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Unambiguous cell line authentication is essential to avoid loss of association between data and cells. The risk for loss of references increases with the rapidity that new human pluripotent stem cell (hPSC) lines are generated, exchanged, and implemented. Ideally, a single name should be used as a generally applied reference for each cell line to access and unify cell-related information across publications, cell banks, cell registries, and databases and to ensure scientific reproducibility. We discuss the needs and requirements for such a unique identifier and implement a standard nomenclature for hPSCs, which can be automatically generated and registered by the human pluripotent stem cell registry (hPSCreg). To avoid ambiguities in PSC-line referencing, we strongly urge publishers to demand registration and use of the standard name when publishing research based on hPSC lines., In this article Kurtz, Seltmann and colleagues propose a standard nomenclature and registry for human pluripotent stem cells. The nomenclature is based on fixed name elements and provides a unique identifier for PSC lines suitable for referencing over diverse data sources, registries, publications, and cell banks. Rigorous application is needed to reduce risks from misidentification and false referencing of lines and data.

Summary The California Institute for Regenerative Medicine has formed a group of clinics called the Alpha Stem Cell Clinics Network. Its goal is to accelerate clinical trials of stem cell-based therapies for diseases with unmet medical needs. In this report, we describe our experience in establishing an Alpha Stem Cell Clinic at City of Hope. Implementation and integration of the clinic into the existing institutional structures required collaboration and cooperation with clinical trial units, nursing administration, and creation of new positions. The highlight of this process and the centerpiece to our success has been the definition of the role of the “hybrid nurse,” a person with nursing competencies in both clinical care and research. Abstract Video Link: https://youtu.be/WOeZrNyXkGU

Summary Human somatic cell reprogramming is a leading technology for accelerating disease modeling and drug discovery. The Deriving Induced Stem Cells Using Stored Specimens (DISCUSS) project is a consensus-building initiative designed to consider how human somatic cells obtained under general biomedical research protocols can be used in induced pluripotent stem cell (iPSC) derivation. We previously published a draft list of points to consider for the use of previously collected specimens in iPSC research and then initiated a structured feedback and comment process. Here, we present a summary of this feedback and revised list of points to consider.

Few areas of scientific inquiry have received the amount of attention from politicians, the media and the ethics community that research involving human stem cells has received. A large part of this attention, particularly in the early days of the field, was focused as much on the controversial nature of the research as on its scientific promise. The primary cause of controversy remains the use and destruction of human embryos to derive stem cells or create human embryonic stem cell (hESC) lines, which is considered by some constituencies to be morally problematic. A common policy response to these issues has been to subject stem cell research to heightened or additional ethics reviews and oversights. Internationally, many jurisdictions have established specific legislation, ethical guidelines and oversight bodies to govern stem cell and related embryo research (Box 1). ### Box 1: Some jurisdictions with heightened ethics review process for stem cell research CANADA UNITED STATES

This article summarizes the recent activity of the International Stem Cell Banking Initiative (ISCBI) held at the California Institute for Regenerative Medicine (CIRM) in California (June 26, 2016) and the Korean National Institutes for Health in Korea (October 19–20, 2016). Through the workshops, ISCBI is endeavoring to support a new paradigm for human medicine using pluripotent stem cells (hPSC) for cell therapies. Priority considerations for ISCBI include ensuring the safety and efficacy of a final cell therapy product and quality assured source materials, such as stem cells and primary donor cells. To these ends, ISCBI aims to promote global harmonization on quality and safety control of stem cells for research and the development of starting materials for cell therapies, with regular workshops involving hPSC banking centers, biologists, and regulatory bodies. Here, we provide a brief overview of two such recent activities, with summaries of key issues raised.

In March 2013, the California Institute for Regenerative Medicine, in collaboration with the NIH Center for Regenerative Medicine, held a 2-day workshop on cell therapies for Parkinson's disease (PD), with the goals of reviewing the state of stem cell research for the treatment of PD and discussing and refining the approach and the appropriate patient populations in which to plan and conduct new clinical trials using stem cell-based therapies for PD. Workshop participants identified priorities for research, development, and funding; discussed existing resources and initiatives; and outlined a path to the clinic for a stem cell-based therapy for PD. A consensus emerged among participants that the development of cell replacement therapies for PD using stem cell-derived products could potentially offer substantial benefits to patients. As with all stem cell-based therapeutic approaches, however, there are many issues yet to be resolved regarding the safety, efficacy, and methodology of transplanting cell therapies into patients. Workshop participants agreed that designing an effective stem cell-based therapy for PD will require further research and development in several key areas. This paper summarizes the meeting.

In May, Oregon Health and Science University (OHSU) announced the successful derivation, by the Mitalipov laboratory, of embryonic stem cells by somatic cell nuclear transfer. This experiment was recognized as a “ formidable technical feat ” and potentially a key step toward developing cell based therapies. The OHSU report is also an example of how a scientifi c breakthrough can inform research ethics. This article suggests ways that nuclear transfer embryonic stem cell lines may contribute to research ethics by adding rigor to studies addressing pressing research questions important to the development of cell - based therapies.

Summary Human somatic cell reprogramming is a leading technology for accelerating disease modeling and drug discovery. Research organizations are sponsoring initiatives to create libraries of induced pluripotent stem cell (iPSC) lines for broad distribution and application. Donor informed consent plays a critical role in supporting the ethical conduct of iPSC research. To date, our organizations have focused on informed consent considerations for somatic cell collection intended specifically for iPSC derivation and distribution. This article considers how somatic cells obtained under general (biomedical) research protocols can be used for iPSC derivation. We present draft Points to Consider regarding the use of human somatic cells for iPSC research. Our goal is to initiate a process designed to develop consensus for the use of previously collected specimens for iPSC research. We anticipate publishing final considerations in early 2014.

Prompted by an increased interest of both research participants and the patient advocacy community in obtaining information about research outcomes and on the use of their biological samples; the international community has begun to debate the emergence of an ethical ‘duty’ to return research results to participants. Furthermore, the use of new technologies (e.g., whole-genome and -exome sequencing) has revealed both genetic data and incidental findings with possible clinical significance. These technologies together with the proliferation of biorepositories, provide a compelling rationale for governments and scientific institutions to adopt prospective policies. Given the scarcity of policies in the context of stem cell research, a discussion on the scientific, ethical and legal implications of disclosing research results for research participants is needed. We present the International Stem Forum Ethics Working Party’s Policy Statement and trust that it will stimulate debate and meet the concerns of researchers and research participants alike.

Research suggests that the representation of scientific and medical issues in the traditional media such as newspapers, TV and radio is an important determinant of public opinion and related public policy outcomes, particularly with regard to attitudes toward stem cell research. With the emergence of social media, the discursive space around public policy issues has expanded to include a new demographic of media consumer who is directly involved in political action. However, little is known about the influence of social media on scientific public policy conversations. We analyzed Twitter posts on two topics relating to stem cell science and policy according to the originator and tone of the tweet, and whether the tweet was intended to be neutral or to further a stated policy position. This analysis provides a means for clarifying the role of social media in influencing public opinion of policy issues such as stem cell research and offers organizations a better understanding of how to more effectively apply social media to advancing their stem cell policy positions.

In 2009 the International Stem Cell Banking Initiative (ISCBI) contributors and the Ethics Working Party of the International Stem Cell Forum published a consensus on principles of best practice for the procurement, cell banking, testing and distribution of human embryonic stem cell (hESC) lines for research purposes [1] , which was broadly also applicable to human induced pluripotent stem cell (hiPSC) lines. Here, we revisit this guidance to consider what the requirements would be for delivery of the early seed stocks of stem cell lines intended for clinical applications. The term 'seed stock' is used here to describe those cryopreserved stocks of cells established early in the passage history of a pluripotent stem cell line in the lab that derived the line or a stem cell bank, hereafter called the 'repository'. The seed stocks should provide cells with suitable documentation and provenance that would enable them to be taken forward for development in human therapeutic applications. WHO recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biologicals and for the characterization of cell banks were updated in 2010 and provide a number of definitions and guiding principles that may apply to stem cells. The term 'cell bank' is used to describe a stock of vials or other containers of cells with consistent composition aliquoted from a single pool of cells of the same culture history (for other specific definitions see PAS 84 [2] and WHO [3] ).Three important assumptions have been made in the preparation of this document. First, that seed stocks of hPSCs are used as starting materials to make cell banks for use in clinical trials. The cell banks made within a clinical trial would need to be established according to Good Manufacturing Practice (GMP) in a facility with a relevant product manufacturing license. These banks would need additional risk assessment focused on the new banking process/reagents and the specific intended clinical application. Second, it has been assumed that undifferentiated pluripotent stem cells would not be inoculated into patients. Third, where feeder cells are used to culture hPSC lines, their cellular nature and intimate contact with the therapeutic cells means that they should be subject to similar risk assessment and banking procedures as applied to the hPSC cells.It is important to note that responsibility for establishing and updating national regulations for medicinal products relies on National Regulatory Authorities. Therefore, national requirements for cell therapy may vary considerably. Accordingly, it is not intended that this international consensus provides comprehensive guidance that will ensure compliance with requirements in any given jurisdiction. Rather, it is designed to aid the development of clinical grade materials by providing points to consider in the preparation of seed stocks of stem cell lines for use in cell therapy. It may arise that there are circumstances where it is not reasonably possible to meet specific procedures presented in this document. Where this is the case any alternative procedures should be justified and mitigate against any adverse consequences. Finally, this document could also serve as a useful reference to assist in the evaluation of potential sources of candidate cell lines for the development of cell-based medicines, and provide the links necessary to identify some of the key differences in regulatory requirements between countries.

CIRM was established in November 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure, which provided $3 billion in fund ing for stem cell research at California universities and research institutions, was overwhelmingly approved by voters, and called for the establishment of an entity to make grants and provide loans for stem cell research. The Proceedings of the California Stem Cell Agency is a monthly series of commentaries, articles, interviews, webinars, forums, and concise reviews on a wide range of topics in regenerative medicine.

Data sharing is an essential element of research; however, recent scientific and social developments have challenged conventional methods for protecting privacy. Here we provide guidance for determining data sharing thresholds for human pluripotent stem cell research aimed at a wide range of stakeholders, including research consortia, biorepositories, policy-makers, and funders. The International Stem Cell Forum and the Stem Cell Network of Canada.

This review was conducted to characterize the nature of contemporary occupational epidemiologic research involving genetic markers, consider how genetic information is unique with regard to its social applications, and examine some of the ethical dilemmas that may arise over the course of studies. We have reviewed the literature and the lessons from our experience in conducting occupational epidemiologic research involving genetic markers. This review describes how occupational epidemiologic studies differ from other epidemiologic studies on issues of participation, confidentiality, and the history of including genetic markers. Of primary concern in occupational studies are genes that have multiple alleles and are sometimes referred to as "metabolic polymorphisms." They generally do not confer risk on their own but rather only in combination with a specific exposure. There is a need for a clear policy and guidelines for the conduct of occupational epidemiologic studies using genetic material. This policy should address all of the steps in study design, implementation, interpretation, and communication of results.

Stem cell repositories, similar to many areas in human scientific research, must balance the interests of the individuals who donate their time and samples to science with the interests of scientific progress. This article seeks to explore how sustained interaction with stem cell donors can advance key donor interests (autonomy and privacy) while also increasing the scientific utility of stem cell lines. The ability to trace stem cell lines to their respective donors – underpinned by robust informed consent – enables donors to gain access to information regarding research outcomes and the uses of their biological samples, while also supporting basic and clinical research by providing a means for quality and safety controls. Measures to recontact donors and also to enable donors to withdraw from research should be well designed to ensure donors’ preferences are respected while mitigating negative consequences resulting from limited data availability or compromised sample quality. To guarantee the integrity of research while respecting donors’ autonomy and preferences, stem cell repositories require a prospective approach to informed consent.

The term “stem cell exceptionalism” has been used to characterize the policy response to controversies surrounding human embryonic stem cell research. For example, governments and funding agencies have adopted policies governing the derivation and use of human embryonic stem cell lines. These policies have effectively served to fill gaps in existing guidelines and regulations and signal that scientists are committed to a responsible framework for the conduct of research involving human embryos. Recent publications discuss whether ethical and policy issues associated with induced pluripotent cells (iPSCs) from non-embryonic sources create a need for further policy intervention. We suggest many of the issues identified by commentators may be addressed through the application of established policy frameworks governing the use of tissue, human stem cells, and research participation by human research subjects. To the extent, iPSC research intersects with hESC research (e.g. the creation of human gametes and/or embryos), the policy framework governing hESC appears sufficiently robust at this time.

Novel methods and associated tools permitting individual identification in publicly accessible SNP databases have become a debatable issue. There is growing concern that current technical and ethical safeguards to protect the identities of donors could be insufficient. In the context of human embryonic stem cell research, there are no studies focusing on the probability that an hESC line donor could be identified by analyzing published SNP profiles and associated genotypic and phenotypic information. We present the International Stem Cell Forum (ISCF) Ethics Working Party's Policy Statement on "Publishing SNP Genotypes of Human Embryonic Stem Cell Lines (hESC)". The Statement prospectively addresses issues surrounding the publication of genotypic data and associated annotations of hESC lines in open access databases. It proposes a balanced approach between the goals of open science and data sharing with the respect for fundamental bioethical principles (autonomy, privacy, beneficence, justice and research merit and integrity).

Summary The regulation of human embryonic stem cell (hESC) research has emerged as an important international policy issue. Many governments around the world have sought to advance the field through the development of regulatory frameworks to guide research activities (Knowles, 2004), providing an opportunity to ensure public confidence and enable a more permissive policy context. However, proliferation of these frameworks has raised concerns among scientists that "piecemeal" regulation may hinder the development of new therapies. We propose that developing reciprocal policy agreements between jurisdictions and agreeing on a global coding information system will maximize the potential benefit for researchers.

In 2000, approximately 20 railroad track workers who filed injury reports or compensation claims for carpal tunnel syndrome were tested by their employer for two genetic traits to determine the work relatedness of the condition. The testing involved deletions, variants, or mutations in the genetic coding for peripheral myelin protein (PMP22) and transthyretin (TTR). This article is an assessment of whether there is a scientific basis for such testing. A review of the scientific literature indicated that neither the scientific basis nor the population validity of the PMP22 or TTR tests for carpal tunnel syndrome were adequately established before use on railroad track workers in 2000. Although ethical and legal issues may predominate in this case, the absence of a compelling scientific basis undermines the decision to conduct the tests.

Social theories of risk suggest that a combination of scientific and cultural perspectives converge to influence risk perception. This article first surveys sociological perspectives suggesting that risks from modern technological development have become predominant concerns in the social consciousness. Particular attention is given to those theses describing how social elements work to create perception of risks in relation to new technologies. The themes that emerge from this survey are then related to contemporary debates concerning biotechnology. Specific attention is given to recent controversies regarding genetically modified crops, and parallels are drawn between debates over nuclear power and biotechnology. A procedural ethic for public discourse and decision making over the diffusion of genetically modified foods is offered. Ethical and social theories are linked with the hope that by recognizing the social dimensions of debates over new technologies a broader framework for conducting risk analysis may emerge.

Genetic screening can identify individuals with increased susceptibility to certain workplace toxicants. One conceivable benefit is a reduction in occupational disease costs. We examine this rationale by considering the associations among genetic traits, exposure, disease risk, and disease incidence. Given appropriate information, we describe methods for computing the expectation and variance of the future number of disease cases and of the differential screening cost per worker hired (a cost-benefit measure). We present two hypothetical scenarios: (1) benzene-induced cancer with few expected cases, and (2) chronic beryllium disease with many expected cases. We show that variability in disease incidence and cost outcomes must be considered because in specific instances, screening can be cost-beneficial on average but yield an unfavorable outcome with high probability. This circumstance pertains to scenarios involving small differences between the expected number of cases in screened versus unscreened cohorts.

Restrictions on United States federal funding have thrust state governments into a leadership role in funding and establishing standards for human embryonic stem cell (hESC) research. In 2004, California voters approved $3 billion over 10 years for public funding of stem cell research through the California Institute for Regenerative Medicine (CIRM), making CIRM one of the world's largest supporters of this pioneering new field. CIRM recently adopted strong, comprehensive, and legally binding regulations for the human stem cell (hSC) research that it funds. Box 1 describes the historical background of CIRM regulations. Because other states and jurisdictions may also be developing standards for hESC research, consideration of the principles that guided the CIRM efforts and the innovative measures that it enacted may be useful to others.