President Clinton is the only President 'on the books' who tried to specifically address TI's related issue, namely his March 27, 1997 Memorandum/ Administrative Order, “Strengthened Protections for Human Subjects of Classified Human Research”, [Federal Registger, May 13, 1997, pp. 26367-26372], which attempt to institute a government-wide Ban on Non-Consensual U.S. Classified Human Research, appears at: http://fas.org/sgp/clinton/humexp.html .
His March 27, 1997 administrative order adopted a major Recommendation of a blue-ribbon panel of Government Experts [ACHRE].
Kenneth Feinberg was on that Committee. [He later was Head Arbitrator/Mediator for the Sept. 11, 2001 Terror Victims fund, and also the Gulf of Mexico oil spill, from the April 2010 Deepwater Horizon Oil rig Spill ].
Jonathan Moreno was among the Staff Researchers [a Senior Policy and Research Analyst], and wrote some books mentioning inadequate legal protections from classified human research.
The October 1995 final Report of the federal Advisory Committee on Human Radiations Experiments [ACHRE], which is cited in each of: Senator Glenn’s S.193 (105th U.S. Congress), and, President Clinton’s March 27, 1997 Administrative Order;, including Recommendation 15 (which includes their recommending “the adoption of a federal policy requiring the informed consent of all human subjects of classified research and that this requirement not be subject to exemption or waiver”), appears at:
https://ehss.energy.gov/ohre/roadmap/achre/report.html , with Recommendation 15 appearing at:
in Summer 2015 U.S. Dept. of Energy made a legal finding that Clinton's Administrative Order was (then) still of legal effect.
A U.S. Dept. of Energy Memo also stated that the Clinton Memo ordered policy changes were on the 'to do list' for OHRP - HHS Office of Human Subjects Protections, which coordinates, but which DOES NOT dictate, changes in federal policy, concerning Human Subject Protections.
In November 2019, the U.S. Dept. of Energy adopted the Clinton Memo requirements, through Agency Policy Directives [but not in C.F.R. - Code of Federal Regulations], which it had begun to adopt through Directives in January 2016. [ https://fas.org/sgp/othergov/doe/n443.1.pdf ]
On January 19, 2017, the 'Revised Common Rule' revision of the Federal Policy for the Protection of Human Subjects was issued. It was the 1st major revision of the Federal Policy for Protection of Human Subjects in 25 years, since the Common Rule joint-policy was first adopted in June 1991.
The revised Policy followed 2 Public Comment periods, in 2011, and 2015(-Jan. 6, 2016), during which victims participated [about 25, and 99, Public Comments, respectively, from about 80 - 85 unique victims (or victim spouses) total].
In issuing the New Policy, U.S. Government conducted what amounts to a Criminal Manipulation or Abuse of the federal rulemaking process, when they gifted to themselves a Grandfather Clause, in the Revised Common Rule (of January 19, 2017), whereby Ongoing Human Research projects or even previously approval proposals (in the possible absence of any actual research or any actual human subjects yet enrolled!), before January 19, 2019, for which a U.S. Department or Agency Head granted a Waiver of all or part of the Common Rule, including Informed Consent [that is, where Informed Consent was among the parts of the Common Rule which were Waived], could continue INDEFINITELY [potentially 'forever', that is, potentially - heaven forbid! - for the lifetime of the Non-Consenting Victim/Human Subject, under the original Common Rule.
This Grandfather Clause violated the normal requirements of federal rulemaking, because it was not proposed in the original proposed rule [the NPRM - Notice of Proposed Rulemaking - of September 8, 2015], and it can in no way be contemplated or reasonably be 'reached' by any proposal or statement in the NPRM.
Enacting that 'Grandfather Clause' was/is a regressive action, and it is contradictory to the proposed NPRM, in that:
- the purpose of this particular federal rulemaking, as explicitly stated in the NRPM, as well as in the preceding July 26, 2011 ANPRM - Advance Notice of Proposed Rulemaking, was:
"to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators".; and,
- one of the most major improvement in the Protection of Human Subjects as contained in the NRPM, was imposing a '1st time ever' restriction of Agency/Department Head Waivers of all or part of the Common Rule, at Common Rule part 45 CFR 46 101(i), whereby any Waivers under the Revised Common Rule would be restricted such that:
"the alternative procedures to be followed [must be] consistent with the principles of the Belmont Report." and
"The waiver notice must include a statement that identifies the conditions under which the waiver will be applied and a justification as to why the waiver is appropriate for the research, including how the decision is consistent with the principles of the Belmont Report."
For the U.S. Government to enact this Grandfather Clause is like saying: 'we had proposed restrictions upon Waivers because the original Waiver clause (.101(i)) enabled an absence of accepted Human Subjects Protections standards'. 'However, the Final Rule has adopted apathy toward the rights and well being of Human Subjects of Ongoing Human Research Projects [including Non-consensual human research] which are being conducted under the original Waiver Clause, and the Final Rule has decided that such un-protective research may go on and on, even indefinitely (for months, or years, or decades).'
[ The (three) explicitly enumerated basic ethical principles of the Belmont Report are: Autonomy [and Respect for Persons]; Beneficence ['do no harm']; and, Justice [equitable distribution of the burdens and benefits of the human research].
Informed Consent in incontrovertibly required by the 1st basic ethical principle of the Belmont Report [respect for the Autonomy of persons].
Also: Any significant denial of the liberty or the security of one's person is a denial of Beneficence - the enjoyment of liberty and the security of one's person are among the most basic 'good things in life' [that is, 'one's body is one's own, and each human being has a right to feel unencumbered by physical impositions upon their body].
Justice - in the sense described in the Belmont Report - is denied by any research which condemns any individual human being, or group of human beings, to being society's 'designated sufferers, month after month, or [heaven forbid!!] year after year, of a particular research intervention, upon their physical human body (or brain), in an effort to acquire scientific data or scientific knowledge'.
After a 1 year delay, the Revised Common Rule went into full after on January 19, 2019 [over 1 and 1/2 years ago].
We victims have been told by multiple lawyers who are experienced in having conducted federal rulemaking challenges, that we victims have a high likelihood of having a Court hold that the Grandfather Clause is illegal. And we also have some likelihood that we could obtain a favorable ruling about the Revised Common Rule or any Common Rule being Unconstitutional if it allows or encourages federal-jurisdiction Non-Consensual Human Research involving physical interventions [including electromagnetic weapon, or any means] upon the physical human body of Human Subjects without providing Notice and Procedural Due Process, as are required by the 5th Amendment, and the 4th Amendment, to the [our] U.S. Constitution.
Estimated cost: about $30,000 - $40,000+ for an experienced lawfirm to (Research and Develop and) file a federal rulemaking challenge, and perhaps some follow-up to the filing of the Complaint to federal Court [probably the D.C. Circuit].
Individu yang Disasarkan
Cá nhân được nhắm mục tiêu
లక్ష్యంగా ఉన్న వ్యక్తి
ඉලක්කගත තනි පුද්ගලයෙකි