NIH Stem Cell Guidelines Emphasize Sharing IP

The NIH released a final copy of Guidelines on Human Stem Cell Research on Tuesday of this week, in response to President Obama's March 9, 2009 Executive Order 13505: Removing Barriers to Responsible Scientific Research Involving Human Stem Cells. The Guidelines attempt to address many of the ethical issues associated with the hotly-debated stem cell issue.

One of the issues addressed is whether or not embryos should be created specifically for research purposes, rather than the current practice of using only those intended for in-vitro fertilization procedures. The Guidelines seem to be heavily concerned with issues surrounding informed consent of donors, the requirement and wording for documents of consent and the issue of financial gain. They include responses to the thousands of comments received from public interest groups, scientific associations, religious organizations, patient advocacy groups and more. Basic issues such as the title and scope of the Guidelines and definition of embryonic stem cells (what stage of blastocyst development and what portion of the cell mass) were covered, along with more complex topics such as the handling and distribution of embryonic stem cells and potential for corruption due to misuse and trade for profit. The Guidelines specify that current NIH policies apply to the sharing of information (IP) and materials (in this case, stem cell lines) to further the research of other parties. The Guidelines contain links to eligibility requirements for NIH funding, and specifically refer to the upholding of the Dickey Ammendment.