Feeds:
Posts
Comments

Archive for May, 2009

Click, comment, share with friends: TODAY IS LAST CHANCE TO COMMENT ON NEW STEM CELL GUIDELINES…

Today, Tuesday, May 26, 2009, is the last day allowed for public comment on the new stem cell guidelines proposed by the National Institutes of Health (NIH).

If you click on http://nihoerextra.nih.gov/stem_cells/add.htm, (before 11:00 Eastern Standard time tonight) you will come to the public comment page. It is all set up for you, easy as pie.

Why should you take the trouble to say something important like “I support the California Institute for Regenerative Medicine’s position on the new stem cell guidelines” (which would be my recommendation)–?

Three reasons:

1. The new guidelines are so cautious and conservative they would disqualify funding for almost all the embryonic stem cell lines made since 1998, when the field began. We owe the brave men and women scientists who worked in a terrifically hostile political climate—their courage, and their work, deserve to be supported now.

2. The economy of the world depends on cure research. Last year, America alone spent $2.3 trillion on medical care costs—more than all federal income taxes put together ($1.8 trillion)—and 75% of that mountain of money went to pay for chronic (incurable) illness and disability.

3. Your family deserves the best medical care science can provide.

We’re out of time, folks. Today is quite literally the last day.

Click, comment, and then share this note with your friends.

Today, please, or the opportunity is gone.

Don C. Reed, father of Roman, paralyzed, and brother of Barbara, who has cancer. For more information, go to http://www.stemcellbattles.com

Read Full Post »

ONE DAY OPPORTUNITY!

ONE DAY OPPORTUNITY
Dear Friend of Stem Cell Research:
Does your Congressional Representative support stem cell research? If so, he/she needs to contact U.S. Representatives Diana DeGette or Mike Castle TODAY—tomorrow at the latest—Friday May 22nd is the deadline. (Sorry for the no-warning, I just found out ten minutes ago!)
Representatives DeGette and Castle as always are leading the charge for stem cell research, and are working to make sure the new NIH guidelines are clear and reasonable. They are asking other Representatives to co-sign their note expressing support for our concerns.
Here is the info to forward to your U.S. Representative.
If you don’t have his/her email address handy, go to this easy-to-use link:

http://www.house.gov/house/Memberwww_by_state.shtml

Click on your state, click on your representative, and just cut, paste, and send the following information.
Thanks so much!
Don C. Reed, http://www.stemcellbattles.com

Letter to NIH re: Draft Stem Cell Guidelines
Deadline – Friday, May 22

CURRENT SIGNERS

Adler • Arcuri • Baird • Baldwin • Becerra • Biggert • Boswell • Capps • Carnahan • Carney • Carson • Castor • Christensen • Clark • Clay • Cleaver • Cooper • Crowley • Cummings • Davis, Danny • Davis, Susan • DeFazio • DeLauro • Dent • Doggett • Edwards, Donna • Ellison • Engel • Etheridge • Farr • Filner • Fudge • Gonzalez • Grayson • Green, Al • Green, Gene • Hall, John • Hare • Harman • Hastings, Alcee • Hinchey • Hirono • Holt • Honda • Inslee • Johnson, Eddie Bernice • Johnson, Hank • Kennedy Kilpatrick • Kind • Kirk • Kosmas • Langevin • Larson • Lee, Barbara • Levin • Lewis, John • Loebsack • Lofgren • Lowey • Maloney • Markey, Betsey • Matsui • McCarthy • McCollum • McDermott McGovern • McMahon • Mitchell • Moore • Murphy, Patrick • Nadler • Olver • Pallone • Pascrell Pastor • Polis • Rahall • Rothman • Sanchez • Schakowsky • Schauer • Schwartz • Scott, Bobby • Serrano • Shea-Porter • Sherman • Sires • Snyder • Space • Sutton • Tauscher • Thompson, Mike Tierney • Tsongas • Tsongas • Van Hollen • Velazquez • Wasserman Schultz • Watson • Watt • Weiner • Wexler • Woolsey • Yarmuth

REMINDER: Rep. DeGette is collecting signatures on the House Floor
As a supporter of stem cell research, we wanted to alert you that the NIH has solicited comments on draft guidelines for human stem cell research required under President Obama’s March Executive Order.
Reps. DeGette and Castle would like to invite your boss to sign a letter to NIH (see below) on the importance of stem cell research; how pleased we are that the guidelines are moving forward; and to urge that NIH address any unresolved issues. Namely, the letter says that:
· Congress recognizes the need for strong federal leadership by the NIH in carrying out a responsible stem cell research program and that we hope the NIH guidelines will become the gold standard for stem cell research.
· Any responsibly derived stem cell lines should be eligible for federal funding, regardless of the date on which they were derived. The NIH should develop criteria for determining whether lines that are currently in use should continue to be eligible for federal funding.
· Congress supports periodic updates to the guidelines and that the NIH should explicitly state that the guidelines will be updated to reflect future ethically responsible and scientifically worthy advances.
Rep. DeGette will be collecting signatures this week only on the House Floor. Please feel free to have your Representative sign directly with Rep. DeGette or to contact Heather Foster (heather.foster@mail.house.gov) in Rep. DeGette’s office and Olivia Kurtz (olivia.kurtz@mail.house.gov) in Rep. Castle’s office to be added.

Thank you!

Letter to NIH re: Draft Stem Cell Guidelines
Deadline – Friday, May 22

May 22, 2009

Dr. Raynard S. Kington Kathleen Sebelius
Acting Director Secretary
National Institutes of Health U.S. Dept. of Health & Human Services
Building 1 Humphrey Building
1 Center Drive, Room 126 MSC0148 200 Independence Ave., SW
Bethesda, MD 10892 Washington , DC 20201

Dear Dr. Kington:

As supporters of embryonic stem cell research, we are excited that expanded stem cell research efforts will soon commence thanks to Executive Order 13505, signed by President Barack Obama on March 9, 2009, and the National Institutes of Health’s (NIH) upcoming final guidelines on human stem cell research. By establishing a predictable framework to guide stem cell research, scientists can confidently pursue the promise of treatments and cures for the most debilitating diseases.
In the face of fragmented state and private research that is currently being undertaken, we recognize the need for strong federal leadership by the National Institutes of Health (NIH) in carrying out a responsible stem cell research program in order to realize the full potential for stem cell therapies. The importance of these guidelines must not be diminished, as it is our hope that they would be adopted as the gold standard across the federal government and around the world.
In reviewing the draft guidelines we would like to make the following comments:
We believe that any responsibly derived stem cell lines should be eligible for federal funding, regardless of the date on which they were derived. In order to maximize the scientific research already underway, the NIH must adopt an inclusive policy that would expand and not limit stem cell research; the NIH should develop criteria for determining whether or not lines that are currently in use should continue to be eligible for federal funding.
We support periodic updates to the guidelines by NIH, so that the guidelines will reflect scientific needs and advances for all forms of ethical stem cell research, and encourage the NIH to expressly state that scientifically worthy advances will be addressed in future updates to the guidelines. Important research tools will likely be discovered in the coming years, necessitating that the guidelines be adapted accordingly. Similarly, we believe that the guidelines should specify only which types of stem cell research are currently eligible to receive federal funding.
Medical and scientific research, including embryonic stem cell research, holds great promise for alleviating the suffering of the 100 million American patients who are living with devastating diseases — from Parkinson’s disease to spinal cord injuries to diabetes — for which there are no good treatments or cures. We thank you again for your commitment to advancing the field and for your consideration of our comments as you work to finalize the guidelines for human stem cell research.

Read Full Post »

AGAINST ALL ODDS: Texans Fight On, Battling for Research

Advocates have a saying: “Everything we do is impossible!”

It’s true, in a way.

Scientists like Dr. Larry Goldstein of San Diego work with essentially invisible specks in a dish of salt water, trying to find cures for the incurable: like Alzheimer’s disease, that cruel memory loss, which can turn a loved one into a stranger: a mother or father with no memory of their own family.

What are the odds in a battle like that? We don’t even know yet when Alzheimer’s begins in the body, let alone how to fight it– but our scientists soldier on, day after day, long hours in the lab, despite discouragement, lack of funding, and political harassment.

Consider also, the odds against the Texans for the Advancement of Medical Research: TAMR. These research supporters have essentially no money. They have exactly one paid lobbyist, Ellen Arnold– who frequently does not get paid. Ms. Arnold’s business sense, fortunately for us all, is overridden by her heart: all too often she fights for free.

Advocates! Texas has people like Judy Haley, Joe and Nina Brown, Beckie McCleery: names to conjure with, folks to remember when times are tough and there seems no hope, in those gloomy dark Novembers of the soul.

Because what is TAMR up against?

The nearly unlimited power of the anti-research Religious Right.

Imagine a political opponent for whom money is almost no object. One key component is the Catholic Church, the world’s largest property holder. Remember the Michigan struggle to remove anti-science restrictions? Every Catholic family (450,000 in the state) received at least two anti-research DVDs and mailings, not to mention everybody in the state was bombarded by expensive TV ads. Wouldn’t you like to have budget resources like that? The Church buildings themselves are sometimes used as meeting places for research opponents. The Bishops send messages to the Churches, which are printed up and handed to the parishioners, who are also lectured at from the pulpit. So that gives the opposition free rent for buildings to organize from—and access to thousands of paid employees—seems to me a violation of the Constitutional separation of Church and State, but it happens anyway.

The Catholic church does enormous amounts of good work and charity; but it is no friend of cure research: having opposed the science of anatomy, surgery, X-rays, vaccination, anesthesia, blood transfusions, more– and this opposition continues today.

The Republican party is enormously influenced by the Religious Right, (Granted, the moderate wing of the GOP is beginning to reassert itself, but the “social conservatives” still hold the upper hand) and Texas is very much Republican state.

So, forget about research in Texas? Biomedicine, back away, the Lone Star State does not want your new jobs here?

Somebody forgot to explain that to Texas.

Texan scientists are staying. Texan patients are becoming advocates, and their families with them. Texas Catholics, like Catholics everywhere, are increasingly pro-research, way ahead of their ultra-conservative leadership.

And TAMR continues its uphill struggle—which they are beginning to win.

Remember that three billion dollar cancer research bill in Texas, pushed by Lance Armstrong? That’s a Texas-sized bill, folks!

Behind the scenes a major wrestling match has been going on, as the Religious Right and its political arm fight desperately to keep any Texas dollars from that bill or others from being spent on early stem cell research.

Recently, a bill AND a rider attached to the Texas state budget would have prohibited embryonic stem cell research in Texas.

But TAMR was involved as usual, working grinding long hours, on the phone till their ears ached, typing emails till they got so tired sometimes the old zzzzzzzzzzzzz key trick would happen, when you fall asleep at the keyboard and the second finger on the left hand presses the wrong key…
TAMR reached out to friends. They asked scientists to set aside their work, inform themselves on the issues, and make phone calls.

Most scientists hate politics. They just want to do the work and be left alone.
But if they don’t help with the political decisions, the opponents of research will make those decisions for them.

I know at least a dozen scientists who set aside their microscopes and made phone calls to legislative aides and Senators and Representatives in Texas.

One of those who stood up and was counted was the aforementioned Dr. Larry Goldstein of California, who set aside his research, and flew to Texas.

There he met with key Texas Senators, updating them on the progress in our field, sharing facts in his usual clear and accurate way. (If you ever get a chance to hear Larry Goldstein talk, don’t miss it—excellent speaker.)

And when the smoke of battle had cleared…

Senator Steven Ogden, Republican author of both an anti-research bill and sn anti-research rider, removed them from consideration. (He replaced them with a bill that “requires reporting of stem cell work from institutions in Texas”, according to TAMR’s Judy Haley. The bill sounds harmless enough, though it requires watching, lest it be used as some form of intimidation; still it is a whole lot better than the two prohibition attempts before.)

Folks, this is a tremendous victory. What it means is, sooner or later, Texas research money will become available for promising avenues to cure.

This is exactly the kind of interstate cooperation we must do, if our loved ones are to get well. No state should be allowed to fight alone. They can and must do the bulk of the labor, as TAMR always does; but we must also stick together, or be run over by the opponents of research.

CAMR (the Coalition for the Advancement of Medical Research) is our national leader, and they must be a part of every struggle. But they cannot do everything. We in the smaller groups have to reach out to each other and help, consistently. If Texas wins, we win: like the Three Musketeers motto, “all for one, and one for all”.

Patient advocates have to work. Politicians have to put up with us. And scientists must get involved.

When we work together, miracles are possible; and I believe we will see some, in our time.

Now, here’s some updates from TAMR.

Dear friends and fellow advocates,
Tomorrow you will read in the newspapers about what a difference one voice added to one more voice can make! We can’t thank you enough for giving TAMR the pleasure of sending the following Press Release out today. It is with much gratitude that we thank all of you who made a special effort to take time out of your day to make those incessant calls and pass the emails to your friends and family. It is with much gratitude that we thank those of you who took the time to go to the Capitol to talk with the legislators, sometimes driving in and back for a 20 minute visit, or all the scientists, the economist who wrote the economic study and all advocates who flew in and waited hours to testify or visit with a legislator. It is with much gratitude that we thank those of you who wrote letters to the editors and our Board of Directors who made endless, seemingly continuous conference calls. And how grateful we are to those of you who have the good fortune to live in Austin and who spent full days at the Capitol making calls, passing out letters and pertinent information and monitoring endless hours of committee meetings waiting to make sure we were aware of any bill or amendment that might be detrimental to our cause. Last, but certainly not the least, we thank Ellen Arnold, our lobbyist, who has to be the best in the world and TAMR is more than fortunate to have her on our team!

We are elated; but there are still 5 pages of bills that we are following to make certain they remain “clean”. So we will not relax our vigil until June 1st, when the House and Senate doors are closed and locked. But this deserves a BIG THANK YOU.
Joe A. Brown
TAMR, President

FOR IMMEDIATE RELEASE CONTACT: Joe Brown (713) 478-9091
May 19, 2009

TEXANS FOR ADVANCEMENT OF MEDICAL RESEARCH (TAMR) APPLAUDS THE CONFERENCE COMMITTEE FOR REMOVING STEM CELL RESEARCH BAN FROM THE STATE BUDGET

Setting up a budget to spend state dollars, including the funding for academic institutions across the state, is the most critical bill of each legislative Session. But this year’s version, Senate Bill 1, took on a problematic tone with a rider attached that would have chased potentially life-saving stem cell research-believed by most scientists and physicians to be the future of medicine-out of the state.

Senate Finance Committee Chairman Steve Ogden introduced the rider, explaining that it would “only” ban state dollars from funding embryonic stem cell research. But the potential was broader. Institutions receiving state dollars (in other words: all our academic institutions in the state, both public and private) would risk losing state funding if embryonic stem cell research was conducted within their facilities. Research, regardless of the source of funding, scientists trained or funded for any project with state funds could not work with the embryonic cells. “Even ongoing work with the ‘approved Bush lines’ would have to be shut down. The chilling effect would create too much uncertainty for risk-averse institutions, and stem cell research (and researchers) would flee to friendly environments in other states,” said Judy Haley, TAMR co-founder.

As the ramifications of such far-reaching consequences, and the will of a majority of Conference Committee members as well as supporters of the research from across the state contacting Senator Ogden, he offered to amend the rider. For some the issue was clear: cells that are currently being discarded as medical waste should not be discarded, but used to search for cures for the terrible diseases like diabetes, Parkinson’s, and cancer. For others, the lack of a public hearing to properly debate stem cell research and make sure that the issues are clearly articulated made the rider-ban unacceptable.

Therefore, Senator Ogden announced in this morning’s conference committee meeting that, “We really couldn’t come to a consensus” so the bill will be silent on the stem cell issue, and the stem cell rider was removed from the budget.

Texans for Advancement of Medical Research (TAMR) commends Senator Ogden and the Budget Conferees for the decision to strip the ban on stem cell research out of the state budget. TAMR President Joe Brown said, “Legislators heard the message-loud and clear-from a public that supports this cutting edge research, and does not want to lose the benefits of having all forms of stem cell research being vigorously pursued in Texas. They know that research today often translates into life-saving treatments in the years ahead.”

In addition to the access to care issues, Dr. Bernard Weinstein wrote an economic impact study highlighting damage to the state’s economy that such policy would create. In this time of economic difficulty, with our world-renowned medical facilities among the most robust industries in the state and with the push to attract more bio-tech companies to Texas, TAMR applauds the wisdom of the Budget Conference Committee, and hopes that Texas will soon see legislation protecting all ethical forms of stem cell research.

TAMR is an organization of scientists, physicians, leading health groups, and individuals who support biomedical research in regenerative medicine for the express purpose of curing diseases and alleviating suffering.

TAMR DESPERATELY NEEDS YOUR FINANCIAL SUPPORT!

TAMR has no staff–we are all volunteers who have spent untold hours and have self-funded supplies, mailings, trips to meet with legislators and to give presentations around the state because we believe in the potential stem cell research holds for our families and yours, as well as for the economy of Texas.
PLEASE HELP!

Give us a hand…reach into your pocket…
__
Click here and make a donation online
or send a check to:
Texans for Advancement of Medical Research or TAMR
P.O. Box 19543
Houston, TX 77224-9543
(If you have forgotten how TAMR fought the battle since 2003, see below.)
TAMR’s all-volunteer army of grassroots advocates put a human face
on the fight to win the battle that is holding so many lives hostage.
TAMR has:
➢ Met with elected officials on an on-going basis
➢ Tracked hundreds of stem cell-related bills
➢ Monitored hundreds of hearings and all Floor debate in both the House and Senate
➢ Hosted Educational Forums for Legislative Staff
➢ Hosted Educational Forums for Freshman Legislators
➢ Conducted mail campaigns throughout the interims, providing educational documents as well as letters of support for esc research from multiple associations – including Hadassah, PAN JDRF, TAMR, ADA, NMSS
➢ Alerted Legislative Leadership Team for possible amendment efforts on the House Floor and prepared legislators for debate
➢ Coordinated efforts of interested organizations and associations
➢ Garnered publicity through press conferences, press briefings, letters to the editor
➢ Served as a resource to help write bills and dozens of amendments
➢ Represented Texans in hearings on both pro-stem cell research and anti-stem cell research legislation
➢ Gathered thousands of letters of support
➢ Organized Texans to submit 452 witness cards in support of stem cell bills
➢ Helped prepare testimonies given in support of stem cell bills
➢ Coordinated Legislative Days at the Capitol
➢ Supplied speakers to give PowerPoint educational presentations in churches, synagogues, political groups, health organizations, etc.
➢ Spoke on the radio, TV and in newspapers in over 36 media outlets from around the state.

Read Full Post »

1 PAGE, 1 PARAGRAPH, 9 DAYS: to Speak Up for Stem Cells…

Dear Stem Cell Research Supporter:

What if you could shape the guidelines allowing scientists to get money for stem cell research? You can… if you act now. The next 9 days are the last of the public comment period for the new stem cell research funding guidelines. Read this one page, write and send one short paragraph—maybe tell a friend or two—and do it now.

Click on (http://nihoerextra.nih.gov/stem_cells/add.htm) and send a message to the National Institutes of Health, the folks who make money decisions for science. The note can be as long as you want it, or as simple as this sentence:

“I support the position of the California Institute for Regenerative Medicine (CIRM) to improve the new federal stem cell research funding guidelines.”

It’s easy enough, that’s for sure—but why should you bother?

The new guidelines (http://stemcells.nih.gov/policy/2009draft.htm) have problems. If they are not fixed, as many as 90% of the currently existing stem cell lines—ones scientists are using right now—could become ineligible for federal funding. One change required is simple, and urgent: a “grandfather clause” so that stem cell lines developed during the Bush Administration may not be disqualified on a minor technicality.

Want more information? Three websites: For an expert analysis, read the 11-page position paper developed by the California stem cell program, the world’s leader: CIRM Comments on Draft NIH Guidelines for Human Stem Cell Research 5/15/09 (REPLACING 5/12/09 version). Or, visit the website of the Coalition for the Advancement for Medical Research http://www.camradvocacy.org, or the Juvenile Diabetes Research Fund, http://www.jdrf.org, for clear “people talk” explanations.

If you prefer to send a hard-copy letter, send it to: NIH Stem Cell Guidelines, MSC 7997, 9000 Rockville Pike, Bethesda, Maryland, 20892-7997

Or use the comment box: (http://nihoerextra.nih.gov/stem_cells/add.htm). It’s easy, and it matters. Either way is fine. But do it now, before the May 26th deadline passes.

It’s time. Haven’t we had enough political delays? We all know someone who suffers an incurable disease or disability, which stem cell research might alleviate, or heal. For me, that person is my paralyzed son, Roman, and also my sister Barbara, who has cancer.

So I ask you. Write your letter. Be among the overworked few who change the world.

Thanks,

Don C. Reed, http://www.stemcellbattles.com

Read Full Post »

CONTACT THE NIH

CONTACT THE N.I.H. TODAY! A personal request from Don C. Reed

Action asked: Click on the following to contact National Institutes of Health:

http://nihoerextra.nih.gov/stem_cells/add.htm.

Dear Stem Cell Research Advocate:

The next 14 days are crucial in the stem cell research struggle.

Here’s why.

Remember when President Obama signed that document removing the Bush stem cell restrictions? That same day he called upon the National Institutes of Health to draft a new set of guidelines for scientists wanting federal funding.

Those guidelines have just been issued. (http://stemcells.nih.gov/policy/2009draft.htm)

The next 14 days are the comment period for the new guidelines for stem cell research, which American scientists will have to live with if they want federal funding. This is the public’s only chance to shape those guidelines: which can be improved—or made worse.

Unfortunately, there are problems!

Not only are the guidelines far more conservative than we had hoped, but opponents of the research are systematically flooding the comment process.

Led by the Catholic Church and other conservative religious bodies, a national campaign has begun: to attack early stem cell research by mass emails to the NIH.
*”The United States Conference of Catholic Bishops (USCCB) launched a new “Oppose Destructive Stem Cell Research” campaign today, equipping citizens to contact Congress and the National Institutes of Health (NIH) to oppose embryonic stem cell research …” — WASHINGTON, May 6 /PRNewswire-USNewswire/ http://www.usccb.org/stemcellcampaign
Is their anti-research campaign having an effect?

Dr. Wise Young of Rutgers University , “… of the 6000 plus comments that NIH has received concerning the draft guidelines, 99% were from people who opposed embryonic stem cell research.”—Carecure Forum http://sci.rutgers.edu/forum/showpost.php?p=1039001&postcount=12

Imagine what the enemies of research will do with a statistic like that! Think of the State Senators and Representatives who have to fight for stem cell funding—they will be hammered—no politician ever wants to stand alone.

Supporters of stem cell research must be heard.

To prevail, we need to do three things: inform ourselves, act individually, and reach out to our networks.

First, read this message all the way through; it contains background information from the Coalition for the Advancement of Medical Research (CAMR), and other sources.

Second, send your message to the government. Click on the comment box you will find at the following url: http://nihoerextra.nih.gov/stem_cells/add.htm

Third, SHARE THIS LETTER—or write your own– email all your contacts.

Any statement of support has impact. One sentence can make a difference.

Something like: “I support embryonic stem cell research, and am glad some of the restrictions are being loosened.” That matters.

Anyone who clicks on the comment box, and writes in a sentence—that message will be tallied as one citizen in support. Of course, you may say more if you want. If you are a long-term research supporter, your letter will be put in the expert witness category.

(If you want to get more involved in shaping the guidelines, that would be helpful. The guidelines are politically very timid, and must be strengthened. Problems:
a “grandfather clause” is needed to insure that every stem cell line already approved under the previous stringent guidelines will be eligible; that alternate sources of stem cell lines such as SCNT and parthenogenesis will not be excluded from funding, and more. (see CAMR comments below.)

But every patient advocate in America must at least click on the comment box, and make a statement in support of early stem cell research. This affects everyone in America, and the world. MORE THAN ONE PERSON IN A FAMILY MAY COMMENT. Every adult friend or family member should click and make a comment– as well as every scientist, medical student, every teacher, every parent—everyone who has a reason to want stem cell therapies and cures.

Here it is, one more time: http://nihoerextra.nih.gov/stem_cells/add.htm.

Or, send a letter (ideally on letterhead) to: NIH Stem Cell Guidelines, MSC 7997, 9000 Rockville Pike, Bethesda , Maryland , 20892-7997

But whatever you are going to do, do it now. There is very little time before the May 26th deadline.

We have worked hard, many years. We are so close. We must not falter now.

Click on the button, send your comments in—do it today, please.

And thanks. You make the difference: you are one of the overworked few who change the world.

P.S. Here is a letter from Amy Comstock-Rick, President of the Coalition for the Advancement of Medical Research (CAMR); I copied it from CAMR’s website, where much more information can be found: http://www.camradvocacy.org.

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 analyze the content, as well as volume, of the comments as it finalizes the guidelines.
It will be critical for NIH to hear from the public 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 share the link to this page with your friends, family, and anyone you know who supports 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.
Thank you!
Sincerely,
Amy Comstock Rick, president
Coalition for the Advancement of Medical Research

Read Full Post »

Please Contact NIH

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

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 26th, 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.

Draft NIH Human Stem Cell Guidelines
Comments Form

Comments Deadline: 11:00pm EST on May 26, 2009.

Comments are requested below, as announced
in the April 23, 2009 Federal Register Notice.

( * = Required Field )

Name of Individual(s)
Submitting Comments:

Affiliation:
Commenting on behalf of:

Self
Organization:
Name of Organization:
Address of Organization:

* Comments:
Please enter your comments on the Draft NIH Human Stem Cell Guidelines, as announced in the April 23, 2009 Federal Register Notice. Please reference specific sections in the document, when applicable. Please note that comments will be publicly available, including those containing personally identifiable or confidential business information.

You may want to copy and paste from a word processor into the text box. Note that text will not be formatted (e.g. will not retain bold, colors and other formatting).

Attachment:
If you need to attach a file with any additional comments or information, the file must have an extension of “txt” (text only).

Note that the form will not submit if an invalid path or filename is entered, so please be sure to click the “Browse” button, then select the file to be uploaded.

Browse to File:
File Description:

* Security Check:
Please Enter the following Random Number in the Box below: 7222

Enter 7222 in this Box.

Note: Collection of this information is authorized under 5 U.S.C. 301; 44 U.S.C. 3101. The primary use of this form is to collect public comments on the draft NIH Human Stem Cell Guidelines. NIH will consider all comments. This information will be used by staff of the NIH, its contractors and others, for the purpose of reviewing, collating or analyzing the comments in developing final NIH Stem Cell Guidelines. Submission of this information is voluntary. By providing comments, you are consenting to their consideration and use by the NIH. All comments received before the close of the comment period, including those containing personally identifiable or confidential business information, will be made available at http://stemcells.nih.gov/index.asp after May 26, 2009. This includes the name and affiliation of those submitting comments (if provided). NIH will not post comments that are not related to the draft Stem Cell Guidelines or that NIH has determined as inappropriate or offensive.

If you have any questions regarding the submission of your comments, please contact StemCellGuidelines@mail.nih.gov.

Go to NIH Stem Cell Information Page

(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 9th, 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 26th. 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 7th.

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 26th 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 http://www.camradvocacy.org/resources/camr_wp.pdf or contact CAMR at 202-725-0339.

Read Full Post »

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

From Don C. Reed

The National Institutes of Health Guidelines for Human Stem Cell Research have just been issued. These are the laws under which all federally-funded stem cell research will be conducted.

But they are not yet carved in stone.

This is the public comment period. For the next 3 weeks, until May 26th, 2009, comments on the guidelines will be accepted.

But– if you are not a scientist, what does this have to do with you?

Everything.

We need you to write a letter, just saying that you support the research.

Consider this: those who oppose the research will definitely be writing in.

Every letter will be tabulated, as well as read.

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

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.

This has happened before.

In 1999, when President Clinton proposed guidelines for federal funding of embryonic stem cell research, there was a public comment period.

According to Lana Skirboll, Ph.D., office of the Director, NIH ___________, more than 80% of the comments were negative.

Imagine being a congressman in a swing state, and you are being hammered by the Religious Right, and you see that what looks like 80% of the interested American public is against the research?

Folks, wherever you are, the NIH needs to hear from you.

If you only send a one sentence letter, that would be great.

If you are a scientist or patient advocate, you will have more to say, which will get your letter put into a different category: like an expert witness gets more credibility.

Ideally? Every scientist in America should write a letter. Every medical student, every teacher, every parent of a child who has now or may contract an incurable disease— for which we want a cure.

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

There are three ways to do it: electronically, and ground mail.

At the end of this letter 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

Here are the guidelines themselves, followed (at the very bottom) by an electronic comment form you could do instantly.

Advice: these letters will be public. If you have other family friends, relatives, and co-workers that want to help (and, they are soooooo welcome) be sure they do not just copy a form letter. The opposition will do this.

What will happen is this: the NIH will hire a contractor to go over all the communications, and sort them. They will be divided up into various categories. Some will offer suggestions: one pile. Others will say, thank you for supporting the research—another pile. After all the hopefully millions of communications are sorted, the results will be published.

This is a major assignment, folks. We need to all write our own letters, and then try to get five more people each to do the same.

Can anybody say: phone tree?

Please help me on this one, folks, we are playing for the big bucks now. Enclosed below are: the form you fill out to make comments, plus the information from the NIH.

Enclosed

[Federal Register: April 23, 2009 (Volume 74, Number 77)]
[Notices]
[Page 18578-18580]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23ap09-42]

———————————————————————–

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Draft National Institutes of Health Guidelines for Human Stem
Cell Research Notice

SUMMARY: The National Institutes of Health (NIH) is requesting public
comment on draft guidelines entitled “National Institutes of Health
Guidelines for Human Stem Cell Research” (Guidelines).
The purpose of these draft Guidelines is to implement Executive

Order 13505, issued on March 9, 2009, as it pertains to extramural NIH-
funded research, to establish policy and procedures under which NIH
will fund research in this area, and to help ensure that NIH-funded
research in this area is ethically responsible, scientifically worthy,
and conducted in accordance with applicable law. Internal NIH
procedures, consistent with Executive Order 13505 and these Guidelines,
will govern the conduct of intramural NIH research involving human stem
cells.
These draft Guidelines would allow funding for research using 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 will continue to be allowed for human stem
cell research using adult stem cells and induced pluripotent stem

cells. Specifically, these Guidelines describe the conditions and
informed consent procedures that would have been required during the
derivation of human embryonic stem cells for research using these cells
to be funded by the NIH. NIH funding for research using human embryonic
stem cells derived from other sources, including somatic cell nuclear
transfer, parthenogenesis, and/or IVF embryos created for research
purposes, is not allowed under these Guidelines.
NIH funding of the derivation of stem cells from human embryos is
prohibited by the annual appropriations ban on funding of human embryo
research (Consolidated Appropriations Act, 2009, Pub. L. 110-161, 3/11/
09), otherwise known as the Dickey-Wicker Amendment.
According to these Guidelines, there are some uses of human
embryonic stem cells and human induced pluripotent stem cells that,
although those cells may come from allowable sources, are nevertheless
ineligible for NIH funding.
For questions regarding ongoing NIH-funded research involving human
embryonic stem cells, as well as pending applications and those
submitted prior to the issuance of Final Guidelines, see the NIH Guide

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-085.html.

DATES: Written comments must be received by NIH on or before May 26,
2009.

ADDRESSES: The NIH welcomes public comment on the draft Guidelines set
forth below. Comments may be entered at: http://nihoerextra.nih.gov/
stem_cells/add.htm. Comments may also be mailed to: NIH Stem Cell
Guidelines, MSC 7997, 9000 Rockville Pike, Bethesda, Maryland 20892-
7997. Comments will be made publicly available, including any
personally identifiable or confidential business information
they
contain.

SUPPLEMENTARY INFORMATION: On March 9, 2009, President Barack H. Obama
issued Executive Order 13505: Removing Barriers to Responsible
Scientific Research Involving Human Stem Cells. The Executive Order
states that the Secretary of Health and Human Services, through the
Director of NIH, may support and conduct responsible, scientifically
worthy human stem cell research, including human embryonic stem cell
research, to the extent permitted by law.
The purpose of these draft Guidelines is to implement Executive
Order 13505, issued on March 9, 2009, as it pertains to extramural NIH-
funded research, to establish policy and procedures under which NIH
will fund research in this area, and to help ensure that NIH-funded
research
in this area is ethically responsible, scientifically worthy,
and conducted in accordance with applicable law. Internal NIH
procedures, consistent with Executive Order 13505 and these Guidelines,
will govern the conduct of intramural NIH research involving human stem
cells.
Long-standing Department of Health and Human Services regulations
for Protection of Human Subjects, 45 CFR part 46, establish safeguards

for individuals who are the sources of many human tissues used in
research, including non-embryonic human adult stem cells and human
induced pluripotent stem cells. When research involving human adult
stem cells or induced pluripotent stem cells constitutes human subject
research, Institutional Review Board review may be required and
informed consent may need to be obtained per the requirements detailed
in 45
CFR part 46. Applicants should consult http://www.hhs.gov/ohrp/
humansubjects/guidance/45cfr46.htm.
As described in these draft Guidelines, human embryonic stem cells
are cells that are derived from human embryos, are capable of dividing
without differentiating for a prolonged period in culture, and are
known to develop into cells and tissues of the three primary germ
layers. Although human embryonic stem cells are derived from embryos,
such stem cells are not themselves human embryos.
Studies of human embryonic stem cells may yield information about
the complex events that occur during human development. Some of the
most
serious medical conditions, such as cancer and birth defects, are
due to abnormal cell division and differentiation. A better
understanding of the genetic and molecular controls of these processes
could provide information about how such diseases arise and suggest new
strategies for therapy. Human embryonic stem cells may also be used to
test new drugs. For example, new medications could be tested for safety
on differentiated somatic cells generated from human embryonic stem

cells.
Perhaps the most important potential use of human embryonic stem
cells is the generation of cells and tissues that could be used for
cell-based therapies. Today, donated tissues and organs are often used
to replace ailing or destroyed tissue, but the need for transplantable
tissues and organs far outweighs the available supply. Stem cells,
directed
to differentiate into specific cell types, offer the
possibility of a renewable source of replacement cells and tissues to
treat diseases and conditions, including Parkinson’s disease,
amyotrophic lateral sclerosis, spinal cord injury, burns, heart
disease, diabetes, and arthritis.

[[Page 18579]]

NIH currently funds ongoing research involving human embryonic stem
cells as detailed under prior Presidential policy. Under that policy,
Federal funds have been used for research on human embryonic stem cells
where the derivation process was initiated prior to 9 p.m. EDT August
9, 2001, the embryo was created for reproductive purposes, the embryo
was no longer needed for these purposes, informed consent was obtained
for the donation of the embryo, and no
financial inducements were
provided for donation of the embryo.
These draft Guidelines would allow funding 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 will continue to be allowed for
human stem cell research using adult stem cells and induced pluripotent

stem cells. Specifically, these Guidelines describe the conditions and
informed consent procedures that would have been required during the
derivation of human embryonic stem cells for research using these cells
to be funded by the NIH. NIH funding for research using human embryonic
stem cells derived from other sources, including somatic cell nuclear
transfer, parthenogenesis, and/or IVF embryos created for research
purposes, is not allowed under these Guidelines.
Please note that, for NIH funded research using the permitted human
embryonic stem cells, the requirements of the Department’s protection
of human subjects regulations, 45 CFR part 46, may or may not apply,
depending on the nature of the research. For further information, see
Human Embryonic Stem Cells, Germ Cells and Cell Derived Test Articles:
OHRP Guidance for Investigators
and Institutional Review Boards.
NIH funding of the derivation of stem cells from human embryos is
prohibited by the annual appropriations ban on funding of human embryo
research (Consolidated Appropriations Act, 2009, Pub. L. 110-161, 3/11/
09), otherwise known as the Dickey-Wicker Amendment.
According to these Guidelines, there are some uses of human
embryonic stem cells
that, although those cells may come from allowable
sources, are nevertheless ineligible for NIH funding.
In developing these draft Guidelines, the NIH consulted its
Guidelines issued in 2000, as well as the thoughtful guidelines
developed by other national and international committees of scientists,
bioethicists, patient advocates, physicians and other stakeholders,
including the U.S. National Academies, the International Society
for
Stem Cell Research, and others.
As directed by Executive Order 13505, the NIH shall review and
update these Guidelines periodically, as appropriate.
The Draft Guidelines Follow:

National Institutes of Health Guidelines for Human Stem Cell Research

I. Scope of Guidelines

These Guidelines describe the circumstances under which human
embryonic stem cells are eligible for use in extramural NIH-funded
research, and they also include a section on uses of human embryonic
stem cells or human induced pluripotent stem cells that are ineligible
for NIH funding.
For the purpose of these Guidelines, “human embryonic stem cells”
are cells that are derived from human embryos, are capable of dividing
without differentiating for a prolonged period in culture, and are
known to develop into cells and tissues of the three primary germ
layers. Although human embryonic stem cells are derived from embryos,
such stem cells are not themselves human embryos.

II. Guidelines for Eligibility of Human Embryonic Stem Cells for Use in
Research

A. The Executive Order: Executive Order 13505, Removing Barriers to
Responsible Scientific Research Involving Human Stem Cells, states that
the Secretary of the Department of Health and Human Services (DHHS),
through the Director of the NIH, may support and
conduct responsible,
scientifically worthy human stem cell research, including human
embryonic stem cell research, to the extent permitted by law.
B. Eligibility of Human Embryonic Stem Cells Derived from Human
Embryos: Human embryonic stem cells may be used in research using NIH
funds, if the cells were derived from human embryos that were created
for reproductive purposes, were no longer needed for this purpose, were

donated for research purposes, and for which documentation for all of
the following can be assured:
1. All options pertaining to use of embryos no longer needed for
reproductive purposes were explained to the potential donor(s).
2. No inducements were offered for the donation.
3. A policy was in place at the health care
facility where the
embryos were donated that neither consenting nor refusing to donate
embryos for research would affect the quality of care provided to
potential donor(s).
4. There was a clear separation between the prospective donor(s)’s
decision to create human embryos for reproductive purposes and the
prospective donor(s)’s decision to donate human embryos for research
purposes.
5. At the time of donation, consent for that donation was obtained
from the individual(s) who had sought reproductive services. That is,
even if potential donor(s) had given prior indication of their intent
to donate to research any embryos that remained after reproductive
treatment, consent for the donation should have been given at the time
of the donation. Donor(s) were
informed that they retained the right to
withdraw consent until the embryos were actually used for research.
6. Decisions related to the creation of human embryos for
reproductive purposes were made free from the influence of researchers
proposing to derive or utilize human embryonic stem cells in research.
Whenever it was practicable, the attending physician responsible for
reproductive clinical care and the researcher deriving
and/or proposing
to utilize human embryonic stem cells should not have been the same
person.
7. Written informed consent was obtained from individual(s) who
sought reproductive services and who elected to donate human embryos
for research purposes. The following information, which is pertinent to
making the decision of whether or not to donate human embryos for
research purposes, was in the written consent form for donation and
discussed with potential donor(s) in the informed consent process:
a. A statement that donation of the embryos for research was
voluntary;
b. A statement that donor(s) understood alternative options
pertaining to use of the embryos;
c. A statement
that the embryos would be used to derive human
embryonic stem cells for research;
d. Information about what would happen to the embryos in the
derivation of human embryonic stem cells for research;
e. A statement that human embryonic stem cells derived from the
embryos might be maintained for many years;
f. A statement
that the donation was made without any restriction
or direction regarding the individual(s) who may receive medical
benefit from the use of the stem cells;
g. A statement that the research was not intended to provide direct
medical benefit to the donor(s);

[[Page 18580]]

h. A statement as to whether or not information that could identify
the donor(s) would be retained prior to the derivation or the use of
the human embryonic stem cells (relevant guidance from the DHHS Office
for Human Research Protections (OHRP) should be followed, as
applicable; see OHRP’s Guidance for Investigators and Institutional
Review Boards Regarding Research Involving Human Embryonic Stem Cells,
Germ Cells, and Stem
Cell-Derived Test Articles and Guidance on
Research Involving Coded Private Information or Biological Specimens,
or successor guidances); and
i. A statement that the results of research using the human
embryonic stem cells may have commercial potential, and a statement
that the donor(s) would not receive financial or any other benefits
from any such commercial development.
C. Prior to the use of NIH funds: Funding recipients must ensure
that: (1) The human embryonic stem cells were derived consistent with
sections II.A and B of these Guidelines; and (2) the grantee
institution maintains appropriate documentation demonstrating such
consistency in accordance with 45 CFR 74.53, which also details rights
of access by NIH. The responsible grantee institutional official must

provide assurances with respect to (1) and (2) when endorsing
applications and progress reports submitted to NIH for projects that
utilize these cells.

III. Research Using Human Embryonic Stem Cells and/or Human Induced
Pluripotent Stem Cells That, Although the Cells May Come From Allowable
Sources, Is Nevertheless Ineligible for NIH Funding

This section governs research using human embryonic stem cells and
human induced pluripotent stem cells, i.e., human cells that are
capable of dividing without differentiating for a prolonged period in
culture, and are known to develop into cells and tissues of the three
primary germ layers. There are some uses of these cells that, although
they may come from allowable sources, are nevertheless ineligible for

NIH funding, as follows:
A. Research in which human embryonic stem cells (even if derived
according to these Guidelines) or human induced pluripotent stem cells
are introduced into non-human primate blastocysts.
B. Research involving the breeding of animals where the
introduction of human embryonic stem cells (even if derived according
to these Guidelines) or human induced pluripotent stem cells may have
contributed to the germ line.

IV. Other Non-Allowable Research

A. NIH funding of the derivation of stem cells from human embryos
is prohibited by the annual appropriations ban on funding of human
embryo research (Consolidated
Appropriations Act, 2009, Pub. L. 110-
161, 3/11/09), otherwise known as the Dickey-Wicker Amendment.
B. NIH funding for research using human embryonic stem cells
derived from other sources, including somatic cell nuclear transfer,
parthenogenesis, and/or IVF embryos created for research purposes, is
not allowed under these Guidelines.

Dated: April 17, 2009.
Raynard S. Kington,
Acting Director, NIH.
[FR Doc. E9-9313 Filed 4-22-09; 8:45 am]

BILLING CODE 4140-01-P

Draft NIH Human Stem Cell Guidelines
Comments Form

Comments Deadline: 11:00pm EST on May 26, 2009.

Comments are requested below, as announced
in the April 23, 2009 Federal Register Notice.

( * = Required Field )

Name of Individual(s)
Submitting Comments:

Affiliation:
Commenting on behalf of:

Self
Organization:
Name of Organization:
Address of Organization:

* Comments:
Please enter your comments on the Draft NIH Human Stem Cell Guidelines, as announced in the April 23, 2009 Federal Register Notice. Please reference specific sections in the document, when applicable. Please note that comments will be publicly available, including those containing personally identifiable or confidential business information.

You may want to copy and paste from a word processor into the text box. Note that text will not be formatted (e.g. will not retain bold, colors and other formatting).

Attachment:
If you need to attach a file with any additional comments or information, the file must have an extension of “txt” (text only).

Note that the form will not submit if an invalid path or filename is entered, so please be sure to click the “Browse” button, then select the file to be uploaded.

Browse to File:
File Description:

* Security Check:
Please Enter the following Random Number in the Box below: 7222

Enter 7222 in this Box.

Note: Collection of this information is authorized under 5 U.S.C. 301; 44 U.S.C. 3101. The primary use of this form is to collect public comments on the draft NIH Human Stem Cell Guidelines. NIH will consider all comments. This information will be used by staff of the NIH, its contractors and others, for the purpose of reviewing, collating or analyzing the comments in developing final NIH Stem Cell Guidelines. Submission of this information is voluntary. By providing comments, you are consenting to their consideration and use by the NIH. All comments received before the close of the comment period, including those containing personally identifiable or confidential business information, will be made available at http://stemcells.nih.gov/index.asp after May 26, 2009. This includes the name and affiliation of those submitting comments (if provided). NIH will not post comments that are not related to the draft Stem Cell Guidelines or that NIH has determined as inappropriate or offensive.

If you have any questions regarding the submission of your comments, please contact StemCellGuidelines@mail.nih.gov.

Go to NIH Stem Cell Information Page

Read Full Post »

Follow

Get every new post delivered to your Inbox.

Join 363 other followers