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 new in-person human subjects non-clinical activities can begin until approved by the department chair (or unit manager). The plan should be forwarded to the College Dean (or HSC Office of Grad Ed and Research, if appropriate) for recording purposes, who will then forward to the WVU Research Office (firstname.lastname@example.org). The WVU RO may engage Tanya Moran (co-Director of Clinical Trials) for her recommendations. If revisions are needed, the WVU RO will work directly with the PI until the plan is satisfactory. Approvals will be communicated with the PI and cc'ed to the relevant chair and dean.
- Standard Operating Procedures for Face-to-Face human subjects research include:
- List of all personnel involved in data collection or in a shared research space (e.g lab, office, studio, etc) must be shared with the department chair. Undergraduates can participate but should not displace graduate students in maintaining the 200 sq.ft. per person minimum in on-campus facilities.
- 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 when possible to physically distance from others by at least 6 feet.
- Participants must use a face mask when research procedures allow; 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, 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 lab, 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) but should be part of the operations plan.
- If non-WVU agencies or research partners are actively engaged in the research, the research should be engaged using the guidelines that are the most stringent unless expressly permitted by the partner agencies.
- 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.
- Both in-state and out-of-state travel to the research site are allowed. Please follow the university guidelines on travel:
- If traveling long distances, stops should only be made for fuel and restrooms. Sanitize and/or wash hands after these activities. Each person on the team should have their own hand sanitizer bottle clearly labeled with their name and bottles should not be shared. Hand washing with soap and water a highly encouraged practice every few hours.
- No more than two people may occupy the row of a vehicle to, from, and at the research site. Masks are to be worn in vehicles when there is more than one person (unless said persons are already in the same household). If possible, travel with windows open. High touch areas (i.e., keys, door handles and steering wheel) must be disinfected before and after each trip and between drivers if there is a driver switch.
- All research team members should bring ample water/liquids and food for themselves in clearly labelled bottles and containers. No sharing of drinks or food is allowed.
- For all face-to-face research activities, researchers should assess whether the benefit for participants is higher than the risk of getting infected. Researchers should also assess their own and their research teams’ risk of conducting the research (Is the risk of getting infected higher than the benefit of conducting the research?) and adjust their data collection method accordingly.