If a Subject’s Care Is Divided Equally Between Two Caregivers, Who Should Sign Caregiver Consent?

Question: 

In an Alzheimer’s study, where there is a caregiver consent form, if a subject’s care is divided equally between two caregivers, who signs the caregiver consent?

– Pharmaceutical industry sponsor

Response: 

Presumably, in a study of this nature, it has been determined that consent is required from caregivers because they are considered to be research subjects due to the nature of their participation in the research. 

Where care is equally divided between two caregivers, who must provide consent would be determined by which caregiver is participating in the research activities that make them a research subject. For example, they are filling out surveys related to caregiver burden. If both caregivers will be participating in research activities, then they should each sign a separate copy of the caregiver consent form. It would also be appropriate in this circumstance to denote this unique situation in the research record to ensure that the caregivers continue to each provide consent if there any changes to the research.

If one or both would not be considered a research subject, the consent form is then just informational for the caregiver. In this circumstance, if the caregiver is not already providing informed consent on behalf of the subject as their legally authorized representative, provision of the consent form to the caregiver would still be appropriate so they are aware of what will be happening in the research study, however consent for caregiver participation would not be required.

In addition to the above considerations, the sponsor may require documentation of caregiver consent even when the caregiver is not engaged in the research activities.