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
- ↑ 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