NIH GUIDELINES FOR HUMAN EMBRYONIC STEM CELL RESEARCH WILL NOT PROTECT PUBLIC HEALTH AND SAFETY

Now that President Obama has mandated tax payers to fund human embryonic stem cell research, he has concomitantly ordered the NIH to establish guidelines for responsible and safe research within human embryonic stem cell research. The NIH is mandated to post these guidelines for public review within 120 days. But President Obama’s order for NIH “guidelines” leaves many of us considerably concerned. “Guidelines” lack essential and enforceable edicts and will not protect public health and safety or biotech worker’s rights.

Unfortunately, the NIH has not established a good track record when it comes to promoting and protecting public health and safety through such guidelines.
In fact the NIH guidelines for “recombinant DNA research” have had several serious problems with protecting public health and safety, including worker’s right. Most disturbingly, the NIH has been involved in denying biotech workers the right to obtain biological exposure records by supporting the position that “trade secrets supersede a worker’s right to this information”. This has left scientists little rights to full disclosure to the characteristics of the biological agents to which they were exposed and which, consequently, inhibits their ability to seek directed medical care. As a result, injured biotech workers have been left ill with no possible medical avenue, while the scientific community remains legally free of any fault or responsibility and the public remains ignorant of the dangers.

NIH guidelines are just that…guidelines and not laws.
Guidelines are not laws. Guidelines are difficult to enforce and will provide legal loop holes in attempting to direct safe and responsible use of human embryonic stem cell research.
1. Guidelines adhere to “self policing policies” with no effective oversight, no mandated transparency and leave little incentive for the violators to report violations.
2. Guidelines are written to protect vested interest within the scientific community and not to prioritize the protection of worker’s health or safety rights or public health and safety.
3. Guidelines provide no whistleblower protections for workers who raise public health and safety issues and who subsequently are shown retaliation.

NIH guidelines only apply to federally funded labs.
The public should be aware that NIH guidelines will only apply to federally funded research laboratories, and not private commercial or pharmaceutical labs employing dangerous embryonic stem cell technologies. Private industry, engaging in human embryonic stem cell research, is wildly unregulated. Many of these labs develop genetically-engineered human infectious agents to make embryonic stem cells “sick” for drug discovery purposes. Nevertheless, these companies work with no legal and enforceable regulations in an environment which obviously poses serious public health and safety concerns.

Laws Needed
Although, President Obama has mandated the NIH to provide “guidelines” for federally funded human embryonic stem cell research, the past has shown that guidelines do not work to protect public health and safety or to ensure rights to biotech workers. We need new laws that are enforceable, that promote transparency and are current to modern day biotechnology. These laws should ensure biotech worker’s rights to a safe workplace and to biological exposure records. These new laws should also provide jurisdiction within both federally-funded and private laboratories throughout the United States where dangerous human embryonic stem cell technologies are being developed. It is especially essential to enact strong whistleblower laws to protect scientists and physicians. This is key to effective regulation in this industry. It is a fact that without free speech and whistleblower protection, public health and safety cannot be protected under any circumstances.

A watchful eye should be cast on the NIH when they propose guidelines for human embryonic stem cell research within 120 days and call for public comment. The public should understand that these “guidelines” are helpful to establish baseline practices within the scientific community. But guidelines are not laws. NIH guidelines do not have the legal power or jurisdiction to provide adequate transparency or protection for public health and safety against the dangers of embryonic stem cell research. We desperately need effective laws and not just NIH “guidelines to regulate human embryonic stem cell technologies. The public has every right to demand that effective laws and regulations be placed upon the embryonic stem cell community immediately since NIH guidelines currently are not and assuredly will not be adequate in the future to protect both worker and public health and safety.


For more on stem cell guidelines see link.