Clinical research changes for College of Medicine take effect Feb. 15, 2021
Effective Monday, Feb. 15, 2021, the following standards are in place for clinical research at Penn State College of Medicine, per Dr. Kevin Black, interim dean, and Dr. Leslie Parent, vice dean for research and graduate studies:
- Clinical research studies involving in-person interactions and having a direct drug or device therapeutic benefit continue to be permitted.
- Each study team should review their protocols and procedures to assure that all activities that can be performed remotely are done so to minimize in-person interaction.
- Double-masking (wearing a procedure mask as the first layer then a cloth mask over it) or adjusting procedure masks to be tight-fitting is recommended for both study personnel and study subjects according to CDC data.
- Observational clinical research studies involving participants who are already on campus for a health care appointment will be permitted if all four of the criteria below are met:
- The study only involves limited sample collections; and
- The participant remains in one location for both the health care visit and research visit; and
- Interaction between study staff and subject is fewer than 15 minutes; and
- The subject’s face mask is not removed at any time.
- Observational clinical research studies that involve participants who are already on campus for a health care appointment that do not meet all of the four above criteria must be submitted for review through the University’s InfoReady system.
- Observational research not in the course of a clinical visit is not permitted at this time. The re-opening of these studies will be reassessed weekly. To prepare for expansion of observational research in this category, please note that studies previously approved through InfoReady will not require resubmission unless there are significant changes to the protocol since the previous review. Investigators who have not yet submitted their protocol through the InfoReady system may begin to submit their studies now in anticipation of restarting observational research.
- Refer to the COVID-19 and Research website for the policies and guidelines governing the research environment during the COVID-19 pandemic.
- Revised Standards for Human Subjects Research
- College of Medicine full COVID-19 guide
- College of Medicine detailed guide on COVID-19 and research
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