COVID-19 Human Subject Research FAQ

The University of Pittsburgh Human Research Protection Office is monitoring the release of information related to COVID-19 from the University of Pittsburgh and from federal agencies.  This information will be updated frequently.   All questions regarding COVID-19 and its effects on human research operations should be directed to askirb@pitt.edu

The staff for all ORP offices are working remotely and continue to operate as usual. Updates and Resources are available at Pitt Research.  Educational programs will be conducted remotely.

University of Pittsburgh

University of Pittsburgh comprehensive COVID-19 Information page

Pitt Research: Office of the Senior Vice Chancellor for Research

Food and Drug Administration (FDA) Information

Essential information for conduct of research involving human subjects

Per the Senior Vice Chancellor for Research’s message on November 20, the University announced that research activities in Tier 3 must not enroll new participants in studies requiring face-to-face interaction or continue to conduct face-to-face visits. On-line visits or data collection that does not require direct participant interaction may continue. No additional restrictions have been placed on Tier 1 and 2 human subject studies (with high or moderate direct benefit to the participants or have a high public health priority).

It is NOT intended that all non-critical research/scholarly activities should stop; indeed, those that can be carried out remotely (planning, writing, literature review, remote data collection, data analysis, remote meetings, etc.) should continue during this time.  Studies with no face-to-face participant interactions such as chart review studies or on-line surveys can continue as approved as resources allow.

Please see the descriptions below to determine the disposition of your research.   All questions should be directed to askirb@pitt.edu

 

Frequently Asked Questions

  1. Can I still conduct research procedures and interact with subjects?
  2. I need to temporarily pause study enrollment, certain study procedures, or the entire study.  What do I do?
  3. Do I need to modify my study to make changes for alternatives to in-person study visits?
  4.  What platform should I use for video conferencing?
  5. If my study requires in-person contact with my subjects, can I continue to do so?
  6.  I need to monitor subjects for safety.  Can I continue to do so?
  7.  How do I request permission from the IRB to continue enrollment or in-person research interactions during High Risk posture for my study requiring in-person interactions? 
  8. What criteria would the IRB use to determine whether enrollment or in-person interactions can continue during High Risk posture for my study requiring in-person interactions?
  9. What information should I include in my RNI submission to obtain permission for additional enrollment or continue in-person interaction with existing subjects during High Risk posture for my study requiring in-person interactions?
  10.  I have IRB approval to continue enrollment or conducting in-person visits, do I need additional approvals before resuming those activities?
  11. Do I need to petition to continue my expanded access protocol?
  12. Contingency plan development
  13. Can I move my consent process to remote or on-line?
  14. Do I need to update my consent form with risks related to COVID-19 exposure?
  15. Do I need IRB approval in order to contact subjects to determine COVID-19 exposure or symptoms?
  16.  What if a subject reports possible COVID-19 exposure or symptoms during a study visit?
  17.  Coordination of COVID-19 research at Pitt and UPMC
  18. Do I need to update my ClinicalTrials.gov study record?
  19. How do I notify the IRB about suspensions or changes on my External IRB protocol?

 

Can I still conduct research procedures and interact with subjects?

Procedures that do not require in-person contact with subjects can continue as approved in the IRB application. 

Researchers must discontinue in-person interaction with subjects in most cases and consider alternative ways to continue study procedures.  For example, interviews may be conducted remotely (See “What platform should I use for video conferencing?”) or the schedule of visits may be safely modified or delayed.  (See “Do I need to modify my study to make changes for alternatives to in-person study visits?”) 

Please contact askirb@pitt.edu with questions

 

I need to temporarily pause study enrollment, certain study procedures, or the entire study. What do I do?

Make note of the temporary pause in your research records.  This does not need to be reported to IRB unless the study hold is initiated at the request of an external funding agency or the study’s Data and Safety Monitoring group (if there is one).

If you are sending a letter to study participants informing them of the pause, please send the letter to askirb@pitt.edu for quick review.  A modification does not need to be submitted to add this letter.

 

Do I need to modify my study to make changes for alternatives to in-person study visits?

You do not need to modify or request an exception in order to hold visits remotely or change the schedule of study visits if the study is exempt or if the IRB application does not describe whether the visit would be in person or remote or give specifics about visit schedule.

Modifications are not needed to temporarily adjust procedures to online or remote during high risk posture.  You will need to request an exception if the study is not exempt and the application specifies in person visits.

Modifications are required if you plan to adjust the procedures to online or remote for the duration of the study.

If you submit a modification related to COVID-19, you should email your IRB Analyst to prioritize these modifications.  Remember that any other changes to a non-exempt study must be approved in advance by the IRB as a Modification to the study, unless they are necessary to eliminate immediate apparent hazards to participants.  Modifications should be submitted through the regular process in PittPRO.

Please contact askirb@pitt.edu with questions.

 

What platform should I use for video conferencing?

Data Security is recommending that researchers use Microsoft Teams, Zoom, Vidyo, or Skype for video conferencing.  Agreements with those vendors provide us with a level of confidence that they will be secure.  Facetime is not recommended for research studies.

If you plan on recording the sessions on one of the above platforms, please make sure it is in a storage location that is managed and has access controls in place.

 

If my study requires in-person contact with my subjects, can I continue to do so?

When the University is operating under a High Risk posture, all in-person interactions with human research subject will cease without additional IRB review and permission to do so. (See “ How do I request permission from the IRB to continue enrollment or in-person research interactions during High Risk posture for my study requiring in-person interactions”).  As of November 20, 2020, the University is operating under Elevated Risk posture and has imposted restrictions on Tier 3 studies.

Studies that received IRB permission to continue enrollment as documented in OSIRIS or PittPRO from March 20, 2020 to May 20, 2020 may continue enrollment and in-person interactions without additional IRB review. 

Please contact askirb@pitt.edu with questions.

updated 11/20/2020

 

I need to monitor subjects for safety.  Can I continue to do so?

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

Researchers should plan for alternatives to in-person monitoring visits, when possible. For example, interviews could be conducted by phone or video conferencing (See “What platform should I use for video conferencing?”). A modified or delayed schedule of monitoring may also be possible.

If visits cannot be performed remotely, please see “If my study requires in-person contact with my subjects, can I continue to do so?” and “How do I request permission from the IRB to continue enrollment or in-person research interactions during High Risk posture for my study requiring in-person interactions”.

These modifications to safety monitoring procedures should be approved in advance by the IRB through the regular modification process in PittPRO, except when necessary to eliminate apparent hazards to a participant and there is not sufficient time to obtain IRB approval.

If you do need to change an approved study visit in order to eliminate apparent immediate hazards to research participants, please report it to Pitt IRB within 5 days, following the Reportable of New Information (RNI) procedures in PittPRO.

Visits that are postponed or subjects seen out of window should also follow the pathway Exception Request if time allows or Reportable New Information if time does not allow.

Please contact askirb@pitt.edu with questions

 

How do I request permission from the IRB to continue enrollment or in-person research interactions during High Risk posture for my study requiring in-person interactions?

If PI feels there is a compelling justification to continue enrollment or to continue interaction with existing subjects for a study requiring in-person interactions during High Risk posture, the study team should follow the Reportable New Information (RNI) procedures in PittPRO to explain the justification.  The IRB will review the submissions in order of priority and according to tier criteria. (See “What criteria would the IRB use to determine whether enrollment or in-person interactions can continue during High Risk posture for my study requiring in-person interactions?” and “What information should I include in my RNI submission to obtain permission for additional enrollment or continue in-person interaction with existing subjects for my study requiring in-person interactions?”)

Studies that received IRB permission to continue enrollment documented in OSIRIS or PittPRO study history from March 20, 2020 to May 20, 2020 may continue enrollment and in-person interactions without requesting IRB permission again.

 

What information should I include in my RNI submission to obtain permission for additional enrollment or continue in-person interaction with existing subjects during High Risk posture for my study requiring in-person interactions?

The submission should contain the following information wherever applicable:

  •  What is the direct benefit to the subject that cannot be obtained outside the study?
  • Why does the study have a high public health priority during the Pandemic?
  • Why can’t the enrollment be postponed until restrictions are lifted?
  • What is the harm to subject or value of data lost if in-person visits are to cease or be delayed until restrictions are lifted?
  • What measures are being taken to minimize in-person visits, e.g. visits may be done remotely or coincide with clinical visits?
  • Any other pertinent information

 

What criteria would the IRB use to determine whether enrollment or in-person interactions can continue during High Risk posture for my study requiring in-person interactions?

IRB will use the tier criteria below to determine whether studies requiring in-person interactions can enroll additional subjects or continue in-person interactions with existing subjects. 

Tier 1 – High Direct Benefit to Research Participants or May Have a High Public Health Priority During the Pandemic

Examples:

  • Research protocols involving treatments for acute, life threatening health conditions (e.g. some treatment trials for cancers), especially if the study population does not have satisfactory treatment options or cannot obtain treatment outside the research setting
  • Protocols involving or about COVID-19 (See “Coordination of COVID-19 Research at Pitt and UPMC”)

IRB may permit additional enrollment or continued in-person interactions with existing subjects for a Tier 1 study.

Tier 2 – Moderate Direct Benefit to Research Participants

Examples:

  • Protocols where stopping the intervention (e.g., some investigational drugs or vaccines or preventative drug regimens) could be harmful
  • Protocols in which research participants are receiving interventions or clinical care that is very interrelated to their research participation (e.g., test results coming back that might have clinical implications for their care)
  • Some protocols evaluating treatments for chronic conditions (e.g., asthma, hypertension, depression, etc.).
  • Protocols involving assessment of the safety or efficacy of an intervention in which, if stopped, the potential societal benefit of the science would be significantly and adversely impacted, for example where a research assessment (blood collection or imaging study) is only valuable if collected at a very specific time. This must be measured against the risk to participants and staff, including the risk of exposure of COVID-19.

IRB may permit in-person interactions with existing subjects but will not permit additional enrollment for a Tier 2 study.  

Tier 3 – Low Direct Benefit to Research Participants and Other Impacts to Research

Examples:

  • Cohort and natural history studies where delays in data collection have limited impact on scientific objectives
  • Protocols in which delays to starting or pausing of research does not substantively impact on research objectives of the research protocol
  •  Protocols in which risks to research participants are higher (e.g., potentially exposing elderly vulnerable individuals to COVID) and benefits of the study to the participants remain minimal
  •  Research with healthy volunteers
  • Any minimal risk studies that require research subjects to travel, that involve undergraduate students, or that are in a community setting and require direct interaction with researchers

Unless the in-person visit coincides with an outpatient clinic visit or the subject is inpatient, IRB will not permit additional in-person enrollment or in-person interactions with existing subjects for a Tier 3 study. Studies with no face-to-face participant interactions such as chart review studies or on-line surveys can continue as approved as resources allow.  Limited exceptions will be considered by the IRB.  Requests should be submitted as Reportable New Information. (“How do I request permission from the IRB to continue enrollment or in-person research interactions” and “What information should I include in my RNI submission to obtain permission for additional enrollment or continue in-person interaction with existing subjects for my study requiring in-person interactions?”)

Please contact askirb@pitt.edu with questions and concerns. 

 (adapted from Johns Hopkins University)

I have IRB approval to continue enrollment or conducting in-person visits, do I need additional approvals before resuming those activities?

Yes, additional institutional requirements may apply depending on circumstances. Departmental representatives should be contacted to determine if additional permissions need to be obtained.

 

Do I need to petition to continue my expanded access protocol?

Expanded access refers to the use of an investigational drug with the primary purpose to diagnose, monitor, or treat a patient’s disease or condition rather than to obtain the kind of information about the drug that is generally derived from clinical trials.

Because expanded access protocols are for patient treatment and are not research, they can continue without additional IRB permission.  Institutional COVID-19 policies for patient contact must be followed. 

 

Contingency Plan Development

Study teams should proactively prepare contingency plans for their active research protocols.  Assess if the disruption of a research protocol might impact the safety of your research participants.

Investigational Drugs: If research participants are on investigational drugs, work with the IDS to determine what the plan would be if the investigational drug could not be dispensed to your research participants. If the investigational drugs cannot be dispensed to research participants, you should make plans to transition research participants back onto their most appropriate clinically available medications. This transition should include consultations with the investigational drug service and the clinical team caring for the research participants.

Research Procedures: PIs need to assess whether any reduction in staff makes it unsafe to complete the planned research procedures. Even 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.

 

Can I move my consent process to remote or on-line?

In appropriate situations, the consent process can be conducted over the phone or by using other technology (See “What platform should I use for video conferencing?”).   Unless your protocol specifically states that consent will be done in person or otherwise prohibits the change, you do not need to modify your protocol.

Greater than Minimal Risk Studies: Consider whether it is necessary to enroll a new subject into the study at this time. If it is determined that it is necessary to enroll new subjects in this study, there are options for remote execution of the consent process.  For most studies that involve a drug, device, or surgical procedure, the consent process must be done face to face by a licensed physician.  In those cases, the process can be carried out via Skype or other similar service.  Contact askirb@pitt.edu if you are unsure if your study requires face to face consent.  For those not requiring face to face, the consent process can be carried out over the phone by the persons approved to obtain consent.  In all cases, the signed consent form must be received prior to beginning any study procedures. 

Minimal Risk Studies: If your research can be conducted remotely or entirely online, these activities may be sustained.  This includes the consent process.  As stated above, you do not need to modify your protocol unless it prohibits carrying out the process remotely.   If your study is approved to obtain signed informed consent, the signed consent form must be received prior to beginning any study procedures. 

In certain minimal risk situations, it may be appropriate to request a waiver to document informed consent.  The waiver allows consent to take place verbally with no signed consent form necessary.  In order to operate on a verbal consent, you must modify your protocol and justify the waiver.  This can be done by selecting “Waiver to document consent” in the Study Scope, #2 section of PittPRO.  If your study is already approved under a waiver to document consent, you do not need to modify unless you are making other changes to the process.

 

Do I need to update my consent form with risks related to COVID-19 exposure?

No. Consent documents should not be updated to include the risks of exposure to COVID-19.  Researchers can instead hand out the information sheet, "Important Information about COVID-19 and Research Participation" in the A-Z Guidance

 

Do I need IRB approval in order to contact subjects to determine COVID-19 exposure or symptoms?

No.  If you implement procedures in order to identify subjects whose visits should be postponed, modified, or delayed, you do not need to modify the IRB application because this activity is not a research procedure. You should follow the recommendations for the institution that you work in.  This includes administration of questionnaires or other procedures to determine COVID-19 exposure or symptoms. 

 

If a subject endorses answers that may indicate exposure or symptoms, they should contact their PCP.

What if a subject reports possible COVID-19 exposure or symptoms during a study visit?

Please follow institutional policy.  If possible, place a surgical mask on the subject and direct them to a private room with a door that can close.  At UPMC locations, contact the Infection Prevention Team through MedCall at 412-647-7000.  At non-UPMC locations, contact the local health department for guidance (Allegheny County Health Department 412-578-8062).

 

Coordination of COVID-19 Research at Pitt and UPMC

Research teams at the University of Pittsburgh and UPMC have mobilized to plan and implement clinical trials and clinical research studies related to COVID-19. Principal investigators planning or conducting COVID-19 related studies, please submit a brief description of your proposal.

For more detailed information, please visit the Clinical and Translational Science Institute (CTSI) COVID-19 research coordination site.

 

Do I need to update my ClinicalTrials.gov study record?

If the Overall Recruitment Status and/ or Individual Site Status of a University of Pittsburgh investigator-initiated clinical study registered on ClinicalTrials.gov is changing due to the COVID-19 situation, you should update the study record as you normally would, within 30 days of the change. If enrollment and/ or other study activities are “on pause” rather than under an official IRB suspension, consider still selecting Suspended, which will populate the Why Study Stopped data element, where you may then more clearly explain the status. Additional information regarding study record maintenance requirements is available on the Office for ClinicalTrials.gov website. Contact CTgov@pitt.edu with questions.

Instructions for updating a study record:

  1. Login to the ClinicalTrials.gov PRS (Organization: UPittsburgh)
  2. Open and update the record, then click “Entry Complete” on the Record Summary page.
  3. The Responsible Party must follow all prompts in the “Next Step” box on the Record Summary page, until the “Release Confirmation” page appears, to approve and submit the updated record for review and posting to the public study record.

 

How do I notify the IRB about suspensions or changes on my External IRB protocol?

For studies that are approved by an external IRB and are in OSIRIS, complete the following steps to update the IRB on changes from in-person to remote visits, any type of suspension, or general changes being made due to COVID-19:

  1. Open the study
  2. Under My Activities, choose “Update Application
  3. Under Update Options, choose “Submit Reportable Event Information”
  4.  Provide details in the box
  5. EXT1.0 – Upload any documentation related to the request
  6. Press OK at the bottom of the page

updated 11/20/2020