In response to the rapidly evolving field of stem cell research, the launch of StemCore marks the establishment of the first independent ethical review board focusing exclusively on stem cell research.
StemCore will function as both a Stem Cell Research Oversight Committee (SCRO), as described in several sets of voluntary guidelines for such research, and as an Institutional Review Board (IRB), as required by regulations governing human subjects research.
The StemCore board consists of highly qualified members with experience and expertise in molecular biology, genetics, clinical care, ethics, law, policy, clinical research, and the regulatory aspects of basic and clinical research. This combined review will eliminate delays, reduce administrative burden, avoid communication problems among boards, and will facilitate a streamlined, consistent review of all issues relevant to conducting stem cell research.
“It is critical that research in this emerging area of science proceeds as quickly as possible and is subject to independent oversight to ensure ethical and regulatory compliance,” said Kathi Hanna, StemCore Co-Chair.
Through its validation process, StemCore can ensure investigators and institutions that the cell lines they are importing or exporting for use in research projects meet all ethical, regulatory, and legal requirements. Moreover, StemCore will create and preserve an electronic dossier of regulatory and supporting documents that verify a cell line’s provenance and integrity, which will prove critical in agency approval of breakthrough therapies.
“One of the biggest hurdles in the early stages of this research is validating that existing cell lines were procured ethically and consistent with applicable regulations,” said Hanna. “StemCore offers a valuable service in facilitating the validation process for each cell line in question.”
As an independent SCRO/IRB, StemCore’s mission is to facilitate the conduct of scientifically and ethically sound research with no conflicts of interest concerning the validity of cell lines or the review of research protocols.