Screening procedures prior to obtaining informed consent
If screening procedures will take place prior to the participant providing informed consent for participation in the research, the investigator may request a waiver of signed informed consent or informed consent for screening activities in the IRB application.
If an oral informed consent process is used, use of a screening script may be necessary.
If screening activities will take place only after the subject has provided informed consent for participation in the research, then the waivers described above are unnecessary.
HIPAA regulations apply to the screening process if it involves review of medical records. Investigators must obtain prospective HIPAA authorization or apply for a waiver of HIPAA authorization and informed consent.
Full procedures and requirements can be found in the document below.