Children Involved as Subjects in Research

Here is a link to Federal Regulations regarding children: Title 45 PART 46 Subpart D—Additional Protections for Children Involved as Subjects in Research.

Exemptions' Applicability

• Exemptions at §46.101(b)(1), (3) through (6) are applicable

• The exemption at §46.101(b)(2) (educational tests) is also applicable...

• the exemption at §46.101(b)(2) for research involving survey or interview procedures or observations of public behavior does not apply

• The exceptions, additions, and provisions for waiver as they appear in paragraphs (c) through (i) of §46.101 of subpart A are applicable to this subpart.

Special Considerations

• "the IRB shall determine that adequate provisions are made for soliciting the assent of the children" (46.408a)

• "the IRB shall determine ... that adequate provisions are made for soliciting the permission of each child's parents or guardian" (46.408b)

• "Where... permission is to be obtained from parents, both parents must give their permission" (46.408b)

• "Permission by parents or guardians shall be documented" (46.408d)