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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: 2 at up to 50% capacity and community/field based research allowed

As we continue to make decisions regarding our response to the COVID-19 pandemic, we keep our focus on the safety of our research participants and the research team members who work for University of Southern California and Keck Medicine of USC. Our secondary goal is to preserve the scientific integrity of the research protocols.

The current phase of the Research Ramp-Up, Phase 2, allows for on campus research activities along with community/field‐based research. At the same time, given the continuing risks associated with in-person interaction, all research that can be done remotely should be done remotely.

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 associated with entering into a setting with others who may be carrying the virus as well as the risks associated with participating in your research.

For all studies that include direct in-person interaction with participants, before submitting to the IRB, you must have approval of either a PI-level plan (for research taking place on USC sites such as University Park Campus and Health Science Campus and off-site facilities such as the Institute for Creative Technology) or a Study-level plan (for community/field-based research) from your school (e.g., Dornsife, KSOM, Ostrow, Rossier, Viterbi) or institute/center (e.g., Institute for Creative Technologies). You will be expected to upload your PI- or Study-level plan approval notice into iStar as part of your iStar application. All members of the study team will also be expected to complete an IRB specific attestation indicating an understanding of the safety measures they are required to undertake while conducting in-person data collection activities. Each study will also undergo a review by USC Environmental Health and Safety (EH&S). In addition, as described in the Community/field-based Research Guidelines, each study team will be expected to complete a “daily log of contacts with whom research staff have had direct interaction,” provide participants with an Information Sheet for COVID-19 Research Protection and Participant Notification, and upload this information into USC SharePoint. This information must be maintained for 2 months and then must be deleted. For more information, see the Frequently Asked Questions section below.

New protocols submitted to the IRB without the requisite PI- or Study-level plan approval notice 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- or Study-level plan from your school and must submit that plan approval notice to the IRB prior to restarting research activities.

Attestation, Approval Letter, and Information Sheet

See Tables 1 and 2 to determine whether you are required to submit in iStar 1) an attestation signed by the PI and members of the study team and 2) your PI- or Study-level plan approval notice (e.g., email or letter) to the IRB. In addition, you will be expected to distribute a COVID-19 information sheet (English/Spanish) specifically focusing on the risks of participating in-person research activities to participants before interacting with them in person.

Table 1. Requirements for all previously approved studies, based on level of review (exempt, expedited, full board)

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Table 2. Requirements for all new studies, based on level of review (exempt, expedited, full board)

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For studies that were previously approved by the IRB that require the IRB attestation, the “Attest to COVID-19 Policies” activity will appear on the study landing page in iStar. In addition, new questions have been added to page 9 of the application regarding in-person data collection for both USC sites and community/field-based activities. These must be answered for any research involving community/field-based activities. Community/field-based research will not be approved until EH&S has reviewed and approved the information provided by the PI/study team in response to the presented questions.

For new studies that require the above, page 9 of the application has new questions that will guide researchers to the activity. Community/field-based research will not be approved until the Study-level plan approval notice has been uploaded and the EH&S review and approval have been completed.

PIs will have a required field to upload their PI-level or Study-level plan approval notice. This field is hidden and not required for anyone who is not the PI.

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

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 10/14)

Attestations

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.

PI-level Plan Approval Notice

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).

Community and Field Based Research

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.

Study Monitors

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).

Keck School of Medicine (KSOM) and LAC+USC (new)
What is the process of resuming research at Keck?

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.

Herman Ostrow School of Dentistry

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.

TrojanLearn and TrojanCheck

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.

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.

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).