Intentional Human Dosing Studies for EPA Regulatory Purposes Scientific and Ethical Issues (2004) / Chapter Skim
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6 Procedures for EPA Review of Intentional Human Dosing Studies
6 Procedures for EPA Review of Intentional Human Dosing Studies
Pages 132-143
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From page 132... ...
. INDEPENDENT REVIEW OF INTENTIONAL HUMAN DOSING STUDIES As described in Chapter 2, in the United States for the last several decades most federally funded human research has been covered by the Common Rule, which requires advance approval of such research by local IRBs.
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From page 133... ...
If all EPA-sponsored human research is conducted at nonfederal institutions and those institutions have appropriate IRBs operating in compliance with the Common Rule, the federal requirements might be satisfied. If EPA were to conduct human research in-house without prior IRB review, it would be violating the Common Rule.
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From page 134... ...
. Similarly centralized and elevated review would be useful for any proposed intentional human dosing studies conducted for EPA regulatory purposes, given their unique risk-benefit calculus, whether EPA sponsored or sponsor initiated.
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From page 135... ...
Recommendation 6-2: Human Studies Review Board To ensure that intentional human dosing studies conducted for EPA regulatory purposes meet the highest scientific and ethical stan dards, EPA should establish a Human Studies Review Board to ad dress in an integrated way the scientific and ethical issues raised by such studies. To the extent possible, this board should review in a timely manner the protocols and the justification for all intentional dosing studies intended for submission to EPA, as well as study results when completed.
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From page 136... ...
. The committee also strongly recommends that the board report directly to the Office of the EPA Administrator, rather than be located in any one EPA operational unit, for two reasons.
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From page 137... ...
Pre-Experiment EPA Review The committee recommends that the Human Studies Review Board should review in advance proposed intentional human dosing studies sponsored or conducted by EPA and all such studies whose sponsors intend to submit them to EPA. The committee concludes that it would be optimal if this review were mandatory, but, because of legal and logistical concerns, it recommends only that EPA consider making it mandatory.
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From page 138... ...
If not, EPA should strongly encourage study sponsors to seek such review. The committee strongly urges that any research sponsored, funded, or conducted by EPA that intentionally exposes research participants to toxic substances also should be submitted to the Human Studies Review Board, to ensure consistency in EPA evaluations of such studies and educate EPA program offices about the issues involved and the board about such research within EPA.
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From page 139... ...
This is a valuable model for allowing reviewers to see all pertinent information while respecting the confidentiality of trade secrets. The committee decided to seek the best of both systems and recommended that the board's deliberations should not be public, but that reports on its deliberations and conclusions should be publicly available, except to the extent that they might reveal protected trade secrets or confidential business information.
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From page 140... ...
The Human Studies Review Board would then provide recommendations to EPA on the scientific and ethical acceptability of such studies. The results of the board's review should be made public, subject to legitimate claims of trade secrets or confidential business information.
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From page 141... ...
First, the committee believes that, over time, the board should do more than review the proposed experiments and experimental results put before it. It will have an excellent opportunity to study intentional human dosing studies and make general recommendations concerning them.
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From page 142... ...
Any such IRB may need special expertise to review these types of studies. Furthermore, to assure that intentional human dosing studies conducted for EPA regulatory decisions meet the highest scientific and ethical standards, the committee recommends that EPA establish a Human Studies Review Board to address in an integrated way the scientific and ethical issues raised by intentional human dosing studies.
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From page 143... ...
Instead, it would offer nonbinding advice to the relevant EPA units about the scientific and ethical acceptability of the submitted and completed research. The proposed review board, its functions, and its record should be assessed after five years.
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