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Office for the Protection of Research Subjects (OPRS)

Develops program-wide policies for the conduct and review of human subjects research at USC, provides education and training and oversees the Institutional Review Boards, which reviews projects involving human subjects research.

COVID-19 Research Ramp-Up

Current Phase: 2A3 (3 stands for 30% capacity)

As of June 8, 2020, USC has begun the process of returning students, faculty, and staff to work in a safe and phased manner as the COVID-19 pandemic abates. We are currently in phase 2A, which begins increased on campus activities with strict physical distancing protocols in place (e.g., research, clinical education, essential Keck healthcare operations). Most operations remain remote/virtual. During this phase, community/field based research involving direct interaction (e.g., interviews, focus groups, surveys, observations, home visits to administer therapy) with participants is not allowed.

As researchers it is your responsibility to ensure those with whom you will have direct in-person participant interaction are fully informed about the risks, not necessarily associated with research participation, but of entering into a setting with others who may be carrying the virus. The research team must follow the USC Guidelines for Resuming Research Operations and the USC COVID-19 Research Ramp Up Table indicating the ramp-up phase the university has entered into.

For new studies that include direct in-person interaction with participants, before submitting to the IRB, your school-level ramp up plan must be approved and in place. In addition, you must have your approved PI-level plan from your school (e.g., Dornsife, KSOM, Rossier, Viterbi) to move forward with your own research. New studies already submitted to the IRB without attestations and a PI-level plan approval notice notice (e.g., email or letter) will be returned to the PI so that the attestation(s) and PI-level plan approval notice can be submitted.

As part of Phase 2A of USC’s Project Restart for research, the Keck School is about to resume some clinical research — specifically research involving direct contact with human study participants on campus — that was paused at the start of the COVID-19 pandemic. Clinical studies that remained active through the initial stage of the pandemic will continue as well, following requirements for Phase 2A. Each PI must submit a plan for conduct of clinical research in Phase 2A through the KSOM Research Resumption Portal. This applies to all studies – new, resuming and ongoing. Please refer to this guidance document for more information.

Protocols submitted before the school-level and PI-level plans have been approved will be returned to the researcher and will not be reviewed by the IRB.

Studies previously approved by the IRB that intend to resume direct in-person interaction with participants must have an approved PI-level plan approval notice from your school and must submit that plan approval notice (e.g., email or letter) to the IRB prior to restarting research activities.

Attestation, Approval Letter, and Information Sheet

See Table 1 to determine whether you are required to submit 1) an attestation signed by the PI and an attestation signed by all members of the study team and 2) your PI-level plan approval notice (e.g., email or letter) to the IRB. You will also be expected to distribute an information sheet specific to COVID-19 to participants before interacting with them in person.

Table 1. Requirements for all studies, based on level of review (exempt, expedited, full board) and subject to Phase Table

(Click on image to enlarge)

For studies that were previously approved by the IRB and that require the above, use the “send message” function in iStar. Once you have completed this action, you may resume study activities.

For new studies that require the above, submit the attestations and the PI-level plan approval notice (e.g., email or letter) using section 40.1 in iStar.

COVID-19 studies will not be pulled from the queue and will be reviewed in the order received.

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.

Below are answers to frequently asked questions. We update this list of questions regularly so you should check back if you are looking for the answer to a question and you do not see it posted here.

COVID-19 Research Ramp-Up FAQs (as of 6/30)

Attestations

Beginning on July 11, 2020, all attestations will be completed in iStar. Each study personnel will receive a notification to complete the attestation through iStar. 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.

Until this function is implemented, use the process outlined below:

  • For studies that were previously approved by the IRB, use the “send message” function in iStar to submit your attestation. You will not receive an auto-acknowledgement from the IRB.
  • For new studies, submit the attestations using section 40.1 in iStar.

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

For studies with a high number of study personnel, each person who expects to obtain consent or have direct in-person interaction with participants must attest. One attestation for all affected study personnel may be submitted or a separate attestation for each member of the study team may be submitted. Submissions may contain electronic signatures and/or “wet” signatures, maybe in a DocuSign document, a Word document, or any other format.

Note: All study personnel listed in iStar 2.1 as obtaining consent and/or interacting with participants must sign the attestation. Studies will not be approved until all study personnel required to complete an attestation have done so.

PI-level Plan Approval Notice

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

Each PI is responsible for submitting a 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.

Once a PI receives approval from his/her/zir respective school (e.g., email or letter) that plan approval notice must be submitted to the IRB prior to restarting research activities. Until July 11, 2020:

  • For studies that were previously approved by the IRB, use the “send message” function in iStar to submit your approval notice. You will not receive an auto-acknowledgement from the IRB.
  • For new studies, submit the approval notice using section 40.1 in iStar.
Keck School of Medicine (KSOM) and LAC+USC

What is the process of resuming research at Keck?

Each PI must submit a plan for conducting research in Phase 2A 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.

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?

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 complete this form to request continuation of study activities. You can use the same link to request continuation of more than one study. This requirement is not related to the USC IRB and is specific to LAC-DHS.

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.

TrojanLearn and TrojanCheck

How do I access the required TrojanLearn course?

All researchers (as well as USC employees) must complete the TrojanLearn module on COVID-19 prior to returning to campus.

Accessing TrojanLearn training through the USC Employee Gateway:

  • Login to TrojanLearn
  • Go to the Search bar at the top right of the screen and type in: Health, Hygiene and Safety.
  • Select the version that applies to you: Health, Hygiene and Safety for Employees, Research Employee, or Research Student
  • Click “Launch” to launch the training module.

How do I access TrojanCheck?

Research team members must use TrojanCheck to access campus:

  • Create an advanced reservation for the building(s) to be accessed
  • Complete the wellness assessment on the day of the visit
  • Record check-in and check-out times for each location visit

Please note that Undergraduate students and volunteers are not permitted on campus to participate in research during phase 2A. USC graduate students, medical students, residents, and fellows may participate, following all applicable policies and procedures. Please reach out to your Faculty Advisor for further information.

Contact

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.