Mar 13, 2020 12:30 PM

Based on the March 13th, 2020 communication from Penn Medicine we are updating the guidance regarding the execution of clinical research.

Note: Although the below guidance applies to Penn Medicine, we recommend that non-Penn Medicine researchers review the guidance for any procedures that may be prudent or necessary to ensure the safety of participants and research staff.

This will apply for a minimum period of 14 days. 

• Non-essential ‘in-person’ clinical research appointments and procedures for research participants should be canceled.

• Research staff should make efforts to use alternative methods to conduct research visits or perform testing such as check-in with participants by phone and/or performing research-related lab testing at lab testing centers, where feasible.

• Research visits that are directly linked to treatment and/or essential for the clinical care of existing research participants should continue to take place. 

• Monitoring and auditing of research studies should be conducted remotely. 

• New clinical research studies and trials that involve utilization of Penn Medicine facilities should not be initiated during this time. COVID 19 related studies are exempt from this requirement. 

• New participant enrollment onto existing studies should only proceed if the principal investigator believes it is in the best interest of the research participant.

• Principal Investigators should let commercial sponsors know that enrollment into ongoing trials is temporarily postponed. 

• As a reminder, when working remotely with PHI, you should only use approved and compliant options, such as Secure Share, PennBox, or other Penn-managed shared drives. 

 

If you have questions about this guidance, please send inquiries to: 

• IRB related inquiries: PROVOST-IRB@pobox.upenn.edu

• Other research related inquiries: psom-ocr@pobox.upenn.edu