The signature statements section is meant to document that a meaningful informed consent process and an assessment of capacity have been conducted. The subject and the person obtaining consent must sign and date the Consent Form.
In the course of review, the IRB will determine whether or not an indepedent assessment of capacity is also required, based on RFMH/OMH guidance. The IRB Approval Notice will confirm the requirements. For additional information, please refer to the RFMH/OMH Website.
For all studies, only those individuals listed in the PSF as being authorized to obtain consent can sign the Consent
For studies that involve a treatment/intervention, consent must be obtained by a licensed professional.
For studies in which medication is administered, consent must be obtained by a physician.
When necessary, add the text for an independent assessment of capacity when one is conducted (in addition to the signature line for the person obtaining consent).
(use this link for studies which may include subjects without capacity)
(use this link for stuies which may not include subjects without capacity)