NIH Reviewing Comments on Stem Cell Research Guidelines

The National Institutes of Health (NIH) is in the process of sorting and reviewing thousands of comments it received regarding its new guidelines on stem cell research.

The U.S. agency had been receiving comments from around the nation after it made public a draft of the guidelines in response to President Obama's executive order on March 8.

Under the direction of the president, NIH plans to issue the final stem cell research guidelines before July 7 – the deadline set by Obama.

"We will develop the guidelines as expeditiously as possible," said Dr. Lawrence Tabak, acting NIH deputy director.

Under the proposed guidelines issued by the NIH, funding will be allowed for research using only those human embryonic stem cells that were derived from embryos created by in vitro fertilization (IVF) for reproductive purposes and were no longer needed for that purpose.

Funding for human stem cell research using adult stem cells and induced pluripotent stem cells, meanwhile, would continue to be allowed funding.

However, NIH said it would not fund research using human embryonic stem cells culled from other sources, including somatic cell nuclear transfer, also known as cloning; parthenogenesis, a process in which embryonic development of eggs are activated artificially without fertilization by a sperm; and fertility clinic embryos created by in vitro fertilization for research purposes.

Despite the limits, staunch conservatives have urged the NIH not to issue its proposed guidelines, alleging that they do not prevent conflicts of interest between the reproductive facility and the research facility and that they set the stage for further abuses by limiting federal funding to cell lines derived from embryos that are "no longer needed" for reproductive purposes.

"Infertility clinics can simply create more embryos at the outset, ostensibly for fertility treatment, so they will have more 'spares' left for research," states comments filed on behalf of several pro-life organizations last Tuesday – the last day the NIH was receiving comments.

The organizations – which include the Alliance Defense Fund, the Family Research Council, Concerned Women for America, the Christian Medical Association, and Advocates International, among others – also criticized the NIH for providing the public with "insufficient time to meaningfully comment on the Draft Guidelines."

"A mere 34-day comment period does not afford interested parties an adequate opportunity to comprehensively review and comment on the Guidelines-especially given the scientific complexity and ethical ramifications of the Guidelines," they added.

Notably, when the NIH published a Notice of its Draft Guidelines for Research Involving Human Pluripotent Stem Cells in the Federal Register nearly 10 years ago, the agency had invited public comments for a period of 60 days.

Furthermore, the NIH subsequently extended the original 60-day comment period for an additional 28 days.

"[T]he inadequate comment period precludes the NIH from having sufficient information to engage in informed rulemaking," the pro-life groups asserted.

However, with the 120-day window that Obama gave coming close to an end, the NIH is likely scrambling to go through the thousands of comments received by opponents and supporters of embryonic stem cell research.

According to acting NIH director Raynard Kington, the agency had received more than 20,000 comments four days before the May 26 deadline.

Though Kington said the agency is aware of concerns being raised, he said he could not comment further until officials have reviewed and considered all public comments.

Obama's call for new guidelines followed his executive order to overturn the limits placed by former President Bush on federal funding for research involving human embryonic stem cells.