Here’s University of Illinois President Tim Killeen’s April 14, 2022 response to a March 16, 2022 letter from Rep. Deanne Mazzochi & five other state legislators, regarding the school’s saliva-testing program.
Posted for general access, public comment, and future reference.
April 14, 2022
VIA Email and US Mail
The Honorable Deanne M. Mazzochi et al
1 South Cass Avenue
Suite 205
Westmont, IL 60559
Dear Representatives,
Thank you for your letter dated March 16, 2022, in which you asked a number of very important and relevant questions. At the University of Illinois, we share your concerns about protecting the privacy of all those involved in SHIELD testing. Indeed, protection of privacy was part of the design of the SHIELD program even before testing began and continues to be considered to this day. We have thus put in place numerous safeguards, which we describe here.
We can assure you that all University-controlled SHIELD saliva samples have been obtained under appropriate consent protocols and have been used solely for the detection of SARS-CoV-2, the virus that causes COVID-19. These samples have never been used to test for drugs or alcohol, nor have they been used for the sequencing of human DNA. Any genomic sequencing done has been only of the virus itself, in order to, for example, aid in identifying variants of the virus. We adhere strictly to the requirements of informed consent for all samples we collect.
There are generally two categories of consent. First, a minority of those who provided samples did so by consenting to allow the use of their samples for research purposes. Those samples were collected following an Institutional Review Board (IRB) evaluation and approval of a research protocol; all such approvals follow regulations found in 45 CFR Part 46. The method of collecting research samples is standard for all human participant-based research. The details of each IRB-approved research protocol and informed consent are specific to the research being conducted. Any specimens that were saved are under the control of the research laboratory and are handled per the informed consent and protocol of the study.
Second, the vast majority of the samples were collected as part of the State of Illinois response to the public health emergency created by the spread of SARS-CoV-2. The Illinois Department of Public Health (IDPH) delegated responsibility for operating some of the state’s COVID-19 response to the University of Illinois through the “SHIELD Illinois” program, specifically for testing within public K-12 schools, community colleges, and universities. The University also provided SHIELD Illinois testing to some private schools and entities as well as the Illinois General Assembly. Saliva samples collected through SHIELD Illinois were tested using the University-created covidSHIELD method, which operates under a U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA), which specifies that covidSHIELD is “for in vitro Diagnostic Use, Rx Only, and for use under Emergency Use Authorization (EUA) only”. In each case, the organization requesting SHIELD Illinois testing (e.g., a school district) was responsible for obtaining the consent of the individuals who provided the saliva samples for testing as required.
IDPH required that we not only report results to them, but also that we save samples for later testing by IDPH for the genetic analysis of the SARS-CoV-2 variant in the positive samples. This helped IDPH track the emergence and spread of SARS-CoV-2 variants, such as “Delta” and “Omicron.” As most of the SHIELD Illinois work was performed at the behest of IDPH, we have been in close collaboration with IDPH during the entirety of the pandemic-related testing. When IDPH asks for a specific sample, we provide that sample to them. IDPH has told us that we need to keep samples for only 30 days; thus, we currently destroy stored samples older than approximately 30 days.
We note in your letter a question about the voluntary nature of the informed consent at the University of Illinois. It is true that admission to campus facilities was predicated upon regular testing. To the extent practicable, we provided employees and students the option to work or take classes off-site. We cannot comment on the requirements set by the organizations that requested SHIELD Illinois testing, except to note again that we required that they obtain the consent of everyone who supplied a saliva sample or be operating under a legal mandate for testing.
We also remind you that the entire testing regime was created during the early stages of the pandemic, when everyone from scientists to physicians to government leaders at the local, state, and federal levels was working to determine how to keep people safe. We were careful to consider all factors, which is why we: designed a test that was the least invasive possible; developed secure information technology (IT) systems to handle data and rapidly report results to individuals, and instituted informed consent that provided assurances that we would handle samples and personal data with the highest of ethical standards. We have maintained those high standards throughout the pandemic.
What follows are answers to your specific questions:
1. Yes, every person who provided saliva samples in the SHIELD research and development program did so through free and voluntary consent and not as a condition of employment or attendance.
2. All individuals who provided saliva samples for pre-EUA analytic data purposes, and indeed for all research and development purposes, gave informed consent per an IRB-approved protocol.
3. The University of Illinois retains samples collected under research protocols that allow the saving of the samples. Samples collected under screening protocols have been saved per the request of IDPH. It is our practice to keep samples collected through SHIELD Illinois for only 30 days per IDPH’s current guidance. We would note that it is a routine practice to keep samples for laboratory training purposes; this is a standard practice in a CLIA-certified laboratory and closely monitored by the laboratory director. Samples used for training are de-identified.
4. Per #3 above, laboratories designated by the University of Illinois Office of the Vice President for Economic Development and Innovation, the office responsible for administering the covidSHIELD EUA, and contracted by the University through the SHIELD Illinois program do keep samples perRepresentative Mazzochi et al IDPH’s guidance. The laboratories also keep samples for training purposes as needed and under the direction of the laboratory director. There are also samples that were collected and saved under IRB-approved research protocols.
5. We are currently testing several thousand samples each day. We keep positive samples per the direction of IDPH, and thus can have several thousand positive samples in laboratory freezers, across multiple locations, at any time. SHIELD Illinois does not have samples that were collected under the screening protocol past approximately 30 days. There are samples in storage for training purposes.
There are also samples saved under research protocols; SHIELD Illinois, however, has not collected samples for research purposes.
6. Samples collected under research protocols are kept for as long as indicated in the protocols. For the samples collected through SHIELD Illinois, per #3 above, we are destroying those samples regularly with the intent to only keep samples for approximately 30 days per IDPH’s guidance. When IDPH told us we need keep samples for only 30 days, we started destroying older samples. Now, the SHIELD Illinois standard practice is to regularly destroy samples after 30 days1
7. We are not aware of samples that are being kept beyond current guidance and practice.
8. Samples are stored in laboratory freezers. Samples are all labelled per the approved protocol and in accordance with standard laboratory practice. Data derived from testing samples are kept in our secure IT systems. Only authorized employees have access to the samples and data. Samples have been sent to IDPH at IDPH’s direction; IDPH then tracks those samples. Research samples are stored and tracked by the research laboratories as authorized under the approved IRB protocols.
9. The University of Illinois designated laboratories have only used samples for the detection of SARS-CoV-2. As noted above, University of Illinois has not analyzed any samples for drugs, alcohol, or human DNA. Samples have been sent to IDPH at their direction. Research samples have only been tested for the uses indicated in the research consent.
10. The University has only tested, and only intends to test, the SHIELD Illinois-collected samples for the presence of SARS-CoV-2. Results from such testing are stored in a secure IT system that meets industry standards and is accessible by the patient (or parent/guardian), the ordering physician, and public health officials. The University does provide samples to IDPH upon request. Samples collected for research purposes will only be analyzed in accordance with the IRB-approved protocol. Organizations can request to directly receive test results of their personnel (e.g., employees and students) if they certify either that they have received informed consent or that they are operating under a legal mandate to receive the results. As with all public health data, if the data are de-identified and used in a manner that complies with federal and state regulations, then those data can be used for research purposes.
11. Samples collected by the University of Illinois under a research protocol and data derived from these research samples are owned by the University. Samples collected through SHIELD Illinois and the data generated from testing those samples are the property of the University. Samples collected through SHIELD Illinois and delivered to IDPH are the property of IDPH, and IDPH owns any data derived from those samples. Test results of the SHIELD Illinois-collected samples are also the property of the individual, as provided through the electronic record system.
12. As noted above, the University of Illinois strictly adheres to the requirements of informed consent. All samples were provided with informed consent or based on a legal mandate for testing.
13. The University has only tested, and only intends to test, the SHIELD Illinois-collected samples for the presence of SARS-CoV-2. Samples collected for research purposes will only be analyzed in accordance with the IRB-approved protocol.
For further discussions regarding the issues that you identified in your letter, we suggest that the Vice President for Economic Development and Innovation, Prof. Jay Walsh, could field your inquiries.
Sincerely,
Timothy Killeen
cc: Jay Walsh, Vice President for Economic Development and Innovation Jennifer Creasey, Senior Director State Relations
1 – The University of Illinois Urbana-Champaign runs a testing program just for the campus community, which was the model upon which SHIELD Illinois was based, and this campus-specific program has historically kept all positive samples. They are currently working with the local public health authority, CUPHD, to determine if these should also be subject to the 30-day guidance from IDPH.
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