This webpage has been created to share the answers to COVID-19-related questions.
Are the IRBs Offices operating as usual?
The IRB offices remain fully operational. Like many other departments, staff have begun transitioning back to the office but will continue with remote work flexibility. IRB meetings will continue to be held virtually until further notice. In addition:
- Highest priority is being given to all questions, requests, and applications (including changes and reportable events) related to COVID-19.
- The IRBs’ point of contact service is available by voicemail only.
- Most consultations and presentations will continue to be done remotely. Some staff may be available for in-person consultations depending on scheduling and preference.
- The IRB Office will remain locked during the day until further notice. Please contact our main number (608-263-2362) or individual staff reviewers, as applicable, if you would like to set up an in-person appointment
Information for Researchers Planning Covid-19 Related Research or Treatment
Are face-to-face research interactions allowed?
Updated guidance on face-to-face research interactions can be found here.
What is the IRB review process for COVID-19 research?
Beginning March 23, 2020, a centralized process for assessing and reviewing some COVID-19 research was implemented. This process applies both to new studies AND changes to already approved studies that involve collecting and or analyzing biospecimens. This process does NOT apply to other studies that qualify for exemption (including chart reviews) nor adding questionnaires to existing studies about subjects’ experience with COVID-19.
Researchers proposing such non-exempt COVID-19 projects should proceed as follows:
- Complete and submit the form found here.
You will need to provide a study synopsis or draft study protocol.
- Projects will be assessed for feasibility within the current clinical context of the pandemic.
- If this is a new project (rather than a change to an existing study), that is approved to move forward with IRB review, we highly recommend these studies be submitted by the Office of Clinical Trials. This will help ensure a streamlined and quicker IRB review process. Please contact Jen Parnell, Director Office of Clinical Trials for assistance (firstname.lastname@example.org).
- At this time, we expect that all non-exempt multi-site COVID-19 research studies will go to the sIRB designated by the sponsor or coordinating center. Teams with investigator-initiated studies should consult with RELIANT (email@example.com) about the best IRB review option (e.g., UW or an independent IRB).
- Researchers with questions about this process should contact Betsy Nugent, Chief Clinical Research Officer, directly.
What if my new COVID-19 study involves collecting and/or analyzing biospecimens?
COVID-19 BioBank Specimens
The UW Carbone Cancer Center (UWCCC) Translational Science BioCore (TSB) BioBank is now serving as the centralized collection, storage, and distribution resource for COVID-19 specimens. Please review the COVID-19 BioBank Resource memo released by the SMPH Associate Dean for Basic Research for more information.
Researchers who wish to use COVID-19 specimens must work with the BioBank in order to obtain available specimens. Because of the BioBank’s honest broker system, IRB review of research studies using BioBank specimens may not be required. This depends on the identifiability of the specimens and the research activities that will be conducted. If researchers plan to use identifiable specimens and/or are conducting FDA-regulated research with the specimens, IRB review is required. Researchers should work collaboratively with the BioBank and the IRB, as needed, to determine whether IRB review of their research study is required.
Note it is likely that not all researchers will be able to obtain these specimens, as they are of limited availability. An institutional application process for securing the use of UWCCC’s BioBank samples for UW researchers in the COVID-19 related research will be announced shortly. Do not contact clinicians directly for specimens, as they are not authorized to provide specimens directly to researchers.
Specimens obtained for research purposes:
A limited number of research studies may require collection of COVID-19 specimens that extends beyond what the UWCCC TSB BioBank can provide. In these cases, obtaining specimens from UW Health patients while they are in clinics or hospitals requires advance approval through the centralized process for assessing and reviewing COVID-19 research. In addition, these studies must use the Office of Clinical Trials (OCT) for study management, subject recruitment, consent, and blood draws, even those with PIs outside of SMPH. This allows OCT staff to coordinate the consenting and any sample collection to minimize impact on subjects and monitor total sample donation. IRB approval must also be in place before collecting the specimens, even if the specimens will ultimately be de-identified or anonymized.
Applying FDA regulations:
Using specimens to develop or test investigational assays or other laboratory tests for clinical diagnostic purposes may require applying FDA regulations to the research. For additional assistance in determining whether FDA regulations apply to the study, please contact the FDA Regulated Research Oversight Program.
Submission to the IRB:
If you have received institutional approval to conduct a new COVID-19 study using specimens and are unsure what type of IRB application is needed, please email IRBDirector@hsirbs.wisc.edu for assistance.
Obtaining Informed Consent from COVID-19 Positive Patients
Obtaining informed consent from patients hospitalized with severe COVID-19 presents a number of challenges both because of decisional incapacity, as well as physical constraints as a result of isolation requirements. This guidance addresses some of the most common issues and concerns and outlines alternative methods for conducting the consent process and obtaining informed consent. This guidance should be considered in supplement to Institutional Policy on Research with Adult Participants Lacking Capacity to Provide Informed Consent.
- If the patient has impaired decisional capacity, due to intubation, loss of consciousness, etc., study teams should obtain consent from the legally authorized representative (LAR) in accordance with Institutional Policy.
- In the case that the subject/LAR is physically unavailable (in some cases, the LAR may also be following quarantine requirements), alternative methods for providing the consent document and obtaining informed consent should be considered.Options for Providing the Informed Consent Form (ICF):a. If possible, the consent form should be provided to the subject/LAR in the isolation unit or quarantine space (the form itself may need to be discarded); ORb. Provide the participant/LAR with an electronic version of the ICF via a tablet, computer, or other device (this includes using UW approved document sharing options like WebEx or a Secure Box Folder); ORc. Provide the ICF via email (this requires written or verbal authorization to receive communications by email after being informed that email is not secure); ORd. Provide an audio recording of the ICF; OR
e. Read the entire consent over the phone/WebEx (only do this if no other option is available).
Considerations for the Informed Consent Process:
a. As always, study teams should review and discuss the ICF with the subject/LAR and answer their questions (this may occur by phone or other electronic communication like WebEx if direct communication with a participant/LAR is not possible).
b. If the subject/LAR agrees to participate, the consent form should be signed if possible.
c. If a paper consent was used and it is able to be removed from the subject/LAR isolation area, this should be done.
d. Alternatively, the signed consent can be uploaded to a system such as REDCap (if possible), WebEx, a Secure Box Folder, or emailed to the study team.
e. If it is not possible to obtain a digital image/electronic copy of the signed page, the study team should both document that an imaging/electronic device was not available and have a witness to the consent process.
f. The witness should sign the consent form (and date the form for FDA regulated research). This is not a waiver of documentation. This assessment is based on FDA information sheet on Informed Consent.
g. The entire consent process must be documented in the study records.
How do I obtain informed consent remotely?
Study teams developing plans for remote consent processes should follow IRB Documenting Consent Electronically or for Remote Subjects Guidance when possible.
For FDA regulated studies that require signed consent (i.e. they cannot justify a waiver of signed consent), if study teams intend to use digital signatures as opposed to handwritten signatures, best practice is to obtain digital signatures through a method that is FDA Part 11 compliant, such as the Part 11 version of DocuSign through the UW-Madison licensed version. (See the Investigator Manual for further guidance.) However, given the unusual circumstances as a result of the pandemic, the FDA has issued comprehensive guidance outlining alternative means of obtaining informed consent when neither wet ink signatures, nor Part 11 compliant electronic signature are possible.
Any method of obtaining informed consent other than a face-to-face consent interview must allow for an adequate exchange of information and documentation, and a method to ensure that the signer of the consent form is the person who plans to enroll as a subject in the clinical investigation or is the legally authorized representative of the subject.
For example, the consent form may be sent to the subject or the subject’s legally authorized representative by mail, facsimile or e-mail, and the consent interview may then be conducted by telephone or via a UW-approved videoconferencing platform (i.e. Webex). This process allows the subject or subject’s legally authorized representative to read the consent form before or during the consent discussion. After the consent discussion, the subject or the subject’s legally authorized representative can sign and date the consent form.
If the signed informed consent document cannot be mailed or collected from the patient’s location and included in the study records, subjects or their LAR may scan the document or take a picture of each page via a smartphone or camera, and send the document back to the study team via a UW approved document sharing option (e.g., uploads to Secure Box Folder, WebEx) or via email or fax. If a picture is used, note that it is best practice for the subject to email a picture of the entire consent form, because then the study team has a record of what information the subject received, and the full document that was signed. If it is not possible to send back the entire form, the subject should email the signature page(s) as well as any pages requiring subject responses, such as checkboxes or initials. In cases where the entire form is not provided, study teams should confirm that the version date and IRB stamp is visible on the page(s) received, in order to document that the subject signed the correct version. The email from the subject can also provide documentation of timing of receipt and should be retained in the research records. See Documenting Consent Electronically or for Remote Subjects Guidance. Alternative methods for obtaining a signature may be appropriate in certain circumstances, as outlined in the FDA guidance referenced above.
Finally, the person signing the consent form must receive a copy of the consent form. Although FDA regulations do not require the subject’s copy to be a signed copy, FDA recommends that a copy of the signed consent form be provided.
As per posted IRB guidance, the use of email to send or receive information that may reveal information about the potential subject’s health requires prior permission. Please see our Use of Email for Research Purposes Guidance for a more comprehensive discussion of these requirements.
Research records should clearly document what method was used to conduct the consent process and document that informed consent was obtained prior to beginning study procedures. Additionally, any alternative consent processes must be reviewed and approved by the IRB prior to implementation. Study teams are advised to avoid using specific product names (e.g. DocuSign, Webex) when describing the consent process in IRB documents, but rather to state that any electronic signature or videoconferencing software will comply with institutional requirements. Study teams conducting research that is subject to HIPAA regulations should consult with their departmental IT and/or HIPAA security officer. Please also see this guidance for a link to HIPAA compliant tools for exchanging and storing PHI.
Please see Remote Study Activities Guidance for more information about how recruitment, research interventions, and data collection can occur remotely.
Do I need to revise my consent documents to reflect the risks of COVID-19 if in-person study interaction will still occur?
At this time, we are not recommending consent documents be revised. Bringing participants to a facility during times in which there are high numbers of COVID-19 cases is strongly discouraged unless appropriate risk mitigation strategies are in place and/or it is for an important safety monitoring visit that cannot be postponed or managed in some other way.
How do I modify my study so study visits can occur remotely?
Although no longer a requirement, study teams may nonetheless consider replacing in-person study visits with “remote” options (or adding as an alternative) for questionnaires, surveys, screening, follow-up, and consenting to allow for flexibility in participation. Please see Remote Study Activities Guidance to help plan for how recruitment, research interventions, and data collection can occur remotely. (Please see the guidance at the bottom of the HIPAA page regarding tools that can be used for remote study visits.) These changes must be approved in advance by the IRB as a change of protocol, unless they are necessary to eliminate apparent immediate hazards to participants.
- For exempt studies, a change does NOT need to be submitted to allow for remote study activities as a result of COVID-19.
- When submitting a COVID-19-related change, please note this in the submit activity form so we can prioritize these changes appropriately.
- Implementing changes to eliminate immediate hazards to subjects can be done prior to receiving IRB approval.
- Other changes to study visits NOT intended to eliminate an apparent immediate hazard to subjects, must be by approved by the IRB before being implemented.
Mandatory Pause Considerations for On-going Research
What if I decide to temporarily halt study visits?
Study teams temporarily halting study visits and not making any other changes to the study should report this to the IRB via a new information report within 5 business days of implementing the halt. Please see the What information should be included in new information reports about halts to study visits/procedures? FAQ for details on what to include in your report.
What about effects on enrollment goals?
Studies that do not meet their enrollment goals because of COVID-19-related issues should be described in a study’s Continuing Review application. The IRB will be mindful of the circumstances when conducting its review. If you are temporarily halting study enrollment and you have no active study subjects, this does NOT need to be reported to the IRB. If, however, you are halting the entire study and this will impact some active subjects, you should inform the IRB. Please see the other FAQs for whether a reportable event or change of protocol would be appropriate.
What about studies for which the UW is serving as the reviewing IRB?
If you have a study for which the UW is serving as the reviewing IRB, the UW study team should notify relying site study teams of the following:
- Any relying sites should follow their own institution’s guidance on interactions with subjects and other COVID-19 measures.
- If the relying site has NOT provided guidance OR their guidance is less stringent than the UW’s, they should follow UW guidance.
- Relying sites should still consult with their own IRBs about any local reporting requirements.
- The UW study team is responsible for notifying relying sites of the above guidance.
If you have questions about the above, please contact the Reliance and Navigation Team (RELIANT; firstname.lastname@example.org) for assistance.
What about studies reviewed by a non-UW-Madison IRB?
If you have a study that has been reviewed by an external IRB (e.g., WIRB or Advarra, another academic institution), we advise the following:
- Study teams should follow the UW’s COVID-19 guidance unless provided with more stringent guidance from the reviewing IRB.
- Study teams should consult with the lead study team, sponsor, and/or the reviewing IRB to determine whether anything needs to be reported about changes to study activities at UW-Madison to the reviewing IRB.
- Study teams do NOT need to submit any COVID-19-related changes to cede applications in ARROW unless required to do so by the reviewing IRB.
If you have questions about the above, please contact the Reliance and Navigation Team (RELIANT; email@example.com) for assistance.
New Information Reports and Changes of Protocol
What information should be included in new information reports about halts to study visits/procedures?
Note that even if you informed the IRB initially of halts to study visits/procedures, if you restarted face-to-face interactions and subsequently halt visits a second time, a separate New Information report should be submitted.
To facilitate review and avoid delays, study teams should be sure to address the following when submitting New Information reports related to COVID-19:
- Do not include specific end dates for the proposed halts/changes. Instead state:
- Regular study activities will resume once UW guidance deems it safe to do so (this avoids having to submit any follow-up reports in case currently predicted end dates are changed)
- Address what study activities are being HALTED as well as if any study activities WILL CONTINUE (e.g. many studies have some activities that are already approved to be completed remotely like questionnaires, subject activity diaries etc.).
- Directly address if you are halting/altering subject safety visits/follow-up
- IF NECESSARY explain how many subjects are currently participating in the study and at what point they are in their participation.
- Describe how changes to subject safety/monitoring visits will be handled and how any risks to subjects will be mitigated.
- Changes made as a result of drug shortages or delays should specifically address:
- How the shortage/delay impacts subject safety, if at all.
- Any steps being taken to mitigate risk.
- Briefly describe how new information is being communicated to subjects. In cases involving interruptions to ongoing study participation and/or changes to subject monitoring, instructions for drug administration, etc. more details may be necessary, including the provision of any subject-facing written communications.
- If this is a multi-site study for which the UW IRB serves as the reviewing IRB for external sites include how you will be communicating this information to the other sites and confirm they are either following their local guidance on COVID-19 or UW’s (if they do not have guidance of their own).
BE CLEAR in your report if any of the above items have been IMPLEMENTED PRIOR TO IRB REVIEW.
What information should I include in my COVID-19-related change of protocol?
In general, it is the same information as outlined in the What information should be included in new information reports about halts to study visits/procedures? FAQ. These changes should primarily focus on changes that have the potential to impact subject safety (changes in study drug administration, changes in the conduct of safety visits/activities, etc.). Note that any remote activities must be completed via one of the approved PHI exchange tools noted in guidance posted at the bottom of this page.
Should I submit a New Information report or a Change of Protocol for my COVID-19-related protocol updates?
Halts to in-person study activities/visits should be reported to the IRB, as outlined in the What information should be included in new information reports about halts to study visits/procedures? FAQ. For most minimal risk studies, these halts to in-person study activities do not require additional action to mitigate effects on subject safety. For potentially therapeutic studies that have currently enrolled subjects, however, the continued conduct of the study may require significant changes to procedures in order to continue to monitor subject safety, provide study drug, or collect critical data. In these situations, a change of protocol should be submitted, rather than a New Information report.
Other Campus Resources
- UW-Madison is providing its COVID-19 updates here.
- Guidance on tools for exchanging and/or storing protected health information (PHI) can be found at the bottom of the HIPAA page. If you have question about this guidance, please contact your HIPAA security and privacy coordinator for assistance.
- COVID-19 related-guidance for clinical trials research can be found here.
- Research and Sponsored Programs (RSP) also has information on COVID-19’s impact on sponsored research, including links to federal agencies.
- The Pharmaceutical Research Center (PRC)’s FAQ can be found here.