What if I want to submit a new study for a potential COVID-19 related drug? What is the right procedure?

If you are submitting a protocol directly related to responding to the COVID-19 pandemic (e.g., drug, device) that will provide potential therapeutic benefit to participants, use the language of “COVID” in the protocol title . These submissions will be given priority and will be reviewed and approved as quickly as possible. The IRB will be the ultimate arbiter of whether a new study is directly related to COVID-19. If a review reveals that the study is not directly related to responding to the COVID-19 pandemic, it will be moved to the normal review process.

What if I want to submit a new study that is not related to COVID-19?

The IRB is continuing to review new applications at this time. All applications (exempt, expedited, full board) not related to COVID-19 will be reviewed in the order received and will be processed through the normal process.

What if I want to submit an amendment that is not directly related to COVID-19?

The IRB is continuing to review amendments at this time. All submissions (expedited, full board) not related to COVID-19 will be reviewed in the order received and will be processed through the normal process.

What if I need to change my data collection approach from direct participant interaction to virtual/remote?

For full board and expedited studies, if an investigator or study team needs to alter data collection activities by shifting to virtual or remote approaches, an amendment should be submitted with the language “COVID” in the iStar amendment title. These submissions will be given priority and will be reviewed and approved as quickly as possible. The IRB will be the ultimate arbiter of whether an amendment is directly related to COVID-19. If a review reveals that the amendment is not directly related to reducing or preventing participant interaction, it will be moved to the regular review process.

Exempt studies do not require an amendment and principal investigators may make changes to their data collection immediately unless doing so changes the risk categorization of the study. If the changes to study activities will affect the risk determination, an amendment will be required.

What if I need to change my data collection approach and I have an IAA with researchers at another institution?

If your study is exempt, as described above, you do not need to submit an amendment to the USC IRB. If you have an IAA with researchers at another institution and they have ceded review to the USC IRB, you will want to communicate the change in protocol to them so that they can communicate the change to their own IRB(s).

If your study is expedited or full board, you do need to submit an amendment to the USC IRB. If the amendment is COVID-19 related, follow the guidance above. Otherwise, the amendment will be reviewed in order received and you should notify the researchers with whom you have the IAA so that they can communicate with their IRB(s) as appropriate.

What if I need to make a change to an industry sponsored study to eliminate or reduce direct participant interaction or address another immediate hazard to participants resulting from COVID-19?

For studies where a change in protocol is undertaken in order to reduce or remove an “immediate hazard to participants,” pursuant to USC HSPP Policy 9.17, participants must be “notified and corrective actions implemented as soon as possible.” Reducing potential exposure to COVID-19 or continuing to provide medically necessary care (including study drug(s)) to participants who have been placed in isolation or quarantine because of suspected or known exposure would be considered to be the reduction or removal of an immediate hazard. The USC IRB encourages sponsors and investigators to take such steps as necessary to eliminate apparent additional risks to participants.

Once corrective actions have been implemented, the IRB must be informed and the investigator must submit a Reportable Event in iStar promptly (within 10 days). Check ‘Protocol Change Initiated to Eliminate Immediate Hazard’ within the submission. The principal investigator must notify the sponsor as required by the sponsor or FDA. An amendment with revised study documents must be submitted to the IRB within 30 days. By using “COVID-19” in the amendment title, these submissions will be given priority and will be reviewed and approved as quickly as possible. Refer to the following link for FDA updates: FDA COVID-19 Guidance.

If there is time to submit an amendment to the study prior to taking corrective action, submit an amendment in accordance with the guidance above by using “COVID” in the title and the amendment will receive priority and be approved as quickly as possible.

If you have been obtaining consent and/or HIPAA authorization through direct participant interaction, you must change your approach to obtaining consent. You must submit an amendment indicating your intention to do so unless exigent circumstances exist and time does not allow for an amendment to be reviewed by the IRB. Under those circumstances, see the previous question regarding immediate hazard to participants resulting from COVID-19.

What if I need to obtain consent electronically?

If you have been obtaining consent through direct participant interaction and need to change your approach to virtual/remote, you may submit an amendment indicating your intention to obtain consent electronically using DocuSign or REDCap.

What if I am unable to obtain a digital signature for consent?

In the event your participant population cannot access DocuSign or another secure and encrypted online platform (e.g., REDCap), you may consider having participants take photographs of their signed consents using their cell phones and emailing them to the study team. Make sure you document the consent process so that anyone examining your approach will be able to see how consent was obtained in good faith. This approach is only available because of the constraints created by COVID-19. If the study is industry sponsored, the study sponsor must be in agreement before considering this manner of consent. Once direct participant interaction is again permitted, you will be required to return to face-to-face interaction or the use of an encrypted platform.

What if I need to obtain a HIPAA authorization?

If you have been obtaining HIPAA authorization through direct participant interaction and need to change your approach, first, you need to submit an amendment. Given the current state of emergency, in the amendment, you may alter your approach to obtaining HIPAA authorization using DocuSign or REDCap for studies that are minimal risk only.

Relying Site

The relying site relies on the IRB of record and cedes most of the responsibilities to the reviewing IRB. Relying sites are responsible for local context.

How do I notify the IRB about a suspension or change in my study that is ceded to a sIRB?

For studies that are ceded to a sIRB, submit an amendment to update the USC IRB on protocol changes, any type of suspension, or general changes made due to COVID-19. The amendment should include “COVID-19” in the title. Upload any associated correspondence received from the IRB of record and/or study sponsor. Participating sites should remain in close contact with the IRB of record and communicate to them changes and contingency plans required by the local site.

The study teams should proactively prepare contingency plans for their active research protocols. Study teams need to assess whether the disruption of a research protocol might impact the safety of research participants and notify the IRB of any changes to mitigate risk. The regulations allow researchers to implement changes to protect the life or physical well-being of a participant, when there is not no time to prospectively seek the approval of the IRB. In such cases, a Reportable Event is required to be submitted no later than 5 days with an amendment to make the appropriate revisions to the application.

Reviewing Site

The reviewing site is the IRB of record and has oversight of all of the research at all sites.

How do I notify the IRB of record about a suspension or change in a study where I serve as the Lead PI for a multi-site study?

Submit an amendment to update the IRB on protocol changes, any type of suspension, or general changes made due to COVID-19. The amendment should include “COVID-19” in the title. Upload any associated correspondence received from the study sponsor.

The investigator for a multi-site study should proactively prepare contingency plans and communicate closely with participant sites. Assess if the disruption of a research protocol might impact the safety of the research participants and notify the IRB and participating sites of any changes to mitigate risk accordingly. Local context considerations will govern which research activities are permitted at each site. Reviewing IRB reporting requirements may differ from local requirements.

What tools are available to access and share data within a study team?

USC faculty have unlimited storage on both OneDrive and Google Drive. Both of these are preferred over VPN approaches as both OneDrive and Google Drive are cloud based and do not depend on the ability to access a local server. Moreover, OneDrive is HIPAA and FERPA compliant for file and document sharing and storage. Research teams may share using OneDrive with anyone within the USC organization. If you have a need to share with a non-USC organization, alternatives do not yet exist but contact OPRS and we will see what can be arranged.

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.