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Special Protections for Children as Research Subjects

Special Protections for Children as Research Subjects 2025

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The document outlines the protocol application process for involving human participants in research at ECHN, specifically focusing on surveys, interviews, and questionnaires. It details important considerations regarding risk assessment, classification of studies as exempt or expedited, informed consent requirements, and guidelines for student researchers. The document also provides a comprehensive guide for writing a research protocol, including sections on study design, funding sources, conflict of interest, data management, risks, confidentiality, and data analysis. Overall, it serves as a roadmap for researchers to ensure ethical compliance and proper planning in conducting studies involving human subjects.

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For which of the following population groups are there special guidelines for their protection as research subjects?

These special populations include infants and children/pediatric populations, adolescents and young adults, older adults, pregnant people, people with disabilities and/or rare disorders, people who have been underrepresented in clinical research (e.g. African Americans, Native Americans, Latinos, or populations with

How are research subjects protected?

In general, human subjects in NIH-funded clinical research, whether healthy volunteers or patient volunteers, are protected under the Federal Policy for the Protection of Human Subjects at 45 CFR 46, also called the Common Rule.

What populations require protection from research?

Thus, federal regulations require additional protections for special participant populations, such as: (1) children, (2) prisoners, (3) pregnant women, (4) activities involving fetuses and human in vitro fertilization, (5) persons with cognitive impairment, (6) economically or educationally disadvantaged persons, and (

Which special populations require special protections if they are research subjects?

These populations include: Fetuses, neonates and children; Individuals with impaired decision-making capacity (cognitively impaired, traumatized, sedated, intoxicated, etc.); Prisoners; The terminally ill; Students or employees; Individuals whose first language is not English;

What are the rights of children in research?

By definition, children are unable to provide informed consent to participate in research, although they might be able to give their assent. The IRB should determine that unless parental permission can be waived adequate provisions are made for soliciting the permission of the parent(s) or legal guardian(s).

What are the two special populations that require protection in criminology and criminal justice research?

The federal regulations require that IRBs give special consideration to protecting the welfare of particularly vulnerable subjects, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.

How are children protected in research?

the research will be conducted in ance with sound ethical principles; and. adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians, as set forth in HHS regulations at 45 CFR 46.408.

Special Protections for Children as Research Subjects 2025

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