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No human research protection exists for Targeted Individuals subjected to secret torturous experiments, whether an adult in Guantanamo Bay or a child in the reader’s neighborhood. Evidence is emerging that the US government is secretly conducting such research on millions of people, committing similar atrocities American soldiers fought and died against Hitler and Nazi Germany for committing.
Congress voted against The Human Research Subject Protection Act of 1997, that the late Senator John Glenn introduced. Since then, human research subjects’ complaints to the White House — such as those by James Walbert; Lisa Becker testifying to President Barack Obama’s Bioethical Study Commission (in the video below); literally thousands of other Americans involved in those Bioethical forums in Washington DC; and even more suffering alone — continue to be systematically dismissed. This crime against humanity is approved by America’s highest government officials.
The following excerpt is from Congressional Record, January 22, 1997, Page S645statements that the late astronaut and Sen. John Glenn presented to introduce his Human Research Subject Protection Act, that Congress refused to pass. (Alliance for Human Research Protection, under leadership of Vera Sharav)
THE CONGRESSIONAL RECORD
January 22, 1997
Statements on Introduced Bills and Joint Resolutions
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.
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. …[end excerpt]
ALLIANCE FOR HUMAN RESEARCH PROTECTION
The Alliance for Human Research Protection (AHRP) is a national network of lay people and professionals dedicated to advancing responsible and ethical medical research practices, to minimizing risks associated with such endeavors, and to ensuring human rights, dignity and welfare of human subjects are protected.
Medical research is not standard medical care: research involves uncertainty and, therefore, risk. Treatment is determined by a protocol seeking to resolve uncertainty and contribute to generalizable knowledge—not necessarily best interest of the individual subject. AHRP recommends 5 Essential Safeguards for ALL human subjects in clinical trials.
Informed consent should never be abrogated for any research involving human subjects, under any circumstances, in any country, regardless of local standards and type of research.
Human subjects enrolled in research will always be subjected to some degree of risk; at a minimum, they might receive a placebo or less effective treatment than standard care. In worst cases, subjects might be irrevocably harmed and even die due to the treatment being tested or experimental procedures used. Patients volunteering to be human subjects must be fully informed about all foreseeable risks—including risks associated with randomization.
Whenever protocols involve invasive interventions—whether to test a new treatment or a treatment used in some form in standard care—the foreseeable risks must be fully disclosed—regardless of whether the research is defined as “comparative effectiveness research” or any other classification of research.
There are currently no mandatory licensure requirements for researchers conducting research on human subjects. AHRP recommends that physicians who conduct medical research involving human beings should be required to undergo rigorous training on how to minimize risks and demonstrate proficiency in ethical and clinical standards, BEFORE licensed to conduct medical experiments in human beings.
AHRP recommends that all clinical trials must include a standard of care comparator arm, to ensure safety of the subjects, and to avoid adopting practices that fail to improve the current standard of care—and may even worsen it.