The Toughest Problem Set: Navigating Regulatory and Operational Challenges on University Campuses

By and on August 27, 2020

When the academic year ended in the spring of 2020, many US university students assumed that a return to campus would be straightforward this fall. However, it is now clear—at least in the near term—that a return to the old “normal” will not be possible. Some universities have concluded that their best course of action is to offer only distanced learning for the time being. Other universities, however, are welcoming students back onto campus, and into residence and dining halls, classrooms, labs and libraries. Each of those universities is developing its own approach to retain the benefits of on-campus student life while reducing risk to the greatest extent possible; nevertheless, some have had to adjust their plans to pivot to remote learning when faced with clusters of positive cases on campus. One thing is clear: The fall semester will be a real-time, national learning laboratory.

Because widespread, rapid testing remains unavailable in many locations, universities have had to find innovative ways to implement testing, tracing and isolation protocols to reduce the risk of transmission among students, faculty and staff. There is no one perfect protocol—all universities are in unchartered waters. But there are a few key components university administrators may want to consider and address:

  • Apps: Symptom checkers, contact tracing and other apps can be useful in identifying and focusing attention on the onset of symptoms, fostering accountability and identifying high-risk exposure. In considering whether to incorporate apps and related technologies into their back to campus plans, universities must anticipate and address considerations related to privacy, security and reporting of results, and will need to consider how such apps are hosted (for example, through Apple’s App Store) and whether any third parties will have access to the personal data collected.
  • Contact Tracing: In addition to the issues noted above, contact tracing efforts also present other challenges, including managing reliability, over/under inclusiveness and liability (for both false positives and false negatives). In addition, the effectiveness of contact tracing is closely tied to its speed and comprehensiveness; to implement a successful contact tracing program, universities will need to balance effectiveness with privacy and autonomy.
  • CLIA: The Clinical Laboratory Improvement Act (CLIA) will require that many of the tests be performed in CLIA-certified (and state-licensed, where required) space. Universities will need to consider how best to handle building out additional compliant space, creating additional “point of care” testing or specimen collection sites if needed to test students, faculty and staff where they are and validating the test(s) being offered. Tests that are not yet validated likely cannot be used to return patient-specific results that inform student and staff care or be used to prompt “official” testing.
  • FDA/Emergency Use Authorizations (EUA): In general, the Food and Drug Administration (FDA) expects developers of molecular, antigen and (in the case of test kit manufacturers) antibody tests to obtain an EUA. However, under FDA enforcement policies during the pandemic, many of these same tests—if validated and offered with appropriate agency-mandated disclaimers—can be offered before the developer obtains an EUA. Specific tests (and testing workflows) should be evaluated on a test-by-test basis to confirm compliance with FDA regulatory requirements.
  • Ordering Tests: In most cases, screening and diagnostic tests can only be ordered by an appropriately licensed practitioner (such as a physician or nurse practitioner). Consideration should be given to coordinating test ordering between an affiliated medical center, student health services and the university.
  • Screening versus Testing: Though there may be differences between the “screening” and “diagnostic” tests for purposes of how such results are used in patient management, both types of tests are subject to FDA (g., EUA) requirements, as well as CLIA requirements insofar as the test returns patient-specific results.
  • Consents, Authorizations, Waivers: Universities will need to give careful consideration to necessary permission documents, including consent to treat, consent to share health information, Health Insurance Portability and Accountability Act (HIPAA) authorizations to disclose protected health information (PHI) (for example, by a medical center to the university), consent to notify parents if the student is no longer a minor, consent to notify public health authorities, attestations and agreements to cooperate with an overall return to school protocol (which may cross-reference certain of these other documents) and waivers of consent, liability and other related considerations. In addition, universities need to consider the best way to obtain these documents prior to, and throughout, the school term.
  • Research: Universities and their affiliated medical centers may be involved in validation studies to confirm additional testing devices, assays and other analytics or may be involved in other types of research related to COVID-19. If this research involves interaction with individuals or identifiable information (as defined under applicable law) such research may constitute research involving human subjects, even if there is no or minimal risk. Institutional Review Board (IRB) oversight and other compliance steps may be necessary.
  • Quarantine: Under certain circumstances (such as high-risk exposure, symptoms prior to a COVID-19 negative test or any positive test), universities will need to consider mandatory quarantine requirements—and where such quarantining should take place. For students living in shared spaces, the university will also have to consider how to address other individuals in that shared space, for example enforcing quarantine of a “healthy” roommate, providing alternative housing for the “healthy roommate” or having infected individuals quarantine outside of their typical residence. If an individual has attended class prior to finding out they are infectious, universities will need protocols capable of scaling to quarantine large numbers of students and faculty, repeatedly, over the course of the academic year. It can be difficult to predict necessary quarantining capacity and to scale (and re-scale) quarantining facilities and approaches even there is a cluster or other spike in cases. Consideration of these operational approaches in advance will be important.
  • Converting to Universal Remote Learning: Despite the best risk reduction protocols, there may be circumstances of community spread of infections that lead a university to determine that it needs to convert for the short or long term to entirely remote learning. For students reliant on university housing and other amenities (like the dining hall), there may not be immediate alternative accommodations if the university requests that students return home. If the university chooses to keep students and faculty on campus for shorter reset periods of quarantine, consideration will need to be given to meals and other amenities no longer able to be secured outside of dining halls and other university facilities.
  • Enforcement/Sanctions: Universities will no doubt seek to draw on school spirit, a sense of resiliency and innovation and a shared set of community values and commitments to encourage compliance. Universities, however, should be prepared for noncompliance by students, faculty and faculty family members with all aspects of the protocol and to determine, for different types of violations, how the university will respond and the corresponding consequences.

The issues and challenges surrounding reopening are—to use a word repeated into irrelevancy—unprecedented. Any reopening will require flexibility, rapid-response re-orientation, patience and adherence to the protocols by staff, students and all other members of the university community. But universities can place themselves in the best position for success if they think through a range of healthcare, privacy, liability and life sciences legal considerations in advance.

Jennifer S. Geetter
  Jennifer S. Geetter advises global life sciences, health care and informatics clients on legal issues attendant to biomedical innovation, research compliance, financial relationship management, digital health practices, and global privacy and data security laws. Jennifer represents a broad range of clients. Read Jennifer Geetter's full bio.

Michael W. Ryan
Michael W. Ryan advises manufacturers, health care providers, developers, and investors on the legal, regulatory, and reimbursement issues that arise during the development and commercialization of medical devices, drugs, biological products, and clinical laboratory testing services. Read Michael Ryan's full bio.




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