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Revised Policies & Procedures - March 2010

In January 2007, leaders from across the Johns Hopkins University established the Johns Hopkins University School of Medicine Embryonic Stem Cell Research Oversight (JHU SOM ESCRO) Committee, consistent with guidelines issued by the National Research Council and the Institute of Medicine.  By January 2010, fifty-seven applications had been reviewed by the ESCRO Committee, third-year review of the first ESCRO-approved application had been completed, and annual review notices began to be sent to principal investigators in a timely manner.

Given the rapidly changing nature of stem cell research, policies, and regulations across jurisdictions, new ethical challenges and scientific dilemmas call for reflection and decision. In March 2010, the ESCRO leadership, committed to ongoing review of the current trends, updated the Policies & Procedures to include oversight of additional types of human pluripotent stem cell (hPSC) research. As such, the name of the Committee changed from “ESCRO” to “ISCRO” (Institutional Stem Cell Research Oversight), consistent with the International Society for Stem Cell Research (ISSCR) term of “SCRO”.  The revision in committee name and purview is based upon evolving science, policy trends, and the desire for consistency. It does not mean, however, that oversight will extend to all stem cell research.

In addition to all research using human embryonic stem (hES) cells and/or somatic cell nuclear transfer (SCNT) involving human cells being conducted by JHU faculty, staff or students or involving the use of JHU facilities, the following is also subject to oversight by the ISCRO Committee:

Other hPSCs (e.g., human induced pluripotent stem cells [iPSCs], human embryonic germ cells [hEGCs]) where the research involves:

1.      Introduction of the cells into humans;

2.      Introduction of the cells into the central nervous system of non-human primates;

3.      Introduction of the cells into non-human animals and there is a reasonable possibility of the cells giving rise to gametes; or,

4.      Creation of gametes or embryos.

As stem cell research continues to be in the forefront of medical research, the ethical controversies over pluripotent stem cells are prominent. The ISCRO Committee collaborates with a variety of entities charged with other aspects of research oversight and will continue to serve as a consultative body for related research that does not fall under its purview.

This is also a reminder that awards funded by the Maryland Stem Cell Research Commission require researchers to obtain approval from the IRB, and possibly the ISCRO Committee prior to commencing work using these funds.

 

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