Clinical research changes for College of Medicine take effect March 15, 2021
Effective Monday, March 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.
- Any research that can be conducted remotely (such as using Zoom) should be conducted remotely.
- Observational studies where subjects are entering campus for non-clinical or research-only reasons will once again be allowed.
- Studies that have been previously reviewed through the InfoReady process, and that do not have significant modifications since they were reviewed, can move forward starting March 15. However, study teams will receive a request for a small amount of additional information.
- Studies without prior approval will need to be reviewed at both the College of Medicine and the university through the InfoReady process.
- The only studies excluded from the InfoReady process are observational clinical research studies involving participants who are already on campus for a health care appointment and where all four of the criteria below are met:
- The study only involves limited sample collections.
- The participant remains in one location for both the health care visit and research visit.
- Interaction between study staff and subject is fewer than 15 minutes.
- 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.
- IRB-approved studies allowed to move forward must adhere to the following additional guidance:
- 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.
- Participants should be provided with information regarding the current COVID-19 pandemic and how best to reduce their risk of infection. This information may be provided in multiple forms suited to the type of contact, including a website link, a telephone script and an in-person handout. If possible, this information should be shared before the research visit. See the CDC COVID-19 link for reference and materials.
- All research participants should be screened remotely using the Clinical Research Study Participant Screening Script.
- Affiliate sites should follow the screening procedures for their sites.
- All activities that can be performed remotely are done so to minimize in-person interaction.
- Ensure the research staff and participants have necessary supplies, such as hand sanitizer that contains at least 60% alcohol, tissues, trash baskets, disposable face masks, and cleaners and disinfectants. Clean frequently touched surfaces and objects with detergent and water prior to disinfection.
- 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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