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Special Protections for Children as Research Subjects 2026

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  1. Click ‘Get Form’ to open it in the editor.
  2. Begin with SECTION I: General Information. Fill in the Study Title, ensuring it reflects the study's purpose accurately. Provide a concise Study Objective summarizing your research.
  3. Complete the Principal Investigator Information section by entering your name, department, contact details, and any Co-Investigator(s) or Student/Resident Researcher(s) information as necessary.
  4. Move to SECTION II: Funding. Specify your funding source and provide additional comments if needed. Ensure you include any relevant grant applications if applicable.
  5. In SECTION III: Conflict of Interest, review the ECHN Conflict of Interest Policy and complete the attached Questionnaire as required.
  6. Proceed through each subsequent section (Background, Hypotheses, Study Design, etc.), providing detailed descriptions and justifications for your research methods and objectives.

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The following are examples of groups that are often considered vulnerable populations or in need of additional protections or considerations in research: Pregnant women Human fetuses Neonates Prisoners Children Individuals with physical disabilities Individuals with mental disabilities or cognitive impairments
Parental Permission Because children are not legally able to provide consent in their own right, the federal regulations generally require that parents or guardians provide permission before children can be enrolled in research.
Protections for Vulnerable Populations (1) Children - see Research with Children and Youth and Research in K-12 Educational Settings. (2) Prisoners. (3) Pregnant Women. (4) Fetuses. (5) Persons with Cognitive Impairment. (6) Economically or Educationally Disadvantaged Persons - see Compensation of Participants.
Does research involving children include special requirements? Yes, subpart D of the HHS regulations at 45 CFR part 46 provides additional protections for children participating in human subjects research.
These populations include: Fetuses, neonates and children; Individuals with impaired decision-making capacity (cognitively impaired, traumatized, sedated, intoxicated, etc.);

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Some types of research are considered exempt even when children are subjects. However, some types of research considered exempt when subjects are competent adults are not exempt when children are subjects. Research involving survey or interview procedures is not exempt when children are subjects.
Pregnant women, prisoners, and minors have specific sections in the federal regulations that provide additional rules for studying these participants.

Related links

2024 Ethics Handbook.

Oct 1, 2024 When conducting research with human subjects, handling human subject information according to HIPAA can provide protection for the subjects withRead more

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