Insoo Hyun

New ISSCR Guidelines Underscore Major Principles for Responsible Translational Stem Cell Research

The International Society for Stem Cell Research (ISSCR) task force that developed new Guidelines for the Clinical Translation of Stem Cells discusses core principles that should guide the responsible transition of basic stem cell research into appropriate clinical applications.

Medical Innovation Versus Stem Cell Tourism

Stem cell tourism is criticized on grounds of consumer fraud, blatant lack of scientific justification, and patient safety. However, the issues are complex because they invoke questions concerning the limits of acceptable medical innovation and medical travel. Here we discuss these issues and articulate conditions under which “unproven” therapies may be offered to patients outside of regular clinical trials.

Setting Global Standards for Stem Cell Research and Clinical Translation: The 2016 ISSCR Guidelines

The International Society for Stem Cell Research (ISSCR) presents its 2016 Guidelines for Stem Cell Research and Clinical Translation (ISSCR, 2016). The 2016 guidelines reflect the revision and extension of two past sets of guidelines (ISSCR, 2006, ISSCR, 2008) to address new and emerging areas of stem cell discovery and application and evolving ethical, social, and policy challenges. These guidelines provide an integrated set of principles and best practices to drive progress in basic, translational, and clinical research. The guidelines demand rigor, oversight, and transparency in all aspects of practice, providing confidence to practitioners and public alike that stem cell science can proceed efficiently and remain responsive to public and patient interests. Here, we highlight key elements and recommendations in the guidelines and summarize the recommendations and deliberations behind them.

Fair payment or undue inducement

Women who donate their eggs for stem-cell research should be compensated in the same way as other healthy research volunteers, argues Insoo Hyun.Stem cell supplyIf it is ethically and legally permissible for women to offer their oocytes for stem-cell research, and if it is acceptable to compensate healthy volunteers for their time and inconvenience when undergoing comparable procedures for research, why do guidelines on stem-cell provision in North America and Europe limit remuneration to womens direct expenses? Insoo Hyun, currently working on the ISSCR International Human Embryonic Stem Cell Research Guidelines Task Force, argues that women should be fully compensated if they provide oocytes for basic research.

iPS Cells: Mapping the Policy Issues

Given the explosion of research on induced pluripotent stem (iPS) cells, it is timely to consider the various ethical, legal, and social issues engaged by this fast-moving field. Here, we review issues associated with the procurement, basic research, and clinical translation of iPS cells.

The Stem Cell Research Environment: A Patchwork of Patchworks

Few areas of recent research have received as much focus or generated as much excitement and debate as stem cell research. Hope for the therapeutic promise of this field has been matched by social concern associated largely with the sources of stem cells and their uses. This interplay between promise and controversy has contributed to the enormous variation that exists among the environments in which stem cell research is conducted throughout the world. This variation is layered upon intra-jurisdictional policies that are also often complex and in flux, resulting in what we term a ‘patchwork of patchworks’. This patchwork of patchworks and its implications will become increasingly important as we enter this new era of stem cell research. The current progression towards translational and clinical research among international collaborators serves as a catalyst for identifying potential policy conflict and makes it imperative to address jurisdictional variability in stem cell research environments. The existing patchworks seen in contemporary stem cell research environments provide a valuable opportunity to consider how variations in regulations and policies across and within jurisdictions influence research efficiencies and directions. In one sense, the stem cell research context can be viewed as a living experiment occurring across the globe. The lessons to be gleaned from examining this field have great potential for broad-ranging general science policy application.

Embryology policy: Revisit the 14-day rule.

On 4 May, two groups reported that they had sustained human embryos in vitro for 12–13 days. Embryos normally implant in the wall of the uterus at around day seven. Until now, no one had reported culturing human embryos in vitro beyond nine days, and rarely have they been sustained for more than seven. This latest advance comes only 21 months after the researchers at the Rockefeller University in New York City (some of whom are involved in the latest embryo-culturing work) announced that, under certain conditions, individual human embryonic stem cells can self-organize into structures akin to the developmental stages of embryos soon after implantation (see ‘Two advances in human developmental biology’). The cells were obtained from pre-existing stem-cell lines (derived from 4–5-day-old embryos donated through fertility clinics). In principle, these two lines of research could lead to scientists being able to study all aspects of early human development with unprecedented precision. Yet these advances also put human developmental Revisit the 14-day rule

Waiver of informed consent, cultural sensitivity, and the problem of unjust families and traditions.

To be autonomous, a person must also have authentic moral values. She must act on her own values, not on values that were improperly pressed upon her. To respect a patients autonomy, then, a caregiver must do more than carry out her requests. The caregiver must honor the patients authentic requests. But how to do that?

A question of ethics: selling autologous stem cell therapies flaunts professional standards.

The idea that the bodys own stem cells could act as a repair kit for many conditions, including cardiac repair, underpins regenerative medicine. While progress is being made, with hundreds of clinical trials underway to evaluate possible autologous cell-based therapies, some patients and physicians are not prepared to wait and are pursuing treatments without evidence that the proposed treatments are effective, or even safe. This article explores the inherent tension between patients, practitioners and the need to regulate the development and commercialization of new cellular therapies--even when the cells come from the patient.

Policy: Global standards for stem-cell research

New guidelines from the International Society for Stem Cell Research offer a model for self-regulation in contentious areas, write Jonathan Kimmelman and colleagues.