Dear Pitt Colleagues,

As Allegheny County continues to experience an increased incidence in positive COVID-19 cases and hospitalizations, Pennsylvania’s Department of Health and Allegheny County issued guidance this week advising residents to stay home and avoid unnecessary travel.

Given this rise in positive cases, Pitt’s Health Care Advisory Group (HCAG) has recommended that the University’s Tier 3 research activities in Allegheny County be conducted remotely without in-person study visits until further notice. The Pittsburgh campus operational posture remains the same, at Elevated risk.

Tier 3 studies are defined on the Institutional Review Board (IRB) website as:

Low Direct Benefit to Research Participants and Other Impacts to Research

• Research with healthy volunteers
• Protocols in which risks to research participants are higher (e.g., potentially exposing elderly vulnerable individuals to COVID) and benefits of the study to the participants remain minimal
• Protocols in which delays to starting or pausing of research does not substantively impact on research objectives of the research protocol
• Any minimal risk studies that require research subjects to travel, that involve undergraduate students, or that are in a community setting and require direct interaction with researchers
• Cohort and natural history studies where delays in data collection have limited impact on scientific objectives

Research activities in Tier 3 must not enroll new participants in studies requiring face-to-face interaction or continue to conduct face-to-face visits. On-line visits or data collection that does not require direct participant interaction may continue. 

No additional restrictions have been placed on Tier 1 and 2 human subject studies (with high or moderate direct benefit to the participants or have a high public health priority).

If you are unsure about the Tier Status of your human participant study, please contact the IRB: askirb@pitt.edu.

Note that there is no restriction on studies that are conducted through remote interaction with subjects, if performed in accordance with an approved IRB protocol. In addition, this restriction only applies to studies conducted in Allegheny County. Studies at other sites should comply with local regulations.

The restriction on in-person interactions with human participants in Tier 3 IRB studies should be implemented as soon as possible, and no later than November 25.

Questions about these restrictions should be directed to the IRB at askirb@pitt.edu. 

Thank you for your cooperation,

-rob

Rob A. Rutenbar
Senior Vice Chancellor for Research