The investigator must obtain informed consent from each subject, or the subject's legally authorized representative, before study related procedures may begin. Informed consent must be obtained using the MHIRB approved informed consent form (See MHIRB Guidelines). Only informed consent forms that have been stamped with the MHIRB seal of approval may be used to obtain consent (photocopies of the IRB approved form should be used). This responsibility is clearly that of the principal investigator (PI). This task may be delegated, provided this is a formally defined task to a person who has received appropriate training and instruction.

The investigator must provide the MHIRB with a list of all individuals authorized and trained to obtain informed consent.