COVID-19 Research FAQs

The following provides guidance for human research regarding studies:

Which human subject research studies should be paused during the COVID-19 pandemic?

Studies that involve contact with study subjects but have no direct benefit to the subject should be paused until further notice.

Examples of paused studies include:

  • Studies collecting human samples or imaging that require study subject contact (e.g., phlebotomy, surveillance biopsy, radiographic imaging, physical examination) without direct diagnostic or therapeutic benefit;
  • Interview studies that can’t be conducted remotely;
  • Observational studies involving group gatherings;
  • Community studies.

Examples of studies not included in the pause:

  • Clinical trials with treatment arms (e.g., oncology clinical trials, interventional studies for devices or therapies with significant benefit to subjects). For purposes of the pause, it is assumed that trials with investigational treatments, including drugs and devices, provide the potential for benefit and should continue.  Investigators should weigh the benefits of the treatment arm against the risks of COVID-19 exposure for study staff or research subjects as they make a decision about continuing these projects;
  • COVID-19 studies, observational or interventional;
Study Types and Actions

Can I submit a new research project? (Added 3/26/20)

Yes. The IRB will continue to review new study submissions through E-IRB.  Priority will be given to research that involves COVID-19.

Depending on the study procedures, you may be asked to replace or delay use of in-person data collection consistent with institutional directives to reduce exposure to COVID-19.

Can I still enroll patients in clinical trials?

Enrollment in clinical trials should be placed on hold immediately, except where treatment during a clinical trial is medically necessary or of potential benefit for the patient, such as some oncology studies and device studies and some clinical trials with investigational drugs. Trials with drugs or devices should continue to enroll new subjects only if there are no other treatments available and the subjects would be placed at risk without treatment. Clinical trials with placebo arms should be placed on enrollment hold.

If suspending new enrollment, contact industry sponsors of these trials immediately and inform them that enrollment for their study is on hold or will experience limited enrollment for up to 90 days if applicable. Document this communication with the industry sponsors.

Can studies being conducted entirely during an inpatient admission continue?

Inpatient studies that do not involve direct patient benefit, or that are not part of COVID-19 research efforts, should be paused. Clinical care of our patients with COVID-19 and other conditions is now the priority. The goal here is to free up all staff to respond to this and to minimize patient contact by non-essential personnel when possible.  Examples of inpatient studies that should be paused include:

  • Comparative effectiveness studies randomizing patients to a placebo/non-intervention arm versus alternative clinical management;
  • Implementation science trials looking at changes in clinical management;
  • Survey research on patient perceptions.

Is an IRB Modification Request required to delay, pause, or temporarily modify research activities due to COVID-19? (Added 3/26/20)

Research protocols or any single component of a research protocol may be delayed/paused or temporarily modified for COVID-19 concerns without submitting a Modification Request to the IRB. Per federal regulations, an investigator can make changes to a protocol to eliminate apparent hazards to research participants without first obtaining IRB approval. The change may apply to a single participant or all participants enrolled in the research study.

However, if changes to research procedures are permanent and not currently approved by the IRB, a Modification Request should be submitted prior to implementing the changes.

For FDA studies, please see next question.

Does FDA require sites to track and report changes that were made without IRB approval to minimize hazards from COVID-19? (Added 3/26/20)

Yes.  Changes to protect the life and well-being of research subjects (e.g., to limit exposure to COVID-19) may be made without IRB approval, but FDA-regulated studies require such changes to be reported afterwards. Investigators should submit an aggregate account of changes implemented without prior IRB approval on one protocol violation report. 

FDA has advised sponsors to collect a list of contingency measures taken; list subjects affected by study number; and indicate the impact on safety or efficacy results, if applicable. Check with the study sponsor on reporting requirements.

Clinical trials that have paused recruitment due to COVID-19, should update their study status on ClinicalTrials.gov record to “active, not recruiting” within 30 days. For questions regarding ClinicalTrials.gov, please contact Emily Bradford at emily.bradford@uky.edu.

Do I need to notify the IRB to pause recruitment?

No. This is not a change to the protocol, but a temporary pause in enrolling additional subjects, so notification is not required. You do need to notify the study sponsor. You should document the pause in your study files.

  • For UK IRB approved research: If study visits can be conducted virtually (e.g., UK Zoom,  or telephone), the study teams should document any missed assessments or items that could not be performed because it was a remote visit.

    They should not submit modifications to add this possibility of remote research visits, as we expect this to be a temporary situation. We will provide further guidance about how and when to submit this documentation.
  • For research approved by another IRB: Please contact that IRB for their instruction. 

How should I manage remote communications or data collection with subjects? (Updated 3/30/20)

Privacy and confidentiality provisions remain critically important at all times, even when working remotely. Please note, collection, transmission, or access to private identifiable data or protected health information, must comply with university and other policies for security of research data. 

Remote interactions that will collect or transfer private identifiable the information or protected health information should use technology that is IT secure or HIPAA compliant (e.g., UK Healthcare Zoom, UK Telehealth, REDCap). UK Healthcare has a HIPAA compliant contract with Zoom for secure videoconferencing. Link to ukth.zoom.us to set up and account with your linkblue ID and password. Refer to UK IT Cybersecurity Best Practices When Working Remotely.

Do not store private identifiable information or protected health information on unsecure devices in order to work remotely. Use University-approved cloud services and VPN access while working at home instead of storing data directly on personal devices. 

If making copies of physical research records or data (paper consent forms, case report forms, questionnaires/surveys, etc.), secure all paper locally following HIPAA principles and return to the IRB-approved location as soon as is practical.

See additional tips for remote security https://www.totalhipaa.com/hipaa-compliance-working-remotely/

Do I need to notify the IRB if all study activities are paused?

Not at this time.  You must notify the study sponsor (see below).  Please track when you pause all study activities and document all missed visits, procedures, appointments, and other relevant study activities.  We are working on a mechanism to report these in aggregate at some point in the near future, rather than reporting each event individually.

Do I need to notify my study subjects of the pause?

Yes.  All active study subjects need to be notified of the pause, and what it means for them.  We recommend that you do this by phone, but mail and e-mail (if you have consent for email contact) may also be used if needed under these circumstances.  You do not need an IRB modification for this notification. 

What should I tell study subjects?

The following sample script may be adapted to fit your particular study:

Hello, <subject name>. I am calling you today to let you know that several actions have been put into place regarding research/clinical trials at the University of Kentucky and all of its locations. Some of these may affect you. These include:

  • New enrollment in clinical trials will be limited until further notice. If you are screening or have recently consented to participate in a clinical trial, please contact ____________.
  • If you are in treatment on a clinical trial, you may continue treatment, although the study visit schedule may change. When you come for your treatment, please be prepared to answer questions about your recent trips and health. This screening is intended to protect you, your family, and our healthcare workers from coronavirus infection. If you are sick, have symptoms, or have had significant exposure to somebody who is infected with coronavirus, your visit may be rescheduled. We will do everything we can to maintain your treatment schedule.
  • If you are having follow up visits, we may reschedule or cancel these visits during the next 90 days or until further notice. These are not treatment visits. A research team member will contact you prior to your next visit.

We understand that you may have concerns about your participation in clinical trials. Please contact <study coordinator> for specific concerns. If you are experiencing adverse events, or have been diagnosed with coronavirus infection, please contact your study team immediately using the 24-hour contact number in your consent form.

Document what you have communicated to your study subjects, the purpose for the communication (COVID 19), and when it was communicated.

Do I need to re-consent subjects on changes to protect from COVID-19? (Added 3/26/20)

In most cases, new information regarding changes to protect from COVID-19 may be provided via a letter or other form of communication. Subjects must be provided with significant new findings that develop during the research which may relate to their willingness to continue participation. However, re-consent is not necessary unless the changes to the research are such that the original consent is no longer valid. See the ORI New Information Guidance for help determining whether notification is adequate for providing new information or re-consent is warranted.

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

No. It is not necessary to submit a modification. Keep documentation of dates, times and subjects who were contacted.

What guidance is available for e-consent or remote consent? (Updated 4/7/20)

The UK Guidance on Unique Informed Consent Circumstances provides alternatives to a face-to-face consent and E-consent is addressed in the ORI Outline of FDA Guidance for Industry: Use of Electronic Informed Consent in Clinical Investigations.

Remote informed consent may be proposed for new COVID-19 research or implemented for an existing protocol in response to  the pandemic.  See ORI guidance for best practice in obtaining remote informed consent.

Do I need to notify the industry sponsor of modifying or pausing my clinical trial? (Updated 3/26/20)

Yes. Contact your study sponsor to discuss how best to move forward with performing remote research visits, when possible. Given that we expect this to be a temporary situation, a protocol modification is not necessary. Sponsors may grant protocol waivers to conduct research in this manner and allow for missed assessments and missed visits to be documented and reported later as this is a required change to research to eliminate apparent hazards to research subjects. If the study is paused, the sponsor will need to be notified.

What guidance does FDA provide for clinical trials during the COVID-19 Pandemic?

The FDA outlines considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice and minimizing risks to trial integrity. Considerations recommended include, among others, sponsors evaluating alternative methods for assessments, like phone contacts or virtual visits and offering additional safety monitoring for those trial participants who may no longer have access to investigational product or the investigational site. 

For more information visit: 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic.

Has the NIH issued any formal guidance on clinical trials or other human subjects research activities?

Yes, although at this point in time the guidance is broad and geared predominately at administrative issues. 

Guidance can be found on the NIH web page for Natural Disasters:  
https://grants.nih.gov/grants/natural_disasters.htm.

What should I do to ensure that subjects in clinical trials remaining open have an adequate supply of study drug?

For clinical trials with investigational drugs, devices and biologics, please confirm with the sponsor that the supply is not at risk. Please review investigational supplies and identify any that will expire within the next 90 days and communicate with the sponsor regarding resupply measures.

What is the suggested COVID-19 screening protocol for study subject visits?

Call every subject the day before a site or home visit and ask the following travel screening questions:

  • Have you or your family members traveled in the last 14 days?

    If yes, ask for dates and locations of travel. If travel was outside of the local upstate region you may elect to postpone the visit by two weeks.
  • Do you or anyone in your home have any of the following symptoms: cough, fever, shortness of breath?  Have you or anyone in your family had any contact with a confirmed COVID-19 patient?

    If yes to either question, then postpone the in-person visit for at least two weeks and make sure they have spoken with a health care professional.
  • All subjects should be re-screened when they arrive for their visit. 

    If a subject presents with the symptoms listed above at their study visit, terminate the visit and have them contact their primary provider.

What should I do about missed visits for trials that remain open?

If a subject misses a scheduled visit during this period, it should be documented including the reason for the missed visit (ex. COVID-19). Contact the study sponsor for guidance on how they would like such notifications and documentation handled. It is likely, given that this will be common during this national emergency, that notification requirements will be given to all study sites.

What should I do to prepare for study subjects being removed from active protocols due to COVID-19 infection?

Review each clinical trial protocol for drug reductions or holds due to serious adverse events or for other reasons. Subject who are diagnosed with COVID-19 will likely be removed from study treatment by the sponsor or investigator. Treatment schedule modifications or removal from the study for subjects who are in quarantine should be discussed with the sponsor. Items should be reported consistent with the UK IRB reporting policies.

Should I modify my study protocol to reduce risk to my study subjects?

When possible, you should consider such modifications.

Eliminating immediate risks may include actions to reduce potential exposure to COVID-19 or to continue to provide medically necessary study care (including study drug) to subjects who have been placed in isolation or quarantine because of suspected or known exposures. We encourage investigators to take necessary steps to eliminate additional risks to subjects.  Even in studies that offer benefit to the patient, investigators should balance the potential benefits with the risk of patient exposure to COVID-19 by further participation.

Depending on the protocol, exposure or a positive test for COVID-19 could be classified as an adverse event, and could also cause a protocol-required reduction or temporary or permanent discontinuation of investigational drug. Giving study drug to isolated or quarantined subjects will also be situational. For example, IV infusions could pose a serious problem if given outside the clinic. The protocols will often indicate under which conditions drugs should be discontinued and how. Death during a study is a serious adverse event.

We recommend that study teams communicate with sponsors/clinical research organizations about these scenarios and document the responses.

What if the sponsor issues new guidance or information about COVID-19 risks for my study?

You will need to submit a modification request to the IRB. Your study may be paused if the sponsor, Data Safety Monitoring Board (DSMB) or you identify any new increased risk to study subjects related to the protocol. 

What should I do about study/sponsor monitor visits?

All monitoring visits, site initiation visits, site qualification visits, should be cancelled immediately and for the next 90 days unless necessary for the safety and/or efficacy of the study treatment. To the extent possible, these visits should occur remotely.

Contact the study sponsor and/or clinical research organization to communicate this information, and to make arrangements or reschedule. 

Document the contact in the study documentation.

What facilities exist for virtual visits with study subjects or study monitors?

Depending on the recipients' resources, communications options include telephone conferencing, UK ZoomUK TelehealthREDCap, and other survey platforms.

What should I do about study samples that need to be shipped to the sponsor?

We recommend contacting the sponsor to delay the shipment, unless the samples cannot be stored. 

Will the IRB continue to accept and review Other Events, Annual Administrative Review, and Continuing Review submissions? (Added 3/26/20)

Yes. The IRB will continue to review these submissions.  AARs and CRs will be approved with the expectation that ongoing research is compliant with applicable restrictions and accommodations for reducing exposure to COVID-19.

Do I have to submit Annual Administrative Review and Continuing Review submissions during pause? (Added 3/26/20)

Yes, as long as you are able to submit the AAR or CR without endangering yourself or staff, the IRB expects to receive these reviews.  If you expect delays, notify the Office of Research Integrity at 859-257-9428 or IRBSubmission@uky.edu.

Are ORI Quality Assurance Wellness Checks being conducted at this time? (Added 4/7/20)

The ORI Quality Improvement/Quality Assurance (QA/QI) Program is not scheduling or conducting any visits at this time due to COVID-19 concerns. We will resume our visits once the university returns to regular business function and the conduct of in-person events.

Investigators who had Wellness Check visits scheduled for late March and all of April 2020 have been contacted and informed their visit will be delayed until after the current COVID-19 restrictions have been lifted and staff/students return to campus. We will work with investigators to reschedule their visit as soon as possible.

Please contact Pam Stafford pastaf3@uky.edu or Kasandra Lambert kasandra.lambert@uky.edu if you have questions or concerns.

Are IRB meetings being conducted remotely? (Added 4/7/20)

Yes. Due to current COVID-19 concerns, IRB meetings are being conducted electronically through Zoom. Investigators will receive an invite containing a Zoom link prior to the meeting.

Investigators should inform ORI staff if they have other study personnel to whom they need a meeting invitation sent. Investigators should not forward the meeting link to their study personnel. It’s important for ORI staff to know everyone who will be attending so they are aware of who is and is not supposed to be admitted into the virtual meeting during each scheduled appointment time.

In addition, the number of attendees for each protocol needs to be limited in order to keep attendance tracking manageable for documentation purposes, so we ask that investigators have no more than two (2) individuals from the list of study personnel join them for the meeting.

What if my protocol was reviewed by an external IRB? (Added 3/26/20)

Check with reviewing IRB on reporting requirements as they may differ with local IRB

What public health surveillance activities are “deemed” not to be human subject research under the revised Common Rule? (Added 3/26/20)

  • The activity must be a public health surveillance activity (45 CFR 46.102(l)(2));
  • The activity must be conducted, supported, requested, ordered, required, or authorized by a public health authority (45 CFR 46.102(k) and 46.102(l)(2)); and
  • The activity must be limited to that necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products) (45 CFR 46.102(l)(2)).

Detailed guidance is available from the Office for Human Research Protections (OHRP).

What if I have additional questions about my study?

For Clinical Research questions: You may contact the Center for Clinical and Translational Sciences by email at CCTS@uky.edu or phone at (859) 323-3775 and your question will be forwarded to a content expert who will try to answer your question.

For General IRB or Human Research questions: You may contact the Office of Research Integrity by email at IRBSubmission@uky.edu or phone at (859) 257-9428 and your question will be forwarded to the appropriate staff member.  If your question is about a particular study, please include the IRB protocol number and PI name.

Page created 3/19/2020 10:00 am

Updated 4/7/2020 1:46 pm