Human Embryonic Stem Cell (hESC) research involves a number of ethical, legal, scientific, and policy issues. Therefore, it is essential to promote responsible practices for performing hESC research. Multiple groups have developed guidelines for hESC research to advance the science in a responsible manner, including the National Academies of Sciences (NAS) and the International Society for Stem Cell Research (ISSCR), an independent, global, nonprofit organization, founded in 2002, that promotes excellence in stem cell science and applications to human health. These organizations recommended that research institutions should create special review bodies to oversee this field of research, with the intention of providing a critical level of review and scrutiny warranted by the complex issues raised by hESC research.
In June 2023, ISSCR issued guidance titled “Standards for Human Stem Cell Use in Research”, which includes a set of recommendations that, when taken together, establish the minimum characterization and reporting criteria for scientists, students, and technicians in basic research laboratories working with human stem cells. This recent guidance includes current industry standards for conducting research with human stem cells.
In order to ensure adherence to ethical and legal principles of hESC research, Yale University has established an Embryonic Stem Cell Research Oversight (ESCRO) Committee as recommended by the National Research Council and Institute of Medicine of the National Academies’ 2005 Guidelines for hESC Research. ESCRO members are appointed by and serve as advisors to the Office of the Provost. The membership of the ESCRO reflects the scientific, medical, and ethical expertise necessary to perform the aforementioned responsibilities, and includes members of the Yale community (faculty, staff and/or students), as well as outside members, at the election of the Provost.
In addition, the University is committed to ensuring that the Federal government’s current prohibitions against direct or indirect use of federal funds for research on Non-Registry hESC Lines are fully observed.
Charge of the ESCRO Committee
- To provide scientific, medical and ethical review of proposed hESC Research, regardless of whether the proposed research also requires consideration by an IRB;
- To provide a focal point for campus consideration of all issues related to derivation and research use of hESC lines;
- To facilitate education of investigators in the ethical, legal, and policy issues involved in hESC Research, including setting minimum educational requirements as prerequisites for conducting hESC Research;
- To assist investigators in assessing which regulations apply to proposed hESC Research activities;
- To ensure that the provenance of hESCs is documented, and that there was IRB approval of the procurement process in order to ensure adherence to the basic ethical and legal principles of informed consent and protection of confidentiality;
- To establish and maintain a registry of Yale hESC Research, including documentation of key personnel, descriptive information about the types of research being performed, and the hESCs in use;
- To review evolving regulations and guidance and make recommendations to update University policy accordingly;
- To ensure that all applicable hESC regulatory requirements are met and that hESC Research is conducted in accordance with the highest ethical standards; and
- To review areas of ethically sensitive research involving the use of iPS cells (for more information and requirements regarding research with iPS cells, please see Policy for the Review of Human Embryonic Stem Cell Research at Yale).
The full Policy for the Review of Human Embryonic Stem Cell Research is located on the Yale University Provost’s Website.