Face-to-Face Research Resumption

These materials are intended to help you design, conduct, and revise your face-to-face (FtF) human subjects research (HSR) in light of the ongoing pandemic.  USM, along with virtually all other research institutions around the country and the world, is requiring additional scrutiny of proposed HSR projects and additional responsibilities of researchers.  In most cases, these added responsibilities involve physical distancing, masking, cleaning precautions other measures as may be prudent on a case-by-case basis.  Human subjects protocols involving only online modes of data gathering, such as Qualtrics surveys, are unaffected.

Faculty submit Request for Return to Research Form https://forms.usm.edu/research/view.php?id=13688

• This form, submitted to and reviewed by the Vice President for Research, must be reviewed and approved prior to IRB submission.  
• This step is required for resuming or initiating FtF HSR research, even if previously granted lab access through a similar process.
• Additionally, members of the College of Education and Health Sciences must follow the CoEHS Return to Research Guidelines. Any must be approved by the Director. Graduate students and undergraduate students may access lab spaces but must follow safety protocols and adhere to capacity limitations. 
• Your contact person for queries involving the VPR Office part of the process is Kimberly.WingoFREEMississippi and see https://www.usm.edu/vice-president-research/covid-19-research-guidelines.php

• When the FtF HSR will be conducted off campus, an additional step is required: after review and approval of the Request for Return to Research, VPR Office sends COVID Authorization & Release Agreement to all identified individuals listed in request
• Once all agreements have been signed and received and approved, VPR Office notifies IRB and the researcher(s), and the IRB approval process can begin.

Researchers then have to submit in Cayuse a modification form to an existing active IRB protocols or submit a new proposal.  In both cases, researchers need to explain in detail how COVID-related safety measures will be integrated into their FtF research procedures.

Compliance with standard laboratory safety protocols and PPE is expected when working within laboratory facilities. Do not share PPE with other research personnel. Non‐disposable PPE should be cleaned/disinfected on a daily basis.

Consult and comply with CDC Prevention Guidelines

• WASH HANDS frequently with soap and water.
• AVOID touching your face or mask with unwashed hands.
• AVOID close contact and practice social distancing.

Regardless of University Response status, the number and duration of FtF personal interactions should be reduced to the minimum needed to conduct the HSR protocol in question.

Time and occupancy within the lab by research personnel should be limited; data workup, analysis, and writing activities should be completed remotely when practicable.

Individuals who have previously tested positive for COVID-19 may participate in FtF HSR provided all three of the following conditions are met:

1. No fevers (temperature >100.4 F) for at least 72 hours (that is three full days of no fever without the use of medicine that reduces fevers such as Tylenol or Ibuprofen); and
2. Other symptoms (for example, cough or shortness of breath) have improved; and
3. At least 14 days have passed since symptoms first appeared.

Asymptomatic persons exposed to a person with known or suspected COVID‐19 infection within 48 hours of symptom onset must follow these instructions as a condition of participation in FtF HSR: 

• Self‐isolate and stay home until 14 days after last exposure to a close contact who is known or suspected to be positive for COVID‐19. (A close contact is defined as a household member, intimate partner, individual providing direct care or other individual -- including lab members on the same shift/rotation or prolonged overlap in the same lab space -- with whom the employee or student has had prolonged close exposure (<6 feet).
•  Self‐monitor for the development of COVID‐19 symptoms such as fever >100.4F, cough, or shortness of breath. If symptoms develop during the 14‐day isolation period, contact Student Health Services at Moffitt Health Center or your primary healthcare provider to discuss the symptoms and testing.
• If symptoms are not developed after experiencing close contact exposure, the person may return to campus and research spaces after 14 days or upon testing negative for COVID‐19.