Does the COVERED project require IRB review?

The CDC IRB has reviewed the project and concluded it is public health surveillance (not human subjects research). Similarly, the sponsoring academic institution IRBs, Olive View-UCLA and the University of Iowa, have agreed with this determination. However, while you should be aware of this guidance, each local IRB will need to make their own determination as to whether these activities are human subjects research. We encourage sites to submit the determination from the CDC, Olive View-UCLA, and the University of Iowa as background for this review.

Are there any patient risks?

Project participants are health care staff, not patients. Patient records will be reviewed to determine the results of COVID-19 testing to inform participant exposures. Patient and participant data will be kept confidential and secure and will not be released outside the study team.

Are there risks to participants?

The only procedures involving participants are completing surveys and allowing blood draws and self-inserted nasal swabs. Surveys are on REDCap and can be completed remotely online. Surveys must be completed in a timely fashion, but they need not be done during patient care. Blood draws involve minimal pain and discomfort. Blood draws will be to test the participant's COVID-19 serology (IgG) and will allow detection of infection, including asymptomatic infection. Self-inserted nasal swabs will be conducted for PCR to detect COVID-19 viral shedding. These results will be provided to the participant. In the case of seroconversion, the participant will be advised to notify their local employee health clinic and personal physician, and local testing may be recommended. Personal participant data will be kept confidential and secure and will not be released to employers or health authorities directly. Before beginning the study, staff will be informed of these project-related risks and their consent will be obtained.

Can Advanced Practice Providers (PA-C, ARNP) be enrolled?

Yes. Any advanced practice provider who provides clinical care in the ED alongside physicians can be enrolled in the physician group.

Should we exclude residents graduating in June?

No – if a resident is graduating in June, he/she may still be included.  If we can continue to follow that resident for the remainder of the 12 weeks, that would be ideal.  If your site has enough participants to enroll without enrolling graduating residents, that is preferred, but senior residents perform many of the endotracheal intubations in some sites and we don’t want to exclude the highest risk cohort.  In some cases, we may need to replace that resident with another from the same site after graduation. 

Do supervising physicians qualify as intubating?

Any physician who is physically standing within 3 feet of the mouth during endotracheal intubation can be included in the intubation cohort.  If supervision is provided from farther away, that participant should not be classified as intubating.  If a supervising physician and an intubator are both exposed to a single case, they should both complete an intubation form.

Are there risks to project assistants or phlebotomists?

Only staff drawing blood will have direct contact with any study participants. Phlebotomy may take place outside of patient care areas. Study staff should get approval from the department supervisor should they wish to go to patient care areas and should follow site's infection control practices. Participants who have symptoms that they believe are compatible with COVID-19 will be referred for evaluation; study staff will not draw blood or be otherwise exposed to these participants until they are cleared to return to work.

What is the time window when blood and nasal specimens may be drawn?

We would like to collect blood and nasal specimens every 2 weeks +/- 2 days.  For example, if 2 weeks for a study participant falls on a Thursday, you may collect specimens any convenient time between Tuesday and Saturday of that week.  If the specimen is collected early or late, however, the “optimal collection day” remains Thursday for the next specimen 2 weeks later.

For the first baseline serology, we would like the specimens to be collected within 48 hours of completing the initial participant enrollment form.

What if someone has a positive baseline serology?

Anyone who has had COVID-19 infection or a positive serology at the time of enrollment screening is ineligible to complete the study.  If the first serology is positive, then that participant will be replaced by another participant within the site.

Will the name of my medical center or study staff be associated with specify results in any published material?

No. We understand that we may collect potentially sensitive information and will not associate any results specifically with any institution or individuals.

Operations and guidelines change quickly at my site.  Is that a problem?

No, that’s okay. The management of this disease is evolving quickly.  Project COVERED will have to be flexible to capture these data despite changes in practice.

What if we don’t have enough people in one of your study groups?  For instance, what if I can only enroll 10 non-clinical staff instead of 20?

We will discuss this on your Site Readiness Call.  We may be able to identify suitable participants from other parts of the hospital.  In some cases, suitable participants will not be available and we will allow for more enrollment at other sites.

How will sites be paid?

Contracts will be established between Olive View-UCLA Education and Research Institute, which will receive funding for the project from the CDC, and the site. Participants will receive compensation on a Visa gift card that will be reloaded weekly on a fee schedule according to study related activities completed each week. 

How will participants be paid?

Participants will receive a gift card by mail after enrolling in the study.  Every week, we will add value to the card based on the activities completed for the week. 

Will site PIs and other study staff be recognized in publications?

The COVERED project will follow the International Committee of Medical Journal Editors (ICMJE) authorship guidelines. Authorship will be tied to project contributions. We intend to set up an Executive and/or a Publication committee from among the site investigators to help develop an authorship policy. We would anticipate for the main paper that each site PI would be recognized with other key team members included as part of a corporate authorship group.

Will data eventually be shared?

We will be developing a data sharing plan. Study investigators who would like access to the data for additional publications will be able to propose novel research study ideas and will have access to the data for the purposes of publication.