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.  Plan Owners 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 Plan Owners to help them develop Plans that include controls, measures and precautions for limiting potential virus transmission.

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,
    • Decision Making Authority,
    • Equity, Diversity, Inclusion and Accommodations,
    • Applicability and Effective Date, and
    • Communication, Monitoring and Enforcement
  • The health and safety of human subjects and study team members is paramount. Therefore, population density and/or physical distancing, as well as other safety protocols and protective measures should align with 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).
  • Plan Owners 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.
  • Plan Owners should ensure that study team members inform human subjects about the following at least twenty-four (24) hours before their study appointment:
    • They may bring one family member or caregiver to physically assist them and/or help them understand instructions and information communicated by the study team members;
    • They may bring one translator (which may be in addition to the family member/caregiver if that person will not serve in that capacity) provided that no  UCI-employed translator will be available;
    • All of the safety protocols and protective measures they (and their family member/caregiver) must follow, including the Executive Directives on Face Coverings and Contact Tracing.
  • Remote Research Activities involving human subjects should follow the safety and mitigation requirements for Remote Research Activities of the current research phase.
  • Plan Owners should consult with the sponsor of their human subjects research study to determine if their approval is required to restart/expand human research. If so, they should seek their sponsor’s approval prior to submitting their Plan for Authorized Official review and approval.
  • Authorized Officials should not approve Plans that do not align with the safety and mitigation requirements of the current research phase.

Clinical Studies

Plan Owners may conduct clinical studies (comprised of clinical trials and observational studies). However, conducting clinical studies is predicated upon Plan Owners aligning their Plans with current research phase safety and mitigation requirements and ensuring that their study teams and human subjects follow them.  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 Plan Owners should consult with the Center for Clinical Research (CCR) for additional resources, including a clinical research checklist for developing Plans.

The matrix below provides additional information regarding clinical study types allowed under UCI’s research phases.

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.)