CGU IRB OPERATIONS DURING THE COVID-19 BREAKOUT AND IMPLICATIONS FOR HUMAN SUBJECTS RESEARCH
If you are continuing with your study during the outbreak, we urge to review your data collection procedures and interventions and give consideration as to how these special circumstances impact the risk to human subjects in your study. The information here is intended to provide guidance for such considerations and for human subjects protections decisions specific to our current conditions.
Given the ongoing pandemic and the changing landscape regarding COVID-19 and associated recommendations from various governing bodies, CGU’s Office of Research, Sponsored Programs and Grants (ORSPG) has finalized new guidance for the conduct of human subjects research effective January 2021. The policy is designed to provide clear guidance relevant to maintaining the health and safety of CGU personnel and potential research subjects.
The policy and related procedures apply to human subjects research (HSR) conducted by CGU faculty and students. Please note that, for the purposes of this policy, “HSR” is expanded to include those scholarly activities that involve humans but are excluded from the federal regulatory definition of ‘human subjects research’ (e.g., evaluation, oral history, journalistic or historical interviews, product development, program improvement activities) because of the potential to involve in-person engagement with human persons for the purpose of research. Similar policies and practices at national organizations and other research institutions, CGU’s broader campus visit protocols, California’s Blueprint for a Safer Economy, and relevant Los Angeles County COVID-19 policies have all informed the development of this policy.
Highlights of the policy are below but please consult the full policy when planning to conduct any in-person human subjects research.
Summary of steps to be taken to resume in-person research:
- CGU investigators should first evaluate whether research procedures can be modified to eliminate in-person contact/engagement with research subjects. During the COVID-19 pandemic, all research that can be conducted remotely should be done so.
- Some essential research may to need to continue, even if modifications cannot be made to eliminate in-person contact.
- CGU investigators whose research cannot be modified to eliminate in-person contact/engagement with human subjects must submit a “Risk Mitigation Plan” for approval by the Research Protocols Risk Assessment Committee (RPRAC).
Where shall I submit my Risk Mitigation Plan?
- Through Axiom Mentor—the same platform CGU currently uses to manage IRB protocols. Adjustments are being made to the pre-protocol guidance tool and protocol page to direct investigators to the appropriate application sections.
What is the turnaround time to review my Risk Mitigation Plan?
- A two-week turnaround time unless otherwise specified is allocated for reviewing each plan. (Deadlines and reminders can be set in Mentor.)
What is considered essential research?
- The foremost example would be existing research for which interruption or modifications to procedures could create greater risks to human subjects. The determination of “essential” research activities will be made jointly by the Primary Investigator (or Faculty Supervisor in the case of student PIs) and the department chair or school dean. Examples of essential research may include, but are not limited to, research that would (a) harm subjects if paused or stopped, (b) severely limit student or faculty progress on achieving time-sensitive research milestones such as those tied to grants, (c) prevent students from completing degree requirements in a timely manner.
We will continue to update the IRB webpage (cgu.edu/irb) and ORSPG webpage (https://my.cgu.edu/research/) as needed in light of changing circumstances. Please note, however, that stricter directives (e.g., lockdowns, campus closures, etc.) from CGU leadership, federal and state government, and/or local municipalities governing your research sites would supersede guidance provided here.
If you have questions about modifying an existing protocol in light of these circumstances contact the IRB Office at firstname.lastname@example.org or 909-607-9406.
Other resources on updates and guidance: