In-person clinical research advances to next phase with July 10 changes
On July 10, 2020, Dr. Lora Weiss, senior vice president for research at Penn State, released a statement allowing for an increase in in-person human subjects research, with appropriate approval, on campus.
Dr. Neal Thomas, Associate Dean for Clinical Research at the College of Medicine, noted that for the College of Medicine, this does not affect observational studies that have already been approved (those conducted with subjects who are on campus for clinical reasons). Any other studies that are observational, where subjects will only be coming to campus for research purposes, will be required to follow the procedures listed here.
Message from Dr. Weiss
In May, we formed a committee to develop the next steps for conducting in-person human subjects research while mitigating the risks of face-to-face interactions during the pandemic. The committee was chaired by Candice Yekel, Associate Vice President for Research and Director of the Office for Research Protections, and included faculty, researchers, IRB professionals and administrators. The committee received additional feedback from other faculty and leadership across multiple colleges.
The overall purpose is to ensure safety precautions are in place before commencing with in-person human subjects research. As a reminder, under the Revised Standards for Human Subjects Research, only drug/device therapeutic studies and observational studies at Penn State Health can be conducted in-person at this time. All other human subjects research must be conducted remotely or paused.
The committee has recommended, as an initial rollout, that a small number of in-person studies be allowed on-campus (Penn State-owned and -operated facilities only). This is separate from IRB approval, since the focus is on precautions related to COVID-19. This plan was presented to ALC, and they are supportive.
In this first phase of beginning to increase in-person human subjects research, we are asking leadership to be discerning and judicious in the research they approve. Deans and chancellors will need to be aware of the required safety procedures. They may want to consolidate research areas, and they will need to balance research progress with the risks of COVID-19. This is not simply a formality. A researcher must demonstrate strong rationale for bringing participants onto campus.
- Researcher submits Request to Conduct In-person Human Subjects Research During COVID-19 Pandemic form via InfoReady. Note that all College of Medicine requests must list Dr. Leslie Parent as approver, and must list her email as firstname.lastname@example.org.
- Dr. Parent will review the requests in InfoReady; she can approve or reject the research proceeding. InfoReady will send an email when a request is ready for review.
- If approved by Dr. Parent, requests will then be forwarded to the Office of the Senior Vice President for Research (OSVPR) for approval.
- Once confirmed by OSVPR in InfoReady and prior to initiating research, studies must have approval from the appropriate compliance committees, such as the IRB.
- Procedures: Request to Conduct Human Subjects Research During COVID-19
- 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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