Given the Shelter in Place orders in effect in six Bay Area counties, all in-person research activities must be suspended. Please use our "COVID-19 Related Modification/Amendment" xForm to request changes to (a) protocol timing (e.g., regarding follow-up study visits), (b) move activities that are currently described as in-person only to online when possible, and (c) change data storage/access to facilitate remote work. Please also develop a plan for informing subjects of the changes. Modifications required for currently active studies given the shelter in place orders will be prioritized for review. Please note that some changes may require a change in level of review (e.g., if you didn't previously collect identifying information but will do so for the online activities), which may add to the review time. If you implemented a change prior to securing IRB approval to eliminate apparent immediate hazards to the subject, please submit a Reportable Events form as soon as possible. As always, please contact us with any questions.

Please note changes made to research in response to a public health threat may be made without first obtaining IRB review and approval provided that the change in the research was made to eliminate apparent immediate hazards to the subject. If this protocol change is made, you must notify the IRB as soon as possible regarding this change, including justification to support why IRB approval could not be obtained beforehand. Please contact us if you have any questions about changes you need to make to protect research subjects.

We have created a separate modification xForm for COVID19-related changes, so that we can readily identify and prioritize these changes. If you have already started/submitted a modification form with the usual header, please email IRB@paloaltou.edufor your submission to be flagged as requiring priority review.

Here are some steps to consider that will allow you to plan ahead for potential disruptions and work together as a team.

Steps you can take now to ensure continuity of your research projects:

1. Prioritize. Depending upon the nature of your research, consider prioritizing work that can only be carried out in person, and put off non-essential work that can be completed remotely, such as data analysis.

2. Identify studies that can or cannot be conducted online or can be delayed.

For studies that can be conducted online, submit a modification to have the changes to procedures (e.g., from in-person focus group to zoom focus group) approved by the IRB. If this involves changes to procedure for already enrolled subjects, include a procedure for informing subjects of the change and instructions for online activities. Please develop alternative instructions for those who do not have adequate internet access to participate online (e.g., let them know if you will contact them in the future when in-person study activities resume). Include any impact on subject payments that the changes may have.

For studies that can be delayed, submit a modification only if this involves a change in procedure (e.g., changes to timing of follow-up visits).

For studies that require remote access to data to continue analysis, file a modification for any data storage or access plan that differs from your approved protocol (e.g., for sensitive data that cannot be stored outside PAU servers, either ensure remote access to the server for the study team or develop a strategy for storing a limited, de-identified dataset in a secure manner that can be accessed by all necessary study team members).

For studies that cannot be conducted online, establish a procedure to inform study subjects of the need to pause the study (which will be used only if necessary, such as if facilities close). This should include information about when and how they will be contacted when the study is resumed again.

3. Identify and document step-by-step procedures and processes that require regular personnel attention and ensure they are is accessible to your study staff.

4. Ensure study staff are well trained to take the responsibilities and are aware of procedures to use in the event study sessions need to be cancelled or postponed.

5. Create a detailed communication plan with study personnel. Ensure all staff are aware of the plan and have email addresses and phone numbers to communicate with each other when needed.

6. Ensure all involved study personnel have online access for Zoom/Skype meetings and (when appropriate) remote access to files, data, servers, as needed.

7. Cross-train research staff to fill in for others who may be out sick or unable to perform work.

Remote access:

· Ensure that those involved in online research projects have access to information they need to carry out work remotely (e.g., access to literature, existing datasets and research-related files, and meeting software, such as Zoom). If this requires a change in data storage procedures, you must have the change approved in advance by the IRB.

· Test and update remote work technologies such as VPN and Zoom conferencing.

· Ensure that under no circumstances researchers take any materials off-site if your approved protocol indicates such materials will be stored at PAU (e.g., in locked cabinets in locked offices) off site.

The Human Research Protection Program (HRPP/IRB) stands ready to support you in planning to ensure that your research activities continue with as little impact as possible. The IRB Office will conduct a priority review of studies require changes in the study procedure/ plan used for emergency closing of PAU facilities/clinics.

Please contact us with any questions at IRB@paloalto.edu

Dear PAU Research Community,

You are all aware of the evolving situation regarding COVID-19. The President’s Cabinet is closely monitoring updates and guidance from the Centers for Disease Control (CDC) and the Santa Clara County Public Health Department.

For the safety of PAU faculty, students, and research participants, we are providing the following recommendations to help researchers prepare for the possibility that in-person research activities at the university or in the community must be suspended.

1. If your research activities occur online but you usually meet with the research team in person, plan to use zoom as an alternative to in-person meetings. Your online research activities can continue uninterrupted.

2. If your research activities occur in person, consider whether an online alternative that (a) still protects your subjects’ privacy and confidentiality and (b) does not compromise the scientific integrity of the study is feasible. If so, file a modification with the IRB to allow the use of either the in-person or online option, so that you are ready to immediately transition to the online option if such a need arises. If no need arises, you may continue with your approved in-person procedures uninterrupted.

3. If your research involves in-person treatment sessions, please contact us to determine the best strategies for protecting your subjects if you are unable to meet with them for a period of time.

You may also want to consider filing a modification to your protocol to allow for more session cancellations due to illness (e.g., if missing a certain number of sessions currently can lead to being removed from the study) as well as a plan to communicate this change to your subjects. This may prevent individuals who are having symptoms from attending sessions out of fear of dismissal from the study.

Please note no changes in the study procedures should be implemented prior to the IRB approval.

We encourage you to submit a modification as soon as possible. If the modifications involve a change that impacts subjects’ experience (meeting online instead of in person), your modification request should include a plan for notifying currently enrolled subjects of the plan.

Please contact us with any questions.