What materials must be submitted to the Office for Human Research Protections with a request for a 407 review for research involving children?
For OHRP to determine whether a 407 review for research involving children should proceed, the institution must submit the following documents/information to the Office for Human Research Protections (OHRP) in both written and electronic (if available) forms: • IRB documentation of required findings under 45 CFR 46.407 that the proposed research does not meet the requirements of 46.404, 46.405, or 46.406, but presents a reasonable opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. • Institution name, institution assurance number, and IRB name. • Institutional contact’s name, title, phone number, fax number, mailing address, and email address. • Title of protocol, and name of principal investigator(s). • HHS application number and name of funding agency. • Relevant HHS grant application or proposal. • Most current version of protocol and grant application submitted to and reviewed by the IRB and modified by the principal inves
