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Human Subjects

Policies & Guidance

Consent and Assent in Research Enrolling Minors

The unique vulnerability of children requires the IRB to analyze additional policies and regulations when children are involved as research subjects. For example, children have not reached their full physical or emotional capacities and are unable to provide legally valid consent for themselves (with a few exceptions). Children are also especially vulnerable to potential coercion, requiring the IRB to review research involving children with particular scrutiny.

Obtaining Informed Consent:

Special consideration should be given to deciding who may consent for a minor, when a minor should provide assent, and when a waiver of informed consent or assent is appropriate.
Indiana law does not specifically address research. As such, the IRB looks to laws regarding general health care as guidance. Under Indiana law, minors generally cannot consent to health care on their own behalf. Instead, consent to health care for minors typically must be obtained from a parent or judicially appointed guardian.

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Obtaining Assent:

The Belmont Report lists “respect for persons” as a major ethical principle of human subjects research.   This principle applies to children as well as adults and, in the pediatric context, translates to obtaining assent from children whenever possible.  Assent is “a child’s affirmative agreement to participate in research.” In adhering to the “respect for persons” principle, mere failure to object to participation should not be considered assent and any dissent or objections raised by a child should be respected.

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Consent For Study Participation By Wards Of The State:

Consent issues can be infinitely more complex when children who are wards of the state are involved in research.  However, assuming that regulatory requirements are met, these children should not be excluded from participating in important research simply because the consent process may be difficult.  As such, investigators should consider the following guidelines when attempting to create a consent plan forwards of the state, but should contact HSO for case-specific guidance and recommendations.

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