COVID-19 (Novel Coronavirus): Frequently Asked Questions Relating to Human Subject Research

Original Post: March 17, 2020

Updated: May 1, 2020

These FAQs contain information about COVID-19 as it relates to the conduct of human subject research. This webpage will continue to be updated frequently as new information is received. Content posted beyond the original post will be noted with the posting date. Please clear your browser history to make sure you are viewing the most current content. 

The FAQs are included in the following major categories that can be accessed by clicking the links below:

 

Planning for COVID-19 

4/15 How Do I Plan For This Rapidly Evolving Situation?

April 15, 2020 

As always, protecting the safety and welfare of research participants who have volunteered to participate in our studies is paramount. We must maintain compliance with human research requirements to both support the protection of participants and the scientific integrity of our research protocols. In addition, we are committed to protecting the safety and welfare of our faculty and staff who are conducting this critically important work in the face of an evolving public health challenge the magnitude of which remains to be determined.  The following points should be considered moving forward:   

  • Research Procedures: PIs need to assess whether any reduction in staff makes it unsafe to complete the planned research procedures. For example, starting IVs might not be easy or safe if experienced staff are not available. 
  • Timely review of research data: If research team members are not available, integration of research care such as reviewing lab results in a timely manner might not be possible and will require special attention under the direction of the study PI. Study teams should consider the availability of appropriate back-ups to the PI to make safety assessments.
  • Investigational Drugs: If research participants are receiving investigational drugs, determine what the plan would be if the investigational drug could not be dispensed to them. You might find a way to deliver investigational drugs to their home. If the investigational drugs cannot be dispensed to research participants, consider plans to transition research participants to the most appropriate clinically available medications. This transition should include consultations with the IRB, the Sponsor (if applicable), investigational drug service and the clinical team caring for the research participants.

For studies that are allowed to continue under the current restrictions, all PIs and study teams should immediately develop a COVID-19 mitigation plan. The plan should include the following elements, at a minimum.

  • Avoid all participants with confirmed COVID-19 infection or requiring potentially aerosolizing procedures.
  • Decrease potential exposure for nonclinical personnel at increased risk of severe illness from COVID-19. People at higher risk include any of the following:
    • Over 65 years of age
    • With underlying health conditions, including heart disease, lung disease, or diabetes
    • With weakened immune systems
    • Who are pregnant
    • Caregivers of children with underlying health conditions
  • Have a protocol for noncontact screening for active symptoms of acute respiratory infection possibly related to COVID-19 or high risk of infection.  This may be accomplished by communication with participants, care providers, chart review, screening surveys, or other options prior to approaching potential research participants. Individuals with active symptoms must be avoided.
  • Reduce face-to-face contact with research participants. For example, this may be accomplished by including barriers between research personnel and participants, and/or using technology (e.g., telephone, email, intercoms) to conduct interviews.
  • Address Personal Protective Equipment (PPE) training status for nonclinical research personnel who need to be within 6 feet of participants, if appropriate for the study. Address sources of PPE for research use. Address methods to reduce PPE usage by all personnel, including limiting requests for second blood draws and sample collections by clinical personnel. 

Changes in Federal Regulations

The Food and Drug Administration (FDA), National Institutes of Health (NIH), and the Office for Civil Rights (OCR) in the Department of Health and Human Services have all issued guidance noting the flexibility that exists in the regulations, and additionally that they are being more flexible in certain areas.

FDA guidance on clinical trials during COVID-19

FDA guidance on remote monitoring devices

NIH guidance on clinical trials during COVID-19

OCR guidance on enforcement discretion in the use of telemedicine

DEA Guidance

CDC Guidance

 

Researchers Conducting COVID-19 Research

4/15 What are the steps required to begin a study related to COVID-19? (CRPC)

April 15, 2020

During this unprecedented time, UVA is seeing an overwhelming research response to the COVID-19 pandemic. The COVID-19 Research Prioritization Committee (CRPC) has been convened in an effort to synergize and support the research efforts of our community in this area, and to ensure the appropriate allocation of limited resources.

The UVA research Institutional Official and VP for Research, Melur K. (Ram) Ramasubramanian, charged this committee with the authority to review COVID-19 research studies that require access to patients, and/or their families, their biospecimens, medical team, or health record data.

CRPC Responsibilities

The primary goal of the COVID-19 Research Prioritization Committee is two-fold:

  • Expedite the highest caliber scientifically sound research to better understand COVID-19 and bring diagnostic, prevention, and treatment options to patients as quickly as possible.
  • Ensure the most appropriate allocation of limited resources (personnel, specimens, supplies, funding, etc.).

The COVID-19 committee serves to prioritize the studies. Its review is designed to curate and manage emergent resources and is not intended as an IRB approval proceed.

CRPC membership

The CRPC is chaired by Linda Duska, MD, Associate Dean for Clinical Research.

The committee is comprised of representatives from the Special Pathogens Unit (clinical and administrative), Infectious Diseases, Biorepository and Tissue Repository Facility (BTRF), Blood Bank, Center for Health Humanities and Ethics, iTHRIV, the IRB-HSR and the SOM Clinical Research Office.

The COVID-19 Research Prioritization Committee will operate with three subcommittees:

Subcommittee

Chair

Treatment protocols

Kyle Enfield, MD

Biospecimens protocols

Coleen McNamara, MD

Public health protocols

Mary Faith Marshall, PhD

How to submit a COVID-19 proposal to the CRPC

Study teams proposing a clinical research study that meets the criteria for CRPC review will:

  • Submit COVID-19 proposal to the SOM Clinical Research Office at uvaclinicaltrials@virginia.edu.
  • Provide details of proposed study, to include:
    • Principal Investigator
    • COVID-19 patient population
    • Estimated number of subjects to be enrolled at UVA
    • Study design
    • Regulatory status
    • Funding source
    • Required resources
    • Anticipated timeline
  • The SOM Clinical Research Office (CRO) will work with study team to document and collate the specifics of each proposed study for review by the CRPC. 
  • The SOM CRO will submit the proposals to the appropriate subcommittee for review.

CRPC Review

The subcommittee will evaluate each proposed study and provide one of the following priority decisions to the study team:

  • May proceed:  study may move forward
  • Deferred:  committee has additional questions/concerns

Notification of CRPC Priority Decision

The PI/study team will be notified of the CRPC’s priority decision for each proposed study.  If given authorization to proceed, the study (if requiring full or expedited IRB review by either the UVA IRB-HSR or an outside IRB of record) must be initiated and moved forward in CRConnect.  The study team must provide the IRB with a copy of the “may proceed” communication received from the CRPC.

If the study is deferred, the study team will be notified of the rationale for the decision and, if applicable, will request more information.   The study team may choose to appeal the committee’s decision. Study teams wishing to appeal will contact the SOM Clinical Research Office to initiate the appeal process.

The IRB HSR and Office of Sponsored Programs will be notified of the CRPC decisions. 

Questions

For questions regarding this process, please contact the Clinical Research Office: uvaclinicaltrials@virginia.edu.

    4/15 I need specimens from those tested for COVID-19. How may I obtain them?

    April 15, 2020

    The School of Medicine has established a specimen bank for specimens of those tested for COVID-19 that is housed in the Biorepository and Tissue Research Facility (BTRF). The School of Medicine has also established the COVID Research Prioritization Committee (CRPC) which will prioritize access to these specimens.  The IRB-HSR and the CRPC will conduct their reviews simultaneously, but the IRB-HSR will not provide an approval to open the study to enrollment until they have received an OK to proceed from the CRPC to allow the study to enroll. 

    To submit a study for review, the study team must:

    • enter the study in CRConnect and obtain a UVA Study Tracking Number;
    • proceed to develop the submission documents (protocol/consents, data security plan etc.) in Protocol Builder.  
    • send the submission documents along with the UVA Study Tracking Number via email to UVAClinicalTrials@virginia.edu.

    The SOM-CTO staff will put the study on the agenda for a future meeting of the CRPC and forward the documents to the IRB-HSR so that pre-review may begin.

      What process should I follow if offered funds to conduct COVID-19 research?

      Conducting work relating to COVID-19 requires approval from senior leadership of the University and may require multiple offices to review and negotiate the terms of the sponsored award and to assist you in obtaining required institutional approvals (e.g., IRB, IBC, etc.). You should immediately contact the School of Medicine Office of Research and the School of Medicine Office of Grants and Contracts   who will then provide you information on next steps.

        Where can I find funding opportunities related to COVID-19?
        4/15 I would like to send or receive COVID-19 related materials (i.e. plasma, virus, pathogens, etc.). What should I do?

        April 15, 2020 

        Note that materials may be transferred within UVA, originate from another organization/collaborator, or be transferred to another organization/collaborator.

        Specimens collected from human subjects must be securely stored in a refrigerator, freezer, or other suitable storage vessel labeled with the universal biohazard symbol. Activities involving the collection, transport and/or storage of human specimens in research buildings must be registered with the UVA Institutional Biosafety Committee. Refer to Interim CDC Laboratory Biosafety Guidelines for COVID-19 for handing of specimens suspected or known to contain SARS-CoV-2 virus, the causative agent for COVID-19. The researcher must update their IBC registration to include COVID-19 research. Contact Paul Skoglund, ps5d@virginia.edu, the IBC  Coordinator. 

        • When receiving material: The organization/collaborator providing material to usually provides a Material Transfer Agreement (MTA). Please request a template from the provider organization/collaborator and forward it to School of Medicine Office of Grants and Contracts for legal review. In the event the provider prefers to use a MTA template from the School of Medicine Office of Grants and Contracts can generate the document. Institutional Biosafety Committee should be contacted for any potential SARS-COV-2  or COVID sample acquisition.
        • When sending material:  School of Medicine Office of Grants and Contracts will prepare and send a draft MTA to the organization /collaborator for review. Those intending to ship samples should complete online EHS Shipping Training.
        5/1 What information is being shared by the FDA?

        5/1

        FDA Information- Medical Devices and the COVID-19 Pandemic

        The FDA shared a press release on March 31, 2020 regarding their accelerated process for the development of novel therapies for COVID-19. For the latest FDA press releases, please see FDA Press Announcements.

         

        Human Subjects Research Related Issues

        Will the UVA IRB’s remain open during this time?

        The UVA IRBs staff may work from home but will always be available for consultation. If you have an urgent request regarding COVID-19, please include COVID-19 in the subject line of the email. Please send urgent emails regarding COVID-19 to IRBHSR@virginia.edu or the IRBSBShelp@virginia.edu

        How should I screen participants for COVID-19?

        March 29, 2020

        Study team members should follow the screening requirements found on the SOM CRO website.  In summary,

        • All research subjects must be screened in accordance to the Medical Center procedures.
        • If research subjects are seen in UVA Medical Center Ambulatory Care area, it is REQUIRED that the research subject first check in with Medical Center Registration to ensure compliance with COVID-19 screening policy.
        • If research subjects are seen in an academic space, the subject must be screened by phone the day prior to scheduled visit, then rescreened when subject presents for visit.
        • Utilize the same screening questions utilized by the Medical Center.
        • Subject must “pass” screening in order to be seen in an academic space.

        Screening must be documented in REDCap system: https://redcapsurvey.healthsystem.virginia.edu/surveys/?s=H9AEYA3DCC

        Is my COVID-19-related project considered research?

        March 24, 2020

        UVA is ready to assist researchers and clinical care providers who are planning COVID-19-related activities that may intersect or overlap with public health authority activities and/or FDA emergency authorizations. In some cases, IRB approval will not be required. The UVA IRBs’ can assess the circumstances, provide advice, and issue determination letters (if warranted). Contact IRBHSR@virginia.edu or the irbsbshelp@virginia.edu.

        4/6 Which human subjects research studies have to be paused?

        April 6, 2020

        Given the current COVID-19 coronavirus outbreak, and the real or perceived risk of exposure, the risk/benefit ratio for research participation must be reassessed for each protocol. Ethical principles of research and federal regulations for the protection of human research subjects require an acceptable risk/benefit ratio. See additional information below.

        Studies for which there is little to no prospect of direct health benefit to subjects 

        For all human subject research studies that involve direct subject contact, and that provide little or no potential health benefit to subjects - human subject direct contact (face to face) must be paused until further notice in recognition of the COVID-19 pandemic. This directive is being made to decrease exposure for our staff, faculty and learners as well as research subjects. All other aspects of the research that do not involve direct human subject contact may be continued.

        Studies for which there is direct health benefit to subjects 

        These studies may continue. To the extent possible, study activities that can be done remotely by telephone or electronically should be done in this way. This includes any phase of an investigational drug trial.   Study teams may find it helpful to review the consent form, which usually includes a statement regarding the benefits of the study, if they exist. This statement is always reviewed and modified by the IRB as needed during their review of the study. 

        What about studies in which it is difficult to determine if there is a direct health benefit to subjects and if the study should be paused or continue?

        Study teams may find it helpful to review the consent form, which usually includes a statement regarding the benefits of the study, if they exist. This statement is always reviewed and modified by the IRB as needed during their review of the study. 

        The study team will have to do a risk benefit analysis on an individual study basis, and attempt to determine if the change would have a significant impact on the scientific integrity of the study and how that weighs against the risk of exposure to COVID 19 to the subject and study team members in addition to considerations such as use of personal protective equipment.  The study team may consider pausing any study procedures that are optional.

        Researchers should also consider any travel restrictions at the time and the risk of virus exposure to the patient, staff and providers vs a benefit to the subject.

        Researchers should ask if a visit is required for patient safety or for study outcomes. If the visit is for patient safety, the decision might favor completing the visit.  Researchers should also keep in mind that even though the potential for benefit may not change, the risk level may change during the course of the pandemic. 

        Certain types of studies will require a discussion between the PI and the subject to evaluate the evolving risk benefit ratio. These types of studies might include enrolling or continuing a subject on a phase 1 study. 

        Other factors to consider include the nature of the investigational product, the ability to conduct appropriate safety monitoring, the potential impact on the investigational product supply chain, and the nature of the disease under study in the trial. Additionally, further safety monitoring may be needed in the case of trial participants who no longer have access to the investigational product or clinical trial site.

        The IRB and the School of Medicine Clinical Research Office are available to discuss the risk benefit ratio to determine if subjects should be enrolled or continue in a study.  We must all be aware that the risk benefit ratio will change over time given the dynamic status of the pandemic. For questions, please send emails to lje5u@virginia.edu.

        I am the sponsor of an IND or IDE. Do I need to notify the FDA if I pause my study conducted under this IND/IDE?

        Yes, the FDA will need to be notified. Contact the School of Medicine Clinical Research Office for specific guidance and information on the notification process.

        Should I notify the industry sponsor if my research activities are paused on my clinical trial?

        If the study needs to be paused, the sponsor will need to be notified.

        I am a PI of an investigational drug/device trial. Do I need to pause my trial?

        No, for purposes of the pause, it is assumed that trials with investigational treatments, including drugs and devices, provide the potential for health benefit and should continue.  However, the PI should always consider the risk benefit ratio. 

        What is the procedure for pausing a study?

        March 24, 2020

        Per the VPR announcement on March 16, 2020: "All human subject research studies that involve direct subject contact, and that provide little or no potential health benefits to subjects - human subject direct contact (face to face) must be paused until further notice in recognition of the COVID-19 pandemic..."

        If the study is paused, delayed, or interactions with subjects are rescheduled because of COVID-19, there is no need to inform the IRB, regardless of review level. This is a temporary change to the IRB’s policy and only apply in situations specifically related to the impact of COVID-19. However, you must:

        • ensure the pause does not increase any risk to study subjects if the study is a greater-than-minimal risk study that provides a potential for health benefit to the subject.
        • contact study subjects who will be affected by this pause and notify them of the change (e.g., a study visit will be cancelled, etc.).

        Investigators should notify the study sponsor and any others necessary, as required.

        Investigators are required to document the pause in the study records along with the justification and any actions taken in the event that this is needed during an audit.  If the study requires a continuation review by the IRB, this information will be requested at the time of the continuation review. 

        4/15 May we continue to receive specimens to our research labs from outside of UVA?

        April 15, 2020:

        Yes, as long as the study fits the criteria for studies that may continue. Another option, if feasible, is to ask the site to hold the specimens until the crisis has resolved. As usual practice, the lab receiving the specimens must be securely stored in a refrigerator, freezer, or other suitable storage vessel labeled with the universal biohazard symbol. Activities involving the collection, transport and/or storage of human specimens in research buildings must be registered with the UVA Institutional Biosafety Committee.  Refer to Interim CDC Laboratory Biosafety Guidelines for COVID-19 for handing of specimens suspected or known to contain SARS-CoV-2 virus, the causative agent for COVID-19.  If the research will include research on COVID 19, the researcher must update their IBC registration to include COVID-19 research. Contact Paul Skoglund, ps5d@virginia.edu, the IBC Coordinator. 

        NOTE: Receiving specimens for a study that does not provide health benefit to the subject is not allowed as this may increase risk of exposure to the virus for staff working in the lab as they have to be on site working in the lab.

        May we receive specimens to our research labs that are requested under a new Determination (e.g. Non –Human Subject, Exempt, Non-Engaged)?

        March 20, 2020:

        No, as these studies do not fit the criteria for studies that may continue. 

        May we continue to collect data and follow up with subjects by telephone when in-person data collection has been paused?

        Yes. Rationale: There is no increased risk to subjects relating to COVID-19.

        4/15 May we continue conducting telephone screening of potential subjects?

        April 15, 2020

        Yes, but ONLY for studies that are allowed to continue without pause (see current restrictions on human subject research).

        IRB-HSR: Potential subjects must be contacted via UVA MyChart or encrypted HSCS mail (following instructions at: https://hit.healthsystem.virginia.edu/index.cfm/departments/security/how-tos/how-to-encrypt-a-medical-center-email/)

        4/15 May I email a subject already enrolled in a study?

        April 15, 2020

        IRB-HSR: Yes, but subjects must be contacted via UVA MyChart or encrypted HSCS mail (following instructions at: https://hit.healthsystem.virginia.edu/index.cfm/departments/security/how-tos/how-to-encrypt-a-medical-center-email/)

        4/6 May we obtain consent over the phone?

        April 6, 2020

        Only if the IRB approved the use of verbal consent (e.g. waiver of documentation of consent).  If the IRB did not approval verbal consent, study teams may discuss the study with a potential subject and answer their questions over the phone, but must have a consent form signed by the subject and the person obtaining consent before any study procedures may begin. 

        For additional information see the questions: 

        • What changes can be implemented without prior notice or approval from a UVA IRB at this time?
        • Are we allowed to use non HIPAA compliant programs such as FaceTime, non HIPAA compliant Zoom or our personal phones to communicate with subjects regarding health information?
        • How can written consent be obtained from subjects if unable to obtain in person?
        5/1 How can written consent be obtained from subjects if unable to obtain in person?

        May1, 2020

        The following information applies if the IRB-HSR OR the IRB-SBS is the IRB of record.  If a UVA IRB is not the IRB of record please consult with the IRB of record.

        Given the VPR announcement on March 16, 2020 and UVA Health stipulations on access to patients, regardless of COVID-19 status, obtaining written consent on a consent form has become more challenging.

        For additional information see the Learning Shot: Use of Electronic Informed Consent

        For studies reviewed by the IRB-SBS, a researcher may either:

        • Send a hard copy of the consent via mail or send as an attachment to email and have the participant print a hard copy for signature.  The participant may then sign a hard copy of the consent, take a picture of or scan the signature page and send to the researcher. The researcher must keep all pages of the approved consent version with the photo of the signature page.

        OR

        • Obtain a signature using DocuSign.

        For studies reviewed by the IRB-HSR:

        Electronic consent may be obtained using DocuSign or REDcap.

        Redcap Account

        REDcap may only be used for studies that are not regulated by the FDA. 

        REDcap is HIPAA compliant and may be used to collect health information. 

        To create an account in REDcap visit the UVA REDcap site at https://redcap.healthsystem.virginia.edu/

        After the study team obtains the approved consent from IRB Pro, the study team must copy and paste the entire consent form, except the signature sections, into REDcap.  In addition, the study team must enter the PI name, study title and the IRB-HSR#/UVA Study Tracking # into the applicable fields.

        Specific instructions are provided at the website URL listed above. 

        For additional questions/assistance  with REDcap email RedCap@hscmail.mcc.virginia.edu

        DocuSign Account

        To obtain a DocuSign account contact the SOM CRO by sending an email to uvaclinicaltrials@virginia.edu. You will need to specify if the request is for general research or requires an FDA Part 11 compliant account.  You will need to wait to receive and email from the SOM CRO (may come from ITS) BEFORE activating the account. 

        Instructions for obtaining eConsent

        If the subject is at UVA Health:

        1. The CRC may ask the health care provider to give the hard copy consent form to the patient so that the CRC does not need to enter the room. 
        2. The consent discussion may take place by phone or other electronic means. The subject may then sign the consent form in hard copy that is provided to them, take a picture of the signature page and send it to the study team. 
        3. The original consent form may be destroyed to avoid COVID-19 transmission. The study team must keep all pages of the version of the consent form signed by the subject with the photo of the signature pages.

        If the study is not FDA regulated:

        1. The consent form may be shared with the subject electronically.
        2. A phone call should still occur for the consent discussion and to confirm that the potential participant has had all questions and concerns addressed prior to electronically signing the consent remotely.  This phone discussion should be documented in the Documentation of Consent Note that accompanies the completed consent. 
        3. The subject may sign the consent form using remote technology via DocuSign or REDcap. 
        4. The hard copy of the consent form may be thrown away to avoid COVID-19 transmission.

        If the study is FDA regulated:

              NOTE:  a study is FDA regulated if the study involves:

        • research on an approved drug, device or biologic
        • evaluation of an unapproved drug, device or biologic (even if determined to be exempt from an IND/IDE or a device determined to be non-significant risk)
        • Using a device in an unapproved indication; even if the device is not being evaluated for safety and effectiveness.
        • Data from the study will be submitted to the FDA.

        Instructions for all studies: 

        1. The consent form may be shared with the subject electronically.
        2. A phone call should still occur for the consent discussion and to confirm that the potential participant has had all questions and concerns addressed prior to electronically signing the consent remotely.  This phone discussion should be documented in the Documentation of Consent Note that accompanies the completed consent. 
        3. The subject may sign the consent form using remote technology via the Part 11 Compliant version of DocuSign (Reminder: REDcap is not Part 11 compliant). 
        4. The hard copy of the consent form may be thrown away to avoid COVID-19 transmission.

        Consent Requirements for UVA IRBs

        Regardless of which UVA IRB (IRB-HSR or IRB-SBS) reviewed the study, in the event that informed consent occurs, the study team will ensure documentation of the consent process includes the following:

        • document how the consent form was transmitted to the subject (e.g. email, fax, mail, etc.)
        • document how the consent form was transmitted to the subject ( e.g. regular mail, email, electronically);
        • documentation of the method used for communication with the subject;
        • means by which agreement was communicated;
        • a subject signature;
        • a signature from a witness or the person obtaining consent (for IRB-HSR studies); and 
        • document how the subject’s signature was obtained.  For example:
          • Electronic signature via DocuSign/ REDcap
          • Scanned and emailed, faxed, or mailed back to the study team
          • Photograph of signature/signature page sent back to the study team

        As per usual guidance from the IRB-HSR:

        1. A person who speaks and understands English, but does not read and write, can be enrolled in a study by "making their mark" on the consent document, when consistent with applicable state law.
        2. A person who can understand and comprehend spoken English, but is physically unable to talk or write, can be entered into a study if they are competent and able to indicate approval or disapproval by other means if
          1. the person retains the ability to understand the concepts of the study and evaluate the risk and benefit of being in the study when it is explained verbally (still competent) and
          2. is able to indicate approval or disapproval to study entry, they may be entered into the study. The consent form will document the method used for communication with the prospective subject and the specific means by which the prospective subject communicated agreement to participate in the study. An impartial third party will witness the entire consent process and sign the consent document.
        May we conduct home visits to collect data in studies with no potential direct benefit to subjects?

        No. Rationale: While the real or potential risk to participants of traveling to a research site, and aggregation at the site, are absent from home visits, there may still be real or apparent risk.

        Do we need approval from the IRB for communications to study subjects explaining the pause in activities?

        March 20, 2020:

        You should consult with the IRB of Record. If a UVA IRB is the IRB of Record, no submission to the IRB is required.  

        May we enroll new subjects on existing studies?

        At this time new subjects may be enrolled on existing studies if the study has the potential for providing health benefits to the subject or if the study requires no in person contact with the subject. Consult with your research dean for advice.

        4/6 What do I need to do if I am considering pausing the collection of an efficacy endpoint in an FDA regulated study?

        April 6, 2020

        FDA recommends consultation with the appropriate FDA review division regarding protocol amendments for the collection of efficacy endpoints, such as virtual assessments or delays in assessments. The study team will have to do a risk benefit analysis on an individual study basis, and attempt to determine if the change would have a significant impact on the study endpoints or the scientific integrity of the study and how that weighs against the risks of exposure to COVID 19 to the subject and study team members in addition to considerations such as use of personal protective equipment.  The study team may lean towards pausing any study procedures that are optional.  If efficacy endpoints cannot be collected in particular situations, the specific COVID-19 limitation should be documented.

        What if I have to change the statistical analysis plan to address changes in the study due to COVID-19?

        March 24, 2020

        Statistical analysis plans should be updated to address how protocol deviations related to COVID-19 and submitted to the IRB as a modification.

        5/1 May I submit a new study to the IRB for review?

        May 1, 2020

        Biomedical Research: Yes, however be aware that even after the study is approved you may not begin enrollment unless the study has no face to face interaction with a subject or the study involves face to face interaction with the subject and the study has a potential for health benefit to the subject.  There are additional restrictions if the study involves health care providers as subjects (e.g. surveying health care providers caring for COVID-19 patients.).  If your study will involve research regarding COVID-19 please see the set of questions in this FAQ under RESEARCHERS CONDUCTING COVID-19 RESEARCH.   

        Social, Behavioral, Educational Research: Yes, but researchers must indicate in their protocol that all research activities will adhere to University COVID-19 restrictions. The IRB-SBS will not approve any study including face-to-face interactions without this statement, even if the researcher does not intend to implement those face-to-face interactions until after current restrictions are lifted.   

        May I initiate a new trial that involves a drug or device?

        Yes, although review priority will be given to studies regarding COVID-19.  The PI should provide a revised risk-benefit statement that explicitly takes the COVID-19 risks into account.

        How should I proceed with a study that has no direct benefit to a subject, but is conducted as part of routine clinical care?

        Example: tissue collection for research studies while a subject is undergoing standard of care surgery.

        The BTRF is no longer accepting specimens for studies that have no benefit.

        I have a subcontract with another site. Do I need to pause if the pause applies to my protocol at UVA? If my study is being conducted off-site, may it continue?

        It depends on the type of study it is.  See previous descriptions of studies or research activities that may continue and those that may not.

        If my study is being conducted entirely during a UVA inpatient admission, may it continue?

        Again, the study may not continue if the study holds no potential for health benefit to the subject.

        How will the pause in research impact studies conducted outside of UVA domestic and international?

        If a study is deemed to have potential health benefit to individual subjects, face to face interactions with subjects may continue, unless there is concern that the risks from COVID-19 outweigh the potential benefits to subjects. Studies that are determined to not provide direct potential health benefit to subjects must be paused. You may want to refer to University travel restrictions during this time.

        Will the pause or change to the method of data collection be considered a protocol deviation?

        March 24, 2020:

        If the study is overseen by a non-UVA IRB, you will need to confer with the IRB of Record. If a UVA IRB is the IRB of Record, no reporting to the IRB is required at this time.  If the study requires a continuation review, information regarding these issues should be documented in the study files and shared with the IRB in the next Continuation Status Report.   

        If I am pausing study procedures, do I need to notify the IRB of Record, for studies relying on an external IRB?

        You are advised to confer with the non UVA IRB.  If they require notification then you should notify them. The regulations allow implementation of a change to study procedures without prospective IRB approval when it is necessary to avoid imminent hazards to subjects.

        What about in-person monitoring of patient safety?

        Some clinical studies involve in-person study visits in order to conduct safety monitoring of the participants. For example, participants in a drug treatment study may need to have regular examinations, interviews, or laboratory tests for specific possible side effects.

        Researchers should plan for alternatives to in-person, patient safety monitoring visits, if possible. If appropriate for the study, this might include:

        • Delay, postpone, or modify the visits
        • Phone or email check-in calls
        • Photos taken and delivered by cell phone (e.g., of wound healing)
        • Use (or establishment) of a mobile specimen collection service
        4/15 What changes can be implemented without prior notice or approval from a UVA IRB at this time?

        April, 15 2020

        If a non-UVA IRB is the IRB of Record for a study, you should consult with them regarding their requirements.

        • Replacing in person signature on consent forms with other approved methods (see the question How can written consent be obtained from subjects if unable to obtain in person?)
        • Replacing in-person visits with telephone calls ( see additional info below).
        • Replacing in-person interviews or surveys with on-line UVA supported Qualtrics survey as long as the questions remain the same.
        • Replacing compensation with cash to compensation with a gift card.
        • Replacing in-person visits that do not require HIPAA oversight with UVA Zoom Conferencing.  You are advised to turn off the Cloud Recording feature.
        • Replacing in-person visits that do require HIPAA oversight with a HIPAA compliant Zoom Conferencing if already available in your department.* 
        • Dropping IRB approved study procedures for Exempt and Expedited research (minimal risk) that do not increase risk to subjects or jeopardize protections for privacy and safety. (e.g. dropping an interaction, curricular implementation, survey or other data point)
        • Data entry tasks for research not requiring HIPAA oversight that require taking paper-based data sources, such as surveys, off grounds as long as it does not increase risk to subjects. This ONLY applies to minimal risk research (exempt or expedited) and data entry must conform to University security standards and/or connect through VPN/Netbadge.
        • Replacing face-to-face recruitment or modifying recruitment procedures involving handing out or posting of flyers on grounds. Previously approved flyers can be posted on-line on public platforms to recruit subjects as long as it does not increase risk to subjects. The ONLY revision to the previously approved flyers should be the inclusion of the supplemental recruitment language provided in this document (see below "Do we need approval from the IRB for changes to recruitment material to explain that participation in the study can continue for the remote activities during the ongoing pandemic?").  If the previously approved recruitment material requires further revisions, please submit to the IRB for review.

        These changes should be documented as a protocol deviation in the study files. A deviation report to a UVA IRB is not required for these changes as they do not increase risk to subjects.  If the study requires continuation review by the full board, the study team will be expected to report these deviations in the continuation status report at the time of the next continuation review. 

        *If your department does not already use the HIPAA compliant version of Zoom, you should request access to WebEx by completing the access request at https://hit.healthsystem.virginia.edu.  If you have a Health System e-mail account (@hscmail.mcc.virginia.edu), choose the “UVA Health Department Meeting Organizer and Meeting Host” role.  This will allow you to utilize your UVA Health login credentials to access WebEx.  If you have an academic e-mail account (@virginia.edu), choose the “Academic Department Meeting Organizer and Meeting Host” role.  These WebEx accounts are secure and can be used for patient/subject visits.  Please note, these accounts are only needed for those organizing/hosting the meetings, meeting attendees do not need a WebEx account.  In addition, the non-HIPAA compliant version of Zoom can continue to be used for staff/team meetings.

        Do we need IRB approval for changes to recruitment material to explain that study procedures may continue for the remote activities?

        No. You may use the following language to supplement currently approved recruitment materials without the need submit updated recruitment material during the pandemic:

        "In light of the current need for social distancing to ensure the highest level of safety for participants in this study, only parts of this study which can be conducted remotely/virtually will be done."

        Optional second sentence that may be included:

        "At a future time, when safe, we hope to schedule the in-person visit(s) with you."

        What changes continue to require prior approval from a UVA IRB?

        March 24, 2020

        If a non-UVA IRB is the IRB of Record for a study, you should consult with them regarding their requirements.

        Changes to the protocol that may impact participant safety or the integrity of the study data.

        This may include:

        • Administering study drug without performing a key safety lab or procedure.
        • Revising or omitting study procedures that are required for safety purposes.
        • Revision or omitting study procedures that impact the integrity of the study data.
        • Adding new study procedures beyond the exclusions listed above even if they are meant to replace face-to-face interactions.
        • Adding new data collection instruments not previously reviewed and approved by the IRB even if they are meant to replace face-to-face interactions.
        5/1 Are we allowed to use non HIPAA compliant programs to communicate with subjects regarding health information? (e.g. FaceTime, personal phone, Zoom)

        May 1, 2020

        At this time, in coordination with University Counsel, Information Security is still enforcing institutional policies on data protection and Information Security.  This means that the use of personal cell phones and use of non-HIPAA compliant Zoom are still not considered acceptable under policy.  UVA has compliant, ready solutions available for solving a lot of the continuity related issues that have come up as part of COVID-19 planning. 

        ITS is currently piloting an app that will allow personal phones to be used that will make the call appear as if it is coming from a UVA phone.  If managers have employees that need to consent research subjects and the study personnel do not already have a UVA issued cellphone, the managers should send one email to uvaclinicaltrials@virginia.edu and submit all of their employees names and UVA phone numbers needing access to the app.

        If your department does not already use the HIPAA compliant version of Zoom, you should request access to WebEx by completing the access request at https://hit.healthsystem.virginia.edu.  If you have a Health System e-mail account (@hscmail.mcc.virginia.edu), choose the “UVA Health Department Meeting Organizer and Meeting Host” role.  This will allow you to utilize your UVA Health login credentials to access WebEx.  If you have an academic e-mail account (@virginia.edu), choose the “Academic Department Meeting Organizer and Meeting Host” role.  These WebEx accounts are secure and can be used for patient/subject visits.  Please note, these accounts are only needed for those organizing/hosting the meetings, meeting attendees do not need a WebEx account.

        The Notification of Enforcement Discretion issued by the HHS Office for Civil Rights provides some leniency; however, if you are communicating with patients who are subjects, you must use WebEx or MyChart. TikTok, Facebook Live, Twitch, or chat rooms like Slack are not compliant.

        If you need additional support to address your immediate needs of connecting with subjects, reach out to the UVA Telehealth group (see: https://uvahealth.com/services/telemedicine/contact-us).

        What changes will require approval from the IRB in the future?

        March 18, 2020

        • For all studies: No approval from the IRB for the above changes is needed at this time.  The changes should be documented in the study files as a protocol deviation. 
        • For Full Board studies ONLY:  For studies requiring continuation review by the Full Board, report this as a protocol deviation at the time of your continuation submission. 
        If I make any of the changes noted above, do I need to submit a modified consent form to the IRB for approval?

        March 18, 2020

        No.  In addition, do not make hand notes or edits to the approved consent form.   For all studies, document these changes in your study file.   For studies requiring continuation review by the Full Board, report this as a protocol deviation at the time of your continuation submission.

        4/15 Do I need to gain additional K-12 permissions when schools resume normal classroom attendance?

        April 15, 2020

        Yes, the researcher will need to check in with the appropriate official at the school to make sure it is still okay for you to conduct your study during 2020.  Teachers and staff in these settings may be under extreme pressure to teach state required curriculum and may not have the time to continue working with researchers in their classroom.  These permissions DO NOT need to be submitted to the IRB, but should be kept in your study files.

        Do I need to modify my consent form to include the risks of SARS-CoV-2 and COVID-19 if there will be in-person interactions?

        If a non UVA IRB is the IRB of record for the study, the study team should confer with the IRB of Record.  At this time, the UVA IRB’s do not believe it is necessary for most studies. Bringing participants to a facility in which there has been a positive or presumptive-positive case of COVID-19 is strongly discouraged unless the study has a potential for benefit to the subject and the visit is for an important safety monitoring that cannot be postponed or managed in some other way.

        What about graduate students performing human subject research?

        March 24, 2020

        If graduate student researchers are performing masters or doctoral research that is subject to a pause, and face-to-face research interactions cannot continue (i.e. be performed remotely, OR are not essential to a subject’s health and have a direct therapeutic benefit), then the faculty member overseeing their research should work with their students to develop revised/alternative plans to enable continued progress towards their degree.

        4/15 Can IDS alter methods of dispensing study drug to subjects?

        April 15, 2020

        This might include options such as mailing the oral study drug to the subject or providing an additional supply of the drug in one shipment. 

        The IDS is able to send a drug shipment of oral drugs to subjects via FedEx or UPS within the state of Virginia. The study is responsible for any shipping charges. The IDS is also able to provide an additional supply of a drug to the subject either by FedEx or UPS or during an in person visit. The IDS requires written approval for these changes from the sponsor or the investigator initiated PI.  For questions contact the IDS office. 

        A subject lives far away from UVA and are asking if they could have blood draws or other study procedures performed closer to home?

        March 20, 2020

        NOTE: This response is valid if a UVA IRB is the IRB of Record.  If a UVA IRB is not the IRB of Record you should consult with them.

        The first thing to ask is if this study falls into the criteria of a study that is to be paused at this time. If so, the study procedures should be paused.

        If it is determined that the study falls into the criteria of a study that should not be paused, the next question is to ask is if the study procedures are bineg done as an outcome measure for the trial.  If so, there is no benefit to the subject, places them at increased risk and should not be done.  If the following types of procedures will be done the PI needs to weigh the risk to the subject of virus exposure based on risk factors (e.g. subject over 65 or do they have an underlying chronic condition that would increase their risk).

        • Blood draw for safety labs
        • Scanning or imaging for safety or disease progression,
        • Administration or dispensing of medication (see question regarding IDS ability to ship drug)

        Note:  Missed tests and missed visits that do not put subjects at risk will be reported to the IRB as a deviation at the time of the next continuing review.  No reporting to the IRB is required at this time. 

        Researchers must also consider the cost of having a test done outside of UVA for research purposes as the cost of the test to the study team may be higher outside of UVA. 

        For additional information see the FDA COVID-19 Guidance.

        My study is a non-blinded randomized trial and 50% of subjects are on placebo. Should the study procedures for subjects on placebo be paused?

        March 20, 2020

        If the study has a sponsor outside of UVA, you should check with the sponsor.  If there is no outside sponsor or the sponsor does not provide any specific guidance, the PI must take all factors into consideration to make the best decision for the safety of the subjects.  If the integrity of the study data cannot be maintained, the PI may decide to stop enrollment.  

        Are sponsors allowed to do remote monitoring?

        March 29, 2020

        Yes.  The IRB does not require the consent form to disclose how monitoring will be done (e.g. on-site or remotely).  CRCs can request access to EpicCare Link for external monitors.  If source data is not collected in Epic, CRCs can provide sponsors with redacted copies of source data. Study teams should review the Data Security Plan to determine if any modifications are needed.

         

         

        Resources: UVA Partner Offices

         

         

        School of Medicine Office for Research

        COVID-19 Resources

        School of Medicine Clinical Research Office

        COVID-19 Guidance

        Environmental Health and Safety (EHS)/ Institutional Biosafety Committee (IBC)

        EHS CV-19 FAQ Webpage: http://ehs.virginia.edu/urgentnotice.html

        The University of Virginia credits Columbia University and the University of Washington for much of the content of this FAQ.