[Pages S3627-S3637]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS
By Mr. LEAHY (for himself, Mr. Campbell, Mrs. Clinton, and Mr.
Schumer):
S. 2431. A bill to amend the Omnibus Crime Control and Safe Streets
Act of 1968 to ensure that chaplains killed in the line of duty receive
public safety officer death benefits; to the Committee on the
Judiciary.
Mr. LEAHY. Madam President, today I proudly join with Senators
Campbell, and Clinton to introduce the Mychal Judge Police and Fire
Chaplains Public Safety Officers' Benefit Act of 2002. I want to thank
my colleagues for their leadership and strong support for public safety
officers and their families. I also commend Representative Nadler and
Representative Manzullo for their leadership on the House version of
this bill.
This bill aims to restructure the Public Safety Officers' Benefits
Program to expressly include chaplains as members of the law
enforcement and fire units in which they serve, and would make these
chaplains eligible for the benefits available to public safety officers
who have died or who have been permanently disabled as a result of
injuries sustained in the line of duty. In addition, the Act would
expand the list of those who may receive benefits in the event of a
public safety officer's death in the line of duty by including as
potential beneficiaries the persons named on the most recently executed
life insurance policy of the deceased officer. In short, this
legislation will ensure that the families of chaplains killed in the
line of duty receive due payments through the Public Safety Officers'
Benefits program.
On September 11, 2001, Father Mychal Judge, a chaplain with the New
York City Fire Department, was killed by falling debris as he
ministered to victims of the horrific terrorist attacks on the World
Trade Center. He was survived solely by his two sisters.
Current law allows the Bureau of Justice Assistance to determine
whether or not a public safety officer died as a direct or proximate
cause of a personal injury sustained in the line of duty, and, if such
criterion is met, directs the BJA to pay a monetary benefit of $250,000
to the surviving family members of the officer. In the case of Father
Judge, the BJA correctly determined that he was eligible for payment of
death benefits. However, Father Judge had no wife or children, and
outlived his parents, and no benefits were paid to his life insurance
beneficiaries, his sisters, as they were ineligible under existing law
to qualify as his beneficiaries and receive death benefits. This case
is not unique, of the approximately 450 public safety officers killed
in the September 11 attacks, there are 10 individuals known to have
died without spouses, children or parents, so the $250,000 death
benefit will not be paid. This is simply wrong.
For the purpose of determining benefit eligibility, the U.S. Code
limits ``public safety officers'' to law enforcement officers;
firefighters; rescue crews; FEMA employees; and members of State,
local, or tribal emergency management or civil defense agencies who
perform official duties in cooperation with FEMA. While the language of
existing law could be interpreted to include chaplains, the Mychal
Judge Police and Fire Chaplains Public Safety Officers' Benefit Act
would resolve any existing ambiguities. It specifically recognizes
chaplains as public servants eligible for Public Safety Officers'
Benefits so long as they serve as officially recognized or designated
members of a legally organized volunteer fire or police department, or
are officially recognized or designated public employees of a legally
organized fire or police department, and was responding to a fire,
rescue, or police emergency when injured or killed.
Additionally, this legislation would expand the list of those allowed
to receive such benefits in the event of an officer's death in the line
of duty. Current law restricts such beneficiaries to the spouse, child,
or parent of the decedent. Our bill would expand this list, which would
still give priority to spouses and children, but, in the event that
neither survived the officer, would allow the monetary benefit to be
paid to the individual designated by such officer as a beneficiary
under the officer's most recently executed life insurance policy. In
the event that there was no such individual named or that an individual
so named did not survive the officer, the benefit would then be paid to
the parents of the officer.
Before us we have yet another unique opportunity to provide much-
needed relief for the survivors of the brave public servants who
selflessly risk and sacrifice their own lives everyday so that others
might live or be comforted. I look forward to continuing to work with
my colleagues on legislation to support our nation's public safety
officers who put their lives at risk every day to protect us, and I
urge the Senate to pass this bill expeditiously.
______
By Mr. SMITH of New Hampshire:
S. 2432. A bill to prohibit the use of fiscal year 2003 Federal funds
for support of the Palestinian Authority pending the cessation of
terrorist activities by the Palestinian Authority; to the Committee on
Foreign Relations.
Mr. SMITH of New Hampshire. Madam President, I rise today to offer a
long-overdue bill for the purpose of defunding terrorism by Yasser
Arafat and his supporters, by shutting off their flow of dollars from
the U.S. Treasury.
It was the belief of the previous administration that Yasser Arafat
and his Palestine Liberation Organization would live up to their
renunciation of terrorism, and the newly-formed Palestinian Authority
headed by Arafat and his PLO cronies could operate as a responsible
governing body to further peace.
Instead, Arafat, the PLO and the PA have used the guise of their new-
found political legitimacy, and agreement to the Tenet peace plan, to
mask their real desires.
The reality of the situation is that the Palestinian Authority is
joined at the hip with the PLO and other terrorist groups, such as
Tanzim, the armed wing of Fatah, the largest faction of the PLO.
Tanzim is headed by a member of the PA's legislature, and is believed
to have developed an alliance with Hamas and the Palestinian Islamic
Jihad.
Our aid frees up other money the PA uses to pay for the bombs that
are killing innocent men, women and children in Israel.
The chart was compiled by my staff from a published list of each such
attack last year. That list is 25 pages long.
We dare not forget the level of terror visited upon Israel by
Palestinian terrorists. The terror attacks in Israel in the year 2001
alone, from the first one on New Year's day, to the last one on
December 12 are sobering: 79 separate incidents; 1220 injured; an
additional 160 killed.
It has been reported that on March 2, 1973, Yasser Arafat ordered the
execution of Cleo Noel, the American Ambassador to the Sudan. Arafat
and his supporters have since been tied to countless acts of terror and
murder. Therefore, it is beyond belief that our country to this day
provides the Palestinian Authority and related entities more than $75
million dollars every year.
[[Page S3628]]
There have been foreign intelligence reports that Arafat has perhaps
$10 billion stowed away, a small fortune. He doesn't ``need'' U.S.
humanitarian aid.
It is flat out wrong to ask American taxpayers to support and
subsidize the PA when Yasser Arafat and the PLO have made no attempt to
use the resources at their disposal to provide the most basic of
humanitarian aid and services to their people. The interest alone from
Arafat's bank account could lift countless Palestinians out of squalid
conditions.
Of course the opponents of my bill will argue that this is just
``humanitarian aid'' for Arafat-friendly NGO's, which begs the reality
that those dollars free up Arafat's other money for him to then use to
pay to manufacture bombs.
We now have the proof, in Arafat's own handwriting, that the
Palestinian Authority is still paying the terrorist's bills.
Consider the proof, on the official letterhead of the Presidential
Bureau of the Palestinian Authority, slash, Palestine Liberation
Organization, bearing the signature of Yasser Arafat just 8 days after
our country was attacked on 9-11, ordering $600 be paid from the
treasury of the Palestinian Authority to each of three terrorists. Two
of them are senior activists of the Fatah terrorist group, one of
these, Ziad Da'as, is the head of the group behind a recent deadly
terrorist attack on a Bat-mitzvah party in Israel. The Israeli Defense
Ministry says they recently captured this document at Arafat's office
in Ramallah.
There is still more proof: an order for Yasser Arafat to the Finance
Ministry of the Palestinian Authority from January 7 of this year. It
was faxed from Fatah on January 20. Here, Arafat orders the
disbursement of $350 to each of the 12 named Fatah activists. According
to the Israeli Defense Ministry, who captured this document at Arafat's
headquarters in Ramallah, each of these 12 individuals are known
terrorists, belonging to Fatah and or Tanzim. Arafat's approval is
given in response to a request of Ra'ed Karmi, then the head of the
Fatah and Tanzim terror groups, which perpetrated numerous murderous
attacks on innocent Israeli civilians since September 2000.
As recently as April 7 of this year, Tim Russert on ``Meet the
Press'' asked the Secretary of State to deny that Arafat is funding
terrorism. Here is what Russert said:
``Israel says documents link Arafat and terrorism. They
seized documents and made them public, which liked the office
of Yasser Arafat with terrorist attacks carried out against
Israeli civilians and other targets. One of the documents,
said to be an invoice submitted by a leading Palestinian
militant group to a Palestinian official.... Among other
items, the invoice requested 20,000 Israeli Shekels, ($4,200
American), to buy electrical and chemical components for the
production of a month's supply of 30 bombs. It's an invoice
of terrorism, said Dori Gold, an advisor to Prime Minister
Sharon. Mr. Secretary, do you believe the Palestinian
Authority harbors or supports terrorism?
Do you know what our Secretary of State replied?
Did he deny the authenticity of this document? He did not.
Did he deny that Arafat paid the bill? He did not.
Did he deny that our taxpayer dollars are thus funding the killing of
innocent men, women and children? He did not.
What he said was, ``It is a complex situation''.
There's nothing complex about it! Our tax dollars should never be
used for terrorism. Period. End of discussion!
I don't care if Arafat has agreed to negotiate.
I don't care if Arafat has agreed to the Tenet plan.
I don't care that we need to keep contacts with the Palestinians, we
can do that anyway without subsidizing, and therefore legitimating,
their activity.
We should not be funding terrorism, and that is all there is to it
The United States should not continue a policy which has utterly
failed to curb the violence on the part of these radical
Islamic terrorist groups that Arafat and the PLO have sway over.
Furthermore, American taxpayers should not be fooled into footing a
bill for ``humanitarian aid'' when Arafat and his regime have no desire
in their hearts to co-exist peacefully with the State of Israel.
When our land was so brutally attacked last fall, the President set a
new agenda. He said, ``From this day forward, any nation that continues
to harbor or support terrorism will be regarded by the United States as
a hostile regime.''
Well, my colleagues, that is what Mr. Arafat and his minions are: a
hostile regime.
Even Secretary Powell, in that ``Meet the Press'' interview conceded
as much. He said that the United States has never shrunk from the
accusation that the Palestinian Authority supports and harbors
terrorism.
So why then, why are we taking tens of millions of dollars every year
out of our taxpayer's pockets and sending it to the P.A. where it can
be used to free up other money to build bombs that suicidal maniacs
strap on themselves to blow up a cafe, or a schoolbus?
The bill I am offering today will put an end to that. I say no more
money should be sent to anyone that will use it in a way that frees up
Arafat to pay his bomb-building bills.
I say no more money that goes to de-stabilizing the powderkeg in the
Middle East.
I say no more money for Arafat's new intifada against Israel.
My colleagues, I strongly urge you to stand with me on the side of
Israel and against terrorism and to support this bill.
I ask unanimous consent that the text of bill be printed in the
Record.
There being no objection, the bill was ordered to be printed in the
Record, as follows:
S. 2432
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. PROHIBITION ON USE OF FISCAL YEAR 2003 FEDERAL
FUNDS FOR SUPPORT OF PALESTINIAN AUTHORITY
PENDING CESSATION OF TERRORIST ACTIVITIES BY
PALESTINIAN AUTHORITY.
(a) Contingent Prohibition on Availability of Fiscal Year
2003 Funds.--Notwithstanding any other provision of law, no
funds available to any department, agency, or other element
of the Federal Government for fiscal year 2003 may be
obligated or expended for the purpose, or in a manner which
would have the effect, of supporting--
(1) the Palestinian Authority;
(2) any entity supported by the Palestinian Authority;
(3) any successor entity to the Palestinian Authority or an
entity referred to in paragraph (2); or
(4) any private, voluntary organization for--
(A) projects related to the Palestinian Authority; or
(B) projects located in Palestine that would otherwise be
undertaken by the Palestinian Authority or an entity referred
to in paragraph (2) or (3).
(b) Termination of Prohibition.--The prohibition in
subsection (a) shall cease to be effective upon the submittal
by the President to Congress of a certification that neither
the Palestinian Authority, nor any entity supported by the
Palestinian Authority, has engaged in planning or carrying
out any terrorist act during the six-month period ending on
the date of the certification.
(c) Support.--For purposes of this section, support shall
include direct and indirect support, whether such support is
financial or otherwise, including support for the Holst Fund
of the World Bank and the United Nations Relief and Works
Agency.
______
By Mr. HUTCHINSON:
S. 2433. A bill to designate the facility of the United States Postal
Service located at 1590 East Joyce Boulevard in Fayetteville, Arkansas,
as the ``Clarence B. Craft Post Office Building''; to the Committee on
Governmental Affairs.
Mr. HUTCHINSON. Madam President, I rise today to introduce
legislation to designate a United States postal facility in
Fayetteville, AK in honor of one of America's greatest heroes and
fellow Arkansan, Clarence B. Craft. This bill would name the facility
at 1590 East Joyce Boulevard as the ``Clarence B. Craft Post Office
Building.'' Mr. Craft passed away on March 28, 2002, but left behind a
legacy of kindness and courage. Prior to his passing he was one of only
148 living persons to be warded our Nation's highest award for actions
above and beyond the call of duty, the Congressional Medal of Honor.
Clarence Craft was an extremely humble person, and rarely talked about
the accolades that made him a ``special man'' as he was described by
those who knew him well. He spent the last twenty-five years of his
life in northwest Arkansas giving selflessly of his time as a volunteer
for
[[Page S3629]]
the Veterans' Affairs Medical Center in Fayetteville. He was a true and
dedicated friend to the veterans, one who lifted their spirits with
personal visits, often visiting every patient in the hospital.
Clarence Craft's actions on May 31, 1945, are truly deserving of this
recognition. On the island of Okinawa, then-Private First Class Craft
launched a one-man attack against the Japanese defense on Hen Hill.
Opposed by forces heavily armed with rifles, machine guns, mortars and
grenades, Clarence Craft killed at least 25 enemy soldiers. His heroic
efforts were the key to the U.S. forces' penetration of a defense that
had repelled repeated, heavy assaults by battalion-sized U.S.
formations for twelve days, and resulted in the entire defensive line
crumbling.
I enthusiastically encourage my colleagues on both sides of the aisle
to support this bill in honoring Clarence B. Craft, an American hero.
I ask unanimous consent that the text of the legislation be printed
in the Record.
There being no objection, the bill was ordered to be printed in the
Record, as follows:
S. 2433
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. CLARENCE B. CRAFT POST OFFICE BUILDING.
(a) Designation.--The facility of the United States Postal
Service located at 1590 East Joyce Boulevard in Fayetteville,
Arkansas, shall be known and designated as the ``Clarence B.
Craft Post Office Building''.
(b) References.--Any reference in a law, map, regulation,
document, paper, or other record of the United States to the
facility referred to in subsection (a) shall be deemed to be
a reference to the Clarence B. Craft Post Office Building.
______
By Mr. SCHUMER (for himself and Mrs. Clinton):
S. 2434. A bill to suspend temporarily the duty on Hydrated
hydroxypropyl methylcellulose; to the Committee on Finance.
Mr. SCHUMER. Madam President, I ask unanimous consent that the text
of the bill be printed in the Record.
There being no objection, the bill was ordered to be printed in the
Record, as follows:
S. 2434
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. HYDRATED HYDROXYPROPYL METHYLCELLULOSE.
(a) In General.--Subchapter II of chapter 99 of the
Harmonized Tariff Schedule of the United States is amended by
inserting in numerical sequence the following new heading:
`` 9902.98.09 Hydrated Free No change No change On or before 12/
hydroxypropyl 31/2005 ''
methylcellulose .
; cellulose, 2-
hydroxypropyl
methyl ether;
cellulose;
hydroxylpropyl
methyl ether
(CAS No. 9004-
65-3) (provided
in subheading
3912.39.00)....
(b) Effective Date.--The amendment made by subsection (a)
applies to goods entered, or withdrawn from warehouse for
consumption, on or after the 15th day after the date of
enactment of this Act.
______
By Mr. SARBANES (for himself, Mr. Dodd, Mr. Schumer, Ms.
Stabenow, Mr. Corzine, Mr. Kerry, Mr. Kennedy, Mr. Durbin, Ms.
Mikulski, Mrs. Clinton, Mrs. Boxer, Mr. Wellstone, Mr.
Torricelli, Mr. Dayton, and Mr. Levin):
S. 2438. A bill to amend the Truth in Lending Act to protect
consumers against predatory practices in connection with high cost
mortgage transactions, to strengthen the civil remedies available to
consumers under existing law, and for other purposes; to the Committee
on Banking, Housing, and Urban Affairs.
Mr. SARBANES. Madam President, earlier today, I had a press
conference with a number of my colleagues, Senators Schumer, Stabenow,
Corzine, and Clinton, as well as Mayor DeStefano of New Haven, CT,
Mayor McCollum from Richmond, VA, Wade Henderson, Executive Director of
the Leadership Conference on Civil Rights, and Tess Canja, a member of
the Board of AARP, to announce the introduction of the ``Predatory
Lending Consumer Protection Act of 2002.''
When I took over as Chairman of the Committee on Banking, Housing,
and Urban Affairs last year, I made it clear that one of my highest
priorities would be to use the Committee as a way to shine a bright
light on the deceptive and destructive practices of predatory lenders.
We then held a series of three hearings, starting in July of 2001 and
continuing through January of this year, at which the Committee heard
from housing experts, community groups, legal advocates, industry
representatives and victims of predatory lending in an effort to
determine how best to address this problem. The bill I am introducing
this afternoon, along with 14 of my colleagues, represents the result
of the recent work of the Committee, as well as efforts from the
previous Congress.
In particular, this legislation builds on the excellent work of my
colleagues in the Senate and Representative LaFalce, with whom I
introduced legislation on this topic in the last Congress.
Homeownership is the American Dream. We say this so often that there
is a danger of the idea becoming almost trivial, or devoid of real
meaning. But it pays to step back for a second and understand how true
and fundamental this is.
Homeownership is the opportunity for Americans to put down roots and
start creating equity for themselves and their families. Homeownership
has been the path to building wealth for generations of Americans,
wealth that can be tapped to send children to college, pay for a secure
retirement, or simply work as a reserve against unexpected emergencies.
It has been the key to ensuring stable communities, good schools, and
safe streets. Common sense tells us, and the evidence confirms, that
homeowners are more engaged citizens and more active in their
communities.
Little wonder, then, that so many Americans, young and old, aspire to
achieve this dream.
The predatory lending industry plays on these hopes and dreams to
cynically cheat people out of their wealth. These lenders target lower
income, elderly, and, often, uneducated homeowners for their abusive
practices. And, as a study released today by the Center for Community
Change so clearly indicates, they target minorities, driving a wedge
between these families and the hope of a productive life in the
economic and financial mainstream of America.
We owe it to these hardworking families to provide protections
against these unscrupulous pirates.
Let me share with you one of the stories we heard at our hearings in
July. Mary Ann Podelco, a widowed waitress from West Virginia, used
$19,000 from her husband's life insurance to pay off the balance on her
mortgage, thus owning her home free and clear. Before her husband's
death, she had never had a checking account or a credit card. She then
took out a $11,921 loan for repairs. At the time, her monthly income
from Social Security was $458, and her loan payments were more than
half this amount. Ms. Podelco, who has a sixth grade education,
testified that after her first refinancing, ``I began getting calls
from people trying to refinance my mortgage all hours of the day and
night.'' Within two years, having been advised to refinance seven
times, each time seeing high points and fees being financed into her
new loan, she owed $64,000, and lost her home to foreclosure.
Ms. Podelco's story is all too typical. Unfortunately, most of the
sharp practices used by unscrupulous lenders and brokers, while
unethical and clearly abusive, are perfectly legal. This bill is
designed to address that problem by tightening the interest rate and
fee triggers that define a high cost loans; the bill improves
protections for borrowers receiving such loans by prohibiting the
financing of exorbitant fees, ``packing'' in of unnecessary and costly
products, such as credit life insurance, and limiting prepayment
penalties. Finally, it protects these consumers' rights to seek redress
by prohibiting mandatory arbitration, as the Federal Trade Commission
proposed unanimously in 2000.
We cannot extol the virtues of homeownership, as we so often do,
without
[[Page S3630]]
seeking at the same time to preserve this benefit for so many elderly,
minority, and unsophisticated Americans who are the targets of
unscrupulous lenders and brokers. This legislation will help achieve
this important goal.
Before closing, let me say that, in addition to the aforementioned
AARP, Leadership Conference on Civil Rights, and Center for Community
Change, CCC, this bill has been endorsed by the National Consumer Law
Center, ACORN, the National League of Cities, National Consumer
Reinvestment Coalition, Consumers Union, Consumer Federation of
America, NAACP, the Self-Help Credit Union, and the U.S. Conference of
Mayors.
Finally, I ask unanimous consent to print in the Record the Executive
Summary of the new CCC study entitled ``Risk or Race? Racial
Disparities and the Subprime Refinance Market.'' While predatory
lending is not by any means exclusively a problem of racial
discrimination, this study demonstrates how much more minorities are
forced to rely on subprime lending as a source of mortgage credit.
Because predatory lending is concentrated in the subprime market, this
study provides new evidence on why the protections provided by the
Predatory Lending Consumer Protection Act are so important.
There being no objection, the material was ordered to be printed in
the Record, as follows:
Risk or Race? Racial Disparities and the Subprime Refinance Market--A
Report of the Center for Community Change
(Prepared by Calvin Bradford, Calvin Bradford & Associates, Ltd.)
executive summary
African-Americans and Hispanics are disproportionately
represented in the subprime home refinance mortgage market.
Surprisingly, this study finds that the disparity between
whites and African-Americans and other minorities actually
grows at upper-income levels and is greater for higher-income
African-American homeowners than for lower-income white
homeowners.
High levels of subprime mortgage lending represent markets
where borrowers are paying unusually high costs for credit,
while often depleting their home equity. Of particular
concern are the consistent and pervasive racial disparities
and concentration of subprime lending in communities of color
and to borrowers of color at all income levels. The
persistent racial patterns found in this analysis raise
questions as to whether factors other than risk alone account
for them.
These patterns exist in all regions and cities of all
sizes, thereby raising concerns about the absence of prime
conventional mortgage loans in these geographic areas. The
subprime market is fertile ground for predatory lending, a
disturbing part of the explosive growth in this market.
Abusive credit practices in the subprime segment of the
mortgage market are stripping borrowers of home equity they
may spend a lifetime building. Thousands of families end up
facing foreclosure, which destabilizes communities and often
shatters families.
The subprime market provides loans to borrowers who do not
meet the credit standards for borrowers in the prime market.
Most subprime borrowers use the collateral in their homes for
debt consolidation or other consumer credit purposes. The
growth in subprime lending has benefitted credit-impaired
borrowers, those who may have blemishes in their credit
records, insufficient credit history, or non-traditional
credit sources. When undertaken responsibly, subprime lending
offers the opportunity to further expand lending markets to
underserved populations.
However, research by the U.S. Department of Housing and
Urban Development (HUD) and others has documented the waive
of foreclosures occurring in the subprime market. High
foreclosure rates for subprime loans indicate that many
subprime borrowers are entering into mortgage loans they
cannot afford. Thus, high levels of subprime lending indicate
markets where borrowers have unusually high risks of losing
their homes. The sheer geographic concentration of these
loans, therefore, may have a significant negative impact not
just on individual borrowers, but on entire neighborhoods.
Foreclosed homes frequently remain vacant for extended
periods, during which they are neglected. These vacant homes
can depress property values and lead to neighborhood
deterioration and disinvestment.
This study represents some important differences from
previous work. It is national in scope, analyzing lending
patterns in all 331 metropolitan statistical areas (MSAs),
and ranking metropolitan areas by a variety of measures of
subprime lending. It also includes a regional analysis,
looking at the variations in lending patterns in different
geographic regions within the country. The study focuses on
single-family conventional refinance loans, where subprime
lending is most concentrated, using 2000 data provided by the
Federal Home Mortgage Disclosure Act. In addition to looking
at lending patterns based on the race and income of the
borrower, the study also analyzes the way these patterns play
out at the neighborhood level and identifies the types of
neighborhoods in which subprime loans are most concentrated.
Finally, in conjunction with this study, the Center for
Community Change is making available an important new
national database on subprime lending, which is posted on our
website at www.communitychange.org.
Our analysis is based on two key measures. One is the
percentage of home refinance loans made to any given racial
or ethnic group that are subprime. The second is a comparison
between this figure and the percentage of subprime refinance
loans made to white borrowers in the same geographic market.
This comparison is expressed as a ratio, the ``racial
disparity ratio.'' A ratio of 1.0 indicates no disparity, a
ratio above 1.0 indicates that minorities are receiving a
higher proportion of subprime loans than whites. The higher
the ratio, the greater the disparity between white and non-
white borrowers.
Key Findings
This study documents the pervasive racial disparities in
subprime lending. Placed in the context of previous research,
this study supports the position that risk alone does not
explain these racial disparities. Our three major findings
are as follows:
1. There are significant racial disparities in subprime
lending, and these disparities actually increase as income
increases.
Lower-income African-Americans receive 2.4 times as many
subprime loans as lower-income whites, while upper-income
African-Americans receive 3.0 times as many subprime loans as
do whites with comparable incomes.
Lower-income Hispanics receive 1.4 times as many subprime
loans as do lower-income whites, while upper-income Hispanics
receive 2.2 times as many of these loans.
At a level of 5.93, St. Louis has the nation's highest
disparity ratio between upper-income African-Americans and
upper-income whites. It was one of five metropolitan areas
where this disparity ratio was greater than 4.0. In another
18 cities, this ratio was between 3.0 and 4.0.
2. High concentrations of subprime lending and racial
disparities in subprime lending exist in all regions of the
nation.
Each region contains metropolitan areas where the level of
subprime lending is above the national average of 25.31%.
In 17 MSAs, the level of subprime lending is more than 1.5
times the national norm. Fourteen of these are in the
Southeast or Southwest, 7 are in Texas. El Paso has the
highest overall level of subprime loans in the nation:
47.28%.
For African-Americans, Hispanics and Native Americans,
disparities exist in all regions of the country, reaching as
high as 3.25 or more in the Midwest and Great Plains.
3. High concentrations of subprime lending and racial
disparities occur in metropolitan areas of all sizes.
Twelve of the 17 metropolitan areas that have
concentrations of subprime lending more than 1.5 times the
national norm have populations below 500,000. For example,
Enid, Oklahoma, the nation's smallest metropolitan area,
ranks #12 in percentage of subprime lending. On the other
hand, 4 of these 17 metropolitan areas are above 1 million in
population.
When we examined disparity ratios for cities in different
size categories, we found the highest disparity ratios for
African-Americans, Hispanics and Native Americans in cities
under 250,000 in population. For example, the highest
disparity ratio for African-Americans is found in Kankakee,
Illinois, with a population of 103,833 and a disparity ratio
of 6.10. For Asians, the highest disparity ratios are
generally found in cities between 500,000 and the 1 million
in population.
Additional Racial Impacts
In examining the racial dynamics of subprime lending, our
research identified three distinct dimensions to the
patterns: (a) high overall percentages of subprime loans made
to African-Americans and Hispanics; (b) high disparity ratios
when these percentages are compared to white borrowers; and,
(c) high disparity ratios for neighborhoods with significant
African-American and Hispanic residents as compared to white
neighborhoods. Examples of these patterns include:
African-Americans
In every single metropolitan area, the percentage of
subprime loans made to African-American borrowers was higher
than the national norm of 25.31%. (Note: certain metropolitan
areas were excluded from this calculation because they had
fewer than 100 loans to African-Americans, which was the
number we set as the threshold for this calculation.)
Buffalo, New York had the highest percentage of subprime
loans to African-Americans, 74.53%.
There were no metropolitan areas where the disparity ratio
for African-Americans fell below 1.64.
The highest disparity ratio for African-Americans was
Kankakee, Illinois, at 6.10. This was followed by Albany,
Georgia, (5.69) and Dothan, Alabama (5.23)
Chicago had the highest disparity ratio for African-
American census tracts: 4.12. It was followed by Milwaukee
(4.04) and Philadelphia (3.40). Eight metropolitan areas had
disparity ratios above 3.0 for African-Americans census
tracts; another 65 cities had disparity ratios above 2.0.
[[Page S3631]]
Hispanics
The highest percentages of subprime loans to Hispanic
borrowers were found in El Paso, Texas, (52.36%) and San
Antonio, Texas (51.46%).
San Jose, California, had a disparity ratio for Hispanics
of 2.45, the highest in the nation. Fourteen metropolitan
areas had disparity ratio above 2.0.
In Corpus Christi, Texas, 75.48% of refinance loans in
Hispanic census tracts were subprime, the highest percentage
of subprime loans in Hispanic tracts in the nation.
Albuquerque, New Mexico, had the highest disparity ratio
for Hispanic census tracts, 2.59.
Conclusion
The persistent racial disparities in levels of subprime
lending found in this analysis do not, in and of themselves,
constitute conclusive proof that there is widespread
discrimination in the subprime lending markets. These
disparities do, however, raise serious questions about the
extent to which risk alone could account for such patterns.
Discrimination has been a persistent problem in the home
finance markets in the United States. The history of mortgage
lending discrimination adds weight to the need to explore
more fully the role that discrimination plays in the subprime
markets through either differential treatment of individual
minority borrowers or through the effects of industry
practices.
The issue of whether there is racial exploitation in the
subprime markets essentially rests on two issues. First, are
the disparities in subprime lending related to race? Second,
can these disparities be fully explained by legitimate risk
factors? Recent research suggests that risk alone does not
explain the huge racial disparities that this study found
across all income levels. Among the factors that influence
the racial disparities in subprime lending:
The absence of active mainstream prime lenders in minority
markets has increased the chances that borrowers in these
communities are paying a high cost for credit. For example,
the finding that racial disparities actually increase as
income increases suggests that a portion of subprime lending
is occurring with borrowers whose credit histories would
qualify them for lower-cost, conventional, prime loans.
Both Fannie Mae and Freddie Mac, the publicly chartered
secondary mortgage market enterprises, have questioned
whether risk explains the use of subprimes loans. Freddie Mac
has estimated that from ``10 to 30 percent of borrowers who
obtained mortgages from the subprime market could have
qualified for a conventional loan through Loan Prospector''
(Freddie Mac's automated underwriting system). (See Freddie
Mac, ``We open Doors for America's Families,'' Freddie Mac's
Annual Housing Report for 1997).
Subprime refinance lending tends to be ``sold'' to
customers rather than ``sought'' by them. Subprime lenders
aggressively market their loans to potential borrowers. These
marketing techniques disproportionately target minority
market segments, often to homeowners with considerable equity
in their homes. Since mainstream prime lenders are absent
from many of these same communities, homeowners are more
susceptible to being persuaded that the more expensive
subprime loans are all that is available to them.
There is other evidence that risk factors do not explain
racial differences in the use of subprime lending. A recent
study by the research Institute for Housing America
concluded, ``after controlling for borrower income, debt, and
credit history, racial groups behave differently.'' (See
Pennington-Cross, Yezer, and Nichols, Credit Risk and
Mortgage Lending: Who Uses Subprime and Why? Research
Institute for Housing America (2000).) Specifically, the
study noted that minorities are more likely to use subprime
lending than whites.
Subprime lending may provide certain borrowers with access
to credit they could not otherwise obtain in the prime
markets. However, the wide disparities in subprime lending to
African-Americans and Hispanics at all income levels, suggest
that factors other than risk may be at work. Further, the
pervasiveness of subprime lending in communities of color, in
all regions and in metropolitan areas of all sizes, raises
important public policy concerns about possible adverse
implications stemming from these heavy geographic
concentrations. It also suggests that minority homeowners may
be particularly vulnerable to predatory lenders, which by
most accounts target communities with high levels of subprime
lending.
______
By Mr. SPECTER (for himself, Mrs. Feinstein, Mr. Hatch, Mr.
Kennedy, Mr. Harkin, Mrs. Boxer, Mr. Durbin, Mr. Miller, Mr.
Corzine, Ms. Mikulski, Mrs. Clinton, and Mr. Thurmond):
S. 2439. A bill to prohibit human cloning while preserving important
areas of medical research, including stem cell research.
Mr. SPECTER. Madam President, I have sought recognition to introduce
legislation to prohibit human cloning while preserving important areas
of medical research, including stem cell research.
I introduce this legislation on behalf of Senator Feinstein, Senator
Kennedy, Senator Hatch, Senator Harkin, Senator Boxer, Senator Durbin,
Senator Thurmond, Senator Miller, Senator Corzine, Senator Mikulski,
Senator Clinton--and I do believe there will be other cosponsors
joining that parade.
Stem cells offer enormous hope for solving some of the most tragic
illnesses confronting Americans--and for that matter people worldwide.
In November of 1998, stem cells burst on the scene, holding this unique
promise. Stem cells are extracted from embryos, and they may be used to
replace defective cells in the human body. For example, enormous
progress has been made on conquering Alzheimer's, conquering
Parkinson's, on cancer, on heart ailments, and many other illnesses.
A controversy arose because they came from embryos and embryos can
produce life. Embryos are characteristically or customarily created for
in vitro fertilization. Normally, about a dozen are created, maybe
three or four are used, and the rest are discarded. It is from those
discarded embryos that the stem cells are extracted. If all of those
embryos could turn into human life, that would obviously be the very
best use of those embryos. But there are some 100,000 in storage, and
it is a practical impossibility for those embryos to be used for human
life.
In last year's appropriation bill coming out of the subcommittee of
Labor, Health, Human Services and Education, where I am the ranking
member, $1 million was appropriated to promote adoption of embryos. We
are now working on legislation to give a tax credit for people who use
the embryos for adoption. But since there are so many of these embryos
which are not going to be utilized for adoption purposes, and the
alternatives are either to discard them or to use them, then it makes
good sense to use them to save lives.
There is general repugnance against reproductive cloning. The
legislation which we are introducing now would ban reproductive cloning
and impose very substantial criminal penalties.
Unfortunately, the scientists use a term, ``therapeutic cloning,''
which has led to confusion and has given a process known as nuclear
transplantation a bad name. Essentially what nuclear transplantation
is, it is to take DNA from a cell of a person who has Parkinson's and
then insert that in a egg of a woman with the DNA removed. Then the
stem cells which are produced from that egg are compatible with the
donor's DNA. For example, those stem cells could be used to combat the
Parkinson's which that individual has.
The legislation contains very substantial protections to be sure that
in the course of this nuclear transplantation none of this will be
implanted in the womb of a woman or otherwise used to produce human
cloning, reproductive cloning--cloning of a person. There are very
tough criminal penalties attached.
To Reiterate, over the past 4 years, the Labor, Health and Human
Services and Education Appropriations Subcommittee has held 14 hearings
at which scientists, patients, and ethicists have described the promise
of stem cell research and nuclear transplantation to produce stem
cells. A problem arises from the fact that scientists misnamed the
promising technique of nuclear transplantation to produce stem cells.
In calling this technique therapeutic cloning, scientists used a word,
which for many Americans, conjures up grotesque images from bad science
fiction movies: mad scientists, bubbling test tubes, and row after row
of zombie-like creatures.
Most Americans equate the word cloning with human reproductive
cloning, where a carbon copy of a person is created in a process that
also gave us Dolly the sheep and CC the cat. By this definition so-
called therapeutic cloning is not really cloning at all. It is a
process that creates embryonic stem cells genetically matched to a
patient for the purpose of repairing unhealthy or injured tissue.
For example, if a patient has heart damage, the genetic material from
one of his cells could be transplanted into a human egg cell that has
had its genetic material removed. After a time, stem cells are
produced, coaxed into becoming heart cells, and transplanted into
[[Page S3632]]
the damaged heart to restore function. Because the cells are an exact
match of the patient's cells, no rejection would occur. Scientists have
suggested that this procedure is better termed nuclear transplantation
to produce stem cells.
Embryonic stem cells can be coaxed into becoming any of the more than
200 types of cells in the human body, and therefore may be used to
treat a vast array of diseases and disorders including heart disease,
Parkinson's disease, diabetes, paralysis, Alzheimer's disease, and
severe burns. Scientists at the National Academy of Sciences estimate
that the combination of nuclear transplantation and stem cell therapies
could spare the lives of 170,000 Americans each year.
History shows us the devastating effects of tying the hands of
scientists for ideological reasons. Galileo was imprisoned for his
support of Copernicus' theory that the planets revolve around the sun.
Pope Boniface VIII banned the practice of cadaver dissection in the
1200's. This set back the understanding of human anatomy and the
practice of medicine for over 300 years. In the 1800's, the Scottish
Calvinist Church objected to the use of anesthesia during labor because
the ``pain of childbirth was God's will.'' Let us not repeat the
mistakes of history.
Recently 40 American Nobel laureates stated that:
legislation [that would ban all cloning] would foreclose
the legitimate use of nuclear transplantation . . . and
impede progress against some of the most debilitating
diseases known to man.
Former Presidents Ford and Carter have written to President Bush
stating their opposition to reproductive cloning and their strong
support for nuclear transplantation to produce stem cells. I believe
that when the facts are weighed there will be strong bipartisan support
for such a policy.
As I said, today, I, along with Senators Feinstein, Kennedy, Hatch,
Harkin, Boxer, Durbin, Miller, Corzine, Mikulski, Clinton, and Thurmond
am introducing a bill which would prohibit human cloning while
preserving important areas of medical research, including nuclear
transplantation to produce stem cells.
Let me review the key provisions of the bill. It would prohibit human
reproductive cloning by imposing a criminal penalty of up to 10 years
in prison and a civil penalty of at least one million dollars. It would
allow medical research into nuclear transplantation to produce stem
cells, also known as therapeutic cloning, thereby allowing promising
research towards cures for a vast array of diseases to go forward. It
would apply strict Federal ethical requirements to all nuclear
transplantation research. These include informed consent, an ethics
board review, and protections for the safety and privacy of research
participants. The legislation imposes a $250,000 civil penalty for
violation of the ethics requirements.
I believe that the Senate should act quickly to ban human cloning. In
the process, we must preserve important areas of medical research, such
as nuclear transplantation to create stem cells. The bill that I and my
colleagues have introduced will do that in an ethical and moral way.
I ask unanimous consent that the text of the bill be printed in the
Record.
There being no objection, the bill was ordered to be printed in the
Record, as follows:
S. 2439
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Human Cloning Prohibition
Act of 2002''.
SEC. 2. FINDINGS.
Congress makes the following findings:
(1) Human cloning is unsafe, immoral, and unacceptable.
(2) Federal legislation should be enacted to prohibit
anyone from attempting to conduct human cloning, whether
using Federal or non-Federal funds.
(3) To deter human cloning, any attempt to create a human
clone should be a felony subject to severe punishment.
(4) The National Academies (including the National Academy
of Sciences and the Institute of Medicine) and the National
Bioethics Advisory Commission recommended that any
legislative action undertaken to ban human cloning should be
careful not to interfere with important areas of scientific
research, such as nuclear transplantation to produce stem
cells.
(5) The National Academies found that there are significant
differences between human cloning and nuclear
transplantation. Specifically, the Academies determined that,
unlike human cloning, the creation of embryonic stem cells by
nuclear transplantation does not involve implantation of an
embryo in a uterus and thus cannot produce a complete, live-
born animal (that is, a ``clone'').
(6) The National Academies found that scientific and
medical considerations that justify a ban on human cloning
are not applicable to nuclear transplantation.
(7) The National Academies concluded that nuclear
transplantation has great potential to increase the
understanding and potential treatment of various diseases and
debilitating disorders, as well as our fundamental biological
knowledge. These diseases and disorders include Lou Gehrig's
disease, Parkinson's disease, Alzheimer's disease, spinal-
cord injury, cancer, cardiovascular diseases, diabetes,
rheumatoid arthritis, and many others.
(8) The National Academies determined that nuclear
transplantation research could improve our ability to
transplant healthy tissue derived from stem cells into
patients with damaged or diseased organs. Such research could
greatly reduce the likelihood that a person's body would
reject that tissue and also help obviate the need for
immunosuppressive drugs, which often have severe and
potentially life-threatening side effects.
(9) Based on these expert conclusions and recommendations
and other evidence, nuclear transplantation is a valuable
area of research that could potentially save millions of
lives and relieve the suffering of countless others, and thus
should not be banned.
(10) The National Academies recommended that nuclear
transplantation experiments should be subject to close
scrutiny under the Federal procedures and rules concerning
human-subjects research.
(11) Given the need for additional oversight in this area,
strict ethical requirements for human subjects research,
including informed consent, safety and privacy protections,
and review by an ethics board, should be prescribed for all
research involving nuclear transplantation, whether using
Federal or non-Federal funds.
(12)(A) Biomedical research and clinical facilities engage
in and affect interstate commerce.
(B) The services provided by clinical facilities move in
interstate commerce.
(C) Patients travel regularly across State lines in order
to access clinical facilities.
(D) Biomedical research and clinical facilities engage
scientists, doctors, and others in an interstate market, and
contract for research and purchase medical and other supplies
in an interstate market.
SEC. 3. PURPOSES.
It is the purpose of this Act to prohibit human cloning and
to protect important areas of medical research, including
stem cell research.
SEC. 4. PROHIBITION ON HUMAN CLONING.
(a) In General.--Title 18, United States Code, is amended
by inserting after chapter 15, the following:
``CHAPTER 16--PROHIBITION ON HUMAN CLONING
``Sec.
``301. Prohibition on human cloning.
``Sec. 301. Prohibition on human cloning
``(a) Definitions.--In this section:
``(1) Human cloning.--The term `human cloning' means
implanting or attempting to implant the product of nuclear
transplantation into a uterus or the functional equivalent of
a uterus.
``(2) Human somatic cell.--The term `human somatic cell'
means any human cell other than a haploid germ cell.
``(3) Nuclear transplantation.--The term `nuclear
transplantation' means transferring the nucleus of a human
somatic cell into an oocyte from which the nucleus or all
chromosomes have been or will be removed or rendered inert.
``(4) Nucleus.--The term `nucleus' means the cell structure
that houses the chromosomes.
``(5) Oocyte.--The term `oocyte' means the female germ
cell, the egg.
``(b) Prohibitions on Human Cloning.--It shall be unlawful
for any person or other legal entity, public or private--
``(1) to conduct or attempt to conduct human cloning; or
``(2) to ship the product of nuclear transplantation in
interstate or foreign commerce for the purpose of human
cloning in the United States or elsewhere.
``(c) Protection of Research.--Nothing in this section
shall be construed to restrict practices not expressly
prohibited in this section.
``(d) Penalties.--
``(1) Criminal penalties.--Whoever intentionally violates
paragraph (1) or (2) of subsection (b) shall be fined under
this title and imprisoned not more than 10 years.
``(2) Civil penalties.--Whoever intentionally violates
paragraph (1) or (2) of subsection (b) shall be subject to a
civil penalty of $1,000,000 or three times the gross
pecuniary gain resulting from the violation, whichever is
greater.
``(3) Forfeiture.--Any property, real or personal, derived
from or used to commit a violation or attempted violation of
the provisions of subsection (b), or any property traceable
to such property, shall be subject to forfeiture to the
United States in accordance with the procedures set forth in
chapter 46 of title 18, United States Code.
[[Page S3633]]
``(e) Right of Action.--Nothing in this section shall be
construed to give any individual or person a private right of
action.''.
(b) Ethical Requirements for Nuclear Transplantation
Research.--Part H of title IV of the Public Health Service
Act (42 U.S.C. 289 et seq.) is amended by adding at the end
the following:
``SEC. 498C. ETHICAL REQUIREMENTS FOR NUCLEAR TRANSPLANTATION
RESEARCH, INCLUDING INFORMED CONSENT,
INSTITUTIONAL REVIEW BOARD REVIEW, AND
PROTECTION FOR SAFETY AND PRIVACY.
``(a) Definitions.--In this section:
``(1) Human somatic cell.--The term `human somatic cell'
means any human cell other than a haploid germ cell.
``(2) Nuclear transplantation.--The term `nuclear
transplantation' means transferring the nucleus of a human
somatic cell into an oocyte from which the nucleus or all
chromosomes have been or will be removed or rendered inert.
``(3) Nucleus.--The term `nucleus' means the cell structure
that houses the chromosomes.
``(4) Oocyte.--The term `oocyte' means the female germ
cell, the egg.
``(b) Applicability of Federal Ethical Standards to Nuclear
Transplantation Research.--Research involving nuclear
transplantation shall be conducted in accordance with
subparts A and B of part 46 of title 45, Code of Federal
Regulations (as in effect on the date of enactment of the
Human Cloning Prohibition Act of 2002).
``(c) Civil Penalties.--Whoever intentionally violates
subsection (b) shall be subject to a civil penalty in an
amount that is appropriate for the violation involved, but
not more than $250,000.
``(d) Enforcement.--The Secretary of Health and Human
Services shall have the exclusive authority to enforce this
section.''.
Mrs. FEINSTEIN. Mr. President, I rise to join my colleagues Senators
Specter, Kennedy, Hatch, Harkin and Thurmond to introduce legislation
banning human cloning, but permitting valuable stem cell research to
continue.
At the dawn of a new era in medicine, it would be unconscionable for
Congress to prohibit medical research that offers hope to so many
people with crippling and often incurable diseases. There is broad
agreement across our society that human reproductive cloning should be
prohibited. And our bill bans human reproductive cloning. But there is
also widescale support to continue research that may yield cures for
paralysis, cancer, Parkinson's disease, Alzheimer's and so many other
illnesses. And our bill allows this important research to continue.
Simply put, nuclear transplantation research has nothing to do with
cloning humans. Rather, it has everything to do with saving lives and
alleviating suffering.
The legislation we are introducing today bans human reproductive
cloning, that is, creating a whole-body, carbon copy of a human being.
Such cloning is unsafe, immoral, and unacceptable. Under the bill,
anyone who even attempts human cloning will be subject to 10 years in
jail and a minimum $1 million fine. However, the bill does not ban
somatic cell nuclear transplantation. This is a technique that offers
enormous potential for providing cures for diseases such as cancer,
diabetes, cystic fibrosis, and heart disease as well as conditions such
as spinal cord injuries, liver damage, arthritis, and burns.
Somatic cell nuclear transportation works like this: 1. The nucleus,
that is, the DNA, is taken from the body cell of a sick person; 2. It
is then injected into an unfertilized egg from which the nucleus has
been removed; and 3. The egg is stimulated to divide and produce stem
cells. These stem cells can potentially grow into any organ or tissue.
This ``new'' organ or tissue would have the same DNA as the sick person
and thus can be implanted without rejection by the person's body. This
could save the lives of the thousands of people every year waiting for
an organ or tissue to be donated or who receive a transplant but suffer
complications from powerful immuno-suppression drugs.
Today, almost 80,000 Americans are waiting for organ transplants,
while hundreds of thousands more need tissue transplants. Nuclear
transplantation research offers many other applications as well. It
could be used to produce human proteins such as blood clotting factors
that aid in healing wounds. It could yield information on stem cell
differentiation, providing valuable information about the mechanism of
aging and the cause of cancer. It could even be used to find a cure for
cancer by teaching us how to reprogram cells. However, we must
acknowledge that nuclear transplantation research, like all scientific
and medical research involving human diseases and conditions, involves
complex ethical issues.
Currently, this research is largely unregulated in the private
sector. That is why this legislation would impose a number of ethical
requirements on it, including informed consent, an ethics board review,
and protections for the safety and privacy of research participants.
These regulations are found in Subparts A and B of 45 CFR 46 and are
incorporated in full into the bill we introduce today. Currently, these
regulations apply to any research done or funded by the federal
government. Our legislation would extend the regulations to all
research involving somatic cell nuclear transplantation.
The bottom line is that these regulations will prevent exploitation
of women as part of nuclear transplantation research and, more
generally, require that researchers do this research in an ethical
manner. These regulations are already routinely applied to government-
funded researchers who do research on human subjects, and they seem to
have worked well. Moreover, the bill provides that anyone engaging in
unethical nuclear transplantation research would face up to a $250,000
fine.
I ask unanimous consent that a summary of Subparts A and B of 45 CFR
46 be printed in the Record directly following my remarks.
The PRESIDING OFFICER. Without objection, it is so ordered.
(See exhibit 1.)
Ms. FEINSTEIN. I would also add that I believe that there may be a
need for even greater oversight over nuclear transplantation research
than is provided in the bill we introduce today.
I intend to work with my colleagues to strengthen this legislation
further before it is enacted. There may well be a need to include
additional provisions for regulation and oversight. For one thing, I
believe that we should add the full text of Subparts A and B of 45 CFR
46 to this legislation to make clear what the bill actually says. And I
will work with my colleagues to do so. Unfortunately, competing
legislation goes far beyond such regulation. It would completely ban
nuclear transplantation--criminalizing scientific research that offers
the promise of saving the lives of millions and relieving the suffering
of countless others. In fact, it would even make it a crime for a
doctor to cure a patient if that cure was developed overseas from
nuclear transplantation research.
I strongly oppose such legislation. I believe that passing such a
sweeping ban would be a huge mistake. As is the case with many medical
technologies, it is not stem cell research techniques that are the
problem, but some of their potential applications. The scientific and
medical evidence is overwhelming that nuclear transplantation offers
the promise of curing many deadly diseases and debilitating conditions.
As Professor Irving Weissman, chair of the National Academies' panel on
cloning, testified before a Judiciary Committee hearing I chaired,
``[T]here are no scientific or medical reasons [for banning nuclear
transplantation], and such a ban would certainly close avenues of
promising scientific and medical research.'' In fact, over 80 major
organizations and associations have already come out in favor of our
approach.
These include the American Medical Association, National Health
Council, Parkinson's Action Network, Juvenile Diabetes Research
Foundation, and Federation of American Societies for Experimental
Biology, which represents over 600,000 medical researchers around the
country. Moreover, the leading blue-ribbon scientific and medical
panels that have examined the cloning issue have also supported our
approach.
The National Bioethics Advisory Commission, the National Academies'
Panel on Scientific and Medical Aspects of Human Cloning, and the
California Advisory Committee on Human Cloning all concluded that we
should ban human reproductive cloning, but not interfere with important
areas of scientific research, including nuclear transplantation.
I have been very moved by the many sick people and their relatives
that have contacted me and told me that my legislation offers them
hope. One of the most compelling stories is that of
[[Page S3634]]
Kris Gulden who testified at our hearing on the subject. Ms. Gulden, a
former veteran police officer, received several awards for her
outstanding law enforcement work. She also maintained an active
schedule outside the office, including winning the women's triathalon
gold medal in August 1996 at the biannual International Police Olympics
in Salt Lake City. Tragically a car struck Ms. Gulden while she was
training for the 1998 AIDS Ride, leaving her with a severe spinal cord
injury. That accident changed her life. Nine days before the accident,
she was participating in a triathalon in Memphis. Nine days after the
accident, she was left exhausted just trying to brush her teeth. I'll
never forget her words: ``In my dreams, I still walk. I run, I play
basketball, and I wear the uniform of the Alexandria Police Department.
When the sun rises each morning, it brings reality with it. I rise to
the sight of a wheelchair, yet I rise with the hope that maybe this
will be the morning that I can move my legs.''
In the face of the enormous promise of nuclear transplantation
research, it is difficult to see why anyone wants to dash the hopes of
Kris Gulden and the millions of others facing debilitating and painful
illnesses and ailments. As former Senator Connie Mack has testified
before the Senate:
A cell isn't human life if it hasn't been fertilized by a
sperm and placed in the womb'' and `[t]he research value of
these cells is enormous. They have the potential to form any
cell in the body and can reproduce indefinitely. Studies in
animals demonstrate that this could lead to cures and
treatments for millions of people.
The legislation we introduce today would ban human reproductive
cloning and preserve valuable medical research. I urge my colleagues to
support this bill.
I would also ask unanimous consent that several letters I have
received supporting the Specter-Feinstein-Kennedy-Hatch approach to
cloning be printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:
Joint Steering Committee
for Public Policy,
Bethesda, MD, April 9, 2002.
Hon. Orrin G. Hatch,
U.S. Senate, Hart Senate Office Building, Washington, DC.
Dear Senator Hatch: I am writing to seek your help with
efforts being made by many disease advocacy groups and by
many of us in the scientific community to protect highly
valuable scientific research from an overzealous legislative
proposal intended to prohibit the cloning of human beings.
The measure in question, S. 1899, introduced by Senator
Brownback and others, would, in effect, establish criminal
penalties for three things: (i) attempts to produce a human
being by methods that include transfer of a somatic cell
nucleus (``nuclear transfer'') and placement of any resulting
embryos into a uterus; (ii) the transfer of a human cell
nucleus into an egg cell for any purposes; and (iii) the
important of any products of nuclear transfer, including
those used for medical treatment.
No scientist of my acquaintance believes that it is
currently appropriate or safe, even if it were feasible, to
undertake the complex process intended to result in the birth
of a cloned human being. For that reason, you are unlikely to
hear objections to the first prohibition established by the
Brownback bill, even from those who may question whether
legislation and criminal penalties are useful instruments for
preventing attempts at cloning that might be undertaken by
irresponsible individuals.
The second and third prohibitions, however, are deeply
disturbing to many people, including those of use who have
given considerable thought to the difficult ethical issues
presented by these new technologies. The third prohibition is
inappropriately punitive in the more obvious way: it could
lead to punishment of seriously ill patients who have gone
abroad to seek novel treatments that are unavailable in this
country because they are based on nuclear transfer. But the
second prohibition is troubling in a more profound way. For
the first time in my experience, an American law would create
criminal penalties for the use of a highly promising
scientific method, regardless of the intent of the
investigator, and would threaten to delay development of new
therapies for common diseases.
To appreciate our concerns, it is important to understand
the nature of what is called ``nuclear transfer''. Recent
studies with experimental animals show that a cell nucleus
containing all, but expressing only some, of the genes of an
organism can undergo extensive changes, or ``reprogramming'',
when moved from one cell environment to another. This means
that a nucleus from a highly specialized cell--for example, a
skin call--can radically revise the set of genes that it uses
when it is put into another cell, such as an egg cell, from
which the pre-existing nucleus has been removed. In the new
environment of the recipient cell, the genes in the nucleus
appear to function as appropriate to that environment.
Thus, when the recipient cell is an egg, the genes regain
the ability to direct the progeny cells, which arise by
division, to form nearly any of the many cell type that are
found in a mature organism, if the cells are coaxed to do so
by appropriate stimuli. This phenomenon has the potential to
lead to great things a deeper understanding of human
development, important insights into disease mechanism, and
the abundant production of normal cells of virtually any
type, which could then be used to treat a wide variety of
diseases. Moreover, if a parent is the source of the
transplanted, reprogrammed nucleus, the normal cells could be
used to treat that individual without fear of immune
rejection.
Clearly we have a lot to learn before we can efficiently
apply nuclear transfer and reprogramming to medical
purposes--most obviously, we need to learn the best recipes
to foster reprogramming and development into the various cell
types. But studies with certain animal models of disease
already show that these strategies can work, and the
fundamental discoveries that have emerged from work with
nuclear transfer offer legitimate hope for still greater
discoveries in the future.
Unfortunately, the opportunities make such discoveries and
develop new therapies may well be denied to American
scientists because of any inappropriate equation of the
method used in reprogramming cells (nuclear transfer) and the
goal of cloning whole organisms. This confusion is based in
part on the use of nuclear transfer in an otherwise very
different multi-step process that led ultimately to the birth
of Dolly the sheep and other cloned animals. Indeed, S. 1899
considers transfer of a human somatic cell nucleus into an
nucleated human egg for the purpose of reprogramming to be a
punishable act of human cloning.
It is crucial to emphasize how nuclear transfer, the
reprogramming step, differs from attempts to generate a full-
fledged organism. Absent transfer to a uterus, the cells that
result from nuclear transfer into an egg cytoplasm will not
form the complex and organized collection of cell types that
characterize a developing organism. The initial aggregate of
fewer than 200 cells, formed after introduction of a nucleus
into an egg, lacks the recognizable types of cells that are
needed to develop into the organs of a human being, and it
is barely visible to the naked eye. Individual cells from
this aggregate, however, can be used to develop stem cell
lines, to study development of specialized cell types in a
Petri dish, and to prepare materials for cell-based
therapies.
Furthermore, in the future, it is possible that cell
reprogramming can be carried out in ways that do not involve
the use of human egg cells or nuclear transfer itself. The
chemicals in the cytoplasm of an egg cell that guide
reprogramming have not yet been identified, but when they are
it will be possible to use other cells and even simpler
defined recipes to reprogram adult cells. Of course, these
things will never happen, at least in this country, if the
use of nuclear transfer to human eggs is outlawed.
The Brownback bill that we are worried about today closely
resembles a bill (S. 1601) proposed in 1998 by Senator Bond
and others. At that time, you helped to derail the passage of
that ill-considered measure with an insightful letter to one
of the bill's sponsors and a speech on the Senate floor. Many
of my colleagues and I believe that the concerns you raised
then about the need to ``ban cloning of human beings but do
so in a way that allows, to the extent ethically proper,
valuable research to continue'' are still valid. For that
reason, I hope you will join us in opposing S. 1899.
Thank you for your consideration of my views on this
important legislation. Needless to say, I am prepared to
discuss any of the points I have made with you or your staff
at any time.
With best personal regards,
Harold Varmus,
Chair, Joint Steering Committee
for Public Policy.
____
California Institute of Technology,
Pasadena, CA, April 8, 2002.
Senator Orrin G. Hatch,
Hart Office Building,
Washington, DC.
Dear Senator Hatch: I am writing in opposition to the
Brownback bill on cloning.
I am a Nobel Laureate who has worked for 40 years in basic
biological science and biotechnology. I have seen how a
glimmer of an idea can grow to transform a technology, and I
have great faith in the ability of basic science to create
miraculous treatments for medical conditions.
The use of nuclear transfer into the embryonic cells for
reproductive purposes (so-called reproductive cloning) is a
technology that is a long way from being safe enough to be
used to create human beings. So, issues of morality aside, I
am totally opposed to using cloning technology for human
reproduction. All of my colleagues with whom I have talked
are equally opposed, but I am aware that there are people
threatening to try to carry out the procedure. Thus, I
support a legislative ban on reproductive cloning. I hope
that any such ban will have a sunset clause so that in 5
years the question can be revisited.
There is another use of somatic cell nuclear transfer into
early embryonic cells
[[Page S3635]]
that is quite different from the process of reproductive
cloning. This is often called therapeutic cloning, although
that is a terminology that many people find confusing. Such
nuclear transfer could be used to produce individual stem
cells that may have extraordinary medical value. It is also a
valuable technique for probing the causes of genetic
diseases. Twice this week, I have heard of new advances that
make such a technology increasingly promising. Furthermore,
the procedure whereby mouse cells derived by somatic cell
nuclear transfer can be used therapeutically has just been
described in the journal Cell, erasing any doubt about the
feasibility of the method. Thus, it would be a great loss to
medical science for somatic cell nuclear transfer for
therapeutic use to be legislatively banned.
I am aware that there are bills in the Senate that would
fit the requirements that I have set out. Senator Feinstein
of my state along with Senator Kennedy has proposed such a
bill as has Senators Specter and Harkin. They make the
distinction between banning nuclear transfer for reproductive
purposes and continuing to allow nuclear transfer for
research and therapeutic purposes. These are bills that I can
support.
Sincerely yours,
David Baltimore,
President.
____
American Association for the
Advancement of Science,
Washington, DC, February 28, 2002.
Dear Senator: The Board of Directors of the American
Association for the Advancement of Science (AAAS) recently
adopted a policy statement on human cloning. I am enclosing a
copy for your attention.
Citing the serious risks associated with the procedure, the
AAAS statement supports a legally enforceable ban on human
reproductive cloning. At the same time, however, it backs
stem cell research using cells derived with nuclear
transplantation techniques, a procedure sometimes called
therapeutic or research cloning. Such research offers
enormous potential health benefits. However, because it also
raises serious ethical, social, and religious concerns, it
must be conducted under close scrutiny by the federal
government.
AAAS is the world's largest general scientific society with
over 135,000 individual members and 275 affiliated societies
representing all fields of science and engineering. Founded
in 1848, it is also the publisher of Science magazine and has
long been a leader in promoting ethical and responsible
science.
Sincerely,
Alan I. Leshner,
Chief Executive Officer.
Enclosure.
AAAS Statement on Human Cloning
The American Association for the Advancement of Science
(AAAS) recognizes the intense debates within our society on
the issue of human cloning. Since 1997, AAAS has engaged the
public and various professional communities in dialogue on
the scientific and social issues associated with human
cloning and stem cell research. Those experiences form the
backdrop for this statement on human cloning.
ban reproductive cloning
AAAS endorses a legally enforceable ban on efforts to
implant a human cloned embryo for the purpose of
reproduction. The scientific evidence documenting the serious
health risks associated with reproductive cloning, as shown
through animal studies, make it unconscionable to undertake
this procedure. At the same time, we encourage continuing
open and inclusive public dialogue, in which the scientific
community is an active participant, on the scientific and
ethical aspects of human cloning as our understanding of this
technology advances.
support stem cell research (including ``research cloning'')
AAAS supports stem cell research, including the use of
nuclear transplantation techniques (also known as research or
therapeutic cloning), in order to realize the enormous
potential health benefits this technology offers. Such
benefits are likely to be many years away. If they are to be
realized at all, however, it will only be through carefully
designed research subject to peer review. Because there are
religious, ethical, and social concerns raised by the
prospect of creating stem cells for research purposes, we
believe that research cloning should only proceed under close
scrutiny by the federal government over both the public and
private sectors.
exercise appropriate oversight
A thorough assessment of existing guidelines and policy,
including consideration of possible new regulations specific
to this type of research, should be undertaken in light of
the concerns surrounding it.
Adopted by the AAAS Board of Directors, Boston,
Massachusetts, February 14, 2002.
____
The American Society
of Human Genetics,
Bethesda, MD, February 5, 2002.
Hon. Dianne Feinstein,
U.S. Senate,
Washington, DC.
Dear Senator Feinstein: The American Society of Human
Genetics (ASHG) is a society of researchers and professionals
in human genetics that represents nearly 8000 scientists,
physicians, nurses, genetic counselors, and students actively
engaged in genetic discovery, teaching, and application of
knowledge of human genetics and the human genome.
As a major scientific organization whose members have broad
expertise and interest in matters related to human genetics,
and in the application of genetic knowledge to the well being
of people, the Society strives to be extremely thoughtful,
thorough and ethical in pondering many of the scientific
issues raised in public debate today. As stewards of the
field of human genetics elected by the membership of the
Society, the Board of Directors of ASHG affirms that basic
research and the development of future applications of that
research require the ongoing commitment to scientific
integrity and social responsibility that has served our
organization well for the last 50 years. In other words,
scientists must proceed with commitment to rigorous critical
evaluation and a heightened sense of responsibility to the
patients who entrust their life and health to us.
In concert with these principles, it is important for you
and your colleagues to know that the ASHG concurs
wholeheartedly with your bill ``The Human Cloning Prohibition
Act'' that bans reproductive human cloning but is finely
crafted so as not to prohibit new and evolving techniques
that could potentially change the course of human illness as
we know it today so that the collective quality of life is
enhanced for all of us. Dr. Bert Vogelstein, in his testimony
before the Labor Health and Human Services subcommittee on
December 4, 2001, so eloquently captured the distinction
surrounding two very different medical endeavors--
regenerative medicine and the cloning of a human--the former
being the potential key to the problem of immune rejection,
the latter being morally and medically unacceptable.
In closing, the Senate must be sure that any legislative
action only bans cloning to create a human being and does no
harm to legitimate biomedical research. Each Senate vote on
proposed legislation must make this distinction clear or any
ban would have profound negative impact on the advances that
have been made thus far in this pioneering and exciting
field.
We congratulate you and your fellow senators for your
insight and conviction to advancing the field of biomedical
research.
Sincerely yours,
Dr. P. Michael Conneally,
ASHG President.
Dr. Joann A. Boughman,
ASHG Executive Vice President.
____
April 12, 2002.
Closing Minds to Stem Cell Research
The United States Senate is about to consider legislation
that will determine the fate of a remarkable new form of
medical research known colloquially as ``therapeutic
cloning''. The research could lead to unprecedented
treatments for human disease, but has fallen prey to the
confused debate over human stem cell research on the one
hand, and the prospects of creating a cloned person on the
other--two very different exercises that are now intricately
entwined.
The debate has its roots in the medical potential of human
stem cells. All the tissues in our bodies arise from stem
cells that are found in the early human embryo. Over the past
several years, scientists have learned how to isolate and
propagate human stem cells. There is hope that we will
eventually be able to use these cells to more effectively
treat cancer, diabetes, spinal cord injury, Alzheimer's and
Parkinson's diseases, and others. This prospect has inspired
great hope among individuals with ailments that had
previously seemed incurable.
Human stem cells can be isolated in several ways. The most
visionary approach utilizes a procedure that was first dubbed
``therapeutic cloning'', but should more accurately be termed
``somatic cell nuclear transfer'' or simply ``nuclear
transplantation''. To perform nuclear transplantation,
scientists replace the genetic material of an unfertilized
human egg with that from an adult cell. The egg is then
induced to proliferate into a primitive structure known as
the ``blastocyst'', from which stem cells can be harvested.
Tissue derived from such stem cells would be immunologically
compatible with the donor of the genetic material, thus
circumventing rejection of the tissue when it is transplanted
into the donor in order to renew a failing organ.
Blastocysts produced by nuclear transplantation can also be
implanted into the uterus in order to produce fully developed
organisms that are genetically identical to the original
donors--``clones'' such as the celebrated sheep Dolly. The
prospect of using such ``reproductive cloning'' to create
humans is repugnant to most scientists and the general public
alike. Consequently, there is widespread support for
legislation that would prohibit the production of human
clones.
But the use of nuclear transplantation to obtain stem cells
is another matter. At the time stem cells would be isolated
from blastocysts produced by nuclear transplantation, the
structures are no larger than the head of a small pin, of the
order of 100-150 cells, and have no distinctive tissues--in
particular, no neural tissue. Moreover, they have been
obtained artificially, without even the intervention of
fertilization, and will not be used to produce cloned
individuals. They are biologically akin to the very early
embryos produced in fertility clinics by fertilization in
test tubes, except that they contain the genes of only one
individual rather
[[Page S3636]]
than those of two. The U.S. condones the discard of surplus
embryos made in fertility clinics. Why should it criminalize
the medical use of blastocysts produced by nuclear
transplantation? Unfortunately, the term
``therapeutic'' cloning'' was originally used to describe
nuclear transplantation, so the procedure is now tarred
with the same brush as reproductive cloning. Rarely has
semantic inaccuracy been more misleading.
The Senate will be offered two very different legislative
approaches to nuclear transplantation. One approach,
sponsored by Senator Sam Brownback, would prohibit both
reproductive cloning and nuclear transplantation itself. The
other approach, sponsored in two similar forms by Senators
Dianne Feinstein and Edward Kennedy, and by Senators Tom
Harkin and Arlen Specter, would ban reproductive cloning, but
permit research with nuclear transplantation to go forward.
Also in the wings is a proposed moratorium on nuclear
transplantation as an alternative to full fledged
prohibition, but this has yet to take legislative form.
The Brownback bill is an onerous piece of legislation. It
would criminalize a form of medical research that is intended
to explore the prospects for stem cell therapies, not to
create cloned persons; importation of treatments developed in
other nations by the use of nuclear transplantation; even the
receipt of such therapies abroad. It holds out the prospect
of a U.S. diabetic returning from Great Britian--where the
production of stem cells by nuclear transplantation is
authorized--with a pancrease restored through the agency of
nuclear transplantation and finding herself a felon.
The proposed moratorium is not a satisfactory alternative.
It raises the specter of interminable discussion and
political machinations, perhaps stalling research on nuclear
transplantation indefinitely. The proponents of a moratorium
argue that ``the widespread creation of clonal embryos would
increase the risk that a human clone would be born, and would
further open the door to eugenic procedures.'' But nuclear
transplantation itself is in no way a ``eugenic procedure''.
And any legislative prohibition of reproductive cloning
automatically forbids the use of nuclear transplantation for
that purpose.
Congress should unite around legislation that would
prohibit reproductive cloning, but permit research on nuclear
transplantation to go forward under suitable regulations and
oversight. The makings of such legislation are already before
the Senate, in the form of the Feinstein-Kennedy and Specter-
Harkin bills. Legislation fashioned from these bills could
offer a forthright, progressive and humane solution to the
impasse over nuclear transplantation. The U.S. public
deserves no less.
Paul Berg, Ph.D.
J. Michael Bishop, MD.
Andrew S. Grove, Ph.D.
Dr. Berg is Emeritus Professor in the Department of
Biochemistry at Stanford University and a Nobel laureate in
chemistry. Dr. Bishop is Chancellor at the University of
California, San Francisco, and a Nobel laureate in Physiology
or Medicine. Dr. Grove is a cofounder and presently chairman
of Intel Corp., and a cancer survivor.
____
Association of American
Universities,
Washington, DC, April 25, 2002.
Hon. Dianne Feinstein,
U.S. Senate,
Washington, DC.
Dear Senator Feinstein: I am writing to let you know that
the Association of American Universities has now adopted a
position on human cloning, which is attached. The AAU
represents 61 leading public and private research
universities in the United States and two in Canada.
Our university membership adopted this statement
unanimously, and we look forward to working with you to enact
legislation consistent with it, which would include the
legislation you have introduced on this topic, S. 1758.
Your leadership in the fight to ensure that appropriate
restrictions against human reproductive cloning are enacted,
while allowing important research on nuclear transplantation
to produce stem cells to continue, is most appreciated.
Cordially,
Nils Hasselmo,
President.
Enclosure.
AAU Statement on Human Cloning
The Association of American Universities has a long history
of supporting academic and scientific freedom. It also
recognizes the importance of conducting research consistent
with ethical, legal, and safety requirements.
AAU strongly opposes human reproductive cloning, and
supports legislation to ban this practice. The National
Academy of Sciences (NAS) has concluded that cloning
procedures are currently not safe for humans and that no
responsible scientists or physicians are likely to undertake
to clone a human. We generally do not support legislation to
limit fields of research, but since some organizations have
announced an intention to clone humans, we concur with the
NAS that a legal ban is more likely to deter any attempt to
close a human than would any voluntary system or moratorium.
The ban should be reconsidered at five-year intervals, based
on current scientific knowledge.
In contrast to human reproductive cloning, AAU continues to
support both basic and applied stem cell research. AAU
therefore supports nuclear transplantation to produce stem
cells, also known as somatic cell nuclear transfer, as
nonreproductive cloning, and as therapeutic cloning. AAU
concurs with the NAS that nuclear transplantation to produce
stem cells has considerable potential for advancing our
fundamental knowledge and developing new medical therapies to
treat debilitating diseases. Continuing the investigation of
stem cells produced by nuclear transplantation is the only
way to assure that the value of this nascent technology is
realized. Before applications to humans should be considered,
we need further study of cells derived from the process of
nuclear transplantation, subject to federal safeguards. This
research should proceed in parallel with other types of stem
cell research, including human embryonic and adult stem cell
research.
Adopted by the AAU Membership on April 23, 2002.
____
Patient Stories From California Supporting Specter-Feinstein Approach
on Cloning
From Stefanie Sonico in Cathedral City, CA
``I totally and completely support stem cell research in
hopes that it will lead to a cure for juvenile diabetes and
other such devastating diseases. My son developed juvenile
diabetes at 20 months old and is now 16 years old. Without
stem cell research, his future is frightening. He does not
need to look forward to kidney failure, eye damage, heart
disease and stroke, and death 15 years before his time. He
needs to believe that the United States of America, a free
country, supports research, done by renowned scientists, to
find a cure for diabetes. He needs to believe that the United
States will not imprison scientists for their knowledge and
their skill. I am a Christian that believes that we have an
obligation to use our God-given brains and skills to better
mankind. The research I support involves a cell in a petri
dish that will produce cells to cure a disease like diabetes
and that is called therapeutic cloning. My son and the
millions of children like him, need the research and the
results that will come from therapeutic cloning. Thank you.''
From Lisbeth Dermody in Monterey, CA
``My son sustained a spinal cord injury 4 years ago and is
now a quadriplegic; my husband developed the first symptoms
of Parkinson's Disease 10 years ago and is now deteriorating
and experiencing Parkinson's dementia. Stem cell therapy is
our best hope that these two brilliant and productive men may
expect some improvement in their lives and an alleviation of
the psychological and physical suffering they endure every
hour of every day. I urge defeat of the Brownback Bill; I
urge support of intelligent and humane research that will
help my loved ones.''
from hellen mueller, modesto, ca
``I am a type 2 diabetic with severe neuropathy. Recently,
I had surgery for thyroid cancer and have lost the use of my
parathyroids. I look to science particularly the science of
cloning for help in treating my ailments. Life has become
difficult as I am in pain much of the time. Even normal
activities are limited for me. I would like to live the years
I have left relatively pain-free, diabetes free too.
My husband has terrible knees. He suffers from degenerative
cartilage and arthritis as does my sister. It would be
wonderful if they could be helped by SCNT [somatic cell
nuclear transplantation]. My husband is still able to work;
however he pays a great price in the pain that he suffers.
Only by using a large amount of pain killers is he able to
get thru a work day. My sister is very incapacitated by her
problems.
My sister's husband has had by-pass surgery which resulted
in cognitive problems. Stem cell research, cloning, etc seem
to be the only hope on the horizon.
In 1990 I lost a husband to ALS [Amyotropic Lateral
Sclerosis or Lou Gehrig's disease]. Today I understand
scientists are very hopeful that stem cell research will lead
to a cure for this killer. He was gone one year after
diagnosis. I was left without a husband, my son without a
father. What a miracle it would be if this could be avoided
for other people.''
____
Summary of Human Subject Regulations as Incorporated Into Specter-
Feinstein Legislation
general research provisions
Types of Research Covered
Would cover ALL research involving somatic cell nuclear
transplantation, regardless of who performs it or whether it
is funded by the government.
Assurance and Certification Procedure
The institution conducting the research must: Submit a
statement of ``written assurance'' outlining the procedures
by which the institution will abide by federal regulations,
and certify that the research has been reviewed and approved
by an institutional review board (IRB) (see below for
definition of IRB).
Penalities
HHS may require that the project be terminated or suspended
if it finds an institution has failed to comply with federal
regulations
HHS may also require the institution to pay a civil penalty
of up to $250,000.
definitions and requirements
Institutional Review Board (IRB)
Research institutions must establish (or hire outside)
Institutional Review Boards to
[[Page S3637]]
review and approve research involving somatic cell nuclear
transplantation. Each IRB must have at least five members.
In order to approve this research involving human subjects,
the IRB must determine that all of the following requirements
are satisfied: Risks to subjects are minimized and are
reasonable in relation to any anticipated benefits and
importance of the knowledge expected; selection of subjects
equitable; informed consent is sought and appropriately
documented from each subject; when appropriate, the research
plan makes adequate provision for monitoring and protecting
the data collected, to ensure the safety and privacy of
subjects; and when some of the subjects are likely to be
vulnerable to undue influence (such as mentally disabled or
disadvantaged persons), additional safeguards must be
included in the study to protect the rights and welfare of
these subjects.
The IRB has the authority to suspend or terminate approval
of research that fails to meet these requirements, or that
has been associated with unexpected serious harm to subjects.
Informed Consent
No investigator may use a human subject in research unless
the investigator has obtained the legally effective informed
consent of the subject.
An investigator can seek consent only under circumstances
that minimize the possibility of undue influence.
No informed consent, whether oral for written, may include
any language through which the subject waives his legal
rights, or the investigator is released from liability for
negligence.
Basic elements of informed consent: The following
information must be provided to each subject: A statement
that the study involves research, an explanation of the
purposes of the research, the expected duration of the
subject's participation, a description of the procedures to
be followed, and identification of any procedures which are
experimental; a description of any reasonably foreseeable
risks or discomforts to the subjects; a description of any
benefits to the subject or to others which may reasonably be
expected from the research; a disclosure of appropriate
alternative procedures or courses of treatment, if any, that
might be advantageous to the subject; a statement
describing the extent, if any, to which confidentiality of
records identifying the subject will be maintained; for
research involving more than minimal risk, an explanation
as to whether the subject will be compensated, and an
explanation as to whether any medical treatments are
available if injury occurs and, if so, what they consist
of, or where further information may be obtained; an
explanation of whom to contact for answers to pertinent
questions about the research and research subjects'
rights, and whom to contact in the event of a research-
related injury to the subject; and a statement that
participation is voluntary, refusal to participate will
involve no penalty or loss of benefits to which the
subject is otherwise entitled, and that the subject may
discontinue participation at any time without penalty or
loss of benefits, to which the subject is otherwise
entitled.
Additional Protections for Pregnant Women and Fetuses
General Restrictions: Research on fetuses and pregnant
women cannot be undertaken, unless: Appropriate studies on
animals and nonpregnant individuals have been completed; the
risk to the fetus is caused solely by interventions or
procedures that hold out the prospect of direct benefit for
the woman or the fetus; or, if there is no such prospect of
benefit, the risk to the fetus is not greater than minimal
and the purpose of the research is the development of
important biomedical knowledge which cannot be obtained by
any other means; any risk is the least possible for achieving
the objectives of the research; if the research holds out the
prospect of direct benefit to the pregnant woman, the
prospect of a direct benefit both to the pregnant woman and
the fetus, or no prospect of benefit for the woman nor the
fetus when risk to the fetus is not greater than minimal and
the purpose of the research is the development of important
biomedical knowledge that cannot be obtained by any other
means, only the mother's consent is needed; if the research
holds out the prospect of direct benefit solely to the fetus
then the consent of both the pregnant woman and the father
must be obtained, except that the father's consent need not
be obtained if he is unable to consent because of
unavailability, incompetence, or temporary incapacity or the
pregnancy resulted from rape or incest; individuals engaged
in the activity will have no part in (i) any decisions as to
the timing, method, and procedures used to terminate the
pregnancy, and (ii) determining the viability of the fetus at
the termination of the pregnancy; and no inducements,
monetary or otherwise, may be offered to terminate pregnancy
for purposes of the activity.
____________________