Summer 2021 Research Guidance
Updated June 17, 2021
NOTE: ALL RESEARCH GUIDANCE IS EVOLVING.
In alignment with Governor Ralph Northam’s Executive Order 72, Executive Order 79, and guidance from the Centers for Disease Control and Prevention on masks, fully vaccinated Virginia Tech students and employees do not have to wear masks in most indoor settings, including laboratory and research spaces.
Unvaccinated individuals are strongly encouraged to make an appointment for vaccination unless there is a medical or religious exemption.
Unvaccinated individuals should continue to wear masks in indoor settings. Face coverings can be reusable or homemade cloth masks, dust masks, or surgical masks.
Unvaccinated individuals must be separated by more than 6 feet at all times, but more space is desired when possible. Consider instituting staggered or alternative scheduling to reduce the number of unvaccinated laboratory personnel present at any given time.
- All approved undergraduate paid, for-credit, and volunteer research and instruction may be in person, provided appropriate approvals and protocols are in place (i.e., PPE use, lab hygiene, Institutional Review Board approvals, etc.).
- All graduate paid, for-credit, and volunteer research and instruction may be in person provided appropriate approvals and protocols are in place (i.e., PPE use, lab hygiene, Institutional Review Board approvals, etc.). This includes students participating in project/thesis/dissertation work.
- Masks and physical distancing are no longer required for research performed in laboratories by vaccinated individuals.
- Unvaccinated individuals or individuals with unknown vaccination status must adhere to appropriate use of PPE with continued strict adherence to safety/hygiene and physical distancing requirements.
- Research conducted in labs must have approval from the appropriate lab manager and principal investigator(s). It is the responsibility of the lab manager or principal investigator to determine appropriate protocols in the laboratory, depending on the vaccination status of individuals in their lab. For guidance on how to determine vaccination status, read the May 18, 2021 campus notice.
- Core facilities should be at full operation.
- Individuals who are at high risk (existing medical condition, age, recent potential exposure, including travel to a high risk zone, possible COVID-19 symptoms, or cohabitating with someone in one of these categories) may choose to not work in the lab. Persons with these concerns should contact the Division of Human Resources.
- Research with human subjects is allowed as permitted by the Institutional Review Board and requires completion and approval of the COVID-19 Resumption of In-person Research Requirements Template. In-person research with human subjects will be carefully considered to ensure that appropriate protocols are in place to protect the safety of subjects and staff.
- Travel, aligned with federal and state regulations, is allowed with approval from the department head.
Virginia Tech Institutional Review Board: Conducting Human Subjects Research
The Virginia Tech Institutional Review Board (IRB) has been monitoring the status of the COVID-19 pandemic and COVID-19 vaccination levels. The below requirements replace existing/past IRB guidance on conducting in-person research during COVID-19.
- It is the principal investigator’s (PI) responsibility to monitor local conditions and to pause in-person research or to institute protective measures when warranted. The Virginia Tech Human Research Protection Program (HRPP) or the Institutional Review Board (IRB) does not need to be notified if the study is paused. If protective measures are such that an amendment is warranted, then an amendment must be submitted. Please keep the vulnerability of the participant population in mind when making decisions about pausing research or instituting protective measures. For example, medically vulnerable populations or protected classes of participants (e.g., children, prisoners, pregnant women) could require special protections. The study team may include protective measures that exceed current state, local, and university requirements.
- The PI should carefully consider which research activities can be conducted remotely/virtually and plan accordingly (following the principle of keeping activities remote when feasible). The PI should communicate the justification for conducting in person activities to all research team members.
- Pre-approved COVID-19 prevention plans for in-person research are no longer needed for new research (including lab and participant standard operating procedures, contact tracing logs, and consent addenda) as long as the team conducts the study according to current IRB, Centers for Disease Control and Prevention (CDC), and university guidance.
- Amendments to approved resumption plans are not needed for studies where such plans are already in place, as long as the team conducts the study according to current IRB, CDC, and university guidance.
- Protocol amendments might be needed to bring protocols into alignment with plans to resume in-person activities. Please carefully review the current, IRB-approved study materials and submit an amendment if one is needed. Amendments are necessary for protocols that included COVID-19 mitigation strategies that the researcher plans to lift.
- Studies that were approved but paused (i.e., studies without resumption plans) may resume with their previously approved research, as long as the team conducts the study according to current IRB, CDC, and university guidance. Due to the long break in research activities, PIs should carefully review the current, IRB-approved study materials and submit an amendment if necessary.
- Vaccination status can be used as an inclusion/exclusion criterion at the PI’s discretion. If used, it must be documented in the eligibility criteria section so that it can be evaluated in the same way as other eligibility criteria (e.g., Does it make sense for this study and this population? Is it discriminatory in this context?). Researchers who plan to use vaccination status as a criterion must weigh whether they will require proof of vaccination (e.g., vaccination card). If so, appropriate care must be taken with such documentation as it can be viewed as sensitive information by some members of the public. Self-disclosed health information is not covered under the Health Insurance Portability and Privacy Act (HIPAA) regulations, so asking for vaccination status is not a HIPAA violation (see https://www.hipaajournal.com/is-it-a-hipaa-violation-to-ask-for-proof-of-vaccine-status/).
- Researchers and study staff who will be interacting with participants should be vaccinated, and be willing to disclose their vaccination status to participants.
- The PI should consult current CDC and university guidance regarding mask-wearing and social distancing requirements, taking into account factors such as research location (e.g., inside or outside), building and room ventilation, and duration of in-person interaction.
- Cleaning and sanitation procedures developed for COVID-19 laboratory SOPs should be retained to the degree possible, based on CDC and university recommendations. This applies to shared equipment, commonly touched surfaces, more frequent changing of HVAC filters, and shared clothing.
Researchers should not come to work if they have any of the following symptoms:
- Fever (temperature >100.4°F)
- Tiredness (fatigue)
- Muscle pain
- Loss of taste or smell
- Difficulty breathing
- Sore throat
Researchers with a fever are not allowed in laboratories/research spaces at any time. If they have a temperature and demonstrate any of the additional COVID-19 symptoms, they must report it to their supervisors and not come to campus.
Researchers who test positive for SARS-CoV-2 must remain in isolation for at least 14 days from symptom onset or until free from unmedicated fever for 72 hours, whichever is longer — or follow current public health official’s guidance. Individuals awaiting test results must remain in isolation.
Vaccinated individuals who have come in close contact with confirmed cases or returned from travel do not need to quarantine unless they become symptomatic. Unvaccinated individuals who have come in close contact with confirmed cases must remain in quarantine for 14 days.
Non-laboratory Based Research Work
Virginia Tech faculty represent a variety of disciplines that have different research practices and in various research spaces. The same safety requirements and considerations for unvaccinated individuals performing non-laboratory research include: proper physical distancing, personal hygiene including wearing face masks at all times, and contact surfaces cleaning as described under key safety expectations.
All visitors to research spaces and labs must adhere to the guidance listed above and in accordance with lab specific protocols.
For questions regarding other health and safety concerns, contact Virginia Tech’s Environmental Health and Safety office: 540-231-3600.