- Federal Register Notice Vol. 68, No. 114, pages 35415-6, dated June 13,2003: Solicitation of Public Review and Comment, available at http://www.hhs.gov/ohrp/references/fr06-13h.pdf [PDF document].
- Correspondence from the IRB referring the proposed research protocol to the Secretary of HHS for consideration under 45 CFR Part 46.407 [PDF Format
] [HTML Format]
- IRB protocol application [PDF Format
]
- IRB deliberations on the proposed research [PDF Format
]
- Parental permission and assent forms [PDF Format ] [HTML Format]
- Relevant excerpts of the NIH grant application [PDF Format ]
- Individual expert reports solicited pursuant to HHS Regulations at 45 CFR 46.407;
* Materials are in Portable Document Format (PDF) to retain the original
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Updated June 13, 2003