Revised Standards for Human Subjects Research Updated

Coronavirus

Office for Research Protections     |     Institutional Review Board      

The Revised Standards for Human Subjects Research have been updated by the Office of the Senior Vice President for Research, in consultation with the Vice Dean for Research and Graduate Studies in the College of Medicine.  Effective August 2, 2021, the conditions for when additional COVID-safety reviews are required is changing. 

Starting August 2, in-person, human subjects research that meets the following six criteria may resume without additional COVID-safety review (important: IRB review and approval is separate from COVID-safety reviews in InfoReady):  

  1. All study staff with face-to-face contact with participants are fully vaccinated (full regimen plus two weeks). [Recommend that Penn State employees upload their vaccination status.]

    1. If study staff choose not to report vaccination status, the study MUST be reviewed viaInfoReady.
  2. For studies conducted indoors, all study staff and participants must remain masked AT ALL TIMES regardless of vaccination status.

    1. Exception: if study staff visit a venue (e.g., community center, public event, K-12 school) and masking for participants is optional, study staff must still wear a mask but participants may follow the venue’s guidance.
    2. All other indoor studies where masks are removed MUST be reviewed via InfoReady.
    3. Note: all home studies continue to require review via InfoReady.
  3. For studies conducted outdoors, study staff must remain masked at all times but participants may be unmasked if they choose.

    1. Exception: on the College of Medicine (COM) campus, both participants and study staff must be masked.
  4. Study does not target high-risk participants for recruitment (high-risk is defined according to CDC).
  5. Participants are screened for COVID following University or College of Medicine procedures.
  6. Appropriate cleaning procedures are in place for shared materials and spaces (University and College of Medicine).

 

If research cannot meet the outlined six criteria, a researcher must follow Procedures to Request to Conduct In-Person Human Subjects Research During COVID-19. 

See the Revised Standards for Human Subjects Research for information specific to College of Medicine and Penn State Health sites.