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EPA Responds to OCA Concerns About Proposed Human Chemical Testing Rule

Read final rule here (excerpts below are taken from this rule)

A number of comments objected to what they perceived to be ‘‘loopholes’’ in the proposed rule’s prohibition on research involving intentional exposure of children. Specifically, they argued that: (1) Proposed § 26.401(a)(1) permitted EPA to waive the prohibition when research was conducted outside the United States; (2) proposed § 26.401(a)(2) permitted EPA to waive any provision of proposed subpart D, including the prohibition; and (3) proposed § 26.408, which authorized an IRB to waive the requirement for assent from children lacking the capacity to give it, and to waive the requirement for permission from abusive or neglectful parents, meant that EPA intended to allow research on mentally retarded, abused, or neglected orphans.

EPA has made several changes in the final rule. The prohibitions appear in separate subparts so that there is less chance someone will misread the provisions intended to confer flexibility in the approach to observational research as applying to research involving intentional exposure. In subpart D, which addresses observational research with children conducted or supported by EPA, EPA has removed or revised the text of §§ 26.401 and 26.408 to make clear that they do not create an opportunity to relax the protections for children.

Some comments objected to the inclusion in the proposed rule of provisions that allowed observational research if an IRB judged the potential risks to subjects as ‘‘minimal.’’ These comments claimed that the concept of ‘‘minimal risk’’ was not adequately defined and potentially subject to abuse. These comments recommended that no observational research be allowed unless there was ‘‘no risk’’ to subjects.

The Common Rule and subpart D of the final rule define minimal risk as ‘‘the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.’’ 40 CFR 26.402. The Agency agrees that this definition leaves room for the exercise of expert judgment by a person reviewing a proposed protocol, and that different people may disagree on whether a particular research technique poses minimal risk. Nonetheless, this definition has been part of the Common Rule since 1991, and this provision has been in the HHS regulations since 1983. Based on its long history of application and the benefits of consistency with HHS, EPA has decided to retain proposed § 26.404 without change. In addition, EPA thinks the prospects for abuse are extremely small since all research allowed using these criteria would need approval both from a local IRB and from EPA’s Human Subjects Research Review Official.

Some comments found unclear the provisions in proposed subpart D allowing the waiver, under narrow conditions, of the requirements for permission of parents and assent of children to participate in observational research conducted or supported by EPA. Other comments objected to these proposed provisions asserting that children should never become subjects in research without their parent’s permission and without their own assent. Still other commenters asserted that the rule should not allow parents to permit their children’s participation in human research unless the children will benefit directly from doing so.

Response: EPA’s final rule has retained the proposed rule text, with only minor changes. EPA believes that these provisions give the Agency needed flexibility to protect the interests of the child when either the child or the parent(s) cannot. For example, the proposal would allow waiver of assent when the child is too young or otherwise unable to make responsible choices, and where the child’s refusal to assent would cause his or her exclusion from research that provides a direct benefit. The proposal also allows waiver of parental permission from a parent who abuses or neglects their children; clearly such parents do not have adequate concern for the child’s welfare to make decisions about whether the child should participate in research. (This provision strengthening the protections for children was widely misinterpreted as indicating EPA’s intention to authorize or conduct research involving intentional exposure of mentally retarded, abused, and neglected children.) To clarify the operation of the provision allowing waiver of parental permission, EPA has modified the text to make clear that any alternative procedure must be ‘‘equivalent’’ to the process of parental permission. By ‘‘equivalent’’ EPA means that the child’s participation must be approved by an adult who by position or relationship puts the child’s well being foremost and who will exercise sufficient diligence to make a considered and informed decision. Otherwise, EPA has decided not to accept the changes recommended by the commenters. EPA relies on the facts that the concepts in this provision comport with the generally accepted legal principles defining the scope of parental authority and that HHS has operated successfully under these provisions for over 20 years. Finally, as noted above, EPA sees considerable benefit from using an approach consistent with that of HHS.

Comment: Some comments complained that the proposed rule did not vest the HSRB with authority to disapprove proposed new research or EPA decisions to rely on the results of completed human studies. Other comments supported giving the HSRB only an advisory role.

Response: EPA believes the HSRB should have an advisory role. The decision to disapprove proposed new research or to decide whether or not to rely on the results of completed studies is inherently governmental. The Agency cannot legally confer authority to make such decisions on an advisory committee. The Agency notes, however, that it expects to give considerable weight to the advice of the HSRB.