UCI’s IRB and HRPP are committed to keeping the research community apprised of actions it is taking and expectations of its human subjects research community in light of the as the SARS-CoV-2/COVID-19 pandemic and the constantly evolving situation at UCI, within our region, nationally and internationally. We encourage all human subjects researchers to regularly check the Office of Research’s Research Continuity webpage.  In addition, the Office of Research (OR) will provide periodic updates via e-mail messages to the campus.

UCI IRB/HRPP Operations

Until further notice, UCI’s IRB/HRPP is fully operational, and will remain fully operational in the event that UCI curtails operations.  OR’s HRP staff are able to and will work remotely in the event it becomes necessary.  In addition, UCI’s IRBs have the capacity and ability to operate remotely.  At this time, the IRB/HRPP is focusing on essential operations, and non-essential operations, such as training and education have been curtailed.

Prioritization of Operations

Until further notice, priority is being given to new protocols or modifications related to investigating COVID-19.  Please contact HRP Staff to prioritize your submission.

HUMAN RESEARCH STUDY CONTINUITY PLANNING AND GUIDANCE

General Guidance:  COVID-19 Secreening

Studies involving in-person interactions with study participants should include a short screening of participants to assess exposure to and symptoms of COVID-19.  A screening process for symptoms, recent travel, or exposure to confirmed cases of COVID-19 is not considered a research procedure and does not require review or approval by the UCI HRPP/IRB. The following approach is advised:

Please call participants prior to their appointment and inform them that they should not come in for the study visit if they have a fever, sore throat, and/or symptoms of acute respiratory distress (cough, difficulty breathing, etc.).  Inform them that they will be immediately sent home if they arrive for their appointment and exhibit any of these symptoms and their appointment will be rescheduled.

Ask participants about recent travel, especially international travel to any of the CDC Level 2 – 3 countries, or whether they have been in close proximity to a person who recently returned from international travel, especially from CDC Level 2 – 3 countries.  If they have, inform them that their appointment will be rescheduled.

Ask participants if they have been in close proximity to a person with a confirmed case of COVID-19, or a person who is currently a person under investigation for COVID-19 infection (i.e., the person has been or will be tested for COVID-19).  If they have, inform them that their appointment will be rescheduled.

Reassure participants that study visit compensation (if applicable) will still be received if their visit needs to be rescheduled.

The above screen procedures should also be conducted for participant appointments where study procedures are conducted at the participant’s residences or at a non-UCI location.

In the event that a participant clears the above screening, but exhibits symptoms at the time of appointment, the study procedures should not be conducted, and the participant should be instructed to return home and to contact (by telephone) their healthcare provider to arrange for an evaluation and their care.  The participant should also be informed that the study personnel will contact them to reschedule the appointment.  If the appointment is at the participant’s residence or at a non-UCI location, please follow the same guidance, and study personnel should immediately leave the premises, report the incident to the Lead Researcher, and follow all UCI procedures and guidance regarding social distancing and self-quarantine as applicable.

Below is suggested screening language:

Within the last 30 days, have you had a fever, cough, sore throat, difficulty breathing, or any other respiratory symptoms?  Do you have any of these symptoms now?

Have you returned from international travel within the last 30 days?  If so, to what countries did you travel?  During your travel, did you pass through or lay over in any of the following countries:  China, Japan, South Korea, Iran, or Italy? (Note, this list of CDC Level 2 – 3 countries may change and should be updated with the countries on the CDC Level 2 and 3 lists at the time of screening.)

Within the last 30 days, have you been in close contact with someone who has a confirmed case of COVID-19 (Coronavirus), or have you been in close contact with someone who will be or has been tested for COVID-19?  If so, and the person was tested, did they test positive for COVID-19?

If a study procedures include collecting biospecimens, all standard precautions and safety procedures should be followed, along with any additional safety procedures determined to be appropriate by the Lead Researcher.  Biospecimens should not be collected from participants who do not clear the above screening.

General Guidance:  Social Distancing

Should researchers elect to practice “social distancing” in lieu of in-person interactions (i.e., change IRB approved study procedures from an in-person interaction to a phone interaction), a modification is not required prior to implementation.  In an effort to facilitate research during this public health crisis, changes to the protocol to implement various methods of social distancing must be added to the protocol at the next modification.

General Guidance:  Clinical Research

The clinical research enterprise at UCI (Center for Clinical Reseach (CCR), Institute for Clinical and Translational Science (ICTS), Chao Family Comprehensive Cancer Center (CFCCC), and Alpha Stem Cell Clinic (ASCC)) is fully committed to the safety of our research participants, staff, faculty, and our community in every aspect of clinical research and clinical trials at all times and in particular during the present uncertainty surrounding COVID-19. Our clinical research enterprises adhere fully to the specific patient and staff safety guidelines currently developed.

The following guidance is effective through April 30th, 2020, and will be updated as conditions change:

During the current COVID-19 outbreak, ensuring health and safety requires the implementation of special precautions and policies affecting UCI Clinical Research facilities. UCI CCR is working with the Office of Research (local and central IRBs) to implement regulatory changes (e.g. See the WCG communication about possible regulatory changes and their implications).

IRB approval is not required when hazard is apparent, as per FDA and HHS regulations.  Changes to the protocol (other than the addition of a COVID-19 screening process) can be added to the protocol at next modification.

UCI Clinical Research Staff will be asked to respect the current UCI Health regulations regarding COVID-19 and will be educated on Enhanced Hand Hygiene and Social Distancing Interventions (see Box 1 on workplace rules from Dalton et al.).

Research treatments requiring hospital/infusion room procedures for patients currently enrolled in clinical trials will continue as scheduled while observing the precautions now enforced for all UCI Health patients (please see the UCI Health Screening policy for patients and other useful protocols).

Shipping of oral investigational products directly to research patients will be considered when allowable.

Whenever possible and permitted per protocol, investigators are encouraged to optimize the use of telemedicine, appropriately protected social media, or video and phone conferencing using proper safeguards for research participant confidentiality.

Clinical trial patients on follow-up after completing the active treatment period and non-therapeutic clinical trial participants might have their visits or study procedures (laboratory and imaging, etc.) rescheduled/delayed if the health system resources are limited due to COVID-19 treatments.

Site visits (e.g. pre-site selection visits, site initiation visits, interim monitoring visits, etc.) conducted by industry partners, auditors and clinical research organizations (CROs) are encouraged to be conducted remotely when possible. When on-site visits must occur, all precautions in affect for visitors at UCI Health must be observed.

Regulatory References

FDA: “Each IRB shall … (a) Follow written procedures for ensuring that changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to the human subjects.” 21 CFR 56.108(a)(4)

HHS: “…Ensuring prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that investigators will conduct the research activity in accordance with the terms of the IRB approval until any proposed changes have been reviewed and approved by the IRB, except when necessary to eliminate apparent immediate hazards to the subject.” 45 CFR 46.108(a)(3)(iii)