Institutional Review Office (IRO) Coronavirus (COVID-19) Frequently Asked Questions

As of late April 2021, IRO is no longer prioritizing new COVID-related research, with the exception of new COVID treatment protocols.

All other applications will be processed in the order received as usual.

The IRO will continue to accommodate rush requests if they meet one of the following criteria:

• Already enrolled participants with life-threatening issues
• Potential future participants with life-threatening issues who have exhausted all other alternatives (treatment studies only)
• Funding emergencies such as Just-in-Time submissions with a clear date indicated

For items that meet the above rush criteria, the process is:

1. On your email submission, put “Rush” at the beginning of the subject line.
2. In the body of the email, include a clear rationale for the rush request. If a specific timeline is requested, please indicate.
3. If the submission is a research modification, also provide the rationale in question 5 of the Modification form.

We request you be sensitive to the high workload of the IRO and IRB Committees—please plan ahead.

Researchers may forego prospective IRB approval for changes in research if the change is “necessary to eliminate apparent immediate hazards to research participants” (per IRB policy 2.5 Modifications to On-Going Activities and federal regulations). You should make such changes and then submit a Research Modification and an Unanticipated Problem Report within 10 days.

Examples of types of changes that would fall under the exception to receiving approval prior to modifying the research:

• Re-consenting an already enrolled participant over the phone vs. in-person
• Replacing protocol-mandated visits to the clinic or other facilities with remote visits
• Allowing blood draws at remote or commercial laboratories
• Other changes to reduce potential exposure to COVID-19, or to continue to provide medically necessary study care (including study drug) to enrolled participants who have been placed in isolation or quarantine because of suspected or known exposures.

The above exception applies to enrolled participants. Generally, if you are making changes in how you will enroll or consent new participants, you need to submit a Research Modification before you make such changes. Delay the consenting visit accordingly until the Modification is approved by the IRB.

No. You can do this as part of regular institutional/clinical screening. This should not require a modification to the research.

If you are doing the screening to collect data for your research, you should submit Research Modification form.

If the enrollment is being suspended solely in response to institutional policies on social distancing, you do not need to notify the IRO. However, you must update your study status in OnCore. Contact the CTMS group for questions about OnCore requirements.

If the enrollment is being suspended in response to a sponsor’s notice that all enrollment must be suspended, you do need to submit a Modification and provide the sponsor’s documentation. You will only be able to reopen enrollment once the sponsor and the institution both allow it, and you must submit a Modification again to re-open in this scenario.

If you formally reported your study status as temporarily closed to accrual on any IRB submission, you should then notify the IRB of your reopening to accrual, either via a Modification or on your next Continuing Review submission if that is happening before you begin accruing again.   

You are not required to notify existing participants that you are temporarily pausing enrolling of new participants.

If your study is reviewed by an External IRB, please consult with that IRB for guidance about whether they require the COVID-19 related suspension to be reported to that IRB. 

If the change is “necessary to eliminate immediate hazards to research participants” (per IRB policy 2.5 Modifications to On-Going Activities and federal regulations), you may make the change right away and then submit a Research Modification and an Unanticipated Problem Report within 10 days. The submission should include your plans to notify participants of research changes or a request to not notify them with specific rationale.  

If the change is less timely, please submit your Modification to IRBinbox@fredhutch.org as normal but include an email subject line that starts with “Coronavirus-related” so the IRO can quickly triage such submissions. The submission should include your plans to notify participants of research changes or a request to not notify them with specific rationale.

If an External IRB is the IRB of record, please consult with the External IRB for guidance. You do not need to submit to the Fred Hutch IRO.

IRB policy 2.5, Modifications to On-Going Activities and the regulations allow researchers to forego prospective IRB approval for changes in research if the change is “…necessary to eliminate apparent immediate hazards to research participants”.

Generally, enrolling a new participant on a trial would not fall under this exception.

To conduct consent discussions remotely, the consent plan needs to first be approved by the IRB. Study teams should submit a Research Modification to the IRB for review and reschedule the participant’s consenting conference to a later date. Please see section 2.a. of IRB Policy 2.11 Informed Consent for details on the remote consent process.

In your Modification, you should specify whether this is a temporary change (because of COVID-19 situation) or if you are requesting this change for the life of the study.

Yes, the IRB will generally allow remote video or phone consenting in the context of the pandemic. You must still obtain a signed consent back from the participant. See IRB Policy 2.11, Informed Consent, section 2.a, for more information about telephonic consent (for example, it’s important to have a way to verify the participant’s identification via phone).

The recommended remote consenting approach is as follows:

1. Contact potential participant to verify correct address and confirm they are ok receiving the consent via mail or email.  You may wish to also schedule the video/phone consent session at this time.
2. Mail/email the consent form to the potential participant.
3. Use video or phone for the consenting conference. Verify the individual’s identity using date of birth or other identifier, or by visually checking a driver’s license on video.
4. If the individual agrees to take part, they sign the form and mail, fax, or scan it back to the study team. 
5. Upon receipt, the individual who conducted the consent discussion then also signs. 
6. Document in the record that consent was done via video or phone.

Your submission to the IRB should include a phone script or other document describing the structure of the consent plan for staff to follow.  

If a study was determined by the IRB to be minimal risk, you may propose an eConsent process (for example, a REDCap-based consent).  Even if the eConsent platform has a signature function, you must also submit a Consent Supplement to request a waiver of documentation of consent (to waive the signature requirement). If HIPAA applies, you must also submit a HIPAA Supplement to request an Alteration of HIPAA (to waive the signature requirement).

If the study is greater than minimal risk, Fred Hutch IRB is not approving eConsent plans at this time because further assessment is required.  You can still request a remote (video/phone) consent process but must obtain a signed consent form from the participant.

If Fred Hutch IRB is the IRB of record:   The answer depends how the visits were described in the approved protocol and consent.

• If the current documents specifically state it’s an in-person visit, you should submit a Modification to the IRB file.
• If the current documents do not specify an in-person visit, and the visits can be entirely done via telehealth, you can proceed with using telehealth visits (without submitting a Modification).
• If the visits need to be changed in another way (i.e., some procedures cannot be done via telehealth), you should submit a Modification.

Please note:  If the change to telehealth needs to be done right away to eliminate an immediate hazard, you can make the change and then submit a Modification after-the-fact along with an Unanticipated Problem Report.

If another IRB is the IRB of record:  Please consult with that IRB. 

Transporting patient records should be avoided where possible.  Scanning and access through a controlled and encrypted device/portal would be a best practice any time staff need to access strictly confidential information from an off-site location.

During this emergency period, IRO can accept electronic signatures on documents, such as IRB submission forms. Acceptable forms of electronic signatures include:

• DocuSign
• Adobe Sign
• Adobe Acrobat or Reader certificate-based signature

Instructions for setting up an Adobe digital signature can be found here: https://helpx.adobe.com/acrobat/using/certificate-based-signatures.html

Of course, you also have the option of providing a wet signature on the paper form, scanning that and sending it with the submission.

Please note, for electronic signatures on informed consent forms, this would require prospective IRB review and approval.

Please see the Office of Sponsored Research (OSR) Coronavirus (COVID-19) and Sponsored Research FAQ here.

If you are simply resuming visits/procedures that are already described within your IRB approved protocol, there is no need to submit an IRB modification to resume those activities.

If you are making any changes to the protocol or to how these resumed visits/procedures will be done (if they will be done differently than as described in the IRB file), please submit a Research Modification for IRB review.

Please note:  Reopening to accrual is addressed separately in a response below.

If your study is reviewed by an External IRB, please consult with that IRB for guidance. 

If the enrollment was suspended only in response to institutional policies on social distancing, and it becomes clear that you can reopen to accrual based on updated institutional policies, you do not need to notify the IRO that you are reopening to accrual.  

However, if you formally reported your study status as temporarily closed to accrual on any IRB submission, you should then notify the IRB of your reopening to accrual, either via a Modification or on your next Continuing Review submission if that is happening before you begin accruing again.    

If your study is reviewed by an External IRB, please consult with that IRB for guidance.