Human Research Protection Program
COVID-19 Quick IRB Tips
Addressing COVID-19 Changes: Quick Tips for Research Teams
(as of 4/1/20)
The topics below summarize the current IRB guidance for adjusting protocols during the COVID-19 pandemic. More details and additional topics are addressed within the Research FAQs that are frequently updated.
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.
Implementing institutional policy about remote study visits
On March 21, 2020, KUMC investigators were instructed to limit face-to-face study visits to those for which remote interactions would not be feasible. If changes to your research are limited to what is necessary to comply with the institutional directive, then IRB approval is not required.
The following are examples to consider:
- Study teams adhere to the institutional directive by revising their methods so that in-person visits are now conducted by teleconference or other remote method.
- In-person consent procedures will now be performed in accordance with the IRB's guidance on Remote Consenting;
- A buccal swab kit is mailed to the subject instead of being obtained in the clinic.
In these examples, the actual study procedures are not changing; only the method of accomplishing the procedures is changing. Therefore, an IRB submission is not required.
Submitting a protocol modification (MOD) in the eIRB system
For changes such as those described above, submit a MOD to the study in eIRB. 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 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 a tracked and clean version.
- 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. pandemic. 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]
Making urgent changes to approved research:
When immediate safety concerns arise, study teams can make changes to their study prior to IRB approval. After implementation:
- Submit an RNI in eIRB detailing the change and the PI's rationale for implementation prior to IRB approval.
- Submit this RNI no later than 5 days following implementation of the change. To facilitate triaging, please include COVID-19 in the title of the RNI.
- If you plan to continue with the change during the pandemic, then submit a MOD as described above.
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.) 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.
- If the above options are not feasible, the participant can send an email to the study team indicating they have read the addendum, had an opportunity for their questions to be answered and agree to continue participating in the trial.
Enrolling new subjects by phone or video:
When new subjects are enrolled by phone or video, study teams should follow the IRB's guidance on remote consent posted on our Topical Guidance page.
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.
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 prior to 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.