Institutional Stem Cell Research Oversight Committee
It is the policy of the Johns Hopkins University (JHU) that some types of research involving human pluripotent stem cells (hPSCs) being conducted by JHU faculty, staff or students or involving the use of JHU facilities or resources shall be subject to oversight by the JHU Institutional Stem Cell Research Oversight (ISCRO) Committee.
Overview of the revised ISSCR guidelines, updates to the JHU ISCRO policy, website, and new required training for conducting certain types of stem cell research.
- All research using human embryonic stem cells (“hESCs”);
- All research using somatic cell nuclear transfer (“SCNT”) involving human cells;
- Other hPSCs (e.g., human induced pluripotent stem cells [“iPSCs”] and human embryonic germ cells [“hEGCs”]) where the research involves:
- Introduction of such cells into humans;
- Introduction of such cells into the central nervous system of non-human primates;
- Introduction of such cells into non-human animals and there is a reasonable possibility of the cells giving rise to gametes;
- Derivation of gametes or embryos from such cells;
- Formation of embryo models derived from such cells; or
- In vitro culture of chimeric embryos (hPSCs introduced into non-human embryos).
Prohibited Research Includes*:
In accordance with prevailing ethical and policy guidance and applicable law and regulation, the following categories of research are currently prohibited at JHU:
- Research involving the introduction of hPSCs into human blastocysts;
- Research involving the introduction of hPSCs into non-human primate blastocysts;
- In general, research involving in vitro culture of any intact human embryo for longer than 14 days or until formation of the primitive streak begins, whichever occurs first;
- Breeding of animals that have or might have had hPSCs introduced into the germ line;
- Using gametes differentiated from human stem cells for in vivo reproduction;
- Gestating human stem cell-based embryo models in the uterus of a human or nonhuman animal;
- Gestating human-animal chimeric embryo(s) in the uterus of a human or non-human primate;
- Transferring embryos following Mitochondrial Replacement Therapy (MRT) into a human uterus; and
- Human reproductive cloning.
*This list may be revised from time to time to reflect changes in prevailing ethical and policy guidance and applicable law and regulation.
Resources
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Research use of human materials to create pluripotent stem cells is subject to oversight by Institutional Review Boards (IRBs). This work can raise ethical challenges, and complex considerations on obtaining appropriate informed consent of donors who contribute human materials for this type of research. The Johns Hopkins Medicine (JHM) IRBs have sample consent template language available and can assist researchers with questions about consent form development. Template consent forms are accessible on the JHM IRB website and researchers may use the JHM IRB Request a Consult Service to seek guidance from a member of the JHM IRB consent form specialist team.
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The International Society for Stem Cell Research (ISSCR)’s revised Guidelines for Stem Cell Research and Clinical Translation (2021) “address the international diversity of cultural, political, legal, and ethical issues associated with stem cell research and its translation to medicine.” This document informs some of JHM’s policy on Human Stem Cell and Related research.
ISSCR is a global nonprofit organization that promotes excellence in stem cell science and applications to human health.
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The National Academies' Guidelines for Human Embryonic Stem Cell Research describes ethical standards for research involving human embryonic stem cells.
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The National Institutes of Health provides resources and guidelines for stem cell research.
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The Maryland Stem Cell Research Fund serves as a resource for stem cell news and funding within Maryland.
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The online training course "Ethical Oversight of Human Stem Cell Research 2010" provides an introduction to both ethical guidelines for human pluripotent stem cell research and to the Policies and Procedures of the Johns Hopkins University Institutional Stem Cell Research Oversight (JHU ISCRO) Committee.
All persons conducting research under JHU ISCRO purview at The Johns Hopkins University must complete the educational module with a passing score of 80%. Certificates of completion should be submitted with the JHU ISCRO application for all listed investigators. Technicians and temporary personnel, although not listed on the application, are also required to complete the course and submit certification to the principal investigator.
Learners may access the course at https://my.jh.edu/. Log in using your JHED ID and password, select the “Education” folder and then “myLearning”. Use the Catalog Search to enter the course title.If you do not have a JHED ID, please call (410) 516-HELP for assistance.
Contact Us
Mailing Address
Institutional Stem Cell Research Oversight Committee
733 N. Broadway
Miller Research Building, (MRB), Suite 117
Baltimore, MD 21205