Standard Operating Procedures (SOP) for Off Campus (any WVU facilities - owned or leased, non-HSC) Face-to-Face (in-person) Human Subjects Research with COVID-19 Impacts. Face-to-Face human subjects research being conducted on the HSC campus should follow the May 8 memo.
The intent of this standard operating procedure (SOP) is to minimize the risk of COVID-19 disease transmission and protect the health and safety of personnel conducting face-to-face human subjects research as well as those who are participating in the research. Failure to follow this SOP may result in suspension of research.
All studies that can continue to collect data remotely should do so. As a reminder, Full Board and Expedited research studies that have not yet amended their WVU IRB protocols to include the option to conduct procedures of their research remotely (who are now collecting data remotely) using video conferencing, phone, electronic surveys, electronic consent (e-consent) and other remote methods should do so.
No in-person human subjects research can begin until approved by the department chair (or unit manager) and College Dean (or designee). If there are any required deviations from the SOP, these must be approved by the Research Office.
- Faculty, students, technicians and other staff must not be compelled to engage in activities that they are not comfortable with. The faculty researcher will inform their staff that they have the right to refuse to engage in activities that could expose them to the public and obtain positive consent of their willingness to assume the risks involved. Each returning researcher who has on-site supervision of graduate students, undergraduates, staff and/or postdocs are required to sign a pledge indicating that they will abide by the university, college, departmental and group plan. Find the PI/Faculty Pledge here.
- Standard Operating Procedures for Face-to-Face human subjects research include:
- List of all personnel that will be involved in the research should be shared with the department chair. Undergraduates can only participate in extraordinary circumstances and must be approved by the research office.
- Face-to-face human subjects research activities must be carried out in a safe way to prevent the spread of COVID-19 as much as possible. Each person on the team is expected to have a face mask and to use their mask at all times and to physically distance from others by at least 6 feet.
- Participants must use a face mask; at all times, the researcher must wear a face mask or have another way to prevent transmission of the virus, e.g., the use of plexiglass barriers (See DIY Face Masks and Shields from Michaels for one possible source), face shields for researchers, etc. Exact PPE use must be part of the plan approved by the unit and college.
- Face-to-face human subjects research must comply with the overall University guidelines for research.
- Steps taken to minimize the risk of COVID-19 disease transmission such as screening participants and staff, wearing a mask, honoring physical distancing, reducing the number of participants in a session, or testing for COVID are not considered part of the research and thus do not require an IRB amendment to the protocol (unless requested by a funder or external IRB).
- No one may participate in any research work if they are feeling ill or if any members of their household are experiencing COVID symptoms. All researchers must be provided with the University handout on the list of COVID symptoms that includes a link to the latest CDC guidelines and must self-isolate if experiencing any COVID symptoms.
In this phase, only participants who are not considered high risk by the CDC can serve as research participants for face-to-face human subjects research. Researchers should ask participants to certify they do not fall into a high risk category before scheduling their research visit. See CDC Guidelines for at-risk people.
All participants must be screened for COVID symptoms by phone the day before their session (same procedure being used by medical clinics) and checked on arrival for their session that they still answer no to all screening questions. See COVID Health Checklist guidance. Researcher certification that they followed this procedure will suffice as the record and no further records need be maintained.
A log of each day’s participants must be recorded for potential contact tracing purposes and must be maintained in a secure location; log entry must be kept for 3 weeks and then securely destroyed; if a research staff member becomes ill with COVID, they must follow the University reporting guidance.
We recommend that researchers develop a contingency plan for carrying on research if one or more personnel becomes sick or is no longer willing to risk conducting the research.
Between research participants all equipment must be disinfected; if data collection involves participants touching computers, disposal keyboard covers should be considered.