I've attached the _lengthy_ comments by Glenn from the Congressional
Record, on his introduction of S.193.  Sorry if this is overkill, but I
thought the comments were very interesting.

sheri alpert

==============================================

---------------------------------------------------------------

CONGRESSIONAL RECORD
Statements on Introduced Bills and Joint Resolutions (Senate
- January 22, 1997)

[P:  S646]

 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 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:

[p. 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.

   Thank you. I yield the floor.