University of Southern California

Research

Clinical Research Guidance

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General
General Principles for Direct‐Contact Human Subjects Research on Campus
Guidelines for Research Participants
Guidelines for the Research Environment
Other Considerations

 

General

This section is focused on (a) members of research teams (faculty, staff, students) and study participants for direct contact human subject research conducted at USC facilities and (b) phase 2 of campus opening.

Progression to subsequent phases will proceed under the general principle that such research should comply with policies and practices in place at USC for analogous clinical care.

Likewise, in a new shut down, allowed activity would return to only studies in which the potential harm of non‐participation in direct contact visits outweighs the risk of COVID‐19.

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General Principles for Direct‐Contact Human Subjects Research on Campus

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Guidelines for Research Participants

  • Consent should be obtained/provided remotely using electronic formats in advance of study visits whenever possible. If consent is obtained at the time of an in‐person visit, e-consent can reduce interpersonal contact, but consenting directly on paper forms is acceptable.
    • See OPRS for guidance on obtaining informed consent electronically via DocuSign or REDCap
  • Health screening should be conducted by phone day prior to visit (for participant and up to one accompanying person if needed)
    • Need for COVID‐19 testing will be determined by the clinical facility or, for nonclinical sites, but University policy
  • Health screening on the day of the visit will be conducted in accordance with facility policies and practices.
    • Research clinics and imaging facilities should follow extant health system practices.
  • Physical distancing of at least six feet must be maintained whenever possible, direct contact with research teams should occur only when required for a study procedure.
    • Specific policies and practices in clinical care facilities will be determined by the facility and should be duplicated in non‐clinical care research facilities.
  • Personal Protective Equipment
    • Appropriate PPE must be provided to study participants to wear at all times.
  • Disinfecting wipes or hand sanitizer should be available wherever participants must touch shared items such pens, electronic devices, medical equipment, exam tables
  • Handwashing is required at beginning and end of each visit
  • Additional practices may be dictated by the relevant facility in higher risk settings

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Guidelines for the Research Environment

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Other Considerations

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