COVID-19: Research Operations at WSU
This document describes WSU’s plan to return to on-site research, scholarship, and creative activities in a staged manner, including system-wide efforts to assist researcher success during the Covid-19 pandemic. WSU research is currently in Stage 3.5 of this guidance (for a comparison of changes within the document between Stage 3 and Stage 3.5, see the track changes version).
The Staged Return to Human Subject Research document is intended to provide guidance for restarting human subject research and applies to protocols with current approval by the Institutional Review Board (IRB).
How does the May 26 WSU mask mandate announcement impact in-person human subjects research?
• In research settings, treat research participants the same as WSU visitors (not volunteers, who are technically unpaid employees):
o Researchers should inform participants of WSU masking policy and that they have the choice to either: 1. Show evidence of vaccination (no information need be collected, just a verification) and not wear a mask or; 2. Not show evidence of vaccination and wear a mask.
o Disclosure of health information must be voluntary.
o Acceptable proof would be any of the forms in the general guidance (e.g. including: CDC vaccination card or photo of vaccination card)
o If a participant does not want to be vaccinated or share that information, they need not show any proof, but they will need to wear a mask.
o It is recommended that researchers NOT keep health records when they are not directly related to research.
o If the researcher did keep a list of participants not required to mask (e.g., for return visits) this would not be HIPAA* protected information but should be stored securely in compliance with WSU data security policies.
o Consider building this into the informed consent process (not the consent form, this can be kept verbal because it is not directly related to the research, but consider utilizing a script for consistency)
• In situations where unvaccinated participants cannot mask (due to the research procedures), the PI will need to address how they will limit risk to participants (e.g. research staff might mask when the participants status is unvaccinated or unknown). Consult with ORA/HRPP for assistance, an IRB protocol amendment may or may not be required.
• In situations where neither researchers nor participants can mask AND vaccination status of anyone is unknown/not vaccinated, the IRB will need to re-assess risk/benefit, this will likely require a protocol amendment, consult with the HRPP to confirm.
*Self-reported health information is not HIPAA protected (but still sensitive if collected).
Monitoring and managing compliance with staged return to on-site research, scholarship, and creative activities – Version 1.0 (9/25/2020)
- Compliance monitoring is one of the seven elements of an effective compliance program, derived from the US Federal sentencing Guidelines (FSG), and is necessary for WSU and its research community to show due diligence in implementing a safe return to the conduct of research and scholarly activities during the COVID-19 pandemic. As recommended by the Attorney General’s Office, and in order to demonstrate that individuals involved in the WSU research enterprise are carrying out the duties of their position in good faith, WSU research faculty, staff and administrators must participate in monitoring and documenting compliance with the requirements to safely return to research (as outlined in the WSU Staged Return to On-site Research, Scholarship and Creative Activities plan).
- Monitoring is accomplished by PIs, research leaders, and/or delegates, that have a Return to Research plan and are engaged in on-site activities. While most labs will have personnel on-site that can verify weekly compliance on an ongoing basis by completing Attachment I, there are rare cases where monitoring frequency may be reduced should there be less frequent on-site activity (i.e., less than weekly), personnel on-site (i.e., only 1 individual in the research space), or other reasons. Monitoring should be completed by personnel already on-site for research activities. Less frequent monitoring needs to be approved by the department chair and local campus unit director (approval documentation must be made available when requested). This monitoring must also be displayed along with the final signed checklist.
Exception Request: Staged return to on-site research, scholarship, and creative activities (10/9/2020): Guidance and Form.
The goal of the Exception Request is to approve activities currently not permitted or clearly addressed under the present “stage” of the “staged return to on-site research, scholarship, and creative activities” guidance via a review process by subject matter experts and college/department/unit leadership on a case-by-case basis. The requests for departures from the guidance must be based on public health authority or medical recommendations and contain appropriate mitigation/safety measures that may not have been clearly addressed or applied directly in the guidance.
WSU is closely monitoring the coronavirus (COVID-19), and has formally activated its system-wide Incident Command System (ICS) team. Please check www.wsu.edu/covid-19/, which provides regular updates and information about the University’s response. WSU has also setup a dedicated email account for questions, comments and suggestions at COVIDemail@example.com.
While we encourage you to review our Q&A page, we recognize that not every concern or question may be addressed, especially those with uniquely individual circumstances. We will continue to provide research related updates through this website and email communications, and take steps to ensure the health and safety of our community.
Our top priority is the safety and health of the research teams (students, staff and faculty), human and animal participants, and the general public, so please use this page as a guiding principle in regards to all decisions made on continuing research.
3/14/2020: The Office of Research has developed a list of considerations to guide your research preparedness in the context of the evolving COVID-19 situation:
- Develop a communication and contingency plan with points of contact that facilitates the dissemination of key information in a timely manner.
- Identify critical job functions and positions, and plan for alternative coverage by cross-training staff and faculty.
- Ensure remote access to necessary information and familiarize your teams with University approved remote access tools to carry out work at a distance. Systems being utilized for remote access should abide by WSU Executive Policy #14 and are subject to WSU Executive Policy #16. Please contact your local IT professionals with any questions.
- Please continue to follow all University data security policies as outlined in WSU Executive Policy #8 and WSU Executive Policy #37.
- Principal investigators should work with their campus, college, and immediate leadership to develop plans in the event a campus is closed. The plan should prioritize safety of all personnel engaged in research, and ensure laboratories and research areas are placed in a safe configuration that is maintainable for an extended period with available custodial/maintenance personnel.
- Keep abreast of any changes in funding agency and other changes in deadlines. We are fully expecting ORSO will be able to submit proposals and process awards even if personnel are working remotely. However, if agencies are officially closed, proposals will most likely remain in a queue, pending resumption of agency operations – as has been the case during federal budget-related shutdowns.
- Please note: The Office of Research will disseminate available information from our sponsors and can work with PIs to obtain the latest information.
- Monitor travel restrictions and use caution in considering travel to a country with restricted access.
- Campuses, colleges, and faculty should pass this information on to their students as appropriate.
- Please refer to your supervisor, and as necessary your leadership team, with any questions.