EPA Proposes Chemical Testing on Some Children

VickyRN, MSN, DNP, RN · Nov 16, 2005

I went to the original EPA site which has the proposal:

http://www.epa.gov/fedrgstr/EPA-GENERAL/2005/September/Day-12/g18010.htm

It is written in such thick government-ese verbage that its true meaning is very difficult to decipher (especially when coming home from a loooong day) :banghead:

I think this is the passage in question:

Sec. 26.405 Research involving greater than minimal risk but
presenting the prospect of direct benefit to the individual subjects.
EPA will conduct or fund research in which the IRB finds that more
than minimal risk to children is presented by an intervention or
procedure that holds out the prospect of direct benefit for the
individual subject, or by a monitoring procedure that is likely to
contribute to the subject's well-being, only if the IRB finds and
documents that:
(a) The risk is justified by the anticipated benefit to the subjects.
(b) The relation of the anticipated benefit to the risk is at least
as favorable to the subjects as that presented by available alternative
approaches.
© Adequate provisions are made for soliciting the assent of the
children and permission of their parents or guardians, as set forth in
Sec. 26.408.
Sec. 26.406 [Reserved]
Sec. 26.407 [Reserved]
Sec. 26.408 Requirements for permission by parents or guardians and
for assent by children.
(a) In addition to the determinations required under other
applicable sections of this subpart, the IRB 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. In determining whether children are capable of assenting, the
IRB shall take into account the ages, maturity, and psychological state
of the children involved. This judgment may be made for all children to
be involved in research under a particular protocol, or for each child,
as the IRB deems appropriate. If the IRB determines that the capability
of some or all of the children is so limited that they cannot
reasonably be consulted or that the intervention or procedure involved
in the research holds out a prospect of direct benefit that is
important to the health or well-being of the children and is available
only in the context of the research, 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 under circumstances in which consent
may be waived in accord with Sec. 26.116(d).
(b) In addition to the determinations required under other
applicable sections of this subpart, the IRB shall determine, in
accordance with and to the extent that consent is required by Sec.
26.116, that adequate provisions are made for soliciting the permission
of each child's parents or guardian. Where parental permission is to be
obtained, the IRB may find that the permission of one parent is
sufficient for research to be conducted under Sec. 26.404 or Sec. 26.405.
© In addition to the provisions for waiver contained in Sec.
26.116, 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 in subpart A of this part and paragraph (b) of this
section, provided an appropriate mechanism for protecting the children
who will participate as subjects in the research is substituted, and
provided further that the waiver is not inconsistent with Federal,
State or local law. The choice of an appropriate mechanism would depend
upon the nature and purpose of the activities described in the
protocol, the risk and anticipated benefit to the research subjects,
and their age, maturity, status, and condition.
(d) Permission by parents or guardians shall be documented in
accordance with and to the extent required by Sec. 26.117.
(e) When the IRB determines that assent is required, it shall also
determine whether and how assent must be documented.
Sec. Sec. 26.409-26.419 [Reserved]
Sec. 26.420 Prohibition of research involving intentional dosing of
children.
Notwithstanding any other provision of this part, under no
circumstances shall EPA or a person when covered by Sec. 26.101(j)
conduct or support research involving intentional dosing of any child.
Sec. 26.421 Prohibition of EPA reliance on research involving
intentional dosing of children.
In its regulatory decision-making under the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) or section 408 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a), EPA shall
not rely on any research involving intentional dosing of any child,
except when such research is deemed scientifically sound and crucial to
the protection of public health, under the procedure defined in Sec.
26.603.
Subpart E--Administrative Actions for Noncompliance
Sec. 26.501 Lesser administrative actions.
(a) If apparent noncompliance with the applicable regulations in
subparts A through D of this part concerning the operation of an IRB is
observed by a duly authorized investigator during an inspection, the
inspector will present an oral or written summary of observations to an
appropriate representative of the IRB. EPA may subsequently send a
letter describing the noncompliance to the IRB and to the parent
institution. The agency will require that the IRB or the parent
institution respond to this letter within a time period specified by
EPA and describe the corrective actions that will be taken by the IRB,
the institution, or both to achieve compliance with these regulations.
(b) On the basis of the IRB's or the institution's response, EPA
may schedule a reinspection to confirm the adequacy of corrective
actions. In addition, until the IRB or the parent institution takes
appropriate corrective action, the Agency may:
(1) Withhold approval of new studies subject to the requirements of
this part that are conducted at the institution or reviewed by the IRB;
(2) Direct that no new subjects be added to ongoing studies subject
to this part;
(3) Terminate ongoing studies subject to this part when doing so
would not endanger the subjects; or
(4) When the apparent noncompliance creates a significant threat to
the rights and welfare of human subjects, notify relevant State and
Federal regulatory agencies and other parties with a direct interest in
the agency's action of the deficiencies in the operation of the IRB.
© The parent institution is presumed to be responsible for the
operation of an IRB, and EPA will ordinarily direct any administrative
action under this subpart against the institution. However, depending
on the evidence of responsibility for deficiencies, determined during
the investigation, EPA may restrict its administrative actions to the
IRB or to a component of the parent institution determined to be
responsible for formal designation of the IRB.
Sec. 26.502 Disqualification of an IRB or an institution.
(a) Whenever the IRB or the institution has failed to take adequate
steps to correct the noncompliance stated in the letter sent by the
Agency under Sec. 26.501(a) and the EPA Administrator determines that
this noncompliance may justify the
[[Page 53866]]
disqualification of the IRB or of the parent institution, the
Administrator may institute appropriate proceedings.
(b) The Administrator may disqualify an IRB or the parent
institution if the Administrator determines that:
(1) The IRB has refused or repeatedly failed to comply with any of
the regulations set forth in this part, and
(2) The noncompliance adversely affects the rights or welfare of
the human subjects of research.
© If the Administrator determines that disqualification is
appropriate, the Administrator will issue an order that explains the
basis for the determination and that prescribes any actions to be taken
with regard to ongoing human research, covered by subparts A through D
of this part, conducted under the review of the IRB. EPA will send
notice of the disqualification to the IRB and the parent institution.
Other parties with a direct interest, such as sponsors and
investigators, may also be sent a notice of the disqualification. In
addition, the agency may elect to publish a notice of its action in the
Federal Register.
(d) EPA may refuse to consider in support of a regulatory decision
the data from human research, covered by subparts A through D of this
part, that was reviewed by a disqualified IRB or conducted at a
disqualified institution, unless the IRB or the parent institution is
reinstated as provided in Sec. 26.504, or unless such research is
deemed scientifically sound and crucial to the protection of public
health, under the procedure defined in Sec. 26.603.
Sec. 26.503 Public disclosure of information regarding revocation.
A determination that EPA has disqualified an institution and the
administrative record regarding that determination are disclosable to
the public under 40 CFR part 2.
Sec. 26.504 Reinstatement of an IRB or an institution.
An IRB or an institution may be reinstated if the Administrator
determines, upon an evaluation of a written submission from the IRB or
institution that explains the corrective action that the institution or
IRB plans to take, that the IRB or institution has provided adequate
assurance that it will operate in compliance with the standards set
forth in this part. Notification of reinstatement shall be provided to
all persons notified under Sec. 26.501©.
Sec. 26.505 Debarment.
If EPA determines that an institution or investigator repeatedly
has not complied with or has committed an egregious violation of the
applicable regulations in subparts A through D of this part, EPA may
recommend that institution or investigator be declared ineligible to
participate in EPA-supported research (debarment). Debarment will be
initiated in accordance with procedures specified at 40 CFR part 32.
Sec. 26.506 Actions alternative or additional to disqualification.
Disqualification of an IRB or of an institution is independent of,
and neither in lieu of nor a precondition to, other statutorily
authorized proceedings or actions. EPA may, at any time, on its own
initiative or through the Department of Justice, institute any
appropriate judicial proceedings (civil or criminal) and any other
appropriate regulatory action, in addition to or in lieu of, and
before, at the time of, or after, disqualification. The Agency may also
refer pertinent matters to another Federal, State, or local government
agency for any action that that agency determines to be appropriate.
Subpart F--Ethical Standards for Assessing Whether to Rely on the
Results of Human Research in EPA Regulatory Decisions
Sec. 26.601 Human research conducted prior to [effective date of the
final rule].
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 data from research that:
(a) Was initiated prior to [effective date of the final rule],
(b) Involved intentional exposure of a human subject,
© Did not involve intentional exposure of a pregnant woman,
fetus, newborn, or child, and
(d) Is being considered under the Federal Insecticide, Fungicide,
and Rodenticide Act or the Federal Food, Drug, and Cosmetic Act.
Sec. 26.602 Human research conducted after [effective date of the
final rule].
EPA will generally accept and rely on relevant, scientifically
valid data from research that:
(a) Was initiated after [effective date of the final rule],
(b) Involved intentional exposure of a human subject,
© Did not involve intentional exposure of a pregnant woman,
fetus, newborn, or child, and
(d) Is being considered under the Federal Insecticide, Fungicide,
and Rodenticide Act or the Federal Food, Drug, and Cosmetic Act only if
EPA has adequate information to determine that the research was
conducted in a manner that substantially complies with subparts A
through D of this part.
Sec. 26.603 Exceptions for human research.
(a) Before reaching a decision not to rely on scientifically useful
and relevant data derived from research that does not meet the
applicable standards of Sec. Sec. 26.601 through 26.602, or that
involves intentional exposure of a pregnant woman, fetus, newborn, or
child, EPA will consider whether the data are crucial to a regulatory
decision that would be more protective of public health than could be
justified without relying on the data.
(b) Before making a decision under this section, EPA will solicit
the views of the Human Studies Review Board and provide an opportunity
for public comment.
© If EPA decides to rely on data derived from a study that does
not meet the applicable standards of Sec. Sec. 26.601 through 26.602,
EPA will include in the explanation of its decision a thorough
discussion of the significant ethical deficiencies of the study, as
well as the full rationale for concluding that relying on the study is
crucial to protection of public health.
[FR Doc. 05-18010 Filed 9-8-05; 9:19 am]
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