Participant Screening Activities Requirements
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.