April 2005 New Guidelines for Stem Cell Research
The National Academies (National Academy of Sciences, National Academy of Engineering, Institute of Medicine and National Research Council) recently funded a report which recommended guidelines fro research involving human embryonic stem cells. Although the adherence to these guidelines is completely voluntary, the Academies are encouraging observance of the guidelines to ensure responsible practices and enhanced integrity of privately funded stem cell research. This document includes recommendations such as:

• The establishment of Embryonic Stem Cell Research Oversight or ESCRO committees which include legal and ethical experts as well as representatives of the public. These committees should review proposals for research that takes stem cells from excess blastocysts at in vitro fertilization clinics or from blastocysts created specifically for stem cell research. They should also review proposed use of blastocysts created by nuclear transfer (therapeutic cloning). Nuclear transfer, under these new guidelines, must not be used for reproductive cloning.
• Human embryos used in culture should not be grown in culture for more than 14 days.
• An IRB should review the procurement of all eggs, sperm, or blastocysts to be used in generating stem cell lines. They should also review donations of somatic cells to be used in creating a blastocyst via nuclear transfer.
• Donor consent should be obtained before a blastocyst is used to extrapolate stem cells. Donors should be informed that they have the right to withdraw their consent at any point before a stem cell line is derived. Practices for generating consent should be analyzed for potential conflicts of interest. The donors should not be paid for any donations and blastocysts left over at in vitro fertilization clinics may not be donated for research without consent.
• Donors should be advised that their information, including their names, could become known by those who work with their stem cells. They should be able to decide whether or not they would like any information obtained through studies of the cell lines. The consent forms must state that the cell lines may be kept and used for many years. Donors also need to be informed that the research involving their stem cells could have potential to become commercial; however donors will not share in any financial benefits.
• Research on existing unidentified embryonic stem cells does not require IRB review unless cells are going to be transplanted into patients.
• No animal embryonic stem cells should be transplanted into a human blastocyst, and approval by and ESCRO committee must be secured before any human cells are put into an animal. No animal who has obtained human embryonic stem cells is allowed to breed. No human embryonic stem cells should be put into nonhuman primate blastocysts.
• Human stem cells should not be introduced into nonhuman mammals unless there is no other experiment that can provide the information needed.

These guidelines, developed by the National Academies were designed on behalf of the scientific community and no government intervention was provided. Compliance is voluntary, however the committee has called on research institutions and private funders to require adherence to these guidelines.
Copies of Guidelines for Human Embryonic Stem Cell Research will be available late in the spring. To purchase the full text, please visit http://www.nap.edu