The following HTML text is provided to enhance online
readability. Many aspects of typography translate only awkwardly to HTML.
Please use the page image
as the authoritative form to ensure accuracy.
Guidelines for Human Embryonic Stem Cell Research
properly controlled. This will not only provide high quality starting materials to facilitate the development of stem cell therapy, but, in providing a centralized resource for researchers, should also reduce the use of surplus embryos for the development of stem cell lines by individual teams.
One of the conditions of the U.K. bank’s establishment was the development of an extensive code of practice for its operations (Medical Research Council, 2004). In addition, it has a clear system of governance, which involves a steering committee for policy, a management committee, and a user and clinical liaison committee.
Tissue-banking policies and practices in connection with a wide array of human cells, tissues, and organs have been established by several public and private entities in the United States, including the National Cancer Institute,2 the National Heart, Lung and Blood Institute,3 and private entities, such as Coriell4 and the American Type Culture Collection.5 In addition, the U.S. Office for Human Research Protections (OHRP) has issued two guidance documents: Issues to Consider in Research Use of Stored Data or Tissues6 and Guidance on Research Involving Coded Private Information or Biological Specimens.7
The guidelines developed by those groups and the U.K. Stem Cell Bank generally adhere to key ethical principles that focus on the need for consent of donors and a system for monitoring adherence to ethical, legal, and scientific requirements. For example, a common requirement is that any identifiable tissue (including coded tissue) that is collected requires IRB review at the site of collection and informed consent of the subject. In addition, most require that, when possible, the informed consent process include information about the repository and the conditions under which materials will be shared. Other policies address the need to protect the privacy of donors. Several models exist for protecting subjects whose specimens are used for research, including the honest-broker model, in which a tissue bank trustee ensures strict control of information flows associated with research that uses banked tissues (see the model developed by OHRP8).
Procedurally, it is common practice that there be a clear policy and system for evaluating requests for samples to see whether each request is consistent with the conditions for sharing samples and with the original informed consent.
At the repository management level, there typically are requirements for safety, security, and risk assessments; validation of submitted material; culturing and ex-