May 11, 2020 - Plans to Reinstitute Human Subjects Research Activities
May 11, 2020
Dear Research Community,
In anticipation of the Commonwealth of Virginia entering into Phase I of its multi-phased approach to lifting COVID-19 restrictions, Virginia Tech is carefully planning how to reinstitute our research activities.
The governor’s move to Phase I is not an automatic reinstatement of in-person research activities. The decision to reinstate non-essential activities is based on state and university allowable movement. When non-essential activities are allowed, the Virginia Tech Human Research Protection Program (HRPP) and Institutional Review Board (IRB) will reinstate human subjects research in accordance with any state or local conditions.
As we prepare for reinstating in-person research activities, please keep the following in mind:
- Until the threat of COVID-19 subsides, all new and reinstated human subjects research that can be conducted virtually, must continue virtually. · HRPP will notify researchers via email and on our website when researchers are permitted to resume face-to-face human subjects research.
- HRPP and the IRB are preparing specific guidance on resuming in-person human subjects research and will share this guidance as soon as it is approved. Guidance will be emailed to all researchers and along with other updates, the information will be posted on the research COVID-19 webpage.
- In the meantime, there are several things research teams can do to prepare to begin or resume in-person research activities (do not submit any of these items to HRPP until instructed to do so by a subsequent email):
- For reinstated research, prepare a Principal Investigator (PI) statement on the effects of COVID-19 and the associated prevention measures (e.g., stay-at-home orders, physical distancing) on the scientific validity of the research project. Please consider the impact on the validity of the outcomes of interest as well as the independent variables you are collecting.
- For new and reinstated research, prepare a PI statement on the specific risks associated with transmission of COVID-19 while conducting in-person activities in the proposed location (e.g., city, state, country) and setting (e.g., school, hospital, nursing home). This statement should conclude with an acknowledgment that the PI is responsible for monitoring COVID-19 resurgence and new restrictions in the study location(s) and setting(s), and that the PI will pause the study when warranted.
- Prepare a COVID-19 risk mitigation standard operating procedures (SOP) for your study using the most current recommended decontamination and transmission-prevention techniques.
- For studies that are being conducted in a behavioral or biomedical laboratory setting, prepare a lab-specific COVID-19 risk mitigation SOP. Also prepare a lay language version of the SOP and provide it to each participant. The mitigation plan must include a plan for contacting participants who might have been exposed to the virus by a member of the research team or another participant who tested positive within 14 days of their study visit.
- For studies conducted outside the laboratory setting, prepare a study-specific COVID-19 risk mitigation SOP. Also prepare a lay language version of the SOP and provide it to each participant. The mitigation plan must include a plan for contacting participants who might have been exposed to the virus by a member of the research team or another participant who tested positive within 14 days of their study visit.
- Ensure that proposed reimbursement and compensation reflect expenses incurred as a result of participation and fair compensation for participant time. Incentives beyond these items should be in line with pre-COVID-19 incentives to prevent undue influence on a participant’s decision to enroll.
- Prepare and have a process for maintaining a daily contact tracing log that is distinct from either the scheduling log or other study rosters. The daily contact tracing log should include participant name and contact information, date of visit, and names of all research personnel and other participants who came into contact with the participant at the visit (information sufficient to conduct two-way contact tracing). The contact tracing log should be stored securely in a separate location from other study data and information. The contact tracing log must be made available for inspection or copying by public health authorities in the event of an exposure to a case of COVID-19. The daily contact tracing log must be expunged (deleted or shredded) 60 days after a participant’s last visit.
As always, HRPP is available to help facilitate the process, so please do not hesitate to reach out to us at email@example.com for assistance or questions.