[Congressional Record Volume 143, Number 5 (Wednesday, January 22, 1997)]
[Senate]
[Pages S644-S648]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. AKAKA:
  S. 186. A bill to amend the Energy Policy and Conservation Act with 
respect to purchases from the strategic petroleum reserve by entities 
in the insular areas of the United States, and for other purposes; to 
the Committee on Energy and Natural Resources.


                   the emergency petroleum supply act

  Mr. AKAKA. Mr. President, today I am introducing the Emergency 
Petroleum Supply Act, a bill to ensure that Hawaii has access to the 
strategic petroleum reserve during an oil supply disruption. The 
Emergency Petroleum Supply Act would guarantee Hawaii oil at a fair 
price and give tankers bound for Hawaii priority loading during an 
emergency.
  This legislation passed the Senate in two previous Congresses. During 
the 104th Congress, the Senate Committee on Energy and Natural 
Resources once again approved the bill. Only the inability of the House 
to adopt strategic petroleum reserve reforms has prevented my bill from 
becoming law. I will work aggressively during the 105th Congress to 
enact this measure.
  The objective of the Emergency Petroleum Supply Act can be summarized 
in one word: access. Because of its tremendous distance from the Gulf 
Coast, Hawaii needs guaranteed access to the strategic petroleum 
reserve [SPR], as well as priority access to the SPR loading docks.
  My bill addresses both these concerns. First, it provides a mechanism 
to guarantee an award of SPR oil. Hawaii's energy companies will be 
allowed to submit binding offers for a fixed quantity of oil at a price 
equal to the average of all successful bids. This concept is modeled 
after the Federal Government's method of selling Treasury bills. It 
would give Hawaii ready access to emergency oil supplies at a price 
that is fair to the Government. Without this bill, Hawaii's energy 
companies, and the population they serve, face the risk that their bid 
for SPR oil would be rejected and that oil inventories would run dry.
  The second component of my bill addresses the problem of delay. The 
Emergency Petroleum Supply Act grants Hawaii-bound ships expedited 
access to SPR loading docks. It would be a terrible misfortune if 
deliveries to Hawaii were delayed because the tanker scheduled to carry 
emergency supplies was moored in the Gulf of Mexico, waiting in line 
for access to the SPR loading docks.
  As any grade-school geography student knows, Hawaii is a long way 
from the Gulf of Mexico, especially when you have to transit the Panama 
Canal. The distance between the SPR loading docks and Honolulu, by way 
of the canal, is 7,000 miles--more than one-quarter of the distance 
around the globe.
  But distance alone is not the issue. When you add together the time 
between the decision to draw down the reserve and the time for oil from 
the reserve to reach our shores, the seriousness of the problem 
emerges. It takes time to solicit and accept bids for SPR oil, time to 
locate and position tankers, time for tankers to wait in line to gain 
access to SPR loading docks, and more time to transit the canal to 
Hawaii. Obviously, Hawaii is at the end of a very, very long supply 
line. People overlook the fact that insular areas have a limited supply 
of petroleum products on hand at any time. While Hawaii waited for 
emergency supplies to arrive, oil inventories could run dry and our 
economy could grind to a halt.
  Recently, the Department of Energy asked Hawaii's East-West Center to 
study this problem. The East-West Center report concluded that my SPR 
access measure ``is an excellent proposal which would greatly reassure 
the islands that their basic needs would be maintained.''
  The East-West Center report provides strong justification for 
granting Hawaii special access to SPR oil during an energy emergency. 
The report found that a major oil supply disruption would have a much 
more severe impact on the Pacific islands than on the rest of the 
United States. Although all of Asia would experience some degree of 
inflation and recession, the small economies of the insular areas would 
be virtually unprotected from volatile economic forces. While the rest 
of the United States does not have to rely on ocean transport from 
other nations for essential goods and services, the economies of Hawaii 
and the Pacific islands are heavily dependent on ocean-borne trade and 
foreign visitors.
  The need for this provision is further justified by a December 1993 
Department of Energy/State of Hawaii analysis of Hawaii's energy 
security which found the following:

       Hawaii depends on imported oil for over 92 percent of its 
     energy. This makes Hawaii the most vulnerable State in the 
     Nation to the disruption of its economy and way of life in 
     the event of a disruption of the world oil market or rapid 
     oil price increases.
       Currently, 40 percent of Hawaii's oil comes from Alaska and 
     the remainder from the Asia-Pacific region. The export 
     capabilities of these domestic and foreign sources of supply 
     are projected to decline by approximately 50 percent by the 
     year 2000. This will likely increase Hawaii's dependence on 
     oil reserves of the politically unstable Middle East.
       Hawaii is also vulnerable to possible supply disruptions in 
     the event of a crisis. The long distance from the U.S. 
     Strategic Petroleum Reserve in Louisiana and Texas, combined 
     with a declining number of U.S.-flag tankers capable of 
     transiting the Panama Canal, make timely emergency deliveries 
     problematic.

  Other studies have consistently verified Hawaii's energy 
vulnerability and its need for special access to the SPR. An analysis 
by Mr. Bruce Wilson, an accomplished oil economist, determined that the 
delivery of SPR oil to Hawaii from the Gulf of Mexico could take as 
long as 53 days. That exceeds the State's average commercial working 
inventory by 23 days. As Mr. Wilson's research shows, an oil supply 
disruption is Hawaii's greatest nightmare.
  Some suggest that market forces will ensure that Hawaii and the 
territories receive the oil they need during an energy emergency. 
Unfortunately, these are the same market forces that cause Hawaii's 
consumers to pay 50 percent more per gallon of gasoline than consumers 
pay on the Mainland. When a crisis hits, our energy prices can double 
or triple.
  Hawaii may be the 50th State, but we deserve the same degree of 
energy security that the rest of the Nation enjoys. It's simply a 
matter of equity. Hawaii's tax dollars help fill and maintain the 
reserve; Hawaii should enjoy the energy security the SPR is designed to 
provide.
  My bill will safeguard Hawaii from the harsh economic consequences of 
an oil emergency. The Emergency Petroleum Supply Act is not only good 
energy policy, it's good economic policy for Hawaii.
  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. 186

       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 ``Emergency Petroleum Supply 
     Act''.

     SEC. 2. PURCHASES FROM STRATEGIC PETROLEUM RESERVE BY 
                   ENTITIES IN INSULAR AREAS OF UNITED STATES.

       Section 161 of the Energy Policy and Conservation Act (42 
     U.S.C. 6241) is amended by adding at the end the following:
       ``(j) Purchases From Strategic Petroleum Reserve by 
     Entities in Insular Areas of United States.--
       ``(1) Definitions.--In this subsection:
       ``(A) Binding offer.--The term `binding offer' means a bid 
     submitted by the State of Hawaii for an assured award of a 
     specific quantity of petroleum product, with a price to be 
     calculated pursuant to this Act, that obligates the offeror 
     to take title to the petroleum product without further 
     negotiation or recourse to withdraw the offer.
       ``(B) Category of petroleum product.--The term `category of 
     petroleum product' means a master line item within a notice 
     of sale.

[[Page S645]]

       ``(C) Eligible entity.--The term `eligible entity' means an 
     entity that owns or controls a refinery that is located 
     within the State of Hawaii.
       ``(D) Full tanker load.--The term `full tanker load' means 
     a tanker of approximately 700,000 barrels of capacity, or 
     such lesser tanker capacity as may be designated by the State 
     of Hawaii.
       ``(E) Insular area.--The term `insular area' means the 
     Commonwealth of Puerto Rico, the Commonwealth of the Northern 
     Mariana Islands, the United States Virgin Islands, Guam, 
     American Samoa, the Republic of the Marshall Islands, the 
     Federated States of Micronesia, and the Republic of Palau.
       ``(F) Offering.--The term `offering' means a solicitation 
     for bids for a quantity or quantities of petroleum product 
     from the Strategic Petroleum Reserve as specified in the 
     notice of sale.
       ``(G) Notice of sale.--The term `notice of sale' means the 
     document that announces--
       ``(i) the sale of Strategic Petroleum Reserve products;
       ``(ii) the quantity, characteristics, and location of the 
     petroleum product being sold;
       ``(iii) the delivery period for the sale; and
       ``(iv) the procedures for submitting offers.
       ``(2) In general.--In the case of an offering of a quantity 
     of petroleum product during a drawdown of the Strategic 
     Petroleum Reserve--
       ``(A) the State of Hawaii, in addition to having the 
     opportunity to submit a competitive bid, may--
       ``(i) submit a binding offer, and shall on submission of 
     the offer, be entitled to purchase a category of a petroleum 
     product specified in a notice of sale at a price equal to the 
     volumetrically weighted average of the successful bids made 
     for the remaining quantity of the petroleum product within 
     the category that is the subject of the offering; and
       ``(ii) submit 1 or more alternative offers, for other 
     categories of the petroleum product, that will be binding if 
     no price competitive contract is awarded for the category of 
     petroleum product on which a binding offer is submitted under 
     clause (i); and
       ``(B) at the request of the Governor of the State of 
     Hawaii, a petroleum product purchased by the State of Hawaii 
     at a competitive sale or through a binding offer shall have 
     first preference in scheduling for lifting.
       ``(3) Limitation on quantity.--
       ``(A) In general.--In administering this subsection, in the 
     case of each offering, the Secretary may impose the 
     limitation described in subparagraph (B) or (C) that results 
     in the purchase of the lesser quantity of petroleum product.
       ``(B) Portion of quantity of previous imports.--The 
     Secretary may limit the quantity of a petroleum product that 
     the State of Hawaii may purchase through a binding offer at 
     any offering to \1/12\ of the total quantity of imports of 
     the petroleum product brought into the State during the 
     previous year (or other period determined by the Secretary to 
     be representative).
       ``(C) Percentage of offering.--The Secretary may limit the 
     quantity that may be purchased through binding offers at any 
     offering to 3 percent of the offering.
       ``(4) Adjustments.--
       ``(A) In general.--Notwithstanding any limitation imposed 
     under paragraph (3), in administering this subsection, in the 
     case of each offering, the Secretary shall, at the request of 
     the Governor of the State of Hawaii, or an eligible entity 
     certified under paragraph (7), adjust the quantity to be sold 
     to the State of Hawaii in accordance with this paragraph.
       ``(B) Upward adjustment.--The Secretary shall adjust upward 
     to the next whole number increment of a full tanker load if 
     the quantity to be sold is--
       ``(i) less than 1 full tanker load; or
       ``(ii) greater than or equal to 50 percent of a full tanker 
     load more than a whole number increment of a full tanker 
     load.
       ``(C) Downward adjustment.--The Secretary shall adjust 
     downward to the next whole number increment of a full tanker 
     load if the quantity to be sold is less than 50 percent of a 
     full tanker load more than a whole number increment of a full 
     tanker load.
       ``(5) Delivery to other locations.--The State of Hawaii may 
     enter into an exchange or a processing agreement that 
     requires delivery to other locations, if a petroleum product 
     of similar value or quantity is delivered to the State of 
     Hawaii.
       ``(6) Standard sales provisions.--Except as otherwise 
     provided in this Act, the Secretary may require the State of 
     Hawaii to comply with the standard sales provisions 
     applicable to purchasers of petroleum product at competitive 
     sales.
       ``(7) Eligible entities.--
       ``(A) In general.--Subject to subparagraphs (B) and (C) and 
     notwithstanding any other provision of this paragraph, if the 
     Governor of the State of Hawaii certifies to the Secretary 
     that the State has entered into an agreement with an eligible 
     entity to carry out this Act, the eligible entity may act on 
     behalf of the State of Hawaii to carry out this subsection.
       ``(B) Limitation.--The Governor of the State of Hawaii 
     shall not certify more than 1 eligible entity under this 
     paragraph for each notice of sale.
       ``(C) Barred company.--If the Secretary has notified the 
     Governor of the State of Hawaii that a company has been 
     barred from bidding (either prior to, or at the time that a 
     notice of sale is issued), the Governor shall not certify the 
     company under this paragraph.
       ``(7) Supplies of petroleum products.--At the request of 
     the governor of an insular area, the Secretary shall, for a 
     period not to exceed 180 days following a drawdown of the 
     Strategic Petroleum Reserve, assist the insular area in its 
     efforts to maintain adequate supplies of petroleum products 
     from traditional and non-traditional suppliers.''.

     SEC. 3. REGULATIONS.

       (a) In General.--The Secretary of Energy shall issue such 
     regulations as are necessary to carry out the amendment made 
     by section 2.
       (b) Administrative Procedure.--Regulations issued to carry 
     out the amendment made by section 2 shall not be subject to--
       (1) section 523 of the Energy Policy and Conservation Act 
     (42 U.S.C. 6393); or
       (2) section 501 of the Department of Energy Organization 
     Act (42 U.S.C. 7191).

     SEC. 4. EFFECTIVE DATE.

       The amendment made by section 2 takes effect on the earlier 
     of--
       (1) the date that is 180 days after the date of enactment 
     of this Act; or
       (2) the date that final regulations are issued under 
     section 3.
       By Mr. GLENN:

  S. 193. A bill to provide protections to individuals who are the 
human subject of research; to the Committee on Labor and Human 
Resources.


                 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

[[Page S646]]

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

[[Page S647]]

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:

       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

[[Page S648]]

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.
  Thank you. I yield the floor.
                                 ______