02/10/2011: Obtaining Informed Consent from Legally Authorized Representatives
In certain studies, when the potential study subject cannot consent for themselves, the IRB gives you permission to allow a Legally Authorized Representative (LAR) of the potential study subject to consent for the study subject. In order for the consent to be legally effective, the relationship of the LAR to the subject must be clearly indicated on the form. The IRB would like to remind research investigators and coordinators of the importance of documenting this relationship on the on the informed consent. To assist, the IRB has recently altered the signature section of the informed consent, now providing a separate line for the LAR to document that relationship.
Please refer to following for additional information on this topic:
In certain studies, when the potential study subject cannot consent for themselves,the IRB may approve your study to allow a Legally Authorized Representative (LAR) of the potential study subject to consent for the study subject. Before seeking consent from a LAR please review the IRB approved Introductory Questionnaire and verify that you selected that a LAR may give consent for the study subject (question 18.i. on our current Introductory Questionnaire).
When obtaining informed consent from a LAR:
- You should insure that you are obtaining consent from the highest priority LAR. For example, although a close friend is a listed proxy who may consent as a LAR, a close friend has the lowest priority of any LAR. You should verify and document that a higher priority LAR (such as a spouse or parent) is not available to provide consent. Not convenient does not meet the standard for not available.
- Should a higher priority LAR become available later and the subject’s participation in the study is ongoing, you must seek re-consent from the higher priority LAR.
- Should the subject themselves later become capacitated (able to provide consent) and the subject’s participation in the study is ongoing, you must seek re-consent from the subject. This includes subjects who may have been enrolled at a time when they were unconscious, or children who were enrolled who subsequently turn 18 during their participation in the study.
- If a higher priority LAR or the subject decline to continue the subject’s participation in the study, you must withdraw the subject from the research. Data collected up to that point may be used but no additional study interventions or data collection may occur.
R. Peter Iafrate, Pharm.D. Chairman, Health Center IRB University of Florida