and community engagement. We used multiple linear regressions to identify predictors of perceptions and attitudes. Results: We recruited 383 researchers. Researchers favored equally the use of broad and tiered consent (44.1% and 39.1%, respectively). Most respondents agreed with the importance of confidentiality protections to ensure data security (91.8%). However, lower percentages were seen regarding the importance of community engagement (64.5%), data sharing with national colleagues and international partners (60.9% and 41.1%, respectively), and biospecimen sharing with national colleagues and international partners (59.9% and 36.2%, respectively). Investigators were evenly split on whether the return of individual research results should depend on the availability or not of a medical intervention that can be offered to address the genetic anomaly (47.5% and 46.4%, respectively). Predictors of attitudes toward biospecimen research included serving on Research Ethics Committees, prior research ethics training, and affiliation with nonacademic institutions. Conclusions: We recommend further exploratory research with researchers regarding the importance of community engagement and to address their concerns about data sharing, with researchers within and outside their countries.

Enabling genomic and biomedical data to be shared for secondary research purposes is not always straightforward for existing “legacy” data sets. Researchers may not know whether their data meet ethical and regulatory requirements for sharing. As a result, these data, collected using public funds and the good will and efforts of the donors and investigators, may not be used beyond their original purpose. Single-use plastics are now being banned in many countries; single-use research should be avoided if possible. This paper describes a filter developed through the driver projects of the Global Alliance for Genomics and Health that can be used by researchers to help them determine the extent of sharing possible for their legacy data and actions to be taken to enable further sharing.

Genomic research is one of the priorities of the country’s scientific and technological development, which have been supported by the instruction of the President to the Government on the development of a program for the development of advanced genomic research and genetic technologies in the Russian Federation, by the national project “Science”, and by the project of tintegrated scientific -technological program “The Postgenomic technologies: editing to synthetic biology”. The target indicator of NP “Science” is to ensure the presence of the Russian Federation among the five leading countries of the world that carry out research and development in areas determined by the priorities of scientific and technological development, and one of the indicators of the implementation of this indicator is “the place of the Russian Federation by share in the total number of applications for a patent for an invention filed in the world”. Comparison of patent activity of residents of theRussian Federationand the leading countries of the world engaged in research and development using the capabilities of highperformance genome sequencing was performed. A map of the competitive landscape in the technological field under consideration has been built, showing that foreign companies such as DowDuPont, Roche Holding and Illumina have already created impressive by volume patent portfolios. It was noted that in order for the developments, that will be created in the world-class genomic technology centers within the NP Science, to be globally competitive, it is already necessary to create conditions for the active participation of the business sector in government projects and programs.

Abstract Background Platforms for sharing genomic and phenotype data have been developed to promote genomic research, while maximizing the utility of existing datasets and minimizing the burden on participants. The value of genomic analysis of trios or family members has increased, especially in rare diseases and cancers. This article aims to argue the necessity of protection when sharing data from both patients and family members. Main text Sharing patients’ and family members’ data collectively raises an ethical tension between the value of datasets and the rights of participants, and increases the risk of re-identification. However, current data-sharing policies have no specific safeguards or provisions for familial data sharing. A quantitative survey conducted on 10,881 general adults in Japan indicated that they expected stronger protection mechanisms when their family members’ clinical and/or genomic data were shared together, as compared to when only their data were shared. A framework that respects decision-making and the right of withdrawal of participants, including family members, along with ensuring usefulness and security of data is needed. To enable this, we propose recommendations on ancillary safeguards for familial data sharing according to the stakeholders, namely, initial researchers, genomic researchers, data submitters, database operators, institutional review boards, and the public and participants. Conclusions Families have played significant roles in genetic research, and its value is re-illuminated in the era of genomic medicine. It is important to make progress in data sharing while simultaneously protecting the privacy and interests of patients and families, and return its benefits to them.

Previous research has consistently highlighted the importance of stakeholder engagement in identifying and developing solutions to ethical challenges in genomic research, especially in Africa where such research is relatively new. In this paper, we examine what constitutes good ethical practice in research, from the perspectives of genomic research participants in Uganda. Our study was part of a multi-site qualitative study exploring these issues in Uganda, Ghana and Zambia. We purposively sampled various stakeholders including genomic research participants, researchers, research ethics committee members, policy makers and community members. This paper presents the findings from in-depth interviews with 27 people with diabetes who had participated in a diabetes genomic study. Data were collected using semi-structured interviews. Manual thematic content analysis was conducted using a framework approach. Findings indicate three key requirements that research participants see as vital for genomic research to be more responsive to research participants' needs and contextual realities: (1) de-emphasising the role of experts and institutions in the consenting process, (2) clarity about the timing and nature of feedback both of findings relevant to the health of individuals and about the broad progress of the study, and (3) more effective support for research participants during and after the study. [ABSTRACT FROM AUTHOR]

Biomedical research is increasingly capitalizing on an array of data to illuminate the interplay between "omics," lifestyle, and health. Leveraging this information presents opportunities to advance knowledge but also poses risks to research participants. In interviews with thought leaders, we asked which data type associated with a hypothetical precision medicine research endeavor was riskiest: 42% chose ongoing access to electronic health records, 17% chose genomic analyses of biospecimens, and 15% chose streaming data from mobile devices. Other responses included "It depends" (15%), the three types are equally risky (8%), and the combination of data types together is riskiest (3%). When asked to consider the hypothetical study overall, 60% rated the likelihood of the risks materializing as low, but 20% rated the potential consequences as severe. These results have implications for study design and informed consent, including placing appropriate emphasis on the risks and protections for the full range of data. [ABSTRACT FROM AUTHOR]

Genomic research raises unique ethical concerns among Alaska Native and American Indian (AN/AI) people and their communities. The Center for the Ethics of Indigenous Genomic Research (CEIGR) was created to foster research that takes these concerns into account while considering the sovereign status of AN/AI tribal nations. Relationships developed within CEIGR have allowed for effective, collaborative research among individuals who come from diverse cultures, political and historical backgrounds, and academic disciplines, and who work for organizations with varying resources, capacities, and expectations. The CEIGR framework may inform other groups seeking to conduct social science research related to genomic research with tribal people and their communities. [ABSTRACT FROM AUTHOR]

This study adopts a heuristic technique to argue the thesis that a set of norms rooted in the African philosophy of Ubuntu can usefully supplement current research guidelines for dealing with incidental findings discovered in genomic research. The consensus regarding incidental findings is that there is an ethical obligation to return individual genetic incidental findings that meet the threshold of analytic and clinical validity, have clinical utility, and are actionable, provided that research contributors have not opted out from receiving such information. This study outlines the hurdles that may hinder the integration of this consensus in mainstream clinical practice, and shows how an ethical theory from the global south may be used to address the same. This will advance the field of ethical, legal and social issues of personalized medicine by providing exposure to the under-represented African perspective on the ethical, legal, and social issues of genomics. [ABSTRACT FROM AUTHOR]

Lack of diversity among genomic research participants results in disparities in benefits from genetic testing. To address this, the Alabama Genomic Health Initiative employed community engagement strategies to recruit diverse populations where they lived. In this paper, we describe our engagement techniques and recruitment strategies, which resulted in significant improvement in representation of African American participants. While African American participation has not reached the representation of this community as a percentage of Alabama's overall population (26%–27%), we have achieved an overall representation exceeding 20% for African Americans. We believe this demonstrates the value of engagement and recruitment where diverse populations reside. [ABSTRACT FROM AUTHOR]

Enabling genomic and biomedical data to be shared for secondary research purposes is not always straightforward for existing "legacy" data sets. Researchers may not know whether their data meet ethical and regulatory requirements for sharing. As a result, these data, collected using public funds and the good will and efforts of the donors and investigators, may not be used beyond their original purpose. Single-use plastics are now being banned in many countries; single-use research should be avoided if possible. This paper describes a filter developed through the driver projects of the Global Alliance for Genomics and Health that can be used by researchers to help them determine the extent of sharing possible for their legacy data and actions to be taken to enable further sharing. [ABSTRACT FROM AUTHOR]

There is growing evidence that human genetics plays a significant role in shaping human responses to infectious diseases. For instance, individuals' genetic susceptibility or resistance to infectious disease is likely to affect disease transmission. Yet little attention has been paid to the ethical, legal, and social implications of research in genomics and infectious disease, despite the unique ethical issues that arise in this arena. This article presents results from a pilot study exploring ethics in research on human genetics and response to HIV and other infectious diseases and is focused on perspectives from expert stakeholders. Whereas chairs of institutional review boards, biobank directors, and researchers in genomics and infectious disease expressed similar views about research privacy in the context of a public health emergency, they expressed different perspectives about the role that public health considerations ought to play in the return of individual results to research participants. These perspectives highlight the need to emphasize the importance of broad dialogue for helping various parties navigate the ethically complex current and future challenges of genomics and infectious disease research. [ABSTRACT FROM AUTHOR]

Northern snakehead Ophiocephalus argus Cantor is an endemic freshwater species in China. This species is widely distributed in the lower Yellow and Yangtze river systems in eastern China. In the present study, six cDNA libraries of Ophiocephalus argus were sequenced using Illumina HiSeq4000 paired-end sequencing technology. 67 564 sequences from 79 500 964 paired-end reads were generated. A total of 7182 unigenes were clustered into 25 functional categories by searching against the COG database, and BLAST2GO search assigned 33 710 unigenes to 59 GO terms. From the 67 564 assembled unique sequences, 21 464 SSRs were identified in 14 997 unique sequences. Among the 7992 with compound formation (SSRs), 100 primer pairs were successfully designed for further validation, and 42 of them produced polymorphic products in Ophiocephalus argus individuals. The number of alleles per locus ranged from 5 to 19, the observed and expected heterozygosity estimates ranged from 0.178 to 0.985 and from 0.421 to 0.929, respectively. The generation of such larges cale sequence data in the present study provides a valuable resource for gene discovery and molecular marker development. [ABSTRACT FROM AUTHOR]

Broad consent – the act of gaining one consent for multiple potential future research projects – sits at the core of much current genomic research practice. Since the 25th May 2018, the General Data Protection Regulation (GDPR) has applied as valid law concerning genomic research in the EU and now occupies a dominant position in the legal landscape. Yet, the position of the GDPR concerning broad consent has recently been cause for concern in the genomic research community. Whilst the text of the GDPR apparently supports the practice, recent jurisprudence contains language which is decidedly less positive. This article takes an in-depth look at the situation concerning broad consent under the GDPR and – despite the understandable concern flowing from recent jurisprudence – offers a positive outlook. This positive outlook is argued from three perspectives, each of which is significant in defining the current, and ongoing, legitimacy and utility of broad consent under the GDPR: the principled, the legal technical, and the practical. [ABSTRACT FROM AUTHOR]

Genebanks were established out of a recognised need not just to provide genetic variation to support breeding objectives but to prevent crop diversity from being lost entirely for future users. Such conservation objectives may have led, over the past few decades, to a gradually diminishing connection between genebanks and current users of diversity. While there continues to be large-scale distribution of germplasm from genebanks to recipients worldwide, relatively little is known or published about the detailed trends in the demand for genebank materials. Meanwhile, the rapid expansion of the applications and uses of modern genomic technologies and approaches is, undoubtedly, having a transformational impact on breeding, research and the demand for certain genetic resources and associated data. These trends will require genebanks to be responsive and to adapt. They also provide important opportunities for genebanks to reorganize and become more efficient individually and as a community. Ultimately, future challenges and opportunities are likely to drive more demand for genetic diversity and provide an important basis for genebanks to gear up.

The need to maintain a high quality of life against a backdrop of its inevitably increasing duration is one of the main problems of modern health care. The concept of "right drug to the right patient at the right time", which at first was bearing the name "personalized", is currently unanimously approved by international scientific community as "precision medicine". Precision medicine takes all the individual characteristics into account: genes diversity, environment, lifestyles, and even bacterial microflora and also involves the use of the latest technological developments, which serves to ensure that each patient gets assistance fitting his state best. In the United States, Canada and France national precision medicine programs have already been submitted and implemented. The aim of this review is to describe the dynamic integration of precision medicine methods into routine medical practice and life of modern society. The new paradigm prospects description are complemented by figures, proving the already achieved success in the application of precise methods for example, the targeted therapy of cancer. All in all, the presence of real-life examples, proving the regularity of transition to a new paradigm, and a wide range of technical and diagnostic capabilities available and constantly evolving make the all-round transition to precision medicine almost inevitable.

There has been growing recognition of the importance of diversity and inclusion of underrepresented minority populations, including immigrants, in genomic research and precision medicine. Achieving diversity has been difficult and has led some scholars to question whether the law is a help or a threat to the inclusion of underserved and underrepresented immigrant populations. In this commentary, I provide an overview of some of the many relevant legal issues affecting the inclusion of immigrants in genomic research and precision health initiatives, such as the All of UsSM Research Program. Development of research recruitment, retention, and data collection plans without also considering the legal and sociopolitical context within which such efforts are to be carried out is risky. Advancing health policy with a goal of eliminating health disparities (or, at a minimum, ensuring that health disparities are not exacerbated by genomic or precision health technologies) requires us to acknowledge the negative effects that immigration policy and criminal justice policy have on the involvement of immigrants in such research and on their health directly. I conclude that it is not a question of whether the law is a help or a threat but, rather, whether we collectively will prioritize authentic diversity and inclusion policies and also insist on compliance with the laws intended to ensure the human right of every individual - regardless of immigration status or national origin - to share in the advancement of science. [ABSTRACT FROM AUTHOR]

Research misconduct and consequential harms have been inflicted upon American Indian/Alaska Native communities for decades. To protect their people and culture and to retain oversight over research, many Native communities have established tribal health research and institutional review boards. The Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study showcases a successful, trusting research collaboration with tribal nations and academic investigators in Oklahoma. In 2006, the TODAY Study investigators proposed a modification of the study protocol to collect biological specimens from participants for genomic analyses and indefinite storage. Partnering American Indian tribal nations elected not to participate in the genomics collection and repository proposal. Reasons included 1) protection of cultural values, 2) concerns regarding community anonymity, 3) a potential threat to tribal services eligibility, 4) broad informed consent language, and 5) vague definitions of data access and usage. The nations believed the proposed genomics analyses presented a risk of harm to their people and nations without clear benefit. Since the 2006 proposal and the advancement of genomics research, many tribal communities in Oklahoma, appreciating the potential benefits of genomic research, are developing policies regarding oversight of/access to data and biological specimens to mitigate risks and provide members and communities with opportunities to participate in safe and meaningful genomic research. [ABSTRACT FROM AUTHOR]

Data-sharing among genomic researchers is promoted for its potential to accelerate our understanding of the molecular basis of cancer. However, with genomic data sharing the risks of re-identifying study participants, revealing personal genomic information and data misuse might increase. This study aims at exploring perceptions of patients and physicians in Oncology regarding their assessment of the informational risks resulting from participating in whole genomic research studies in order to improve the informed consent process. For this purpose, we conducted a qualitative focus group study at the National Center for Tumor Diseases (NCT). Patients and oncologists assessed the informational risks either as minimal or as greater than minimal, depending on the context factors of occupational status, age, and patients' prognosis. Interestingly, even patients who assumed a greater risk did not refrain from participating in genomic research, provided that certain informational and institutional safeguards are implemented. Moreover, they expected comprehensive disclosure of the risks resulting from genomic data sharing. These results suggest (1) comprehensive disclosure of the risks of genomic research to potential study participants in genomic research to facilitate risk assessment and sound decision making, (2) establishing independent governance entities in order to minimize the informational risks of genomic research, and (3) implementing data sharing policies which offer guidance for physicians and researchers involved in genomic research. [ABSTRACT FROM AUTHOR]

Achieving the objectives of rolling out genomic research programs in sub-Saharan Africa depends on how prepared indigenous biomedical researchers are for this type of research. We explored the level of preparedness of biomedical researchers in a sub-Saharan African country using in-depth interviews to obtain data on their understanding of genomics and genomic research and assess their awareness of the scope of the country's code of health research ethics. Thirty biomedical researchers were interviewed. Only eight were familiar with concepts of genomics, a form of "genomic health literacy." The majority were not aware of the country's code of research ethics. This study showed that generally biomedical researchers were not genomic health literate, unaware of the code and its limitations as a source of ethical guidance for the conduct of genomic research. These findings underscore the need for educational training in genomics and creating awareness of ethical oversight for genomic research in sub-Saharan Africa. [ABSTRACT FROM AUTHOR]

The Great East Japan Earthquake (GEJE) and resulting tsunami of March 11, 2011 gave rise to devastating damage on the Pacific coast of the Tohoku region. The Tohoku Medical Megabank Project (TMM), which is being conducted by Tohoku University Tohoku Medical Megabank Organization (ToMMo) and Iwate Medical University Iwate Tohoku Medical Megabank Organization (IMM), has been launched to realize creative reconstruction and to solve medical problems in the aftermath of this disaster. We started two prospective cohort studies in Miyagi and Iwate Prefectures: a population-based adult cohort study, the TMM Community-Based Cohort Study (TMM CommCohort Study), which will recruit 80 000 participants, and a birth and three-generation cohort study, the TMM Birth and Three-Generation Cohort Study (TMM BirThree Cohort Study), which will recruit 70 000 participants, including fetuses and their parents, siblings, grandparents, and extended family members. The TMM CommCohort Study will recruit participants from 2013 to 2016 and follow them for at least 5 years. The TMM BirThree Cohort Study will recruit participants from 2013 to 2017 and follow them for at least 4 years. For children, the ToMMo Child Health Study, which adopted a cross-sectional design, was also started in November 2012 in Miyagi Prefecture. An integrated biobank will be constructed based on the two prospective cohort studies, and ToMMo and IMM will investigate the chronic medical impacts of the GEJE. The integrated biobank of TMM consists of health and clinical information, biospecimens, and genome and omics data. The biobank aims to establish a firm basis for personalized healthcare and medicine, mainly for diseases aggravated by the GEJE in the two prefectures. Biospecimens and related information in the biobank will be distributed to the research community. TMM itself will also undertake genomic and omics research. The aims of the genomic studies are: 1) to construct an integrated biobank; 2) to return genomic research results to the participants of the cohort studies, which will lead to the implementation of personalized healthcare and medicine in the affected areas in the near future; and 3) to contribute the development of personalized healthcare and medicine worldwide. Through the activities of TMM, we will clarify how to approach prolonged healthcare problems in areas damaged by large-scale disasters and how useful genomic information is for disease prevention.

Harms and risks to groups and third-parties can be significant in the context of research, particularly in data-centric studies involving genomic, artificial intelligence, and/or machine learning technologies. This article explores whether and how United States federal regulations should be adapted to better align with current ethical thinking and protect group interests. Three aspects of the Common Rule deserve attention and reconsideration with respect to group interests: institutional review board (IRB) assessment of the risks/benefits of research; disclosure requirements in the informed consent process; and criteria for waivers of informed consent. In accordance with respect for persons and communities, investigators and IRBs should systematically consider potential group harm when designing and reviewing protocols, respectively. Research participants should be informed about any potential group harm in the consent process. We call for additional public discussion, empirical research, and normative analysis on these issues to determine the right regulatory and policy path forward.

Copyright of Dilemas Contemporáneos: Educación, Política y Valores is the property of Dilemas Contemporaneos: Educacion, Politica y Valores and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

One of the central ethical tenets of research in developing countries is the sponsor's obligation to benefit host participants and communities. Two known models of benefits provision dominate the ethical discourse of research in developing countries. The first model, known as the "reasonable availability," endorses the obligation to provide interventions proven to be effective at the end of a study. This contrasts with the second model, known as "fair benefits," which endorses other forms of benefits that host communities may deem as fair beyond those derived directly from the study's findings. This paper explores a third benefit model consistent with the writings of the Human Hereditary and Health in Africa (H3Africa) research initiative. The H3Africa-a North-South collaborative initiative predicated by U.S. National Institutes of Health, the Wellcome Trust and the African Society of Human Genetics upholds a benefit model that endorses capacity building as the primary obligation of its research agenda. This is evident by the endorsement of mechanisms to strengthen capacity building in its research projects. While capacity building remains a plausible means of improving the expertise, quality and independence of research in Africa, sustainable measures are needed to realizing the full potential for African-led research on the continent. [ABSTRACT FROM AUTHOR]