RESEARCH CONTINUITY: Research Ramp-up

Guidance for Expanding Human Subjects Research Activities

The Guidance for Expanding Human Subjects Research Activities provided below supplements the Framework for UCI Phased Research Activities.

Because human subjects research differs from study-to-study due to a variety of factors, this guidance does not address all circumstances and planning scenarios.  Rather, it is general guidance intended to help faculty and independent researchers (“Plan Owners”) to develop plans that include controls, measures and precautions for limiting potential virus transmission and maintaining low population density in research spaces (“Plans”).  UCI’s research activities will progress in a carefully measured fashion and will parallel the California’s resiliency roadmap stages and other public health and higher education guidance.

Guidance for Expanding Human Subjects Research Activities

  • All Guiding Principles contained in the Framework for UCI Phased Research Activities apply to human subjects research, as do the sections on:
    • UCI’s Research Phases Mirroring the State of California Roadmap,
    • Decision Making Authority,
    • Equity, Diversity, Inclusion and Accommodations,
    • Applicability and Effective Date, and
    • Communication, Monitoring and Enforcement
  • Population density in UCI research facilities should not exceed 30% of pre-pandemic levels, except as provided for below in the Clinical Studies section.
  • Plan Owners should review the General Points of Consideration (available on the Research Continuity website) for those points applicable to their research programs.
  • Plan Owners should follow the process implemented by their Authorized Official (dean or SRP/ORU director) to complete their Plans. These should also identify special or unique circumstances and the precautions Plan Owners will implement to address them.
  • Authorized Official approval is required if any planned Phase 2 research activities will utilize UCI research facilities.
  • Access to UCI research facilities is limited to UCI personnel and registered students. Human research participants may not be physically present at any UCI research facilities excepted as provided for in the Clinical Studies section below.
  • If the site for a human research study is located in space that UCI does not own or control, UCI personnel should follow the site’s guidelines and precautions, provided that doing so does not cause them to violate UCI policy. If a site does not have published guidelines and precautions, UCI personnel should follow UCI guidance and policies.  Delay research activities until a later phase if circumstances at a site may prevent personnel from either following the site’s guidelines and precautions or UCI’s guidance and policies.
  • The Vice Chancellor for Research will issue an announcement to inform the research community when UCI will move from one phase to the next. Only then may researchers conduct study activities approved for that phase.

Clinical Studies

Plan Owners may conduct clinical studies (comprised of clinical trials and observational studies) in a clinical care setting with Authorized Official approval.  In addition, the population density restriction noted above does not apply when conducting clinical studies in UCI clinical care facilities.

The matrix below provides additional information regarding the types of clinical studies allowed under UCI’s research phases.  Please review Expanding Clinical Research Activities for complete information.  Researchers should also consult with the Center for Clinical Research (CCR) for additional resources, including a clinical research checklist for developing Plans.

CLINICAL RESEARCH

Study TypesUCI Research Phase 1UCI Research Phase 2UC Research Phase 3UCI Research Phase 4
Interventional treatment trialsAllowedAllowedAllowedAllowed
Interventional supportive care, diagnostic, and prevention trialsNot AllowedAllowedAllowedAllowed
Time-sensitive assessments of currently enrolled participants in longitudinal observational studiesNot Allowed if the Study Requires in Person VisitsAllowedAllowedAllowed
Ancillary and correlative trials conducted in conjunction with a routine care/medically necessary visit with study personnel adhering to all required/appropriate safety measures and precautionsNot Allowed if the Study Requires in Person VisitsAllowedAllowedAllowed
Cross-sectional or routine observational studiesNot Allowed if the Study Requires in Person VisitsNot Allowed if the Study Requires in Person VisitsNot Allowed if the Study Requires in Person VisitsAllowed
All other types of clinical researchNot Allowed if the Study Requires in Person VisitsNot Allowed if the Study Requires in Person VisitsNot Allowed if the Study Requires in Person VisitsAllowed