AHRP Comments Re: EPA Proposed Rule for Human Pesticide Research
Wed, 30 Nov 2005
Help us stop a proposed government policy that would lead to the proliferation of unthinkable human pesticide experiments such as the infamous CHEERS experiment.
CHEERS was designed to expose toddlers to pesticides so that EPA investigators could record the effects of the poisonous substance on the children’s health.
The EPA failed to convince anyone that CHEERS was a permissible human experiment: it: was terminated following Congressional intervention.
EPA’s Propsed Rule is an effort to legitimize experiments like CHEERS and to permit disabled infants, children, pregnant women, not to mention, adults – to be exposed to unethical experiments testing hazardous toxic substances.
EPA’s pronouncement that the agency would “categorically prohibit…any study involving intentional dosing of pregnant women, fetuses, or newborns,” is a false and deceptive statement. Because EPA’s proposal includes an escape hatch from ALL regulatory protections for human subjects of research under EPA jurisdiction.
If you think we are mistaken, See EPA’s Proposed Rule, Section 26.603– Exception for Human Research http://www.epa.gov/fedrgstr/EPA-GENERAL/2005/September/Day-12/g18010.htm
The AHRP comments (below) address only some of the proposed regulatory loopholes. An example that others may want to comment on is section 26. 601, which reads:
“Unless there is clear evidence that the conduct of that research was fundamentally unethical (e.g., the research was intended to seriously harm participants or failed to obtain informed consent), or was significantly deficient relative to the ethical standards prevailing at the time the research was conducted, EPA will generally accept and rely on relevant, scientifically valid dataŠ”
Help us stop a morally depraved policy from being enacted.
Sound the alarm wherever you can–tell your neighbors send your comments against the EPA Proposal either by e-mail to: firstname.lastname@example.org–be sure to include– Docket ID # OPP2003-0132 [*]
or sign an ACTION letter prepared by Public Employees for Environmental Responsibility (PEER): http://www.demaction.org/dia/organizations/PEER/campaign.jsp?campaign_KEY=1282&t=send-a-letter.dwt
Send a letter and stay tuned AHRP will provide updates as they occur–
Together with other advocates we were instrumental in stopping CHEERS– with your help we will stop this travesty.
Contact: Vera Hassner Sharav
To: President George W. Bush (email@example.com)
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Promoting Openness, Full Disclosure, and Accountability
EPA Proposed Rule for Pesticide Research
The Alliance for Human Research Protection (AHRP) strongly objects to several provisions of the EPA Proposed Rule: Protections for Subjects in Human Research
[Federal Register: September 12, 2005; 70 FR 53837-53866; Docket ID # OPP2003-0132].
AHRP¹s objections are made on the basis of the ethical principles laid down in the Nuremburg Code, the World Medical Association Declaration of Helsinki, Good Clinical Practice guidelines endorsed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) the Food and Drug Administration (FDA), and the United States Common Rule.
The Nuremburg Code was enunciated by the judges of the US tribunal after condemning to death or life-imprisonment the Nazi physicians who were responsible for the hideous, immoral experiments on concentration camp prisoners during WWII. These doctors defended their crimes against humanity as pursuant to achievement of the official mission and policies of Hitler¹s Third Reich. The Nuremburg Code has been cited as authority by the US Supreme Court [United States et al. v Stanley, 483 US 669, 687, 710 (1987)], and more recently by the Maryland Court of Appeals in a case involving an EPA-funded lead-poison exposure experiment conducted on disadvantaged toddlers. [Grimes v Kennedy Krieger Institute, 366 Md. 29, 782 A.2d 807 (Md. Aug. 16, 2001)].
The World Medical Association developed the Declaration of Helsinki as a statement of international ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Principle 9 states that no national ethical, legal or regulatory requirement should be allowed to reduce or eliminate any of the protections for human subjects set forth in the Declaration.
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. The Food and Drug Administration is cosignatory. The GCP states its guidelines should be followed by the investigators generating clinical trial data that are intended for submission to regulatory authorities. Guideline principles are also to be applied to other clinical investigations that may have an impact on the safety and well-being of human subjects.
The Common Rule is United States policy that applies to all research involving human subjects which is conducted, supported, or otherwise “subject to regulation by any federal department or agency.” The EPA has unilaterally declared itself exempt from strict application of the Common Rule, which will become painfully evident in several of its proposed regulations governing pesticide research.
Each of these sources unequivocally asserts the primacy of non-coerced fully informed consent of human research subjects as the basic requirement and restate the original Nuremberg Code mandate that voluntary, informed consent of the test subject is “absolutely essential,” and that the test subject must have “legal capacity to give consent” and must be “so situated as to exercise free power of choice.” These codes, rules, declarations, and guidelines all affirm that risks to subjects are to be minimized, that the well-being of the human subject should take precedence over the interest of science and society, and that a trial should be initiated and continued only if the anticipated benefits justify the risks. They also identify vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or otherwise economically or educationally disadvantaged persons, that should receive special protections. Special attention is required for those who cannot give or refuse consent for themselves to ensure their vulnerability is not exploited and that their best interest is served. See: http://www.tera.org/pubs/comparisontable.
Although EPA claims at the outset that “This proposed ruleŠ would significantly strengthen the ethical framework for conducting and reviewing human studies,” and would “categorically prohibit any intentional dosing studies involving pregnant women or children as subjects,” the final provision in the proposed rule would, in fact, enable the EPA to suspend any federal protections for human subjects in EPA-conducted research (Œfirst- party research¹); in research by others with support from the EPA (Œsecond-party research¹); as well as research conducted by industry without government funding (Œthird-party research¹) which is submitted to the EPA in support of reducing safety standards. In effect, the EPA proposed rule demolishes all applicable ethical codes governing research involving human subjects.
AHRP objects to the following provisions of the EPA proposed rule for pesticide research:
1. Notwithstanding the EPA announced ban on “conducting any study involving intentional dosing of pregnant women, fetuses or newborns,” the proposed rule would allow these vulnerable populations to be subjected to pesticide experiments that do not fall within the narrow definition of “intentional dosing.”
For example, “observational” studies, such as the Kennedy-Krieger Institute/John Hopkins University lead-poisoning experiment and the terminated EPA “CHEERS” experiment, would be permissible under the proposed rule. In these studies, investigators documented the adverse effects on children of ongoing exposure to pesticides (or other toxic poisonous substances). The EPA Appropriation Act of 2006 [Pub. L. No. 109-54] prohibits “the use of pregnant women, infants or children as subjects.”
The EPA proposed rule violates the congressional ban on such research.
2. Subjecting children who “cannot be reasonably consulted,” by implication such as those who are mentally handicapped or orphaned newborns to be experimented on with permission from the institution or guardian in charge of the individual, the child may be exposed to chemicals for the sake of research.
EPA proposal justification: 70 FR 53865 – 40 CFR 26.408(a) “The IRB (Independent Review Board) shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent…If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement…”
AHRP objection: The EPA proposed rule violates the 2006 EPA Appropriation Act, which explicitly requires that the EPA pesticide-research rule to be “consistent with the principles of the Nuremberg Code with respect to human experimentation.” Indeed, the EPA position turns on its head international and national law and conventions governing the conduct of research involving human subjects. If adopted, the EPA proposed rule would put the United States at odds with the international community of nations and elicit their condemnation. Further, adoption of the EPA proposed rule will predictably cause litigation to stop implementation of research projects that waive the assent requirement, provoke negative publicity for the EPA, and waste millions of taxpayer dollars by EPA defense of these projects.
3. Parental consent forms are not necessary for testing on children who have been “neglected or abused.”
EPA proposal justification: 70 FR 53865 – 40CFR 26.408(c) “If the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements…”
AHRP objection: The EPA proposed rule cynically attempts to take advantage of legal loopholes which permit state or local government authorities acting in loco parentis to give substitute consent for neglected or abused children. Ironically, if the EPA proposed rule is adopted and implemented, such neglected or abused children in many cases will be subjected to dangers far greater than those for which they were taken in the first place from their parents for protection by state or local government authorities. Further, adoption of the EPA proposed rule will draw the EPA into conflicts with the courts which authorized removal of these children from their parents and placed them into the protective custody of state or local government authorities. Again, there will be predictable negative publicity for the EPA and the waste of taxpayer dollars in defense of the indefensible.
4. Chemical studies on any children outside of the U.S. are acceptable.
EPA proposal justification: 70 FR 53864 – 40 CFR 26.401 (a)(2) “To What Do These Regulations Apply? It also includes research conducted or supported by EPA outside the United States, but in appropriate circumstances, the Administrator may, under § 26.101(e), waive the applicability of some or all of the requirements of these regulations for research…”
AHRP objection: Adoption of the EPA proposed rule would clearly breach all of the aforementioned ethical codes and would put the United States outside the pale of the international community by violating several United Nations covenants to which the United States is signatory, including:
(1) the Universal Declaration of Human Rights,
(2) the Declaration on the Right and Responsibility of Individuals, Groups and Organs of Society to Promote and Protect Universally Recognized Human Rights and Fundamental Freedoms: A/RES/53/144,
(3) the Declaration on Social and Legal Principles relating to the Protection and Welfare of Children, with Special Reference to Foster Placement and Adoption Nationally and Internationally, and
(4) Principles for the protection of persons with mental illness and the improvement of mental health care.
5. The last provision of the EPA proposed rule advances an “extraordinary procedure” whereby the EPA can conduct “scientifically sound but ethically deficient human research” if it deems such research “crucial to fulfilling its mission to protect the public health,” and permits the EPA to accept data from unethical, harmful human
EPA proposal justification: 70 FR 53857-40 CFR 26.603 “EPA proposes an extraordinary procedure applicable if scientifically sound but ethically deficient human research is found to be crucial to EPA¹s fulfilling its mission to protect public health. This procedure would also apply if a scientifically sound study covered by proposed 40 CFR § 26.221 or § 26.421–i.e., an intentional dosing study involving pregnant women or children as subjectsŠ”
AHRP objection: Section 26.603 of the EPA proposed rule would virtually eliminate all protections for human subjects, and would override the congressional prohibitions of the EPA Appropriation Act of 2006. For the EPA to argue a special privilege to pursue human research that it freely admits would be “scientifically sound but ethically deficient” is pure chutzpah, and meant to put itself above all limits of national and international law and regulations governing human research.
When formulating the proposed rule, surely EPA officials must have known that national and international ethical principles mandate that the well-being of the human subject should take precedence over the interest of science and society. Yet under Section 26.603 of the proposed rule, the EPA helps itself to an “extraordinary procedure” whereby it can, if it so chooses, eliminate all constraints and applicable restrictions on toxic human experiments, including experiments involving intentional dosing of pregnant women, fetuses and newborns.
To adopt the EPA proposed rule would bring the United States full circle to pre-Nuremberg trial conditions wherein doctors and officials of the Nazi government conducted hideous experiments on concentration camp inmates because they deemed such experiments as furthering the mission of the Third Reich. For a US government agency to take such an immoral stance would predictably draw international condemnation and render the United States a pariah in the international community of nations. It is unimaginable that the Bush Administration would sign off on the proposed rule, so why does the EPA put it out for public comment in the first place?
In view of the Maryland Court of Appeals decision in the cases of Grimes v Kennedy-Krieger Institute and Higgins v Kennedy-Krieger Institute, the EPA proposed rule clearly defies the court by aggressively promoting the very practices which the court maintained “we or any community should be ever unwilling to accept.” In condemning the EPA-supported lead-poison exposure experiment conducted on poor, inner-city minority children by Johns Hopkins University researchers, the court cited the Nuremberg Code and unambiguously criticized the research community that permitted it, stating:
“It is not in the best interest of a specific child, in a nontherapeutic research project, to be placed in a research environment, which might possibly be, or which proves to be, hazardous to the health of the child. We have long stressed that the ‘best interests of the child’ is the overriding concern of this Court in matters relating to children. Whatever the interests of a parent, and whatever the interests of the general public in fostering research that might, according to a researcher’s hypothesis, be for the good of all children, this Court’s concern for the particular child and particular case, over-arches all other interests. It is, simply, and we hope, succinctly put, not in the best interest of any healthy child to be intentionally put in a nontherapeutic situation where his or her health may be impaired, in order to test methods that may ultimately benefit all children. . . . To think otherwise, to turn over human and legal ethical concerns solely to the scientific community, is to risk embarking on slippery slopes, that all too often in the past, here and elsewhere, have resulted in practices we, or any community, should be ever unwilling to accept.” See: http://www.courts.state.md.us/opinions/coa/2001/128a00.pdf.
The AHRP strongly objects to the EPA proposed rule for pesticide experiments because there is no legitimate justification for subjecting any child to dangerous experiments with toxic substances. Nor should any child¹s disability or special status as an orphan or ward of the state – because of parental abuse or neglect – be an occasion for singling such children out for illegitimate experimentation.
Human rights belong to all human beings regardless of attributes or special circumstances. To ignore international and national law and conventions governing the conduct of research involving human subjects is morally reprehensible and akin to child abuse. Safeguards against abuse must be equally applied to all children by virtue of their shared humanity and rights.
The paradigm for action that the EPA is proposing follows the practice in Nazi Germany. The EPA proposed rule would exploit the most vulnerable disadvantaged children under the guardianship of state authorities whose responsibility is to act in loco parentis. The EPA would thrust children already handicapped by virtue of disability, institutionalization, or foster care placement into dangers far greater than those for which they had been taken into protective custody from their parents in the first place. The EPA proposed rule would thus establish a policy reminiscent of the inhumane maltreatment cruelty toward children with disabilities in Nazi Germany. To gain insight into how government policies adopted “for the good of society” have trampled on individual rights, see: “Hitler¹s Unwanted Children With Disabilities, Orphans, Juvenile Delinquents, and Non-Conformist Young People” by AHRP board member, Sally M. Rogow, Professor Emerita, University of British Columbia: http://www.nizkor.org/ftp.cgi/people/r/rogow.sally/hitlers-unwanted-children.
The AHRP believes that adoption of the EPA proposed rule for pesticide research would breach all biomedical and behavioral ethical codes, as well as several international covenants. Such a policy would put the United States outside the pale of the international community. It would bring the United States full circle to pre-Nuremberg trial conditions wherein Nazi officials conducted hideously immoral experiments on concentration camp inmates because they deemed such experiments as furthering the mission of the Third Reich. To adopt the EPA proposed rule for pesticide research would predictably draw international condemnation and render the United States a pariah in the international community of nations.
John H. Noble, Jr, PhD
Professor Emeritus, SUNY/Buffalo
Vera Hassner Sharav
EPA Administrator: Stephen Johnson–Office of the Administrator, call 202-564-4700
[*] An error in the docket number given in the original infomail has been corrected in this