Last updated September 15, 2020
Requirements for Resuming Face-to-Face Research
To resume face-to-face human subjects research your department will need to have an approved Department Research Reopening Plan that addresses the research activities to be conducted, whether on- or off-campus. If your department does not already have an approved plan it will need to develop one. If your department does have a plan but it does not address the kind of research you need to perform, an amendment can be submitted by the plan coordinator through the ReADY portal for review and approval. Note that the review and approval of Department Reopening Plans is separate from the IRB approval process and does not involve the Compliance team in RSP. Once your department has an approved plan you may resume IRB approved face-to-face human subjects research in accordance with the safety measures and other elements of the plan.
Please bear in mind that if you plan to conduct face-to-face human research, Western is still in operating level 2, as defined by Incident Management and confirmed by University leadership (see the Safe Start webpage). This means that only employees who have a need to come to campus may do so, and that need must be documented in some way—whether through an approved departmental reopening plan or approval to be included on the critical employee list (for faculty who need to come to campus regularly), or through the submission of an on-campus visit form (if the visits are rare or irregular). IRB approval does not, in itself, constitute approval to conduct face-to-face research as long as Western continues to operate under COVID-19 restrictions.
If you made temporary revisions to an active study in response to COVID-19, you may revert back to your originally approved procedures once your Department Research Reopening Plan is approved. Alternatively, if you choose to permanently incorporate any of those temporary changes, we ask that you submit a Modification Form to request a permanent change to your research by the end of fall quarter.
For questions regarding human subjects approvals or reversing temporary revisions, please contact email@example.com.
Contacting Our Office
RSP is open and continuing operations as normal but will not be staffed in person. Phones and emails are being answered as normal. Institutional Review Board (IRB) meetings will continue during the academic year but will be conducted remotely. The IRB does not meet during intersession or over Summer quarter.
I am unable to obtain a written signature on the Application Approval Signatures page. What can I do?
The Human Subjects Application Approval Signatures E-sign Form can replace written signatures. Please continue to submit the rest of your application materials to the compliance email inbox for review.
My study is about COVID-19 or is specifically related to the pandemic, can my application be prioritized?
Applications specific to the pandemic will be prioritized to the extent possible. We are receiving many applications related to the pandemic however, so we appreciate your patience.
Research Consult Appointments
We are available for remote advising appointments via Zoom. Please contact our office to request a virtual Zoom meeting or call.
Do you need a guest lecturer about research? Invite a research compliance member to attend your virtual class! We can join your Zoom class session to discuss requested topics.
Please email firstname.lastname@example.org with the topics of interest, possible dates and times, and the length of time desired for the lecture.
Restrictions on In-Person Study Activities
RSP is following the Governor’s Stay Home, Stay Healthy directive and the guidance of University administration.
Study activities that are limited to remote interactions (online, phone, mail) may continue without disruption.
In-person study interactions AND on-premises activities must be discontinued until the required steps for resuming face-to-face research are completed. These steps are listed above under the “Requirements for Resuming Face-to-Face Research” section.
Effect of the Restrictions on Pending IRB Applications
Review of submitted applications will continue. Studies that involve in-person interactions may be approved with the condition that enrollment cannot begin until the required steps for resuming face-to-face research are completed.
Modifying Research Activities
In March, to facilitate smooth transitions from in-person activities to temporary online activities, certain minimal risk studies were allowed to temporarily revise their procedures without submitting a modification so long as certain criteria were met. Please see the section “Requirements for Resuming Face-to-Face Research” on how to manage these temporary procedures now. Please do not make any additional temporary revisions at this time.
Data and Security Protection Considerations for Remote Work with Human Subjects
- Confirm that data/records/equipment/supplies are permitted to be taken off-campus and accessed remotely.
- Remove identifiers from data (de-identify) or create subsets of de-identified data with which to work remotely.
- Ensure that remote access to electronic data files meets your approved level of data protection. This includes the use of a VPN and encrypted hard drive and/or storage media.
Electronic Data Records
- Avoid working on shared computers and devices if possible.
- Generally, avoid using public Wi-Fi.
- Do not send Level 3 or Level 4 data sets via email without encryption.
Identifiable or Sensitive Paper Records/Documents/Questionnaires/Logs
- Keep records in a secure location when not in immediate use. Use locked storage whenever possible.
- Flip-over or cover identifiers when stepping away from such records.
- Stay organized and know what physical information is in your possession.
Data Collection Activities
- When conducting interviews via phone or videoconferencing, take precautions to protect participant privacy.
- Secure your space before the meeting.
- Do not conduct a video interview in a common room where other members of the household may overhear.
- Inform other members of the household of confidentiality expectations.
- Ensure that identifying information about participants is not visible through your camera.
- If you intend to share your screen, be mindful of what you might be sharing. Be careful to avoid sharing identifying information about other participants.
- Ensure only the intended people are in the meeting.
- Do not use identifying information in meeting titles or descriptions, including participant initials or names.
- Secure your space before the meeting.
- Separate participant contact/identifier information from data, or link indirectly via codes and a key. Store the key linking identifiers and data in a secure location separate from the data.
- Do not utilize video or audio recording data collection activities unless approved by the IRB. Note: Recording may change the IRB’s data security/confidentiality assessment. Such a change may not be implemented without prior approval or confirmation. This applies to both Exempt and Non-exempt human subjects research.
- Ensure any necessary safety precautions can be followed in a remote site, including spotters to prevent falls, and presence of available and functional safety equipment.