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Research Involving Vulnerable Populations Children

There are specific requirements that apply to ALL NIH-funded human subjects research involving children: 

1. HHS Regulatory Requirement Protections (Subpart D)

  • Protections for children as subjects in research
  • Child defined in 46.402 as:
    An individual who has not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.

2. NIH Policy Requirements

  • Inclusion of children in research:
    Provision of a description of the inclusion of children or a justification for the exclusion of children for scientific or ethical reasons in proposed studies.
  • A Child is defined in the NIH Policy for Inclusion of Children in Research as:
    An individual under the age of 18 (updated January 2016).

This Site Describes:

1. HHS Regulatory Requirements for Research Involving Children Described in Subpart D

  • Definitions Specific to the Regulatory Requirements Described in Subpart D
  • Categories of Permitted Research Involving Children
  • OHRP Role in Assessing Proposed Research Not Approvable Under a Permitted Category of Research Involving Children
  • Requirements for Child Assent and Parent/Guardian Permission
  • Child Wards in Research

2. Exempt Human Subjects Research Involving Children

3. NIH Policy Requirements for the Inclusion of Children in Research

  • Implementation of the NIH Policy for the Inclusion of Children in Research
  • PHS 398 Instructions with Respect to the Inclusion of Children in Research

4. PHS 398 Application Instructions for Completing the Human Subjects Section for Proposed Research Involving Children

  • Risks to Subjects
  • Adequacy of Protection Against Risks
  • Potential Benefits to Subjects and to Others
  • Importance of Knowledge to be Gained
  • Inclusion
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