If at least one person on a study will be consenting/engaging in direct in-person interaction with participants (indicated in 2.1 AND 9.1.1 of the iStar application), the “Attest to COVID-19 Policies” activity will appear on the study landing page. Once the attestation has been completed, it will apply across all studies for which that person expects to obtain consent or have direct in-person interaction with participants.

Please note that you will have to complete the attestation again in iStar even if you had previously submitted it.

USC studies will be halted from executing any “Submit” activities until all individuals (who need to attest) have attested. On approved studies, there will be a box with the names of individuals who have not yet signed their attestations (on existing non-exempt studies).

Once all individuals required to do so have signed their attestation, an email will get sent out to the PI/Faculty Advisor/Study Coordinator.

Please refer to the Attestation Guidance document and Attestation FAQs for more information.

What is the process for submitting a PI-level plan approval notice? 

Each PI is responsible for submitting a PI-level Plan that is reviewed at the level of his/her/zir department and then school, to ensure comprehensive adherence to the school’s Provost approved school-level plan, including those related to participant and study personnel safety practices. In the event you are at a location that does not have a Research Dean (e.g., Institute for Creative Technologies), please contact the Office of Research for guidance.

Once a PI receives approval from his/her/zir respective school (e.g., email or letter) that plan approval notice must be uploaded in iStar prior to submitting an application to the IRB. If there are no in-person activities conducted, please select “no” in response to the question “Will anyone on this study have direct in-person interaction with participants?” (Section 9.1.1).

For previously approved studies, if in person activities are conducted, the PI, Co-Investigator, Faculty Advisor, Study Coordinator or Study Contact can upload the PI-level plan approval notice via the attestation procedure in the study home page.

iStar allows the PI-level plan approval notices to be linked to the PI. Rather than uploading the plan approval notice for each study where the PI is listed, the plan approval notice now requires a single upload. Because of this, any plan approvals previously uploaded, will have to be re-uploaded by a member of the study team. We apologize for any inconvenience caused and hope the one-time upload process will simplify matters for all users.

Please refer to the Attestation Guidance document for more information.

What is the process for submitting a Study-level plan approval notice? 

Each PI who is resuming community/field-based research is responsible for submitting a Study-level plan that is reviewed within his/her/zir school. Confer with your Research Dean or designee to determine the right point of contact within the school. This review is intended to ensure comprehensive adherence to the school’s Provost approved school-level plan, including those related to participant and study personnel safety practices. In the event you are at a location that does not have a Research Dean (e.g., Institute for Creative Technologies), please contact the Office of Research for guidance.

Once a PI receives approval from his/her/zir respective school (e.g., email or letter) that plan approval notice must be uploaded in iStar prior to submitting an application to the IRB. If there are no in-person interactions with participants in the community/field, please select “no” in response to the question “Will in person interaction with participants occur in the field / in the community?” (Section 9.1.2).

Study-specific research plans, meeting the expectations set out in this document, must be submitted for approval by the PI’s vice/associate/divisional dean of research or designee. In the event you are at a location that does not have a Research Dean (e.g., Institute for Creative Technologies), please contact the Office of Research for guidance.

Prior to engaging in research activities in any community/field settings, research staff must be tested and confirmed negative for COVID-19 in accordance with local testing guidelines/requirements. Participants must also be provided with the COVID-19 Information Sheet (English/Spanish) detailing the risks associated with COVID-19.

Principal investigators must complete and upload a daily log of contacts with whom research staff have had direct interaction (research participants and agency staff) for the purpose of participant notification. Research staff must provide to each participant an information sheet that explains the collection of data for the purpose of participant notification in the case of infection.

The guidelines for community/field research not involving human subjects can be found here.

Are study monitors permitted on campus?

Study monitors are only permitted on campus if it is not possible to conduct the monitoring remotely. Please view the USC CTSI established requirements for more information.

If it is necessary for a monitor to come to campus, they must register with IntelliCentrics (aka RepTrax). 1 person (1 monitor) is permitted on-site. Intellicentrics registration process is only required for monitors entering Keck Medicine facilities Only.

For monitors visiting any non-clinical, free-standing research facility on campus, monitors only need to conform to all other requirements (1 monitor max, trojan check, PPE, physical distancing).

Each PI must submit a plan for conducting research in Phase 2 through the KSOM Research Resumption Portal. This applies to all studies–new, resuming, and ongoing. Once the PI receives an approval notice through the portal, that will need to be submitted to the IRB. Please note that studies that remained active through the initial stage of the pandemic will not need to submit to the approval notice to the IRB.

Please refer to this guidance document for more information. If you experience issues with the KSOM Portal, please contact David Galassi (dgalassi@usc.edu)

What if I am changing my study procedures to send drugs and/or devices to the participant’s home? 

Research activities where the investigator is sending drugs and/or devices through the mail to a participant for home use are considered “remote” research. The study team must articulate the safety measures it will take to ensure whatever it is sending is safe for the participant to receive (inside the envelope or package, not the actual envelope or package). The study team also must indicate what safety measures it will take when it receives anything back from the participants to ensure what it receives back does not present a risk for members of the study team.

Because these qualify as “remote” data collection, these specific types of activities do not require a PI-level plan or attestation(s). This does not include activities where a member of the team or a home health nurse would go into someone’s home to conduct research related activities or to drop off or pick up research related materials. Those remain as Phase 3 activities.

What if I temporarily paused direct in-person research activities without communicating that action to the IRB and I now want to resume those activities?

You are required to obtain a school-level plan and submit the plan approval notice to the IRB along with the attestation for any and all personnel who will be consenting and having direct in-person interaction with participants . Follow the instructions above with respect to how to complete both of these actions.

If you paused direct in-person research activities on an industry sponsored clinical trial because the sponsor requested you do so, you are required to submit the plan approval notice to the IRB along with the attestation for any and all personnel who will be consenting and having direct in-person interaction with participants . Follow the instructions above with respect to how to complete both of these actions.

What is the process of resuming research at LAC-DHS? (new)

The Los Angeles County Department of Health Services’ Research Oversight Board continues to require all research activities at LAC-DHS to be paused at this time with few exceptions.

If you have a study that you would like to continue at LAC-DHS, you must:

1. Review Figures 1 and 2 in the Research Approval Form to determine workflow before/after IRB approval.
2. Complete all sections of the form.
3. Send the study protocol along with the form to the following three individuals for their signature:
   (1) County Administrator for the PI’s department
   (2) County Clinical lead overseeing the area where most patients will be enrolled, and
   (3) Gregory Vermillion, DNP, LAC+USC Assistant Nursing Director.
4. Email the completed, signed form to suail.fabros@med.usc.edu.

Please note that if you have not received specific approval to continue your research project(s) through this mechanism, you should not be conducting research at LAC+USC.

Please refer to this memo for the updates to the guidelines for research during the COVID-19 pandemic.

Where do I find the Coronavirus Screening Questionnaire or Wellness Assessment?

You can access the Coronavirus Screening Questionnaire here and it is also available at KSOM. The Wellness Assessment is what is being used in TrojanCheck.

What is the process of resuming research at Herman Ostrow School of Dentistry?

Each PI must submit a plan for conducting research in Phase 2 through the Herman Ostrow School of Dentistry Clinical Research Restart Portal. This applies to all studies–new, resuming, and ongoing. Once the PI receives an approval notice through the portal, that will need to be submitted to the IRB. Please note that studies that remained active through the initial stage of the pandemic will not need to submit to the approval notice to the IRB.

To return to campus, you must take the mandatory ‘Health, Hygiene and Safety Training’ module in TrojanLearn (requires flash-compatible browser). This will help you better understand the health and hygiene requirements for returning to campus, and why it’s important for you to be aware of how the virus spreads. You will not be able to complete the Trojan Check and reservation without completing this first.

Please take the training course that is most appropriate for your status at USC.

• Health, Hygiene and Safety for Students
• Health, Hygiene and Safety for Research Students
• Health, Hygiene and Safety for Research Employees
• Health, Hygiene and Safety for Employees

How do I access TrojanCheck?

Before coming to campus, you will need to complete a daily wellness assessment (Trojan Check) affirming that you have not recently been exposed to or diagnosed with COVID-19, and that you are not currently experiencing any symptoms consistent with COVID-19. Within one hour of completing the required training module, you will have access to Trojan Check. Once you have completed Trojan Check, you will be allowed to make a reservation to come to campus. At the end of the process, you will receive an access pass with a QR code to enter the campus or your specific building. Unaffiliated study team members will access Trojan Check via the “guest” option.

Questions? View an overview video of Trojan Check along with step-by-step videos for how to log in, create reservations and complete your wellness assessment.

Departments that currently require a paper version (English and Spanish) may download the paper versions of these questionnaires.

Please note that very limited and strictly overseen undergraduate research on campus is allowed under the rules explained here.

Procedure for Visitors to Campus During Phase 2
Visitors of any sort should be called out in each school’s Restart plan and reviewed/approved accordingly.

During Phase 2, any non-USC visitor approved for campus entry should complete this form found here on a daily basis and file it with the host department. Each visitor will also be required to register and make a building-specific visitor reservation via iVIP.

What do I do if I become aware of study activity that puts study participants at risk?

If you become aware of study activities or practices that you feel put study participants at risk in any way contact OPRS at oprs@usc.edu or visit the website Complaints, Concerns and Report of Misconduct.

Who do I contact for additional information?

For general questions, please reach out to Julie Slayton – jslayton@usc.edu

For study specific questions, please use the “Send Message to IRB” button in iStar or email the IRB analyst assigned to your study.

The Office of Research website provides guidelines for the safe, cautious, and phased ramp-up of USC research activities during COVID-19 as well as FAQs related to research.

To notify the university about a positive case of COVID-19, call 213-740-6291. To arrange for testing due to exposure or symptoms, call USC Student Health at 213-740-9355 (WELL).