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.

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University of Pittsburgh comprehensive COVID-19 Information page

Pitt Research COVID-19 Operations Page

Frequently Asked Questions

Essential information for the the conduct of research involving human subjects

Per the Senior Vice Chancellor for Research’s message on December 14, 2020, the University expects research operations to continue as safely as possible.  While research ramp down similar to March is not anticipated, targeted controls may be needed to align with evolving governmental guidance and risk postures.

Update: (12/14/2020)

Research activities in Tier 3 (See What are the definitions of study tiers) can be resumed in cases where 1) the Principal Investigator (PI) attests that the enhanced precautions listed below have been incorporated into their research practices and communicated to all research staff, trainees and faculty; and 2) the PI has provided this attestation as an electronic signed letter to the Responsibility Center head; and 3) in-person interactions with human participants do not occur in a community setting, including but are not limited to a home, church, community center (e.g. YMCA, Hill House, Kingsley Center etc.  Please check with your Department Chair or Dean to determine what needs to be submitted to the Responsibility Center.

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). Those activities that can be carried out remotely (planning, writing, literature review, remote data collection, data analysis, remote meetings, etc.) should be done as such 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 check with your Department Chair or Dean to determine what needs to be submitted to the Responsiblity Center.

Questions about the attestation letter should be directed to the PI’s Responsibility Center leader.  All other questions should be directed to askirb@pitt.edu

What are the definitions of study tiers?

The University and the IRB use the guide below to define studies and determine permissible study actions

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)

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.

TIER 3 – LOW DIRECT BENEFIT TO RESEARCH PARTICIPANTS AND OTHER IMPACTS TO RESEARCH

Examples:

  • Research with healthy volunteers
  • 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., requiring elderly or other vulnerable individuals to travel and potentially be exposed to COVID) and benefits of the study to the participants remain minimal.
  • 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
  • Cohort and natural history studies where delays in data collection have limited impact on scientific objectives

Clarifications on Tier 3 (1/15/2021)

  • Tier 3 human subjects studies with <6 feet of separation between investigator and subject are permitted, provided that both the investigator and subject are wearing a mask, even if the contact is for over 15 minutes.   Close contact should be minimized as much as possible.
  • Studies involving the distribution of samples to off-campus locations such as a home, or retrieval of samples, are permitted provided that no entry into the facility or direct interaction with subjects occurs

Adapted from Johns Hopkins University)

 Frequently Asked Questions

  1. What are the definitions of the study tiers?
  2. Can I still conduct research procedures and interact with subjects?
  3. I need to temporarily pause study enrollment, certain study procedures, or the entire study. What do I do?
  4. Do I need to modify my study to make changes for alternatives to in-person study visits?
  5. What platform should I use for video conferencing?
  6. If my study requires in-person contact with my subjects outside of clinical care encounters, can I continue to do so?
  7. I need to monitor subjects for safety.  Can I continue to do so?
  8. How do I request permission from the IRB to continue restricted study activities for the tier of my study?
  9. What information should I include in my RNI submission to request permission for restricted study activities?
  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. My study requires COVID testing for research purposes.  Can I obtain testing through the University or UPMC?
  18. Coordination of COVID-19 Research at Pitt and UPMC
  19. Do I need to update my ClinicalTrials.gov study record?
  20. 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?

Wherever possible, alternative ways to minimize in-person interactions with subjects outside of clinical care encounters should be considered.  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?)

Studies that do not require in-person contact with subjects can continue as approved in the IRB application. Studies that require in-person research procedures need to complete University research restart process prior to initiating or resuming in-person research procedures.  Permissible in-person research activities outside of clinical encounters depend on the study tier status and tier specific restrictions that may be in place (See What Are the Definitions of Study Tiers).  These restrictions will evolve with governmental regulations and University risk postures.  Please see the UPDATE section under Essential information for conduct of research involving human subjects for the latest restrictions.

To complete the IRB portion of the restart process, please submit a Reportable New Information through PittPRO. 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 outside of clinical care encounters, can I continue to do so?

Studies that require in-person research procedures need to complete University research restart process prior to initiating or resuming in-person research procedures.  Permissible in-person research activities outside of clinical encounters depend on the study tier status (See “What Are the Definitions of Study Tiers”) and tier specific restrictions that may be in place. (See UPDATE section under “Essential information for conduct of research involving human subjects.”)

To complete the IRB portion of the restart process, please submit a Reportable New Information.  Please contact askirb@pitt.edu with questions.

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 restricted research activities for the tier of my study?”)

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 restricted study activities for the tier of my study?

If PI feels there is a compelling justification to continue activities currently restricted for the tier of his/her study, the study team should follow the Reportable New Information (RNI) procedures in PittPRO to explain the justification. (See “What Information should I include in my RNI submission to request permission for restricted study activities”)

What information should I include in my RNI submission to request permission for restricted study activities?

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 already gathered on the subject 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. some visits may be done remotely or moved to coincide with clinical visits?
  • Any other pertinent information

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.

For studies involving UPMC sites, please contact Office of Sponsored Programs and Research Support (OSPARS) at OSPARS@upmc.edu for permission to access UPMC facilities.

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

My study requires COVID testing for research purposes.  Can I obtain testing through the University or UPMC?

The general principles that UPMC and the University of Pittsburgh have and will continue to apply when being asked to commit UPMC COVID-19 testing resources toward research efforts are:

  • For COVID-19 related studies (including investigator-initiated), testing may be performed in UPMC laboratories, depending on lab capacity. HOWEVER, testing kits (including reagents) MUST be supplied by the study team from a non-UPMC source. An Institutional Account is required to cover the cost of testing.
  • For clinical trials unrelated to COVID-19 that require testing per the research protocol: testing may be performed at the UPMC South Side testing center, depending on testing center capacity. A physician order to perform testing is required and an Institutional Account is required to cover the cost of testing. Please contact Meredith Axe axem@upmc.edu to arrange testing.
  • For clinical trials unrelated to COVID-19, UPMC and the University of Pittsburgh cannot accommodate requests for testing. We encourage Principal Investigators to work with the study or industry sponsor to identify a central study or a third-party laboratory.
  • Symptomatic testing or (clinically indicated) asymptomatic screening that is conducted as part of routine patient care (regardless of research participation) - may be included in study protocols. However, criteria for testing/screening that utilizes UPMC clinical labs must conform to current UPMC clinical guidelines. Costs for clinical-indicated testing should not be billed to research sponsors.

(v.12/15/2020)