Bioethics Commission comment
The below text is the original content of the petition. It has been changed by MoveOn.ORG; they will not restore the original petition.
I would like to thank this commission for their efforts to recommend ethical protections for human subjects. Much work in the form of regulatory and legislative changes are needed.
Ethical protections for human subjects are essential considering the past history of non-consensual research by United States Military and intelligence agencies in collaboration with educational institutions such as Harvard, John Hopkins, MIT, Princeton, and Stanford; pharmaceutical companies such as Eli Lily; medical schools and hospitals; the American Psychological Association; the National Institutes of Health, the Veterans Administration Center, U.S. Public Health Service and others.
Examples of past non-consensual experimentation include the Tuskegee Syphilis Experiment, The Manhattan Project, The Willowbrook Experiment, and Radiation Experiments.
Mind control experiments such as Project CHATTER, Project BLUEBIRD, Project ARTICHOKE, Project MKULTRA, Project MKSEARCH, Project MKNAOMI and others were often interwoven with radiation experiments and research on chemical and biological weapons. Psychiatrists, psychologists, neurosurgeons and other contractors conducting the work were embedded in a broad network of doctors and some of the research was published in medical journals.
Non-consensual victims of experimentation have experienced covert COINTELPRO type tactics including those used in Project MKDELTA . MKDELTA materials were used for harassment, discrediting, or disabling purposes. These tactics were usually trauma based and devastating to the victims.
As previously reported to this commission in 2011 and continuing to be reported in increasing numbers to this day United States citizens and others are reporting non-consensual experimentation. In 2011 it was reported to this commission that there were approximately 3000 known victims. Four years later those numbers have grown to over 4000 victims, an increase of at least 33%.
Due to past history, previous testimony and statements provided to this commission, and continuing reports of non-consensual research ethical protections for human subjects in the form of regulatory changes are critical.
As we understand Subpart A of the U.S. Department of Health and Human Services' (HHS) regulations, Protection of Human Subjects (codified at 45 C.F.R Part 46), also known as the Common Rule,existing loopholes need to be closed.
For example there is no oversight for some non-federal entities such as private corporations and contractors and foreign entities; and some federal departments and agencies. Oversight is needed for all entities conducting research on American citizens and U.S. persons as well as research conducted on foreign soil.
Loopholes allow for experimentation when the identify of the subject is unknown to the investigator (for example Subject 9,543); or when there is no physical intervention or interaction with the subject by an investigator as occurs in remote experimentation. Also, research activities are permitted for some demonstration and service programs for public benefit; department or agency heads can waive consent in certain cases; institutions can register their own institutional review board (IRB); and IRBs can waive consent in certain instances. There are other loopholes not described here. Additional protections are also needed for children, prisoners and those of impaired consent.
In light of the testimony given in 2011 and existing loopholes in federal regulations we are shocked and dismayed that the only notable recommendation the Bioethics Commission made regarding the consent process is to add people of impaired consent. Ethical protections for human subjects necessitate regulatory changes.
Additionally, criminal penalties must be legislated for research involving human subjects when bodily integrity and autonomy are violated as for other criminals who are routinely punished with convictions for assault, fraud and homicide. Unethical treatment of human beings can only be prosecuted when laws and regulations are in place.
Even if a researcher, physician, institution, other is engaged in socially beneficial research that might lead to cures or treatments for devastating diseases it is imperative that each person's autonomy, self-determination, human dignity and constitutional rights prevail over scientific advancement and social benefit.
We victims of non-consensual research are being tortured in a most unethical and inhumane manner. We experience COINTELPRO type tactics as well as torture. Children are being experimented upon and tortured.
Over fifty years ago American citizens reported being victims of non-consensual human experimentation and reports continue to this day. Over fifty years later we still don't have the necessary reforms to protect U.S. citizens and others from non-consensual research. As a society we must ensure that research subjects possess human rights that are inviolate.
This commission includes members of institutions that have participated in unethical research in the past. This commission does not include a single victim of non-consensual research. They have the insight that only a victim could impart.
Thank you for your efforts to recommend ethical protections for human subjects. Much work still remains to be done.
Sincerely,