COVID-19 Quick IRB Tips
Addressing COVID-19 Changes: Quick Tips for Research Teams
as of 05/18/2020
Current IRB guidance to adjust protocols during the COVID-19 pandemic are summarized on this page. Details and additional topics are frequently updated in the FAQs for Researchers.
Research that has already been approved by the IRB:
- Per institutional policy, in-person visits are only allowed if the study is a therapeutic drug or device trial. Whenever feasible, visits should be conducted remotely.
- In-person visits that involve safety labs must continue. Options for drawing the labs include, but are not limited to: using the Fairway CTSU, using a commercial lab, and involving the subject's PCP if they are willing. Please consult with your sponsor about the best approach to ensure ongoing safety of subjects within the clinical trial.
- Oral study drug can be shipped to the subject when approved by the sponsor.
Making urgent changes to approved research:
Federal regulations allow study teams to make immediate changes in research to avoid imminent harm. During the pandemic, many studies are undergoing changes to limit exposure to COVID-19. Any such changes should be immediately implemented to help ensure safety for participants and study team members. Study teams should read the remainder of this page to learn about IRB requirements in certain situations.
COVID-19 Changes that require IRB approval:
IRB submission is required if you alter study conduct. Examples of changes that require IRB approval include, but are not limited to:
- Elimination of study procedures
- Change in the frequency of procedures
- Changes to the type of research data being collected
- Use of off-site labs
- Use of home health for study visits
- Changes to the method of drug delivery
- Changes to clinical care that affect research outcomes
- Using a remote process to consent or re-consent, in some circumstances (see Obtaining consent through remote means section below)
The IRB recognizes that study teams must always prioritize safety for participants and IRB submission may need to be postponed. However, study teams are asked to submit these changes for IRB review within at least 60 days after implementation.
Submitting a protocol modification (MOD) in the eIRB system:
For changes such as those described above, submit a MOD to the study in the eIRB system. In your request, address the impact on the safety and welfare of subjects as well as data integrity. Please be sure to include "COVID19" in the mod summary.
- The MOD should include a document that describes these temporary changes. The document can be a revised protocol, a protocol addendum or a letter from sponsor. If you are revising your protocol, please include both tracked changes and clean versions.
- Please specify whether the protocol changes are temporary, during response to the pandemic, or permanent changes to study conduct.
- Below is sample text that could be used to update your protocol:
During the COVID-19 pandemic, we will modify this protocol to conduct virtual study visits. We will employ [cite the technology and methods you plan to use.]
Study visits will be altered as follows: [provide description]
The following data points will not be collected during this time: [provide description]
In order to ensure subject safety and welfare we will [provide description]
In order to address data integrity issues, we will: [provide description]
Obtaining consent through remote means:
In response to the pandemic, many study teams are switching their consenting process from an in-person interaction to obtaining consent through remote means. For consent forms that require a signature, investigators must follow the IRB's Guidance about Remote Consent.
IRB review and approval is required with urgent implementation of the new consent process in some circumstances:
- If the protocol or consent form describes an in-person consenting process, such as noting that informed consent will be obtained during a clinic visit, then an IRB submission must be made to update those documents.
- If the study sponsor distributes a memo instructing study teams to obtain informed consent remotely, then the memo and other revised documents should be submitted for review.
It is the study team's responsibility to review study documents to determine whether an IRB modification is needed. The modification for remote consent could be combined with other changes.
If the protocol and consent form do not specify that informed consent will be obtained in person, then study teams can follow the IRB's guidance document without an IRB submission because they are complying with the institutional directive.
Electronic signatures on consent documents:
Electronic signatures for consent may be used, depending on the type of study. For research that is not regulated by FDA, signatures can be obtained through REDCap or other institutionally-approved software. For research that is FDA-regulated, electronic signatures must be obtained through software that meets the requirements of 21 CFR Part 11. Investigators can use DocuSign, CRIS/VELOS, or another method approved by the study sponsor.
Re-consenting for COVID-19 changes:
In many cases, formal re-consenting will not be required for changes during the pandemic. Instead, study teams should notify subjects of these changes by phone and/or email, documenting their communications in study records.
- Switching study visits from in-person to video teleconferencing does not need formal reconsenting.
- Shipping oral drug to subject's home may not require re-consenting unless shipping requires release of PHI to a third party that is not covered under the HIPAA authorization. (This should be rare because the sponsor's business partners are typically mentioned as recipients of PHI.) Study teams should follow guidance from sponsors. Drug shipments must continue to meet FDA requirements for drug accountability and any state laws for the pharmacy.
- If the sponsor will start using a home health agency to conduct study visits, the IRB expects some form of permission from the subject because new parties will be interacting directly with participants. This could be accomplished through a brief consent addendum.
- Overall, if multiple aspects of the study are changing, the study team should prepare a brief consent addendum. Please contact the IRB for a template that could be used.
Signatures on consent addendums:
If re-consenting occurs, there are several ways to document the consent.
- If the participant has ready access to a printer and scanner, the consent document should be signed and scanned back to the study team.
- Alternatively, the signature on the document could be photographed and texted to the study team.
- The consent form could be sent to the subject through an FDA=compliance software such as DocuSign (for FDA-regulated research),CRIS/VELOS, or through REDCap (for non-regulated research).
Adverse events related to COVID-19:
Study teams must report to the IRB if a KUMC participant experiences a serious adverse event that is both unexpected and related to their study participation. If a participant is hospitalized or dies due to COVID-19, the principal investigator should evaluate the event according to the IRB's standard policies. The Reportable Adverse Events Form can be used to document the PI's decision. For all adverse events, study teams should notify the sponsor, medical monitor and DSMBs when required by the protocol.
Suspending enrollment only:
Suspension of enrollment does not need to be reported to the IRB.
Suspending the entire study:
If temporarily suspending research activities has no effect on the safety or welfare of participants, it does not need to be reported to the IRB.
If you are suspending a therapeutic trial and transferring subjects to standard care, submit the suspension to the IRB and discuss how you will ensure safe transition of your subjects.
If temporarily suspending research activities could increase the risk of harm or affect the welfare of subjects, submit a RNI for IRB review and approval before suspending these activities. Include COVID19 in the RNI Title. Select "Suspension" as the information type.
COVID-19-related changes for studies under an External IRB:
Changes made by KUMC study teams must be approved by the external IRB in accordance with their policy. No submission to the KUMC IRB is needed unless the changes are KUMC-specific or impact KUMC subjects differently.
During the pandemic, it is very important for study teams to know and follow reporting requirements of the external IRB related to non-compliance with the protocol.
Questions from sponsors:
If your sponsor has questions about how KUMC is implementing changes related to COVID-19, please refer them to the Research Institute website.