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.  Researchers and Authorized Officials should review that information first so that they have proper context when reviewing the below information.

Because human subjects research differs from study-to-study, this guidance does not address all circumstances and planning scenarios.  Rather, it is general guidance for researchers to help them ensure the health, safety, and welfare of human research subjects while California’s COVID-19 state of emergency order remains in effect.

Guidance for Expanding Human Subjects Research Activities

  • The Framework for UCI Phased Research Activities  applies to all human subjects research
  • The health and safety of human subjects and study team members is paramount. Therefore, safety protocols and protective measures should meet or exceed the current research phase safety and mitigation requirements, as well as all guidelines and requirements issued by the Office of Research and the Institutional Review Board (IRB).
  • Lead Researchers should develop and implement safety protocols and protective measures for human subjects specific to virus transmission risks associated with the study’s activities, procedures, setting, and location. They should also consult with the IRB to determine if any of the safety protocols or protective measures will trigger a required protocol modification.
  • Lead Researchers should ensure that study team members inform human subjects (at least 24 hours before their study appointment) about the Executive Directives on Face Coverings and Contact Tracing and any study-specific safety protocols or protective measures they are required to follow.
  • Remote Research Activities involving human subjects should follow the safety and mitigation requirements for Remote Research Activities of the current research phase.
  • Lead Researchers should consult with the sponsor of their human subjects research study to determine if their approval is required to restart/expand human research.

Clinical Studies

Lead Researchers may conduct clinical studies (comprised of clinical trials and observational studies). In doing so, however, the Lead Research is responsible for ensuring that research subjects and study staff follow established safety protocols and protective measures.  Special safety protocols and protective measures apply to clinical studies performed as In-Person Research Activities in UCI Health-designated clinical spaces.  School of Medicine Lead Researchers should consult with the Center for Clinical Research (CCR) for additional resources.

CLINICAL STUDIES1

Study TypesPhase 1Phase 2Phase 3Phase 4
Interventional treatment trialsAllowedAllowedAllowedAllowed
Interventional supportive care, diagnostic, and prevention studiesNot AllowedAllowedAllowedAllowed
Time-sensitive assessments of currently enrolled participants in longitudinal observational studiesNot Allowed if the Study Requires in Person VisitsAllowedAllowedAllowed
Ancillary and correlative studies conducted in conjunction with a routine care/medically necessary visit with study personnelNot 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 VisitsAllowedAllowed
All other types of clinical studiesNot Allowed if the Study Requires in Person VisitsNot Allowed if the Study Requires in Person VisitsAllowedAllowed

[1] For clinical studies conducted in UCI Health-designated clinical space, all patients/study participants must be taken through ambulatory screening measures per current UCI Health Policy (maintained on the UCI Health EIP SharePoint site.)