institutions and investigators adhere to applicable regulatory requirements and, given the increasing frequency of international collaboration in hES cell research, it will be important to monitor regulatory developments in other countries. The ESCRO committees will be charged with ensuring that U.S. investigators follow standards and procedures consistent with current regulations and with the guidelines recommended in this report.
FDA’s Good Laboratory Practice regulations pertain to the management of laboratories that are developing products that might eventually be introduced into humans (for example, in a clinical trial). Those regulations do not cover basic exploratory studies conducted to determine whether a test article has any potential utility or to determine its physical or chemical characteristics, but they do encompass in vivo or in vitro experiments to determine their safety—an activity that would be characteristic of the preclinical phase of hES cell research. Failure to conform to FDA regulations, although not itself a violation of law, would render any hES cell lines less useful if they are considered for tissue transplantation or other cell-based therapies.
Investigators and institutions involved in hES cell research should conduct the research in accordance with all applicable laws and guidelines pertaining to recombinant DNA research and animal care.
hES cell research leading to potential clinical application must be in compliance with all applicable Food and Drug Administration (FDA) regulations. When FDA requires that a link be maintained to the donor source, investigators and institutions must ensure that the confidentiality of the donor is protected, that the donor understands that a link will be maintained and that, where applicable, federal human subjects protections and the Health Insurance Portability and Accountability Act or other privacy protections are followed.
As hES cell research advances, it will be increasingly important for institutions that obtain, store, and use cell lines to have confidence in the value of stored cells, that is, confidence that they were obtained ethically and with informed consent of donors, that they are well characterized and screened for safety, and that their maintenance and storage meet the highest scientific standards.
Institutions that are banking or plan to bank hES cell lines should establish uniform guidelines to ensure that donors of material give informed consent through a process approved by an Institutional Review Board, and that meticulous records are maintained about all aspects of cell culture. Uniform tracking systems and common guidelines for distribution of cells should be established.