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Human Subjects

Policies & Guidance

Research with Individuals Lacking Consent Capacity

When the IRB reviews research involving individuals who may lack the capacity to provide consent for themselves, the IRB must determine and document that the research plan includes appropriate mechanisms for:

  • Assessing potential subjects’ capacity to consent, and reassessing that capacity on an ongoing basis.
  • Identifying and obtaining consent from an appropriate representative if the potential subject lacks capacity.
  • Obtaining assent from the potential subjects, when appropriate.

Investigators who submit research with this vulnerable population should be ready to provide information about these mechanisms and their implementation in the specific study in each IRB application. Departmental or institutional SOPs may be provided to the IRB when relevant, but rarely apply to all studies, so investigators are required to specifically provide this information in each and every study.

The following information provides guidance to the IU research community for creating and implementing these mechanisms.

Defining consent capacity

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Assessing consent capacity

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Determining who can provide initial consent for potential subjects

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Obtaining consent from guardians

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Obtaining dual consent from the subject and LAR

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Obtaining assent from subjects who lack consent capacity

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Documenting the assessment and consent process

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Research with inpatient psychiatric subjects

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