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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.