Legislative Corner


This area focuses on issues concerning legislation, legal issues, and government investigations concerning mind control.



There were two important bills in the House and Senate, but they ahve been tabled for some time.

H.R. 3946 of the 104th Congress introduced by Rep. Torricelli:

"To amend title 28 of the United States Code to provide for a remedy against the United States for claims based upon conduct involving human experimentation, to provide a remedy against the United States with respect to constitutional and human rights violations, and for other purposes.

:And S. 193 of the 105th Congress by Sen. Glenn:

"To provide protections to individuals who are the human subject of research.

Short, well written letters to your senators and representatives supporting these bills would help a lot I think. The text of the bills and legislative history are available at http://thomas.loc.gov, which isa gold mine of info on bills and the function of Congress. The search engine is a little hard to get used to, but very powerful onece you get a handle on it.


Sen. Glenn's remarks from the Congressional Record for Jan 22, 1997:

HUMAN RESEARCH SUBJECT PROTECTION ACT

Mr. GLENN. Madam President, I rise today to introduce the
Human Research Subject Protection Act of 1997. I send the
bill to the desk.

The PRESIDING OFFICER. The bill will be received and
appropriately referred.

Mr. GLENN. Madam President, if I approached any Senator here
and I said, `You did not know it, but the last time they
went to the doctor or went to the hospital, your wife or
your husband or your daughter or your son became the subject
of a medical experiment that they were not even told about.
They were given medicine, they were given pills, they were
given radiation, they were given something and were not even
told about this, were not even informed about it, yet they
are under some experimental research that might possibly do
them harm--maybe some good will come out of it, but maybe it
will do them harm also--but they do not know about it,'
people would laugh at that and say that is ridiculous. That
cannot possibly happen in this country. Yet, that very
situation is what this piece of legislation is supposed to
address.

I have been in public life and have served this country for
many years. Frankly, I do not think too many things that I
see surprise me anymore about our laws and about Government.
Three years ago, though, I began to learn about a gap in our
legal system that does truly concern me. In 1993 the
Governmental Affairs Committee began to investigate the cold
war radiation experiments. These experiments are one of the
unfortunate legacies of the cold war, when our Government
sponsored experiments involving radiation on our own
citizens without their consent. They did not even know the
experiments were being run on them. It was without their
consent.

One of the most infamous of these experiments took place in
my own State of Ohio, when scores of patients at the
University of Cincinnati were subjected to large doses of
radiation during experimental treatments, without their
consent, without their informed consent. During the course
of this investigation, I began to ask the question, what
protections are in place to prevent such abuses from
happening again? What law prohibits experimenting on people
without their informed consent?

What I found, when I looked into it, is there is no law on
the books requiring that informed consent be obtained. More
important, I believe there is a need for such a law, as
there continue to be cases where this basic right--I do view
it as a basic right--is abused. As I started out, I would
like to put this on a personal level for everyone of my
colleagues. You just think about your own family, your own
son, your own daughter, or grandchildren who might be, the
next time they go to a doctor, the subject of some medical
experiment that they are not even told about. I do not think
there can be many things more un-American than that.

With the introduction of this bill today I hope to begin the
process of correcting some serious gaps in our legal system.
I want to make clear right now I am not seeking to bring
medical research to a screeching halt. Please do not anybody
at NIH, or anybody doing research throughout this country,
think we are trying to stop that. We are not. That is not my
intent and not the intent of this bill.

This country has the very finest health care system in the
world, in part because of basic research. In fact, in large
part because we have put more effort, more resources, more
of our treasure into health research than any other nation
in this world. In fact, I believe most people are not
opposed to participating themselves in scientific research,
if they are told about the pros and the cons. That is the
goal of this legislation, to make sure that people have the
appropriate information to make an informed choice about
their medical treatment.

Everyone listening today probably has heard of the Nuremberg
Code. That is the list of 10 ethical research principles
which were produced as part of the judgment against Nazi
physicians who engaged in truly heinous medical experiments
during World War II.

The first principle of the Nuremberg Code states that the
voluntary consent of the human subject of research is
absolutely essential. Unfortunately, as we look back through
our history since the late 1940's, it appears that
researchers in America may not have taken all that Nuremberg
lesson completely to heart.

I ask my colleagues what the following names might have in
common: thalidomide, Tuskegee, and Willowbrook?

Well, the answer is that these are all sad examples of
unethical research conducted in the United States, and in
the United States well after the Nuremberg Code was issued,
adopted and worldwide attention had been focused on some of
the abuses of that time during World War II.

Given this history, I find it astounding that even after
Nuremberg, the thalidomide babies, Willowbrook, Tuskegee and
the cold war radiation experiments, and who knows how many
other cases, we still don't have a law on our books
requiring that informed consent--those two words, `informed
consent'--be obtained prior to conducting research on human
subjects.

I have had research conducted on me because of my past
activities before I came to the Senate in the space program
and so on, but I knew what was being looked at, what was
being tried. I knew the objectives of it, and I was willing
to do that. I was happy to do it. But it was informed
consent that I had personally, and I knew what I was getting
into and glad to do it.

I think most people feel the same way. If they know what
they are getting into and they feel there is a good purpose
to it, they are willing to do it. But to do research on
people when they don't even know what the research or the
medicines or

the radiation is that is being tried on them, I think is
unconscionable.

What it comes down to is there are no criminal fines or
penalties for violating the spirit or the letter of that
Nuremberg Code that should be the basis of all of our
informed consent in this country.

In fact, our own Constitution says, `The right of the people
to be secure in their persons . . . shall not be violated.'

So there is no explicit statutory prohibition against
improper research. I must add that just because there is no
law on the books does not mean there are no protections for
people from unethical medical or scientific research.

These tragic incidents I have mentioned have resulted in
changes in the way human research subjects are treated. I
don't want to misrepresent this, because there is a very
elaborate system of protections that have developed over the
years. Unfortunately, though, this system does have some
gaps and, if enacted, I believe this legislation will close
those gaps.

Let me briefly describe the system that is currently in
place.

Regulations governing the protection of human research
subjects were issued by the Department of Health, Education,
and Welfare in 1974 and may be found at part 46 of title 45
of the Code of Federal Regulations.

In 1991, 10 years after a recommendation of a
congressionally chartered Presidential advisory board, 16
other agencies adopted a portion of this rule, a portion of
the rule to apply to research that these agencies sponsored.
And at that point, these regulations became known as the
common rule.

The common rule requires research institutions receiving
Federal support and Federal agencies conducting research to
establish committees, and these are known as--the shorthand
version is IRB's--Institutional Review Boards. Their job is
to review research proposals for risk of harm to human
subjects and to perform other duties to protect human
research subjects.

The common rule also stipulates requirements related to
informed consent, how researchers must inform potential
subjects of the risks to which they, as study participants,
agree to be exposed.

It should also be noted that HHS regulations contain
additional protections not included in the common rule for
research involving vulnerable populations; namely, pregnant
women, fetuses, subjects of in vitro fertilization research,
prisoners and children. No other Federal agency has adopted
these additional protections.

Several mechanisms have been developed by HHS and research
institutions over the years to extend the common-rule
protections to more people. For example, many, but not all,
research institutions which receive some Federal support
voluntarily apply common-rule guidelines to all research
conducted at their institutions.

Additionally, in order to receive approval for a drug or
device from the Food and Drug Administration, a research
institution or pharmaceutical company must comply with the
requirements of the common rule as administered by the FDA.

In addition to the Federal regulations, most professional
medical societies and associations have adopted ethical
codes of conduct regarding research.

The first such ethical code, called the Helsinki Code, was
adopted by the World Medical Association in 1964. So it has
been on the books for a long time. Since that time, other
prominent organizations, like the American Medical
Association, the American Society for Clinical
Investigation, and the American Federation of Clinical
Research have also adopted such ethical codes.

Most recently, in October 1995, the President exhibited, I
believe, strong leadership and established the National
Bioethics Advisory Commission, NBAC. This had been a long
time coming. It had been suggested, but no one had ever gone
ahead and done this, and the President exerted the
leadership and established the NBAC.

Quite simply, the scientific and ethical issues which the
NBAC are supposed to evaluate represent some of the most
important, some of the most complex and controversial
questions of our time. NBAC's input will be critical to
informed policymaking for both the legislative and executive
branches.

The two primary goals of NBAC are to, first, evaluate the
current level of compliance of Federal agencies to the
common rule, and, second, evaluate the common rule and
advise both the executive and legislative branches on any
changes that might be needed to it.

I very strongly support the work of the NBAC but recently
have become extremely concerned to hear that more than 15
months after its establishment, the NBAC is still operating
with a volunteer staff. It was my understanding that a
number of Federal agencies supported the creation of the
NBAC and agreed to back up their support with resources and
staff. Some NBAC members have stated in public meetings that
they are frustrated with the progress the Commission is
making and attribute the slow pace to the lack of resources.
Additionally, the resource problem may be limiting the
number of meetings of the Commission.

Further, if this problem is not resolved in the near term,
the Commission may have to stop meeting altogether. I sent a
letter to the President's science adviser a few days ago,
Dr. John Gibbons, to express my concerns about this. Dr.
Gibbons was working to resolve this funding problem, which I
view as an urgent priority.

I am very glad to announce--as a matter of fact, it was just
today--that these groups in Government that are interested
in this had a meeting under Dr. Gibbons' leadership, and the
$1.6 million that was supposed to accrue from these
different agencies to be used by the NBAC is now
forthcoming. So the NBAC is now funded so they can do the
job they were originally supposed to do.

We are very glad to say that has happened just today, and I
am glad it happened today, just when I am introducing this
bill, because it looks as though we now truly are moving to
support the NBAC that did not receive the kind of monetary
support, the kind of funding that we thought it was going to
have when it was first formed a year and a half ago.

There are a number of existing mechanisms that do protect
human research subjects today. In fact, in March of 1996,
the GAO reported to me that the testing protection system
has reduced the likelihood of serious abuses from occurring.
However, the GAO also pointed out a number of weaknesses and
gaps in the current system.

There are at least four areas, four major gaps.

First, not all agencies have adopted the common rule,
including agencies that currently sponsor research involving
human subjects. The Department of Labor and the Nuclear
Regulatory Commission are examples of agencies that sponsor
such research but those agencies have not adopted the common
rule, which I think they should have.

Second, the common rule's research is voluntarily applied in
many cases. Most institutions which receive Federal funds
will voluntarily apply the common rule to all research
conducted at their institution. However, not all research
institutions adopt this policy. And in any case, if any
improper research is discovered at these institutions, there
are very few steps available to the Federal Government to do
much about it.

Third, a private institution or a researcher who conducts
nonfederally funded research or is not seeking approval of a
drug or device with the FDA does not have to apply the
principles of the common rule to its research. In other
words, there is a huge area of all the private medical
research out there that is not under the common rule unless
they just choose themselves to just voluntarily do it.

Fourth, no Federal agency, other than HHS, has applied the
additional protections described in 45 CFR 46 for vulnerable
populations--pregnant women and their fetus, children,
prisoners--to their own research. So the purpose of this
legislation is to help close the gaps that exist within the
current system for protecting research subjects.

Well, is there really a problem out there?

Is this just a paper loophole that I am trying to close?

Unfortunately, Mr. President, there are ongoing problems
with inappropriate, ethically suspect research on human
subjects. It is difficult to know the extent of such
problems because information is not collected in any formal
manner on human research.

The Cleveland Plain-Dealer in my home State of Ohio has
recently reported in a whole series of articles, after much
investigation of this issue. And I quote from them:

                                [Page: S647]

What the government lacks in hard data about humans, it more
than makes up for with volumes of statistics about
laboratory animals. Wonder how many guinea pigs were used in
U.S. research? The Agriculture Department knows: 333,379.
How many hamsters in Ohio? 2,782.

So we have all this data on animals and little on human
beings. I would hasten to add that the guinea pigs the
Plain-Dealer refers to are the four-legged kind too and not
the guinea pigs that are humans being used for research.

The reason we know so much about the use of animals in
research is that we have laws governing the handling and
treatment of them.

For example, the Animal Welfare Act requires that certain
minimum standards be maintained when using animals in
research.

Let me give you some recent examples which indicate why,
notwithstanding the common rule and the other protections
that are in place, I think additional protections are needed
in statute.

In 1994-95, in an effort to explore the rights and interests
of people currently involved in radiation research conducted
or sponsored by the Federal Government, the Presidential
Advisory Committee on Human Radiation Experiments conducted
an in-depth review of 125 research projects funded by HHS,
DOE, DOD, VA, and NASA. According to the ACHRE report:

Our review suggests that there are significant deficiencies
in some aspects of the current system for the protection of
human subjects.

The ACHRE found that documents provided to IRB's often did
not contain enough information about topics that are central
to the ethics of research involving human subjects. In some
cases the committee found it was difficult to assess the
scientific merit of a protocol based on the documentation
provided.

ACHRE's report states that some consent forms studied by the
committee are--and I quote--

. . . flawed in morally significant respects, not merely
because they are difficult to read but because they are
uninformative or even misleading.

The report states further:

Our review also raises serious concerns about some research
involving children and adults with questionable
decision-making capacity.

And the ACHRE concludes:

All told, the documents of almost half the studies reviewed
by the committee that involved greater than minimal risk [to
the subject] raised serious or moderate concerns.

That is a horrible indictment.

As I mentioned earlier, from December 15 to 18, 1996, the
Cleveland Plain-Dealer published a series of articles
entitled `Drug Trials: Do People Know the Truth About
Experiments.'

And I want to give credit to the people that worked on that.
Keith Epstein, has covered Capitol Hill here and has written
much and done much investigative reporting working on this,
as did Mr. Sloat, S-l-o-a-t, Bill Sloat. Those two fellows
worked on this and did a great job in pointing out some of
the problems that still exist. And we have talked to them
about some of these things.

The Plain-Dealer uncovered a number of disturbing cases,
very disturbing cases as a matter of fact, where people were
either unaware of the fact that they were involved in
research or were not provided full information about
potential side effects of research. The series raises very
serious questions about the adequacy of our current system
of protecting human research subjects.

The Plain-Dealer found, for example, of `4,154 FDA
inspections of researchers testing new drugs on people
[since 1977] . . . more than half the researchers were cited
by FDA inspectors for failing to clearly disclose the
experimental nature of their work.'

Another serious finding in this series is that researchers
who receive the most severe penalty by the FDA, being
designated `Disqualified Investigators,' have little fear of
this fact being found out by their peers or patients. One of
the articles discusses potentially serious problems in the
way research conducted outside of the United States is
incorporated into applications for drug approvals in the
United States.

The Plain-Dealer uncovered much evidence to suggest that the
Federal Government continues to sponsor research where
informed consent is not obtained. And this fact disturbed me
greatly also.

On November 14, 1996, the Wall Street Journal published an
article that examined the practice at one pharmaceutical
firm, Eli Lilly and Co. in using homeless alcoholics in
their clinical trials. The article raises some disturbing
questions about the quality of the phase I trials conducted
by this one company. Also serious ethical questions are
raised concerning the appropriateness of paying homeless
alcoholics significant sums to be human guinea pigs. It is
not clear from the article whether these tests were reviewed
by any IRB.

On December 27, 1996, the New York Times reported on a New
York State appeals court ruling which found that the State's
rules governing psychiatric experiments on children and the
mentally ill were unconstitutional. The court found that the
rules did not adequately protect people who, because of age
or illness, cannot give informed consent to take part in
drug tests or other experiments. The article mentions 10 to
15 of the 400 psychiatric experiments covered by the ruling
as being `privately financed' and therefore outside the
coverage of Federal rules.

How would you like it if your father, mother, son or
daughter, husband, wife was in one of those institutions and
was having experiments conducted on them without your
knowing about it or without them knowing about it? That is
what we are up against.

On August 15, 1994, the New York Times reported on ethical
and legal questions regarding a company's efforts to promote
a drug that can make some children grow taller than they
otherwise would. The drug in question, Protropin, has been
approved by FDA for use in children whose bodies do not make
sufficient quantities of human growth hormone. However, once
approved, doctors may prescribe it for other purposes at
their discretion. In this case the company was apparently
surveying schools for short children and then trying to
funnel those children to doctors who would prescribe the
drug whether or not the children lacked the human growth
hormone. This unapproved research was occurring without the
oversight of an IRB. And at least 15,000 children have taken
this drug.

Another illustration of the precarious coverage of the
common rule occurred in 1995 when it became known that
researchers from the Center for Reproductive Health at the
University of California Irvine, were fertilizing humans and
implanting theses in different mothers without the consent
of the donor. This research was not being funded by any
Federal agency; however, NIH was funding more than $20
million worth of other research at the university. Even
though several internal and external investigations by the
university and the district attorney were being conducted on
this experiment, a clarifying moment occurred when
investigators from OPRR visited UC Irvine early last year.
These investigators reminded university officials of the
common rule;

the fact that the university had agreed to apply it to all
research conducted there--through OPRR's assurance process;
and that NIH was currently funding a good deal of research
at the institution. Within a week of OPRR's visit, the
university took public action to halt the research and
formally investigate the researchers.

On October 10, 1994, the New York Times reported on a New
York doctor who adopted two types of drugs approved by FDA
for cancer treatment and stomach ulcers for an unapproved
use to perform nonsurgical abortions. The article quotes the
doctor saying that in 121 of 126 cases his approach was
successful. The remaining five cases required surgery to
complete the procedure. Because the drugs were FDA approved
and the doctor was not funded or connected to federally
sponsored research, no IRB or approved informed consent
procedures were required. Apparently, each patient signed a
three-page consent form, but this was not approved by an
IRB. According to the Times, once FDA approves a drug,
physicians are generally allowed to use it for off label
purposes.

Now Mr. President, some of the issues discussed in these
articles are problems with how the common rule itself is
being applied. Some of these examples illustrate the gaps in
the common rule coverage. My legislation will address both
the coverage and the application of the common rule.

Now how precisely would the legislation work?

It would require all research facilities to register with
HHS. Registration shall include: First, statement of
principles governing the research facility in its conduct of
human subject research; second, designation of the official
responsible for all human subject; third, designation of
membership roster of IRB(s); and fourth, attestation that
the research facility is complying with the protection
requirements of the common rule.

The legislation includes a grandfather provision for all
research entities which currently have negotiated project
assurances with HHS. The vast majority of research
facilities have such assurances.

The legislation contains a 3-year reregistration
requirement.

The legislation includes criminal penalties for failure to
comply with the act. Therefore, if enacted it would be a
felony offense to experiment on someone without their
informed consent.

The intent therefore of this legislation is twofold: First,
to fill in the gaps of coverage of the common rule by
requiring all research involving human subjects to abide by
the rule; and second, to elevate the importance of
conducting research ethically, the bill provides criminal
fines and penalties for failure to comply with the
requirements of this law, and by extension 45 CFR 46.

Finally Mr. President, my legislation would codify a
recommendation which the

Advisory Committee on Human Radiation Experiments made
regarding the conduct of classified research involving human
subjects.

Specifically, the advisory committee recommended that
informed consent of all human subjects of classified
research be required, and that such requirement not be
subject to waiver or exemption. Under current rule and
executive order, it is possible to waive informed consent
and IRB review for classified research. Title II of this
legislation would prohibit the waiver of either informed
consent or IRB review for classified research.

The advisory committee also recommended that human subjects
of classified research be provided with certain information
regarding that research. My legislation would require that
such subjects be information concerning: First, the identify
of the sponsoring Federal agency; second, a statement that
the research involves classified information; and third, an
unclassified description of the purpose of the research.

Mr. President I have tried today to briefly lay out the case
for the need for the legislation I am introducing. I know
that my colleague from Ohio, Senator DeWine, is also
concerned about the issues I have raised today, and about
those that appeared last month in the Plain Dealer. I
believe that he has requested that the chairman of the Labor
and Human Resources Committee hold hearings on this subject.
I think that is entirely appropriate. And I hope that this
legislation could be considered in that process. I look
forward to working with the Labor Committee in this regard.

I do not claim to have the magic bullet solution with this
bill. However, I believe there are some key principles which
should guide the Senate's consideration of this legislation.
These principles are:

First, informed consent and independent review of
experiments involving human subjects must be required.

Second, anyone who violates the right of research subject to
have informed consent, should be held criminally responsible
for that violation.

I want to put this in personal terms once again. You can
imagine your spouse, husband, wife, father, mother,
children, being experimented on without your knowledge or
their knowledge. That is unconscionable, and we should not
permit that. This legislation will close many of the
loopholes that permit that to happen now.

As the legislative process moves ahead, it is certain that
the bill will undergo scrutiny and amendments. But I think
the outcome, if this legislation is enacted into law, will
be improved protections for all Americans.

Madam President, obviously, I welcome any cosponsors on this
legislation. I will be sending out a `dear colleague' letter
to all the offices, and I hope we get a good response to
that. I think there are very few Senators who will not back
this when they hear what can happen then to them, their
families, and their constituents back home, if we do not
pass something like this.

I think this is many years overdue. I don't want to scare
people to death with this, because I think most of the
research in this country is conducted in a way that is good
and is with informed consent--in most cases. But just the
few examples that I have mentioned here today, as well as
the articles in the Cleveland Plain Dealer and New York
Times I quoted from, indicate there is still a very major
problem in this area and one that we want to close the gaps
on so that no American is subjected to experiments like
this, unless they know exactly what is going on and have
given informed consent.



Office of Human Radiation Experiments home page

This link is the home of the Office of Human Radiation Experiments, where the ACHRE report Senator Glenn refers to can be found.
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