This webpage has been created to share the answers to COVID-19-related questions.
Are the IRBs Offices operating as usual?
Last updated: 05.20.2020
The IRB offices remain fully operational, although staff are working remotely and IRB meetings are being held virtually. In addition:
- Highest priority is being given to all questions, requests, and applications (including changes and reportable events) related to COVID-19.
- The HS IRBs’ point of contact service is available by voicemail only.
- Until further notice, our office will no longer provide in-person consultations or presentations.
Do all human subjects regulations apply as usual during this pandemic?
Last updated: 03.25.2020
Yes. IRB regulatory requirements have not changed as a result of the current public health emergency. We are providing as much flexibility to researchers as currently allowed under federal regulations and guidance. These flexibilities will continue to be updated on our COVID-19 page.
Information for Researchers Planning Covid-19 Related Research or Treatment
What is the IRB review process for COVID-19 research?
Last updated: 05.01.2020
Effective March 23, 2020, a centralized process for assessing and reviewing some COVID-19 research has been 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?
Last updated: 05.13.2020
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
Last updated: 04.02.2020
Obtaining informed consent from patients with 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); OR
b. 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); OR
c. Provide the ICF via email (this requires written or verbal authorization to receive communications by email after being informed that email is not secure); OR
d. 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?
Last updated: 10.21.2020
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 Documenting Consent Electronically or for Remote Subjects Guidance for details.) 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.
Mandatory Pause Considerations for On-going Research
Can I still interact with my study subjects?
Last update: 4.14.2020
As of April 14, 2020, all face-to-face study visits must be temporarily halted until at least June 30, 2020 to align with other campus guidance. Study teams have the option to postpone visits or submit a change of protocol to conduct visits remotely (see below). This applies to ALL human subjects research conducted by UW-Madison researchers, regardless of reviewing IRB. Human subjects research that is conducted online or using other remote data collection methodologies (email, mail, phone, etc.) may continue.
Exceptions to this hiatus are therapeutic studies involving drugs or devices, or other research activities that are critical to the health/safety of patients or study participants. These studies may continue using face-to-face interactions. The determination of whether a research visit is essential to the health/safety of a participant is determined by the principal investigator, the participant, and the participant’s care provider, and should be informed by current public health guidance regarding the COVID-19 outbreak.
Even for therapeutic studies, we recommend moving toward remote data collection methods to the extent possible (for instance, telephone or electronic methods for screening or follow-up).
What about study enrollment?
Last updated: 3.16.2020
Study teams should halt or delay subject enrollment if appropriate based on COVID-19-related public health recommendations, facility requirements, study team availability, and/or subject populations considered at high risk for susceptibility to COVID-19. These kinds of temporary halts to study enrollment do NOT need to be reported to the IRB. Suspensions of study enrollment due to non-COVID-19-related safety concerns of DSMB/DMC findings must still be reported to the IRB per usual.
What if I decide to temporarily halt study visits?
Last update: 3.25.2020
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.
How do I modify my study so study visits can occur remotely?
Last update: 5.28.2020
Study teams should consider replacing in-person study visits with “remote” options for questionnaires, surveys, screening, follow-up, and consenting. 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.
Do I need to revise my consent documents to reflect the risks of COVID-19 if in-person study interaction will still occur?
Last updated: 3.16.2020
At this time, we are not recommending consent documents be revised. Bringing participants to a facility in which there has been a positive or presumptive-positive case of COVID-19 is strongly discouraged unless it is for an important safety monitoring visit that cannot be postponed or managed in some other way.
What about effects on enrollment goals?
Last updated: 3.25.2020
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?
Last Updated: 3.17.2020
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?
Last updated: 3.17.2020
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.
- Guidance for studies reviewed by the NCI CIRB can be found here.
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?
Last updated: 11.16.2020
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.).
- Note: You do have the option of submitting a change of protocol to allow for completion of study activities remotely. See our guidance for further details: https://kb.wisc.edu/images/group78/98594/UWHC_COVID-19_Guidance.pdf
- For up-to-date guidance on what research activities are allowable, please visit the
- and consult with your department/division/center.
- 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?
Last update: 3.25.2020
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?
Last updated: 3.25.2020
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.
FAQs for Restarting Face-to-Face Research
Do the Safer Badgers building access requirements apply to research participants?
Last updated: 1.22.2021
Beginning Jan. 25, UW–Madison graduate/professional students and employees coming to campus will need to use the Safer Badgers app to show they are in compliance with campus health and safety requirements in order to access campus buildings.
The Safer Badgers building access requirement only applies to students and employees at UW–Madison. It does not apply to research participants who are unaffiliated with UW–Madison. However, to access campus buildings, visitors must be escorted by a member of the campus community with whom they have business. For face-to-face research participants, this should be a study team member who will greet them and escort them to the research site. The person hosting the visitor is responsible for ensuring the visitor follows all campus health protocols, including wearing a face covering and physically distancing.
While the Safer Badgers requirements are in place, campus buildings will be closed to the general public and many will be monitored by Badger Wellness Ambassadors. These ambassadors will permit entry only to individuals in compliance with campus health and safety protocols and granted building access through a screen in the Safer Badgers app called the Badger Badge, visitors with a business purpose escorted by employees and students using the Safer Badgers app, or to contractors and delivery personnel in uniform.
Employees and students who will come to campus for any reason should download the Safer Badgers app to schedule their tests, manage their results, and access their badge to ensure they can gain access to campus buildings.
Employees and graduate students who do not need to access UW–Madison buildings will not need to get tested, though they may want to consider being prepared in case they should need to visit campus on short notice.
UW Health employees who are not dual employees of UW–Madison, as well as UW Health patients and research study participants, will also be treated as visitors. Additionally, anyone entering a UW Health facility is required to continue to follow masking, visitor limitation, physical distancing and other protocols, as required by the facility.
Dual employees of SMPH and UW Health must be in compliance with campus testing requirements in order to access campus buildings. The dual employee notice is linked on the SMPH Intranet COVID-19 Operations page. These employees must have a negative test on file within the previous eight days of their visit to campus. The only exception is for employees who are simply passing straight through Health Sciences Learning Center between the hospital and the parking garage, bike racks or bus stops.
For more information about community members visiting campus facilities, see the COVID Response FAQ and filter by “community”: https://covidresponse.wisc.edu/faq/audience/community/.
The Safer Badgers’ app is available for download at https://saferbadgers.wisc.edu
Information on building access is posted here.
For more information and answers to questions about UW–Madison’s COVID-19 response, visit the webpage for FAQs.
What role can the IRB play for department chairs, center directors, and deans who are determining whether specific research studies can reopen face-to-face visits?
Last updated: 7.1.2020
Department chairs, center directors, and deans are responsible for making decisions about which studies in their department, center, and/or school can restart face-to-face visits. Because COVID-19 is not considered a risk of participating in research, but rather a risk of everyday life, the IRB does not require re-review of the risks of previously approved studies. In addition, screening and testing activities meant to prevent the spread of COVID-19 are public safety activities and must be followed. As such, these are not considered study specific research activities and DO NOT need to be reviewed by the IRB.
However, in some circumstances, changes are needed to address scientific or subject population concerns related to COVID-19. For example, a study was previously approved by the IRB to enroll subjects age 65 and older for a set of exercise tests. Because older adults are at higher risk for severe illness from COVID-19, the study team plans to change the frequency and types of exercise tests being conducted in the research study in order to limit subjects’ exposure to viral droplets. In this case, the study team would need to submit a change of protocol to the IRB in order to change the study-specific activities.
The IRB is available as a resource for department chairs, center directors, and deans to address questions about whether changes are needed to specific research studies prior to restarting face-to-face visits. The IRB can advise on what study changes could be made to address department chairs, center directors, and dean’s concerns about subject population, study design, study location changes, or other related issues. For questions, please contact IRBDirector@hsirbs.wisc.edu.
What are the first steps for study teams to get approval to restart face-to-face visits for an IRB-approved study?
Last updated: 6.8.2020
It’s important for researchers to recognize that there may be IRB implications when restarting face-to-face research visits with human subjects. However, given the campus’s phased in approach to restarting, there are multiple steps that need to occur prior to working with the IRB on restart requirements.
The campus has determined that IRB-approved face-to-face human subjects interactions for studies that provide the potential for direct and meaningful benefits to individual participants may resume on or about June 1, 2020, at the earliest, while restarting remaining necessary face-to-face study interactions will resume no earlier than July 1, 2020. These dates are tentative and subject to change.
Department chairs, center directors, and deans are responsible for making decisions about which studies in their department, center, or school can restart face-to-face visits. In order to receive approval from the necessary department chair, center director, and/or dean, researchers must submit an application to request return to on-campus research through the OVCRGE portal. In addition to the OVCRGE approval form, SMPH studies also require the completion of the SMPH approval form; more information on SMPH reboot requirements are provided here. The study will then be reviewed by the appropriate individual(s) or committee to determine if face-to-face activities can resume, based on specific guidance and processes determined by the researcher’s school/college/center and research site.
Much of this review process will focus on requirements outside the IRB’s purview, including social distancing practices, PPE availability, study staffing needs, study location requirements, and more. These requirements should be addressed as part of the departmental chair, center director, or dean approval process and prior to submitting any changes of protocol to the IRB. Please visit the following sites for guidance on these campus related requirements:
What is required from an IRB standpoint before restarting face-to-face research activities?
Last updated: 7.1.2020
As part of the departmental chair, center director, or dean approval process, researchers may be asked to provide their study protocol or other IRB-related materials for their review. The purpose of this is so that the individuals reviewing the restart request can ensure that the research study complies with campus requirements for reopening. This will also allow them to make any necessary determinations about prioritizing studies for restart.
Screening and testing activities meant to prevent the spread of COVID-19 are public safety activities and must be followed. As such, these are not considered study specific research activities and DO NOT need to be reviewed by the IRB.
However, in some circumstances, changes to IRB application materials may ultimately be required prior to restarting face-to-face research activities. Changes may be needed to address scientific or subject population concerns related to COVID-19. For example, a study was previously approved by the IRB to enroll subjects age 65 and older for a set of exercise tests. Because older adults are at higher risk for severe illness from COVID-19, the study team plans to change the frequency and types of exercise tests being conducted in the research study in order to limit subjects’ exposure to viral droplets.
In this case, the study team would need to submit a change of protocol to the IRB in order to change the study-specific activities.
The IRB is available as a resource for researchers to help address questions about whether changes are needed to specific research studies prior to restarting face-to-face visits. The IRB can advise on what changes could be made to address concerns about subject population, study design, or other related issues. Please contact the IRBs Office with questions.
Are protocol and consent form changes required by the IRB for all studies prior to restarting face-to-face interactions?
Last updated: 5.28.2020
No, changes are not required by the IRB for all studies prior to restarting. The risk of acquiring COVID-19 is not specifically a research risk, but rather a risk of everyday life, unfortunately. Therefore, at this time, it is not necessary for all studies involving in-person interactions to add risks related to COVID to their study materials or the consent document.
Study teams must provide subjects with information about what to expect during their face to face interaction, including screening, physical distancing, and measurements in place to minimize risks associated with the spread of COVID-19. These protection measures are required by the institution in order to safely conduct face-to-face visits. They are not considered research specific activities and as such, do not need to be submitted to the IRB for review. Several campus groups are working on templates and other resources and we will provide links to these when they’re available.
What if I’m planning a new research study that requires face-to-face human subjects research activities?
Last updated: 5.28.2020
The same requirements apply to new IRB approved research studies as those that are restarting face-to-face visits. If you do not yet have IRB approval, please submit to the IRB.
All research tasks that can be performed remotely should continue to be performed remotely, even after the phase-in start date. If your new study has activities that can be conducted remotely, these should be built into the IRB application materials at the time of approval or via a change of protocol after initial approval. Guidance is available on remote visit requirements and considerations for human subjects research, see Remote Study Activities Guidance.
The steps to apply for conducing new research with face-to-face visits is the same as for already approved studies. Please see the FAQ titled, What are the first steps for study teams to get approval to restart face-to-face visits for an IRB-approved study?.
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.