When President Obama asked the National Institutes of Health to review existing human stem cell research guidelines and issue new guidance within 120 days, we immediately began a comprehensive review that resulted in the draft Guidelines we published on April 23, 2009. As of July 7, the final Guidelines on Human Stem Cell Research have taken effect, and we believe that these guidelines achieve both of the President’s clearly stated goals of advancing the field of human embryonic stem cell research and raising the bar for ethical standards.
We kept these goals in mind as we analyzed and reflected on the 49,000 comments we received from scientific organizations, patient advocacy groups, medical and religious organizations, as well as private citizens and members of Congress. We believe that these Guidelines are responsive to the public comments and that they will expand stem cell research while ensuring that all NIH-funded research involving human embryonic stem cells will be conducted in an ethical and responsible way.
It is important to note that no changes were made to the basic requirements of eligibility–the embryo donated for research must have been created for reproductive purposes, and it must have been in excess of clinical need. Furthermore, written informed consent for research must have been obtained from the donor. No research using stem cells derived from products of Somatic Cell Nuclear Transfer or parthenogenesis, or from embryos created for research purposes using in vitro fertilization, will be eligible for NIH funding.
While written consent is required, the new Guidelines endorse an informed consent process where all necessary details are explained to and understood by the embryo donor or donors. Thus, applicants for NIH funding who seek to use human embryonic stem cells in their research must demonstrate their ability to realize the process of informed consent.
Your comments highlighted the fact that principles of ethical research, such as voluntary informed consent, have not varied over time. What continue to evolve, however, are the requirements for implementation and procedural safeguards. The new Guidelines enable ethical, responsible human stem cell research, and that can only be carried out through the thoughtful, respectful process of voluntary informed consent that these Guidelines expect.