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Revised clinical research standards for College of Medicine, Penn State Health take effect June 1

New guidance for clinical research at Penn State Health and Penn State College of Medicine takes effect June 1 as work on the campus in Hershey moves to the next phase.

There are two sets of phases for research ramp-up: one at the University level from the Office of the Senior Vice President for Research, and one for the College of Medicine.

Researchers should follow the guidance from both the University and the College of Medicine.

Under the new guidance, observational studies at Penn State Health (inpatient and outpatient) locations may resume under the following conditions (must follow guidelines):

  • The subject will be present on campus for a clinical reason (either outpatient clinical visit or inpatient hospitalization or procedure).
  • Approval has been obtained to recruit patients for the specific study in writing (via email) from the medical director of the unit.
  • Use of PPE (mask, gowns, face shields, etc.) follows practices of good stewardship as outlined by Penn State Health.
  • All studies and study changes have IRB approval. See the IRB COVID-19 guide for required IRB submissions for modifications and reporting study deviations.

See page 3 of the Revised Standards for Human Subjects Research for additional guidelines for research visits.

The revised standards are available in Box at psu.box.com/v/COVIDResearchVisits. They will be updated as the situation further develops, and continuing updates will be made on the College of Medicine’s coronavirus page at med.psu.edu/coronavirus and Penn State’s Research website at research.psu.edu.

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