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Clinical research standards for College of Medicine

Effective Aug. 2, 2021, the following standards are in place for clinical research at Penn State College of Medicine:

  • Clinical research studies involving in-person interactions and having a direct drug or device therapeutic benefit continue to be permitted and do not need to submit through the university’s InfoReady process.
  • Any research that can be conducted remotely (such as using Zoom) should be conducted remotely.
  • In-person, human subjects research that meets the following criteria may resume without additional COVID-safety reviews and approval via InfoReady (Note: 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). It is recommended Penn State staff upload their vaccination status.
      • If study staff choose not to report vaccination status, the study must be reviewed via InfoReady.
    2. For studies conducted indoors, all study staff and participants must remain masked at all times regardless of vaccination status.
      • If study staff visit a venue such as a community center, public event or K-12 school where masking is optional, study staff must still wear a mask but participants may follow the venue’s guidance. All other indoor studies where masks are removed must be reviewed via InfoReady.
      • 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. Exception: On the College of Medicine campus, both participants and study staff must be masked.
    4. The study does not target high-risk participants for recruitment (high-risk is defined according to CDC).
    5. Participants are screened for COVID-19 using the Clinical Research Study Participant Screening Script.
    6. Appropriate cleaning procedures are in place for shared materials and spaces.
  • In-person, human subjects research that does not meet criteria 1 through 6 above must submit through the InfoReady process for review.
  • Studies that have been previously reviewed through the InfoReady process should continue as approved. Modifications to the study that comply with the above six criteria are permitted without additional InfoReady review.
  • Observational clinical research studies where subjects are entering campus for non-clinical or research-only reasons are allowed.
    • Observational studies involving participants who are already on campus for a health care appointment and where all four of the criteria below are met do not require further approval through InfoReady:
      1. The study only involves limited sample collections.
      2. The participant remains in one location for both the health care visit and research visit.
      3. Interaction between study staff and subject is fewer than 15 minutes.
      4. The subject’s face mask is not removed at any time.
  • On-campus and in-person COVID-19-related research may be allowable with appropriate IRB and Biosafety approvals. COVID-19-related research must be approved by unit leadership.
  • Remote study sponsor and monitor visits for clinical trials or other human subject-related research are encouraged. However, exceptions for in-person visits for site qualification, site initiation, study closeout or monitoring may now be allowable if permission is granted.
  • Refer to the COVID-19 and Research website for the policies and guidelines governing the research environment during the COVID-19 pandemic.

See the full revised standards for clinical research here

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