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Codex of clinical research
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Legally acceptable representative

From Codex of clinical research

Legally acceptable representative (LAR) – is individual authorized to provide consent on behalf of a participant from vulnerable population who is unable to provide informed consent themselves. This could include minors, individuals with cognitive impairments, or incapacitated adults. LAR could be a legal guardian, parent, or other individual designated by law to make decisions on behalf of the participant.

Definitions

ICH E6(R2)

1.37 Legally Acceptable Representative:
An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject’s participation in the clinical trial [1].

See also

Another relevant pages

Links to this page

References

  1. ICH, 2016, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf Accessed Sep 2023

External links