Answer to the Trivia Question:
An individual’s consent capacity is not simply present or absent but is best understood as occurring along a continuum.
The ethical principal of respect for persons, involves assessing an individual subject’s decision making capacity, and where possible, using enhancements to facilitate understanding and enable participation in the consent process to the extent they are able.
The UK Impaired Consent Capacity (ICC) Policy & Form T allows an investigator to self-assess capacity dimensions relative to the context of their research, and tailor a plan for assessing capacity.
Excluding subjects from a beneficial study out of convenience or always relying on a Legally Authorized Representative without assessing capacity, is counter to the ethical conduct of research.
If encountering consent impaired prospective subjects is likely and exclusion is unjustified, investigators must develop an assessment plan for determining capacity in order to know when to exclude. For guidance on the ICC Policy click the link below.
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