[Congressional Record Volume 148, Number 129 (Friday, October 4, 2002)]
[Senate]
[Pages S9993-S9994]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. BAUCUS:

[[Page S9993]]

  S. 3059. A bill to provide for the distribution of judgment funds to 
the Assiniboine and Sioux Tribes of the Fort Peck Reservation; to the 
Committee on Indian Affairs.
  Mr. BAUCUS. Mr. President, I rise today to introduce a bill to 
provide for the use and distribution of judgment funds awarded to the 
Assiniboine and Sioux Tribes of the Fort Peck Reservation in northeast 
Montana.
  In 1987, the Assiniboine and Sioux Tribes of the Fort Peck 
Reservation brought suit against the United States to recover interest 
earned on their trust funds while those funds were in Special Deposit 
and IMPL-Agency accounts. The case was filed in the United States 
Claims court, and docketed as No. 773-87-L.
  After the Court ruled that the United States was liable to the Fort 
Peck Tribes and individual Indians for interest on those funds, the 
Tribes and the United States reached an agreement for settling claims 
in the case, for the sum of $4,522,551.84. The court approved the 
settlement agreement.
  The settlement agreement further provided that the judgment be 
divided between the Fort Peck Tribes and those individual Indians who 
are found to be eligible to share in the judgment. On January 31, 2001, 
the court approved a stipulation between the parties that defined the 
procedures by which the Fort Peck Tribes' and individual Indians' 
respective shares in the judgment would be determined and distributed 
to them.
  Pursuant to the Court-approved stipulation in the case, on February 
14, 2001, a portion of the Tribe's share of the judgment was deposited 
into an account in Treasury for the use of the Fort Peck Tribes. As 
provided by the Court-approved stipulation, those funds are to be 
available for immediate use by the Tribe pursuant to a plan adopted 
under the Indian Tribal Judgment Funds Use or Distribution Act, 25 
U.S.C. 1401 et seq. The Court-approved stipulation further recognized 
that the Tribe will most likely receive additional payments from this 
settlement once the work identifying all individuals eligible to share 
in the judgment is completed and the pro rata shares are finally 
computed. Those funds, too, are to be available for use by the Tribe in 
accord with a plan adopted under the Tribal Judgment Funds Use or 
Distribution Act.
  As required by the stipulation and the Tribal Judgment Funds Use or 
Distribution Act, the Tribe developed a plan for the use of the Tribe's 
share of the settlement. Under the plan, the Tribe's share of the 
judgment will be used for tribal health, education, housing and social 
services program.
  The Tribe submitted its plan to the Department of the Interior for 
review and approval. Public hearings were held during which the views 
and recommendations of Tribal members were heard regarding the plan. 
The Tribe has been advised that the Department of Interior has no 
objection to the Tribe's plan and can approve it. However, although the 
plan was developed and public hearing held during 2001, the Interior 
Department did not complete its review of the plan, nor submit the 
approved plan to Congress within the one-year deadline imposed by the 
Tribal Judgment Funds Use or Distribution Act. As a result, in order 
for the Fort Peck Tribe to make use of the judgment awarded to the 
Tribe, it is necessary for Congress to formally adopt legislation 
approving the Tribe's plan. The proposed bill language, would serve 
this purpose.
  This judgment is based on money that rightfully belongs to the Fort 
Peck tribes and should be moved expeditiously through Congress. I look 
forward to working with the Committee on Indian Affairs to move this 
legislation forward.
                                 ______
                                 
      By Mr. KENNEDY:
  S. 3060. A bill to amend the Public Health Service Act to provide 
protections for human participants in research; to the Committee on 
Health, Education, Labor, and Pensions.
  Mr. KENNEDY. Mr. President, today I am introducing legislation to 
achieve reforms in our system of oversight for protecting the safety of 
human subjects in research. As the Institute of Medicine report 
released today again demonstrates, reforms are long overdue. The moment 
has come to take action to restore the trust and confidence of those 
who serve as subjects in clinical trials and other forms of research.
  We passed the National Research Act over twenty years ago as an 
important step toward protecting against inhuman research experiments 
and conditions. We have developed guidelines to ensure that people 
participating in medical research have clearly agreed to be a part of 
the study and will be treated humanely during the study.
  These protections benefit the people participating as subjects in 
medical research, but they also help those conducting the research. If 
patients fear that they will not be protected or that the researchers 
do not have their best interests in mind, patients will not volunteer 
to take part in these needed tests.
  As we all know, a revolution is taking place in medicine today. 
Scientists have mapped the human genome. They have made incredible 
breakthroughs in treatments for cancer and AIDS. It is not unreasonable 
to expect that we will see cancer cured, a quadriplegic stand up and 
walk, new drugs that prevent Alzheimer's and AIDS, and other advances 
we cannot even begin to imagine. But for all these advances to take 
place, new treatments will first have to be tested on human subjects. 
For these studies to succeed, patients must have confidence in our 
system and must be willing to participate in medical research. We must 
protect patients when they volunteer for these tests. To do otherwise 
would jeopardize this very hopeful future.
  Many of those who participate in these studies are the most 
vulnerable members of our society and are the most in need of our 
protection. We are now benefiting from drugs that have been developed 
and tested outside the United States. Our country is based on the 
premise that all people are created equal. Basic protections that are 
good enough for research subjects in the United States should be good 
enough for research subjects in other nations who volunteer for tests 
that will benefit all of us.
  We also must face the fact that medical research is constantly 
changing. Protections that were put in place 20 years ago no longer 
cover all human research projects. New studies in areas such as gene 
therapy have raised safety and ethical concerns requiring special 
scrutiny.
  Institutional Review Boards, which review the safety and ethical 
acceptability of research involving human subjects, are overworked and 
underfunded. Loopholes in the system allow researchers who have had 
proposals rejected by one Board to reapply to a second Board in the 
hope of obtaining a more lenient review--all without notifying the 
second Board of the decision of the first. We do little to train 
researchers about methods for protecting human subjects. Many 
researchers with the best intentions are not knowledgeable of the 
latest changes to regulations.
  These shortcomings cry out for a response, especially at this moment 
in history that holds so much promise for future medical research. The 
legislation I am introducing addresses these issues by expanding 
research subject protections and strengthening the review and oversight 
mechanisms to ensure that all human subjects are properly protected.
  The legislation will, for the first time, ensure that all 
participants in such research are protected by a comprehensive and 
strong set of safeguards. The legislation provides clear statutory 
authorization for these protections and establishes a central office to 
review and amend current rules for the protections.
  The legislation will improve Institutional Review Boards by 
strengthening firewalls against conflicts of interest and enhancing 
training for Board members. The bill will provide the Boards with the 
funding they need to be effective, by allowing human subject protection 
costs to be charged as direct costs on federal grants. The bill will 
end ``IRB shopping'', the practice in which a proposal rejected by one 
Board for ethical reasons is submitted to a second Board in the hope of 
obtaining a more lenient review. The legislation will require that 
every Board receives accreditation to assure that it is carrying out 
its duties effectively and rigorously.
  The legislation will assist researchers in learning more about the 
best practices for protecting human subjects, by creating programs to 
improve

[[Page S9994]]

training for researchers in good research practices. The bill 
strengthens the firewalls against financial conflicts of interest for 
researchers, and will require the establishment of regulations to 
govern payment of research subjects.
  The legislation will also enhance the ethical review of clinical 
trials conducted overseas with federal funding or submitted to FDA for 
review, by requiring that research conducted overseas that falls within 
U.S. regulatory jurisdiction must be reviewed and approved by a U.S. 
Institutional Review Board. The bill enhances the review of areas of 
research that raise special safety concerns, such as gene therapy and 
xenotransplantation.
  We must act now to improve our protections for human research 
subjects, so that patients will feel confident enough to volunteer for 
the many vital research projects that will be developed in coming 
years. These reforms will have a significant role in improving medical 
care. But even more important, these safeguards will protect our fellow 
human beings. The people this bill protects are not numbers of 
statistics. They are someone's mother, daughter, or spouse. Mistakes 
and abuses that hurt them affect their families, friends, and 
communities.
  We are a great people and a great nation. We are a moral people and 
an ethical nation. We must do all we can to see that our great medical 
advances of the future do not come at an unnecessary cost of death and 
suffering by patients who first volunteered to test these new medical 
treatments. I look forward to working with my colleagues to enact these 
needed reforms as soon as possible.
  I ask unanimous consent that a section-by-section analysis of the 
bill be printed in the Record.
  There being no objection, the analysis was ordered to be printed in 
the Record, as follows:

                    The Research Revitalization Act

       The current oversight system for protecting human subjects 
     is overdue for reform. Rules for research subject protection 
     do not cover all research. Protections for research subjects 
     are largely based on regulation rather than statute. There is 
     no Federal lead agency charged with amending and issuing 
     guidance on the rules for research subject protections, 
     resulting in an often confusing set of divergent regulations 
     across different Federal research agencies. In addition, 
     since no single agency can amend the research rules, the 
     rules themselves have not been updated in years and have not 
     kept pace with the changing nature of research. To address 
     these problems, the bill will: 1. Ensure that all human 
     subjects in all research are covered by strong protections. 
     2. Provide a clear statutory authorization for research 
     subject protections. 3. Establish a central office to amend 
     the rules for research subject protection.
       Institutional Review Boards, IRBs are committees at 
     universities and hospitals that review the safety and ethical 
     acceptability of research involving human subjects. The IRB 
     system is under severe strain for several reasons. First, 
     IRBs are overworked and underfunded. Second, IRBs vary widely 
     in their training and effectiveness. Third, conflicts of 
     interest threaten the integrity or research. Fourth, 
     investigators can engage in ``IRB shopping'' whereby a 
     proposal rejected by one IRB for ethical reasons can be 
     submitted to a second board in the hope of a more lenient 
     review all without notifying the second IRB of the decision 
     of the first. To address these problems the bill will: 1. 
     Require accreditation of all IRBs to ensure that they do 
     their jobs adequately. To be accredited, IRBs would not only 
     have to review proposals to conduct research, but also 
     monitor such research once it is initiated. 2. End ``IRB 
     shopping'' by requiring notification of previous proposal 
     rejection. 3. Establish rules for financial conflict of 
     interest for IRB members. 4. Allow IRB expenses to be charged 
     as direct costs on Federal grants, so that universities can 
     give IRBs the resources they need to do their job. 5. Allow, 
     on a voluntary basis, a central IRB to review projects 
     conducted a multiple local research sites to provide for more 
     effective and efficient review.
       Investigators conducting human subject research are often 
     poorly trained in protecting human subjects. As revealed by 
     the controversies surrounding gene therapy, financial 
     conflicts of interest can often compromise the objectivity or 
     researchers. Finally, payment of research subjects is 
     becoming common, but few standards have been established to 
     govern when and how a subject can or should be compensated. 
     To address these problems, the bill will: 1. Require HHS to 
     establish a model program to train researchers in good 
     research practices and then provide grants to allow 
     universities to establish similar programs. 2. Strengthen 
     current rules on financial conflict of interest for 
     researchers. Numerous studies have shown that the existing 
     system does a poor job in protecting against conflict of 
     interest. The proposal follows recent recommendations by the 
     AAMC. 3. Establish standards to govern payments to research 
     subjects.
       Research projects involving human subjects that use federal 
     funds or support a submission to the FDA are subject to US 
     regulations even when conducted overseas. When conducted on 
     poorly educated and/or impoverished populations in nations 
     with weak local oversight, such research raises special 
     ethical concerns. First, subjects may not be adequately 
     protected when an ethical review is conduced in a country 
     without a strong infrastructure for research subject 
     protection. Second, there are significant ethical concerns 
     about conducting high-risk research on local populations who 
     will never receive the benefits of the products being tested 
     on them. Third, some subjects receive placebos or non-
     treatment, even when effective treatments are available and 
     could be given to patients. The bill will: 1. Require review 
     by a US-accredited IRB of all human subject research 
     conducted overseas that falls within US regulatory 
     jurisdiction. This requirement would be waived where 
     standards of review are equivalent to those in the US, e.g. 
     EU, Australia, Canada. 2. Require rules governing the use of 
     placebos or non-treatment when effective therapies could be 
     administered to research subjects.
       Certain areas of research, such as gene therapy or 
     xenotransplantation, raise unusual safety concerns. NBAC has 
     recommended special scrutiny for such areas, beyond simple 
     IRB review. The bill will require special monitoring of 
     adverse events in clinical trials of such research so that 
     threats to patient safety can be identified.
                                 ______