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University clarifies standards related to clinical research visits

In the context of rapidly evolving circumstances regarding COVID-19, and the University’s focus on social distancing and the health and well-being of the community, the Office of the Senior Vice President for Research of Penn State issued new guidance March 15 to the Penn State research community regarding human subjects-related research visits.

Lora Weiss, PhD, Senior Vice President for Research, Penn State, in consultation with Leslie J. Parent, MD, Associate Vice President for Health Sciences Research, Penn State, and Vice Dean for Research and Graduate Studies in the College of Medicine, issued the revised standards, which apply to all human subjects-related research visits at all Penn State colleges and campuses and all Penn State Health sites during COVID-19 outbreak.

In summary, research visits should be performed remotely (e.g., by phone, Zoom or other means) whenever possible. Studies involving face-to-face interaction with participants with no direct drug or device therapeutic benefit are to be postponed until further notice, effective March 15, 2020.

The office also issued a clarification on March 27, 2020, noting that for research at Penn State Health, any observational study (whether inpatient or outpatient) that requires any additional face-to-face contact with patients will not be allowed.

In addition, to demonstrate stewardship of personal protective equipment that is necessary for the safety of providers, any sample collection that requires any use of PPE (masks, gowns, face shields, etc.) is not allowed, except as part of an interventional study with the potential for direct patient benefit.

Due to biosafety concerns, and in conjunction with the CDC recommendations for specimen handling from COVID-19 patients, any study that aims to enroll COVID-19 subjects will require a modification to the protocol for IRB approval, which will include a biosafety review. COVID-19 patients cannot be enrolled on existing protocols without this modification approved.

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/covid.

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