Recommendation 4.1: The stem cell research community should promote accurate, current, balanced, and responsive public representations of stem cell research. Transfer of human stem cell-based embryo models to the uterus of either a human or animal host.Research under this category should not be pursued because of broad international consensus that such experiments lack a compelling scientific rationale or are widely considered to be unethical. These integrated stem cell-based embryo models should be maintained in culture for the minimum time necessary to achieve the scientific objective.Ģ.2.3B Category 3B: Prohibited research activities. Generation of stem cell-based embryo models that represent the integrated development of the entire embryo including its extraembryonic membranes.Forms of research requiring comprehensive review by a specialized review process encompass the following activities: The research should use the minimum number of embryos necessary to achieve the scientific objective. All such research should have a compelling scientific rationale and necessitate the use of these materials rather than employ alternative models. A comprehensive review should be coordinated with other relevant oversight, such as that provided by human subjects review committees, in vitro fertilization (IVF) clinic oversight bodies, and animal research review processes (see 2.2.1), and the research should comply with local law and policy. Forms of research with embryos, certain chimeras, and stem cell-based embryo models that are permissible only after review and approval through a specialized scientific and ethics review process. Committees with the jurisdiction over the relevant research should oversee the provenance of cells, tissues and derived human pluripotent stem cell lines to ensure that procurement and derivation is deemed acceptable according to the principles outlined in this document (see section 2.3.5) and is in compliance with rigorous scientific, legal, and ethical standards.Ģ.2.2 Category 2. Scientists pursuing Category 1A and B research are recommended to consult with appropriate institutional review committees or the committee or body responsible for the specialized scientific and ethics review process (see Recommendation 2.1.3) to determine the categorization of new research proposals. Research that entails the in vitro formation of human stem cell-based embryo models that are not intended to represent the integrated development of the entire embryo including its extraembryonic membranes.Category 1B research includes the following activities: ![]() Research that is reportable to the entity or body responsible for the specialized scientific and ethics oversight process, but not normally subject to further or ongoing review, at the discretion of the entity responsible for the oversight process and subject to regulations and policies in the jurisdiction. These would include but are not restricted to models of amnion formation, neural tube development, development of primordial germ cells, placental structures, 2D or 3D models of gastrulation or post-gastrulation events, and in vitro stem cell-derived organoids in culture that recapitulate most aspects of organ function, but not those that fall under subsequent categories.Ģ.2.1B: Category 1B. Research on stem cell culture systems that model specific stages of development or specific anatomic structures rather than the continuous development of an intact embryo or fetus.Category 1A research includes the following activities: Research determined to be exempt from a specialized scientific and ethics oversight process after being assessed by the appropriate existing mandates and committees for laboratory research. Other sections of the Guidelines may be relevant to such research (e.g., Section 2.1 Review Process, Section 2.3 Procurement and Informed Consent of Human Biological Materials, and Section 4. This page assembles the sections of the Guidelines that specifically address research involving stem cell-based embryo models. COVID-19 Resources for the Stem Cell Community >.Lawrence Goldstein Science Policy Fellowship Program.Code of Conduct for ISSCR Meetings and Events.Circle of Stem Cell Institute and Center Directors.Zhongmei Chen Yong Awards for Scientific Excellence.ISSCR Outstanding Young Investigator Award.Tab will move on to the next part of the site rather than go through menu items. Enter and space open menus and escape closes them as well. Up and Down arrows will open main level menus and toggle through sub tier links. ![]() Left and right arrows move across top level links and expand / close menus in sub levels. ![]() The site navigation utilizes arrow, enter, escape, and space bar key commands.
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