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 I 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 loopholes allow for experimentation when there is no physical intervention or interaction with the subject by an investigator as occurs in remote experimentation and previously reported to this commission by victims; or when the identify of the subject is unknown to the investigator (for example Subject 9,543). 

Also there is no oversight for some non-federal entities such as private corporations and contractors and foreign entities; as well as 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.

Additionally 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 I was 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. After experiencing painful vibrations in my forehead with associated blood in my mucous, vibrations of my organs and more I sought help in the form of testing. 

Test results included materials specifically used in the manufacture of neural dust as researched and developed by the University of California, Berkley. Neural Dust is an ultrasonic low power implantable form of brain-machine interface which as originally designed includes a subdural transceiver, an external transceiver and cmos chips implanted into the cortex.
 

Additionally, an ELF/EMF scan found 20 sites on my body that emit emf emissions beyond normal for the human body and consistent with implants.  Also, the scan showed my body receiving governmental frequencies that were not observed during ambient conditions; my body was acting as a receiver. 

This is only one example of the continued collaboration between United States government agencies and others who receive funding from those agencies. I do not consent nor  have I  knowingly consented to any form of research, experimentation or implantation.

Not everyone can afford to pay for testing nor should we have to.   We need the medical community to evaluate our medical complaints in a scientific manner and not subjectively rule out complaints as mental illness.  We also need an investigation into our complaints of non-consensual research and covert psychological operations.

 

In addition to regulatory changes, 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.

 

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,

Karla Smith