Hospitals & Asylums

Human Rats Amendments HA-25-10-09

By Tony J. Sanders

To amend the Protection of Human Research Subjects 45 CFR 46 first passed by the National Research Act signed July 12, 1974. Title II, Public Law 93-348, to rename the legal justification for Institutional Review Boards (IRBs) to Institutional Ethics Committees (IEC), to extend the human research protection of IECs to certify all institutional bio-hazardous and animal laboratory research in their institution against cross-contamination and leak, to require all laboratories possessing, stockpiling and/or using bio-hazardous or pathogenic substances to be certified by their IEC and submit this information and the diseases caused by the pathogens to their regional Poison Control Center, to inform the public the Poison Control Center is statistically prepared to receive calls pertaining to the exposure to malevolently leaked laboratory pathogens that cause diagnosable disease and to link incidence reports with possible laboratory leaks who can be ordered to destroy their stockpiles of bio-hazardous and pathogenic materials, to authorize the Poison Control Centers to periodically inspect all licensed bio-hazardous and animal laboratories and to allow long term awareness of the hazards of biological experimentation under human research protection policy to the Nuremburg Code and the derogation of obligations under the Convention on the Prevention and Punishment of the Crime of Genocide under Art. 6(3) of the International Covenant on Civil and Political Rights.

Be the Democratic and Republican (DR) poison party dissolved, referred to the Office for Human Research Protection and American Association of Poison Control Centers, for publication in the Federal Register and amendment of the Code of Federal Regulations

Art. 1 The Case for Amending National Research Act of 1974

A.The National Research Act of July 12, 1974. Title II, Public Law 93-348 regulates the Protection of Human Research Subjects 45 CFR 46. Under the National Research Act; the Office for Human Research Protection (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP helps ensure this by providing clarification and guidance, developing educational programs and materials, maintaining regulatory oversight, and providing advice on ethical and regulatory issues in biomedical and behavioral research.

1.There are a number of flaws in this statute arising from the same hypocrisy that undermined the CSA and Drug Enforcement Administration (DEA) in the 1970s under the informed consent requirements of Nuremburg Code. First, the law does isolate bio-medical and behavioral research, it instead exempts social research. Second, the term Institutional Review Board (IRB) is hypocritical and in the long run promotes the persecution of innocent civilians engaged in innocent behavior such as marijuana consumption, instead of the university bio-medical researchers leaking large quantities of pathogens into the community for the financial gain of the medical establishment, estate lawyers and the political security of the corrupt regime. Third, there is absolutely no recognition or prohibition of the pathogens and poisons, that give rise to genuine concern for the human research subject. Fourth, by myopically reviewing informed consent used in legitimate research the ethical review boards fails to recognize, prevent, prohibit and punish the leaking of pathogens and poisons from animal laboratories into circulation in the human population. Fifth, the attitude of the law is very permissive and there need to be civil and criminal penalties and a geographic inspection regime for pathogens that compliments the protection of human research subjects. Sixth, analysis of long run policy ramifications is derogated from preventing and punishing the crime of genocide.

Art. 2. Policy Applies to the Isolation of all Bio-medical and Behavioral Research

A. The first section §46.101, to what does this policy apply, must be amended to that the first phrase in paragraph (a) “Except as provided in paragraph (b) of this section” is repealed and “bio-medical and behavioral” inserted before the orphan word “research” so that the first sentence reads, “This policy applies to all bio-medical and behavioral research involving human subjects conducted, supported or otherwise subject to regulation by any federal department or agency which takes appropriate administrative action to make the policy applicable to such research”. The second and third sentences in (a) and (a)(1&2) are also so amended to isolate bio-medical and behavioral research.

1.§46.101(b) pertaining to exemptions is repealed in its entirety and the subsequent paragraphs (c-i) are re-lettered (b-h) and the footnote at the end is stricken whereas the exemptions no longer apply. Whereas this Act extends the application of this policy to legislate cooperation, knowledge exchange, discipline and separation to prevent cross-contamination and conflict of interest between Institutional Ethics Committee (IEC) research and the geographic regulation and inspection of bio-medical research laboratories, primarily animal laboratories, licensed to possess and use pathogens that produce diagnosable diseases in humans, particularly those bio-hazardous laboratories in the same institution; a new paragraph (i) shall state:

(i)Bio-hazardous research involving pathogenic substances, including animal laboratory research, shall be subjected to cross-examination by institutional ethics committees for the Protection of Human Research Subjects to prevent conflict of interest and the cross-contamination of human research programs and to punish accidental and malevolent leaks of dangerous substances into the community brought to their attention. To improve the geographic control of bio-hazardous materials in biomedical research laboratories, and to protect the population against being involuntary research subjects thereto, the national network of Poison Control Centers shall assist the federal government to monitor and periodically inspect all possession and use of pathogenic substances in licensed bio-medical research laboratories in their jurisdiction and make this information available to institutional ethics committees, public health authorities and general public.

2.§46.102 (e) Research subject to regulation must isolate bio-medical research and replace federal department and agency with the Office for Human Research Protection so, “Research subject to regulation, and similar terms are intended to encompass those bio-medical and behavioral research activities for which the Office for Human Research Protection has specific responsibility for regulating as a research activity”. Paragraphs (g-h &j) must be changed so IRB reads “Institutional Ethics Committee (IEC)”. Colloquially ethics is the key word and may be termed ethical review board, institutional ethics committee or other title designating responsibility for Ethics. A paragraph (k) must be added pertaining to bio-hazardous materials, so:

(k) Bio-hazardous materials means any toxic substance, bacteria, virus or disease pathogen capable of causing illness or death in humans, animals or plants, particularly those possessed for use in bio-medical and toxicology laboratory research, that are not intended for human use.

3.§46.103 (b) IRB is changed to IEC. The final sentence at (b)(1) is repealed. Reference to IRBs in (b)(2-5) and (d) are changed to IECs. The first sentence in (f) ends at agency to repeal reference to exempted research. Reference to IRBs in (f) are changed to IECs.

Art. 3 Reservations for the Nuremburg Code

A.§46.104-106 are reserved and to extend human research protection to involuntary research subjects they are amended at 104 to recognize the Nuremburg Code that is fundamental to the regulation of biological experimentation, 105 Poison Control Center bio-hazardous research monitoring and incident reporting, 106 responsibilities of the IEC for animal laboratory and bio-hazardous research at their institutions, as follows:

§46.104 The Nuremburg Code

The Nuremburg Code as reprinted from Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2, pp. 181-182.. Washington, D.C.: U.S. Government Printing Office, 1949, provides:

(a).The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.

(b) The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.

(c) The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.

(d) The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.

(e) The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.

(f) No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.

(g) The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.

(h) Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.

(i) The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.

(j) During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.

(k) During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he or she has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him or her that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

Art. 4 Poison Control Center Bio-hazardous Research Monitoring and Incident Reporting

§46.105 Poison Control Center bio-hazardous research monitoring and incident reporting

(a)Each laboratory engaged in bio-medical research involving the possession and use of bio-hazardous substances or pathogens, intended for, or suspected of, producing diagnosable disease in animals or humans shall, on top of all existing obligations under local, state and federal law, report their possession and planned use of licensed or uncontrolled toxic substances or pathogens, to the regional Poison Control Center.

(1) The Poison Control Center shall require all bio-hazardous research conducted in an institution with a bio-medical IEC to be certified by the IEC and to verify compliance with pertinent local, state and federal regulations pertaining to hazardous material handling and laboratory security.

(2) Poison Control Centers shall periodically inspect the documentation and security of all laboratories licensed to possess and use bio-hazardous substances and pathogens. In their inspections they shall make a determination as to whether or not the usage of the bio-hazardous material or pathogen is suspicious.

(b) Poison Control Centers shall be knowledgeable of the diseases that can be caused by the bio-hazardous research supplies or pathogens under their supervision, facilitate statistical reporting, inform the public that they are now taking reports from people who suspect they are being sickened by the malevolent release of pathogens from bio-medical research laboratories and take incident and death reports from the public.

(1)Poison Control Centers shall detect biological experiments using toxic substances and pathogens without any informed consent. Poison Control Centers shall link reports of illnesses and death suspected to be the result of laboratory leaks to the possessors of the pathogens that could cause such illness, to formulate a credible hypothesis from which laboratory(ies) the pathogen is leaking from, and conduct an investigation of the facility(ies) and their suppliers in co-operation with the IEC.

(c) Upon probable cause the Poison Control Center may order the revocation of any license to possess or use any bio-hazardous substances, and order the destruction of any pathogen possessed by a licensed bio-medical or toxicology research laboratory. Such an order must be reported to the IEC. The Poison Control Center may authorize further administrative, civil and criminal investigation and/or penalties, as needed

Art. 5 IEC Responsibility for Bio-hazardous and Animal Laboratory Research

§46.108 IEC responsibility for bio-hazardous and animal laboratory research

(a)The IEC shall certify all bio-medical and chemical laboratories in their institution possessing bio-hazardous materials and/or conducting toxic animal laboratory research.

(1)IEC certification shall be in addition to any other approval system for bio-hazardous or animal laboratory research in effect in the institution, local, state or federal law.

(2) IEC certification is intended to serve as an extra ethical safeguard against the risk of grave violations of informed consent requirements posed by bio-hazardous and animal laboratory research.

(b) The IEC shall inform toxic researchers:

(1)There is an ethical responsibility to prevent the harmful leaking of bio-hazardous substances and pathogens, no informed person would consent to be exposed to, from containment within their approved experimental research laboratories.

(2) They are obligated under this policy to have all possession and use of bio-hazardous substances and pathogens certified by the IEC for the benefit of the Poison Control Center.

(3) That other human research monitored by the IEC must not be cross-contaminated and that the IEC has an isolated responsibility to be fully informed of institutional bio-hazards posed by toxic and animal laboratory research and may occasionally take formal action to eliminate a perceived threat.

(4) That the IEC is available for consultation on ethical issues.

(1) The IEC finds animal cruelty is not justified by medical need.

(2) The possession of bio-hazardous or pathogenic substances is not justified by experimental needs and can be easily replaced if needed or there is an ethical concern with the supplier.

(3) There is an irregularity in the documentation or bio-hazardous materials are unaccounted for.

(4) If the laboratory or staff are subjected to administrative or legal proceedings.

(d) Of their own accord, upon probable cause, an IEC may refuse to certify the purchase or acquisition of bio-hazardous or pathogenic materials for an experiment. The IEC may also order a laboratory to destroy their stockpiles of a bio-hazardous substance or pathogen and/or terminate an ongoing experiment.

Art. 6 Institutional Ethical Commitment (IEC) to Quitting IRB

A.§46.107 IRB Membership is amended so it read, “IEC Membership”. Reference to IRBs in paragraphs (a-f) are amended to IEC.§46.108 IRB Functions and Operations is amended to “IEC Functions and Operations” both references to IRB are changed to IEC.§46.109 IRB review of research is changed to “IEC review of research”. All references to IRBs in (a-e) are changed to IEC. §46.110 must be amended at (a) so after HHS, it is inserted “or successor organization,” all subsequent reference to IRBs in (b-d) must be changed to IEC.

1.§46.111 Criteria for IRB approval of research is amended so it reads, “Criteria for IEC approval of research”. References to IRB in (a)(2&3) shall be changed to IEC. At (a)(2) the final sentence whereby, “the IEC should not consider the possible long-range effects of applying knowledge gained in research (for example the possible effects of the research on public policy) as among the research risks that all within the purvey of its responsibility” should be amended so, “the IEC should not consider the possible long-range effects of applying knowledge gained in research (for example the possible effects of the research on public policy) in any light but whether the effects of the research might derogate obligations under the Convention on the Prevention and Punishment of the Crime of Genocide of 9 December 1948 in contravention to Art. 6(3) of the International Covenant on Civil and Political Rights of 16 December 1966”. At (a)(3) the term cognizant of should be changed to “concerned for” and after the list of vulnerable people insert, “prepared to discipline researchers for discrimination and abuse”. At the end of (b) insert “and prevent and punish the misconduct of researchers”.

2.§46.112 both references to IRBs are changed to IECs. §46.113 Suspension or termination of IRB approval of research is amended to “Suspension or termination of IEC approval of research” and all three references to IRBs are changed to IECs. §46.114 reference to IRB is changed to IEC and at the end of the second sentence is inserted, “and all applicable laws”/. §46.115 IRB records is changed to “IEC Records”, reference to IRBs in (a)(2)(4-6) is changed to IEC. §46.116 reference to IRB at (c&d) is changed to IEC. §46.117 reference to IRB in (a)(b)(2) and (c) is changed to IEC. §46.118 Applications and proposals lacking definitive plans for the involvement of human subjects is amended to repeal everything after sentence two and append in its stead, “These application must be reviewed by an IEC before an award may be made”. §46.119 IRB is changed to IEC.

3. §46.201 the first phrase in (a) is repealed and bio-medical is inserted so (a) begins, “This subpart applies to all bio-medical research involving pregnant women, human fetuses and neonates of uncertain viability, or nonviable neonates…”. (b) is repealed and (c) and (d) are relettered (b) and (c) respectively. (c) now (b) is amended and the provisions of §46.101(b-i) are applicable, the reference in the second sentence is change to §46.101(e). The title of §46.203 is changed so it reads, “Duties of IECs in connection with research involving pregnant women, fetuses, and neonates” and the two references to IRBs are changed to IEC. §46.205 at (b)(1) IRB is changed to IEC. §46.207 and (a) IRB is changed to IEC.

4. §46.304 Composition of Institutional Review Boards where prisoners are involved is amended to “Composition of IECs where prisoners are involved” and other reference is changed to IEC. §46.305 Additional duties of the Institutional Review Boards where prisoners are involved is changed to “Additional duties of the IECs where prisoners are involved” and reference at (a) is changed to IEC. §46.306 at both (a)(1) and (2)(iv) Institutional Review Board is changed to IEC. §46.401(a)(2) that allows the Secretary to waive requirement or research involving children is repealed (b) and (c) pertaining to exemptions are also repealed, bio-medical and behavioral research is inserted in (a) so it reads, “This subpart applies to all bio-medical and behavioral research involving children as subjects, conducted or supported by the Department of Health and Human Services”. §46.403 IRB duties is changed to IEC duties and both references to IRB are changed to IEC. §46.404 two reference to IRB are changed to IEC. §46.405 two references to IRB are changed to IEC. §46.406 two references to IRB are changed to IEC. §46.407 reference to IRB in beginning and at (a) are changed to IEC. §46.408 7 references to IRB in (a) 2 in (b) 1 in (c) 1 in (e) are changed to IEC. §46.409 two references to IRB at (b) are changed to IEC.

Art. 7 Federal Responsibilities for Grave Breeches of Human Research Protection

§46..121 Federal Responsibilities for Grave Breeches of Human Research Protection

(a) People reporting grave breeches of human research protection shall be treated confidentially, to protect their identity until such a time when their ethical and legal research has been purchased and it is determined to be safe and in their best interest to disclose. The federal government must not delay paying a nominal fee to the alleged victim(s) for the privilege of investigating and more if the damages are corroborated under Art. 14 of the Convention against Torture and other Cruel, Inhuman and Degrading Treatment or Punishment of 10 December 1984.

(1) Grave breeches of Human Research Protection shall include intentional and unintentional torture, killing, fraud and abuse.

(b) The overall significance of this section is that human research subjects, victims of biomedical experimentation and independent ethical and legal researchers are entitled to a share of the federal research grant(s) that they sue. For their part, the federal government shall assure that research grants are disbursed equitably to the ethical adversaries and victims of biomedical and behavioral research to facilitate the cross-examination and termination of dangerous experiments as well as the government wide debarment and punishment of unethical researchers.

Art. 8 Ongoing Ethical Concerns

A.While there continue to be ethical concerns regarding the wisdom of human research protection policy these amendments greatly improve human research protection in the United States. The continuing concerns are: (1) Should behavioral research continue to be exposed to the danger of cross-contamination with bio-medical research? (2) Is the language too permissive of research, harmful to the patient, that might benefit medical science? (3) Are the informed consent loopholes in research involving children abused? (4) Is additional protection needed on animal laboratory and bio-hazardous research?