Pre-Screening of Potential Subjects
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HSPP Use Only:
Guidance Pre-screening v2021-09
Guidance
The Principal Investigator is responsible for ensuring subjects that participate in research meet the
inclusion and exclusion criteria. Pre-screening of study subjects is crucial to ensure the safety of
subjects. To prescreen for eligibility, Investigators frequently need access to identifiable private
information.
To access identifiable private information found in a medical record or stored identifiable
biospecimen, the access requires either:
• The potential subject’s authorization, or
• A waiver of authorization granted by the IRB. s.
To request a waiver of authorization to screen for eligibility only, submit the request as part of the
eIRB submission using the Appendix for Waiver or Alteration of Consent or PHI.
Requirements
• Treating physicians who are also listed as researchers on an IRB-approved study may review
the medical records of their own patients for inclusion/exclusion criteria for the study
without an IRB-approved full or partial waiver.
• Treating physicians who are not involved in the research study, but are affiliated with the
Principal Investigator’s Department, may give their permission to the Principal Investigator
and/or a delegated research member to access their patients’ PHI provided there is an IRB-
approved waiver of PHI Authorization in place.
• Treating physicians who are not involved in research may directly inform patients about
studies and ask if they would like to speak to study staff. If a patient decides to participate
and signs a PHI Authorization or an IRB approved waiver of PHI Authorization is in place, the
research staff may access the medical record.
• If a subject indicates to a treating physician that s/he would like to learn about a research
study, study personnel may contact the patient to present the details.
