THE N.I.H. NEEDS TO HEAR FROM YOU!  (Seriously, this is very important.)

from Don C. Reed

The new National Institutes of Health Guidelines for Human Stem Cell Research have just been issued.

They would significantly loosen the Bush restrictions. If you are glad about that, it is important to say so—because the opposition is mounting a full-scale attack.

This is the all-important public comment period. For the next 3 weeks, until May 26^th, 2009, comments on the guidelines will be accepted from you, me, everybody.

Some folks will say, hey, I am not a scientist, I don't know what kind of guidelines are good-- what does this have to do with me?

Everything.

Here's why.

Those who oppose the research will definitely be writing in.  

Opponents are already being organizing a mass letter-writing campaign.

Every letter will be tabulated, divided into counted piles: for, or against.

What if the majority of people writing in are against embryonic stem cell research? That figure will be used against us at every opportunity: quoted by every anti-research legislator, at every budget hearing from now on.

The NIH needs to hear from you.

If you only send a one sentence letter, that would be great. The little electronic letter box is right below. It is so easy to fill it out.

Folks, this is for everyone, and accordingly, everyone needs to weigh in on it.

Here is an electronic form, which you can use.  Or go to http://nihoerextra.nih.gov/stem_cells/add.htm and post your comments there.

Or, write a snail mail letter, to: NIH Stem Cell Guidelines, MSC 7997

9000 Rockville Pike, Bethesda, Maryland, 20892-7997

Below is the form you can use, followed by some comments from CAMR, the Coalition for the Advancement of Medical Research (the outstanding national organization which leads the way in virtually everything on stem cell research), and then the link to the complete information from the NIH itself.

(the next part is from CAMR)

Help Ensure Strong Federal Support for Embryonic Stem Cell Research –

Submit Comments to the NIH on its Draft Guidelines

As you know, President Obama recently issued an Executive Order instructing the National Institutes of Health (NIH) to develop guidelines to establish a framework for federal funding of embryonic stem cell research.  NIH has released its draft guidelines, and the public has the opportunity to comment on the draft over the next few weeks.  NIH will be analyzing the content, as well as volume, of the comments as it finalizes the guidelines. 

Although the Executive Order was a major step forward, there are sections of the draft guidelines that should be changed and/or clarified to ensure that the framework created builds on current progress. A background document is attached for your information. 

It will be critical for NIH to hear from the public on these issues during the comment period.  Please follow the instructions below to submit your comments to ensure that the final guidelines are crafted in a way that ensures that this science advances as quickly as possible.  And, please forward this alert to your family, friends, and people you know who support embryonic stem cell research. 

How to submit your comments:

·         Click http://nihoerextra.nih.gov/stem_cells/add.htm to be connected to the NIH comment form;

·         Provide your name, and select `self' for Affiliation; and

·         Copy and paste the text below into the comment box, provide the security check ID on the form, and click `submit comments.'

Suggested  comment text (copy and paste into Comment section of NIH comment form and edit as appropriate for you):

Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders.  I am not a scientist, but I have been following progress in this field with great interest.  Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible.  The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress. 

I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding.  It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived.  This will ensure that the final guidelines build on progress that has already been made. 

I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT).  Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways.  If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses.

NIH Draft Guidelines

Background

On March 9^th, President Obama issued an Executive Order instructing the National Institutes of Health (NIH) to develop guidelines to establish a framework for federal funding of embryonic stem cell research.  The NIH, in implementing the Executive Order, recently published draft guidelines in the Federal Register.  The full text can be obtained at http://edocket.access.gpo.gov/2009/pdf/E9-9313.pdf. The public has thirty days to submit comments on the draft guidelines; comments must be received by NIH by May 26^th.  Once the comment period is over, NIH will review the content and volume of comments as it drafts its final guidelines, expected to be issued on or before July 7^th. 

Summary

The draft guidelines establish a framework for federal funding of embryonic stem cells that were derived from embryos created for reproductive purposes and were in excess of clinical need.  In addition, to be eligible for federal funding, the guidelines impose significant eligibility criteria on the donation process of the embryo used to derive the stem cell line.  The criteria include:

·        All options for the use of the embryos were explained to the donor;

·        No inducements were offered for the donation;

·        A policy was in place at the facility where the embryos were donated that ensures that the decision to donate embryos for research would not affect the quality of care provided;

·        There was a separation between the donor's decision to create embryos for reproductive purposes and the donor's decision to donate embryos for research;

·        Consent for the donation was obtained at the time of donation from the individual who sought reproductive services;

·        Whenever practicable, the physician responsible for the donor's reproductive clinical care was not the same person as the researcher deriving the stem cells; and

·        Written informed consent was obtained from individuals who sought reproductive services and who elected to donate embryos for research purposes (specific criteria is listed for the informed consent process).

We believe that these ethical parameters are appropriate for new stem cell lines that are created in 2009 and thereafter.  Unfortunately, the draft guidelines do not explicitly ensure that current lines that are already being used in research will be eligible for federal funding.  It is our recommendation that the final guidelines include a provision that allows for inclusion of current lines, already being used in very important research, if those lines were derived using the prevailing ethical practices at the time. 

The draft guidelines prohibit federal funding of research using embryonic stem cells derived from other sources such as somatic cell nuclear transfer (SCNT), IVF embryos created for research purposes, and parthenogenesis.  It is our belief that these very promising research techniques have potential that is beyond what is possible with embryonic stem cell lines that are derived from the IVF process and should be eligible for federal funding. 

Why it's Important to Submit Comments and How You Can Help

Although the draft guidelines represent a big step forward and create an ethical framework that will allow for federal funding of additional stem cell research in the future, there are a number of areas where the guidelines need to be clarified and/or changed to ensure that current research is allowed to continue and no new bureaucratic hurdles are created that would slow the pace of progress.  

The main areas of concern are highlighted in the template we have provided to you. 

NIH will be evaluating the public's response to the draft guidelines and both the content of the remarks as well as the volume will guide the NIH as it finalizes the guidelines.  It is critical that you help us generate as many comments focused on the points highlighted in the template as possible between now and the May 26^th filing deadline.  You do not need to be a researcher to submit comments – each comment will be recorded and counted.  Please use the template provided to submit your comment and forward it on to your family, friends, colleagues, and anyone you know who supports embryonic stem cell research. 

If you have any questions about the current status of human embryonic stem cell research, please visit www.camradvocacy.org/resources/camr_wp.pdf  or contact CAMR at 202-725-0339.